Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial
Phase: NA
Conditions: Alopecia, Androgenetic
Sponsor: Kerastem Technologies, LLC

Kerastem Technologies, LLC 
16.1. Appendices 
 
 
 
16.1.1 Protocol and Amendments 
 
 
 
 
1. Summary of Changes – Clinical Protocol 
 
2. Protocol Version A, 21 August 2015 
 
3. Protocol Version B, 24 November 2015 

 
 
Summary of Changes Document – Clinical Protocol 
In November 2015 the STYLE Clinical Trial Protocol—Rev A, August 21, 2015 was modified to Rev B, 
November 24, 2015. This document highlights the changes that were made in the revision. 
 
1. Blinding (Section 5.3): we adjusted the document to accurately reflect which parties are 
blinded and unblinded in carrying out the protocol. Given that a no-fat control is 
currently a group within the study and it is unfeasible to disguise this treatment relative to 
a fat containing arm, the sponsor, data management personnel (CRO), and study monitors 
will be aware of which treatment the subject received. It is imperative to note that the 
above parties have no potential impact in either the outcome or risk profile as core 
analysis (e.g., global and macrophotography) will remain conducted by blinded 
observers. It should also be noted that the statistician working to analyze the data will 
also remain blinded. 
 
2. Questionnaires (Sections 8, 9.6, & Appendix A): we adjusted the protocol to remove 
inconsistencies with the timing of both investigator and subject questionnaires. Both of 
these questionnaires (attached in the correspondence) are not relevant for any pre- 
procedure assessment as they reflect perceived changes subsequent to the intervention. 
As such, the sections of the document reflecting this timing have been amended 
accordingly. This change has no potential impact in either the outcome assessment or risk 
profile of the protocol. 
 
3. Timing of visit (Sections 9.1 & Appendix A): the original protocol called for 
acquisition of both global and macrophotography at Day -1. In the course of working 
with the approved vendor (Canfield Scientific), it became evident that this time period 
would not allow adequate time to monitor for the quality of the images obtained. As such, 
we are proposing that both global and macro photography is acquired at least one month 
and no later than one week prior to the scheduled intervention to allow for this critical 
quality assessment. With this change, we are eliminating one round of global 
photography. This change has no potential impact in either the outcome assessment or 
risk profile of the protocol. 

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Subcutaneous Transplantation of Autologous Cell Enriched Adipose 
Tissue For Follicular Niche Stimulation in EarlY Stage ALopEcia 
Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial 
 
 
STYLE Clinical Trial 
Version A 
21August2015 
NCT number: 
     NCT02503852 
 
 
 
 
Kerastem 
420 Stevens Avenue, Suite 220 
Solana Beach, CA 92075, USA 
Phone: +1 (858) 348-8050 
www.kerastem.com 
 
 
 
 
 
CONFIDENTIAL 
 
The information contained herein is confidential and proprietary information of Kerastem Technologies, LLC. It is intended solely for 
the use of Kerastem Technologies, LLC and its designated clinical Investigators or Institutional Review Committees, and others directly 
involved in this clinical investigation who are bound to the confidentiality obligations of a Confidentiality Agreement between Kerastem 
Technologies, LLC and the Investigators participating in this study. If you are not the designated recipient, please call us (collect) 
immediately at +1(858) 348-8050 to arrange for the return of this information. Any review, dissemination, distribution, copying, or use of 
this information by anyone other than the designated recipient(s) is strictly prohibited. 

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TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................................. 2 
STYLE TRIAL PROTOCOL APPROVAL FORM ................................................................. 5 
INVESTIGATOR STATEMENT PAGE ................................................................................... 6 
STYLE TRIAL - PROTOCOL SUMMARY ............................................................................. 9 
1 OBJECTIVE ......................................................................................................................... 13 
2 BACKGROUND ................................................................................................................... 13 
2.1 
ALOPECIA ANDROGENETICA .............................................................................................................. 13 
2.1.1 Clinical Experience with ADRCs .................................................................... 17 
3 RATIONALE ........................................................................................................................ 18 
4 STUDY DESIGN ................................................................................................................... 18 
4.1 
STUDY POPULATION .............................................................................................................................. 19 
4.2 
SAMPLE SIZE ............................................................................................................................................ 19 
4.3 
CLINICAL SITES ....................................................................................................................................... 19 
4.4 
STUDY DURATION .................................................................................................................................. 19 
4.5 
STUDY ENDPOINTS ................................................................................................................................. 19 
4.5.1 Primary Endpoint............................................................................................ 19 
4.5.2 Secondary Endpoints ...................................................................................... 19 
4.5.3 Exploratory Endpoints .................................................................................... 19 
4.5.4 Safety Endpoints.............................................................................................. 19 
4.6 
INCLUSION CRITERIA ............................................................................................................................ 19 
4.7 
EXCLUSION CRITERIA ........................................................................................................................... 20 
5 ENROLLMENT .................................................................................................................... 21 
5.1 
SUBJECT ENROLLMENT ........................................................................................................................ 21 
5.2 
RANDOMIZATION AND SUBJECT IDENTIFICATION ....................................................................... 21 
5.3 
BLINDING PROCEDURES AND SAFEGUARDS .................................................................................. 22 
5.4 
SUBJECT WITHDRAWAL AND REPLACEMENT ............................................................................... 22 
6 CELUTION & PUREGRAFT SYSTEMS ......................................................................... 23 
6.1 
CELUTION & PUREGRAFTSYSTEM DESCRIPTIONS ...................................................................... 23 
6.2 
DEVICE CHARACTERIZATION AND INTENDED USE ..................................................................... 23 
6.3 
CONTRAINDICATIONS............................................................................................................................ 23 
6.4 
INTENDED CLINICAL PERFORMANCE ............................................................................................... 23 
6.5 
CELUTION & PUREGRAFT SYSTEM OUTPUT; PHYSICAL, CHEMICAL, AND 
PHARMACEUTICAL PROPERTIES OF ADRCS ................................................................................. 24 
6.6 
PROPOSED MECHANISM OF ACTION OF CELL ENRICHED AUTOLOGOUS FAT GRAFTS ... 25 

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7 STUDY TREATMENTS ...................................................................................................... 25 
7.1 
PRODUCT DESCRIPTION – CELL-ENRICHED AUTOLOGOUS FAT .............................................. 26 
7.1.1 Active Treatment Dose Control ...................................................................... 26 
7.2 
PRODUCT DESCRIPTION - CONTROL DOSE..................................................................................... 26 
7.2.1 Justification of Control Dose .......................................................................... 27 
7.3 
STUDY TREATMENT PRE-INJECTION STERILITY TESTING ........................................................ 27 
7.3.1 ADRC Characterization .................................................................................. 28 
8 STUDY ASSESSMENTS ..................................................................................................... 28 
8.1 
MEDICAL HISTORY, PHYSICAL EXAMINATION & VITAL SIGNS ............................................. 28 
8.2 
HAIR & SCALP EVALUATION ASSESSMENTS ................................................................................ 29 
8.3 
PRIOR AND CONCOMITANT MEDICATIONS .................................................................................... 29 
8.3.1 Prohibited Medications ................................................................................... 29 
8.4 
LABORATORY PROCEDURES ............................................................................................................... 30 
8.5 
ADVERSE EVENTS .................................................................................................................................. 30 
9 STUDY VISIT REQUIREMENTS ..................................................................................... 30 
9.1 
SCREENING (WITHIN 28 DAYS PRIOR TO PROCEDURE) .................................................. 30 
9.2 
PRE-OPERATIVE PROCEDURES (DAY -2; PERFORMED WITHIN 48 HOURS OF THE 
LIPOSUCTION) .............................................................................................................. 30 
9.3 
PROCEDURE DAY (DAY 1) ........................................................................................... 31 
9.3.1 Fat Harvest ..................................................................................................... 31 
9.3.1.1 General requirements ....................................................................... 31 
9.3.2 Between Fat Harvest and ADRC Injection ..................................................... 33 
9.3.3 Fat + ADRC Injection ..................................................................................... 33 
9.4 
IMMEDIATELY POST-INJECTION (DAY 1)...................................................................... 34 
9.5 
POST-INJECTION FOLLOW-UP VISITS (WEEK 1) ............................................................ 34 
9.6 
POST-INJECTION FOLLOW-UP VISITS (WEEKS 6, 12, 24, AND 52).................................. 34 
9.7 
EARLY TERMINATION EVALUATION ................................................................................................ 34 
10 RISK/BENEFIT ANALYSIS ............................................................................................... 36 
10.1 
RISKS .......................................................................................................................................................... 36 
10.1.1 Subcutaneous DeliveryRisk Analysis .............................................................. 36 
10.1.2 Subcutaneous Injection Risk Management ..................................................... 36 
10.1.3 Celution & Puregraft System Risk Analysis .................................................... 37 
10.1.4 Overall Study Risk Management ..................................................................... 37 
10.1.5 Fat Harvest Risk Analysis ............................................................................... 37 
10.2 
POTENTIAL BENEFITS ............................................................................................................................ 39 
11 STATISTICAL METHODS AND DATA ANALYSIS ..................................................... 39 
11.1 
GENERAL CONSIDERATIONS ............................................................................................................... 39 
11.2 
DETERMINATION OF SAMPLE SIZE.................................................................................................... 39 
11.3 
DATA ANALYSES .................................................................................................................................... 39 
11.3.1 Primary Endpoint Analysis ............................................................................. 40 
11.3.2 Secondary and Exploratory Endpoint Analysis .............................................. 40 
11.3.3 Subgroup Analysis .......................................................................................... 40 
11.4 
BACKGROUND, DEMOGRAPHIC ANALYSES ................................................................................... 40 

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11.5 
SUBJECT DISPOSITION & ANALYSIS POPULATIONS .................................................................... 41 
11.6 
HANDLING OF MISSING DATA ........................................................................................................... 41 
11.7 
PROTOCOL DEVIATIONS ....................................................................................................................... 41 
11.8 
DATA MONITORING COMMITTEE ...................................................................................................... 41 
11.8.1 Adverse Events Initiating Safety Review ......................................................... 42 
12 ADVERSE EVENTS / SERIOUS ADVERSE EVENTS ................................................... 42 
12.1 
DEFINITIONS ............................................................................................................................................. 42 
12.2 
PROCEDURES FOR AE REPORTING ................................................................................................... 43 
12.3 
ADVERSE EVENT TERMINOLOGY ...................................................................................................... 43 
12.3.1 Injection Site Related Adverse Events ............................................................. 43 
13 EMERGENCY DEVIATION FROM THE PROTOCOL ............................................... 43 
14 REGULATORY OBLIGATIONS AND STUDY REQUIREMENTS ............................ 44 
14.1 
FDA AND INSTITUTIONAL REVIEW BOARD APPROVAL ............................................................ 44 
14.2 
INFORMED CONSENT ............................................................................................................................. 44 
14.3 
MONITORING PROCEDURES AND DATA MANAGEMENT ........................................................... 44 
14.3.1 Site Qualification ............................................................................................ 44 
14.3.2 Site Training.................................................................................................... 44 
14.3.3 Monitoring ...................................................................................................... 44 
14.3.4 Reporting Requirements .................................................................................. 46 
14.3.5 Data Management ........................................................................................... 46 
14.4 
STUDY CENTER AND INVESTIGATOR REQUIREMENTS ............................................................... 46 
14.4.1 Study Center Requirements ............................................................................. 47 
15 PUBLICATIONS .................................................................................................................. 47 
16 REFERENCES ...................................................................................................................... 48 
APPENDIX A: SCHEDULE OF PROCEDURES ................................................................... 51 
APPENDIX B: ADVERSE EVENT TERMINOLOGY AND GRADING ............................ 52 
APPENDIX C: SUMMARY OF CLINICAL WORKFLOW ................................................ 54 

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STYLE TRIAL PROTOCOL APPROVAL FORM 
 
Study Title: 
Subcutaneous Transplantation of Autologous Cell Enriched 
Adipose Tissue For Follicular Niche Stimulation in EarlY 
Stage ALopEcia Androgenetica (STYLE): a Randomized, 
Blinded, Controlled Trial 
 
Short Title: 
STYLE Trial 
 
Protocol Version A Date: 
21 August 2015 
 
 
This study protocol was subjected to critical review. The information it contains is consistent 
with the sponsor’s current knowledge of the risks and benefits of the investigational product, as 
well as with the moral, ethical and scientific principles governing clinical research as set out in 
the Declaration of Helsinki, as amended in 2013, Good Clinical Practice (GCP) Consolidated 
Guidance in guidelines of the International Conference on Harmonization (ICH) E2 & E6, and 
21CFR 11, 50, 54, 56, 812, 814 and 820. The study will also be carried out in keeping with all 
applicable laws, rules, and regulations. 
 
 
 
 
 
 
 
 
 
 
Eric Daniels 
Date (dd/mmm/yyyy) 
Chief Medical Officer 
Kerastem Technologies, LLC 

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INVESTIGATOR STATEMENT PAGE 
 
Study Sponsor: 
Kerastem Technologies, LLC 
Clinical Trial: 
STYLE Trial 
Protocol Version A: 21August2015 
 
Study Title: Subcutaneous Transplantation of Autologous Cell Enriched  Adipose  
Tissue For Follicular Niche Stimulation in EarlY Stage ALopEcia 
Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial 
 
The information contained in this document and all information provided to you related to this 
protocol are the confidential and proprietary information of Kerastem (Sponsor) and except as 
may be required by federal, state or local laws or regulations, may not be disclosed to others 
without prior written permission of Sponsor. The Principal Investigator at each site may, 
however, disclose such information to supervised individuals working on the protocol, provided 
such individuals agree to be bound to maintain the confidentiality of such protocol information. 
 
I agree to abide by the statement of confidentiality. 
I agree to provide my curriculum vitae. 
I agree to disclose if I was involved in an investigation or other research that was terminated, and 
an explanation of the circumstances that led to termination 
I agree to conduct the study according to this protocol. Any changes in procedure will only be 
made if necessary to protect the safety, rights, or welfare of patients. 
I agree to comply with the current ICH, GCP and CFR Guidelines. 
I agree to conduct the study in person or to supervise the study. 
I agree to ensure that all who assist me in the conduct of the study have access to the study 
protocol and any amendments and are aware of their obligations. 
As an investigator for the STYLE Trial, I intend to commit to conducting the investigation in 
accordance with the investigator agreement, the investigational plan, Part 812 and other 
applicable FDA regulations and conditions of approval imposed by the reviewing IRB and FDA. 
I agree to supervise all testing of the device involving human subjects and will ensure that the 
requirements for obtaining informed consent are met. As an investigator, I am committed to 
provide sufficient and accurate financial disclosure information and update information if any 

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relevant changes occur during the investigation and for one year following the completion of the 
study. 
 
 
 
 
Principal Investigator (Print Name and Title) 
 
 
 
 
Principal Investigator (Signature) 
Date (dd/mmm/yyyy) 

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STUDY CONTACTS 
 
 
STYLE Trial Sponsor 
 
Kerastem Technologies, LLC 
420 Stevens Avenue, Suite 220 
Solana Beach, CA 92075, USA 
Phone: +1(858) 348-8050 
Fax: +1(858) 217-5134 
 
Safety (SAE) Notifications: 
24 Hour Study Telephone: +1(858) 353-0469 
 
Medical Monitor 
 
Eric Daniels, MD 
Chief Medical Officer 
Kerastem Technologies, LLC 
420 Stevens Avenue, Ste. 220 
Solana Beach, CA 92075, USA 
Phone: +1(858) 348-8050 
Fax: +1(858) 217-5134 

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STYLE TRIAL - PROTOCOL SUMMARY 
 
Title 
Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue 
For Follicular Niche Stimulation in EarlY Stage ALopEcia Androgenetica 
(STYLE): a Randomized, Blinded, Controlled Trial 
Test Products 
Celution® System (Celution Device, Celution Consumable Set and Celase) 
used for processing of Autologous Adipose Derived Regenerative Cells 
(ADRCs) combined with adipose tissue processed and purified with 
Puregraft® 50 System 
Objective 
The primary objective of this study is to evaluate the safety and feasibility of 
the Celution and Puregraft Systems in the processing and preparation of an 
autologous fat graft enriched with adipose-derived regenerative cells 
(ADRCs) in the treatment of early alopecia androgenetica. 
Design 
Prospective, Randomized, Controlled Safety and Feasibility Trial 
Sample Size 
70 patients (40 ADRC + adipose, 20 fat only control, 10 no-fat control ) 
Study 
Location 
Up to (8) sites in the United States 
Indication 
Androgenic Alopecia (Androgenetica Alopecia, AGA) 
Visit 
Schedule 
Screening (Day -28 to Day -1), Procedure Day (Day 1), and follow up visits 
at weeks 1, 6, 12, 24 and 52 weeks 
Treatment 
Arms 
Subjects will be randomized 2:2:2:1 to receive either 0.1ml/cm2 scalp of 
autologous fat enriched with 0.5 x 106 ADRC/cm2 scalp (n=20), 0.1 ml/cm2 
scalp of autologous fat enriched with 1.0 x 106 ADRCs/cm2 scalp (n = 20), 
0.1ml/cm2 scalp of autologous fat enriched with a matching saline control 
(fat alone control; n=20), or 0.1 ml/cm2 scalp of saline enriched with a 
matching dose of saline (no-fat control; n=10). In each subject, 40 square 
centimeters of scalp will be treated. 
The study treatment will be delivered in the subcutaneous adipose layer of the 
scalp in via two separate injections – one of either 0.1ml/cm2 scalp of adipose 
or saline followed by a second injection of ADRCs or saline per square 
centimeter of scalp. 
Primary 
Endpoint 
Safety & tolerability through 24 weeks 
Secondary 
Endpoints 
• Trichograms (Hair Growth) at 24 weeks 
• Trichograms (Hair Density)at 24 weeks 
• Global photographs to assess scalp coverage at 24 weeks 

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• Hair Investigator Satisfaction Survey at 24 weeks 
Exploratory 
Endpoints 
• Trichograms (Hair Growth)at times other than 24 weeks 
• Trichograms (Hair Density) at times other than 24 weeks. 
• Trichograms (Hair Thickness) at times other than 24 weeks 
• Global photographs to assess scalp coverage other than 24 weeks 
• Hair Investigator Satisfaction Survey at times other than 24 weeks. 
Safety 
Endpoints 
Adverse events, Serious Adverse Events, UADEs 
Inclusion & 
Exclusion 
Criteria 
Inclusion Criteria 
1. Males with a diagnosis of Alopecia Androgenetica 
2. Females with a diagnosis of Alopecia Androgenetica 
3. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, 
IV-A, based on Norwood-Hamilton Scale (Figure 1) 
4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based 
on the Savin Scale (Figure 2) 
5. Provide written informed consent and comply with the study 
requirements 
6. For women of childbearing potential: Negative pregnancy test at 
screening visit plus subject agrees to maintain two forms of 
contraception for the duration of the study. 
7. Subject is willing to maintain a consistent hair length and natural hair 
color, without the use of any coloring agents, during the study period. 
8. Ability to complete study procedures, patient surveys, and pictures. 
9. Subject is ≥ 18 years of age. 
10. Body Mass Index < 40kg/m2 
Exclusion Criteria 
1. Subjects who have used minoxidil, or any oral or topical medication 
including over the counter and herbal medications for the treatment of 
hair loss within 6 months of study screening, or finasteride or 
dutasteride within 12 months of study screening 
2. Treatment with an investigational product or procedure within 30 days 
or plans to participate in another clinical study 
3. Subject who has previously failed or has been deemed non-responsive 
to a previous experimental hair loss treatment. 
4. Subject must have no previous hair transplant, cell treatment, micro 
needling, or any other treatment in the last 6 months in the scalp. 
5. Subject is currently suffering from an active autoimmune disease such 
as serum lupus erythematosus, or alopecia areata. Subject is currently 
suffering from dermatologic condition in the treatment area or has a 
significant scar in the hair treatment area that, in the opinion of the 
investigator, will make hair growth difficult (such as systemic burns, 

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etc.). 
6. History of autoimmune disease or organ transplantation or a patient on 
immunosuppressive medication(s). 
7. Diagnosis of cancer, receiving active treatment 
8. Active systemic infection 
9. Requires chronic antibiotics, systemic corticosteroids 
10. Use of systemic agents that increase bleeding or clotting, or disorders 
associated with these effects, including patients receiving GIIB/IIIa 
inhibitors within 2 weeks prior to the study procedure through to 1 
week after the study procedure. 
11. Clinically significant medical or psychiatric illness currently or within 
30 days of study screening as determined by the investigator 
12. Prior surgery in the treatment area 
13. Any disease or condition (medical or surgical) that, in the opinion of 
the investigator, might compromise dermatologic, hematologic, 
cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central 
nervous system function; or any condition that would place the subject 
at increased risk 
14. Pregnant or lactating women or women trying to become pregnant 
15. Known allergic reaction to components of study treatment and/or 
study injection procedure 
16. Subject has any disorder that may prevent compliance to study 
procedures and visits 
17. Subject who is part of the study staff, a family member or friend 
18. Diabetes or thyroid disorder 
19. Subject who has a sensitive, irritated, or abraded scalp area. 
20. Women who have an alternate diagnosis that is associated with hair 
loss. 
21. Body Mass Index < 18kg/m2 
22. Clinically significant abnormal findings on laboratory screening 
panels, including hemoglobin ≤ 10 g/dL. 
23. Hepatic dysfunction, as defined as aspartate aminotransferase (AST), 
alanine aminotransferase (ALT), or bilirubin levels > 1.5 times the 
upper limit of normal range (x ULN) prior to randomization. 
24. Chronic renal insufficiency as defined as a serum creatinine > 1.5 mg/dL in 
men or > 1.2 mg/dL in women. 
25. An elevated PT/PTT, INR, or platelet count < 100 x 109/L 

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ABBREVIATIONS 
 
ADL 
Activities of Daily Living 
AGA 
Androgenic Alopecia 
ADRC 
Adipose-Derived Regenerative Cells 
AE 
Adverse Event 
ANC 
Absolute neutrophil count 
ANCOVA 
Analysis of covariance 
AFT 
Autologous Fat Transfer 
CFU-F 
Colony Forming Units Fibroblast 
CFR 
Code of Federal Regulations 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
ET 
Early Termination 
FPHL 
Female Pattern Hair Loss 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization 
ID 
Identification 
IFU 
Instructions for Use 
IV 
Intravenous 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
IVRS 
Interactive Voice Response System 
IWRS 
Interactive Web Response System 
MPHL 
Male Pattern Hair Loss 
PI 
Principal Investigator 
pRBC 
Pack Red Blood Cells 
PTE 
Per Treatment Evaluation 
RBC 
Red Blood Cell 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
WBC 
White Blood Cell 

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1 
OBJECTIVE 
 
The primary objective of this study is to evaluate the safety and efficacy of the Cytori Celution 
and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with 
adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica. 
 
 
2 
BACKGROUND 
 
2.1 
Alopecia Androgenetica 
 
Alopecia Androgenetica (AGA) is the most common form of both male pattern hair loss (MPHL) 
and female pattern hair loss (FPHL)1,2 with the condition affecting approximately 50% of the 
male population and less than 45% of women going through life with a full head of hair. The 
degree of hair loss in the male patient is generally classified using the Norwood Hamilton 
Classification (Figure 1) and FPHL is evaluated based on the Savin scale (Figure 2)1,3. The 
incidence and prevalence of the condition are generally well documented in both genders. Stough 
and co-workers reported that in White males, 30% have AGA by age 30 and 50% by age 50 with 
lower incidences seen in African American, Chinese, and Japanese populations3. In a population 
based report looking at MPHL, the authors reported that in the 30-35 years age group, grade I 
hair loss was 51%, while grade II was 43% and grade VI was only approximately 19%--clearly 
highlighting early hair loss in the younger population4. Of the 1,005 men in the study aging from 
30-50 years, 44% were found to have grades I-III hair loss. 
 
In women, diffuse thinning and loss of hair density with maintenance of the frontal hairline 
describe the typical pattern of loss5. In one report, the prevalence of early, clinically detectable 
FPHL was 12% of females between 20-29 years of age and 25% by 49 years of age2. In the table 
presented below (Table 1), Gan and Sinclair documented the distribution of hair loss in 752 
women using a modified 5-point grading scale6. Below the age of 40 years, 99% of women 
reporting loss documented early stage loss. 
 
 
In sum, a significant percentage of both male and female population suffer from AG at a 
relatively early age. 

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Figure 1—MPHL Norwood Hamilton Classification 
 
 
 
Class I represents an adolescent or juvenile hairline and it not actually balding. The adolescent 
hairline generally rests on the upper brow crease. 
 
Class II indicates a progression to the adult or mature hairline which sits a finger breath (1.5cm) 
above the upper brow crease, with some temporal recession. This also does not represent balding. 
 
Class III is the earliest stage of male hair loss. It is characterized by a deepening temporal recession. 
 
Class III Vertex represents early hair loss in the crown (vertex). 
 
Class IV Is characterized by further frontal hair loss and enlargement of vertex, but there is still a 
solid band of hair across top separating front and vertex. 
 
Class V the bald areas in the front and crown continue to enlarge and the bridge of hair separating 
the two areas begins to break down. 
 
Class VI occurs when the connecting bridge of hair disappears leaving a single large bald area on the 
front and top of the scalp. The hair on the sides of the scalp remains relatively high. 

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Figure 2—FPHL Ludwig Scale 
 
The current treatment regimen for alopecia androgenetica is a spectrum ranging from non- 
invasive medicinal approaches to robot-assisted surgical transplantation of thousands of 
follicular units. On the non-invasive side, the two medicines currently approved for treatment of 
genetic pattern alopecia by the FDA are finasteride (for men only) and minoxidil8,9. Both of these 
medicines carry untoward side-effects. For finasteride, sexual dysfunction, particularly for the 
younger patient who is most likely to present with early hair loss, was seen in between 2.1% and 
3.8% of men10. Initial treatment of early alopecia is typically non-invasive and the two 
medications approved by the FDA today are minoxidil and finasteride. For minoxidil, it is 
reported that approximately one-third of patients with AA respond with new hair growth11. In 
contrast, invasive transplant options are generally not offered to patients with early AA and if so, 
require significant financial resources. As a result, there remains a significantly large gap 
between these medicinal and transplant options. Hence a distinct medical need remains specific 
to addressing early alopecia. 
During hair follicle growth (anagen), the hair follicle delves deep into the rich dermal 
macroenvironment as it grows to maturity where it is surrounded by large lipid-filled adipocytes. 
These intradermal adipocytes regenerate with faster kinetics than other adipose tissue depots and 
such growth parallels with the hair cycle, suggesting an interplay exists between hair follicle 
cells and adipocyctes12. Thus, it has been established that adipose is an integral part of the 
normal hair cycle and it is hypothesized that telogen may be due to an absence of adipose tissue 
as it is reported that hair loss and decreased adipocytes occur together12,13. Therefore, the 
transplantation of adipose tissue, or autologous fat transfer (AFT), into the subcutaneous layer of 
fat in the scalp for purposes of stimulating hair growth is consistent with the reported literature 
that indicates hair loss and adipose loss occur in tandem. 

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Autologous Fat Transfer 
 
In an AFT procedure, a patient’s subcutaneous adipose tissue is aspirated from one location (most 
commonly the abdomen or thighs) and transferred into another depot of subcutaneous fat located 
throughout the body (e.g., mid-face). This procedure is reported to be practiced by physicians for over 
100 years and autologous fat should be free from problems often associated with artificial materials or 
from allergic reactions14. However, AFT is not without its own limitations most significant of 
which is the fact that an unpredictable amount of the transferred fat can die as a result of damage 
during tissue harvest, processing, and implantation leading to loss of volume and a degree of 
unpredictability in outcome. 
 
The process of fat transfer necessarily involves disconnecting the fat from its blood supply, 
implanting it into the defect, and then waiting for natural healing processes to incorporate the 
transferred tissue with native fat. Survival of the transferred tissue is dependent upon harvest and 
processing approaches that maximize tissue viability15. It is also dependent upon simple  
diffusion to supply nutrients and oxygen and to remove wastes until such time as healing 
processes restore its blood supply. Diffusion through a solid tissue such as fat is only effective 
across a distance of a few millimeters. Consequently, any transferred tissue that is more than a 
few millimeters away from the blood supply of recipient site tissue is at risk of dying. Loss of 
graft tissue from this problem is a frequent problem. Clinicians frequently overcorrect adding 
extra tissue in an effort to compensate for inevitable tissue loss that has been estimated at 
between 20-80% of the implanted tissue16-18. As a result of this unpredictability defect repair 
frequently requires multiple repeated or staged procedures performed at intervals of three or 
more months. For example, one large study reports up to five treatments needed (mean = three 
treatments) in order to achieve success in restoring volume19. This leads to delays in achievement 
of effective treatment of the defect, expense, and the higher morbidity of repeated tissue 
collection and implantation. 
 
A number of investigators have evaluated ways by which the healing process can be modulated 
in an effort to understand and augment graft retention and, thereby, limit the number of 
procedures needed to achieve successful treatment. For example, animal studies have shown that 
use of agents that stimulate the healing process (for example, gene therapy with factors that 
stimulate new blood vessel growth20) can increase the survival of transferred tissue and that, 
conversely, agents that inhibit healing reduce survival21. Recent preclinical and clinical data have 
shown in addition to being a source of tissue for soft tissue filling, human adipose tissue contains 
cells that have the ability to promote healing22,23. Zhu et al have used an animal model to show 
that coating one volume of adipose tissue with cells isolated from another volume of adipose 
tissue results in an approximate doubling of graft retention at six and nine months24. This finding 
has been confirmed by an independent study25. The concept of this approach is that signals 
generated at the interface between implanted fat and adjacent breast fat will induce improved 
healing. Increasing the number of cells capable of generating these signals at this interface will 
lead to successful tissue retention. 
 
In addition, Puregraft processed adipose has an excellent safety profile in aesthetic body 
contouring26. 
Currently, there are few, if any, minimally invasive, autologous cell therapeutic modalities being 
developed that address early alopecia. However, analyses from other therapeutic applications of 

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ADRCs and AFT suggest that a cell-enriched based approach for the treatment of early alopecia 
may be of significant benefit. 
 
2.1.1 Clinical Experience with ADRCs 
 
To date, thousands of patients have been treated with autologous ADRCs isolated using the 
Celution System (Cytori Therapeutics, San Diego, USA). Celution processed ADRCs have an 
excellent safety profile in a variety of conditions including acute myocardial injury, patients with 
chronic heart muscle damage, breast insufficiency following lumpectomy (a cell-enriched AFT 
procedure), chronic cutaneous wounds, and urinary incontinence, and most recently in a small 
study of scleroderma patients27-32. 
In addition, Puregraft processed adipose has an excellent safety profile in aesthetic body 
contouring26. 
Cytori’s initial clinical experience in treating pathological conditions was in the myocardium, 
The PRECISE Clinical Trial evaluated the safety and feasibility of intramyocardial 
administration of ADRCs in patients with chronic myocardial ischemia not amenable to 
revascularization.27 Clinical results at 18 months have demonstrated safety and signs of 
feasibility. PRECISE was a prospective, double-blind, randomized, parallel group, placebo- 
controlled, sequential dose escalation study which enrolled 27 subjects. Following baseline 
electromechanical mapping, subjects received ≤ 15 intramyocardial injections of ADRCs (n=21; 
median dose of ADRCs 42 x 106 per subject) or placebo (n=6: indistinguishable solution) in the 
area(s) of the heart with inducible ischemia. ADRCs were processed using the Cytori Celution 
System. ADRC-treated subjects demonstrated improvement in maximum oxygen consumption 
(VO2max) relative to a placebo control. Adverse events and serious adverse events were equally 
distributed across all treatments groups with angina reported as the most frequent SAE. 
 
The APOLLO Clinical Trial was a safety and feasibility study of ADRCs processed by the 
Celution System and delivered via the intracoronary route in the treatment of patients with ST- 
segment elevation myocardial infarction (STEMI).28 This was a prospective, double-blind, 3:1 
randomized (ADRC: Placebo), parallel group, placebo-controlled trial. A total of 14 patients 
were enrolled and treated according to protocol, 10 patients received ADRCs and four received 
placebo. 
 
The APOLLO study demonstrated that liposuction adipose harvest for the purpose of processing 
and returning autologous ADRCs via the intracoronary infusion of 20 x 106 ADRCs can be 
performed with an acceptable safety profile. 
 
Case series have described benefits in the treatment of radiation injury, fistulas and stress urinary 
incontinence. Yoshimoto et al. described efficacy of ADRC treatment in three patients presenting 
with chronic radiation injuries with ulcers and severe fibrosis.29 They reported increases in local 
blood circulation at the site by ultrasound and dramatic wound healing. Gotoh et al recently 
described improvements in urinary incontinence following ADRC injections in a case series of 
11 men who underwent radical prostatectomy.30 Of note, enhanced ultrasonography showed a 
progressive increase in blood flow to the injected area in all patients. Borowski reported 
complete wound closure of three patients treated for long-standing cryptoglandular fistula-in-ano 

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using ADRCs.31An open label trial in 12 patients with systemic scleroderma from France 
examining the effects of subcutaneous administration of ADRCs to all fingers has recently been 
published.32 Data at six months indicated significant improvements in Cochin score, Raynaud’s 
severity score, and in the Scleroderma Health Assessment Questionnaire (SHAQ). The procedure 
was tolerated well without complications. 
 
 
3 
RATIONALE 
 
For both sexes, the negative physical and psychological effects of AGA have been documented. 
In Stough’s report, the authors indicate that while the condition may not appear to cause direct 
physical harm in men, hair loss can protect against sunburn, cold temperatures, mechanical 
injury, and ultraviolet light3. Beyond the physical, hair loss is known to psychologically affect 
the balding individual’s perceptions of themselves. This is particularly true when looking at 
FPHL, where Cash and co-workers reported that while AA was a stressful experience for both 
sexes, it was substantially more distressing for women7. In sum, the impact of the condition 
should not be relegated as simply aesthetic in nature, and therefore satisfactory treatment 
regimens are necessary. 
 
 
4 
STUDY DESIGN 
 
The STYLE Trial is a prospective, randomized, multi-center device trial intended to evaluate the 
safety and efficacy of the Celution and Puregraft Systems in the processing and preparation of an 
autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment 
of early alopecia androgenetica. Patients may be included if they are undergoing an elective 
cosmetic liposuction. Following informed consent and screening evaluations, eligible subjects 
will undergo pre-operative testing. Subjects will then undergo a fat harvest using local anesthesia 
with or without conscious sedating. Subjects will be randomly assigned to receive a fat graft cell 
enriched with ADRCs (available in two different doses), a fat graft without cell enrichment using 
a visually-matched blood saline solution (fat alone control), or a saline injection (no-fat control) 
in a 2:2:2:1 ratio. 
 
While undergoing liposuction, lipoaspirate will be processed in the Puregraft System to remove 
the lipoaspirate of impurities and in the Celution System to isolate and concentrate ADRCs. 
After the liposuction is completed), patients will have, under a ring block local anesthesia (see 
further description below), a subcutaneous scalp injection of either Puregraft purified autologous 
fat or saline (no-fat control) followed by a separate second injection, of either ADRCs (available 
in two different doses), a visually-matched blood saline solution (fat alone control), or saline (no- 
fat control) in a 2:2:2:1 ratio. 
 
 
All subjects will undergo clinical evaluations and laboratory testing prior to and after the 
procedure as outlined in Section 9.0, Study Assessments, and in the Schedule of Procedures 
(Appendix A). 

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4.1 
Study Population 
 
Subjects with documented early stage alopecia androgenetica will be evaluated for this study. 
 
4.2 
Sample Size 
 
The STYLE Clinical Trial will have a sample size of 70 patients. 
 
4.3 
Clinical Sites 
 
Up to eight (8) clinical centers in the United States will be selected to participate in the STYLE 
Clinical Trial. 
 
4.4 
Study Duration 
 
Enrollment of subjects will occur over approximately 6 months. For each patient, the study 
duration will include a screening period of up to 28 days and a 52 week follow-up period. 
Therefore, the study duration is estimated to be 18 months. 
 
4.5 
Study Endpoints 
 
4.5.1 Primary Endpoint 
 
Safety & tolerability throughout 24 weeks 
 
4.5.2 Secondary Endpoints 
 
1. Trichograms (Hair Growth)t 24 weeks (change from baseline) 
2. Trichograms (Hair Density) at 24 weeks (change from baseline) 
3. Global photographs at 24 weeks (change from baseline) 
4. Hair Investigator Satisfaction Survey at 24 weeks (change from baseline) 
 
4.5.3 Exploratory Endpoints 
 
1. Trichograms  (Hair Growth)at times other than 24 weeks 
2. Trichograms (Hair Density) at times other than 24 weeks 
3. Trichograms (Anagen/Telogen Rate, Hair Thickness) at times other than 24 weeks 
4. Global photographs other than 24 weeks 
5. Hair Investigator Satisfaction Survey at times other than 24 weeks 
 
4.5.4 Safety Endpoints 
 
Adverse events, Serious Adverse Events, and UADEs 
 
4.6 
Inclusion Criteria 
 
Subjects will be enrolled into this study only if they meet ALL of the following criteria: 
1. Males with a diagnosis of Alopecia Androgenetica 
2. Females with a diagnosis of Alopecia Androgenetica 

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3. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on 
Norwood-Hamilton Scale (Figure 1) 
4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale 
(Figure 2) 
5. Provide written informed consent and comply with the study requirements 
6. For women of childbearing potential: Negative pregnancy test at screening visit plus 
willingness to maintain two forms of contraception for the duration of the study. 
7. Subject is willing to maintain a consistent hair length and natural hair color, including the 
absence of coloring agents, during the study period. 
8. Ability to complete study procedures, patient surveys, and pictures. 
9. Subject is ≥ 18 years of age. 
10. Body Mass Index < 40kg/m2 
 
4.7 
Exclusion Criteria 
 
Subjects will not be enrolled into this study if they meet ANY of the following criteria: 
1. Subjects who have used minoxidil, or any oral or topical medication including over the 
counter and herbal medications for the treatment of hair loss within 6 months of study 
screening, or finasteride or dutasteride within 12 months of study screening 
2. Treatment with an investigational product or procedure within 30 days or plans to 
participate in another clinical study 
3. Subject who has previously failed or has been deemed non-responsive to a previous 
experimental hair loss treatment. 
4. Subject must have no previous hair transplant, cell treatment, micro needling, or any 
other treatment in the last 6 months in the scalp. 
5. Subject is currently suffering from an active autoimmune disease such as serum lupus 
erythematosus, or alopecia areata. Subject is currently suffering from dermatologic 
condition in the treatment area or has a significant scar in the hair treatment area that, in 
the opinion of the investigator, will make hair growth difficult (such as systemic burns, 
etc.). 
6. History of autoimmune disease or organ transplantation or a patient on 
immunosuppressive medication(s). 
7. Diagnosis of cancer, receiving active treatment 
8. Active systemic infection 
9. Requires chronic antibiotics, systemic corticosteroids 
10. Use of systemic agents that increase bleeding or clotting, or disorders associated with 
these effects, including patients receiving GIIB/IIIa inhibitors within 2 weeks prior to the 
study procedure through to 1 week after the study procedure. 
11. Clinically significant medical or psychiatric illness currently or within 30 days of study 
screening as determined by the investigator 
12. Prior surgery in the treatment area 
13. Any disease or condition (medical or surgical) that, in the opinion of the investigator, 
might compromise dermatologic, hematologic, cardiovascular, pulmonary, renal, 
gastrointestinal, hepatic, or central nervous system function; or any condition that would 
place the subject at increased risk 
14. Pregnant or lactating women or women trying to become pregnant 

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15. Known allergic reaction to components of study treatment and/or study injection 
procedure 
16. Subject has any disorder that may prevent compliance to study procedures and visits 
17. Subject who is part of the study staff, a family member or friend 
18. Diabetes or thyroid disorder 
19. Subject who has a sensitive, irritated, or abraded scalp area. 
20. Women who have an alternate diagnosis that is associated with hair loss. 
21. Body Mass Index < 18 kg/m2 
22. Clinically significant abnormal findings on laboratory screening panels, including 
hemoglobin ≤ 10 g/dL. 
23. Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine 
aminotransferase (ALT), or bilirubin levels > 1.5 times the upper limit of normal range (x 
ULN) prior to randomization. 
24. Chronic renal insufficiency as defined as a serum creatinine > 1.5 mg/dL in men or > 1.2 mg/dL 
in women. 
25. An elevated PT/PTT, INR, or platelet count < 100 x 109/L 
 
 
5 
ENROLLMENT 
 
5.1 
Subject Enrollment 
 
Patients are considered enrolled in this study when all of the following have occurred: 
 
1. Written informed consent is obtained 
2. All inclusion criteria and no exclusion criteria have been met 
3. All screening evaluations are complete 
 
5.2 
Randomization and Subject Identification 
 
All subjects will undergo liposuction and will be randomized into one of four parallel arms in a 
2:2:2:1 ratio to receive either low dose ADRCs cell enriched fat (n=20), high dose ADRC cell 
enriched fat (n=20), non-cell enriched autologous fat alone control (n=20), or no-fat control 
saline injections (n=10). Randomization will be via an interactive voice/web response system 
(IVRS/IWRS), or an alternatively acceptable system, and occur on the procedure day, prior to 
the start of liposuction. 
 
Patients randomized into the study will be assigned the treatment corresponding to the next 
available number in the computer-generated randomization schedule. The dose of the test 
material (ADRCs or placebo) is discussed in Section 6.3. 
 
Randomization and dose preparation will be performed by an unblinded pharmacist, or other 
designated qualified personnel, as outlined in the Study Reference Manual. The unblinded 
pharmacist or designee will not be involved in study patient care, management or follow up 
procedures and assessments. 

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5.3 
Blinding Procedures and Safeguards 
 
The following will be the “blinded parties”, meaning that the listed will have no knowledge of 
the patient’s treatment assignment: 
• Patients 
• Core Laboratories 
• Data Management personnel 
• Sponsor 
• Study Monitors 
The “unblinded parties”, meaning those that will or may have knowledge of a patient’s 
treatment assignment, will be the following:- 
• Investigators 
• Unblinded Pharmacist or designee involved in the dose preparation procedures and 
randomization of the patient 
• Data Monitoring Committee Members 
• Unblinded Statistician 
The study blind should not be broken except in a medical emergency (where knowledge of the 
test material received would affect the treatment of the emergency) or regulatory requirement 
(e.g., for SAEs or death). 
If unblinding becomes necessary, the Investigator should notify the Sponsor or the Medical 
Monitor as soon as possible. If the blind is broken, the date, time and reason must be recorded in 
the Subject’s electronic case report form (eCRF), together with a note of a protocol violation if 
applicable, and any applicable reports [e.g. Adverse Event (AE)]. 
 
5.4 
Subject Withdrawal and Replacement 
 
Subjects may withdraw from the study at any time and for any reason without penalty or 
prejudice to his or her future medical care. If a subject is prematurely withdrawn from the study 
for any reason, the reason(s) for withdrawal must be recorded in the Subject’s source 
documentation and on the eCRF. 
 
The Investigator must make every effort to perform the Early Termination evaluations. This visit 
shall take place as soon as possible after it is determined that the Subject will be withdrawn from 
the study and will comprise the observations and procedures scheduled at the next visit. 

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6 
CELUTION & PUREGRAFT SYSTEMS 
 
6.1 
Celution& Puregraft System Descriptions 
 
The Celution System consists of a stand-alone re-useable hardware unit called the Celution 
Device, the Celution Consumable Set, and Celase®. The Celution System prepares an ADRC 
output from adipose tissue collected by standard liposuction techniques. 
 
Following the collection of tissue, the adipose tissue is introduced into the device’s collection 
canister in order to wash the adipose tissue and remove deleterious substances (such as cellular 
debris)(Detailed instructions for use are found in the Celution User Manual, the Celution 
Consumable IFU and the Celase IFU). 
 
The Puregraft 50 System is a sterile, single use, closed system intended for the preparation and 
delivery of autologous fat grafts back to the same patient for cosmetic and reconstructive surgery 
applications. The dual filtration bag system utilizes its swabable luer activated valves to connect 
to an off-the-shelf sterile luer lock syringe and its attached slider is used to facilitate the 
movement of liquids through the filter mesh and out of the Puregraft bag through the drain stub 
as waste. Detailed instructions for use are found in the Puregraft IFU). 
 
6.2 
Device Characterization and Intended Use 
 
In combination with the Puregraft 50 System, the Celution System (Celution Device, Celution 
Consumables Set, and Celase reagent) is intended to digest adipose tissue in order to further 
extract, wash and concentrate adipose derived regenerative cells (ADRCs) intended for 
combination with autologous fat and reimplantation subcutaneously into the scalp for 
investigational use in the STYLE clinical trial. 
 
The Puregraft 50 System is intended to process and purify adipose tissue to be combined with 
concentrated stromal stem cells and other associated progenitor cells intended for autologous 
implantation subcutaneously into the scalp for investigational use in the STYLE clinical trial. 
 
6.3 
Contraindications 
 
1. Non-autologous use is contraindicated 
2. Use of any tissues other than adipose is contraindicated 
 
6.4 
Intended Clinical Performance 
 
The Celution System is designed to process lipoaspirated tissue and separate ADRCs from 
adipose tissue by enzymatic disassociation of the tissue and using buoyancy differences to 
separate the ADRCs from lipid containing adipocytes at the point of care. When ADRCs are 
prepared using the Celution System, the resultant cell suspension contains all of the components 
naturally occurring in the native tissue. Preparation of autologous ADRCs for subcutaneous 
delivery using the Celution System involves no cell culture and can be prepared and re-implanted 
into the same patient within three hours from completion of lipoaspiration. 

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The total viable cell count and percentage viability for each sample will be used as the 
acceptance criteria. This will be assessed for each patient to decide whether the cell output is 
acceptable, and to prepare the prescribed dose. The viable cell count will be performed by the 
commercially available NucleoCounter® Automated Cell Counting System. Using a small sample 
of the Celution System output, the NucleoCounter Automated Cell Counting System provides a 
count of both live and dead nucleated cells in the total sample. All personnel involved will be 
trained according to standardized procedures and work instructions. Cytori has performed 
characterizations of the live cell output obtained by the Celution System and this is consistently 
70% viability or greater. This sample count is used to calculate the total number of live nucleated 
cells from the total preparation, to arrive at percentage of viable cells that are available for 
introduction into the patient. 
 
The Puregraft System is designed to prepare purified lipoaspirate. This purification involves the 
near complete removal of free lipid, RBCs, and WBCs. All personnel involved will be trained 
according to standardized procedures and work instructions. 
 
6.5 
Celution& Puregraft System Output; Physical, Chemical, and Pharmaceutical 
Properties of ADRCs 
 
The output of the Celution System is an ADRC output obtained from autologous lipoaspirate 
tissue. The suspension of viable ADRCs has been characterized with an average viability of 
>70% and the average yield is 3.24 x 105 ± 1.48 of mononuclear cells per gram of adipose tissue 
entered into the Celution System. An index of regenerative cell potential, the CFU-F assay, 
shows that 1.51% of those ADRCs form colonies (mean range of 0.13 to 4.08% colony forming 
units). 
 
The product is a suspension of cells in a diluent. The cellular components of the suspension are 
made up of nucleated and non-nucleated cells. The non-nucleated cells are red blood cells (RBC) 
that comprise > 95% of the total cell suspension. The nucleated cells make up approximately 0.1 
– 5% of the total cell suspension. Nucleated cells are present in the following approximate 
minimum percentages: CD 31+, CD 34+ (> 2%); CD 34+, CD 31-, CD  45-  (>  10%); CD  45+, 
CD 31-, CD 34- (> 15%). The combination of these three phenotypes will account for greater 
than 90% of nucleated cells in the product. Table 1 summarizes the ADRC cellular suspension 
processed by the Celution System. 
 
Table 1. ADRC cellular suspension components and concentrations 
 
Cell Type 
Phenotype 
Relative Identity of Nucleated 
Cell Population 
% of total 
cell suspension 
Non-nucleated Cells 
Red Blood Cells 
> 95% 
Nucleated Cells 
CD 31+, CD 34+ 
> 2% 
0.1-5% 
CD 34+, CD 31-, CD 45- 
> 10% 
CD 45+, CD 31-, CD 34- 
> 15% 

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Puregraft 50 System 
 
The Puregraft 50 System is used in conjunction with a lipoplasty device (user supplied) and does 
not contact the patient as it does not connect to vacuum. The Puregraft 50 System is only used on 
the back table in the operating room to rinse and filter an adipose tissue graft and prepare the 
graft for eventual injection back into the same patient during the same surgical procedure. The 
Puregraft 50 System is a bag with two tubing stubs/ports (tissue and drain) and is designed to 
harvest, rinse and filter the adipose tissue, and subsequently drain excess rinse solution away 
from the adipose tissue. The rinsed and filtered adipose tissue is then removed from the Puregraft 
bag using syringes (user supplied) and ultimately transplanted back into the same patient. The 
Puregraft 50 System includes a slider tool that is attached to the exterior of the Puregraft bag. 
The slider is used to compress the Puregraft bag as a means to facilitate the movement of liquids 
through the filter mesh and out of the Puregraft bag through the drain stub/port as waste. 
 
6.6 
Proposed Mechanism of Action of Cell Enriched Autologous Fat Grafts 
 
The proposed mechanism of action of autologous fat grafts enriched with ADRCs prepared with 
both the Puregraft and Celution Systems is postulated to be follicular niche stimulation. This 
stimulation is believed to occur through modulation of inflammation, promotion of angiogenesis 
and prevention of cell apoptosis. Studies suggest that cell enriched autologous graft therapy 
changes the inflammatory response and augments the regenerative response. Studies have 
detected significant amounts of paracrine growth factors, which have been shown to facilitate 
vascularization, and as well as those associated with anti-inflammatory effects, thereby, 
ameliorating injury by proinflammatory cytokines. Viability characterization of ADRCs as 
described above in addition to pre-clinical animal data from Cytori and other published reports 
support this hypothesis. 
 
 
7 
STUDY TREATMENTS 
 
Subjects will be randomized 2:2:2:1 to active treatment (autologous fat enriched with ADRCs), 
autologous fat alone control, or no-fat control as follows: 
Active (0.5 x 106 ADRCs/cm2 scalp): 
20 Subjects 
Active (1.0 x 106 ADRCs/cm2 scalp): 
20 Subjects 
Autologous fat alone control: 
20 Subjects 
No-fat control (saline) 
10 Subjects 
 
The study treatment will be administered as subcutaneous injections of either fat or saline into 
the subcutaneous fat layer of the scalp (40cm2 of scalp) of each subject. Each square centimeter 
of scalp will be injected with 0.1 mL of purified autologous fat or saline followed by separate 
injection of either low or high dose ADRC injection per cm2 scalp, or saline (fat alone control 
and the no-fat control). To account for the variability seen in advanced grades of hair loss 
(Norwood Grade II and IV), treatment areas will be focused in the mid-scalp and crown (vertex). 

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The leading edge of hair loss will not be treated, including the peri-orbital region as fat grafting 
in the peri-orbital region has been associated with higher-risk complications. 
 
 
 
 
7.1 
Product Description – Cell-enriched autologous fat 
 
The active treatment used for the STYLE Trial will be cell-enriched autologous fat obtained 
from the study subject’s own adipose tissue which is prepared using the Puregraft and Celution 
Systems. 
 
The excipients in the cell suspension are composed of residual Celution System reagents and 
diluent. Specifically, the residual reagents are collagenase (<0.005 Wünch Units/mL) and 
thermolysin neutral protease (< 30 caseinase Units/mL). The diluentis Lactated Ringers solution 
(USP). 
 
Adipose tissue processing is detailed in both the Puregraft and Celution System Users Manuals. 
Preparation of the active study treatment is provided in the Study Reference Manual. 
 
7.1.1 Active Treatment Dose Control 
 
Autologous adipose purified with the Puregraft System can be readily removed directly with a 
sterile 1mL syringe to obtain a volume of 0.1mL for injection. 
 
ADRC Cell count and viability will be controlled using the NucleoCounterAutomated Cell 
Counting System (Enfield, CT) at each site using the following acceptance criteria: 
 
• Nominal cell count: 40 x 106 ADRCs 
• A minimum cell count within 50% of the nominal cell count is required (i.e., a dose as 
low as 20 x 106 ADRCs is acceptable if 40 x 106 ADRCs is not be available) 
• Cell viability: ≥ 70% 
If cell viability is <70%, as determined by the NucleoCounter Automated Cell Counting 
System, the subject will not be treated. 
• Negative result in Gram stain testing (see Section 7.3) 
7.2 
Product Description – Control Doses 
 
The fat alone control dose will be purified autologous tissue prepared by the Puregraft System 
that is not enriched with ADRCs but with saline. The amount of fat injected will be 0.1 mL/cm2 
of scalp. The fat alone control dose will also include injection of a saline solution which is mixed 
with 0.1mL to 0.2 mL of the study Subject’s own freshly drawn blood to achieve a dilution that 
is visually indistinguishable from ADRCs. The saline injection of the fat-alone control must test 
negative in a Gram stain test of sterility prior to being administered (see Section 7.3). Preparation 
of the fat-alone control dose is provided in the Study Reference Manual. 

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The no-fat control dose will be 0.1ml/cm2 of scalp of saline injected (delivered by a blunt tip 
cannula) followed by a second matching dose of saline solution (via a 25G needle) to 0.1ml/cm2 
of scalp. 
 
7.2.1 Justification of Control Dose 
 
To reduce the risk of bias (selection bias, performance bias, detection bias and attrition bias), all 
patients will undergo pre-specified screening procedures, fat harvest, and injection of active 
treatment or placebo. The justification and rationale of the placebo dose arm include: 
 
1. In the presence of a concurrent placebo control group, demographics and patient selection 
is more likely to be balanced allowing for more reliable interpretation of study results. 
 
2. Minimize the potential of the Hawthorne effect creating a positive impression of efficacy 
that may overstate the actual treatment effect. 
 
7.3 Study Treatment Pre-Injection Sterility Testing 
 
Following cell processing in the Celution System, sterility testing will be performed as described 
below and more fully in the Study Reference Manual. 
 
A negative Gram stain test result is required prior to injection of ADRCs and/or fat alone control. 
A negative Gram stain test result is not required prior to injection of saline in the no-fat control 
arm. If the sample is determined to be positive for bacteria then the cellular administration 
procedure must be stopped and the subject should not receive any study treatment. 
 
Further testing (BacT Alert Culture and Sensitivity) will be performed in order to test for the 
presence of any low level microbial contamination that might not be apparent in the gram stain 
test. Should a culture be deemed positive for microbial activity, the investigator will be 
immediately notified. The study patient will be evaluated and a course of treatment and/or 
antibiotics may be administered, as determined by the study investigator. The source of the 
contamination will be evaluated as appropriate. The FDA and IRB will be notified within 15 
days of the investigator being made aware of any positive test results. 
 
The following flow chart describes the activities associated with positive or negative outcomes in 
these two tests of sample sterility. 
 
Figure 3: Sterility Testing of ADRC and Fat Alone Control Samples 

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7.3.1 ADRC Characterization 
 
In order to characterize the phenotype of ADRCs obtained from patients with alopecia 
androgenetica, adipose tissue will be obtained during the elective cosmetic liposuction.; up to 
360 mL of this tissue (maximum that can be processed by Celution Device) will be used to 
prepare the active study treatment (ADRCs) using the Celution System. Once it is determined 
that the cell dose has been achieved according to criteria described in Section 7.1.1, any 
remaining adipose tissue may be shipped to an outsourced facility of the Sponsor (if within two 
hours of the outsourced laboratory) according to procedures outlined in the Study Reference 
Manual. 
 
In the Sponsor’s outsourced contract laboratory, ADRCs will be prepared from collected adipose 
tissue using the same Celution System as used in the clinic and the cell output characterized 
using colony forming unit – fibroblast (CFU-F), a measure of the number of adipose stem cells, 
and multiparametric flow cytometry analyses used to define the major non-progenitor cell 
populations in ADRCs. In the flow analyses ADRCs will be stained using antibodies directed to 
CD31, CD34, CD136 and CD45 proteins. Based on the expression of these four markers, the 
major populations will be defined as follow: 
 
Leukocytes 
CD45+ 
Endothelial Cells 
CD34+/CD31+/CD45- 
Stromal Cells 
CD34+/CD31-/CD45- 
Mural cells 
CD34-/CD31-/CD45-/CD146+ 
 
If sufficient cells are available, additional characterization of subpopulations will be performed 
using antibodies such as CD3, CD14, CD19, and CD16/56. 
 
8 
STUDY ASSESSMENTS 
 
All assessments will be conducted at specific time points as outlined in this section and in the 
Schedule of Assessments in Appendix A. 
 
8.1 
Medical History, Physical Examination & Vital Signs 
Negative 
No Further 
Action 
Positive 
NO PATIENT 
TREATMENT 
Bac-T Test 
Positive 
IRB and FDA 
within 15 Days 
Gram Stain 
Negative 
No Further 
Action 
Negative 
Bac-T Test 
TREAT 
PATIENT 
Investigator 
Notification 
Positive 
Notify IRB and 
FDA within 15 
Days 

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A complete medical history will be collected at the Screening Visit and will include demographic 
information as well as current and past medical conditions. Updated medical history information 
is to be collected at the Day -1 including any event that has occurred since the Screening Visit 
that could be considered an adverse event. Any adverse event that occurs after the ICF is signed 
and prior to administration of the study drug is to be recorded as an update to the Medical 
History. 
 
Physical examinations should be based on the following body systems: general appearance, head 
(ear, eyes, nose and throat), cardiovascular, respiratory, abdomen, musculoskeletal, neurological, 
lymph nodes, and skin. Vital signs to be obtained include the following: 
 
• Blood pressure (systolic and diastolic; mm/Hg) 
• Heart rate (beats per minute) 
• Body temperature (°F) 
• Respiration rate (per minute) 
8.2 
Hair & Scalp Evaluation Assessments 
 
The physical status and satisfaction of the subjects’ scalp and hair will be evaluated using several 
assessment tools. The assessment tools are listed below and detailed information and instructions 
provided in the Study Reference Manual. 
 
• Hair Investigator Satisfaction Survey 
• Trichogram analysis 
• Global photography 
8.3 
Prior and Concomitant Medications 
 
Any medication a subject receives is considered a concomitant medication, and must be recorded 
in the subject’s source documentation throughout the study. All concomitant medications will be 
recorded in the eCRF from 90 days prior to screening through 24 weeks post procedure. 
 
Information to be recorded on the eCRF will include: generic medication name, route of 
administration, dosage, indication, start date, and stop date. Medications used as part of the 
liposuction and injection procedure do not need to be recorded in the eCRF but should be 
recorded as part of the operative records. As needed analgesic medications will be recorded by 
the subject’s in a daily medication diary for the 14 days immediately preceding the next study 
visit. 
 
8.3.1 Prohibited Medications 
 
Subjects should not receive the following medications: 
 
• Minoxidil, or any oral or topical medication including over the counter and herbal 
medications for the treatment of hair loss within 6 months of study screening, or 
finasteride or dutasteride within 12 months of study screening 

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• Treatment with an investigational product or procedure within 30 days of study screening 
 
• Systemic steroids exceeding prednisone 10 mg daily (or equivalent) 
• Biologic agentsor immunosuppressive medications within 90 days of the Screening Visit 
If treatment with any prohibited medication becomes necessary during study participation, the 
subject will be discontinued from the trial. 
 
8.4 
Laboratory Procedures 
 
All laboratory assessments will be performed locally at each center’s laboratory by means of 
their established methods (using site specific laboratory normal values). Blood and urine samples 
should be taken using standard techniques and samples should be stored and shipped according 
to the laboratory guidelines. 
 
8.5 
Adverse Events 
 
Adverse events will be recorded Starting on Day 1, immediately after study procedure has started 
and through to the End-of-Study (Week 24), Any adverse events experienced between signing 
the ICF and prior to administration of the study drug will be recorded in the medical history. See 
Section 12 for more information pertaining to recording of adverse events. 
 
9 
STUDY VISIT REQUIREMENTS 
 
The Schedule of Procedures is outlined in Appendix A. 
 
9.1 
Screening (within 28 days prior to procedure) 
 
Subjects will undergo the following screening procedures: 
 
• Written informed consent 
• Inclusion and exclusion criteria evaluation 
• Medical history 
• Prior and concomitant medications 
• Physical examination 
• Laboratory Tests 
o CBC with Platelets 
o Electrolytes, alkaline phosphatase, bilirubin, AST, ALT, BUN, Creatinine 
o PTT, PT/INR 
• Vital signs 
• Pregnancy test (urine) for female patients of child-bearing potential 
• Physician Hair Assessment questionnaire 
• Evaluation of suitability for fat tissue harvest and liposuction procedure(see Section 
9.3.3.1) 
 
9.2 
Pre-Operative Procedures (Day -1; performed within 24 hours of the liposuction) 

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• Confirm inclusion/exclusion criteria 
• Physical Examination 
• Vital Signs 
• Assessment for Adverse Events 
• Concomitant Medications 
o Collect daily medication diary completed for 14 days immediately preceding visit 
• Laboratory Tests 
o CBC with Platelets 
o Electrolytes, alkaline phosphatase, bilirubin, AST, ALT, BUN, Creatinine 
o PTT, PT/INR 
• Pregnancy test (urine) for female patients of child-bearing potential 
• Investigator and Subject Hair Assessment questionnaire 
The following tests are to be performed: 
• Global Photography 
• Trichogram with tattooing 
9.3 
Procedure Day (Day 1) 
 
9.3.1 
Fat Harvest 
 
9.3.1.1 General requirements 
 
• Fat harvest will be performed on the day of treatment as part of an independent, elective 
cosmetic liposuction. 
• Fat harvest planning should include assessment of patients general health condition to 
undergo the procedure 
• Standard tissue calipers or expert plastic surgical examination should be used to assess 
possible body sites for subcutaneous fat tissue. Patients should have greater than or equal 
to 2 cm of subcutaneous fat tissue available in each contemplated area to be suitable for 
liposuction 
• Prepare up to 3 sites, including the preferred abdomen and flanks along with the inner 
and the outer thighs and  the  posterior  and  anterior  thighs.  To  estimate  harvestable  
fat from the harvest site    the     following     guideline     may     be     used: Estimated  
fat from the harvest site = volume of the site/8 = length of the marked skin x width of the 
marked skin x height (i.e. caliper skin-fold thickness) / 8. All patients who have 
inadequate fat deposits (i.e. < 200 ml of lipoaspirate from 3 bilateral sites) are to be 
excluded from the study. Any patient with an area of active skin infection in the site of 
lipoharvest will be excluded from the study. 
• As noted elsewhere in this protocol, fat harvest should NOT be performed on patients 
who have received any anticoagulant within 1 hour of liposuction, substantial 
anticoagulation (e.g.: GIIb/IIIa inhibitor class drugs) within the two weeks prior to fat 
harvest, or who have an abnormal aPTT. 
• Fat tissue should be obtained under sterile technique using local anesthesia with or 
without conscious sedation. General anesthesia should not be used. 

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9.3.1.2 Fat Harvest Procedure 
 
Fat harvest from small volume liposuction is a standard procedure practiced by trained 
physicians in a variety of settings and using a variety of techniques. However, a specific set of 
guidelines have been established for the collection of fat that can then be used for the optimized 
preparation of ADRCs. These guidelines, which are recommendations and not requirements, 
include the following; 
 
· 
Syringe-based fat harvest is preferred. 
· 
Use up to 32 cm long, 3-5 mm inner diameter Toomey cannula with a standard tip 
· 
60 mL Toomey syringes are used for tissue acquisition 
· 
Use  14 gauge, up to 30 cm, blunt LAMIS infiltrator for tumescent fluid 
administration 
· 
Symmetric fat removal is required keeping the overall area of aspiration as small as 
possible 
· 
The abdominal region is the preferred site for fat harvest 
 
1. 
Local anesthesia with or without conscious sedation; general anesthesia is not permitted 
for fat harvest 
2. 
Using sterile technique, prepare up to 3 sites, including the preferred abdomen and 
flanks along with the inner and the outer thighs and the posterior and anterior thighs. 
3. 
Make an approximately 0.5 cm stab skin incision 
4. 
Infiltrate tumescent solution using a blunt LAMIS infiltrator and a volume ratio of 1:1 
of tumescent solution to fat to be harvested 
 
Tumescent fluid formula: 
· 
500 mL of Lactated Ringers solution 
· 
20 mL of 1% Lidocaine 
· 
1 mg of epinephrine 
 
5. 
To sufficiently induce vasoconstriction/hemostasis during the liposuction procedure a 
minimum of 500 mL of tumescent fluid must be used. 
6. 
After approximately 10 minutes, the adipose tissue is harvested through the same incision, 
using the aspiration cannula attached to the Toomey syringe 
7. 
After the syringe is filled (complete filling is not required), cap syringe and replace with 
empty one 
8. 
Continue fat harvest until desired volume is safely achieved, with the target volume of 
adipose tissue harvested limited to approximately 450 mL 
9. 
Fat harvest will be limited to areas where tumescent fluid has been infiltrated 
10. Vital signs are monitored continuously during liposuction procedure 
11. Close surgical incision with appropriate suture 
12. Apply pressure bandage immediately upon conclusion of tissue harvest 
 
NOTE: Approximately 0.5 mL blood must be drawn and delivered to the unblinded staff prior to 
dose preparation. The blood will be used to prepare the fat alone control (see Section 7.2). 

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9.3.1.3 – Fat Harvest Stopping Rules 
The physician performing the fat harvest procedure should continuously monitor the patient for 
signs of significant bleeding from the puncture site(s) and overall hemodynamic stability. The 
liposuction procedure should be terminated if any of the following occur: 
 
1. 
Drop in systolic blood pressure < 90mm/Hg that is unresponsive to volume or 
pressor support 
2. 
Profuse or uncontrollable bleeding from the puncture site(s) 
3. 
Rapid expansion of subcutaneous space at the liposuction site(s) related to bleeding 
into the subcutaneous space 
4. 
Hemoperitoneum or pnuemopertinoeum 
5. 
Hemothorax or pneumothorax 
6. 
Evidence of perforation of a vascular structure that requires ligature or surgical 
control 
7. 
Evidence of perforation into abdominal cavity, peritoneum or gastrointestinal organ 
 
Should any of the above occur, the fat harvest procedure should be terminated and the patient 
treated according to standard of care. DO NOT PROCEED WITH INJECTION. Complete the 
study specific SAE form and notify the sponsor within 24 hours. 
 
 
9.3.2 Between Fat Harvest and ADRC Injection 
 
Vital signs will be monitored continuously between the fat harvest and cell injection procedures. 
 
9.3.3 Fat + ADRC Injection 
 
The following procedure is recommended for subcutaneous injection into the scalp for the 
treatment of baldness due to alopecia androgenetica: 
 
Autologous Fat & Saline Injection 
This fat or saline injection procedure will occur after the completion of the liposuction. Aseptic 
technique should be maintained throughout the procedure. A treatment grid will be prepared in 
the area to be treated. The grid is a piece of silicone rubber that is placed on the scalp of the 
subject in the desired position and a surgical skin marker is used to mark each of the holes which 
are spaced every centimeter. The recipient site is anesthetized using a local ring block with 1% 
lidocaine with 1:100,000 epinephrine. Aliquots of 0.2mL should be injected in a circular ring 
fashion and the dosage should be adjusted according to the response of the patient and the site of 
administration. The lowest concentration and the smallest dose producing the required effect 
should be given. The maximum dose delivered should not exceed 7mg/kg. Sedation may be 
employed to minimize patient discomfort at the discretion of the investigator. Tissue from the 
Puregraft 50 is prepared in separate, sterile 1mL luer lock syringes, and an 11-blade scalpel can 
be used to make a stab incision (incision is made at a strategic insertion point to facilitate access 
to the area to be treated) to allow insertion of a 0.9mm-1.2mm diameter blunt-tip cannula. This 

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cannula is then inserted into the subcutaneous adipose tissue plane and the tip is fanned into each 
1 square centimeter grid to deliver 0.1mL of tissue or saline (no-fat control). 
 
ADRC & Saline Injection 
After preparation of the ADRCs, either the low or high dose of ADRC or saline will be injected 
using a 25G needle directly through the skin into the layer of subcutaneous adipose using the 
identical grid markings made in the paragraph described above. Additional local anesthesia ± 
sedation may be applied as deemed necessary by the investigator. 
 
 
A summary of the clinical workflow is described in Appendix C. 
 
9.4 
Immediately Post-Injection (Day 1) 
 
• Vital Signs will be monitored for one hour following the injection procedure 
• HGB/HCT blood level will be evaluated 
• Assessment of injection and fat harvest site 
• Overall physical assessment 
9.5 
Post-injection Follow-up visits (Week 1) 
 
• Physical examination 
• Vital Signs 
• Assessment for Adverse Events 
9.6 
Post-injection Follow-up visits (Weeks 6, 12, 24, and 52) 
 
• Physical examination 
• Vital Signs 
• Assessment for Adverse Events 
 
The following tests are to be performed: 
 
• 
• Global photography 
• Physician hair assessment questionnaire 
A summary table of all follow up evaluations is outlined in Appendix B: Schedule of Procedures 
 
9.7 
Early Termination Evaluation 
 
Subjects that discontinue early from the study, unless consent is withdrawn, shall have an Early 
Termination (ET) evaluation. This visit shall take place as soon as possible after it is determined 
that the Subject will be withdrawn from the study. 
 
If the ET Visit occurs prior to the Week 24 visit the observations and procedures for the ET Visit 
are the same as those required at the Week 24. 

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The reason for early withdrawal must always be clearly documented in the Subject’s source 
documentation. Contact with the Subject must be attempted to determine overall health status, 
and contact details must be documented in the Subject’s source documentation. If lost to follow- 
up, details of three contact attempts must be documented in the Subject source documentation 
and every effort must be made to determine if the Subject has expired. 

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10 RISK/BENEFIT ANALYSIS 
 
10.1 
Risks 
 
The use of adult regenerative cells from adipose tissue and other sources has shown 
improvement in muscular (cardiac) function after injection into ischemic areas of the heart. The 
PRECISE Clinical Trial has shown an acceptable safety profile and signs of benefits following 
intramyocardial administration of ADRCs processed by the Celution System. Every potential 
complication of ADRC injections are unknown at this time; however injection of cells from 
adipose tissue have been delivered with guided intramyocardial injections with no clinical 
significant sequelae. A clinical trial of 12 patients with hand dysfunction and pain from 
scleroderma followed for 6 months showed minor adverse events related to subcutaneous 
injection, typical liposuction adverse events, and no adverse events directly related to ADRCs. 
 
10.1.1 Subcutaneous Delivery Risk Analysis 
 
Risks involved with subcutaneous delivered adipose plus cells include: 
 
• Hematoma or bleeding 
• Infection 
• Inflammation, rash, or papules at the injection site 
• Nerve injury, pain, paresthesias or sensory disturbances 
• Diminished function 
• Shock loss 
Direct intramuscular injections of Celase has been carried out in rodent models showing a 
margin of safety of greater than 10 for injection of Celase into the heart muscle. In addition, 
intra-ventricular applications of ADRCs into rat hearts during efficacy studies did not result in 
adverse events over 12 weeks of follow-up. Further, as noted above, 21 patients treated by direct 
injection into the muscle of the heart in the course of the PRECISE study exhibited no adverse 
events associated with ADRC injection In addition, a study of 12 patients with subcutaneous 
injection in the fingers of patients with scleroderma showed minor adverse events and no serious 
adverse events. 
 
10.1.2 Subcutaneous Injection Risk Management 
 
Investigators and all study personnel will be trained in the details of all aspects of the study 
procedures. To minimize risks and increase the chances of a favorable clinical outcome the 
following measures are required: 
 
• Enrollment of Subjects who qualify per the inclusion/exclusion criteria in the protocol 
• Strict adherence to the study protocol 
• Use sterile technique throughout the procedure 
• Use standard of care for the monitoring of and treatment of possible adverse events 
following injection procedure 

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10.1.3 Celution & Puregraft System Risk Analysis 
 
The investigators and all study personnel will be trained in the details of all aspects of the study 
procedures relevant to their particular area of responsibility. 
 
• Train investigators and all study personnel in the details of the operation of the Celution 
& Puregraft System. 
• Inspect the package integrity and sterility indicators on all disposables used with the 
devices and maintain sterility of the fluid paths. 
• Follow Instructions for Use for the Celution & Puregraft Systems, including all warnings, 
precautions and contraindications. 
 
10.1.4 Overall Study Risk Management 
 
The following measures implemented by Kerastem will minimize the risks associated with 
patients’ participation in clinical studies: 
 
• Kerastem selects personnel (Kerastem employees, agents, licensees, and clinical 
investigators at the sites) with extensive experience in conducting clinical studies and in 
performing procedures involved in the protocol including fat harvest and procedures 
involving the hands 
• All examinations, treatment procedures, and interpretation of clinical data generated 
during the study is directed, overseen and analyzed by an appropriately licensed and 
credentialed physician who has been trained to the clinical study protocol. 
• Kerastem developed the clinical protocol and training programs to ensure that the study 
personnel at Kerastem and at the clinical sites have a strong knowledge and 
understanding of the clinical protocol, including patient selection criteria and procedure 
requirements. 
• Kerastem will ensure that the investigators are trained to the procedure requirements in 
the protocol, and the Instructions for Use for the Celution and Puregraft Systems. 
• Kerastem carefully developed patient eligibility criteria for the investigation including 
clearly defined inclusion and exclusion criteria to ensure that only properly selected 
patients will be enrolled in the clinical study. 
• The protocol is designed so that patient treatment and follow-up procedures will be 
consistent with those of the clinically established standard of care. 
 
10.1.5 Fat Harvest Risk Analysis 
 
The risks of standard small volume liposuction in healthy patients are known and are minimal 
and recovery is usually fast. Following standard liposuction the following effects can be 
expected: 
 
Common 
· 
Edema and redness of the liposuction areas for a few days 
· 
Moderate contusion of the liposuction areas for a few months 
· 
Uncommon 
· 
Persistent edema 

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Rare 
· 
Persistent bleeding 
· 
Hematoma 
· 
Visible puncture sites 
 
· 
Infection 
· 
Deep Vein thrombosis (DVT) 
· 
Persistent bleeding requiring transfusion 
 
 
10.1.6 Fat Harvest Risk Management 
 
The Investigators and all study personnel will be trained in the details of all aspects of the study 
procedures. Standardization of fat harvest techniques is critical to a good clinical outcome. To 
minimize risks and increase the chances of a favorable clinical outcome the following measures 
are required for the liposuction procedure: 
 
• Performed by an appropriately licensed and credentialed physician 
• Monitoring of vital signs throughout the procedure. 
• Sterile technique is followed throughout. 
• The adipose tissue is handled gently at all times. 
• HGB, HCT prior to and 1-2 hours post-procedure 
• To sufficiently induce local vasoconstriction/hemostasis during the fat harvest procedure, 
a minimum of 500 mL of tumescent fluid is used containing: 
o 500 mL of Lactated Ringers solution 
o 20 mL of 1% Lidocaine 
o 1 mg of epinephrine 
• A blunt 14 to 16 gauge LAMIS infiltrator (or equivalent) will be used for infiltration with 
tumescent solution 
• After ~10 minutes, the adipose tissue may be harvested through the same incision, using 
the aspiration cannula attached to a syringe 
• A blunt cannula with a minimum inner diameter of 3 mm is preferred for lipoaspiration. 
• Lipoaspiration is recommended to be done manually using a syringe (60 mL Toomey 
syringe is preferred). 
• Enrollment of only patients who qualify per the inclusion / exclusion criteria defined in 
the protocol) including screening blood work 
• Strict adherence to the study protocol 
• Standard of care for the monitoring of and treatment who experience any adverse event 
for liposuction 
• Target volume of adipose tissue is limited to approximately 450 mL 
• Close surgical incision with appropriate suture 
• Apply pressure bandage immediately upon conclusion of tissue harvest 
 
Fat harvest should NOT be performed on patients who have received any anticoagulant within 1 
hour of the procedure, substantial anticoagulation (e.g.: GIIb/IIIa inhibitor class drugs) within 
two weeks prior to fat harvest, or who have an abnormal PTT. 

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10.2 Potential Benefits 
 
This clinical investigation is designed as a safety and efficacy study. Therefore, it is not known at 
this time whether any direct subject benefit can be expected. Given the proposed mechanism of 
action of autologous adipose enriched with or without ADRCs, we expect there may also be a 
beneficial effect in the treatment of baldness due to alopecia androgenetica. Previous ex-US 
patient experience with similar inclusion/exclusion criteria documented encouraging positive 
efficacy results and a favorable benefit to risk profile (abstract accepted at 2014 International 
Federation of Adipose Therapeutics and Science (IFATS) Annual Meeting-November 2014). 
 
 
11 STATISTICAL METHODS AND DATA ANALYSIS 
 
This is a multi-centre, single-blinded, randomized, parallel group, controlled study to evaluate 
the preliminary safety of cell-enriched autologous fat compared to placebo in patients with 
baldness due to alopecia androgenetica. The primary endpoint will be the safety and tolerability 
of the procedure. 
 
An analysis of covariance (ANCOVA), with the baseline measure used as a covariate, will be 
used for the analyses of the secondary efficacy endpoints. Comparisons of each active arm with 
placebo will be made using Dunnett comparisons. The ITT population will be used for the 
primary analysis; the analysis will also be performed in the PTE population and will be 
considered as supportive of the ITT analysis. 
 
11.1 
General Considerations 
 
All statistical tests will be two sided, and statistical significance will be assessed with respect to a 
nominal p-value of 0.05. Before the first data review meeting of the DMC is held, a separate 
statistical analysis plan (SAP) will be completed, providing detailed methods for the analyses 
outlined in the following subsections. The SAP will detail all planned analyses and will serve as 
a statistical programming requirements document. 
 
11.2 
Determination of Sample Size 
 
The sample size for the trial has been set at 70, based on clinical considerations and is not based 
on formal power calculations. 
 
The objective of the STYLE Trial is to assess the safety and preliminary efficacy of cell-enriched 
autologous adipose delivered via a subcutaneous route in the treatment of baldness due to 
alopecia androgenetica. As the primary endpoint is safety and tolerability, the investigators 
believe that a sample of 20 subjects per arm and a 10 patient no-fat saline control is adequate. 
 
11.3 
Data Analyses 
 
Safety and efficacy endpoints will be summarized by treatment group using descriptive statistics 
(n, mean, SD, median, minimum, and maximum), for quantitative variables and frequencies and 
percentages for categorical variables. Laboratory data will also be summarized using shift tables 

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between before procedure and at Day 1, post procedure, with values categorized as less than 
lower limit of normal range, within normal range, and above upper limit of normal range. 
 
For quantitative efficacy variables, summaries will be provided at each post-baseline visit time 
point. Additionally variables will be analyzed using ANCOVA models with adjustment for the 
baseline value of the variable. 
 
Related adverse events will be analyzed separately for those related to ADRCs and the delivery 
of ADRCs (i.e., injection site such as shock loss). A separate safety analysis will be performed 
for Adverse Events of Interest (Appendix B, Adverse Event Terminology and Grading). 
 
11.3.1 Primary Endpoint Analysis 
 
The primary endpoint for the study is safety and tolerability through 24 weeks 
The hypotheses are: 
Adverse event rates through 24 weeks for active treatment will be less than or equal to 
adverse events rates published for autologous fat grafting. 
 
Vital sign abnormalities through 24 weeks for active treatment will be less than or equal 
to those published for autologous fat grafting. 
 
Physical exam abnormalities through 24 weeks for active treatment will be less than or 
equal to those published for autologous fat grafting. 
 
The corresponding null hypotheses are that the adverse event rates will be greater for active 
treatment arms than for placebo. 
 
Statistical testing will not be performed for these hypotheses, but the safety endpoints will be 
evaluated clinically. 
 
11.3.2 Secondary and Exploratory Endpoint Analysis 
 
The secondary endpoints are change from baseline in the (a) Average Trichogram growth rates at 
24 weeks, (b) Average Trichogram density rate at 24 weeks, and (c) global photographs at 24 
weeks and (d) hair Investigator Satisfaction Survey at 24 weeks. Multiplicity adjustment will not 
be made when testing the three secondary endpoints. 
 
Exploratory endpoints are listed in Section 4.5. As these are exploratory, p-values for each 
analysis will not be corrected for multiple comparisons. These analyses will provide evidence 
concerning the safety of effectiveness of the product. 
 
11.3.3 Subgroup Analysis 
 
Statistical analysis of efficacy and safety endpoints will be performed in the total group. 
 
11.4 
Background, Demographic Analyses 

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Demographic data, medical history, concomitant disease will be summarized by means of 
descriptive statistics (n, mean, SD, median, minimum and maximum) or frequency tables, 
stratified by treatment. 
 
11.5 
Subject Disposition & Analysis Populations 
 
Reasons for withdrawal post-randomization will be summarized. 
 
The treatment analyses will be performed on intent-to-treat basis as well as on a per-treatment- 
evaluable basis, as defined below: 
 
Safety: All treated subjects; subjects will be analyzed as treated. 
 
Intent-to-Treat (ITT): All randomized subjects; randomization will occur on procedure day prior 
to liposuction. Subjects will be included in the analysis as randomized 
 
Per-Treatment-Evaluable (PTE): All randomized subjects who have received treatment and 
follow-up information is available. Protocol violators, where the violation is judged to affect the 
interpretation of the treatment effect will be excluded. All exclusions will be made prior to the 
breaking of the treatment blind. 
 
11.6 
Handling of Missing Data 
Safety data will not be imputed. 
PTE data will not be imputed. 
Missing efficacy data will be imputed for the ITT analysis population. For missing data caused 
by worsening of scleroderma (either hand or systemic manifestation), the missing value will be 
replaced by the least favorable observation from the prior Visits excluding baseline. For other 
missing data, last observation carried forward will be the primary method of imputation. As a 
sensitivity analysis, multiple impute ion methods (SAS PROC MI and PROC MIANALIZE) will 
be used. 
 
For the analysis of quality of life, missing responses to individual questionnaire items will be 
imputed using the methods prescribed by the questionnaire vendor. 
 
11.7 
Protocol Deviations 
 
Deviations from the protocol including violations of inclusion/exclusion criteria will be assessed 
as “minor” or “major” in cooperation with the Sponsor. Deviations will be defined prior to un- 
blinding. Major deviations may result in removal from the PTE analysis population. 
 
11.8 
Data Monitoring Committee 
 
The independent Data Monitoring Committee (DMC) will be comprised of medical specialists 
and a biostatistician who are not participants in the study. The DMC will be provided with all 
safety data as well as efficacy data for the primary and secondary endpoints in order to fully 

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evaluate the benefit to risk profile of the study procedures. The DMC will be responsible for the 
review of the data and generate recommendations on the conduct of the trial. 
 
The DMC will be asked to review data and generate recommendations after 10, 20 and 40 
subjects have at least 1 week of follow-up. 
 
 
11.8.1 Adverse Events Initiating Safety Review 
 
The Sponsor is to be informed of the following adverse events within 24 hours of the site 
becoming aware of the event: 
• Gangrene of the scalp in two (2) or more within fourteen (14) days of the procedure 
• Infection of the scalp requiring hospitalization and intravenous antibiotics in two (2) or 
more patients within seven (7) days of the procedure 
Within 24 hours of notification, the Sponsor will report the event to the DMC Chair for 
evaluation. The DMC Chair will review the event and decide whether to convene a meeting of 
the DMC. 
In all cases, the DMC Chair or the DMC will be responsible for recommendations to continue 
the trial, continue the trial with modifications, pause the trial such that further evaluation can be 
conducted, or terminate the trial. 
 
 
12 ADVERSE EVENTS / SERIOUS ADVERSE EVENTS 
 
12.1 
Definitions 
 
An adverse event (AE) is defined as any undesirable experience occurring to a Subject during 
the course of the study, whether or not it is related to the test material or the study procedure. 
Expected adverse events are those that are listed as known risks of the liposuction or injection 
procedure including those described in this protocol, informed consent, and/or the Investigator’s 
Brochure. 
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that: 
• Results in death, 
• Is life-threatening, 
• Requires or prolongs Subject hospitalization 
• Results in persistent or significant disability or incapacity 
• Is an important medical event(s) that may not be immediately life-threatening or 
result in death or hospitalization but that may jeopardize the Subject or require 
intervention to prevent one of the above outcomes 
• Is a congenital anomaly/birth defect. 
Medical and scientific judgment should be exercised in deciding whether a case is serious and 
whether expedited reporting is appropriate. 

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An Unanticipated Adverse Device Effect is defined as any serious adverse effect on the health 
and safety or any life-threatening problem or death caused by, or associated with the Celution or 
Puregraft system devices, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application or any other 
unanticipated serious problem with the Celution or Puregraft system devices that relates to the 
rights, safety or welfare of subjects. 
 
12.2 
Procedures for AE Reporting 
 
All AEs will be recorded by the investigator or designee on the appropriate electronic case report 
form (eCRF). Events that occur prior to the liposuction-related activities, including those that are 
considered serious, are to be recorded in the medical history. Events, including SAEs, which 
occur after liposuction-related activities are initiated on procedure day, are to be recorded on the 
AE eCRF. The investigator will evaluate the relationship of the adverse event to both the test 
material and study procedure as unrelated, unlikely, possibly, probably, or definitely related and 
will record the findings, including all pertinent details of the event on the eCRF. 
 
In addition, the Investigator or designee will report any serious adverse events, including UADE, 
occurring during this study to the Sponsor and Medical Monitor as soon as possible, but no later 
than 24 hours after the Investigator first identifies the adverse event. 
 
The Investigator will take appropriate measures to ensure the subject’s well-being and document 
these measures on the appropriate eCRF. 
 
All serious adverse events experienced will be monitored until the event has resolved, any 
abnormal laboratory values have returned to baseline or stabilized at a level acceptable to the 
Investigator and Medical Monitor, or until there is a satisfactory explanation for the changes 
observed. 
 
12.3 
Adverse Event Terminology 
 
Specific adverse events of interest are described in Appendix B, Adverse Event Terminology and 
Grading (from National Cancer Institute Common Terminology Criteria for Adverse Events). 
When an AE of interest occurs, the Investigator will apply the terminology in Appendix B, 
Adverse Event Terminology and Grading and indicate the grading. 
 
12.3.1 Injection Site Related Adverse Events 
 
Injection site related adverse events are outlined in Appendix B, Adverse Event Terminology and 
Grading (i.e. from National Cancer Institute Common Terminology Criteria for Adverse Events). 
 
 
13 EMERGENCY DEVIATION FROM THE PROTOCOL 
 
In case of an emergency threatening the continued well being of the Subject, the Investigator 
may deviate from the protocol. The circumstances necessitating the deviation and the 

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intervention(s) required will be recorded on the eCRF. The Sponsor must be notified as soon as 
possible, but no later than 5working days after event(s) occurred. 
 
 
 
 
14 REGULATORY OBLIGATIONS AND STUDY REQUIREMENTS 
 
14.1 
FDA and Institutional Review Board Approval 
 
Study initiation will not take place until the following regulatory requirements are met: 
 
• Food and Drug Administration (FDA) approval with accompanying approval letter. 
• Local Institutional Review Board (IRB) full approval with accompanying approval letter. 
14.2 
Informed Consent 
 
Written informed consent will be obtained from all Subjects prior to the initiation of any study 
specific procedures. No tests or procedures required in this protocol that are outside the standard 
practice for treating hamstring tears will be initiated prior to obtaining written informed consent. 
The original ICF will be filed in the Investigator Site File. 
 
14.3 
Monitoring Procedures and Data Management 
 
14.3.1 Site Qualification 
 
A site qualification visit will be performed to evaluate site facilities, Investigator qualifications, 
adequacy of staffing, and understanding of clinical and regulatory requirements. 
 
14.3.2 Site Training 
 
All Investigators and appropriate study staff will be required to participate in a site training (or 
initiation if appropriate) to provide orientation and training to the Celution System, the Puregraft 
System, the STYLE Trial protocol, eCRFs and other study related documents and procedures. 
 
14.3.3 Monitoring 
 
During the course of the study, a representative of the Sponsor will make site visits to review 
protocol compliance, compare eCRFs and individual subject’s medical records, assess test article 
accountability, and ensure that the study is being conducted according to pertinent regulatory 
requirements. eCRF entries will be verified with source documentation. The review of medical 
records will be performed in a manner to ensure that Subject confidentiality is maintained. 
Reviewing the eCRFs for completeness and clarity, and cross-checking with source documents 
and reviewing any discrepancies or issues with the Investigator will be required to monitor the 
progress of the study. Moreover, regulatory authorities (United States Food and Drug 
Administration) and/or the Sponsor’s Clinical Quality Assurance Group may wish to carry out 
such source data checks and/or on-site audit inspections. Direct access to source data will be 

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required for these inspections and audits; they will be carried out giving due consideration to 
data protection and medical confidentiality. 

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14.3.4 Reporting Requirements 
 
The following reports are required of the Investigator: 
 
• eCRFs for each subject entered into the study (this includes all screen failures as well) 
• Reports of any SAEs within 24 hours of becoming aware of events 
• Final report at the conclusion of the study 
• Progress reports to the Sponsor, clinical monitor, and IRB at regular intervals – at least 
yearly 
• Report to the Sponsor, within 5 working days, of withdrawal of approval by the 
reviewing IRB 
• Report to the Sponsor and IRB of any emergency changes made to the protocol to protect 
the life or physical wellbeing of a Subject no later than 5working days after the 
emergency occurred 
 
14.3.5 Data Management 
 
Data management will be conducted by the Sponsor or designee, and will include a data 
management plan and data verification guide developed according to protocol requirements. 
 
14.4 
Study Center and Investigator Requirements 
 
To protect the rights and welfare of Subjects, the study will be conducted in conformance with 
the Declaration of Helsinki, the guidelines on GCPs, Code of Federal Regulations (21 CFR 11, 
50, 56, 812, 814 and 820) and applicable local laws and regulations pertaining to the conduct of 
the study and the protection to human Subjects. 
 
All Investigators, sub-investigators and study personnel are required to read and follow the 
protocol, as well as any literature that accompanies the products prior to conducting the study 
procedure for the first time. In addition, all Investigators will sign and date the Investigator 
Statement Page of this protocol. All Investigators participating in this study will be trained in the 
proper use of the study procedure and in the components of this protocol. 
 
The Principal Investigator (PI) is ultimately responsible for the conduct of this study; however, 
he/she may designate a member of his/her staff to assist with the collection of data and 
completion of eCRFs. The designee(s) will be documented on an authorization form that is 
signed by the PI and kept in the Regulatory Binder, to be updated as necessary. Current copies of 
the authorization form will be forwarded to the Sponsor. 
 
Obtaining informed consent in accordance with national policy is mandatory for Subject 
participation. All Subject data is kept confidential and procedures will be implemented to ensure 
that Subject confidentiality is not compromised. 
 
If additional materials are used for screening and recruitment or provided to study Subjects (i.e. 
advertisements, recruitment materials) they must be approved by Kerastem and the Institutional 
Review Board at the clinical site prior to use. Documentation of the approved informed consent 
must be provided to Kerastem prior to study commencement at the clinical site. 

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After a Subject has signed the Informed Consent Form, an eCRF will be initiated. After this 
point, the reason(s) must be documented on the report form for any Subject who has dropped, 
withdraws, or for any reason cannot complete this study. 
 
14.4.1 Study Center Requirements 
 
Due to the nature of the STYLE Trial, centers will be considered for participation only if the 
meet the following minimum facility requirements: 
 
1. Familiarity with FDA authorized IDE and/or IND Clinical Trials within the United States 
2. Affiliated pharmacy or laboratory capable of performing clinical trial randomization and 
cell dose preparation 
3. Ability to adhere to strict compliance with the STYLE clinical protocol for all study 
related procedure and observations. 
4. 
 
15 PUBLICATIONS 
 
Following completion of the study, Kerastem will present the study data in a clinical study report 
that will be delivered to the FDA according to US regulations. 
 
In the event the investigator wishes to present or publish any study data (partial or complete), 
he/she must submit the presentation / publication draft to Kerastem for review within 30 days of 
the planned submission or presentation. 

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16 REFERENCES 
 
 
1. 
Otberg N, Finner AM, Shapiro J. Androgenetic Alopecia. Endocrinol Metab Clin North Am. 
2007; 36(2):379-98. 
2. 
Dinh QQ, Sinclair R. Female pattern hair loss: Current treatment concepts. Clinical Interventions 
in Aging. 2007;2(2):189-99. 
3. 
Stough D, Stenn K, Haber R, Parsley WM, Vogel JE, Whiting DA, Washenik K. Psychological 
effect, pathophysiology, and management of androgenetic alopecia in men. May Clin Proc. 2005; 
80(10):1316-22. 
4. 
Krupa Shankar DS, Chakravarthi M, Shilpakar R. Male Androgenetic Alopecia: 
Population-Based Study in 1,005 Subjects. Int J Trichology. 2009;1(2):131-33 
5. 
Ghanaat M. Types of Hair Loss and Treatment Options, Including the Novel Low-level 
Light Therapy and its Proposed Mechanism. South Med J. 2010;103(9):917-21... 
6. 
Gan DCC, Sinclair RD. Prevalence of Male and Female Pattern Hair Loss in Maryborough. J 
Investig Dermatol Symp Proc. 2005;10:184-89. 
7. 
Cash TF, Price VH, Savin RC. Psychological effects of androgentic alopecia on women: 
comparisons with balding men and with female control subjects. J Am Acad Dermatol. 
1993;29(4):568-75. 
8. 
Shapiro J, Kaufman KD. Use of finasteride in the treatment of men with androgenetic alopecia 
(male pattern hair loss). J Investig Dermatol Symp Proc. 2003;8(1):20-3. 
9. 
Ross EK, Shapiro J. Management of hair loss. Dermatol Clin. 2005;23(2):227-43. 
10. 
Mysore V. Finasteride and sexual side effects. Indian Dermatol Online J. 2012;3(1):62-65. 
11. 
Magerl M, Paus R, Farjo N, Muller-Rover S, Peters EM, Foitzik K, Tobin DJ. Limitations of 
human occiptal scalp hair follicle organ culture for studying the effects of minoxidil as a hair 
growth enhancer. Exp Dertmatol. 2004;13(10:535-42. 
12. 
Festa, E., Fretz, J., Berry, R., Schmidt, B., Rodeheffer, M., Horowitz, M. and Horsley, V. 
“Adipocyte Lineage Cells Contribute to the Skin Stem Cell Niche to Drive Hair 
Cycling.” Cell, 146: 761 – 771, 2011. 
13. 
Schmidt, B. and Horsley, V. “Unraveling Hair Follicle-Adipocyte Communication.” 
Experimental Dermatology, 21: 827 – 830, 2012. 
14. 
Coleman SR. Structural fat grafts: the ideal filler? Clin Plast Surg. 2001;28:111-9. 
15. 
Locke MB, de Chalain TM. Current practice in autologous fat transplantation: suggested 
clinical guidelines based on a review of recent literature. Ann Plast Surg. 2008;60:98- 
102. 
16. 
Missana MC, Laurent I, Barreau L, Balleyguier C. Autologous fat transfer in 
reconstructive breast surgery: indications, technique and results. Eur J Surg Oncol. 
2007;33:685-690. 

STYLE; Version A 
21 August 2015 
CONFIDENTIAL 
Page 49 of 54 
 
17. 
Zocchi ML, Zuliani F. Bicompartmental breast lipostructuring. Aesthetic Plast Surg. 
2008;32:313-328. 
18. 
Yoshimura K, Sato K, Aoi N et al. Cell-assisted lipotransfer for cosmetic breast 
augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 
2008;32:48-55. 
19. 
Illouz YG, Sterodimas A. Autologous Fat Transplantation to the Breast: A Personal 
Technique with 25 Years of Experience. Aesthetic Plast Surg. 2009. 
20. 
Yi CG, Xia W, Zhang LX et al. VEGF gene therapy for the survival of transplanted fat 
tissue in nude mice. J Plast Reconstr Aesthet Surg. 2007;60:272-278. 
21. 
Yamaguchi M, Matsumoto F, Bujo H et al. Revascularization determines volume 
retention and gene expression by fat grafts in mice. Exp Biol Med (Maywood ). 
2005;230:742-748. 
22. 
Akita S, Akino K, Hirano A, Ohtsuru A, Yamashita S. Mesenchymal stem cell therapy 
for cutaneous radiation syndrome. Health Physics. 2010;in press. 
23. 
Alvarez PD, Garcia-Arranz M, Georgiev-Hristov T, Garcia-Olmo D. A new 
bronchoscopic treatment of tracheomediastinal fistula using autologous adipose-derived 
stem cells. Thorax. 2008;63:374-376. 
24. 
Zhu M, Zhou Z, Chen Y et al. Supplementation of fat grafts with adipose-derived 
regenerative cells improves long-term graft retention. Ann Plast Surg. 2010;64:222-228. 
25. 
Matsumoto D, Sato K, Gonda K et al. Cell-assisted lipotransfer: supportive use of human 
adipose-derived cells for soft tissue augmentation with lipoinjection. Tissue Eng. 
2006;12:3375-3382. 
26. 
Gerth DJ, King B, Rabach L et al. Long-term Volumetric Retention of Autologous Fat 
Grafting Processed with Closed-Membrane Filtration. Aesthetic Surgery Journal. 2014; 
July (epub ahead of print) 
27. 
PRECISE Clinical Trial, ClinicalTrials.gov 
http://clinicaltrials.gov/ct2/show/NCT00426868?term=precise+heart&rank=4 
28. 
APOLLO CLinical Trial, 
ClinicalTrials.govhttp://clinicaltrials.gov/ct2/show/NCT00442806?term=apollo++heart& 
rank=1 
29. 
Yoshimoto H, Akino K, Hirnao A, Yamashita S, Ohtsuru A, Akita S. Efficacy of 
patients’ own adipose-derived regfenreative cells for chronic intractable radiation 
injuries. Journal of Wound Technology 2010;10:22-5. 
30. 
Gotoh M, Yamamoto T, Kator M, Majima T, Toriyama K, Kamei Y, Matsukawa Y, 
Hirakawa A, Funahashi Y. Regernative treatment of male stress urinary incontinence by 
periurethral injection of autologous adipose-derived regenerative cells: 1-year outcomes 
in 11 patients. Int J Urology 2013; doi:10.1111/iju/12266. 
31. 
Borowski DW, Gill TS, Agarwal AK, Bhaskar P. Autologous adipose-tisseu derived 
regenerative cells for the tratment of complex cryptoglandular fistula-in-ano: a report of 
three cases. BMJ;2012; doi:10.1136/bcr-2012-006988. 

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32. 
Granel B, Dauma A, Jouve E, Harle JR, Nguyen PS, Chabannon C, Colavolpe N, Reyneir 
JC, Truillet R, Mallet S, Baiade A, Casanova D, Giraudo L, Arnaud L, Veran J, Sabatier 
F, Magalon G. Safety, tolerability and potential efficacy of injection of autologous 
adipose-derived stromal vascular fraction in the fingers of patietns with systemic 
sclerosis: an open-label phase I trial. Ann Rheum Dis 2014; doe:10.1136/annrheumdis- 
2014-205681. 

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APPENDIX A: SCHEDULE OF PROCEDURES 
 
Pre-procedure 
Assessment 
Procedure Day 
Post-Operative 
Follow-up Week 
Day -28 to Day-3 
Day -1 
Day1 
1 
± 1 day 
6 
± 3 days 
12 
± 1 wk 
24 
± 2 wks 
52 
± 2 wks 
Informed consent 
X 
Confirm Inclusion / Exclusion criteria 
X 
X 
Medical history including 
Demographics 
X 
X1 
Physical examination 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signs 
X 
X 
X2 
X 
X 
X 
X 
X 
Laboratory tests 
X 
X 
X 
Pregnancy test3 
X 
X 
X 
Injection assessment 
X 
Global Photography 
X 
X 
X 
X 
X 
X 
Trichogram capture 
X 
X 
X 
X 
X 
Investigator Hair Satisfaction 
Questionnaire 
X 
X 
X 
X 
X 
X 
Subject Hair Satisfaction Questionnaire 
X 
X 
X 
X 
X 
Randomization 
X 
Sterility Testing 
X 
Injection Procedure 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
1. 
Adverse Events that occur prior to the liposuction-related activities, including those that are considered serious, are to be recorded in the medical history. 
2 
Vital signs will be monitored according to institutional procedures; it is suggested that vitals be monitored frequently during the fat harvest, between fat harvest and cell 
injection and during cell injection procedure and for at least one hour following the injection procedure 
3 
Women of child-bearing potential 

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APPENDIX B: ADVERSE EVENT TERMINOLOGY AND GRADING 
(Adapted from National Cancer Institute Common Terminology Criteria for Adverse Events) 
 
Severity Grading 
Adverse Event 
Short Name 
1 
2 
3 
4 
5 
Bruising (in absence of 
Grade 3 or 4 
thrombocytopenia) 
Bruising 
Localized or in a 
dependent area 
Generalized 
- 
- 
- 
Hyperpigmentation 
Hyperpigmentation 
Slight or localized 
Marked or generalized 
- 
- 
- 
Hypopigmentation 
Hypopigmentation 
Slight or localized 
Marked or generalized 
- 
- 
- 
Injection site reaction/ 
extravasation changes 
Injection site 
reaction 
Pain; itching; 
erythema 
Pain or swelling, with 
inflammation or 
phlebitis 
Ulceration or necrosis 
that is severe; 
operative 
intervention indicated 
- 
- 
Hematoma 
Hematoma 
Minimal symptoms, 
invasive intervention 
not indicated 
Minimally invasive 
evacuation or 
aspiration indicated 
Transfusion, 
interventional 
radiology, or 
operative intervention 
indicated 
Life-threatening 
consequences; 
major urgent 
intervention 
indicated 
Death 
Hemorrhage/bleeding 
associated with surgery, 
intra-operative or 
postoperative 
Hemorrhage with 
surgery 
- 
- 
Requiring transfusion 
of 2 units non- 
autologous pRBCs 
beyond protocol 
specification; 
postoperative 
interventional 
radiology, 
endoscopic, or 
operative 
intervention indicated 
Life-threatening 
consequences 
Death 

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Severity Grading 
Adverse Event 
Short Name 
1 
2 
3 
4 
5 
Infection with normal 
Infection with normal 
- 
Localized, local 
IV antibiotic, 
Life-threatening 
Death 
ANC or Grade 1 or 2 
ANC at the site of 
intervention indicated 
antifungal, or 
consequences (e.g., 
Neutrophils at the site of 
liposuction or ADRC 
antiviral intervention 
septic shock, 
liposuction or cell- 
injection 
indicated; 
hypotension, 
enriched injection 
interventional 
acidosis, necrosis) 
radiology or operative 
intervention indicated 
Pain at the site of 
Pain 
Mild pain not 
Moderate pain; pain 
Severe pain; pain or 
Disabling 
- 
liposuction or cell- 
interfering with 
or analgesics 
analgesics severely 
enriched injection 
function 
interfering with 
interfering with ADL 
function, but not 
interfering with ADL 

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APPENDIX C: SUMMARY OF CLINICAL WORKFLOW 
 

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Subcutaneous Transplantation of Autologous Cell Enriched Adipose 
Tissue For Follicular Niche Stimulation in EarlY Stage ALopEcia 
Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial 
 
 
STYLE Clinical Trial 
Version B 
24November2015 
 
 
 
Kerastem 
420 Stevens Avenue, Suite 220 
Solana Beach, CA 92075, USA 
Phone: +1 (858) 348-8050 
www.kerastem.com 
 
 
 
 
 
CONFIDENTIAL 
 
The information contained herein is confidential and proprietary information of Kerastem Technologies, LLC. It is intended solely for 
the use of Kerastem Technologies, LLC and its designated clinical Investigators or Institutional Review Committees, and others directly 
involved in this clinical investigation who are bound to the confidentiality obligations of a Confidentiality Agreement between Kerastem 
Technologies, LLC and the Investigators participating in this study. If you are not the designated recipient, please call us (collect) 
immediately at +1(858) 348-8050 to arrange for the return of this information. Any review, dissemination, distribution, copying, or use of 
this information by anyone other than the designated recipient(s) is strictly prohibited. 

STYLE; Version B 
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Page 2 of 53 
 
 
TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................................. 2 
STYLE TRIAL PROTOCOL APPROVAL FORM ................................................................. 5 
INVESTIGATOR STATEMENT PAGE ................................................................................... 6 
STYLE TRIAL - PROTOCOL SUMMARY ............................................................................. 9 
1 OBJECTIVE ......................................................................................................................... 13 
2 BACKGROUND ................................................................................................................... 13 
2.1 
ALOPECIA ANDROGENETICA .............................................................................................................. 13 
2.1.1 Clinical Experience with ADRCs .................................................................... 17 
3 RATIONALE ........................................................................................................................ 18 
4 STUDY DESIGN ................................................................................................................... 18 
4.1 
STUDY POPULATION .............................................................................................................................. 19 
4.2 
SAMPLE SIZE ............................................................................................................................................ 19 
4.3 
CLINICAL SITES ....................................................................................................................................... 19 
4.4 
STUDY DURATION .................................................................................................................................. 19 
4.5 
STUDY ENDPOINTS ................................................................................................................................. 19 
4.5.1 Primary Endpoint............................................................................................ 19 
4.5.2 Secondary Endpoints ...................................................................................... 19 
4.5.3 Exploratory Endpoints .................................................................................... 19 
4.5.4 Safety Endpoints.............................................................................................. 19 
4.6 
INCLUSION CRITERIA ............................................................................................................................ 19 
4.7 
EXCLUSION CRITERIA ........................................................................................................................... 20 
5 ENROLLMENT .................................................................................................................... 21 
5.1 
SUBJECT ENROLLMENT ........................................................................................................................ 21 
5.2 
RANDOMIZATION AND SUBJECT IDENTIFICATION ....................................................................... 21 
5.3 
BLINDING PROCEDURES AND SAFEGUARDS .................................................................................. 22 
5.4 
SUBJECT WITHDRAWAL AND REPLACEMENT ............................................................................... 22 
6 CELUTION & PUREGRAFT SYSTEMS ......................................................................... 22 
6.1 
CELUTION & PUREGRAFTSYSTEM DESCRIPTIONS ...................................................................... 22 
6.2 
DEVICE CHARACTERIZATION AND INTENDED USE ..................................................................... 23 
6.3 
CONTRAINDICATIONS............................................................................................................................ 23 
6.4 
INTENDED CLINICAL PERFORMANCE ............................................................................................... 23 
6.5 
CELUTION & PUREGRAFT SYSTEM OUTPUT; PHYSICAL, CHEMICAL, AND 
PHARMACEUTICAL PROPERTIES OF ADRCS ................................................................................. 24 
6.6 
PROPOSED MECHANISM OF ACTION OF CELL ENRICHED AUTOLOGOUS FAT GRAFTS ... 25 

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7 STUDY TREATMENTS ...................................................................................................... 25 
7.1 
PRODUCT DESCRIPTION – CELL-ENRICHED AUTOLOGOUS FAT .............................................. 25 
7.1.1 Active Treatment Dose Control ...................................................................... 26 
7.2 
PRODUCT DESCRIPTION - CONTROL DOSE..................................................................................... 26 
7.2.1 Justification of Control Dose .......................................................................... 26 
7.3 
STUDY TREATMENT PRE-INJECTION STERILITY TESTING ........................................................ 27 
7.3.1 ADRC Characterization .................................................................................. 27 
8 STUDY ASSESSMENTS ..................................................................................................... 28 
8.1 
MEDICAL HISTORY, PHYSICAL EXAMINATION & VITAL SIGNS ............................................. 28 
8.2 
HAIR & SCALP EVALUATION ASSESSMENTS ................................................................................ 29 
8.3 
PRIOR AND CONCOMITANT MEDICATIONS .................................................................................... 29 
8.3.1 Prohibited Medications ................................................................................... 29 
8.4 
LABORATORY PROCEDURES ............................................................................................................... 29 
8.5 
ADVERSE EVENTS .................................................................................................................................. 30 
9 STUDY VISIT REQUIREMENTS ..................................................................................... 30 
9.1 
SCREENING (WITHIN 28 DAYS PRIOR TO PROCEDURE) .................................................. 30 
9.2 
PRE-OPERATIVE PROCEDURES (DAY -2; PERFORMED WITHIN 48 HOURS OF THE 
LIPOSUCTION) .............................................................................................................. 30 
9.3 
PROCEDURE DAY (DAY 1) ........................................................................................... 31 
9.3.1 
Fat Harvest ..................................................................................................... 31 
9.3.1.1 General requirements ....................................................................... 31 
9.3.2 Between Fat Harvest and ADRC Injection ..................................................... 33 
9.3.3 Fat + ADRC Injection ..................................................................................... 33 
9.4 
IMMEDIATELY POST-INJECTION (DAY 1)...................................................................... 33 
9.5 
POST-INJECTION FOLLOW-UP VISITS (WEEK 1) ............................................................ 34 
9.6 
POST-INJECTION FOLLOW-UP VISITS (WEEKS 6, 12, 24, AND 52).................................. 34 
9.7 
EARLY TERMINATION EVALUATION ................................................................................................ 34 
10 RISK/BENEFIT ANALYSIS ............................................................................................... 35 
10.1 
RISKS .......................................................................................................................................................... 35 
10.1.1 Subcutaneous DeliveryRisk Analysis .............................................................. 35 
10.1.2 Subcutaneous Injection Risk Management ..................................................... 35 
10.1.3 Celution & Puregraft System Risk Analysis .................................................... 36 
10.1.4 Overall Study Risk Management ..................................................................... 36 
10.1.5 Fat Harvest Risk Analysis ............................................................................... 36 
10.2 
POTENTIAL BENEFITS ............................................................................................................................ 38 
11 STATISTICAL METHODS AND DATA ANALYSIS ..................................................... 38 
11.1 
GENERAL CONSIDERATIONS ............................................................................................................... 38 
11.2 
DETERMINATION OF SAMPLE SIZE.................................................................................................... 38 
11.3 
DATA ANALYSES .................................................................................................................................... 38 
11.3.1 Primary Endpoint Analysis ............................................................................. 39 
11.3.2 Secondary and Exploratory Endpoint Analysis .............................................. 39 
11.3.3 Subgroup Analysis .......................................................................................... 39 
11.4 
BACKGROUND, DEMOGRAPHIC ANALYSES ................................................................................... 39 

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11.5 
SUBJECT DISPOSITION & ANALYSIS POPULATIONS .................................................................... 40 
11.6 
HANDLING OF MISSING DATA ........................................................................................................... 40 
11.7 
PROTOCOL DEVIATIONS ....................................................................................................................... 40 
11.8 
DATA MONITORING COMMITTEE ...................................................................................................... 40 
11.8.1 Adverse Events Initiating Safety Review ......................................................... 41 
12 ADVERSE EVENTS / SERIOUS ADVERSE EVENTS ................................................... 41 
12.1 
DEFINITIONS ............................................................................................................................................. 41 
12.2 
PROCEDURES FOR AE REPORTING ................................................................................................... 42 
12.3 
ADVERSE EVENT TERMINOLOGY ...................................................................................................... 42 
12.3.1 Injection Site Related Adverse Events ............................................................. 42 
13 EMERGENCY DEVIATION FROM THE PROTOCOL ............................................... 42 
14 REGULATORY OBLIGATIONS AND STUDY REQUIREMENTS ............................ 43 
14.1 
FDA AND INSTITUTIONAL REVIEW BOARD APPROVAL ............................................................ 43 
14.2 
INFORMED CONSENT ............................................................................................................................. 43 
14.3 
MONITORING PROCEDURES AND DATA MANAGEMENT ........................................................... 43 
14.3.1 Site Qualification ............................................................................................ 43 
14.3.2 Site Training.................................................................................................... 43 
14.3.3 Monitoring ...................................................................................................... 43 
14.3.4 Reporting Requirements .................................................................................. 45 
14.3.5 Data Management ........................................................................................... 45 
14.4 
STUDY CENTER AND INVESTIGATOR REQUIREMENTS ............................................................... 45 
14.4.1 Study Center Requirements ............................................................................. 46 
15 PUBLICATIONS .................................................................................................................. 46 
16 REFERENCES ...................................................................................................................... 47 
APPENDIX A: SCHEDULE OF PROCEDURES ................................................................... 50 
APPENDIX B: ADVERSE EVENT TERMINOLOGY AND GRADING ............................ 51 
APPENDIX C: SUMMARY OF CLINICAL WORKFLOW ................................................ 53 

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STYLE TRIAL PROTOCOL APPROVAL FORM 
 
Study Title: 
Subcutaneous Transplantation of Autologous Cell Enriched 
Adipose Tissue For Follicular Niche Stimulation in EarlY 
Stage ALopEcia Androgenetica (STYLE): a Randomized, 
Blinded, Controlled Trial 
 
Short Title: 
STYLE Trial 
 
Protocol Version A Date: 
21 August 2015 
 
 
This study protocol was subjected to critical review. The information it contains is consistent 
with the sponsor’s current knowledge of the risks and benefits of the investigational product, as 
well as with the moral, ethical and scientific principles governing clinical research as set out in 
the Declaration of Helsinki, as amended in 2013, Good Clinical Practice (GCP) Consolidated 
Guidance in guidelines of the International Conference on Harmonization (ICH) E2 & E6, and 
21CFR 11, 50, 54, 56, 812, 814 and 820. The study will also be carried out in keeping with all 
applicable laws, rules, and regulations. 
 
 
 
 
 
 
 
 
 
 
Eric Daniels 
Date (dd/mmm/yyyy) 
Chief Medical Officer 
Kerastem Technologies, LLC 

STYLE; Version B 
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Page 6 of 53 
 
INVESTIGATOR STATEMENT PAGE 
 
Study Sponsor: 
Kerastem Technologies, LLC 
Clinical Trial: 
STYLE Trial 
Protocol Version A: 21August2015 
 
Study Title: Subcutaneous Transplantation of Autologous Cell Enriched  Adipose  
Tissue For Follicular Niche Stimulation in EarlY Stage ALopEcia 
Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial 
 
The information contained in this document and all information provided to you related to this 
protocol are the confidential and proprietary information of Kerastem (Sponsor) and except as 
may be required by federal, state or local laws or regulations, may not be disclosed to others 
without prior written permission of Sponsor. The Principal Investigator at each site may, 
however, disclose such information to supervised individuals working on the protocol, provided 
such individuals agree to be bound to maintain the confidentiality of such protocol information. 
 
I agree to abide by the statement of confidentiality. 
I agree to provide my curriculum vitae. 
I agree to disclose if I was involved in an investigation or other research that was terminated, and 
an explanation of the circumstances that led to termination 
I agree to conduct the study according to this protocol. Any changes in procedure will only be 
made if necessary to protect the safety, rights, or welfare of patients. 
I agree to comply with the current ICH, GCP and CFR Guidelines. 
I agree to conduct the study in person or to supervise the study. 
I agree to ensure that all who assist me in the conduct of the study have access to the study 
protocol and any amendments and are aware of their obligations. 
As an investigator for the STYLE Trial, I intend to commit to conducting the investigation in 
accordance with the investigator agreement, the investigational plan, Part 812 and other 
applicable FDA regulations and conditions of approval imposed by the reviewing IRB and FDA. 
I agree to supervise all testing of the device involving human subjects and will ensure that the 
requirements for obtaining informed consent are met. As an investigator, I am committed to 
provide sufficient and accurate financial disclosure information and update information if any 

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relevant changes occur during the investigation and for one year following the completion of the 
study. 
 
 
 
 
Principal Investigator (Print Name and Title) 
 
 
 
 
Principal Investigator (Signature) 
Date (dd/mmm/yyyy) 

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STUDY CONTACTS 
 
 
STYLE Trial Sponsor 
 
Kerastem Technologies, LLC 
420 Stevens Avenue, Suite 220 
Solana Beach, CA 92075, USA 
Phone: +1(858) 348-8050 
Fax: +1(858) 217-5134 
 
Safety (SAE) Notifications: 
24 Hour Study Telephone: +1(858) 353-0469 
 
Medical Monitor 
 
Eric Daniels, MD 
Chief Medical Officer 
Kerastem Technologies, LLC 
420 Stevens Avenue, Ste. 220 
Solana Beach, CA 92075, USA 
Phone: +1(858) 348-8050 
Fax: +1(858) 217-5134 

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STYLE TRIAL - PROTOCOL SUMMARY 
 
Title 
Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue 
For Follicular Niche Stimulation in EarlY Stage ALopEcia Androgenetica 
(STYLE): a Randomized, Blinded, Controlled Trial 
Test Products 
Celution® System (Celution Device, Celution Consumable Set and Celase) 
used for processing of Autologous Adipose Derived Regenerative Cells 
(ADRCs) combined with adipose tissue processed and purified with 
Puregraft® 50 System 
Objective 
The primary objective of this study is to evaluate the safety and feasibility of 
the Celution and Puregraft Systems in the processing and preparation of an 
autologous fat graft enriched with adipose-derived regenerative cells 
(ADRCs) in the treatment of early alopecia androgenetica. 
Design 
Prospective, Randomized, Controlled Safety and Feasibility Trial 
Sample Size 
70 patients (40 ADRC + adipose, 20 fat only control, 10 no-fat control ) 
Study 
Location 
Up to (8) sites in the United States 
Indication 
Androgenic Alopecia (Androgenetica Alopecia, AGA) 
Visit 
Schedule 
Screening (Day -28 to Day -7), Pre-Procedure Day (Day -1)Procedure Day 
(Day 1), and follow up visits at weeks 1, 6, 12, 24 and 52 weeks 
Treatment 
Arms 
Subjects will be randomized 2:2:2:1 to receive either 0.1ml/cm2 scalp of 
autologous fat enriched with 0.5 x 106 ADRC/cm2 scalp (n=20), 0.1 ml/cm2 
scalp of autologous fat enriched with 1.0 x 106 ADRCs/cm2 scalp (n = 20), 
0.1ml/cm2 scalp of autologous fat enriched with a matching saline control 
(fat alone control; n=20), or 0.1 ml/cm2 scalp of saline enriched with a 
matching dose of saline (no-fat control; n=10). In each subject, 40 square 
centimeters of scalp will be treated. 
The study treatment will be delivered in the subcutaneous adipose layer of the 
scalp in via two separate injections – one of either 0.1ml/cm2 scalp of adipose 
or saline followed by a second injection of ADRCs or saline per square 
centimeter of scalp. 
Primary 
Endpoint 
Safety & tolerability through 24 weeks 
Secondary 
Endpoints 
• Trichograms (Hair Growth) at 24 weeks 
• Trichograms (Hair Density) at 24 weeks 
• Global photographs to assess scalp coverage at 24 weeks 

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• Hair Investigator Satisfaction Survey at 24 weeks 
Exploratory 
Endpoints 
• Trichograms (Hair Growth)at times other than 24 weeks 
• Trichograms (Hair Density) at times other than 24 weeks. 
• Trichograms (Hair Thickness) at times other than 24 weeks 
• Global photographs to assess scalp coverage other than 24 weeks 
• Hair Investigator Satisfaction Survey at times other than 24 weeks. 
Safety 
Endpoints 
Adverse events, Serious Adverse Events, UADEs 
Inclusion & 
Exclusion 
Criteria 
Inclusion Criteria 
1. Males with a diagnosis of Alopecia Androgenetica 
2. Females with a diagnosis of Alopecia Androgenetica 
3. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, 
IV-A, based on Norwood-Hamilton Scale (Figure 1) 
4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based 
on the Savin Scale (Figure 2) 
5. Provide written informed consent and comply with the study 
requirements 
6. For women of childbearing potential: Negative pregnancy test at 
screening visit plus subject agrees to maintain two forms of 
contraception for the duration of the study. 
7. Subject is willing to maintain a consistent hair length and natural hair 
color, without the use of any coloring agents, during the study period. 
8. Ability to complete study procedures, patient surveys, and pictures. 
9. Subject is ≥ 18 years of age. 
10. Body Mass Index < 40kg/m2 
Exclusion Criteria 
1. Subjects who have used minoxidil, or any oral or topical medication 
including over the counter and herbal medications for the treatment of 
hair loss within 6 months of study screening, or finasteride or 
dutasteride within 12 months of study screening 
2. Treatment with an investigational product or procedure within 30 days 
or plans to participate in another clinical study 
3. Subject who has previously failed or has been deemed non-responsive 
to a previous experimental hair loss treatment. 
4. Subject must have no previous hair transplant, cell treatment, micro 
needling, or any other treatment in the last 6 months in the scalp. 
5. Subject is currently suffering from an active autoimmune disease such 
as serum lupus erythematosus, or alopecia areata. Subject is currently 
suffering from dermatologic condition in the treatment area or has a 
significant scar in the hair treatment area that, in the opinion of the 
investigator, will make hair growth difficult (such as systemic burns, 

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etc.). 
6. History of autoimmune disease or organ transplantation or a patient on 
immunosuppressive medication(s). 
7. Diagnosis of cancer, receiving active treatment 
8. Active systemic infection 
9. Requires chronic antibiotics, systemic corticosteroids 
10. Use of systemic agents that increase bleeding or clotting, or disorders 
associated with these effects, including patients receiving GIIB/IIIa 
inhibitors within 2 weeks prior to the study procedure through to 1 
week after the study procedure. 
11. Clinically significant medical or psychiatric illness currently or within 
30 days of study screening as determined by the investigator 
12. Prior surgery in the treatment area 
13. Any disease or condition (medical or surgical) that, in the opinion of 
the investigator, might compromise dermatologic, hematologic, 
cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central 
nervous system function; or any condition that would place the subject 
at increased risk 
14. Pregnant or lactating women or women trying to become pregnant 
15. Known allergic reaction to components of study treatment and/or 
study injection procedure 
16. Subject has any disorder that may prevent compliance to study 
procedures and visits 
17. Subject who is part of the study staff, a family member or friend 
18. Diabetes or thyroid disorder 
19. Subject who has a sensitive, irritated, or abraded scalp area. 
20. Women who have an alternate diagnosis that is associated with hair 
loss. 
21. Body Mass Index < 18kg/m2 
22. Clinically significant abnormal findings on laboratory screening 
panels, including hemoglobin ≤ 10 g/dL. 
23. Hepatic dysfunction, as defined as aspartate aminotransferase (AST), 
alanine aminotransferase (ALT), or bilirubin levels > 1.5 times the 
upper limit of normal range (x ULN) prior to randomization. 
24. Chronic renal insufficiency as defined as a serum creatinine > 1.5 mg/dL in 
men or > 1.2 mg/dL in women. 
25. An elevated PT/PTT, INR, or platelet count < 100 x 109/L 

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ABBREVIATIONS 
 
ADL 
Activities of Daily Living 
AGA 
Androgenic Alopecia 
ADRC 
Adipose-Derived Regenerative Cells 
AE 
Adverse Event 
ANC 
Absolute neutrophil count 
ANCOVA 
Analysis of covariance 
AFT 
Autologous Fat Transfer 
CFU-F 
Colony Forming Units Fibroblast 
CFR 
Code of Federal Regulations 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
ET 
Early Termination 
FPHL 
Female Pattern Hair Loss 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization 
ID 
Identification 
IFU 
Instructions for Use 
IV 
Intravenous 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
IVRS 
Interactive Voice Response System 
IWRS 
Interactive Web Response System 
MPHL 
Male Pattern Hair Loss 
PI 
Principal Investigator 
pRBC 
Pack Red Blood Cells 
PTE 
Per Treatment Evaluation 
RBC 
Red Blood Cell 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
WBC 
White Blood Cell 

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1 
OBJECTIVE 
 
The primary objective of this study is to evaluate the safety and efficacy of the Cytori Celution 
and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with 
adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica. 
 
 
2 
BACKGROUND 
 
2.1 
Alopecia Androgenetica 
 
Alopecia Androgenetica (AGA) is the most common form of both male pattern hair loss (MPHL) 
and female pattern hair loss (FPHL)1,2 with the condition affecting approximately 50% of the 
male population and less than 45% of women going through life with a full head of hair. The 
degree of hair loss in the male patient is generally classified using the Norwood Hamilton 
Classification (Figure 1) and FPHL is evaluated based on the Savin scale (Figure 2)1,3. The 
incidence and prevalence of the condition are generally well documented in both genders. Stough 
and co-workers reported that in White males, 30% have AGA by age 30 and 50% by age 50 with 
lower incidences seen in African American, Chinese, and Japanese populations3. In a population 
based report looking at MPHL, the authors reported that in the 30-35 years age group, grade I 
hair loss was 51%, while grade II was 43% and grade VI was only approximately 19%--clearly 
highlighting early hair loss in the younger population4. Of the 1,005 men in the study aging from 
30-50 years, 44% were found to have grades I-III hair loss. 
 
In women, diffuse thinning and loss of hair density with maintenance of the frontal hairline 
describe the typical pattern of loss5. In one report, the prevalence of early, clinically detectable 
FPHL was 12% of females between 20-29 years of age and 25% by 49 years of age2. In the table 
presented below (Table 1), Gan and Sinclair documented the distribution of hair loss in 752 
women using a modified 5-point grading scale6. Below the age of 40 years, 99% of women 
reporting loss documented early stage loss. 
 
 
In sum, a significant percentage of both male and female population suffer from AG at a 
relatively early age. 

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Figure 1—MPHL Norwood Hamilton Classification 
 
 
 
Class I represents an adolescent or juvenile hairline and it not actually balding. The adolescent 
hairline generally rests on the upper brow crease. 
 
Class II indicates a progression to the adult or mature hairline which sits a finger breath (1.5cm) 
above the upper brow crease, with some temporal recession. This also does not represent balding. 
 
Class III is the earliest stage of male hair loss. It is characterized by a deepening temporal recession. 
 
Class III Vertex represents early hair loss in the crown (vertex). 
 
Class IV Is characterized by further frontal hair loss and enlargement of vertex, but there is still a 
solid band of hair across top separating front and vertex. 
 
Class V the bald areas in the front and crown continue to enlarge and the bridge of hair separating 
the two areas begins to break down. 
 
Class VI occurs when the connecting bridge of hair disappears leaving a single large bald area on the 
front and top of the scalp. The hair on the sides of the scalp remains relatively high. 

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Figure 2—FPHL Ludwig Scale 
 
The current treatment regimen for alopecia androgenetica is a spectrum ranging from non- 
invasive medicinal approaches to robot-assisted surgical transplantation of thousands of 
follicular units. On the non-invasive side, the two medicines currently approved for treatment of 
genetic pattern alopecia by the FDA are finasteride (for men only) and minoxidil8,9. Both of these 
medicines carry untoward side-effects. For finasteride, sexual dysfunction, particularly for the 
younger patient who is most likely to present with early hair loss, was seen in between 2.1% and 
3.8% of men10. Initial treatment of early alopecia is typically non-invasive and the two 
medications approved by the FDA today are minoxidil and finasteride. For minoxidil, it is 
reported that approximately one-third of patients with AA respond with new hair growth11. In 
contrast, invasive transplant options are generally not offered to patients with early AA and if so, 
require significant financial resources. As a result, there remains a significantly large gap 
between these medicinal and transplant options. Hence a distinct medical need remains specific 
to addressing early alopecia. 
During hair follicle growth (anagen), the hair follicle delves deep into the rich dermal 
macroenvironment as it grows to maturity where it is surrounded by large lipid-filled adipocytes. 
These intradermal adipocytes regenerate with faster kinetics than other adipose tissue depots and 
such growth parallels with the hair cycle, suggesting an interplay exists between hair follicle 
cells and adipocyctes12. Thus, it has been established that adipose is an integral part of the 
normal hair cycle and it is hypothesized that telogen may be due to an absence of adipose tissue 
as it is reported that hair loss and decreased adipocytes occur together12,13. Therefore, the 
transplantation of adipose tissue, or autologous fat transfer (AFT), into the subcutaneous layer of 
fat in the scalp for purposes of stimulating hair growth is consistent with the reported literature 
that indicates hair loss and adipose loss occur in tandem. 

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Autologous Fat Transfer 
 
In an AFT procedure, a patient’s subcutaneous adipose tissue is aspirated from one location (most 
commonly the abdomen or thighs) and transferred into another depot of subcutaneous fat located 
throughout the body (e.g., mid-face). This procedure is reported to be practiced by physicians for over 
100 years and autologous fat should be free from problems often associated with artificial materials or 
from allergic reactions14. However, AFT is not without its own limitations most significant of 
which is the fact that an unpredictable amount of the transferred fat can die as a result of damage 
during tissue harvest, processing, and implantation leading to loss of volume and a degree of 
unpredictability in outcome. 
 
The process of fat transfer necessarily involves disconnecting the fat from its blood supply, 
implanting it into the defect, and then waiting for natural healing processes to incorporate the 
transferred tissue with native fat. Survival of the transferred tissue is dependent upon harvest and 
processing approaches that maximize tissue viability15. It is also dependent upon simple  
diffusion to supply nutrients and oxygen and to remove wastes until such time as healing 
processes restore its blood supply. Diffusion through a solid tissue such as fat is only effective 
across a distance of a few millimeters. Consequently, any transferred tissue that is more than a 
few millimeters away from the blood supply of recipient site tissue is at risk of dying. Loss of 
graft tissue from this problem is a frequent problem. Clinicians frequently overcorrect adding 
extra tissue in an effort to compensate for inevitable tissue loss that has been estimated at 
between 20-80% of the implanted tissue16-18. As a result of this unpredictability defect repair 
frequently requires multiple repeated or staged procedures performed at intervals of three or 
more months. For example, one large study reports up to five treatments needed (mean = three 
treatments) in order to achieve success in restoring volume19. This leads to delays in achievement 
of effective treatment of the defect, expense, and the higher morbidity of repeated tissue 
collection and implantation. 
 
A number of investigators have evaluated ways by which the healing process can be modulated 
in an effort to understand and augment graft retention and, thereby, limit the number of 
procedures needed to achieve successful treatment. For example, animal studies have shown that 
use of agents that stimulate the healing process (for example, gene therapy with factors that 
stimulate new blood vessel growth20) can increase the survival of transferred tissue and that, 
conversely, agents that inhibit healing reduce survival21. Recent preclinical and clinical data have 
shown in addition to being a source of tissue for soft tissue filling, human adipose tissue contains 
cells that have the ability to promote healing22,23. Zhu et al have used an animal model to show 
that coating one volume of adipose tissue with cells isolated from another volume of adipose 
tissue results in an approximate doubling of graft retention at six and nine months24. This finding 
has been confirmed by an independent study25. The concept of this approach is that signals 
generated at the interface between implanted fat and adjacent breast fat will induce improved 
healing. Increasing the number of cells capable of generating these signals at this interface will 
lead to successful tissue retention. 
 
In addition, Puregraft processed adipose has an excellent safety profile in aesthetic body 
contouring26. 
Currently, there are few, if any, minimally invasive, autologous cell therapeutic modalities being 
developed that address early alopecia. However, analyses from other therapeutic applications of 

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ADRCs and AFT suggest that a cell-enriched based approach for the treatment of early alopecia 
may be of significant benefit. 
 
2.1.1 Clinical Experience with ADRCs 
 
To date, thousands of patients have been treated with autologous ADRCs isolated using the 
Celution System (Cytori Therapeutics, San Diego, USA). Celution processed ADRCs have an 
excellent safety profile in a variety of conditions including acute myocardial injury, patients with 
chronic heart muscle damage, breast insufficiency following lumpectomy (a cell-enriched AFT 
procedure), chronic cutaneous wounds, and urinary incontinence, and most recently in a small 
study of scleroderma patients27-32. 
In addition, Puregraft processed adipose has an excellent safety profile in aesthetic body 
contouring26. 
Cytori’s initial clinical experience in treating pathological conditions was in the myocardium, 
The PRECISE Clinical Trial evaluated the safety and feasibility of intramyocardial 
administration of ADRCs in patients with chronic myocardial ischemia not amenable to 
revascularization.27 Clinical results at 18 months have demonstrated safety and signs of 
feasibility. PRECISE was a prospective, double-blind, randomized, parallel group, placebo- 
controlled, sequential dose escalation study which enrolled 27 subjects. Following baseline 
electromechanical mapping, subjects received ≤ 15 intramyocardial injections of ADRCs (n=21; 
median dose of ADRCs 42 x 106 per subject) or placebo (n=6: indistinguishable solution) in the 
area(s) of the heart with inducible ischemia. ADRCs were processed using the Cytori Celution 
System. ADRC-treated subjects demonstrated improvement in maximum oxygen consumption 
(VO2max) relative to a placebo control. Adverse events and serious adverse events were equally 
distributed across all treatments groups with angina reported as the most frequent SAE. 
 
The APOLLO Clinical Trial was a safety and feasibility study of ADRCs processed by the 
Celution System and delivered via the intracoronary route in the treatment of patients with ST- 
segment elevation myocardial infarction (STEMI).28 This was a prospective, double-blind, 3:1 
randomized (ADRC: Placebo), parallel group, placebo-controlled trial. A total of 14 patients 
were enrolled and treated according to protocol, 10 patients received ADRCs and four received 
placebo. 
 
The APOLLO study demonstrated that liposuction adipose harvest for the purpose of processing 
and returning autologous ADRCs via the intracoronary infusion of 20 x 106 ADRCs can be 
performed with an acceptable safety profile. 
 
Case series have described benefits in the treatment of radiation injury, fistulas and stress urinary 
incontinence. Yoshimoto et al. described efficacy of ADRC treatment in three patients presenting 
with chronic radiation injuries with ulcers and severe fibrosis.29 They reported increases in local 
blood circulation at the site by ultrasound and dramatic wound healing. Gotoh et al recently 
described improvements in urinary incontinence following ADRC injections in a case series of 
11 men who underwent radical prostatectomy.30 Of note, enhanced ultrasonography showed a 
progressive increase in blood flow to the injected area in all patients. Borowski reported 
complete wound closure of three patients treated for long-standing cryptoglandular fistula-in-ano 

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using ADRCs.31An open label trial in 12 patients with systemic scleroderma from France 
examining the effects of subcutaneous administration of ADRCs to all fingers has recently been 
published.32 Data at six months indicated significant improvements in Cochin score, Raynaud’s 
severity score, and in the Scleroderma Health Assessment Questionnaire (SHAQ). The procedure 
was tolerated well without complications. 
 
 
3 
RATIONALE 
 
For both sexes, the negative physical and psychological effects of AGA have been documented. 
In Stough’s report, the authors indicate that while the condition may not appear to cause direct 
physical harm in men, hair loss can protect against sunburn, cold temperatures, mechanical 
injury, and ultraviolet light3. Beyond the physical, hair loss is known to psychologically affect 
the balding individual’s perceptions of themselves. This is particularly true when looking at 
FPHL, where Cash and co-workers reported that while AA was a stressful experience for both 
sexes, it was substantially more distressing for women7. In sum, the impact of the condition 
should not be relegated as simply aesthetic in nature, and therefore satisfactory treatment 
regimens are necessary. 
 
 
4 
STUDY DESIGN 
 
The STYLE Trial is a prospective, randomized, multi-center device trial intended to evaluate the 
safety and efficacy of the Celution and Puregraft Systems in the processing and preparation of an 
autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment 
of early alopecia androgenetica. Patients may be included if they are undergoing an elective 
cosmetic liposuction. Following informed consent and screening evaluations, eligible subjects 
will undergo pre-operative testing. Subjects will then undergo a fat harvest using local anesthesia 
with or without conscious sedating. Subjects will be randomly assigned to receive a fat graft cell 
enriched with ADRCs (available in two different doses), a fat graft without cell enrichment using 
a visually-matched blood saline solution (fat alone control), or a saline injection (no-fat control) 
in a 2:2:2:1 ratio. 
 
While undergoing liposuction, lipoaspirate will be processed in the Puregraft System to remove 
the lipoaspirate of impurities and in the Celution System to isolate and concentrate ADRCs. 
After the liposuction is completed), patients will have, under a ring block local anesthesia (see 
further description below), a subcutaneous scalp injection of either Puregraft purified autologous 
fat or saline (no-fat control) followed by a separate second injection, of either ADRCs (available 
in two different doses), a visually-matched blood saline solution (fat alone control), or saline (no- 
fat control) in a 2:2:2:1 ratio. 
 
 
All subjects will undergo clinical evaluations and laboratory testing prior to and after the 
procedure as outlined in Section 9.0, Study Assessments, and in the Schedule of Procedures 
(Appendix A). 

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4.1 
Study Population 
 
Subjects with documented early stage alopecia androgenetica will be evaluated for this study. 
 
4.2 
Sample Size 
 
The STYLE Clinical Trial will have a sample size of 70 patients. 
 
4.3 
Clinical Sites 
 
Up to eight (8) clinical centers in the United States will be selected to participate in the STYLE 
Clinical Trial. 
 
4.4 
Study Duration 
 
Enrollment of subjects will occur over approximately 6 months. For each patient, the study 
duration will include a screening period of up to 28 days and a 52 week follow-up period. 
Therefore, the study duration is estimated to be 18 months. 
 
4.5 
Study Endpoints 
 
4.5.1 Primary Endpoint 
 
Safety & tolerability throughout 24 weeks 
 
4.5.2 Secondary Endpoints 
 
1. Trichograms (Hair Growth)t 24 weeks (change from baseline) 
2. Trichograms (Hair Density) at 24 weeks (change from baseline) 
3. Global photographs at 24 weeks (change from baseline) 
4. Hair Investigator Satisfaction Survey at 24 weeks (change from baseline) 
 
4.5.3 Exploratory Endpoints 
 
1. Trichograms  (Hair Growth)at times other than 24 weeks 
2. Trichograms (Hair Density) at times other than 24 weeks 
3. Trichograms (Anagen/Telogen Rate, Hair Thickness) at times other than 24 weeks 
4. Global photographs other than 24 weeks 
5. Hair Investigator Satisfaction Survey at times other than 24 weeks 
 
4.5.4 Safety Endpoints 
 
Adverse events, Serious Adverse Events, and UADEs 
 
4.6 
Inclusion Criteria 
 
Subjects will be enrolled into this study only if they meet ALL of the following criteria: 
1. Males with a diagnosis of Alopecia Androgenetica 
2. Females with a diagnosis of Alopecia Androgenetica 

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3. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on 
Norwood-Hamilton Scale (Figure 1) 
4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale 
(Figure 2) 
5. Provide written informed consent and comply with the study requirements 
6. For women of childbearing potential: Negative pregnancy test at screening visit plus 
willingness to maintain two forms of contraception for the duration of the study. 
7. Subject is willing to maintain a consistent hair length and natural hair color, including the 
absence of coloring agents, during the study period. 
8. Ability to complete study procedures, patient surveys, and pictures. 
9. Subject is ≥ 18 years of age. 
10. Body Mass Index < 40kg/m2 
 
4.7 
Exclusion Criteria 
 
Subjects will not be enrolled into this study if they meet ANY of the following criteria: 
1. Subjects who have used minoxidil, or any oral or topical medication including over the 
counter and herbal medications for the treatment of hair loss within 6 months of study 
screening, or finasteride or dutasteride within 12 months of study screening 
2. Treatment with an investigational product or procedure within 30 days or plans to 
participate in another clinical study 
3. Subject who has previously failed or has been deemed non-responsive to a previous 
experimental hair loss treatment. 
4. Subject must have no previous hair transplant, cell treatment, micro needling, or any 
other treatment in the last 6 months in the scalp. 
5. Subject is currently suffering from an active autoimmune disease such as serum lupus 
erythematosus, or alopecia areata. Subject is currently suffering from dermatologic 
condition in the treatment area or has a significant scar in the hair treatment area that, in 
the opinion of the investigator, will make hair growth difficult (such as systemic burns, 
etc.). 
6. History of autoimmune disease or organ transplantation or a patient on 
immunosuppressive medication(s). 
7. Diagnosis of cancer, receiving active treatment 
8. Active systemic infection 
9. Requires chronic antibiotics, systemic corticosteroids 
10. Use of systemic agents that increase bleeding or clotting, or disorders associated with 
these effects, including patients receiving GIIB/IIIa inhibitors within 2 weeks prior to the 
study procedure through to 1 week after the study procedure. 
11. Clinically significant medical or psychiatric illness currently or within 30 days of study 
screening as determined by the investigator 
12. Prior surgery in the treatment area 
13. Any disease or condition (medical or surgical) that, in the opinion of the investigator, 
might compromise dermatologic, hematologic, cardiovascular, pulmonary, renal, 
gastrointestinal, hepatic, or central nervous system function; or any condition that would 
place the subject at increased risk 
14. Pregnant or lactating women or women trying to become pregnant 

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15. Known allergic reaction to components of study treatment and/or study injection 
procedure 
16. Subject has any disorder that may prevent compliance to study procedures and visits 
17. Subject who is part of the study staff, a family member or friend 
18. Diabetes or thyroid disorder 
19. Subject who has a sensitive, irritated, or abraded scalp area. 
20. Women who have an alternate diagnosis that is associated with hair loss. 
21. Body Mass Index < 18 kg/m2 
22. Clinically significant abnormal findings on laboratory screening panels, including 
hemoglobin ≤ 10 g/dL. 
23. Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine 
aminotransferase (ALT), or bilirubin levels > 1.5 times the upper limit of normal range (x 
ULN) prior to randomization. 
24. Chronic renal insufficiency as defined as a serum creatinine > 1.5 mg/dL in men or > 1.2 mg/dL 
in women. 
25. An elevated PT/PTT, INR, or platelet count < 100 x 109/L 
 
 
5 
ENROLLMENT 
 
5.1 
Subject Enrollment 
 
Patients are considered enrolled in this study when all of the following have occurred: 
 
1. Written informed consent is obtained 
2. All inclusion criteria and no exclusion criteria have been met 
3. All screening evaluations are complete 
 
5.2 
Randomization and Subject Identification 
 
All subjects will undergo liposuction and will be randomized into one of four parallel arms in a 
2:2:2:1 ratio to receive either low dose ADRCs cell enriched fat (n=20), high dose ADRC cell 
enriched fat (n=20), non-cell enriched autologous fat alone control (n=20), or no-fat control 
saline injections (n=10). Randomization will be via an interactive voice/web response system 
(IVRS/IWRS), or an alternatively acceptable system, and occur on the procedure day, prior to 
the start of liposuction. 
 
Patients randomized into the study will be assigned the treatment corresponding to the next 
available number in the computer-generated randomization schedule. The dose of the test 
material (ADRCs or placebo) is discussed in Section 6.3. 
 
Randomization and dose preparation will be performed by an unblinded pharmacist, or other 
designated qualified personnel, as outlined in the Study Reference Manual. The unblinded 
pharmacist or designee will not be involved in study patient care, management or follow up 
procedures and assessments. 

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5.3 
Blinding Procedures and Safeguards 
 
The following will be the “blinded parties”, meaning that the listed will have no knowledge of 
the patient’s treatment assignment: 
• Patients 
• Core Laboratories 
• Statistician 
The “unblinded parties”, meaning those that will or may have knowledge of a patient’s 
treatment assignment, will be the following:- 
• Investigators 
• Unblinded Pharmacist or designee involved in the dose preparation procedures and 
randomization of the patient 
• Data Monitoring Committee Members 
The study blind should not be broken except in a medical emergency (where knowledge of the 
test material received would affect the treatment of the emergency) or regulatory requirement 
(e.g., for SAEs or death). 
If unblinding becomes necessary, the Investigator should notify the Sponsor or the Medical 
Monitor as soon as possible. If the blind is broken, the date, time and reason must be recorded in 
the Subject’s electronic case report form (eCRF), together with a note of a protocol violation if 
applicable, and any applicable reports [e.g. Adverse Event (AE)]. 
 
5.4 
Subject Withdrawal and Replacement 
 
Subjects may withdraw from the study at any time and for any reason without penalty or 
prejudice to his or her future medical care. If a subject is prematurely withdrawn from the study 
for any reason, the reason(s) for withdrawal must be recorded in the Subject’s source 
documentation and on the eCRF. 
 
The Investigator must make every effort to perform the Early Termination evaluations. This visit 
shall take place as soon as possible after it is determined that the Subject will be withdrawn from 
the study and will comprise the observations and procedures scheduled at the next visit. 
 
 
6 
CELUTION & PUREGRAFT SYSTEMS 
 
6.1 
Celution& Puregraft System Descriptions 
 
The Celution System consists of a stand-alone re-useable hardware unit called the Celution 
Device, the Celution Consumable Set, and Celase®. The Celution System prepares an ADRC 
output from adipose tissue collected by standard liposuction techniques. 

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Following the collection of tissue, the adipose tissue is introduced into the device’s collection 
canister in order to wash the adipose tissue and remove deleterious substances (such as cellular 
debris)(Detailed instructions for use are found in the Celution User Manual, the Celution 
Consumable IFU and the Celase IFU). 
 
The Puregraft 50 System is a sterile, single use, closed system intended for the preparation and 
delivery of autologous fat grafts back to the same patient for cosmetic and reconstructive surgery 
applications. The dual filtration bag system utilizes its swabable luer activated valves to connect 
to an off-the-shelf sterile luer lock syringe and its attached slider is used to facilitate the 
movement of liquids through the filter mesh and out of the Puregraft bag through the drain stub 
as waste. Detailed instructions for use are found in the Puregraft IFU). 
 
6.2 
Device Characterization and Intended Use 
 
In combination with the Puregraft 50 System, the Celution System (Celution Device, Celution 
Consumables Set, and Celase reagent) is intended to digest adipose tissue in order to further 
extract, wash and concentrate adipose derived regenerative cells (ADRCs) intended for 
combination with autologous fat and reimplantation subcutaneously into the scalp for 
investigational use in the STYLE clinical trial. 
 
The Puregraft 50 System is intended to process and purify adipose tissue to be combined with 
concentrated stromal stem cells and other associated progenitor cells intended for autologous 
implantation subcutaneously into the scalp for investigational use in the STYLE clinical trial. 
 
6.3 
Contraindications 
 
1. Non-autologous use is contraindicated 
2. Use of any tissues other than adipose is contraindicated 
 
6.4 
Intended Clinical Performance 
 
The Celution System is designed to process lipoaspirated tissue and separate ADRCs from 
adipose tissue by enzymatic disassociation of the tissue and using buoyancy differences to 
separate the ADRCs from lipid containing adipocytes at the point of care. When ADRCs are 
prepared using the Celution System, the resultant cell suspension contains all of the components 
naturally occurring in the native tissue. Preparation of autologous ADRCs for subcutaneous 
delivery using the Celution System involves no cell culture and can be prepared and re-implanted 
into the same patient within three hours from completion of lipoaspiration. 
 
The total viable cell count and percentage viability for each sample will be used as the 
acceptance criteria. This will be assessed for each patient to decide whether the cell output is 
acceptable, and to prepare the prescribed dose. The viable cell count will be performed by the 
commercially available NucleoCounter® Automated Cell Counting System. Using a small sample 
of the Celution System output, the NucleoCounter Automated Cell Counting System provides a 
count of both live and dead nucleated cells in the total sample. All personnel involved will be 
trained according to standardized procedures and work instructions. Cytori has performed 
characterizations of the live cell output obtained by the Celution System and this is consistently 

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70% viability or greater. This sample count is used to calculate the total number of live nucleated 
cells from the total preparation, to arrive at percentage of viable cells that are available for 
introduction into the patient. 
 
The Puregraft System is designed to prepare purified lipoaspirate. This purification involves the 
near complete removal of free lipid, RBCs, and WBCs. All personnel involved will be trained 
according to standardized procedures and work instructions. 
 
6.5 
Celution& Puregraft System Output; Physical, Chemical, and Pharmaceutical 
Properties of ADRCs 
 
The output of the Celution System is an ADRC output obtained from autologous lipoaspirate 
tissue. The suspension of viable ADRCs has been characterized with an average viability of 
>70% and the average yield is 3.24 x 105 ± 1.48 of mononuclear cells per gram of adipose tissue 
entered into the Celution System. An index of regenerative cell potential, the CFU-F assay, 
shows that 1.51% of those ADRCs form colonies (mean range of 0.13 to 4.08% colony forming 
units). 
The product is a suspension of cells in a diluent. The cellular components of the suspension are 
made up of nucleated and non-nucleated cells. The non-nucleated cells are red blood cells (RBC) 
that comprise > 95% of the total cell suspension. The nucleated cells make up approximately 0.1 
– 5% of the total cell suspension. Nucleated cells are present in the following approximate 
minimum percentages: CD 31+, CD 34+ (> 2%); CD 34+, CD 31-, CD  45-  (>  10%); CD  45+, 
CD 31-, CD 34- (> 15%). The combination of these three phenotypes will account for greater 
than 90% of nucleated cells in the product. Table 1 summarizes the ADRC cellular suspension 
processed by the Celution System. 
 
Table 1. ADRC cellular suspension components and concentrations 
 
Cell Type 
Phenotype 
Relative Identity of Nucleated 
Cell Population 
% of total 
cell suspension 
Non-nucleated Cells 
Red Blood Cells 
> 95% 
Nucleated Cells 
CD 31+, CD 34+ 
> 2% 
0.1-5% 
CD 34+, CD 31-, CD 45- 
> 10% 
CD 45+, CD 31-, CD 34- 
> 15% 
 
 
Puregraft 50 System 
 
The Puregraft 50 System is used in conjunction with a lipoplasty device (user supplied) and does 
not contact the patient as it does not connect to vacuum. The Puregraft 50 System is only used on 
the back table in the operating room to rinse and filter an adipose tissue graft and prepare the 
graft for eventual injection back into the same patient during the same surgical procedure. The 
Puregraft 50 System is a bag with two tubing stubs/ports (tissue and drain) and is designed to 
harvest, rinse and filter the adipose tissue, and subsequently drain excess rinse solution away 

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from the adipose tissue. The rinsed and filtered adipose tissue is then removed from the Puregraft 
bag using syringes (user supplied) and ultimately transplanted back into the same patient. The 
Puregraft 50 System includes a slider tool that is attached to the exterior of the Puregraft bag. 
The slider is used to compress the Puregraft bag as a means to facilitate the movement of liquids 
through the filter mesh and out of the Puregraft bag through the drain stub/port as waste. 
 
6.6 
Proposed Mechanism of Action of Cell Enriched Autologous Fat Grafts 
 
The proposed mechanism of action of autologous fat grafts enriched with ADRCs prepared with 
both the Puregraft and Celution Systems is postulated to be follicular niche stimulation. This 
stimulation is believed to occur through modulation of inflammation, promotion of angiogenesis 
and prevention of cell apoptosis. Studies suggest that cell enriched autologous graft therapy 
changes the inflammatory response and augments the regenerative response. Studies have 
detected significant amounts of paracrine growth factors, which have been shown to facilitate 
vascularization, and as well as those associated with anti-inflammatory effects, thereby, 
ameliorating injury by proinflammatory cytokines. Viability characterization of ADRCs as 
described above in addition to pre-clinical animal data from Cytori and other published reports 
support this hypothesis. 
 
 
7 
STUDY TREATMENTS 
 
Subjects will be randomized 2:2:2:1 to active treatment (autologous fat enriched with ADRCs), 
autologous fat alone control, or no-fat control as follows: 
Active (0.5 x 106 ADRCs/cm2 scalp): 
20 Subjects 
Active (1.0 x 106 ADRCs/cm2 scalp): 
20 Subjects 
Autologous fat alone control: 
20 Subjects 
No-fat control (saline) 
10 Subjects 
 
The study treatment will be administered as subcutaneous injections of either fat or saline into 
the subcutaneous fat layer of the scalp (40cm2 of scalp) of each subject. Each square centimeter 
of scalp will be injected with 0.1 mL of purified autologous fat or saline followed by separate 
injection of either low or high dose ADRC injection per cm2 scalp, or saline (fat alone control 
and the no-fat control). To account for the variability seen in advanced grades of hair loss 
(Norwood Grade II and IV), treatment areas will be focused in the mid-scalp and crown (vertex). 
The leading edge of hair loss will not be treated, including the peri-orbital region as fat grafting 
in the peri-orbital region has been associated with higher-risk complications. 
 
 
 
 
7.1 
Product Description – Cell-enriched autologous fat 

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The active treatment used for the STYLE Trial will be cell-enriched autologous fat obtained 
from the study subject’s own adipose tissue which is prepared using the Puregraft and Celution 
Systems. 
 
The excipients in the cell suspension are composed of residual Celution System reagents and 
diluent. Specifically, the residual reagents are collagenase (<0.005 Wünch Units/mL) and 
thermolysin neutral protease (< 30 caseinase Units/mL). The diluentis Lactated Ringers solution 
(USP). 
 
Adipose tissue processing is detailed in both the Puregraft and Celution System Users Manuals. 
Preparation of the active study treatment is provided in the Study Reference Manual. 
 
7.1.1 Active Treatment Dose Control 
 
Autologous adipose purified with the Puregraft System can be readily removed directly with a 
sterile 1mL syringe to obtain a volume of 0.1mL for injection. 
 
ADRC Cell count and viability will be controlled using the NucleoCounterAutomated Cell 
Counting System (Enfield, CT) at each site using the following acceptance criteria: 
 
• Nominal cell count: 40 x 106 ADRCs 
• A minimum cell count within 50% of the nominal cell count is required (i.e., a dose as 
low as 20 x 106 ADRCs is acceptable if 40 x 106 ADRCs is not be available) 
• Cell viability: ≥ 70% 
If cell viability is <70%, as determined by the NucleoCounter Automated Cell Counting 
System, the subject will not be treated. 
• Negative result in Gram stain testing (see Section 7.3) 
7.2 
Product Description – Control Doses 
 
The fat alone control dose will be purified autologous tissue prepared by the Puregraft System 
that is not enriched with ADRCs but with saline. The amount of fat injected will be 0.1 mL/cm2 
of scalp. The fat alone control dose will also include injection of a saline solution which is mixed 
with 0.1mL to 0.2 mL of the study Subject’s own freshly drawn blood to achieve a dilution that 
is visually indistinguishable from ADRCs. The saline injection of the fat-alone control must test 
negative in a Gram stain test of sterility prior to being administered (see Section 7.3). Preparation 
of the fat-alone control dose is provided in the Study Reference Manual. 
 
The no-fat control dose will be 0.1ml/cm2 of scalp of saline injected (delivered by a blunt tip 
cannula) followed by a second matching dose of saline solution (via a 25G needle) to 0.1ml/cm2 
of scalp. 
 
7.2.1 Justification of Control Dose 
 
To reduce the risk of bias (selection bias, performance bias, detection bias and attrition bias), all 
patients will undergo pre-specified screening procedures, fat harvest, and injection of active 
treatment or placebo. The justification and rationale of the placebo dose arm include: 

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1. In the presence of a concurrent placebo control group, demographics and patient selection 
is more likely to be balanced allowing for more reliable interpretation of study results. 
 
2. Minimize the potential of the Hawthorne effect creating a positive impression of efficacy 
that may overstate the actual treatment effect. 
 
7.3 
Study Treatment Pre-Injection Sterility Testing 
 
Following cell processing in the Celution System, sterility testing will be performed as described 
below and more fully in the Study Reference Manual. 
 
A negative Gram stain test result is required prior to injection of ADRCs and/or fat alone control. 
A negative Gram stain test result is not required prior to injection of saline in the no-fat control 
arm. If the sample is determined to be positive for bacteria then the cellular administration 
procedure must be stopped and the subject should not receive any study treatment. 
 
Further testing (BacT Alert Culture and Sensitivity) will be performed in order to test for the 
presence of any low level microbial contamination that might not be apparent in the gram stain 
test. Should a culture be deemed positive for microbial activity, the investigator will be 
immediately notified. The study patient will be evaluated and a course of treatment and/or 
antibiotics may be administered, as determined by the study investigator. The source of the 
contamination will be evaluated as appropriate. The FDA and IRB will be notified within 15 
days of the investigator being made aware of any positive test results. 
 
The following flow chart describes the activities associated with positive or negative outcomes in 
these two tests of sample sterility. 
 
Figure 3: Sterility Testing of ADRC and Fat Alone Control Samples 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.3.1 ADRC Characterization 
Negative 
No Further 
Action 
Positive 
NO PATIENT 
TREATMENT 
Bac-T Test 
Positive 
IRB and FDA 
within 15 Days 
Gram Stain 
Negative 
No Further 
Action 
Negative 
Bac-T Test 
TREAT 
PATIENT 
Investigator 
Notification 
Positive 
Notify IRB and 
FDA within 15 
Days 

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In order to characterize the phenotype of ADRCs obtained from patients with alopecia 
androgenetica, adipose tissue will be obtained during the elective cosmetic liposuction.; up to 
360 mL of this tissue (maximum that can be processed by Celution Device) will be used to 
prepare the active study treatment (ADRCs) using the Celution System. Once it is determined 
that the cell dose has been achieved according to criteria described in Section 7.1.1, any 
remaining adipose tissue may be shipped to an outsourced facility of the Sponsor (if within two 
hours of the outsourced laboratory) according to procedures outlined in the Study Reference 
Manual. 
 
In the Sponsor’s outsourced contract laboratory, ADRCs will be prepared from collected adipose 
tissue using the same Celution System as used in the clinic and the cell output characterized 
using colony forming unit – fibroblast (CFU-F), a measure of the number of adipose stem cells, 
and multiparametric flow cytometry analyses used to define the major non-progenitor cell 
populations in ADRCs. In the flow analyses ADRCs will be stained using antibodies directed to 
CD31, CD34, CD136 and CD45 proteins. Based on the expression of these four markers, the 
major populations will be defined as follow: 
 
Leukocytes 
CD45+ 
Endothelial Cells 
CD34+/CD31+/CD45- 
Stromal Cells 
CD34+/CD31-/CD45- 
Mural cells 
CD34-/CD31-/CD45-/CD146+ 
 
If sufficient cells are available, additional characterization of subpopulations will be performed 
using antibodies such as CD3, CD14, CD19, and CD16/56. 
 
8 
STUDY ASSESSMENTS 
 
All assessments will be conducted at specific time points as outlined in this section and in the 
Schedule of Assessments in Appendix A. 
 
8.1 
Medical History, Physical Examination & Vital Signs 
 
A complete medical history will be collected at the Screening Visit and will include demographic 
information as well as current and past medical conditions. Updated medical history information 
is to be collected at the Day -1 including any event that has occurred since the Screening Visit 
that could be considered an adverse event. Any adverse event that occurs after the ICF is signed 
and prior to administration of the study drug is to be recorded as an update to the Medical 
History. 
 
Physical examinations should be based on the following body systems: general appearance, head 
(ear, eyes, nose and throat), cardiovascular, respiratory, abdomen, musculoskeletal, neurological, 
lymph nodes, and skin. Vital signs to be obtained include the following: 
 
• Blood pressure (systolic and diastolic; mm/Hg) 
• Heart rate (beats per minute) 
• Body temperature (°F) 
• Respiration rate (per minute) 

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8.2 
Hair & Scalp Evaluation Assessments 
 
The physical status and satisfaction of the subjects’ scalp and hair will be evaluated using several 
assessment tools. The assessment tools are listed below and detailed information and instructions 
provided in the Study Reference Manual. 
 
• Hair Investigator Satisfaction Survey 
• Patient Satisfaction Survey 
• Trichogram analysis 
• Global photography 
8.3 
Prior and Concomitant Medications 
 
Any medication a subject receives is considered a concomitant medication, and must be recorded 
in the subject’s source documentation throughout the study. All concomitant medications will be 
recorded in the eCRF from 90 days prior to screening through 24 weeks post procedure. 
 
Information to be recorded on the eCRF will include: generic medication name, route of 
administration, dosage, indication, start date, and stop date. Medications used as part of the 
liposuction and injection procedure do not need to be recorded in the eCRF but should be 
recorded as part of the operative records. As needed analgesic medications will be recorded by 
the subject’s in a daily medication diary for the 14 days immediately preceding the next study 
visit. 
 
8.3.1 Prohibited Medications 
 
Subjects should not receive the following medications: 
 
• Minoxidil, or any oral or topical medication including over the counter and herbal 
medications for the treatment of hair loss within 6 months of study screening, or 
finasteride or dutasteride within 12 months of study screening 
• Treatment with an investigational product or procedure within 30 days of study screening 
 
• Systemic steroids exceeding prednisone 10 mg daily (or equivalent) 
 
• Biologic agentsor immunosuppressive medications within 90 days of the Screening Visit 
If treatment with any prohibited medication becomes necessary during study participation, the 
subject will be discontinued from the trial. 
 
8.4 
Laboratory Procedures 
 
All laboratory assessments will be performed locally at each center’s laboratory by means of 
their established methods (using site specific laboratory normal values). Blood and urine samples 
should be taken using standard techniques and samples should be stored and shipped according 
to the laboratory guidelines. 

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8.5 
Adverse Events 
 
Adverse events will be recorded Starting on Day 1, immediately after study procedure has started 
and through to the End-of-Study (Week 24), Any adverse events experienced between signing 
the ICF and prior to administration of the study drug will be recorded in the medical history. See 
Section 12 for more information pertaining to recording of adverse events. 
 
9 
STUDY VISIT REQUIREMENTS 
 
The Schedule of Procedures is outlined in Appendix A. 
 
9.1 
Screening (within 28 to 7 days prior to procedure) 
 
Subjects will undergo the following screening procedures: 
 
• Written informed consent 
• Inclusion and exclusion criteria evaluation 
• Medical history 
• Prior and concomitant medications 
• Physical examination 
• Laboratory Tests 
o CBC with Platelets 
o Electrolytes, alkaline phosphatase, bilirubin, AST, ALT, BUN, Creatinine 
o PTT, PT/INR 
• Vital signs 
• Pregnancy test (urine) for female patients of child-bearing potential 
• Evaluation of suitability for fat tissue harvest and liposuction procedure(see Section 
9.3.3.1) 
 
The following tests are to be performed: 
 
• Global Photography 
• Trichogram with tattooing 
 
9.2 
Pre-Operative Procedures (Day -1; performed within 24 hours of the liposuction) 
 
• Confirm inclusion/exclusion criteria 
• Physical Examination 
• Vital Signs 
• Assessment for Adverse Events 
• Concomitant Medications 
o Collect daily medication diary completed for 14 days immediately preceding visit 
• Laboratory Tests 
o CBC with Platelets 
o Electrolytes, alkaline phosphatase, bilirubin, AST, ALT, BUN, Creatinine 
o PTT, PT/INR 

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• Pregnancy test (urine) for female patients of child-bearing potential 
9.3 
Procedure Day (Day 1) 
 
9.3.1 
Fat Harvest 
 
9.3.1.1 General requirements 
 
• Fat harvest will be performed on the day of treatment as part of an independent, elective 
cosmetic liposuction. 
• Fat harvest planning should include assessment of patients general health condition to 
undergo the procedure 
• Standard tissue calipers or expert plastic surgical examination should be used to assess 
possible body sites for subcutaneous fat tissue. Patients should have greater than or equal 
to 2 cm of subcutaneous fat tissue available in each contemplated area to be suitable for 
liposuction 
• Prepare up to 3 sites, including the preferred abdomen and flanks along with the inner 
and the outer thighs and  the  posterior  and  anterior  thighs.  To  estimate  harvestable  
fat from the harvest site    the     following     guideline     may     be     used: Estimated  
fat from the harvest site = volume of the site/8 = length of the marked skin x width of the 
marked skin x height (i.e. caliper skin-fold thickness) / 8. All patients who have 
inadequate fat deposits (i.e. < 200 ml of lipoaspirate from 3 bilateral sites) are to be 
excluded from the study. Any patient with an area of active skin infection in the site of 
lipoharvest will be excluded from the study. 
• As noted elsewhere in this protocol, fat harvest should NOT be performed on patients 
who have received any anticoagulant within 1 hour of liposuction, substantial 
anticoagulation (e.g.: GIIb/IIIa inhibitor class drugs) within the two weeks prior to fat 
harvest, or who have an abnormal aPTT. 
• Fat tissue should be obtained under sterile technique using local anesthesia with or 
without conscious sedation. General anesthesia should not be used. 
 
9.3.1.2 Fat Harvest Procedure 
 
Fat harvest from small volume liposuction is a standard procedure practiced by trained 
physicians in a variety of settings and using a variety of techniques. However, a specific set of 
guidelines have been established for the collection of fat that can then be used for the optimized 
preparation of ADRCs. These guidelines, which are recommendations and not requirements, 
include the following; 
 
· 
Syringe-based fat harvest is preferred. 
· 
Use up to 32 cm long, 3-5 mm inner diameter Toomey cannula with a standard tip 
· 
60 mL Toomey syringes are used for tissue acquisition 
· 
Use  14 gauge, up to 30 cm, blunt LAMIS infiltrator for tumescent fluid 
administration 
· 
Symmetric fat removal is required keeping the overall area of aspiration as small as 
possible 

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· 
The abdominal region is the preferred site for fat harvest 
 
1. 
Local anesthesia with or without conscious sedation; general anesthesia is not permitted 
for fat harvest 
2. 
Using sterile technique, prepare up to 3 sites, including the preferred abdomen and 
flanks along with the inner and the outer thighs and the posterior and anterior thighs. 
3. 
Make an approximately 0.5 cm stab skin incision 
4. 
Infiltrate tumescent solution using a blunt LAMIS infiltrator and a volume ratio of 1:1 
of tumescent solution to fat to be harvested 
 
Tumescent fluid formula: 
· 
500 mL of Lactated Ringers solution 
· 
20 mL of 1% Lidocaine 
· 
1 mg of epinephrine 
 
5. 
To sufficiently induce vasoconstriction/hemostasis during the liposuction procedure a 
minimum of 500 mL of tumescent fluid must be used. 
6. 
After approximately 10 minutes, the adipose tissue is harvested through the same incision, 
using the aspiration cannula attached to the Toomey syringe 
7. 
After the syringe is filled (complete filling is not required), cap syringe and replace with 
empty one 
8. 
Continue fat harvest until desired volume is safely achieved, with the target volume of 
adipose tissue harvested limited to approximately 450 mL 
9. 
Fat harvest will be limited to areas where tumescent fluid has been infiltrated 
10. Vital signs are monitored continuously during liposuction procedure 
11. Close surgical incision with appropriate suture 
12. Apply pressure bandage immediately upon conclusion of tissue harvest 
 
NOTE: Approximately 0.5 mL blood must be drawn and delivered to the unblinded staff prior to 
dose preparation. The blood will be used to prepare the fat alone control (see Section 7.2). 
 
9.3.1.3 – Fat Harvest Stopping Rules 
The physician performing the fat harvest procedure should continuously monitor the patient for 
signs of significant bleeding from the puncture site(s) and overall hemodynamic stability. The 
liposuction procedure should be terminated if any of the following occur: 
 
1. 
Drop in systolic blood pressure < 90mm/Hg that is unresponsive to volume or 
pressor support 
2. 
Profuse or uncontrollable bleeding from the puncture site(s) 
3. 
Rapid expansion of subcutaneous space at the liposuction site(s) related to bleeding 
into the subcutaneous space 
4. 
Hemoperitoneum or pnuemopertinoeum 
5. 
Hemothorax or pneumothorax 
6. 
Evidence of perforation of a vascular structure that requires ligature or surgical 
control 

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7. 
Evidence of perforation into abdominal cavity, peritoneum or gastrointestinal organ 
 
Should any of the above occur, the fat harvest procedure should be terminated and the patient 
treated according to standard of care. DO NOT PROCEED WITH INJECTION. Complete the 
study specific SAE form and notify the sponsor within 24 hours. 
 
 
9.3.2 Between Fat Harvest and ADRC Injection 
 
Vital signs will be monitored continuously between the fat harvest and cell injection procedures. 
 
9.3.3 Fat + ADRC Injection 
 
The following procedure is recommended for subcutaneous injection into the scalp for the 
treatment of baldness due to alopecia androgenetica: 
 
Autologous Fat & Saline Injection 
This fat or saline injection procedure will occur after the completion of the liposuction. Aseptic 
technique should be maintained throughout the procedure. A treatment grid will be prepared in 
the area to be treated. The grid is a piece of silicone rubber that is placed on the scalp of the 
subject in the desired position and a surgical skin marker is used to mark each of the holes which 
are spaced every centimeter. The recipient site is anesthetized using a local ring block with 1% 
lidocaine with 1:100,000 epinephrine. Aliquots of 0.2mL should be injected in a circular ring 
fashion and the dosage should be adjusted according to the response of the patient and the site of 
administration. The lowest concentration and the smallest dose producing the required effect 
should be given. The maximum dose delivered should not exceed 7mg/kg. Sedation may be 
employed to minimize patient discomfort at the discretion of the investigator. Tissue from the 
Puregraft 50 is prepared in separate, sterile 1mL luer lock syringes, and an 11-blade scalpel can 
be used to make a stab incision (incision is made at a strategic insertion point to facilitate access 
to the area to be treated) to allow insertion of a 0.9mm-1.2mm diameter blunt-tip cannula. This 
cannula is then inserted into the subcutaneous adipose tissue plane and the tip is fanned into each 
1 square centimeter grid to deliver 0.1mL of tissue or saline (no-fat control). 
 
ADRC & Saline Injection 
After preparation of the ADRCs, either the low or high dose of ADRC or saline will be injected 
using a 25G needle directly through the skin into the layer of subcutaneous adipose using the 
identical grid markings made in the paragraph described above. Additional local anesthesia ± 
sedation may be applied as deemed necessary by the investigator. 
 
 
A summary of the clinical workflow is described in Appendix C. 
 
9.4 
Immediately Post-Injection (Day 1) 
 
• Vital Signs will be monitored for one hour following the injection procedure 
• HGB/HCT blood level will be evaluated 

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• Assessment of injection and fat harvest site 
• Overall physical assessment 
9.5 
Post-injection Follow-up visits (Week 1) 
 
• Physical examination 
• Vital Signs 
• Assessment for Adverse Events 
9.6 
Post-injection Follow-up visits (Weeks 6, 12, 24, and 52) 
 
• Physical examination 
• Vital Signs 
• Assessment for Adverse Events 
 
The following tests are to be performed: 
 
• Subject questionnaire 
• Global photography 
• Hair Investigator Satisfaction Survey 
A summary table of all follow up evaluations is outlined in Appendix B: Schedule of Procedures 
 
9.7 
Early Termination Evaluation 
 
Subjects that discontinue early from the study, unless consent is withdrawn, shall have an Early 
Termination (ET) evaluation. This visit shall take place as soon as possible after it is determined 
that the Subject will be withdrawn from the study. 
 
If the ET Visit occurs prior to the Week 24 visit the observations and procedures for the ET Visit 
are the same as those required at the Week 24. 
 
The reason for early withdrawal must always be clearly documented in the Subject’s source 
documentation. Contact with the Subject must be attempted to determine overall health status, 
and contact details must be documented in the Subject’s source documentation. If lost to follow- 
up, details of three contact attempts must be documented in the Subject source documentation 
and every effort must be made to determine if the Subject has expired. 

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10 RISK/BENEFIT ANALYSIS 
 
10.1 
Risks 
 
The use of adult regenerative cells from adipose tissue and other sources has shown 
improvement in muscular (cardiac) function after injection into ischemic areas of the heart. The 
PRECISE Clinical Trial has shown an acceptable safety profile and signs of benefits following 
intramyocardial administration of ADRCs processed by the Celution System. Every potential 
complication of ADRC injections are unknown at this time; however injection of cells from 
adipose tissue have been delivered with guided intramyocardial injections with no clinical 
significant sequelae. A clinical trial of 12 patients with hand dysfunction and pain from 
scleroderma followed for 6 months showed minor adverse events related to subcutaneous 
injection, typical liposuction adverse events, and no adverse events directly related to ADRCs. 
 
10.1.1 Subcutaneous Delivery Risk Analysis 
 
Risks involved with subcutaneous delivered adipose plus cells include: 
 
• Hematoma or bleeding 
• Infection 
• Inflammation, rash, or papules at the injection site 
• Nerve injury, pain, paresthesias or sensory disturbances 
• Diminished function 
• Shock loss 
Direct intramuscular injections of Celase has been carried out in rodent models showing a 
margin of safety of greater than 10 for injection of Celase into the heart muscle. In addition, 
intra-ventricular applications of ADRCs into rat hearts during efficacy studies did not result in 
adverse events over 12 weeks of follow-up. Further, as noted above, 21 patients treated by direct 
injection into the muscle of the heart in the course of the PRECISE study exhibited no adverse 
events associated with ADRC injection In addition, a study of 12 patients with subcutaneous 
injection in the fingers of patients with scleroderma showed minor adverse events and no serious 
adverse events. 
 
10.1.2 Subcutaneous Injection Risk Management 
 
Investigators and all study personnel will be trained in the details of all aspects of the study 
procedures. To minimize risks and increase the chances of a favorable clinical outcome the 
following measures are required: 
 
• Enrollment of Subjects who qualify per the inclusion/exclusion criteria in the protocol 
• Strict adherence to the study protocol 
• Use sterile technique throughout the procedure 
• Use standard of care for the monitoring of and treatment of possible adverse events 
following injection procedure 

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10.1.3 Celution & Puregraft System Risk Analysis 
 
The investigators and all study personnel will be trained in the details of all aspects of the study 
procedures relevant to their particular area of responsibility. 
 
• Train investigators and all study personnel in the details of the operation of the Celution 
& Puregraft System. 
• Inspect the package integrity and sterility indicators on all disposables used with the 
devices and maintain sterility of the fluid paths. 
• Follow Instructions for Use for the Celution & Puregraft Systems, including all warnings, 
precautions and contraindications. 
 
10.1.4 Overall Study Risk Management 
 
The following measures implemented by Kerastem will minimize the risks associated with 
patients’ participation in clinical studies: 
 
• Kerastem selects personnel (Kerastem employees, agents, licensees, and clinical 
investigators at the sites) with extensive experience in conducting clinical studies and in 
performing procedures involved in the protocol including fat harvest and procedures 
involving the hands 
• All examinations, treatment procedures, and interpretation of clinical data generated 
during the study is directed, overseen and analyzed by an appropriately licensed and 
credentialed physician who has been trained to the clinical study protocol. 
• Kerastem developed the clinical protocol and training programs to ensure that the study 
personnel at Kerastem and at the clinical sites have a strong knowledge and 
understanding of the clinical protocol, including patient selection criteria and procedure 
requirements. 
• Kerastem will ensure that the investigators are trained to the procedure requirements in 
the protocol, and the Instructions for Use for the Celution and Puregraft Systems. 
• Kerastem carefully developed patient eligibility criteria for the investigation including 
clearly defined inclusion and exclusion criteria to ensure that only properly selected 
patients will be enrolled in the clinical study. 
• The protocol is designed so that patient treatment and follow-up procedures will be 
consistent with those of the clinically established standard of care. 
 
10.1.5 Fat Harvest Risk Analysis 
 
The risks of standard small volume liposuction in healthy patients are known and are minimal 
and recovery is usually fast. Following standard liposuction the following effects can be 
expected: 
 
Common 
· 
Edema and redness of the liposuction areas for a few days 
· 
Moderate contusion of the liposuction areas for a few months 
· 
Uncommon 
· 
Persistent edema 

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Rare 
· 
Persistent bleeding 
· 
Hematoma 
· 
Visible puncture sites 
 
· 
Infection 
· 
Deep Vein thrombosis (DVT) 
· 
Persistent bleeding requiring transfusion 
 
 
10.1.6 Fat Harvest Risk Management 
 
The Investigators and all study personnel will be trained in the details of all aspects of the study 
procedures. Standardization of fat harvest techniques is critical to a good clinical outcome. To 
minimize risks and increase the chances of a favorable clinical outcome the following measures 
are required for the liposuction procedure: 
 
• Performed by an appropriately licensed and credentialed physician 
• Monitoring of vital signs throughout the procedure. 
• Sterile technique is followed throughout. 
• The adipose tissue is handled gently at all times. 
• HGB, HCT prior to and 1-2 hours post-procedure 
• To sufficiently induce local vasoconstriction/hemostasis during the fat harvest procedure, 
a minimum of 500 mL of tumescent fluid is used containing: 
o 500 mL of Lactated Ringers solution 
o 20 mL of 1% Lidocaine 
o 1 mg of epinephrine 
• A blunt 14 to 16 gauge LAMIS infiltrator (or equivalent) will be used for infiltration with 
tumescent solution 
• After ~10 minutes, the adipose tissue may be harvested through the same incision, using 
the aspiration cannula attached to a syringe 
• A blunt cannula with a minimum inner diameter of 3 mm is preferred for lipoaspiration. 
• Lipoaspiration is recommended to be done manually using a syringe (60 mL Toomey 
syringe is preferred). 
• Enrollment of only patients who qualify per the inclusion / exclusion criteria defined in 
the protocol) including screening blood work 
• Strict adherence to the study protocol 
• Standard of care for the monitoring of and treatment who experience any adverse event 
for liposuction 
• Target volume of adipose tissue is limited to approximately 450 mL 
• Close surgical incision with appropriate suture 
• Apply pressure bandage immediately upon conclusion of tissue harvest 
 
Fat harvest should NOT be performed on patients who have received any anticoagulant within 1 
hour of the procedure, substantial anticoagulation (e.g.: GIIb/IIIa inhibitor class drugs) within 
two weeks prior to fat harvest, or who have an abnormal PTT. 

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10.2 Potential Benefits 
 
This clinical investigation is designed as a safety and efficacy study. Therefore, it is not known at 
this time whether any direct subject benefit can be expected. Given the proposed mechanism of 
action of autologous adipose enriched with or without ADRCs, we expect there may also be a 
beneficial effect in the treatment of baldness due to alopecia androgenetica. Previous ex-US 
patient experience with similar inclusion/exclusion criteria documented encouraging positive 
efficacy results and a favorable benefit to risk profile (abstract accepted at 2014 International 
Federation of Adipose Therapeutics and Science (IFATS) Annual Meeting-November 2014). 
 
 
11 STATISTICAL METHODS AND DATA ANALYSIS 
 
This is a multi-centre, single-blinded, randomized, parallel group, controlled study to evaluate 
the preliminary safety of cell-enriched autologous fat compared to placebo in patients with 
baldness due to alopecia androgenetica. The primary endpoint will be the safety and tolerability 
of the procedure. 
 
An analysis of covariance (ANCOVA), with the baseline measure used as a covariate, will be 
used for the analyses of the secondary efficacy endpoints. Comparisons of each active arm with 
placebo will be made using Dunnett comparisons. The ITT population will be used for the 
primary analysis; the analysis will also be performed in the PTE population and will be 
considered as supportive of the ITT analysis. 
 
11.1 
General Considerations 
 
All statistical tests will be two sided, and statistical significance will be assessed with respect to a 
nominal p-value of 0.05. Before the first data review meeting of the DMC is held, a separate 
statistical analysis plan (SAP) will be completed, providing detailed methods for the analyses 
outlined in the following subsections. The SAP will detail all planned analyses and will serve as 
a statistical programming requirements document. 
 
11.2 
Determination of Sample Size 
 
The sample size for the trial has been set at 70, based on clinical considerations and is not based 
on formal power calculations. 
 
The objective of the STYLE Trial is to assess the safety and preliminary efficacy of cell-enriched 
autologous adipose delivered via a subcutaneous route in the treatment of baldness due to 
alopecia androgenetica. As the primary endpoint is safety and tolerability, the investigators 
believe that a sample of 20 subjects per arm and a 10 patient no-fat saline control is adequate. 
 
11.3 
Data Analyses 
 
Safety and efficacy endpoints will be summarized by treatment group using descriptive statistics 
(n, mean, SD, median, minimum, and maximum), for quantitative variables and frequencies and 
percentages for categorical variables. Laboratory data will also be summarized using shift tables 

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between before procedure and at Day 1, post procedure, with values categorized as less than 
lower limit of normal range, within normal range, and above upper limit of normal range. 
 
For quantitative efficacy variables, summaries will be provided at each post-baseline visit time 
point. Additionally variables will be analyzed using ANCOVA models with adjustment for the 
baseline value of the variable. 
 
Related adverse events will be analyzed separately for those related to ADRCs and the delivery 
of ADRCs (i.e., injection site such as shock loss). A separate safety analysis will be performed 
for Adverse Events of Interest (Appendix B, Adverse Event Terminology and Grading). 
 
11.3.1 Primary Endpoint Analysis 
 
The primary endpoint for the study is safety and tolerability through 24 weeks 
The hypotheses are: 
Adverse event rates through 24 weeks for active treatment will be less than or equal to 
adverse events rates published for autologous fat grafting. 
 
Vital sign abnormalities through 24 weeks for active treatment will be less than or equal 
to those published for autologous fat grafting. 
 
Physical exam abnormalities through 24 weeks for active treatment will be less than or 
equal to those published for autologous fat grafting. 
 
The corresponding null hypotheses are that the adverse event rates will be greater for active 
treatment arms than for placebo. 
 
Statistical testing will not be performed for these hypotheses, but the safety endpoints will be 
evaluated clinically. 
 
11.3.2 Secondary and Exploratory Endpoint Analysis 
 
The secondary endpoints are change from baseline in the (a) Average Trichogram growth rates at 
24 weeks, (b) Average Trichogram density rate at 24 weeks, and (c) global photographs at 24 
weeks and (d) hair Investigator Satisfaction Survey at 24 weeks. Multiplicity adjustment will not 
be made when testing the three secondary endpoints. 
 
Exploratory endpoints are listed in Section 4.5. As these are exploratory, p-values for each 
analysis will not be corrected for multiple comparisons. These analyses will provide evidence 
concerning the safety of effectiveness of the product. 
 
11.3.3 Subgroup Analysis 
 
Statistical analysis of efficacy and safety endpoints will be performed in the total group. 
 
11.4 
Background, Demographic Analyses 

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Demographic data, medical history, concomitant disease will be summarized by means of 
descriptive statistics (n, mean, SD, median, minimum and maximum) or frequency tables, 
stratified by treatment. 
 
11.5 
Subject Disposition & Analysis Populations 
 
Reasons for withdrawal post-randomization will be summarized. 
 
The treatment analyses will be performed on intent-to-treat basis as well as on a per-treatment- 
evaluable basis, as defined below: 
 
Safety: All treated subjects; subjects will be analyzed as treated. 
 
Intent-to-Treat (ITT): All randomized subjects; randomization will occur on procedure day prior 
to liposuction. Subjects will be included in the analysis as randomized 
 
Per-Treatment-Evaluable (PTE): All randomized subjects who have received treatment and 
follow-up information is available. Protocol violators, where the violation is judged to affect the 
interpretation of the treatment effect will be excluded. All exclusions will be made prior to the 
breaking of the treatment blind. 
 
11.6 
Handling of Missing Data 
Safety data will not be imputed. 
PTE data will not be imputed. 
Missing efficacy data will be imputed for the ITT analysis population. For missing data caused 
by worsening of scleroderma (either hand or systemic manifestation), the missing value will be 
replaced by the least favorable observation from the prior Visits excluding baseline. For other 
missing data, last observation carried forward will be the primary method of imputation. As a 
sensitivity analysis, multiple impute ion methods (SAS PROC MI and PROC MIANALIZE) will 
be used. 
 
For the analysis of quality of life, missing responses to individual questionnaire items will be 
imputed using the methods prescribed by the questionnaire vendor. 
 
11.7 
Protocol Deviations 
 
Deviations from the protocol including violations of inclusion/exclusion criteria will be assessed 
as “minor” or “major” in cooperation with the Sponsor. Deviations will be defined prior to un- 
blinding. Major deviations may result in removal from the PTE analysis population. 
 
11.8 
Data Monitoring Committee 
 
The independent Data Monitoring Committee (DMC) will be comprised of medical specialists 
and a biostatistician who are not participants in the study. The DMC will be provided with all 
safety data as well as efficacy data for the primary and secondary endpoints in order to fully 

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evaluate the benefit to risk profile of the study procedures. The DMC will be responsible for the 
review of the data and generate recommendations on the conduct of the trial. 
 
The DMC will be asked to review data and generate recommendations after 10, 20 and 40 
subjects have at least 1 week of follow-up. 
 
 
11.8.1 Adverse Events Initiating Safety Review 
 
The Sponsor is to be informed of the following adverse events within 24 hours of the site 
becoming aware of the event: 
• Gangrene of the scalp in two (2) or more within fourteen (14) days of the procedure 
• Infection of the scalp requiring hospitalization and intravenous antibiotics in two (2) or 
more patients within seven (7) days of the procedure 
Within 24 hours of notification, the Sponsor will report the event to the DMC Chair for 
evaluation. The DMC Chair will review the event and decide whether to convene a meeting of 
the DMC. 
In all cases, the DMC Chair or the DMC will be responsible for recommendations to continue 
the trial, continue the trial with modifications, pause the trial such that further evaluation can be 
conducted, or terminate the trial. 
 
 
12 ADVERSE EVENTS / SERIOUS ADVERSE EVENTS 
 
12.1 
Definitions 
 
An adverse event (AE) is defined as any undesirable experience occurring to a Subject during 
the course of the study, whether or not it is related to the test material or the study procedure. 
Expected adverse events are those that are listed as known risks of the liposuction or injection 
procedure including those described in this protocol, informed consent, and/or the Investigator’s 
Brochure. 
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that: 
• Results in death, 
• Is life-threatening, 
• Requires or prolongs Subject hospitalization 
• Results in persistent or significant disability or incapacity 
• Is an important medical event(s) that may not be immediately life-threatening or 
result in death or hospitalization but that may jeopardize the Subject or require 
intervention to prevent one of the above outcomes 
• Is a congenital anomaly/birth defect. 
Medical and scientific judgment should be exercised in deciding whether a case is serious and 
whether expedited reporting is appropriate. 

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An Unanticipated Adverse Device Effect is defined as any serious adverse effect on the health 
and safety or any life-threatening problem or death caused by, or associated with the Celution or 
Puregraft system devices, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application or any other 
unanticipated serious problem with the Celution or Puregraft system devices that relates to the 
rights, safety or welfare of subjects. 
 
12.2 
Procedures for AE Reporting 
 
All AEs will be recorded by the investigator or designee on the appropriate electronic case report 
form (eCRF). Events that occur prior to the liposuction-related activities, including those that are 
considered serious, are to be recorded in the medical history. Events, including SAEs, which 
occur after liposuction-related activities are initiated on procedure day, are to be recorded on the 
AE eCRF. The investigator will evaluate the relationship of the adverse event to both the test 
material and study procedure as unrelated, unlikely, possibly, probably, or definitely related and 
will record the findings, including all pertinent details of the event on the eCRF. 
 
In addition, the Investigator or designee will report any serious adverse events, including UADE, 
occurring during this study to the Sponsor and Medical Monitor as soon as possible, but no later 
than 24 hours after the Investigator first identifies the adverse event. 
 
The Investigator will take appropriate measures to ensure the subject’s well-being and document 
these measures on the appropriate eCRF. 
 
All serious adverse events experienced will be monitored until the event has resolved, any 
abnormal laboratory values have returned to baseline or stabilized at a level acceptable to the 
Investigator and Medical Monitor, or until there is a satisfactory explanation for the changes 
observed. 
 
12.3 
Adverse Event Terminology 
 
Specific adverse events of interest are described in Appendix B, Adverse Event Terminology and 
Grading (from National Cancer Institute Common Terminology Criteria for Adverse Events). 
When an AE of interest occurs, the Investigator will apply the terminology in Appendix B, 
Adverse Event Terminology and Grading and indicate the grading. 
 
12.3.1 Injection Site Related Adverse Events 
 
Injection site related adverse events are outlined in Appendix B, Adverse Event Terminology and 
Grading (i.e. from National Cancer Institute Common Terminology Criteria for Adverse Events). 
 
 
13 EMERGENCY DEVIATION FROM THE PROTOCOL 
 
In case of an emergency threatening the continued well being of the Subject, the Investigator 
may deviate from the protocol. The circumstances necessitating the deviation and the 

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intervention(s) required will be recorded on the eCRF. The Sponsor must be notified as soon as 
possible, but no later than 5working days after event(s) occurred. 
 
 
 
 
14 REGULATORY OBLIGATIONS AND STUDY REQUIREMENTS 
 
14.1 
FDA and Institutional Review Board Approval 
 
Study initiation will not take place until the following regulatory requirements are met: 
 
• Food and Drug Administration (FDA) approval with accompanying approval letter. 
• Local Institutional Review Board (IRB) full approval with accompanying approval letter. 
14.2 
Informed Consent 
 
Written informed consent will be obtained from all Subjects prior to the initiation of any study 
specific procedures. No tests or procedures required in this protocol that are outside the standard 
practice for treating hamstring tears will be initiated prior to obtaining written informed consent. 
The original ICF will be filed in the Investigator Site File. 
 
14.3 
Monitoring Procedures and Data Management 
 
14.3.1 Site Qualification 
 
A site qualification visit will be performed to evaluate site facilities, Investigator qualifications, 
adequacy of staffing, and understanding of clinical and regulatory requirements. 
 
14.3.2 Site Training 
 
All Investigators and appropriate study staff will be required to participate in a site training (or 
initiation if appropriate) to provide orientation and training to the Celution System, the Puregraft 
System, the STYLE Trial protocol, eCRFs and other study related documents and procedures. 
 
14.3.3 Monitoring 
 
During the course of the study, a representative of the Sponsor will make site visits to review 
protocol compliance, compare eCRFs and individual subject’s medical records, assess test article 
accountability, and ensure that the study is being conducted according to pertinent regulatory 
requirements. eCRF entries will be verified with source documentation. The review of medical 
records will be performed in a manner to ensure that Subject confidentiality is maintained. 
Reviewing the eCRFs for completeness and clarity, and cross-checking with source documents 
and reviewing any discrepancies or issues with the Investigator will be required to monitor the 
progress of the study. Moreover, regulatory authorities (United States Food and Drug 
Administration) and/or the Sponsor’s Clinical Quality Assurance Group may wish to carry out 
such source data checks and/or on-site audit inspections. Direct access to source data will be 

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required for these inspections and audits; they will be carried out giving due consideration to 
data protection and medical confidentiality. 

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14.3.4 Reporting Requirements 
 
The following reports are required of the Investigator: 
 
• eCRFs for each subject entered into the study (this includes all screen failures as well) 
• Reports of any SAEs within 24 hours of becoming aware of events 
• Final report at the conclusion of the study 
• Progress reports to the Sponsor, clinical monitor, and IRB at regular intervals – at least 
yearly 
• Report to the Sponsor, within 5 working days, of withdrawal of approval by the 
reviewing IRB 
• Report to the Sponsor and IRB of any emergency changes made to the protocol to protect 
the life or physical wellbeing of a Subject no later than 5working days after the 
emergency occurred 
 
14.3.5 Data Management 
 
Data management will be conducted by the Sponsor or designee, and will include a data 
management plan and data verification guide developed according to protocol requirements. 
 
14.4 
Study Center and Investigator Requirements 
 
To protect the rights and welfare of Subjects, the study will be conducted in conformance with 
the Declaration of Helsinki, the guidelines on GCPs, Code of Federal Regulations (21 CFR 11, 
50, 56, 812, 814 and 820) and applicable local laws and regulations pertaining to the conduct of 
the study and the protection to human Subjects. 
 
All Investigators, sub-investigators and study personnel are required to read and follow the 
protocol, as well as any literature that accompanies the products prior to conducting the study 
procedure for the first time. In addition, all Investigators will sign and date the Investigator 
Statement Page of this protocol. All Investigators participating in this study will be trained in the 
proper use of the study procedure and in the components of this protocol. 
 
The Principal Investigator (PI) is ultimately responsible for the conduct of this study; however, 
he/she may designate a member of his/her staff to assist with the collection of data and 
completion of eCRFs. The designee(s) will be documented on an authorization form that is 
signed by the PI and kept in the Regulatory Binder, to be updated as necessary. Current copies of 
the authorization form will be forwarded to the Sponsor. 
 
Obtaining informed consent in accordance with national policy is mandatory for Subject 
participation. All Subject data is kept confidential and procedures will be implemented to ensure 
that Subject confidentiality is not compromised. 
 
If additional materials are used for screening and recruitment or provided to study Subjects (i.e. 
advertisements, recruitment materials) they must be approved by Kerastem and the Institutional 
Review Board at the clinical site prior to use. Documentation of the approved informed consent 
must be provided to Kerastem prior to study commencement at the clinical site. 

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After a Subject has signed the Informed Consent Form, an eCRF will be initiated. After this 
point, the reason(s) must be documented on the report form for any Subject who has dropped, 
withdraws, or for any reason cannot complete this study. 
 
14.4.1 Study Center Requirements 
 
Due to the nature of the STYLE Trial, centers will be considered for participation only if the 
meet the following minimum facility requirements: 
 
1. Familiarity with FDA authorized IDE and/or IND Clinical Trials within the United States 
2. Affiliated pharmacy or laboratory capable of performing clinical trial randomization and 
cell dose preparation 
3. Ability to adhere to strict compliance with the STYLE clinical protocol for all study 
related procedure and observations. 
4. 
 
15 PUBLICATIONS 
 
Following completion of the study, Kerastem will present the study data in a clinical study report 
that will be delivered to the FDA according to US regulations. 
 
In the event the investigator wishes to present or publish any study data (partial or complete), 
he/she must submit the presentation / publication draft to Kerastem for review within 30 days of 
the planned submission or presentation. 

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16 REFERENCES 
 
 
1. 
Otberg N, Finner AM, Shapiro J. Androgenetic Alopecia. Endocrinol Metab Clin North Am. 
2007; 36(2):379-98. 
2. 
Dinh QQ, Sinclair R. Female pattern hair loss: Current treatment concepts. Clinical Interventions 
in Aging. 2007;2(2):189-99. 
3. 
Stough D, Stenn K, Haber R, Parsley WM, Vogel JE, Whiting DA, Washenik K. Psychological 
effect, pathophysiology, and management of androgenetic alopecia in men. May Clin Proc. 2005; 
80(10):1316-22. 
4. 
Krupa Shankar DS, Chakravarthi M, Shilpakar R. Male Androgenetic Alopecia: 
Population-Based Study in 1,005 Subjects. Int J Trichology. 2009;1(2):131-33 
5. 
Ghanaat M. Types of Hair Loss and Treatment Options, Including the Novel Low-level 
Light Therapy and its Proposed Mechanism. South Med J. 2010;103(9):917-21... 
6. 
Gan DCC, Sinclair RD. Prevalence of Male and Female Pattern Hair Loss in Maryborough. J 
Investig Dermatol Symp Proc. 2005;10:184-89. 
7. 
Cash TF, Price VH, Savin RC. Psychological effects of androgentic alopecia on women: 
comparisons with balding men and with female control subjects. J Am Acad Dermatol. 
1993;29(4):568-75. 
8. 
Shapiro J, Kaufman KD. Use of finasteride in the treatment of men with androgenetic alopecia 
(male pattern hair loss). J Investig Dermatol Symp Proc. 2003;8(1):20-3. 
9. 
Ross EK, Shapiro J. Management of hair loss. Dermatol Clin. 2005;23(2):227-43. 
10. 
Mysore V. Finasteride and sexual side effects. Indian Dermatol Online J. 2012;3(1):62-65. 
11. 
Magerl M, Paus R, Farjo N, Muller-Rover S, Peters EM, Foitzik K, Tobin DJ. Limitations of 
human occiptal scalp hair follicle organ culture for studying the effects of minoxidil as a hair 
growth enhancer. Exp Dertmatol. 2004;13(10:535-42. 
12. 
Festa, E., Fretz, J., Berry, R., Schmidt, B., Rodeheffer, M., Horowitz, M. and Horsley, V. 
“Adipocyte Lineage Cells Contribute to the Skin Stem Cell Niche to Drive Hair 
Cycling.” Cell, 146: 761 – 771, 2011. 
13. 
Schmidt, B. and Horsley, V. “Unraveling Hair Follicle-Adipocyte Communication.” 
Experimental Dermatology, 21: 827 – 830, 2012. 
14. 
Coleman SR. Structural fat grafts: the ideal filler? Clin Plast Surg. 2001;28:111-9. 
15. 
Locke MB, de Chalain TM. Current practice in autologous fat transplantation: suggested 
clinical guidelines based on a review of recent literature. Ann Plast Surg. 2008;60:98- 
102. 
16. 
Missana MC, Laurent I, Barreau L, Balleyguier C. Autologous fat transfer in 
reconstructive breast surgery: indications, technique and results. Eur J Surg Oncol. 
2007;33:685-690. 

STYLE; Version B 
24 November 2015 
CONFIDENTIAL 
Page 48 of 53 
 
17. 
Zocchi ML, Zuliani F. Bicompartmental breast lipostructuring. Aesthetic Plast Surg. 
2008;32:313-328. 
18. 
Yoshimura K, Sato K, Aoi N et al. Cell-assisted lipotransfer for cosmetic breast 
augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 
2008;32:48-55. 
19. 
Illouz YG, Sterodimas A. Autologous Fat Transplantation to the Breast: A Personal 
Technique with 25 Years of Experience. Aesthetic Plast Surg. 2009. 
20. 
Yi CG, Xia W, Zhang LX et al. VEGF gene therapy for the survival of transplanted fat 
tissue in nude mice. J Plast Reconstr Aesthet Surg. 2007;60:272-278. 
21. 
Yamaguchi M, Matsumoto F, Bujo H et al. Revascularization determines volume 
retention and gene expression by fat grafts in mice. Exp Biol Med (Maywood ). 
2005;230:742-748. 
22. 
Akita S, Akino K, Hirano A, Ohtsuru A, Yamashita S. Mesenchymal stem cell therapy 
for cutaneous radiation syndrome. Health Physics. 2010;in press. 
23. 
Alvarez PD, Garcia-Arranz M, Georgiev-Hristov T, Garcia-Olmo D. A new 
bronchoscopic treatment of tracheomediastinal fistula using autologous adipose-derived 
stem cells. Thorax. 2008;63:374-376. 
24. 
Zhu M, Zhou Z, Chen Y et al. Supplementation of fat grafts with adipose-derived 
regenerative cells improves long-term graft retention. Ann Plast Surg. 2010;64:222-228. 
25. 
Matsumoto D, Sato K, Gonda K et al. Cell-assisted lipotransfer: supportive use of human 
adipose-derived cells for soft tissue augmentation with lipoinjection. Tissue Eng. 
2006;12:3375-3382. 
26. 
Gerth DJ, King B, Rabach L et al. Long-term Volumetric Retention of Autologous Fat 
Grafting Processed with Closed-Membrane Filtration. Aesthetic Surgery Journal. 2014; 
July (epub ahead of print) 
27. 
PRECISE Clinical Trial, ClinicalTrials.gov 
http://clinicaltrials.gov/ct2/show/NCT00426868?term=precise+heart&rank=4 
28. 
APOLLO CLinical Trial, 
ClinicalTrials.govhttp://clinicaltrials.gov/ct2/show/NCT00442806?term=apollo++heart& 
rank=1 
29. 
Yoshimoto H, Akino K, Hirnao A, Yamashita S, Ohtsuru A, Akita S. Efficacy of 
patients’ own adipose-derived regfenreative cells for chronic intractable radiation 
injuries. Journal of Wound Technology 2010;10:22-5. 
30. 
Gotoh M, Yamamoto T, Kator M, Majima T, Toriyama K, Kamei Y, Matsukawa Y, 
Hirakawa A, Funahashi Y. Regernative treatment of male stress urinary incontinence by 
periurethral injection of autologous adipose-derived regenerative cells: 1-year outcomes 
in 11 patients. Int J Urology 2013; doi:10.1111/iju/12266. 
31. 
Borowski DW, Gill TS, Agarwal AK, Bhaskar P. Autologous adipose-tisseu derived 
regenerative cells for the tratment of complex cryptoglandular fistula-in-ano: a report of 
three cases. BMJ;2012; doi:10.1136/bcr-2012-006988. 

STYLE; Version B 
24 November 2015 
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32. 
Granel B, Dauma A, Jouve E, Harle JR, Nguyen PS, Chabannon C, Colavolpe N, Reyneir 
JC, Truillet R, Mallet S, Baiade A, Casanova D, Giraudo L, Arnaud L, Veran J, Sabatier 
F, Magalon G. Safety, tolerability and potential efficacy of injection of autologous 
adipose-derived stromal vascular fraction in the fingers of patietns with systemic 
sclerosis: an open-label phase I trial. Ann Rheum Dis 2014; doe:10.1136/annrheumdis- 
2014-205681. 

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APPENDIX A: SCHEDULE OF PROCEDURES 
 
Pre-procedure 
Assessment 
Procedure Day 
Post-Operative 
Follow-up Week 
Day -28 to Day-7 
Day -1 
Day1 
1 
± 1 day 
6 
± 3 days 
12 
± 1 wk 
24 
± 2 wks 
52 
± 2 wks 
Informed consent 
X 
Confirm Inclusion / Exclusion criteria 
X 
X 
Medical history including 
Demographics 
X 
X1 
Physical examination 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signs 
X 
X 
X2 
X 
X 
X 
X 
X 
Laboratory tests 
X 
X 
X 
Pregnancy test3 
X 
X 
X 
Injection assessment 
X 
Global Photography 
X 
X 
X 
X 
X 
Trichogram capture 
X 
X 
X 
X 
X 
Investigator Hair Satisfaction 
Questionnaire 
X 
X 
X 
X 
Subject Hair Satisfaction Questionnaire 
X 
X 
X 
X 
Randomization 
X 
Sterility Testing 
X 
Injection Procedure 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
1. 
Adverse Events that occur prior to the liposuction-related activities, including those that are considered serious, are to be recorded in the medical history. 
2 
Vital signs will be monitored according to institutional procedures; it is suggested that vitals be monitored frequently during the fat harvest, between fat harvest and cell 
injection and during cell injection procedure and for at least one hour following the injection procedure 
3 
Women of child-bearing potential 

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APPENDIX B: ADVERSE EVENT TERMINOLOGY AND GRADING 
(Adapted from National Cancer Institute Common Terminology Criteria for Adverse Events) 
 
Severity Grading 
Adverse Event 
Short Name 
1 
2 
3 
4 
5 
Bruising (in absence of 
Grade 3 or 4 
thrombocytopenia) 
Bruising 
Localized or in a 
dependent area 
Generalized 
- 
- 
- 
Hyperpigmentation 
Hyperpigmentation 
Slight or localized 
Marked or generalized 
- 
- 
- 
Hypopigmentation 
Hypopigmentation 
Slight or localized 
Marked or generalized 
- 
- 
- 
Injection site reaction/ 
extravasation changes 
Injection site 
reaction 
Pain; itching; 
erythema 
Pain or swelling, with 
inflammation or 
phlebitis 
Ulceration or necrosis 
that is severe; 
operative 
intervention indicated 
- 
- 
Hematoma 
Hematoma 
Minimal symptoms, 
invasive intervention 
not indicated 
Minimally invasive 
evacuation or 
aspiration indicated 
Transfusion, 
interventional 
radiology, or 
operative intervention 
indicated 
Life-threatening 
consequences; 
major urgent 
intervention 
indicated 
Death 
Hemorrhage/bleeding 
associated with surgery, 
intra-operative or 
postoperative 
Hemorrhage with 
surgery 
- 
- 
Requiring transfusion 
of 2 units non- 
autologous pRBCs 
beyond protocol 
specification; 
postoperative 
interventional 
radiology, 
endoscopic, or 
operative 
intervention indicated 
Life-threatening 
consequences 
Death 

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Severity Grading 
Adverse Event 
Short Name 
1 
2 
3 
4 
5 
Infection with normal 
Infection with normal 
- 
Localized, local 
IV antibiotic, 
Life-threatening 
Death 
ANC or Grade 1 or 2 
ANC at the site of 
intervention indicated 
antifungal, or 
consequences (e.g., 
Neutrophils at the site of 
liposuction or ADRC 
antiviral intervention 
septic shock, 
liposuction or cell- 
injection 
indicated; 
hypotension, 
enriched injection 
interventional 
acidosis, necrosis) 
radiology or operative 
intervention indicated 
Pain at the site of 
Pain 
Mild pain not 
Moderate pain; pain 
Severe pain; pain or 
Disabling 
- 
liposuction or cell- 
interfering with 
or analgesics 
analgesics severely 
enriched injection 
function 
interfering with 
interfering with ADL 
function, but not 
interfering with ADL 

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APPENDIX C: SUMMARY OF CLINICAL WORKFLOW