Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial
Phase: NA
Conditions: Osteoarthritis (OA)
Sponsor: GID BIO, Inc.

Adipose-derived SVF for the Treatment of Knee OA 
Protocol # GIDOA-01 
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THE GID GROUP 
CLINICAL RESEARCH PROTOCOL 
USE OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL 
VASCULAR FRACTION TO TREAT OSTEOARTHRITIS OF THE 
KNEE: A CONTROLLED, RANDOMIZED, DOUBLE-BLINDED 
TRIAL 
Protocol Number: 
GIDOA-01 
Date and Version Number: 
October 1, 2015 Ver. 3.0 
Investigational Device: 
GID SVF-2 
Study Phase: 
Pivotal 
Sponsor-Investigator: 
The GID Group   
901 Front St. Suite 240 
Louisville, CO 80026 
Funding Organization: 
NA 
Site Investigators:  
Site: Rothman Institute (RI) 
Name: Brad Tucker, MD 
 
Telephone:800.321.9999 
 
 
 
E-mail: Bradford.tucker@rothmaninstitute.com 
 
Site: The Cooper Health System 
Name: Larry Miller, MD 
 
Telephone: 856.968.7845 
 
 
E-mail: miller-lawrence@cooperhealth.edu Site: Texas 
Plastic Surgery 
Name: Jaime R. Garza, MD 
Telephone: (210) 616-0301 
Email: jrgmd@txps.net 
 
 
 
Approval: 
 
 
 
 
PI or Sponsor Signature (Name and Title)  
 
Date 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time.  The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.   

Adipose-derived SVF for the Treatment of Knee OA 
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PROTOCOL AGREEMENT 
I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and 
providing The GID Group with complete and timely information, as outlined in the 
protocol.  It is understood that all information pertaining to the study will be held strictly 
confidential and that this confidentiality requirement applies to all study staff at this site. 
Furthermore, on behalf of the study staff and myself, I agree to maintain the procedures 
required to carry out the study in accordance with accepted GCP principles and to abide 
by the terms of this protocol. 
Protocol Number: GIDOA-01 
Protocol Title:  Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat 
Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial 
Protocol Date:  October 1, 2015 
 
 
 
Investigator Signature  
 
Date 
 
Print Name and Title 
Site # 
 
 
Site Name 
 
Address 
 
 
 
 
 
Phone Number 
 
 
 

Adipose-derived SVF for the Treatment of Knee OA 
Protocol # GIDOA-01 
Confidential                                                 Ver. 3.0  
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Table of Contents 
1 
PURPOSE OF THE INVESTIGATION ......................................................................................... 10 
1.1 
Overview of Investigation and Clinical Plan ................................................................... 10 
1.2 
Name of Investigational Device ..................................................................................... 11 
1.3 
Intended use of the investigational device .................................................................... 11 
1.4 
Objectives of the clinical investigation .......................................................................... 11 
1.4.1 
Primary objective ................................................................................................... 11 
1.4.2 
Secondary objectives ............................................................................................. 11 
1.5 
Anticipated Duration of the clinical investigation ......................................................... 11 
2 
CLINICAL PROTOCOL .............................................................................................................. 11 
2.1 
Protocol number and title .............................................................................................. 11 
2.2 
Protocol version, number and date ............................................................................... 11 
2.3 
Study design ................................................................................................................... 11 
2.3.1 
General study design ............................................................................................. 11 
2.3.2 
Study design schematic .......................................................................................... 13 
2.4 
Subject selection ............................................................................................................ 14 
2.4.1 
General characteristics of the proposed subject populations ............................... 14 
2.4.2 
Anticipated number of research subjects .............................................................. 14 
2.4.3 
Inclusion criteria ..................................................................................................... 14 
2.4.4 
Exclusion criteria .................................................................................................... 15 
2.5 
Study procedures ........................................................................................................... 15 
2.5.1 
Screening procedures ............................................................................................ 15 
2.5.2 
Concomitant Medications ...................................................................................... 16 
2.5.3 
Study treatment ..................................................................................................... 16 
2.5.4 
Study treatment procedures .................................................................................. 17 
2.5.5 
Allocation to treatment ......................................................................................... 20 
2.5.6 
Unblinding .............................................................................................................. 21 
2.5.7 
Treatment adherence ............................................................................................ 21 
2.5.8 
Withdrawal of subjects due to non-compliance .................................................... 21 
2.5.9 
Procedures to assess efficacy ................................................................................ 21 
2.5.10 
Procedures to assess safety ................................................................................... 21 

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2.5.11 
Schedule of study visits .......................................................................................... 22 
2.5.12 
Subject Compensation ........................................................................................... 22 
2.6 
Study outcome evaluations ........................................................................................... 23 
2.6.1 
Study endpoints ..................................................................................................... 23 
2.6.2 
Sample size determination .................................................................................... 23 
2.6.3 
Outcome data and data analysis ............................................................................ 23 
3 
RISK ANALYSIS ........................................................................................................................ 24 
3.1 
Anticipated risks ............................................................................................................. 24 
3.2 
Adverse events and reporting ........................................................................................ 24 
3.2.1 
Adverse event definitions ...................................................................................... 24 
3.2.2 
Eliciting adverse event information ....................................................................... 24 
3.2.3 
Recording and assessment of adverse events ....................................................... 25 
3.2.4 
Abnormal test findings ........................................................................................... 25 
3.2.5 
Causality and severity assessment ......................................................................... 25 
3.2.6 
Stopping Rules........................................................................................................ 26 
3.2.7 
Reporting adverse events to the FDA .................................................................... 26 
3.2.8 
Reporting adverse events to the responsible IRB .................................................. 27 
3.3 
Withdrawal of subjects prior to completion of the study ............................................. 27 
4 
DESCRIPTION OF THE INVESTIGATIONAL DEVICE .................................................................. 27 
5 
MONITORING PROCEDURES .................................................................................................. 27 
6 
LABELING ................................................................................................................................ 27 
7 
INFORMED CONSENT ............................................................................................................. 28 
8 
IRB INFORMATION ................................................................................................................. 28 
9 
OTHER INSTITUTIONS............................................................................................................. 29 
10 ADDITIONAL RECORDS AND REPORTS ................................................................................... 29 
10.1 
Data handling and record-keeping ................................................................................ 29 
10.2 
Record maintenance and retention ............................................................................... 29 
10.3 
Data Management ......................................................................................................... 31 
 

Adipose-derived SVF for the Treatment of Knee OA 
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LIST OF ABBREVIATIONS 
ADSC 
adipose-derived stromal cells 
AE 
adverse event 
ASA 
American Society of Anesthesiologists 
BMI 
body mass index 
BP 
blood pressure 
CFR 
Code of Federal Regulations 
CRF 
case report form 
CTCAE 
Common Terminology Criteria for Adverse Events 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HR 
heart rate 
ICD 
informed consent document 
ICH 
International Conference on Harmonisation 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
K-L Scale 
Kellgren-Lawrence Osteoarthritis Scale 
• Grade 0, None – No radiographic features of OA are present 
• Grade 1, Doubtful – Doubtful narrowing of joint space and 
possible osteophytic lipping 
• Grade 2, Minimal – Definite osteophytes and possible narrowing 
of joint space on anteroposterior weight-bearing radiograph 
• Grade 3, Moderate – Moderate multiple osteophytes, definite 
narrowing of joint space and some sclerosis and possible 
deformity of bone ends 
• Grade 4, Severe – Large osteophytes, marked narrowing of joint 
space, severe sclerosis and definite deformity of bone ends  
LR 
lactated Ringer’s 
OA 
osteoarthritis 
PI 
Principal Investigator 
RR 
respiratory rate 
SAE 
serious adverse event 
SVF 
stromal vascular fraction 
UADE 
unanticipated adverse device effect 
UAE 
unanticipated adverse event 
VAS 
visual analog scale 
WOMAC 
Western Ontario and McMaster Universities Osteoarthritis Index 
 
 
 

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PROTOCOL SYNOPSIS 
TITLE 
Use of Autologous Adipose-Derived Stromal Vascular 
Fraction to Treat Osteoarthritis of the Knee: A Controlled, 
Randomized, Double-Blinded Trial 
SPONSOR 
The GID Group 
FUNDING 
ORGANIZATION 
NA 
NUMBER OF SITES  
Up to 3 sites 
RATIONALE 
This study will examine the safety and efficacy of autologous 
adipose-derived stromal vascular fraction (SVF) cells 
processed with the GID SVF-2 device for pain, function and 
stiffness in the knees of osteoarthritic subjects.  
 
Osteoarthritis is the main form of arthritis and affects over 20 
million people in the United States.  In the knee it can cause 
severe pain, reduced functionality and increased stiffness thus, 
a treatment that would reduce pain, increase function and 
reduce stiffness would be of benefit to many people. 
STUDY DESIGN 
This is a multi-center, prospective, randomized, blinded, 
interventional safety and efficacy study. 
PRIMARY 
OBJECTIVE 
To evaluate the safety of a single injection of autologous 
adipose-derived SVF for treatment of osteoarthritis of the knee. 
SECONDARY 
OBJECTIVE 
To evaluate the initial efficacy of a single injection of 
autologous adipose-derived SVF for reduction of pain and 
stiffness and increased functionality in patients with 
osteoarthritis of the knee. 
NUMBER OF 
SUBJECTS 
39 
SELECTION 
CRITERIA 
Inclusion Criteria: 
1. Grade II or Grade III osteoarthritis using Kellgren-
Lawrence grading scale (K-L Grade) as diagnosed using 
weight bearing X-ray, physician review, and/or pre-op MRI  
2. Study Subjects must have failed a minimum of at least two 
conservative therapies, spanning a period of at least 3 
months, including (i) oral pain medications, (ii) physical 
therapy, (iii) corticosteroid injection of the knee, (iv) 
viscosupplementation injection of the knee   
3. Study Subjects must be willing to voluntarily give written 
Informed Consent to participate in the study and sign the 
Health Insurance Portability and Accountability Act 
(HIPAA) authorization before any study procedures are 
performed 
4. Males and females 40-75 years old   
5. Subjects will be in good health (ASA Class I-II) with a 
BMI < 35 

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6. Subjects must have continued pain in the knee despite 
conservative therapies for at least 3 months   
7. Subjects with unilateral disease must present with a knee 
pain score ≥6 and ≤16 using the short-form WOMAC pain 
(A1 subscale, 20 total points)   
8. Subjects with bilateral disease will only be treated in one 
knee.  The treated knee must have K-L grade II or III with a 
pain score ≥6 and ≤16 using the short-form WOMAC pain 
(A1 subscale, 20 total points) and the contralateral knee has 
a K-L grade of I or II with a pain score <6 using the short-
form WOMAC pain (A1 subscale, 20 total points)   
9. Subjects must speak, read and understand English 
10. Subjects must be reasonably able to return for multiple 
follow-up visits 
Exclusion Criteria: 
1. Subjects whose knee pain is caused by, (i) diffuse edema, 
(ii) displaced meniscus tear, (iii) lesion greater than 1 cm in 
any direction, or (iv) osteo chondritis desicans 
2. Subjects who have had surgery of either knee within 6 
months prior to the screening visit   
3. Subjects who have had a major injury to the 
targeted/treatment knee within 12 months prior to enrolling 
in the study 
4. Subjects who have had an injection in either knee in the 
prior 3 months, including corticosteroids, 
viscosupplementation or platelet rich plasma (PRP) 
5. Subjects who have gout, rheumatoid arthritis, lupus 
arthropathy, psoriatic arthritis, avascular necrosis, severe 
bone deformity, infection of the knee joint, fibromyalgia, 
pes anserine bursitis, or neurogenic or vascular 
claudication.  
6. Subjects who have symptomatic OA of the hips, spine, or 
ankle that would interfere with the evaluation of the treated 
knee 
7. Subjects that are unwilling to stop taking prescription or 
over the counter pain medication 7 days prior to any visit  
8. Subjects that are allergic to lidocaine, epinephrine or 
valium 
9. Subjects with a history of bleeding disorders, 
anticoagulation therapy that cannot be stopped as follows 
prior to injection; Thrombolytics and anti-platelet 
medication including but not limited to Coumadin 
(warfarin) for 3 days, Plavix (colpidogrel) for 3 days, 
ASA/NSAIDs/fish oil supplements for 7 days, Xeralta® 
(rivaroxaban) for 24 hours 

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10. Subjects with systemic immunosuppressant use within six 
(6) weeks from screening and subjects with HIV/viral 
hepatitis 
11. Subjects with chondrocalcinosis, Paget’s disease and 
Villonodular synovitis 
12. Subjects that use any form of tobacco  
13. Women that are pregnant or planning to become pregnant 
during the study  
14. Subjects on long term use of oral steroids  
15. History of any chemotherapy or radiation therapy on the 
targeted/treatment leg or adipose harvest site  
16. Subjects currently on worker’s compensation 
INVESTIGATIONAL 
DEVICE / 
INTENDED USE 
GID SVF-2 
The GID SVF-2 device is indicated for use for harvesting, 
filtering, separating, and concentrating autologous stromal 
vascular fraction cells from adipose tissue for reintroduction to 
the same patient during a single surgical procedure for 
treatment of pain associated with joint osteoarthritis. The GID 
SVF-2 device is to be used only with the GID SVF Procedure 
Pack. 
CONTROL GROUP  
This study is a 3-arm study with a placebo control group.  The 
study arms are: 1) low-dose group (15 million SVF cells in 4 
ml of lactated Ringer’s (LR)), 2) high-dose group (30 million 
SVF cells in 4 ml of LR), and placebo control group (0 SVF 
cells in 4 ml of LR).  
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Subjects may have up to 4 weeks between screening and 
treatment.  After treatment follow-up visits will be at 2 days, 6 
weeks; 3 and 6 months; with safety follow-up phone calls or 
visits at 1 and 2 years.     
Subject Screening:  up to 4 weeks 
Subject Treatment:  1 day 
Subject Follow-up: 6 months 
Subject Safety Follow-up: 2 years 
The total duration of the study is expected to be 1 year (6 
months to complete recruiting and 6 months to complete 
follow-up) with safety follow-up completing within 3 years. 
CONCOMITANT 
MEDICATIONS 
The following medications should be stopped or are not 
allowed during the study as follows:  
ANY Pain Medication 7 DAYS PRIOR to any Visit. 
Prior to Surgery the subject may not take any medications and 
over-the-counter drugs as follows: 
a. 14 days Prior to Surgery 
• Oral steroids that are short course (less than 14 days 
total) 

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b. 7 days Prior to Surgery 
• Pain medications (all);  
• ASA/NSAIDs/fish oil supplements 
c. 3 days Prior to Surgery -  
• Thrombolytics and anti-platelet medication including 
but not limited to Coumadin (warfarin), Plavix 
(colpidogrel) 
d. 24 hours Prior to Surgery –  
• Xeralta® (rivaroxaban)  
After Surgery the subject may not take any medications and 
over-the-counter drugs as follows:   
a. For 24 hours After Surgery –  
• Xeralta® (rivaroxaban) 
b. For 3 days After Surgery -  
• Thrombolytics and anti-platelet medication including 
but not limited to Coumadin (warfarin), Plavix 
(colpidogrel),  
• ASA/NSAIDs/fish oil supplements   
c. Oral steroids for duration of study 
All concomitant medications will be recorded on the 
Concomitant case report form at each subject follow-up visit. 
SAFETY 
EVALUATIONS 
Incidence and severity of adverse events and comparison of 
MRI images from baseline to 6 months for any unusual 
findings.   
EFFICACY 
EVALUATIONS & 
PRIMARY 
ENDPOINT 
Pain, function and stiffness will be compared at baseline and 6 
months post-operatively using the validated short-form of the 
WOMAC instrument and a Visual Analog Scale (VAS) for 
pain.  
Efficacy will be achieved if either SVF dose is shown to be 
superior to the placebo group at the 6-month time point.  The 
measures of interest are from baseline to 6 months of the 
changes in the WOMAC and VAS pain scales and comparison 
to the placebo control group. 
PLANNED INTERIM 
ANALYSES 
After the first 15 subjects have completed the 6 week follow-
up, an interim analysis for safety will be conducted.  If there 
are two (2) or fewer adverse events less than grade 4 on the 
Common Terminology Criteria for Adverse Events (CTCAE) 
scale, then the high dose will be administered. Serious adverse 
events will be monitored on an ongoing basis throughout the 
study and safety follow-up period. 
STATISTICS  
 
The primary efficacy will be evaluated using Dunnett’s 
multiple comparison with a control test. 
RATIONAL FOR 
NUMBER OF 
SUBJECTS 
The samples size determination is based on the primary 
efficacy endpoint using the WOMAC score (scaled to 100 
points full scale) and evaluated using Dunnett’s multiple 

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comparison with a control one-sided (i.e., superiority) test.  
Assuming a standard deviation of 14 points and a difference to 
detect (i.e., minimal clinically significant difference) of at least 
17 (representing about a 33% decrease from baseline) points 
with an α = 0.05 significance level and a power of 80% a 
conservative sample size of 11 subjects per group is needed.   
This sample size estimate is based on a Bonferroni correction 
and as such is conservative (i.e., larger than necessary). Thus, 
the goal will be to have no fewer than 11 subjects per treatment 
group. To account for possible exclusions/lost to follow-up of 
data an additional 2 subjects per treatment group (20%) will be 
added for a sample size of 13 subjects per group for a total 
enrolled sample size of 39 subjects. 
1 PURPOSE OF THE INVESTIGATION 
1.1 Overview of Investigation and Clinical Plan  
Osteoarthritis (OA) is known as degenerative arthritis or degenerative joint 
disease or osteoarthrosis, and represents a group of mechanical abnormalities 
involving degradation of joints, including the articular cartilage and subchondral 
bone. Symptoms typically may include joint pain, tenderness, stiffness, locking, 
and sometimes effusion. Clinical treatment generally involves a life-long 
combination of exercise, lifestyle modifications, and/or analgesics. If pain 
becomes debilitating, joint replacement surgery may be an option to improve 
the quality of life.  
A new and novel treatment strategy has had preliminary success in preclinical 
studies as well as in pilot clinical studies that have utilized the autologous 
stromal vascular fraction (SVF) cells derived from adipose tissues. The SVF is a 
concentration of nucleated cells normally present in the adipose tissue.  This 
treatment strategy uses the autologous SVF cells derived from harvested 
adipose tissue within a single clinical procedure (bedside).  The adipose tissue is 
harvested under sterile conditions, then washed, then dissociated using 
enzymatic digestion, then the SVF cells are concentrated and returned to the 
patient using a syringe injection to the joint space. 
This IDE application addresses the GID SVF-2 medical device and GID SVF 
Procedure Pack produced by The GID Group, Inc. for collection and processing 
of adipose tissue including collect, wash, dissociate, separate, and concentrate 
SVF cells from human lipoaspirate.  The GID Group, Inc. and its contract 
manufacturer are both FDA-registered and audited, MDD certified, and 
ISO13485:2003 certified companies.  Both maintain a Quality Management 
System (QMS) compliant with the Quality System Regulation (QSR) to provide 
the framework of controls for the facility and processes employed in the 
manufacture, assembly, labeling and distribution of medical devices. 
This clinical trial with this IDE proposal is a multi-center, randomized, double-
blinded, controlled clinical study to investigate the safety and efficacy in the use 
of adult autologous adipose SVF for the treatment of pain associated with joint 

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OA.  The hypothesis of this trial is that the proposed clinical outcome measures 
of reduced pain resulting from the treatment of OA of the knee joint with 
autologous adipose SVF tissue will be superior to a placebo control treatment. 
1.2 Name of Investigational Device 
GID SVF-2 and GID SVF Procedure Pack 
1.3  Intended use of the investigational device 
The GID SVF-2 device is indicated for use for harvesting, filtering, separating, 
and concentrating autologous stromal vascular fraction cells from adipose tissue 
for reintroduction to the same patient during a single surgical procedure for 
treatment of pain associated with joint osteoarthritis. The GID SVF-2 device is 
to be used only with the GID SVF Procedure Pack. 
All materials supplied for the proposed study are for investigational use only 
and are to be used solely within the context of the approved protocol. 
1.4 Objectives of the clinical investigation 
1.4.1 Primary objective 
Evaluate the safety of the GID SVF-2 for the treatment of osteoarthritis in 
the knee in humans. 
1.4.2 Secondary objectives 
Evaluate the efficacy of the GID SVF-2 for the treatment of osteoarthritis 
of pain, stiffness and functionality associated with osteoarthritis of the 
knee in humans. 
1.5  Anticipated Duration of the clinical investigation 
It is anticipated that the trial duration will not exceed 1 year; 6 months for 
recruitment and 6 months follow-up with an additional 2 years for safety 
follow-up. 
2 CLINICAL PROTOCOL 
2.1 Protocol number and title  
GIDOA-01: Use of Autologous Adipose-Derived Stromal Vascular Fraction to 
Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded 
Trial  
2.2 Protocol version, number and date  
Version 3.0, GIDOA-01, October 1, 2015   
2.3 Study design 
2.3.1 General study design 
This is a multi-center, prospective, randomized, blinded, interventional 
safety and efficacy study.  The study is designed as a dose escalation, 
parallel-groups design (uncorrelated, unpaired, independent groups) with 

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placebo control. There are three groups: treatment group high dose (H) 
receives injection of 4 cc of LR with 30 million SVF cells; treatment 
group low dose (L) receives injection of 4 cc of LR with 15 million SVF 
cells; placebo control group (C) receives injection of 4 cc of LR with zero 
SVF cells (Figure 2).   
An SVF dose escalation design will be included in the study.  The first 
fifteen (15) subjects will be randomized to low dose or placebo as follows: 
nine (9) subjects will receive the low SVF dose (15 x 106 cells) and six (6) 
subjects will receive the placebo (no SVF cells).  When all fifteen (15) 
subjects have reached the 6 week follow up the cohort of 15 will be 
evaluated for adverse events and any safety issues.  If there are two or less 
adverse events of less than grade 4 on the Common Terminology Criteria 
for Adverse Events (CTCAE) scale in the low SVF dose group, then the 
remaining twenty-four (24) subjects will be randomized to receive the 
following doses: four (4) subjects will receive the low SVF dose (15 x 106 
cells), thirteen (13) subjects will receive the high SVF dose (30 x 106 
cells) and seven (7) subjects will receive the placebo dose.   
 
 

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2.3.2 Study design schematic 
Figure 1 Study Flow Schematic 
 
Surgery/Baseline 
Subject completes WOMAC and VAS 
then liposuction, randomization to: 
1) Low Dose SVF or
2) Placebo 
knee injection 
Office Visit  - 48 hours Post-op
Complete CRFs
Office Visit  - 6 week Post-op
Subject completes WOMAC & VAS
Office Visit  - 3 months Post-op
Subject completes WOMAC & VAS
Office Visit  - 6 months Post-op
Subject completes WOMAC & VAS
MRI of knee 
Office Visit  - 1 year Post-op
Subject is queried for adverse events
MRI of knee
Office Visit or phone call  - 2 year 
Post-op
Subject is queried for adverse events
Study Exit
Yes
Complete Screening Log noting 
reason subject does not qualify
No
No
Yes
No
Screen Subject
In office or by phone
Complete Screening document Did the subject meet 
the screening criteria
Office Visit Pre-op 
Explain study, If subject interested & meets criteria then Authorized 
physician or staff member administers Consent.  Did the subject 
complete the Informed Consent?
GIDOA-01
Were there 5 or more adverse 
events related to the device? 
Begin enrolling high dose subjects
Stop study
Yes

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2.4 Subject selection 
2.4.1 General characteristics of the proposed subject populations 
Subjects will consist of males and females between the ages of 40 and 75 
with Kellgren-Lawrence OA grading scale (K-L Grade) II or III and a 
WOMAC pain score ≥ 6 ≤ 16 on a 20 point scale in one knee and a 
WOMAC pain score ≤ 6 for the contralateral knee if the subject has 
bilateral disease. 
2.4.2 Anticipated number of research subjects 
Enrollment was determined to be 39 based on a minimally clinically 
significant difference of 17 points on the WOMAC pain score with an α = 
0.05 significance level and a power of 80% (11 subjects/group) plus an 
additional 2 subjects per group (20%) for lost to follow up. 
2.4.3 Inclusion criteria 
1. Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading 
scale (K-L Grade) as diagnosed using weight bearing X-ray, 
physician review, and/or pre-op MRI.  
2. Study Subjects must have failed a minimum of at least two 
conservative therapies, spanning a period of at least 3 months, 
including (i) oral pain medications, (ii) physical therapy, (iii) 
corticosteroid injection of the knee, (iv) viscosupplementation 
injection of the knee.   
3. Study Subjects must be willing to voluntarily give written Informed 
Consent to participate in the study and sign the Health Insurance 
Portability and Accountability Act (HIPAA) authorization before any 
study procedures are performed. 
4. Males and females 40-75 years old.   
5. Subjects will be in good health (ASA Class I-II) with a BMI < 35. 
6. Subjects must have continued pain in the knee despite conservative 
therapies for at least 63 months.   
7. Subjects with unilateral disease must present with a knee pain score 
≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total 
points).   
8. Subjects with bilateral disease will only be treated in one knee.  The 
treated knee must have K-L grade II or III with a pain score ≥6 and 
≤16 using the short-form WOMAC pain (A1 subscale, 20 total 
points) and the contralateral knee has a K-L grade of I or II with a 
pain score <6 using the short-form WOMAC pain (A1 subscale, 20 
total points).   
9. Subjects must speak, read and understand English. 
10. Subjects must be reasonably able to return for multiple follow-up 
visits. 
 
 

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2.4.4 Exclusion criteria 
1. Subjects whose knee pain is caused by, (i) diffuse edema, (ii) 
displaced meniscus tear, (iii) lesion greater than 1 cm in any 
direction, or (iv) osteo chondritis desicans. 
2. Subjects who have had surgery of either knee within 6 months prior 
to the screening visit.   
3. Subjects who have had a major injury to the targeted knee within 12 
months prior to enrolling in the study. 
4. Subjects who have had an injection in either knee in the prior 3 
months, including corticosteroids, viscosupplementation or platelet 
rich plasma (PRP). 
5. Subjects who have gout, rheumatoid arthritis, lupus arthropathy, 
psoriatic arthritis, avascular necrosis, severe bone deformity, infection 
of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or 
vascular claudication.   
6. Subjects who have symptomatic OA of the hips, spine, or ankle that 
would interfere with the evaluation of the treated knee. 
7. Subjects that are unwilling to stop taking prescription or over the 
counter pain medication 7 days prior to any visit 
8. Subjects that are allergic to lidocaine, epinephrine or valium 
9. Subjects with a history of bleeding disorders, anticoagulation therapy 
that cannot be stopped as follows prior to injection Thrombolytics and 
anti-platelet medication including but not limited to Coumadin 
(warfarin) for 3 days, Plavix (colpidogrel) for 3 days, 
ASA/NSAIDs/fish oil supplements for 7 days, Xeralta® 
(rivaroxaban) for 24 hours. 
10. Subjects with systemic immunosuppressant use within six (6) weeks 
from screening and subjects with HIV/viral hepatitis. 
11. Subjects with chondrocalcinosis, Paget’s disease and Villonodular 
synovitis 
12. Subjects that use any form of tobacco  
13. Women that are pregnant or planning to become pregnant during the 
study. 
14. Subjects on long term use of oral steroids 
15. History of any chemotherapy or radiation therapy of the 
targeted/treatment leg or adipose harvest site.   
16. Subjects currently on worker’s compensation 
2.5 Study procedures 
2.5.1 Screening procedures 
Initial screening may be done over the phone or at the medical office.  
Subjects will be asked questions from a screening form and if they meet 
the criteria on the form will be asked if they are interested in coming back 
for an office screening visit.  A copy of the Informed Consent Document 

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will be mailed to the subject.  After the subject has signed the Informed 
Consent, the subject will be evaluated for Grade II or Grade III 
osteoarthritis (K-L scale) as diagnosed using X-ray, physician review, 
and/or pre-op MRI.  If potential participant meets the grading criteria, then 
they will be evaluated for the remaining inclusion/exclusion criteria.   
2.5.2 Concomitant Medications 
The following medications should be stopped or are not allowed during 
the study as follows:  
ANY Pain Medication 7 DAYS PRIOR to any Visit. 
Prior to Surgery the subject may not take any medications and over-the-
counter drugs as follows: 
a. 14 days Prior to Surgery  
• Oral steroids that are short course (less than 14 days total) 
b. 7 days Prior to Surgery 
• Pain medications (all);  
• ASA/NSAIDs/fish oil supplements 
c. 3 days Prior to Surgery   
• Thrombolytics and anti-platelet medication including but not 
limited to Coumadin (warfarin), Plavix (colpidogrel),  
d. 24 hours Prior to Surgery   
• Xeralta® (rivaroxaban)  
After Surgery the subject may not take any medications and over-the-
counter drugs as follows:   
a. For 24 hours After Surgery  
• Xeralta® (rivaroxaban) 
b. For 3 days After Surgery -  
• Thrombolytics and anti-platelet medication including but not 
limited to Coumadin (warfarin), Plavix (colpidogrel),  
• ASA/NSAIDs/fish oil supplements   
c. Oral steroids for duration of study 
 
All concomitant medications will be recorded on the Concomitant case 
report form at each subject follow-up visit. 
2.5.3 Study treatment 
The subject’s adipose tissue will be acquired through liposuction of the 
abdomen or thigh and will be suctioned directly into the GID SVF-2 
device.  The harvested adipose tissue will be enzymatically digested and 
centrifuged in the same GID SVF-2 device to produce SVF cells.   The 
subject will then be treated with an injection in the knee of 4 ml of LR 
containing one of the following: 

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a) Low Dose - 15 x 106 (range 12.5 x 106 – 17.2 x 106) nucleated SVF 
cells;  
b) High Dose - 30 x 106 (range 27.5 x 106 – 32.5 x 106) nucleated SVF 
cells; or  
c) Placebo - 0 SVF cells.   
Treatment will be randomized and both the physician and subject will be 
blinded to the dosage. 
2.5.4 Study treatment procedures 
1. Liposuction 
The procedure will be performed at the clinical site according to 
standard clinical practice for all participants.   
2. Processing of Collected Fat 
The fat will be processed by the processing technician, who will not 
be involved in safety or efficacy evaluation.  Processing of the fat will 
be done immediately after harvest in the operating room on a sterile 
table that is not visible to any study personnel.  The processing 
technician will use the GID SVF Procedure Pack for fat processing.    
All tissue contacting equipment (GID SVF-2, syringes, tubing) will 
be sterile single-use laboratory disposables.  All procedures must be 
followed as outlined in the IFU.  Figure 2 shows an overview of the 
adipose lipoaspirate processing.  

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Figure 2 Overview of Adipose Lipoaspirate Processing 
 
Process 
Adipose tissue disassociation
~. 5 to 1cc SVF pellet available 
Release Criteria 
Met
Retest
limited to two 
retests
Dose =  Placebo 
Prepare Dose
~up to 4 cc of 
resuspension 
 Inject into 
knee
Subject is 
withdrawn 
from Study
Collect 
~125cc of Adipose Lipoaspirate
Collect & Test
~0.5 cc for Release Assays
Wash 
~100 cc will be available for 
processing 
Resuspend 
SVF pellet in 4 cc LR
~ 5 cc SVF available for testing and 
dose
Prepare & Send 
~0.5cc of 
resuspension to 
Central lab
Release Criteria Met
No
No
No
Yes
Yes
Yes
Flow Diagram from Processing of Adipose Lipoaspirate to SVF Injection

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3. Dose Escalation, Dosing and Release Criteria 
The first group of 15 subjects will be randomized to receive one of 
the following SVF doses:   
• Low SVF dose, 15 x 106 (range 12.5 x 106 – 17.5 x 106) 
nucleated SVF cells, suspended in 4 ml of lactated 
Ringer’s (9 subjects) or 
• Placebo control, 0 SVF cells, in 4 ml of lactated Ringer’s 
(6 subjects) 
If there are two or less adverse events of less than grade 4 on the 
Common Terminology Criteria for Adverse Events (CTCAE) scale, 
then the remaining twenty-four (24) subjects will be randomized to 
receive the following doses: 
• Low SVF dose, 15 x 106 (range 12.5 x 106 – 17.5 x 106) 
nucleated SVF cells, suspended in 4 ml of lactated 
Ringer’s (4 subjects) or 
• High SVF dose, 30 x 106 (range 27.5 x 106 – 32.5 x 106) 
nucleated SVF cells, suspended in 4 ml of lactated 
Ringer’s (13 subjects) or 
• Placebo control group, 0 SVF cells, in 4 ml of lactated 
Ringer’s (7 subjects) 
Release Criterion for each injection of the SVF cells will be: 
• a minimum of 70% viability (Chemometec NC-200) cells 
and 
• total nucleated cell count in dose range (Chemometec NC-
200) and 
• endotoxin assessment using rapid methodology with 
endotoxin level ≤ 200 EU per dose and 
• no gram negative detected.   
The data for the cell yield, viability, endotoxin and gram ID 
assessments are recorded on the Cell Count Assay case report form.  
   
Release Criteria Not Met:   
• If the dose is equal to placebo, then continue with the 
study checking the ‘Release’ box on the Cell Count Assay 
CRF. 
• If the release criteria are not met, then all criteria will be 
retested with only one retest allowed per release criteria.   
• If the retest does not meet the release criteria, then the 
patient is withdrawn from the study (see Section 3.3). 

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Release Criteria Are Met: 
• The box for ‘Release’ is checked and the processing 
technician signs the Cell Count Assay form. 
The form will not be added to the subject’s binder until after the study 
has been completed and all unblinding is complete.  
4. Injection of Cells  
The anteromedial or superolateral portal of the treatment knee will be 
prepared for injection. These locations were chosen due to ease of 
access into the intra-articular space and to avoid injecting into the fat 
pad of the knee.  No sedation or pain medication will be administered 
to the patient.  An ethyl chloride topical anesthetic will be sprayed on 
the injection site until the skin color changes to white. Lidocaine local 
anesthetic will be injected using a 25 gauge needle to numb the skin 
and subcutaneous tissues. Verification of the needle in the 
intraarticular space of the knee will be done by visual evidence of 
synovial fluid upon aspiration or ultra sound guidance.  The knee will 
be aspirated up to a maximum of 5 ml using an 18 gauge/1.5 inch 
needle.  Then all of the 4 cc SVF cells suspension will be injected 
into the intra-articular space through the same 18 gauge/1.5 inch 
needle.    The needle will then be removed and direct pressure over 
the injection site will placed for approximately ten (10) seconds.  
Hemostasis after injection will be confirmed, the injection site will 
then be cleaned with an alcohol wipe and covered with a sterile 
bandage. This can be removed the next morning. The patient will be 
given crutches and asked to be non-weight bearing on the injected 
knee for two (2) days.  The patient will be encouraged and allowed to 
bend and flex the knee as long as non-weight bearing conditions are 
maintained.  Patients will be given written instructions concerning 
after-injection and liposuction care and encouraged to call the 
administering physician at any time with questions and concerns. The 
patient will be asked to wait in the waiting room for 45 minutes 
before leaving.  
2.5.5 Allocation to treatment 
Subjects will be enrolled consecutively at each site.  Due to the objectives 
of the study, the identity of test and control treatments will not be known 
to investigators, research staff, or subjects.  The following study 
procedures will be in place to ensure double-blind administration of study 
treatments.   
▪ Access to the randomization code will be strictly controlled and only 
the processing technician, who will not be involved in safety or 
efficacy evaluation, will know to which group the subject is 
randomized on the day of the surgery.   
▪ The processing technician will process the SVF or placebo syringe out 
of sight of any personnel involved in the study.  The technician will 

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mask the syringe (tape) before it is seen by any study personnel so 
that no one will be able to identify the treatment by sight. 
2.5.6 Unblinding 
The processing technician will have sole control of the Identification of 
Treatment by Subject log. If the need arises to unblind the treatment for a 
patient (i.e. adverse event) the processing technician can consult the log 
for treatment identification.   
2.5.7 Treatment adherence  
Each subject will be given an information sheet containing instructions for 
pre and post-operative care of their knee and liposuction site.  At all of the 
following study visits each subject will be asked to fill out questionnaires 
and questioned about their knee.     
2.5.8 Withdrawal of subjects due to non-compliance 
Subjects may be terminated from the study at the discretion of the PI only 
for reasons related to the study examinations that would jeopardize the 
subject’s health and/or welfare if they were to continue in the study.  
Subjects may voluntarily withdraw from the study at any time without 
prejudice.  
Subjects who are withdrawn will not be replaced if they have received 
study treatment and if it is determined that there is not sufficient data for 
analysis the subject’s data will be removed from analysis.    
2.5.9 Procedures to assess efficacy 
Efficacy will be determined by the change in score on the WOMAC 
questionnaire completed by the patient between baseline and 6 months 
post-op.  Measurements consist of 3 sub scores; 1) pain with 5 questions 
and 20 total points; (2) stiffness, with 2 questions and 8 total points and 
(3) functionality with 7 questions and 28 total points, for a total score of 
56 points, the total score will be normalized to 100 points.  A decreasing 
score is indicative of a positive change, i.e. less pain, less stiffness and 
more functionality.   
Additionally, at baseline, 6 weeks, 3 months and 6 months, each subject 
will be asked to rate their pain using a visual analog scale (VAS), a 
horizontal 100 mm line with anchors of ‘no pain’ and ‘worst imaginable 
pain’.  The patient will be asked to mark a point on the line to indicate 
their pain intensity when climbing or descending stairs.  
 
2.5.10 Procedures to assess safety 
Adverse events will be continuously monitored by the PIs, the 
independent Safety Monitor and sponsor to evaluate safety of the device 
and treatment up to 2 years.  

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MRI’s will be taken pre-treatment, 6 months and 1 year according to the 
following sequence: 
• Sequence: proton density fat saturation (PD fat sat) 
• Sagittal plane only 
• Magnet: 3.0T or 1.5T with knee coil (8-16 channel)    
2.5.11 Schedule of study visits 
Initial screening may be done over the phone or at the office.  All 
subsequent visits will be at the site offices with the 2 year safety 
evaluation to be completed at the office or over the phone (Appendix A). 
Prior to surgery the subjects will come into the office for an evaluation 
visit where they will be enrolled in the study and the inclusion/exclusion 
criteria will be conducted.  If they qualify for the study the subject will 
have an MRI of their treatment knee.  Subjects will return to the office 2 
days post-surgery to have the surgery and injection site inspected.  At the 
remaining 6 week, 3 month and 6 month visits the surgery and injection 
site will be evaluated and the subject will complete the VAS and 
WOMAC questionnaires. MRI’s of the knee will be taken at the 6 month 
and 1 year visits for evaluation of any adverse changes to the joint space.  
At the 1 year safety follow-up visit the subject will return to the office to be 
evaluated for any safety concerns.  Safety assessments will be completed 
using MRI, study questionnaires, and physical examination.  It is anticipated 
that these visits should range from 15 minutes to 1 hour depending on the 
type of questions and measurements needed.  The subject will be contacted 
2 years after surgery for an additional safety update.  
2.5.12 Subject Compensation 
There will be no cost to the subjects other than the initial screening visits, 
which will be billed to the subject’s insurance.  Subjects will be given a 
stipend of $350.00 to participate in the study to defray the cost to complete 
the 4 post-operative clinical office visits (Table 1)   Subjects will receive 
compensation only at the time of these visits.  Subjects will not be 
compensated for missed visits or visits outside the required 4 visits.   
 
 

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 Table 1 Schedule of Subject Compensation 
Time after Treatment 
Compensation 
2 days (15 minutes) 
$ 50 
6 weeks (15 minutes) 
$ 50 
3 months (15 minutes) 
$ 50 
6 months (1 hour) 
$200 
Total 
$350 
2.6 Study outcome evaluations 
2.6.1 Study endpoints 
Safety: Safety endpoints are adverse events at any time point and MRI of 
the knee at 6 months and 1 year for any findings indicating that the device 
is not safe as used. 
Efficacy: This will be achieved if either dose is shown to be superior (i.e., 
less pain, better function and less stiffness) to the placebo group at the 6-
month time.  The measure of interest is the change in the WOMAC score 
and VAS pain scale from baseline.  The hypotheses of interest are: 
H0: µL = µC and µH = µC 
Ha: µL < µC and/or µH < µC 
2.6.2 Sample size determination 
The samples size determination is based on the primary efficacy endpoint 
using the WOMAC score (100 points full scale) and evaluated using 
Dunnett’s multiple comparison with a control one-sided (i.e., superiority) 
test.  Assuming a standard deviation of 14 points and a difference to detect 
(i.e., minimal clinically significant difference) of at least 17 (representing 
about a 33% decrease from baseline) points with α = 0.05 significance 
level and a power of 80% a conservative sample size of 11 subjects per 
group is needed.  This sample size estimate is based on a Bonferroni 
correction and as such is conservative (i.e., larger than necessary). Thus, 
the goal will be to have no fewer than 11 subjects per treatment group. To 
account for possible exclusions/lost to follow-up of data an additional 2 
subjects per treatment group (20%) will be added for a sample size of 13 
subjects per group for a total enrolled sample size of 39 subjects.  
2.6.3 Outcome data and data analysis 
Data analysis will be performed by a trained statistician using appropriate 
statistical methods and software (e.g. JMP or SAS). Descriptive statistics 
will be presented as means, standard deviations, medians and ranges for 
the continuous variables and as counts and percents for categorical 
variables. An alpha level of 5% will be used for all analyses, unless 
otherwise stated.  Demographics will be tabulated overall and by relevant 
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The primary efficacy will be evaluated using Dunnett’s multiple 
comparison with a control test (one-sided for superiority). 
The safety analysis will be descriptive and narrative in nature, with SAE's 
and AE's tabulated by body system, preferred term, severity and relation to 
procedure. 
MRIs will be evaluated for any anomalies or safety issues as observed by 
the PI. 
3 RISK ANALYSIS 
3.1 Anticipated risks 
The Study adds no expected risks or the need for additional safety precautions 
for the subject beyond what they would have for small volume liposuction 
surgery and a knee injection. These are detailed in the Informed Consent 
materials. 
3.2 Adverse events and reporting  
3.2.1 Adverse event definitions 
Adverse Event (AE): Any untoward medical occurrence in a clinical 
study of an investigational device; regardless of the causal relationship of 
the problem with the device or, if applicable, other study treatment or 
diagnostic product(s). 
Unanticipated adverse event (UAE): Any adverse effect, the frequency, 
specificity or severity of which is not consistent with the risk information 
described in the clinical study protocol(s). 
Serious adverse event (SAE): An adverse event is considered “serious” 
if, in the view of either the investigator or the sponsor, it results in any of 
the following outcomes:  
• death  
• a life-threatening AE 
• inpatient hospitalization or prolongation of existing hospitalization 
• a persistent or significant disability/incapacity 
• 
a congenital anomaly/birth defect. 
 
Unanticipated adverse device effect (UADE): Any serious adverse 
effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the 
investigational plan or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of subjects. 
3.2.2 Eliciting adverse event information 
Clinical study subjects will be routinely questioned about adverse effects 
at all study visits. 

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3.2.3 Recording and assessment of adverse events 
All observed or volunteered adverse events (serious or non-serious) and 
abnormal test findings, regardless of treatment group, if applicable, or 
suspected causal relationship to the investigational device or, if applicable, 
other study treatment or diagnostic product(s) will be recorded in the 
subjects’ case histories.  For all adverse events, sufficient information will 
be pursued and/or obtained so as to permit 1) an adequate determination of 
the outcome of the effect (i.e., whether the effect should be classified as a 
serious adverse event) and; 2) an assessment of the casual relationship 
between the adverse event and the investigational device or, if applicable, 
the other study treatment or diagnostic product(s).    
Adverse events or abnormal test findings felt to be associated with the 
investigational device or, if applicable, other study treatment or diagnostic 
product(s) will be followed until the effect (or its sequelae) or the 
abnormal test finding resolves or stabilizes at a level acceptable to the 
sponsor and investigator. 
3.2.4 Abnormal test findings 
An abnormal test finding (i.e. sterility of SVF) will be classified as an 
adverse event if one or more of the following criteria are met: 
• The test finding is accompanied by clinical symptoms 
• The test finding necessitates additional diagnostic evaluation(s) or 
medical/surgical intervention; including significant additional 
concomitant drug or other therapy (Note: simply repeating a test 
finding, in the absence of any of the other listed criteria, does not 
constitute an adverse effect.) 
• The test finding leads to a change in study dosing or exposure or 
discontinuation of subject participation in the clinical study 
• The test finding is considered an adverse event by the sponsor and 
investigator 
If a culture results in a positive sterility test it will be considered an 
abnormal test finding and reported to the FDA within 30 days.  This report 
will include results of any investigation into the cause and any corrective 
action taken.  The subject will be monitored for infection or other signs 
that may be attributed to the sterility failure.  
If any serious or unexpected adverse events related to abnormal test 
findings occur due to the device, the FDA, IRB and other investigators 
will be notified within 10 days of first learning of the event. 
3.2.5 Causality and severity assessment 
The sponsor, safety monitor and investigator will promptly review 
documented adverse events and abnormal test findings to determine 1) if 
the abnormal test finding should be classified as an adverse event; 2) if 
there is a reasonable possibility that the adverse event was caused by the 

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investigational device or other study treatments; and 3) if the adverse 
event meets the criteria for a serious adverse event. Adverse events will be 
scaled according to Common Terminology Criteria for Adverse Events 
(CTCAE, ver. 4.03: June 14, 2010).  
If the sponsor, safety monitor and/or investigator’s final determination of 
causality is “unknown and of questionable relationship to the 
investigational device or other study treatments,” the adverse event will be 
classified as associated with the use of the investigational device or other 
study treatments for reporting purposes.  If the sponsor, safety monitor 
and/or investigator’s final determination of causality is “unknown but not 
related to the investigational device or other study treatments,” this 
determination and the rationale for the determination will be documented 
in the respective subject’s case history.  
3.2.6 Stopping Rules 
This study will be stopped prior to its completion if the intervention is 
associated with adverse effects that call into question the safety of the 
subjects as follows; (1) if there are 5 or more device related adverse events 
of severity greater than grade 4 on the CTAE scale; (2) if more than 20% 
of subjects (8 subjects) receiving SVF report an increase in pain to a level 
greater than eight (8) on the VAS pain scale or function decreases more 
than 50% compared to baseline functional assessment using the WOMAC 
function assessment subscale A3; (3) if escalation difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the 
study endpoints; (4) any new information becomes available during the 
trial that necessitates stopping the trial.  Any subject that has been treated 
prior to stopping the study for any reason will be monitored for adverse 
effects and if such events occur the subject will be treated until resolution.    
3.2.7 Reporting adverse events to the FDA 
For any observed or volunteered adverse event that is determined to be a 
UADE or any abnormal test findings, the investigator shall submit the 
event to the sponsor and FDA through the FDA’s FDA Adverse Event 
Reporting System (FAERS).   
A copy of this report will be provided to all participating study 
investigators.   
The event will be submitted to the FDA as soon as possible and, in no 
event, later than 10 working days after the investigator first receives notice 
of the UADE and 30 days in the case of abnormal test findings  
If, following receipt and investigation of follow-up information regarding 
an adverse event that was previously determined not to be a UADE, the 
sponsor, safety monitor and/or investigator determines that the event does 
meet the requirements for expedited reporting, the sponsor and/or 
investigator will submit the event to FAERS as soon as possible, but in no 
event later than 10 working days, after the determination is made. 

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Subsequent to the initial submission of a completed FAERS, the sponsor 
and/or investigator will submit additional information concerning the 
reported adverse event or abnormal test finding as requested by the FDA. 
3.2.8 Reporting adverse events to the responsible IRB 
For any adverse event determined to be a UADE or any abnormal test 
findings, the investigator will submit a copy of the FAERS report to the 
IRB as soon as possible and, in no event, later than 10 working days after 
the sponsor and/or investigator first receives notice of the UADE or 30 
days for an abnormal test finding. 
Follow-up information to reported adverse events and abnormal test 
findings will be submitted to the IRB as soon as the relevant information 
is available.   
3.3 Withdrawal of subjects prior to completion of the study 
Any subject that has been treated prior to withdrawal from the study for any 
reason will be monitored for adverse effects and if such events occur the subject 
will be treated until resolution and their medical outcome is determined. 
4 DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, 
filtering, separating, and concentrating autologous stromal vascular fraction cells 
from adipose tissue for reintroduction to the same patient during a single surgical 
procedure for treatment of pain associated with joint osteoarthritis. The GID SVF-2 
device is to be used only with the GID SVF Procedure Pack. 
The GID SVF-2 device is a canister with various ports molded from polymer 
materials and a convenient tray. The canister is a closed system protecting the tissue 
aspirate through the harvesting process. The harvested tissue is deposited into the 
canister and filtered to capture the tissue and separate the fluid portion. 
Functional Principle: 
The harvested tissue and fluids are aspirated into a filter in the canister which 
captures the tissue particles and allows fluids through.  The harvested tissue may be 
rinsed with a sterile LR solution injected through the Patient port or Luer port. A 
manual stirring assembly allows the user to mix the tissue and fluids during the 
filtering process. Waste fluids are transferred to a waste container that is in-line with 
the aspiration device. 
5 MONITORING PROCEDURES 
Monitoring for safety will be conducted by an independent safety monitor with the 
assistance of the PI and sponsor.  A study monitor will monitor the study for 
compliance with the clinical protocol.     
6 LABELING 

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The canister packaging is labeled for identity and an “Instructions for Use” and 
“User’s Manual” is provided with each unit.  
The labeling will contain the statement "CAUTION - Investigational Device.  
Limited by Federal (or United States) Law to Investigational Use." [21 CFR 
812.5(a)].   
7 INFORMED CONSENT 
Informed consent will be obtained in accordance with the Declaration of Helsinki, 
ICH GCP, US Code of Federal Regulations for Protection of Human Subjects (21 
CFR 50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance 
Portability and Accountability Act (HIPAA, if applicable), and local regulations. 
The Sponsor and/or Investigator will prepare the informed consent form and HIPAA 
authorization and provide the documents to IRB for approval.  The written consent 
document will embody the elements of informed consent as described in the 
International Conference on Harmonisation (ICH) and will also comply with local 
regulations. The Sponsor and Investigator will retain an IRB-approved copy of the 
Informed Consent Form in the study master file. 
A properly executed, written, informed consent will be obtained from each subject 
prior to entering the subject into the trial.  Information should be given in both oral 
and written form and subjects (or their legal representatives) must be given ample 
opportunity to inquire about details of the study.  A copy of the signed consent form 
will be given to the subject or legal representative of the subject and the original will 
be maintained with the subject’s study binder. 
8 IRB INFORMATION 
The protocol and consent form will be reviewed and approved by the applicable IRB 
of each participating center prior to study initiation.  UADEs will be reported to the 
IRB in accordance with the standard operating procedures and policies of the IRB, 
and the Investigator will keep the IRB informed as to the progress of the study.  The 
Investigator will obtain assurance of IRB compliance with regulations. 
Any documents that the IRB may need to fulfill its responsibilities (such as protocol, 
protocol amendments, consent forms, information concerning patient recruitment, 
payment or compensation procedures, or other pertinent information) will be 
submitted to the IRB.  The IRB’s written unconditional approval of the study protocol 
and the informed consent form will be in the possession of the Investigator before the 
study is initiated.  The IRB’s unconditional approval statement will be transmitted by 
the Investigator to the Sponsor prior to the shipment of study supplies to the site.  
This approval must refer to the study by exact protocol title and number and should 
identify the documents reviewed and the date of review. 

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Protocol and/or informed consent modifications or changes may not be initiated 
without prior written IRB approval except when necessary to eliminate immediate 
hazards to the patients or when the change(s) involves only logistical or 
administrative aspects of the study.  Such modifications will be submitted to the IRB 
and written verification that the modification was submitted and subsequently 
approved should be obtained.   
The IRB must be informed of revisions to other documents originally submitted for 
review; new information that may affect adversely the safety of the patients of the 
conduct of the study; an annual update and/or request for re-approval; and when the 
study has been completed. 
9 OTHER INSTITUTIONS 
NA 
10 ADDITIONAL RECORDS AND REPORTS   
10.1 Data handling and record-keeping 
All Case Report Forms will be completed for each subject enrolled into the 
clinical study.  The investigator will review, approve and sign/date each 
completed CRF; the investigator’s signature serving as attestation of the 
investigator’s responsibility for ensuring that all clinical and laboratory data 
entered on the CRF are complete, accurate and authentic.   
Any missing, unused, or spurious data will be noted in the study records.   All 
efforts will be made to account for missing data.  Data may be removed if it 
does not meet quality criteria such as unreadable data or data entered with more 
than one value. 
Source Data are the clinical findings and observations, laboratory and test data, 
and other information contained in Source Documents.  Source Documents are 
the original records (and certified copies of original records); including, but not 
limited to, hospital medical records, physician or office charts, physician or 
nursing notes, subject diaries or evaluation checklists, pharmacy dispensing 
records, recorded data from automated instruments, x-rays, etc.  When 
applicable, information recorded on the CRF shall match the Source Data 
recorded on the Source Documents.   
10.2 Record maintenance and retention  
The sponsor and investigator will maintain records in accordance with 21 CFR 
812, Subpart G, to include: 
Item 
Sponsor Investigator 
FDA correspondence related to the IDE application 
and Investigational Plan; including copies of 
submitted Form FDA 3500A, supplemental IDE 
applications, current investigator lists, progress 
reports, notice of device recall or disposition,  
X 
 

Adipose-derived SVF for the Treatment of Knee OA 
Protocol # GIDOA-01 
Confidential                                                 Ver. 3.0  
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Item 
Sponsor Investigator 
FDA notice of device recall or disposition, copies of 
submitted Form FDA 3500A 
X 
X 
IRB correspondence (including approval 
notifications) related to the clinical protocol; 
including copies of adverse event reports and annual 
or interim reports 
X 
X 
Current and past versions of the IRB-approved 
clinical protocol and corresponding IRB-approved 
consent form(s) and, if applicable, subject 
recruitment advertisements 
X 
X 
Signed Investigator’s Agreements and Certifications 
of Financial Interests of Clinical Investigators 
X 
X 
Curriculum vitae (investigator and clinical protocol 
sub-investigators) 
X 
X 
Certificates of required training (e.g., human subject 
protections, Good Clinical Practice, etc.) for sponsor 
and investigator and listed sub-investigators 
X 
X 
Normal value(s)/range(s) for 
medical/laboratory/technical procedures or tests 
included in the clinical protocol 
X 
X 
Laboratory certification information 
X 
X 
Instructions for on-site preparation and handling of 
the investigational device and/or study treatment or 
diagnostic product(s), and other study-related 
materials (i.e., if not addressed in the clinical 
protocol) 
X 
X 
Master randomization list 
 
X 
Signed informed consent forms 
 
X 
Completed Case Report Forms, signed and dated by 
investigator 
 
X 
Source Documents or certified copies of Source 
Documents 
 
X 
Monitoring visit reports 
X 
X 
Copies of sponsor and investigator correspondence 
to sub-investigators, including notifications of 
adverse effect information 
X 
X 
Subject screening and enrollment logs 
 
X 
Subject Identification Log 
 
X 
Investigational device accountability records, 
including documentation of device disposal 
X 
X 
Final clinical study report. 
X 
X 
 
Staff at all facilities have training in GCP regulations, HIPAA and patient 
confidentiality.  

Adipose-derived SVF for the Treatment of Knee OA 
Protocol # GIDOA-01 
Confidential                                                 Ver. 3.0  
Page 31 of 32 
During the study, patient data paperwork will be kept using standard patient 
records criteria, confidentiality and information security procedures that include 
limited access, Co-PI oversight of records and secured files.  The data will be 
stored consistent with the clinics Records Retention Policies. 
The subject will be assigned an anonymous, unique identifier called the Subject 
ID unrelated to the subject’s name from a list of possible ID’s.  The subject’s 
name and corresponding identifier will be recorded in a study look up 
document, which shall be kept at the study site consistent with confidential 
document policies. 
The subject ID of excluded subjects will not be re-assigned.  Information 
describing the reason(s) for exclusion will be documented on the 
Inclusion/Exclusion CRF. 
CRFs will be labeled with the subject’s Subject ID and no subject identifying 
information will appear on reports, publications, or other disclosures of clinical 
study outcomes. 
The sponsor and investigator will retain the specified records and reports for up 
to two years after the marketing application is approved for the investigational 
device; or, if a marketing application is not submitted or approved for the 
investigational device, until two years after investigations under the IDE have 
been discontinued and the FDA so notified. 
10.3 Data Management 
The sites will send CRFs to the sponsor for data entry.  CRFs may be sent via 
FedEx, fax or uploaded to the secure, HIPAA compliant share site.  Data from 
the CRFs will be entered into a clinical data management system (CDMS) by 
the sponsor.   
The data management system will have verifications and restrictions on data 
entry.  The data entry will be 100% reviewed by an independent reviewer for 
accuracy.  Erroneous, questionable or missing data will be collected on a Data 
Clarification Form (DCF) for each site and sent to the site for correction.  The 
DCF will have an area for the site to make corrections or the site may make the 
correction on the original CRF and return to the sponsor. 
Once all data has been entered, clarification and queries have been resolved, and 
the data is determined to be clean the database will be declared locked. 
 
 

Adipose-derived SVF for the Treatment of Knee OA 
Protocol # GIDOA-01 
Confidential                                                 Ver. 3.0  
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Appendix A – Schedule of Visits and Procedures 
Case Report Form 
Eligibility 
Screening   
Pre-
Surg.  
 
Surg.   
 
2 days  
±24 hours   
Post-op 
6 weeks  
(±1 week)  
Post-op 
3 months  
(±2 weeks)  
Post-op 
6 months  
(±2 weeks)  
Post-op 
Safety  
1 year  
(±1 month)  
Safety  
2 years  
(±1 month) 
As 
Needed 
Screening Form  
X 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion  
 
X 
 
 
 
 
 
 
 
 
MRI 
 
X 
 
 
 
 
X 
X 
 
 
Demographics 
 
X 
 
 
 
 
 
 
 
 
Vital Signs 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Surgery/Knee 
Injection CRF  
 
 
X 
 
 
 
 
 
 
 
Cell Count Assay  
 
 
X 
 
 
 
 
 
 
 
Cell Culture Assay 
 
 
X 
 
 
 
 
 
 
 
Pain Evaluation 
(VAS) 
 
X 
X 
 
X 
X 
X 
 
 
 
Short Form 
WOMAC 
 
X 
X 
 
X 
X 
X 
 
 
 
Concomitant 
Medications 
 
X 
X 
X 
X 
X 
X 
 
 
 
Safety Follow-up 
 
 
 
 
 
 
 
X 
X 
 
Subject Exit 
 
 
 
 
 
 
 
 
X 
X 
Adverse Events 
 
 
 
 
 
 
 
 
 
X