Comparison of the Cellular Content of Bone Marrow Aspiration From the Posterior Superior Iliac Spine and Deep Humeral Harvest in Patients Undergoing Rotator Cuff Repair
Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Sponsor: Andrews Research & Education Foundation

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Version Date: 12AUG2022 
1
Title: Comparison of the Cellular Content of Bone Marrow Aspiration from the Posterior 
Superior Iliac Spine and Deep Humeral Harvest in Patients Undergoing Rotator Cuff Repair   
 
Principal Investigator:  
Joshua Hackel M.D. 
 
Co-Investigators:  
 
Adam Anz, M.D. 
James Andrews M.D 
 
 
 
 
Brett Kindle M.D. 
 
 
 
 
Steve Jordan M.D. 
 
 
 
 
Roger Ostrander M.D  
 
 
 
 
Funding Mechanism:   
State of Florida 
 
Institution(s):   
 
Andrews Research & Education Foundation (AREF) 
 
 
 
 
1020 Gulf Breeze Pkwy. 
 
 
 
 
Gulf Breeze, FL 32561 
 
 
 
 
(850) 916- 8570 
 
 
 
 
 
 
 
 

Comparison of the Cellular Content of Bone Marrow Aspiration from the Posterior Superior Iliac Spine 
and Deep Humeral Harvest in Patients Undergoing Rotator Cuff Repair  Joshua Hackel M.D. 
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Abbreviations and Definition 
AE 
Adverse Event 
ACDA Anti-Coagulant Citrate Dextrose A 
BMA Bone Marrow Aspirate 
CBC Complete Blood Count 
cBMA Concentrated Bone Marrow Aspirate 
CFU-F Colony Forming Unit-Fibroblast 
Cm      Centimeter  
EDC Electronic Data Capture 
HIPAA Health Insurance Portability and Accountability Act 
HPC 
Hematopoietic Progenitor Cell 
ICF      Informed Consent Form 
IRB 
Institutional Review Board 
IV 
Intravenous 
MPCs Mesenchymal Progenitor Cells  
mL 
Milliliters 
PI 
Principal Investigator 
SAE 
Severe Adverse Event 
SOC 
Standard of Care 
TNC Total Nucleated Cell 
UP  
Unanticipated Problem 

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Table of Contents 
1 
Background / Scientific Rationale ................................................................................... 5 
2 
Study Design ................................................................................................................... 6 
3 
Objectives ....................................................................................................................... 6 
3.1 Primary Objective .....................................................................................................................6 
3.2 Secondary Objective .................................................................................................................6 
3.3 Primary Effectiveness Endpoints ...............................................................................................7 
3.4 Secondary Effectiveness Endpoints............................................................................................7 
4 
Hypotheses ..................................................................................................................... 7 
4.1 Null Hypothesis: .......................................................................................................................7 
4.2 Alternative Hypothesis:.............................................................................................................7 
5 
Participant Recruitment and Screening ........................................................................... 7 
5.1 Screening Process: ....................................................................................................................7 
5.1.1 Inclusion Criteria: ...................................................................................................................7 
5.1.2 Exclusion Criteria: ..................................................................................................................7 
5.2 Informed Consent 21 CFR 50 .....................................................................................................8 
5.3 Consent Withdrawal: ................................................................................................................8 
5.4 Benefits: ...................................................................................................................................8 
5.5 Compensation: .........................................................................................................................9 
6 
Treatment Plan ............................................................................................................... 9 
6.1 Surgical Procedure and cBMA Collection: ..................................................................................9 
6.2 Cellular Analysis: .................................................................................................................... 10 
7 
Review of Safety ........................................................................................................... 10 
7.1 Adverse Event (AE) ................................................................................................................. 10 
7.2 Serious Adverse Event (SAE) .................................................................................................... 10 

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7.3 Unanticipated Problem (UP): .................................................................................................. 11 
7.4 AE & SAE Collection and Reporting .......................................................................................... 11 
7.5 Risks and Discomforts: ............................................................................................................ 11 
8 
Data Management Procedures ..................................................................................... 12 
10 Statistical Considerations .............................................................................................. 12 
11  Quality Control and Assurance ...................................................................................... 12 
12 References .................................................................................................................... 13 
 
 
 

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1 
Background / Scientific Rationale 
Musculoskeletal injury is a significant global health concern, with injury contributing to large 
amounts of patient pain, disability, and a decrease in overall wellbeing [1]. Emerging areas of 
research and treatment in orthopedic injuries using stem and progenitor cells have shown great 
potential.  Stem cells are biological cells which differentiate into many types of human tissue. 
Stem cells differentiate into specific cell lineages to manage healthy tissues and cells, as well as 
repair damaged tissues and cells.  Stem cells can specialize into progenitor cells, which have 
gone one step further toward a specific differentiation pathway.  Progenitor cells then change 
according to the given environment (i.e., growth factors, stress) and perform specific cellular 
functions.  Progenitor cells are found in many tissues, including the peripheral blood and bone 
marrow.  Progenitor cells act as important repair cells for the musculoskeletal system, 
specifically for bone and cartilage [1]. These progenitor cells are mobilized and activated to the 
peripheral blood circulation during episodes of stress, injury, and exercise [2, 3].  Cell therapies 
using progenitor cells have shown great potential for addressing acute, chronic, and traumatic 
orthopedic injury.  
One cell therapy of interest currently involves bone marrow aspiration and concentration.  Bone 
marrow aspiration and concentration is a method of progenitor cell harvest.  Orthopedic surgeons 
have begun to augment surgical procedures and treat degenerative conditions such as 
osteoarthritis and cartilaginous injury with injections of concentrated bone marrow aspirate 
(cBMA) [4-8] .The use of cell therapies may contribute to decreased recovery time and 
morbidity rates [9-11].  Hernigou et al. showed significant improvement in patient outcomes 
could be achieved by the use of cBMA as an adjunct therapy in standard of care rotator cuff 
repair (RCR) [5]. In clinical application, studies have suggested that the success of these 
treatments is dependent on the total quantity and utility of harvested progenitor cells [5,7].  
While bone marrow aspiration is frequently utilized for orthopedic point of care applications, the 
number of progenitor cells harvested is variable and dependent on body mass, aspiration 
technique, and location of harvest [5, 12].  Optimizing the harvest procedure is a key step in the 
development of bone marrow aspirate for orthopedic applications.  Studies have attempted to 
find the most appropriate locations for harvesting bone marrow aspirate [13-17]. The preferred 
site for bone marrow extraction is the posterior iliac spine [13-17]. The posterior iliac spine 
yields the greatest concentration of viable nucleated cells when compared to the anterior iliac 
spine [13]. The posterior iliac spine also yields a greater concentration of nucleated cells when 
compared to other appendicular osseous sites, including the distal femur, proximal tibia, distal 
tibia, calcaneus, and proximal humerus [13-16].  In one study, the cBMA harvested from the 
posterior superior iliac spine (PSIS) resulted in a 3.0 times greater cellular yield and an 8.3 times 
greater proliferative cell product than cBMA from the proximal humerus [17] . Determining the 
quantity of progenitor cells in these samples can provide clinicians with a more cost-effective 
alternative for harvesting progenitor cells that can be used for surgical augmentation. However, 

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the potential for progenitor cells to be harvested from the diaphysis of the humerus (deep 
humerus) has yet to be quantified. Thus, this the aim of this study is to analyze the cellular 
characteristics of cBMA from two extraction sites (PSIS and deep humerus) from patients 
undergoing standard-of-care arthroscopic rotator cuff repair surgery.  Additionally, we aim to 
determine if patient positioning during PSIS harvest has any effect on the cellular content of 
collected cBMA. 
2 
Study Design 
This is a single site, comparative quantitative analysis study of the cellular characteristics of 
bone marrow aspirate from two extraction sites (PSIS and deep humerus) from patients 
undergoing standard-of-care arthroscopic rotator cuff repair surgery.  30 total patients will be 
recruited through the Andrews Institute physician practices.  Potential participants will be 
prescreened for inclusion and exclusion criteria through standard of care medical evaluations. 
Once a potential participant has agreed to be involved in the study, they will go through the 
described informed consent process.  Patients meeting the inclusion criteria will have the study 
explained to them by one of the members of the research team, and they will be given an 
opportunity to participate if they are interested.  No specific advertising or recruitment material 
will be utilized.  
After the described screening and informed consent process have been completed, all 
participants will undergo standard-of-care arthroscopic rotator cuff repair surgery.  During all 
surgeries, bone marrow will be aspirated from the PSIS and from the deep humerus.  The first 15 
participants will have bone marrow aspirated from the PSIS while in the prone position on the 
operating table.  The final 15 participants will have bone marrow aspirated from the PSIS while 
in the lateral decubitus position on the operating table.  Both cohorts will undergo deep humeral 
harvest intraoperatively in the lateral decubitus position.  One mL of cBMA from each harvest 
site from each surgery will be removed and sent to the AREF Regenerative Medicine Center 
(RMC) for analysis.  The remaining cBMA will be used to augment the rotator cuff repair 
surgery. 
3 
Objectives 
3.1 Primary Objective 
The primary objective of this study is to determine whether the PSIS or deep humeral 
harvest produces a greater cellular harvest in patients undergoing rotator cuff repair.  
3.2 Secondary Objective 
The secondary objective is to determine if prone verses lateral decubitus participant 
positioning influences the quantity of harvested cells from the PSIS. 

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3.3 Primary Effectiveness Endpoints 
The primary effectiveness endpoints of this study include cellular content measures of 
cBMA collected from each extraction site (as outlined in section 6.2). 
3.4 Secondary Effectiveness Endpoints 
The secondary effectiveness endpoints of this study include cellular content measures of 
cBMA collected from each anatomical position (as outlined in section 6.2). 
4 
Hypotheses 
 
4.1 Null Hypothesis:  
H0 - Participants will have similar cellular content (in vitro) in bone marrow aspirate 
taken from the PSIS and from deep humeral harvest.  Additionally, patient positioning 
will not affect the cellular content of bone marrow from the PSIS.  
 
 
4.2 Alternative Hypothesis:  
H1 - Participants will not have similar cellular content (in vitro) in bone marrow aspirate 
taken from the PSIS and from deep humeral harvest.  Additionally, patient positioning 
will affect the cellular content of bone marrow from the PSIS. 
5 
Participant Recruitment and Screening 
5.1 Screening Process: 
Once interested participants are identified and prescreened, a screening visit will be 
scheduled (visit 1).  During the screening visit, a screening form will be completed which 
includes the inclusion and exclusion criterion below.  If an individual answers "yes" to 
any of the initial screening exclusion questions, they will be informed that they do not 
qualify for the study, and they will be informed that they can keep their screening form 
and their medical care will not be adversely affected by not enrolling in the study.  If all 
answers are "no" then the form will be placed in the study documents and the enrollment 
process will continue. 
5.1.1 Inclusion Criteria:  
 18-80 years of age 
 Diagnosis of a rotator cuff tear requiring arthroscopic rotator cuff repair 
5.1.2 Exclusion Criteria:  
 Patients who require superior capsular reconstruction or revision rotator cuff 
repair  
 Diabetes  
 Immune disorders  

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 Past medical history of a metastatic or other cancer which required 
chemotherapy/radiation therapy  
 Rheumatoid arthritis 
 Is unable to comprehend the study documents or give informed consent  
Once the screening requirements are met, the informed consent form will be provided to 
the participant on paper or electronically via REDCap for review ensure the volunteer 
understands the details of the study including the benefits and risk factors. The subject 
will be provided sufficient time to consent and sign the informed consent form (ICF). The 
principal investigator (PI) and study/research team will be available to answer any 
questions or provide clarifications during the informed consent process.  
5.2 Informed Consent 21 CFR 50 
In adherence to the 21 CFR 50, Protection of Human Subjects Guidelines, the informed 
consent process will be performed by one of the study investigators or staff, in the 
research office that has received training on the informed consent process.  No aspects of 
the study will be conducted prior to obtaining informed consent from each participant.  
The purpose and methods of the study along with the expected effects will be reviewed 
with each potential participant.  Each participant will be provided a copy of the consent 
and sufficient time will be given for the opportunity to read and ask any questions about 
the study.  After signing of the informed consent document, participants will be given a 
copy for their records.  
The designee will review with each participant that they are free to refuse to the study or 
to withdraw from it at any time. 
5.3 Consent Withdrawal: 
During the informed consent procedure, participants will be informed that if at any point 
during the study, consent may be withdrawn.  To withdraw consent, participants can 
request in writing to withdraw HIPAA authorization and the research site will not use or 
provide any health information to researchers. At this time, the link between the 
participant’s health information will be severed with the research team. This process for 
consent withdrawal will be reviewed with each participant and identified barriers will be 
addressed at the time of informed consent.  
5.4 Benefits:  
Participants may directly benefit from improved healing via cBMA augmentation of their 
rotator cuff repair as a result of agreeing to participate in the study. Participants will 
receive at no extra charge cell augmentation therapy of their rotator cuff repair.  Indirect 
benefits include additional medical care and follow-up after surgery. This study may help 

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direct clinical practice in developing preferred techniques to augment orthopedic surgical 
procedures (aspirational benefit).  
5.5 Compensation: 
Compensation will not be provided to participants for participating in this study. 
6 
Treatment Plan 
After the described screening and informed consent process have been completed, all 
participants will undergo standard-of-care arthroscopic rotator cuff repair surgery.  During all 
surgeries, bone marrow will be aspirated from the PSIS and from the deep humerus.  The first 15 
participants will have bone marrow aspirated from the PSIS while in the prone position on the 
operating table and deep humerus during the surgery in the lateral decubitus position.  The final 
15 participants will have bone marrow aspirated from the PSIS while in the lateral decubitus 
position on the operating table and deep humerus during the surgery in the lateral decubitus 
position.  Bone Marrow Aspirate will be concentrated at a 12% hematocrit setting independently 
from each site.  One mL of cBMA from each harvest site from each surgery will be removed and 
sent to the AREF RMC for analysis.  The remaining cBMA will be used to augment the rotator 
cuff repair surgery.  
6.1 Surgical Procedure and cBMA Collection: 
The first 15 participants will be placed in the prone position on the operative table for the 
bone marrow harvest from the PSIS.  After bone marrow harvest from the PSIS, the 
patient will be placed in the lateral decubitus position for the rotator cuff repair.  Rotator 
cuff repair is always performed in either the lateral decubitus position or an upright, 
seated position called the beach chair position.  The final 15 participants will placed in 
the lateral decubitus position on the operative table for the bone marrow harvest and the 
rotator cuff repair. The PSIS harvest will be performed first.  The skin will be prepped 
and draped in sterile fashion over the PSIS.  Lidocaine 1% will be used to anesthetize the 
skin around the incision location. A stab incision will be made in the skin over the PSIS.  
Two 30 cc syringes and a traditional 11-gauge, 11 cm Jamshidi needle (Ranfac 
Corporation, Avon, MA, USA) will be pre-rinsed with heparin.  The two 30 cc syringes 
will be loaded with 4 cc of anticoagulant citrate dextrose solution-A (ACDA). The needle 
will be advanced into the bone marrow cavity 3-4 cm. 30 mL of bone marrow will be 
aspirated while the needle is withdrawn and rotated with one syringe.  The needle will 
then be reinserted divergently, and another 30 mL of bone marrow aspirated with the 
second syringe.  This method has been described and quantitively studied with similar 
harvest to a multiple puncture technique (18).  A sterile dressing will be applied.  The 
participant will be re-prepped and draped in standard fashion for shoulder arthroscopy.  A 
diagnostic arthroscopy will be performed, and the rotator cuff tear identified.  While 

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viewing from the standard posterior portal in the subacromial space, a spinal needle will 
be used to localize the location and trajectory for placement of the first suture anchor for 
the rotator cuff repair.  Once the placement of the proposed anterior suture anchor is 
confirmed, the 11-gauge bone marrow harvest needle will be placed into this location and 
the arm adducted.  The needle will then be advanced into the humeral diaphysis as far as 
the needle length allows.  Two 30 mL syringes will be pre-filled with 4 mL of ACD-A 
and used to harvest 60 mL of bone marrow aspirate.  The bone marrow samples will then 
be processed independently using the Arthrex Angel blood processing system (Arthrex, 
Naples, FL) using the 12% hematocrit setting with two separate disposables.  One mL of 
cBMA from each harvest site will be removed and sent to the AREF RMC for analysis. 
The remaining cBMA will be used to augment the rotator cuff repair surgery.  
 
6.2 Cellular Analysis:  
Cellular analysis of each cBMA sample from the two collection sites per participant will 
include a Complete Blood Cell (CBC) count, a Total Nucleated Cell (TNC), viability 
count, and cell culture analysis.  
The CBC count will be performed using an automated hemocytomter (XN-350; Sysmex, 
Kungsbacka, Sweden) and will include red blood cell (RBC), white blood cell (WBC), 
monocyte, platelet, and hematopoietic progenitor cell (HPC) concentration. 
The TNC and viability count will be performed using an automated cell counter.  
Cell culture experiments will include Colony Forming Unit-fibroblast (CFU-F) counts 
and the potential for additional stem or progenitor cell analysis procedures. If stem or 
progenitor cells are observed during culturing, additional experiments will be conducted 
to analyze differentiation potential (differentiation assays) and cell-surface markers (flow 
cytometry). 
7 
Review of Safety 
7.1 Adverse Event (AE) 
An adverse event is any untoward or unfavorable medical occurrence in the human 
subject, including any abnormal sign, symptom, or disease, temporally associated with 
the subject’s participation in the research, whether considered related to the subject’s 
participation in the research. 
7.2 Serious Adverse Event (SAE) 
Serious adheres events are any events that: 
 Result in death 

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 Is life threatening, or places the participant at immediate risk of death from the event 
as it occurred 
 Requires or prolongs hospitalization 
 Causes persistent or significant disability or incapacity 
 Results in congenital anomalies or birth defects 
 Is another condition which investigators just to represent significant hazards 
7.3 Unanticipated Problem (UP): 
Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets the 
following criteria.  
 unexpected, in terms of nature, severity, or frequency, given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the study population.  
 related or possibly related to participation in the research (in this guidance document, 
possibly related means there is a reasonable possibility that the incident, experience, 
or outcome may have been caused by the procedures involved in the research); 
 suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
7.4 AE & SAE Collection and Reporting 
Throughout the study the research team will monitor the occurrence of AE and SAE. 
Data will be collected if an instance occurs, and the PI will be notified.  All AE data, such 
as onset date, resolution date, outcome and treatments given will be documented in the 
source documents and will be recorded in the EDC and analyzed for severity to follow 
reporting protocol if severity level. 
Follow-up will occur using the provided safety monitoring form if AE occurs.  The 
follow up will end either when the symptoms resolve or up to 30 days past the end of the 
study participation. 
7.5 Risks and Discomforts: 
Standard sterile precautions for surgical procedures will be utilized for the rotator cuff 
repair surgery, but with any surgery there is risk of infection, bleeding, and swelling. 
There will also be a small needle insertion hole into the humerus and the iliac crest for 
the bone marrow stem cell collection, which will be about the same size as an IV 
insertion.  This may have some minor pain or swelling and there is a very minor risk of 
infection.  Pain post procedure can occur but is usually self-limiting.  Bruising may also 

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occur.  As with any research involving patients there is the inherent risk of a breach in 
patient confidentiality though this will be minimized using participant code numbers and 
adherence to all HIPAA guidelines.  
8 
Data Management Procedures 
All personal information is strictly confidential, and no names will be disclosed except as 
required by law.  Data from cellular analysis and demographics will be compiled in Microsoft 
Excel.  The spreadsheet will not contain protected health information as all compiled data will be 
de-identified.  The spreadsheet will be stored in a secure password protected folder on a laptop 
that only the study Investigators will have access to and will be permanently deleted following 
publication of any and all manuscripts, if any, written as a result of this research. Records related 
to this study will be securely retained in a secure location for a period of 3 years after the 
completion of the study or longer as required by law.  At that time, all records will be properly 
destroyed.  
9 
Data Analysis  
A combination of Excel and SAS Studio (Version 3.8 on SAS 9.4, SAS Institute Inc., Cary, NC) 
will be used for data analysis. All compiled data will be de-identified.   
10 
Statistical Considerations 
Descriptive statistics will be compiled for all numeral measures (Demographics, CBC, TNC, 
viability, CFU-F).  Data will be analyzed for differences between experimental groups (PSIS v. 
deep humeral harvest, Prone vs. lateral decubitus positions) using 1-Way ANOVA and 
appropriate post-hoc analysis procedures (ex: Tukey’s Honestly Significant Difference (HSD)).  
A significant p-value of < 0.05 for rejecting the null hypothesis will be used for all measures.  
11  
Quality Control and Assurance 
All protocols will be monitored and analyzed data will be checked for accuracy by the principal 
investigator and /or a designated AREF research team member.  All medical data will be kept in 
compliance with HIPAA guidelines. 
 
 

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12 
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