Clinical trial NCT03379168
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis mesenchymal stem cell adipose tissue injection nonoperative treatment
Sponsor: Dustin L. Richter, MD
Start date: 2018-04-01; Completion date: 2023-10-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Knee osteoarthritis (OA) causes patients considerable joint pain and leads to instability, reduced range of motion, and functional limitations. Current treatment limitations have generated interest in alternative options to restore function and alleviate joint pain, some with the aim of healing damaged articular cartilage. There has been preliminary support in the literature for reduced pain and improved functional performance in patients who receive mesenchymal stem cells (MSCs) as part of a treatment regimen. MSCs can be costly and are limited by complex regulatory issues. This interest in an alternative isolation method lead to the development of Lipogems. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. In addition, given the limitations of prior research on the efficacy of intra-articular corticosteroids, the investigators will also include this as an additional study group to compare to placebo. There have been case reports published showing favorable outcomes. This would be the first study reporting data on the efficacy of Lipogems for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of patients.

The investigators hypothesize that patients who receive an injection of Lipogems will experience a decrease in pain of the affected knee and an increase in joint functionality in comparison to placebo. The investigators also hypothesize that patients who receive an intra-articular corticosteroid will experience decreased pain or improved functionality in the affected joint compared to placebo.

Detailed description:
Objectives:

1. The purpose of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. Based on limitations of prior research, intra-articular corticosteroids are included as a study group to be evaluated for impact on pain relief and joint functionality in comparison to placebo.
2. The investigators hypothesize that patients who receive an injection of Lipogems will experience a decrease in pain of the affected knee and an increase in joint functionality in comparison to placebo. The investigators also hypothesize that patients who receive an intra-articular corticosteroid will experience decreased pain or improved functionality in the affected joint.

Background:

Osteoarthritis (OA) causes patients considerable joint pain and leads to instability, reduced range of motion, and functional limitations. Pathologic findings of OA include decreased articular cartilage, joint space narrowing, osteophytes, subchondral sclerosis and bone cysts. Currently, treatment options are confined to symptom management only. Options for treatment include: topical preparations, nonsteroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, and, in severe cases, total knee arthroplasty. Review of recent recommendations shows limitations to all available treatments. Oral NSAIDs have shown relief, but is limited to patients without risk factors or contraindications. Topical NSAIDs are recommended in elderly patients or those with GI risk factors, rather than oral NSAIDs. However, pain improvement took 12 weeks and was not long-lived, potentially due to compliance issues in application. A recent systematic review of intra-articular corticosteroids reported that, due to low-quality evidence, it is inconclusive whether intra-articular corticosteroids provided any short or long-term pain relief. Taylor's review of hyaluronic acid treatment is hampered by the variability of preparations currently on the market and shortage of double-blind placebo controlled studies, but conflicting data is reported. Osteoarthritis Research Society International currently recommends corticosteroid injections for short-term pain relief only, and is inconclusive in recommending hyaluronic acid.

The aforementioned treatment limitations have generated interest in alternative options to restore function and alleviate joint pain, some with the aim of healing damaged articular cartilage. It is well known that articular cartilage is avascular and lacks innervation, which limits its intrinsic healing and repair capabilities. Chondrocytes, derived from MSCs, have limited potential to replicate, which also limits the intrinsic healing and repair capabilities of articular cartilage. The stromal vascular fraction, containing adipose derived mesenchymal stem cells (MSCs), has historically been isolated successfully via enzymatic processes. There has been preliminary support in the literature for reduced pain and improved functional performance in patients who received MSCs as part of treatment. However, approaches to isolate MSCs are costly, time consuming, require extensive lab equipment, and are currently limited by complex regulatory issues.

Thus, interest in an alternative isolation method lead to the development of Lipogems. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection.

As new technologies are becoming available for the treatment of OA, it is important that investigators gather high-quality data on their efficacy and outcomes. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. In addition, given the limitations of prior research on the efficacy of intra-articular corticosteroids, the investigators will also include this as an additional study group to compare to placebo. Although Lipogems is relatively new to the United States, it has been used for a variety of orthopaedic arthroscopic applications overseas including the treatment of knee OA and is being used more frequently now in the United States. As of now, there are no published studies reporting the outcomes of patients who receive Lipogems for knee OA. There have been case reports published showing favorable outcomes. Thus, this would be the first study reporting data on the efficacy of Lipogems for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of patients. It would also be the only study to date comparing Lipogems to intra-articular corticosteroids and placebo injections. The investigators feel this study design will provide new insight into the efficacy of Lipogems for pain relief of symptomatic knee OA as well as offer new data on the efficacy of intra-articular corticosteroids in this application.

Arms: arm 1: Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee. arm 2: Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee. arm 3: Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Interventions: intervention 1: Microfragmented Adipose Tissue (Lipogems) intervention 2: Corticosteroid injection intervention 3: Saline
Intervention descriptions: intervention 1: Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections. intervention 2: Cortisone is a standard of care injection to reduce joint inflammation. intervention 3: Sterile saline injection will act as a placebo group.

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 1 of 40
Version Date: March 29, 2018
PROTOCOL TITLE:
 “Evaluating the efficacy of micro-fragmented adipose tissue and intra-articular 
corticosteroid injections for symptomatic knee osteoarthritis: a randomized, 
placebo controlled study”
PRINCIPAL INVESTIGATOR:
Dustin Richter, MD
UNMH Department of Orthopaedics
VERSION NUMBER:
6
DATE:
03/29/18
REGULATORY FRAMEWORK:
Please indicate all that apply:
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
HHS (Department of Health and Human Services)
VA
Other:      
Is this a clinical trial under ICH-GCP E6?   
 Yes   
 No
If yes, please confirm that the research team is familiar with and agrees to comply 
with the investigator requirements cited in ICH-GCP E6.  
 Yes   
 No 
ICH-GCP E6 can be accessed by copying and pasting this URL into your 
browser: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 2 of 40
Version Date: March 29, 2018
Table of Contents
1.
Objectives.....................................................................................................................4
2.
Background ..................................................................................................................4
3.
Study Design ................................................................................................................4
4.
Inclusion and Exclusion Criteria ..................................................................................4
5.
Number of Subjects......................................................................................................4
6.
Study Timelines............................................................................................................5
7.
Study Endpoints ...........................................................................................................5
8.
Research Setting...........................................................................................................5
9.
Resources Available.....................................................................................................5
10.
Prior Approvals.........................................................................................................6
11.
Multi-Site Research ..................................................................................................6
12.
Study Procedures ......................................................................................................7
13.
Data Analysis............................................................................................................7
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects.............................8
15.
Withdrawal of Subjects.............................................................................................8
16.
Data Management/Confidentiality............................................................................8
17.
Data and Specimen Banking...................................................................................10
18.
Risks to Subjects.....................................................................................................10
19.
Potential Benefits to Subjects .................................................................................11
20.
Recruitment Methods..............................................................................................11
21.
Provisions to Protect the Privacy Interests of Subjects ..........................................11
22.
Economic Burden to Subjects.................................................................................11
23.
Compensation .........................................................................................................12
24.
Compensation for Research-Related Injury............................................................12
25.
Consent Process......................................................................................................13
26.
Documentation of Consent .....................................................................................15
27.
Study Test Results/Incidental Findings ..................................................................16
28.
Sharing Study Progress or Results with Subjects...................................................17
29.
Inclusion of Vulnerable Populations ......................................................................17
30.
Community-Based Participatory Research.............................................................18
31.
Research Involving American Indian/Native Populations .....................................18
32.
Transnational Research...........................................................................................19
33.
Drugs or Devices ....................................................................................................19
Checklist Section ...............................................................................................................20


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 3 of 40
Version Date: March 29, 2018
1. Objectives
1.1. The purpose of this study is to evaluate the possible benefits of reduced 
joint pain and increased joint functionality in participants with knee 
osteoarthritis after the injection of Lipogems. Based on limitations of 
prior research, intra-articular corticosteroids are included as a study 
group to be evaluated for impact on pain relief and joint functionality in 
comparison to placebo.
1.2. We hypothesize that participants who receive an injection of Lipogems will 
experience a decrease in pain of the affected knee and an increase in joint 
functionality in comparison to placebo. We also hypothesize that participants 
who receive an intra-articular corticosteroid will experience decreased pain or 
improved functionality in the affected joint.
2. Background
2.1. Osteoarthritis (OA) causes patients considerable joint pain and leads to 
instability, reduced range of motion, and functional limitations. Pathologic 
findings of OA include decreased articular cartilage, joint space narrowing, 
osteophytes, subchondral sclerosis and bone cysts.1 Currently, treatment options 
are confined to symptom management only. Options for treatment include: 
topical preparations, nonsteroidal anti-inflammatory drugs (NSAIDs), intra-
articular injections, and, in severe cases, total knee arthroplasty. Review of 
recent recommendations shows limitations to all available treatments. Oral 
NSAIDs have shown relief, but is limited to patients without risk factors or 
contraindications. Topical NSAIDs are recommended in elderly patients or those 
with GI risk factors, rather than oral NSAIDs. However, pain improvement took 
12 weeks and was not long-lived, potentially due to compliance issues in 
application.2,3 A recent systematic review of intra-articular corticosteroids 
reported that, due to low-quality evidence, it is inconclusive whether intra-
articular corticosteroids provided any short or long-term pain relief.4 Taylor’s 
review of hyaluronic acid treatment is hampered by the variability of 
preparations currently on the market and shortage of double-blind placebo 
controlled studies, but conflicting data is reported.3 Osteoarthritis Research 
Society International currently recommends corticosteroid injections for short-
term pain relief only, and is inconclusive in recommending hyaluronic acid.5 
The aforementioned treatment limitations have generated interest in alternative 
options to restore function and alleviate joint pain, some with the aim of healing 
damaged articular cartilage. It is well known that articular cartilage is 
avascular and lacks innervation, which limits its intrinsic healing and repair 
capabilities. Chondrocytes, derived from MSCs, have limited potential to 
replicate, which also limits the intrinsic healing and repair capabilities of 
articular cartilage.6,7 The stromal vascular fraction, containing adipose derived 
mesenchymal stem cells (MSCs), has historically been isolated successfully via 
enzymatic processes. 8 There has been preliminary support in the literature for 


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 4 of 40
Version Date: March 29, 2018
reduced pain and improved functional performance in patients who received 
MSCs as part of treatment.7,9,10 However, approaches to isolate MSCs are costly, 
time consuming, require extensive lab equipment, and are currently limited by 
complex regulatory issues.11-13
Thus, interest in an alternative isolation method lead to the development of 
Lipogems. Lipogems is a technique to harvest, process, and inject minimally 
manipulated adipose tissue. This procedure is enzyme free and requires no 
clonal expansion or manipulation. Lipoaspirate is harvested and washed in 
saline solution, then processed through a closed-system device that micro-
fragments the adipose tissue. This mechanical process retains the vascular 
architecture, mature pericytes, and MSCs for autologous injection.12,13
As new technologies are becoming available for the treatment of OA, it is 
important that we gather high-quality data on their efficacy and outcomes. The 
goal of this study is to evaluate the possible benefits of reduced joint pain and 
increased joint functionality in participants with knee osteoarthritis after the 
injection of Lipogems. In addition, given the limitations of prior research on 
the efficacy of intra-articular corticosteroids, we will also include this as an 
additional study group to compare to placebo. Although Lipogems is relatively 
new to the United States, it has been used for a variety of orthopaedic 
arthroscopic applications overseas including the treatment of knee OA and is 
being used more frequently now in the United States. As of now, there are no 
published studies reporting the outcomes of patients who receive Lipogems for 
knee OA. There have been case reports published showing favorable outcomes. 
Thus, this would be the first study reporting data on the efficacy of Lipogems 
for pain relief in knee OA in a randomized, controlled clinical trial with a larger 
sample of participants. It would also be the only study to date comparing 
Lipogems to intra-articular corticosteroids and placebo injections. We feel this 
study design will provide new insight into the efficacy of Lipogems for pain 
relief of symptomatic knee OA as well as offer new data on the efficacy of intra-
articular corticosteroids in this application. 
2.2. We do not have any preliminary data. There is, at this point, no study published 
explicitly evaluating the efficacy of Lipogems in patients with knee osteoarthritis, 
although Lipogems has been used for this purpose and is acknowledged in case 
reports. One case study by Striano et al reports decreased knee pain and no 
adverse side effects following injection of Lipogems.14 
2.3. Estimates say that there are between 15-27 million US adults age 25 or older 
with clinical OA of at least one joint, and that 49.7% of people over the age of 65 
report that they have diagnosed arthritis.15-17 The lifetime risk of symptomatic 
knee osteoarthritis is estimated to be 13.8%, and an even higher risk is identified 
for obese persons (19.7%) and females (16.3%).18
OA is not exclusive to patients over 65. Recent estimates show that 
approximately 6.6 million people between the ages of 45-64 had OA in 2011-


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 5 of 40
Version Date: March 29, 2018
2012. Furthermore, it is estimated that 1.7 million adults under the age of 45 had 
OA in the same year. 17 Thus, the burden of OA is much more widespread than 
the elderly population.
Current therapies are limited to symptom management only, none curative or 
capable of stopping the progress of disease. Thus, a staggering number of 
Americans of all ages are living with a chronically painful joint condition. 
Furthermore, with the burden of an aging population and high rate of obesity in 
the United States, the management and treatment of OA will continue to be an 
important health concern.
As new technologies are becoming available for the treatment of OA, it is 
important that we gather high-quality data on their efficacy and outcomes. The 
goal of this study is to evaluate the possible benefits of reduced joint pain and 
increased joint functionality in participants with knee osteoarthritis after the 
injection of Lipogems. In addition, given the limitations of prior research on 
the efficacy of intra-articular corticosteroids, we will also include this as an 
additional study group to compare to placebo. This would be the first study to 
evaluate the efficacy of Lipogems for pain relief in knee OA in a randomized, 
controlled clinical trial with a large sample of participants. It would also be the 
only study to date comparing Lipogems to intra-articular corticosteroids and 
placebo injections. We feel this study design will provide new insight into the 
efficacy of Lipogems for pain relief of symptomatic knee OA as well as offer 
new data on the efficacy of intra-articular corticosteroids for this application. .
3. Study Design
3.1. This study will be conducted as a randomized, placebo-controlled clinical trial. 
Participants will be randomized to receive either Lipogems, intra-articular 
corticosteroids, or a placebo injection of saline. Lipogems is cleared for use by 
the FDA in orthopaedics and arthroscopy and is offered as a treatment option for 
knee osteoarthritis. This study will be evaluating the effectiveness (not safety) of 
Lipogems when compared to corticosteroids and placebo. Thus, no information 
will be submitted to the FDA.
3.2. It is not feasible to blind participants who are randomized to receive Lipogems, 
as adipose tissue must be obtained from the participant. However, participants 
randomized to receive intra-articular corticosteroids or placebo injections will 
be blinded. 
3.3. Randomization will be stratified according to baseline pain severity as defined 
here, ethnicity, and age to ensure a balanced assignment across the three groups 
with respect to important determinants. Stratification will not be based on 
radiographic severity as previous studies have shown no correlation between the 
radiographic severity of knee osteoarthritis and the pain experienced by the 
patient.
4. Inclusion and Exclusion Criteria


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 6 of 40
Version Date: March 29, 2018
4.1. Participants will be recruited from the patient population at the clinics of Dustin 
Richter, MD, Robert Schenck, MD, Andrew Veitch, MD and Suki Pierce, PA-C at 
the University of New Mexico’s Orthopaedic Department. Since all potential 
participants will be independently seeking care for osteoarthritis, the 
participating clinicians and research staff will screen the patients for inclusion 
criteria during their standard examination. Qualifying patients will be offered 
enrollment into the study at that time.  
4.2. Inclusion criteria include being the age of eighteen or older, diagnosed 
symptomatic knee osteoarthritis, and radiographic evidence of knee 
osteoarthritis. For the purposes of this study, radiographic evidence of knee 
osteoarthritis is defined at any one or more of the following: osteophytes, joint 
space narrowing, loss of articular cartilage thickness, subchondral sclerosis or 
cysts. Patients will also meet inclusion criteria if their intake sheet pain score is 
at least a 3 out of 10, as pain scores less than 3 are unlikely to show a clinically 
meaningful improvement from any treatment option. Patients will be excluded 
from the study if they have a history of treatment with any intra-articular knee 
injection or have current ligament instability as demonstrated by a positive 
Lachman Test, Anterior or Posterior Drawer Test, or positive Valgus or Varus 
Stress Test. 19 Patients with a known allergy to lidocaine will also be excluded 
from the study. Patients will be excluded if they do not meet our above-mentioned 
severity criteria with a pain score of at least 3 on the intake sheet.
4.3. This study will only include English or Spanish speaking adults over the age of 
eighteen who are capable of independently consenting to participate in a 
research study. This study will not include any children, pregnant women, or 
prisoners. Women of childbearing age will be included only after they have had a 
negative urine pregnancy test at point of care.
4.4. Individuals under the age of 18 will be excluded from this study. As osteoarthritis 
is largely considered a degenerative joint disease, this population is highly 
unlikely to have osteoarthritis of the knee and thus will not be eligible for the 
study. 
5. Number of Subjects
5.1. This study will take place solely at the University of New Mexico Hospital. 
5.2. Based on our power analysis, we need 75 participants to complete the study. All 
subjects will have been pre-screened for eligibility by the participating 
clinicians. 
5.3. We will take advantage of the 5-repeated measurements of joint pain and 
functionality from each patient, and compare the post-treatment trajectory of 
joint pain and functionality over follow-up between a pair of treatment groups. 
This approach facilitates group comparisons (1) at individual follow-up times, 
(2) life course of effects over the entire follow-up period. This will be done by 
means of mixed-effects regression models which incorporate both within-patient 


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 7 of 40
Version Date: March 29, 2018
(over time) and between-patient variations, and are more flexible in making 
inference on group differences. The method also allows for the inclusion of 
multiple covariates (see below) in the model to quantify effects attributable to the 
treatments. We will also consider repeated measurement analysis of covariance 
and pairwise comparison (e.g. t-tests) to validate our analysis with respect to 
robustness and sensitivity. We will follow LaPrade’s recent recommendations of 
minimal reporting requirements for treatments that potentially include 
mesenchymal stem cells, such as Lipogems. This includes age, gender, diabetes 
status, inflammatory conditions, pre-existing joint problems, and current NSAID 
use.19 Since patient perception of post-treatment pain as measured by the VAS 
scale is a main variable of interest in our hypothesis, we searched the literature 
for previous studies in which the variability of pain using a VAS scale was 
investigated.20-23 We estimated that the standard deviation likely to be found for 
our own observations will be approximately 35 on a 100 point scale, 
conservatively. We assume that most clinicians will consider a difference in post-
treatment pain of about 15 points to be clinically important, as supported by 
Tashjian et al, who estimated 1.4 cm as the minimal clinically important 
difference on a 10 cm scale. To determine an adequate sample size for our pilot, 
we assumed average change in pain score over the follow-up to be 10-15, and 
standard deviation to be 10-20. To have 80% power with a 5% Type I error rate, 
an approximate 2-way ANOVA model suggest sample size in the range of 18-49 
per group. We adopt n=22 as our minimum sample size per group based on the 
assumption of 15-point change in pain score over time on average and a 20-point 
standard deviation over time. Within the recruitment time window, we will aim to 
enroll n=25 or more participants in each of the three treatment arms so long as 
the logistics permit. We expected the mixed-effect model will increase the power 
by utilizing the longitudinality of the data, compensating potential loss of power 
due to drop-outs and serial correlation. 
6. Study Timelines
6.1. Describe:

Individuals who agree to participate in this study will be enrolled during an 
initial screening visit which they will have independently sought and 
scheduled. Their participation will involve one procedure visit, two brief 
follow-up visits, and three online completion of surveys. We anticipate that it 
will take approximately 15 months from date of enrollment to complete each 
individual subject’s procedure and follow-up visits, allowing time for 
flexibility in scheduling based on the clinician and subject’s schedules. 

We estimate that it should take approximately three months to enroll 75 
subjects. We anticipate this being feasible based on the four participating 
clinicians’ current schedules. Roughly, an orthopaedic surgeon may see 
upwards of 50 patients a day. Approximately 10% of these patients have knee 
OA and potentially qualify for the study. 


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 8 of 40
Version Date: March 29, 2018

We anticipate the data analysis to take a maximum of two months following 
the completion of all data collection.
7. Study Endpoints
7.1. This study will conclude once all active, enrolled participants have completed 
their one-year follow-up.
7.2. Participants will be followed via standard of care and monitored at follow-up 
appointments. After we have had 10 participants enrolled in each group, we will 
do a preliminary evaluation of the available data. 
7.3. Not applicable. We will not have exploratory endings.
8. Research Setting
8.1. Research will be conducted at the University of New Mexico Hospital 
Orthopaedic Clinics of Dustin Richter, MD, Robert Schenck, MD, Andrew 
Veitch, MD and Suki Pierce, PA-C. Research, including all patient visits and 
procedures, will also be conducted at the CTSC.
8.2. Participants will be recruited from the patient population at the clinics of Dustin 
Richter, MD, Robert Schenck, MD, Andrew Veitch, MD and Suki Pierce, PA-C at 
the University of New Mexico’s Orthopaedic Department. Since all potential 
participants will be independently seeking care for osteoarthritis, the 
participating clinicians and research staff will screen the patients for inclusion 
criteria during their standard examination.
8.3. Procedures and follow-up visits will be performed at the CTSC facilities on 
North Campus. 
8.4. Not applicable. There will be no community advisory board
8.5. Not applicable. No research will be conducted outside of UNM HSC or CTSC.
9. Resources Available
9.1. Dustin Richter, MD (PI):
As an Assistant Professor in the Department of Orthopaedics at the University of 
New Mexico in Albuquerque, Dr. Richter practices Orthopaedic surgery with an 
emphasis on care of the athlete. He is new faculty and has been in practice since 
2016. He is fellowship trained in sports medicine (University of Virginia, 2016) 
and has worked as a team physician for most of his training. In addition, he has 
worked at a level I trauma center throughout his Orthopaedic career. In addition 
to managing complex traumatic injuries and fractures, he performs routine and 
complex surgeries treating athletic injuries (for example, ACL tears of the knee, 
rotator cuff tears of the shoulder, shoulder dislocations, and fractures of all 
types) and utilizes arthroscopy for many of his surgeries. His practice is divided 
between shoulder, knee sports surgeries, and hip arthroscopic procedures. 
As a sports surgeon, he routinely sees patients of all ages with knee pain. Many 


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 9 of 40
Version Date: March 29, 2018
of these patients have pain as a result of osteoarthritis which has not been 
previously diagnosed. He pursues a conservative treatment algorithm with these 
individuals that consists of activity modification, weight loss, oral anti-
inflammatories, and intra-articular knee cortisone injections or hyaluronic acid 
injections prior to referring the patient to any of his colleagues for consideration 
of a reconstructive procedure (knee replacement). His research interests have 
included: Multi-ligamentous knee injuries, knee cartilage repair, and evidence-
based medicine with a focus on quality and value-added care. Specifically 
related to this proposal, he recently published a comprehensive review in Sports 
Health evaluating the efficacy of knee articular cartilage repair and restoration 
techniques. He has also studied and published on the psychosocial and 
demographic factors influencing pain scores of patients with knee osteoarthritis 
(UNMORJ 2016). Lastly, he also recently published on looking at the value in 
healthcare regarding inpatient versus outpatient partial knee replacements.
For this proposal, he will serve as the Principal Investigator and will be the 
primary contact for all correspondence related to the study.  He will be 
responsible for contributing to the overall design and conduct of the study.  He 
will oversee subject recruitment and follow-up for and will be responsible for 
supervision of the research support staff at the University of New Mexico. He 
will assure integrity and security of the data and will be responsible for timely 
completion of progress reports as well as preparation of abstracts and 
manuscripts to disseminate the results.  He will use his collective research and 
administrative experience to ensure that the study is completed within budget and 
in compliance with all federal and University of New Mexico regulations.
Lauren Faber, MS1:
Lauren Faber is a first-year medical student at the University of New Mexico 
School of Medicine. She graduated from the University of New Mexico in 2011, 
earning her Bachelor of Arts in Psychology with Summa Cum Laude honors. She 
has previous bench research experience at UNM’s Center for Evolutionary and 
Theoretical Immunology. She has also worked closely with the Research 
Coordinator at Southwest Women’s Health, assisting in clinical studies by 
consenting patients, monitoring implantation of study protocols, and managing 
and reporting data. She is currently in good standing at UNM SOM and was 
selected for an honors research track, “Community of Scholars,” for 
demonstrating a passion for research. 
Robert Schenck, MD: 
Dr. Schenck, current Professor and Chair in the Department of Orthopaedics 
and Rehabilitation at the University of New Mexico, has been a full-time 
academic physician since starting orthopaedic career as an instructor at the 
University of Texas. After his medical training at Johns Hopkins, he pursued 
fellowship training in sports medicine with subspecialty training in foot and 
ankle surgery. He has also served as an athletic team physician for most of his 
career. As Chair for the last 10 years, he has mentored faculty and created a 
department which has seen three-fold growth in both faculty size and revenues. 


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
Page 10 of 40
Version Date: March 29, 2018
He is a member of numerous orthopaedic groups and associations and has 
served the American Board of Orthopaedic Surgery for 10 years as an Oral 
Examiner and a Question Writing Task Force participant for Part I of the written 
ABOS examination. He was selected to be an accompanying “godfather” for the 
2017 Latin American Society of Knee Arthroscopy and Sports Medicine 
fellowship. He has substantial research experiencing and has contributed over 
150 articles to medical publications.
Andrew Veitch, MD:
Dr. Veitch is a board certified orthopaedic surgeon who is fellowship trained in 
orthopaedic sports medicine. He is an associate professor at the University of 
New Mexico and has been the Head Team Physician for Varsity Lobo Athletic 
Teams since 2004. The focus of his medical practice is on sports injuries, knee 
injuries, and shoulder injuries. He also performs fracture care. His prior 
research experience results in publications on ankle arthrodesis to treat arthritis, 
tendon repair, and fractures. He has also given multiple lectures on knee injuries 
and articular cartilage injuries. 
Jory Wasserburger, MD:
Dr. Wasserburger is a resident in the Department of Orthopaedics and 
Rehabilitation at the University of New Mexico. He began his education at the 
University of Wyoming earning a Bachelor of Science in Nursing with honors. In 
2012, he entered medical school at the University of Washington. At Washington, 
he gained clinical research experience exploring heterotopic ossification 
prevention in elbow fractures and propionibacterium acnes infection of total 
shoulder arthroplasty. During his residency he has continued clinical research 
by publishing case series, case reports, and posters. Additionally, he volunteered 
to be the team physician for the Valencia High School football team.  
Carina Suki Pierce, PA-C:
Suki is a certified physician assistant who specializes in orthopaedic sports 
medicine. She completed her medical education at the University of New Mexico 
in 2009. She runs an injection clinic and has substantial experience with 
injections for knee osteoarthritis. 
9.2. Dustin Richter, MD, Robert Schenck, MD and Andrew Veitch, MD will be 
responsible for making medical decisions during procedures and at follow-up 
visits. Suki Pierce, PA-C, will be responsible for medical decision making for 
injections and visits done at her clinic.  
9.3. Other resources available to conduct the research include:

We anticipate needing 75 total subjects enrolled who have finished the study 
to completion. Based on the current clinic schedules of Dr. Richter, Dr. 
Schenck, Dr. Veitch, and Pierce, PA-C, we feel it is reasonable to expect to 
enroll the necessary number of participants in the study time period. 

We anticipate that this study will approximately one year from date of onset to 
complete. All study subjects are expected to have completed their 


PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue 
and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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requirements within 15 months of enrollment. We anticipate needing two 
months for data analysis. 

The facilities available for the research include: University of New Mexico 
Hospital including clinics and operating facilities for patient recruitment, the 
facilities made available for the Orthopedic Department, the CTSC facilities 
for participant procedures and follow-up, and the UNM IDS Pharmacy for 
drug storage and handling. 

Subjects that may desire further medical attention may request to be removed 
from participation in the study and can then choose to pursue further care 
with the physician of their choice.

All persons assisting with the study will be trained on the protocol, consent 
process, and data collection by Dustin Richter, MD, the principal 
investigator, prior to participating in the study. 

We will also be utilizing the CTSC research facility and resources for 
conducting this study, including their statistical department, rooms and 
facilities, and their study coordinators to help gather survey data.
10.Prior Approvals
10.1. We will be awaiting funding approval and IRB approval prior to conducting the 
research. We have already received departmental approval. 
10.2. Departmental Review Form.
10.3. Not applicable. No x-rays are required during participation in the study. 
Patients who qualify for the study will have obtained standard of care x-rays 
prior to enrollment in the study as part of their provider’s evaluation.
10.4. Drug attachment.
11.Multi-Site Research
11.1. Not applicable. This study will be conducted at the University of New Mexico 
Hospital and CTSC and will not include any other sites
11.2. Not applicable. This study will be conducted at the University of New Mexico 
Hospital and CTSC and will not include any other sites. 
11.3. Not applicable. The treatments used in this study are FDA approved and being 
used in the manner intended.
12.Study Procedures 
12.1. In chronological order, all research procedures and interventions being 
performed and when they are performed.
1. Participants will be screened prior to enrollment. Depending on their 
medical history and prior consultations, they will likely have a physical exam 
and x-rays of the affected knee(s). This is standard of care and will happen 
prior to enrollment in the study. X-ray images and medical data from these 
visits may be used for the purposes of analyzing statistical data. 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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2. Upon enrollment, participants will be randomized to a treatment group and 
scheduled for their injection procedure. 
3. At their injection visit, participants will complete the Western Ontario and 
McMaster Universities Osteoarthritis Index, a Visual Analog pain scale, and 
the Knee Injury and Osteoarthritis Outcome Score scales to establish a 
baseline. They will also fill out a medication log to document any medications 
that they take, including oral pain medications, although we will not be 
intervening with oral medications. They will complete these surveys and the log 
again at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the injections
4. Participants will receive their assigned injection. Participants who are 
randomized to the placebo group will receive an injection of 7cc of sterile 
saline. Participants who are randomized to the corticosteroid group will receive 
an injection of 2cc (80mg) of Kenalog-40 (triamcinalone acetonide injectable 
suspension, USP) mixed with and 5 cc of 1% plain lidocaine for a total of 7cc of 
fluid injected. Kenalog injections are part of the current standard of care for 
patients with osteoarthritis of the knee. Participants who are randomized to the 
Lipogems treatment group will undergo a lipoaspiration from their abdomen 
and autologous injection of the harvested adipocytes into their knee. It is 
standard to harvest three to four times more adipose tissue than is planned to be 
injected to account for tissue processing by the Lipogems device. We plan to 
inject 7cc of autologous adipose tissue. Thus, we will harvest between 25 and 
30 cc of adipose tissue from each patient. The tissue will be processed 
immediately and 7cc will be injected. Any remaining adipose tissue will be 
disposed of immediately in biohazardous waste.  Lipogems is currently 
approved for orthopedic and arthroscopic procedures; thus, this would be an 
on-label use. All injections will be performed in the clinic by Dr. Richter, Dr. 
Schenck, and Pierce PA-C as an in-office procedure.
5. Participants will be scheduled to return for in-person follow-up visits with a 
research staff member at 6 weeks and 6 months after their injection, where they 
will again complete a medication log, Western Ontario and McMaster 
Universities Osteoarthritis Index, a VAS pain scale, and the Knee Injury and 
Osteoarthritis Outcome Score scales. They will also complete the above surveys 
and log at 2 weeks, 3 months, and 1 year post injection, but these will be 
completed online. The above mentioned surveys and medication log will be 
generated in RedCap and emailed securely to participants for their completion. 
If participants do not have email or access to the internet, these surveys will be 
completed over the phone and entered into RedCap by research staff. 
6. Upon completion of their 1-year questionnaires, participants who were 
randomized to receive Lipogems or Corticosteroid injections will be finished 
participating in the study. 
7. Upon completion of their 1-year questionnaires, participants who were 
randomized to receive placebo injections will be offered the choice to cross-
over to the corticosteroid group. Whether they choose to have the injection or 
not, their participation in the study will be completed.  


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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13.Data Analysis
13.1. We will take advantage of the 5-repeated measurements of joint pain and 
functionality from each patient, and compare the post-treatment trajectory of 
joint pain and functionality over follow-up between a pair of treatment groups. 
This approach facilitates group comparisons (1) at individual follow-up times, 
(2) life course of effects over the entire follow-up period. This will be done by 
means of mixed-effects regression models which incorporate both within-patient 
(over time) and between-patient variations, and are more flexible in making 
inference on group differences. The method also allow for the inclusion of 
multiple covariates (see below) in the model to quantify effects attributable to 
the treatments. We will also consider repeated measurement analysis of 
covariance and pairwise comparison (e.g. t-tests) to validate our analysis with 
respect to robustness and sensitivity.
13.2. Since patient perception of post-treatment pain as measured by the VAS scale is 
a main variable of interest in our hypothesis, we searched the literature for 
previous studies in which the variability of pain using a VAS scale was 
investigated.20-23 We estimated that the standard deviation likely to be found for 
our own observations will be approximately 35 on a 100 point scale, 
conservatively. We assume that most clinicians will consider a difference in 
post-treatment pain of about 15 points to be clinically important, as supported 
by Tashjian et al, who estimated 1.4 cm as the minimal clinically important 
difference on a 10 cm scale. To determine an adequate sample size for our pilot, 
we assumed average change in pain score over the follow-up to be 10-15, and 
standard deviation to be 10-20. To have 80% power with a 5% Type I error an 
approximate 2-way ANOVA model suggest sample size in the range of 18-49 
per group. We adopt n=22 as our minimum sample size per group based on the 
assumption of 15-point change in pain score over time on average and a 20-
point standard deviation over time.
14.Provisions to Monitor the Data to Ensure the Safety of Subjects
14.1. Corticosteroids are standard of care. Lipogems is approved for use in 
orthopaedics and arthroscopic procedures. Participants will be closely followed 
by the participating clinicians/investigators through the follow-up visits 
required for participation. All measures will be taken to ensure that participants 
receive appropriate care. 
14.2. Patients will be informed of the risks of participating prior to enrolling in the 
study and may choose to enroll or not enroll. They will be reminded of expected 
post-procedural findings and will be monitored for adverse reactions by the 
participating clinicians at their follow-up visits.
14.3. The data monitoring committee will consist of Dr. Dustin Richter, Dr. Daniel 
Wascher [Orthopaedic Sports Medicine], Dr. Gehron Treme [Orthopaedic 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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Sports Medicine]; this committee will conduct a preliminary review of the 
existing data once 10 participants have been enrolled in each group. 
14.4. The existing literature has been reviewed regarding Lipogems. A board 
certified plastic surgeon was consulted regarding adverse effects of 
lipoaspiration procedures and the adverse risks are detailed in this protocol 
and the consent form. 
14.5. N/A. Safety data is not collected in this study.
14.6. The research will be suspended and/or terminated if there is an unexpected 
serious adverse event that requires further investigation.
15.Withdrawal of Subjects
15.1. We do not anticipate any medical reasons to withdraw subjects from the study 
without their consent. If participants are not adherent and miss follow-up 
appointments, refuse to be scheduled, or do not respond to scheduling requests, 
they will be withdrawn from the study. 
15.2. Participants may withdraw at their request and continue to seek standard of 
care treatments with the physician of their choice. No labs/tapering of meds/or 
physical exams are necessary to withdraw.
15.3. Partial withdrawal will be permitted if a patient desires to continue 
participating in data collection but no longer wishes to be seen for follow-up. 
The questionnaires would be completed online only. All previously collected 
data will still be used for research purposes unless the patient explicitly asks for 
data to be excluded.
15.4. If a patient withdraws, all previously collected data will still be used for 
statistical analysis unless the participant explicitly asks for their previous data 
to be excluded from further consideration. Describe the disposition of existing 
data/specimens when a subject withdraws.
15.5. If a patient requests to be withdrawn, Dustin Richter, MD, the principal 
investigator, must be made aware. If the patient requested that their data be 
destroyed and not used for analysis, then the data will be properly destroyed. 
Otherwise, data that was collected prior to withdrawal from the study may be 
used for analysis.
16.Data Management/Confidentiality
16.1. Members of the research team will be permitted to access the participants’ 
medical records through PowerChart to confirm participant eligibility and 
document procedures and follow-up visits. PHI will be reviewed as part of the 
normal screening process in clinic.
16.2. Members of the research team will have access to direct identifiers only as 
necessary to confirm participant eligibility and document procedures and 
follow-up visits. 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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16.3. The research team will have access to the patient’s PHI, as data may be needed 
from their consultation visits prior to enrollment in the study. Furthermore, they 
will have access to the medical record as procedures and follow-up visits will 
be documented in their medical records.
16.4. Not applicable. The study team may only know of any sensitive PHI if noted in 
medical chart. 
16.5. Not applicable. 
16.6. Participants will fill out questionnaire at their procedure and their 6 week and 
6 month visits. These questionnaires will be filled out on paper and will only 
have the participant’s unique identifier number on them. The data will be 
entered into RedCap by a member of the research staff. These paper copies will 
be kept in a locked file cabinet in Dustin Richter, MD’s office behind a locked 
door. In addition, each participant will be assigned a number from 001-100. 
This code will be kept on a password protected excel file on Dustin Richter, 
MD’s password protected computer located in his office behind a locked door. 
Only the PI and research staff will have access to any of these documents. No 
data is to be transported or transmitted to any other computer or location. 
Participants will also complete the questionnaires via RedCap (or phone if the 
patient doesn’t have email or internet access) at 2 weeks, 3 months, and 1 year 
post injection. If a patient has internet access and email, surveys will be sent 
and completed securely via RedCap. If performed by phone, the member of the 
research staff will collect the data on paper and it will then be transcribed into 
RedCap. 
Data will be kept for one year after full completion of data collection to allow 
time for data analysis and manuscript writing. Paper files, such as consent 
forms and questionnaires, will be appropriately shredded and disposed of. 
Excel files will be deleted. As no additional copies will be stored, this will 
destroy all of the identifiers and excel logs.
16.7. Each participant will be assigned a number from 001-100. This code will be 
kept on a password protected excel file on Dustin Richter, MD’s password 
protected computer located in his office behind a locked door. There will only 
be patient names and unique identification numbers on this document. Only the 
PI and research staff will have access to the document.
16.8. Not applicable. As participants will be answering questionnaires and filling 
them out on their own, there is no need for quality control.
16.9. Not applicable. Data will not be transferred or transmitted to outside locations 
or entities. Any paper copies of questionnaires will be collected within CTSC 
facilities and will be input into RedCap. Paper copies will be stored as outlined 
in this protocol.
16.10.
There will be data collected via a secure RedCap survey. Participants will 
be emailed a link to complete the questionnaires. This secure email will be sent 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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through RedCap and all data will be gathered through RedCap. RedCap is a 
secure web application frequently utilized to collect data for research, including 
HIPAA compliant information.
16.11. Not applicable. Data will not be collected by audio or video recording. 
16.12. Not applicable. No photographs of participants will be taken at any point 
during the study. 
17.Data and Specimen Banking
17.1. Not applicable. There will not be any data or specimen banking. 
17.2. Not applicable. This is not a multi-center study, nor will any data or specimens 
be banked. 
18.Risks to Subjects
18.1. This study involves risks to the participants as corticosteroids and Lipogems 
are both used by clinicians as part of the current standard of care for knee 
osteoarthritis. One potential risk that may arise is a breach in patient 
confidentiality. Although such a breach is unlikely to occur and should not 
negatively impact patient health or well-being, we will take precautions to 
minimize this risk. All investigators and members of the study team will strictly 
adhere to the HIPAA and patient confidentiality guidelines set forth by the 
hospital. All research staff will adhere to the guidelines set forth in the Data 
Management/Confidentiality portion of this protocol. 
Intra-articular knee injections, such as corticosteroids and Lipogems, are 
employed in routine clinical practice for the treatment of knee osteoarthritis. 
With any injection, there is a risk of local adverse reaction such as pain or 
swelling, and a risk of infection. In addition to an injection, Lipogems 
requires a lipoaspiration procedure from the patient’s abdomen. Some risks of 
lipoaspiration include seromas and hematomas requiring drainage, infections, 
changes to the skin including hyperpigmentation, scarring, or induration. Very 
rarely, more serious complications (including skin necrosis or local anesthetic 
toxicity) may arise. 24,25
18.2. We have received input from a board certified plastic surgeon on the risks of 
lipoaspiration. We have also reviewed the existing literature. Corticosteroid 
injection is part of the standard of care for treating knee osteoarthritis. As 
Lipogems is still a relatively new treatment option, there may be unforeseen 
risks.
18.3. Patients who are pregnant will not be eligible for participation. Patients must 
verbally confirm they are not pregnant prior to enrollment in the study and 
prior to receiving their injection.
18.4. Not applicable. There are no risks to others who are not subjects.


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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18.5. To minimize risk, all injections will be performed following standard of care 
sterile techniques and treatment guidelines. We will have a board certified 
plastic surgeon trained in lipoaspiration train the study investigators 
accordingly. To protect patient confidentiality, we will take the necessary 
precautions to protect patient data. All electronic files will be password 
protected and stored on a password protected computer behind a locked door. 
All paper documents will be kept in a locked filing cabinet in a locked office. 
19.Potential Benefits to Subjects
19.1. Potential benefits include the possibility of reduced pain and/or increased 
functionality of the affected knee after injection with Lipogems or 
corticosteroids. 
20.Recruitment Methods
20.1. Upon funding and IRB approval, participants will be recruited from the patient 
population at the clinics of Dustin Richter, MD, Robert Schenck, MD, and Suki 
Pierce, PA-C at the University of New Mexico Hospital’s Orthopaedic 
Department. Patients at these clinics are independently seeking evaluation of 
orthopaedic problems. The participating clinicians and research staff will 
screen the patients for inclusion during their standard examination.
20.2.
Review of relevant prior medical records (x-ray’s, primary care/referring 
physician evaluations, and orthopaedic records including current visit 
findings and imaging) will be conducted to screen for eligible 
participants.
20.3. Subjects will be recruited by participating physicians and research staff via 
word of mouth at pre-existing patient visits. If we are having difficulty with 
subject recruitment, we may consider advertising.
Additionally, a non-publically-displayed patient flyer will be created to relay 
brief, informative details about the study design to surgical staff (eg, patient 
inclusion/exclusion criteria, follow-up length, etc). 
21.Provisions to Protect the Privacy Interests of Subjects
21.1. All discussion of the study, including the informed consent process, will be 
conducted in a private exam room with only the clinician, relevant research 
staff, and patient in the room. All procedures and follow-up visits will be 
performed in private exam rooms with only the patient, the clinicians, necessary 
medical personnel, and necessary research staff present. Investigators will 
abide by standard patient confidentiality practices and will adhere to HIPAA 
protocols. 
21.2. All discussion of the study, including the informed consent process, will be 
conducted in a private exam room with only the clinician, relevant research 
staff, and patient in the room. All procedures and follow-up visits will be 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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Version Date: March 29, 2018
performed in private exam rooms with only the patient, the clinicians, necessary 
medical personnel, and necessary research staff present. Investigators will 
abide by standard patient confidentiality practices and will adhere to HIPAA 
protocols. 
22.Economic Burden to Subjects
22.1. See below table.
Responsible Party
Research Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Lipogems Injection
7cc of autologous adipose tissue
1 (randomization 
dependent)
Lipoaspiration
25-30cc of adipose tissue harvested
1 (randomization 
dependent)
Intra-articular corticosteroid injection
2cc (80mg) of Kenalog-40 (triamcinalone 
acetonide injectable suspension, USP) plus 
5 cc 1% lidocaine
1 (randomization 
dependent)
Placebo saline injection
7cc sterile saline
1 (randomization 
dependent)
Procedure Visit
1
Follow-Up Visits (6 weeks, 6 months)
2
Responsible Party
Standard of Care Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Evaluation by clinician prior to participation
1
Routine x-rays prior to participation
Varies by clinician
     
     
22.2. There are no additional costs to participants. 
22.3. The study will pay for all procedures and drugs involved in the study, including: 
corticosteroids and Lipogems. Lipogems has agreed to cover the costs of 
the kits for all study participants randomized to receive Lipogems.
22.4. While we do not anticipate any serious adverse events, there are risks involved 
with undergoing medical procedures. Corticosteroid injections are currently 
included as part of the standard of care for treating osteoarthritis of the knee, 
and Lipogems is FDA approved for autologous use in orthopaedic surgery. 
Thus, any adverse events experienced by the patient will fall under insurance 
coverage for standard of care procedures. All adverse events will be reported 
as required by the University. Depending on the severity of event, the 
investigators will consider the adverse event and reserve the right to hold 
enrollment or close the study early.
22.5. See consent form for discussion of costs.


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
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23.Compensation
23.1. Participants will be compensated for their participation by receiving a 
reloadable gift card. They will receive $25 at each in person follow-up visit. 
They will be compensated $10 each time they complete the online surveys. Each 
participant will be asked to return for 2 follow-up visits (6 weeks and 6 months, 
post-procedure) and complete the online surveys 3 times for a total of $80 
compensation for participating. 
24.Compensation for Research-Related Injury
24.1. If a patient elects to withdraw from the study, i.e. for further treatment/care 
elsewhere, the patient may withdraw. We do not anticipate any more risk than 
standard of care would provide to the patient. The patient can elect to pursue 
standard of care treatments as determined by the patient and their physician.
24.2. Study subjects will be monitored at follow-up appointments. If a subject is 
unhappy with their treatment outcome throughout the course of the study, they 
may elect to withdraw from the study and pursue their own care with the 
physician of their choice.
25.Consent Process
25.1. Participants must provide research staff with informed consent prior to 
enrolling in the study. 
25.1.1. Consent may be obtained by Dr. Richter, Dr. Schenck, Dr. Veitch, Dr. 
Wasserburger, and Lauren Faber and any other approved investigators 
listed in the Click IRB record. The process for obtaining informed consent 
and consent form will be reviewed with each member of the research staff 
responsible for obtaining consent by Dustin Richter, MD.
25.1.2. Consent will take place at the various clinics/hospitals associated with the 
University of New Mexico Hospital and the Orthopedics Department. 
Consent will only be obtained in a private patient room. No one besides 
the patient and study staff will be in the room at the time of consent. If the 
patient requests a family member or friend be in the room during the time 
of their appointment/consent, the patient’s request will be honored. 
25.1.3. The study, possibly treatment outcomes, and follow-up requirements will 
be explicitly stated at the time of consent. The patient will be made aware 
of their standard of care treatment options and will also be invited to 
participate in the study. The consent process will emphasize that patients 
have the right to accept or deny entry into the study with no consequences 
on their care. 
25.1.4. Potential subjects will be offered the choice to participate if they meet 
eligibility criteria at visits with their provider prior to enrollment in the 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
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study. The study will be explained at that time. If the patient is interested, 
informed consent will happen at that time. 
25.1.5. Patients will provide consent for participation prior to enrolling in the 
study. This consent covers the injection and all follow-up visits. At each 
visit, participants will be asked if they wish to continue in the study and 
will provide verbal consent. 
25.1.6. During informed consent, the person obtaining consent will utilize teach-
back and ask the patient to explain, in their own words, what the study 
entails and what they are consenting to.
25.1.7. People obtaining consent will utilize teach back to make sure that patients 
understood the study, what possible treatment outcomes are, and what 
follow-up is required of study participants. 
Subjects not fluent in English
25.1.8. This study will also include Spanish speaking participants.
25.1.9. For informed consent, explanation of the study, and all visits thereafter, a 
translator will be available to translate for the patient and the clinician. 
The informed consent document will be translated to Spanish.
25.1.10. Not applicable. No short-form consent documents will be used. There 
will be one standard informed consent document that must be explained to 
the patient and read by the patient prior to enrollment. 
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative
25.1.11. Not applicable. This study will only be enrolled individuals with full, 
independent ability to provide legally effective consent. 
25.1.12. All subjects are required to have full, independent ability to provide 
legally effective consent. 
25.1.13. During the consent process, those obtaining consent will utilize teach-
back to ensure that the individual understands what participation in the 
study entails. Individuals will be asked to explain, in their own words, 
what they are agreeing to before giving informed consent. For individuals 
who are Spanish speaking, an interpreter will be made available to help 
with the consent process. If an individual is unable to explain the study or 
verbalize what they are agreeing to, he/she will not be enrolled.  
25.1.14. As above, teach-back and asking the individuals to explain what their 
agreement to participate entails will be utilized during the consent process 
to ensure that individuals understand the study prior to providing 
informed consent. The research staff member obtaining consent are 
responsible for confirming that an individual can provide consent. 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
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Research staff members will document this process by signing their 
respective portion of the informed consent document.
25.1.15. The participant’s decisional capacity will be assessed at each visit 
(procedure, where consent is given, and four follow-up exams) by the 
participating clinicians.
25.1.16. Not applicable. Patients will have full capacity to provide consent prior 
to enrolling in the study.
25.1.17. Not applicable. This study will only enroll participants who can 
independently give informed consent.  
25.1.18. Not applicable. No research will be conducted outside of New Mexico 
for this study. 
25.1.19. Not applicable. Consent to participate in this study must be given by the 
participant. 
25.1.20. Not applicable. If a patient is unable to provide informed consent they 
will be excluded from the study.
Subjects who are not yet adults (infants, children, teenagers)
25.1.21. Not applicable. No individuals under the age of 18 will be enrolled in 
this study.
25.1.22. Verification of patient’s date of birth will allow selection of participants 
over the age of eighteen. 
25.1.23. Not applicable. No parental permission will be obtained as all study 
participants are required to be eighteen years of age or older and capable 
of providing independent, legally effective consent.
Describe whether parental permission will be obtained from:
25.1.24. Not applicable. No permissions from individuals other than the patient 
will be required as all study participants are required to be eighteen years 
of age or older and capable of providing legally effective consent.
25.1.25. Not applicable. Children will not be enrolled in this study.
25.1.26. Not applicable. Children will not be enrolled in this study.
25.1.27. Not applicable. Children will not be enrolled in this study.
26.Documentation of Consent
26.1. This study will utilize an informed consent document in order to maintain 
documentation that the patient has given consent to participate in the study. 
26.2. Not applicable. This study will not require the use of stored tissue samples.
26.3. Consent for this study will be obtained verbally and in-person by the 
participating clinicians, medical students, or research staff.


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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27.Study Test Results/Incidental Findings
27.1. Individual Results: Participants will be made aware of any physical findings 
in-person at their follow-up visits. Participants will still be kept blinded to their 
treatment group, as this is a single-blinded study. Once they have completed 
their one year follow-up questionnaire, the participants will be unblinded and 
those in the placebo group will be offered the opportunity to cross-over and 
receive a corticosteroid injection.
27.2. Incidental Findings: We do not anticipate coming across any incidental 
findings. If found, they will be disclosed to the patient. 
28.Sharing Study Progress or Results with Subjects
28.1. Not applicable. Subjects will not be provided with trial progress while the study 
remains underway. 
28.2. Participants will be made aware of what arm of the study they were assigned to. 
Lipogems participants will have known since assigned to that group, as the 
procedure cannot be blinded. However, as this is a single-blinded study, 
placebo and corticosteroid participants will be made aware of their treatment at 
the conclusion of the study. Placebo participants will be given the option to 
receive a corticosteroid injection after they complete their 1 year questionnaire. 
29.Inclusion of Vulnerable Populations
29.1. Not applicable. The study does not involve individuals who are vulnerable to 
coercion or undue influence.
30.Community-Based Participatory Research
30.1. Not applicable. There will not be any community involvement in this study. 
31.Research Involving American Indian/Native Populations
31.1. This is neither an inclusion or exclusion criteria for the study. Participants will 
be offered the chance to participate and the study will be explained at length to 
potential participants. Participants are free to decline the study if would prefer 
not to participate. They will continue to receive the standard of care. 
32.Transnational Research
32.1. Not applicable. Our study will not involve transnational research. 
33.Drugs or Devices
33.1. All drugs and devices are approved and cleared by the FDA.
Lipogems (brand name: Lipogems System, manufacturer: Lipogems 
International S.p.A., no generic currently on the market) device kits will be sent 
to Dustin Richter, MD at the University of New Mexico Hospital after a 
participant has enrolled in the study and been randomly assigned to receive 


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and intra-articular corticosteroid injections for symptomatic knee osteoarthritis: 
a randomized, placebo controlled study”
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Lipogems. Treatment drugs and devices will be stored, handled, and 
dispensed by a licensed pharmacist at UNM IDS Pharmacy. Drugs will be 
stored under proper conditions of sanitation, temperature, light, moisture, 
ventilation, segregation, safety, and security. These items will be stored in 
accordance with existing hospital policy and storage requirements. Dustin 
Richter, MD, Robert Schenck, MD, and Andrew Veitch, MD will be authorized 
to perform Lipogems procedures. Dustin Richter, MD, Robert Schenck, MD, 
Andrew Veitch, MD and Suki Pierce, PA-C are authorized to give corticosteroid 
or placebo injections.   
33.2. Not applicable. No drugs or devices in this study are investigational. They are 
all marketed and none are being used off-label. 
33.3. Not applicable.


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Checklist Section
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research.
I.
Waivers or Alterations of Consent, Assent, and HIPAA Authorization
A. Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you 
can review private information to identify potential subjects and/or determine 
eligibility prior to approaching potential subjects for consent or parental permission.
1. Describe the data source that you need to review (e.g., medical records):
     
2. Describe the purpose for the review (e.g., screening):
     
3. Describe who will conducting the reviews (e.g., investigators, research staff):
     
4. Do all persons who will be conducting the reviews already have permitted 
access to the data source?
 Yes
 No. Explain:      
5. Verify that each of the following are true or provide an alternate justification 
for the underlined regulatory criteria:
a) The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of the 
records review will not be used for any purposes other than those 
described above.
 True
 Other justification:      
b) The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached for 
consent to participate in the research and are free to decline.  Further, 
the information accessed during the records review will not be 
disclosed to anyone without a legitimate purpose (e.g., verification of 
eligibility).


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intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
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 True
 Other justification:      
c) The research could not practicably be carried out without the waiver or 
alteration because there is no other reasonably efficient and effective 
way to identify who to approach for possible participation in the 
research.  
 True
 Other justification:      
d) Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation.  (Regulatory criteria: Whenever appropriate, the 
subjects will be provided with additional pertinent information after 
participation.)
 True
 Other justification:      
Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will 
review to identify potential subjects and/or determine eligibility include Protected 
Health Information (PHI).
6. Will you be recording any PHI when conducting the records review to identify 
potential subjects and/or determine eligibility?
 Yes. Describe: 
 No
7. If you answered “Yes” to question 6 above, please describe when you will 
destroy identifiers (must be the earliest opportunity consistent with the 
conduct of the research) or provide justification for why they must be 
retained:
     
8. The PHI accessed or recorded for identification/screening purposes will not be 
reused or disclosed to (shared with) any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under 
the Privacy Rule.
 True


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intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
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 False
B. Waiver of Documentation of Consent
Complete this checklist if you intend to obtain consent verbally but will not be 
obtaining signatures from subjects on a consent form to document consent.  Waivers 
of documentation of consent are commonly requested when using scripts, information 
sheets, or email or survey introductions to present the elements of consent instead of 
using a traditional consent form.
1. Are you requesting a waiver of documentation of consent for some or all 
subjects?
 All
 Some. Explain:      
2. Provide justification for one of the following:
a) That the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern.
     
b) That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context.
     
3. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form?
 Yes. Please attach a copy to your submission in Click.
 No
C. Alteration of Consent
Complete this checklist if you intend to obtain consent but will be eliminating or 
altering one or more of the required elements of consent. Alterations of consent are 
commonly requested for research involving deception or for minimal risk research 
when an abbreviated consent is desired and one or more of the required element are 
not relevant to the research.


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intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
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Note: FDA-regulated research is not eligible for an alteration of consent.
1. Which element(s) of consent do you wish to eliminate and why?
     
2. Which element(s) of consent do you wish to alter and why?
     
3. Provide justification for each of the following regulatory criteria:
a) The research involves no more than minimal risk to the subjects:
     
b) The waiver or alteration will not adversely affect the rights and 
welfare of the subjects:
     
c) The research could not practicably be carried out without the waiver or 
alteration:
     
d) Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation:
     
D. Full Waiver of Consent/Parental Permission
Complete this checklist if you are requesting a full waiver of consent for all subjects 
or certain subject groups (e.g., retrospective cohort).  Full waivers of consent are 
commonly requested when the research does not include any opportunity for 
interaction with subjects (e.g., chart review).
Note: FDA-regulated research is not eligible for a full waiver of consent using these 
criteria.  If you believe that your FDA-regulated research may be eligible for a waiver 
under another mechanism, such as planned emergency research, contact the HRPO 
for assistance in determining what information to provide to the HRRC.
1. Are you requesting a waiver for some or all subjects?
 All
 Some. Explain:      
2. Provide justification for each of the following regulatory criteria:
a) The research involves no more than minimal risk to the subjects:


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b) The waiver or alteration will not adversely affect the rights and 
welfare of the subjects:
     
c) The research could not practicably be carried out without the waiver or 
alteration:
     
d) Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation:
     
E. Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs)
Complete this checklist if you are requesting a full waiver of consent for all subjects 
or certain subject groups (e.g., retrospective cohort) and the research involves the 
evaluation of a public benefit or service program.  
1. Are you requesting a waiver for some or all subjects?
 All
 Some. Explain:      
2. Provide justification for each of the following regulatory criteria:
a) The research or demonstration project is to be conducted by or subject 
to the approval of state or local government officials and is designed to 
study, evaluate, or otherwise examine: (i) public benefit or service 
programs; (ii) procedures for obtaining benefits or services under those 
programs; (iii) possible changes in or alternatives to those programs or 
procedures; or (iv) possible changes in methods or levels of payment 
for benefits or services under those programs:
     
b) The research could not practicably be carried out without the waiver or 
alteration.
     
F. Full Waiver of HIPAA Authorization
Complete this checklist if you are requesting a full waiver of the requirement to 
obtain HIPAA authorization for all subjects or certain subject groups (e.g., 


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intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
randomized, placebo controlled study”
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retrospective cohort).  Full waivers of HIPAA authorization are commonly requested 
when the research does not include any opportunity for interaction with subjects 
(e.g., chart review).
1. Are you requesting a waiver of authorization for some or all subjects?
 All
 Some. Explain:      
2. Describe your plan to protect health information identifiers from improper use 
and disclosure:
     
3. Describe your plan to destroy identifiers at the earliest opportunity consistent 
with conduct of the research (absent a health or research justification for 
retaining them or a legal requirement to do so):
     
4. Describe why the research could not practicably be conducted without the 
waiver or alteration:
     
5. The PHI accessed or recorded for identification/screening purposes will not be 
reused or disclosed to (shared with) any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under 
the Privacy Rule.
 True
 False
G. Other Waiver Types
If you are seeking another waiver type (e.g., Planned Emergency Research, Waiver of 
Parental Permission to Protect Child Participants, Enforcement Discretion for In 
Vitro Diagnostics, etc. contact the HRPO office for assistance in determining what 
information to submit for the HRRC’s consideration.
II. Vulnerable Populations
A. Adults with Cognitive Impairments


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intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
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Complete this checklist if the subject population will include adults with cognitive 
impairments.  
This checklist does not need to be completed if the research doesn’t involve 
interactions or interventions with subjects and will be conducted under a waiver of 
consent.
1. Describe why the objectives of the study cannot be met without inclusion of 
adults with cognitive impairments.
     
2. Describe how capacity to consent will be evaluated.
     
3. If subjects may regain capacity to consent, or if subjects may have fluctuating 
capacity to consent, describe your plans to evaluate capacity to consent 
throughout the research and to obtain consent to continue participation if 
capacity is regained.
     
4. Describe your plans, if any, to provide information about the research to 
subjects and the steps you will take to assess understanding.
     
5. Describe your plans to obtain assent, including whether assent will be 
obtained from none, some, or all subjects.
     
6. Describe why risks to subjects are reasonable in relation to anticipated 
benefits to the subjects.
     
7. If this study involves a health or behavioral intervention, describe why the 
relation of the anticipated benefit to the risk of the research is at least as 
favorable to the subjects as that presented by alternative procedures.
     
8. Describe your plans for monitoring the well-being of subjects including any 
plans to withdraw subjects from the research if they appear to be unduly 
distressed.
     


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B. Children
Complete this checklist if the subject population will include children.
1. Select the category of research that you believe this research falls within and 
provide justification for any associated criteria.  If there are different 
assessments for different groups of children or arms (e.g., placebo vs. drug), 
include a memo to provide an assessment for each group.  
 Research not involving greater than minimal risk. (Minimal risk means 
that the probability and magnitude of harm or discomfort anticipated 
in the research are not greater in and of themselves than those 
ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests.)
 Research involving greater than minimal risk but presenting the 
prospect of direct benefit to the individual subjects.
Provide justification for each of the following criteria:
(1) The risk is justified by the anticipated benefit to the subjects:
     
(2) The relation of the anticipated benefit to the risk is at least as 
favorable to the subjects as that presented by available 
alternative approaches:
     
 Research involving greater than minimal risk and no prospect of direct 
benefit to individual subjects, but likely to yield generalizable 
knowledge about the subject's disorder or condition.
Provide justification for each of the following criteria:
(1) The risk represents a minor increase over minimal risk:
     
(2) The intervention or procedure presents experiences to subjects 
that are reasonably commensurate with those inherent in their 
actual or expected medical, dental, psychological, social, or 
educational situations:
     
(3) The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition which is of 


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intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
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vital importance for the understanding or amelioration of the 
subjects' disorder or condition
     
C. Pregnant Women and Fetuses
Complete this checklist if the subject population will include pregnant women and 
fetuses.
This checklist does not need to be completed if the research is both minimal risk and 
is not conducted, funded, or otherwise subject to regulation by DHHS, DOD, EPA, or 
VA.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical studies, including studies on 
pregnant animals, and clinical studies, including studies on non-pregnant 
women, have been conducted and provide data for assessing potential risks to 
pregnant women and fetuses.
     
2. The risk to the fetus is caused solely by interventions or procedures that hold 
out the prospect of direct benefit for the woman or the fetus; or, if there is no 
such prospect of benefit, the risk to the fetus is not greater than minimal and 
the purpose of the research is the development of important biomedical 
knowledge which cannot be obtained by any other means.
     
3. Any risk is the least possible for achieving the objectives of the research.
     
D. Neonates of Uncertain Viability or Nonviable Neonates
Complete this checklist if the subject population will include neonates of uncertain 
viability.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical and clinical studies have been 
conducted and provide data for assessing potential risks to neonates.
     
2. Each individual providing consent is fully informed regarding the reasonably 
foreseeable impact of the research on the neonate.
     


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3. Individuals engaged in the research will have no part in determining the 
viability of a neonate.
     
4. The research holds out the prospect of enhancing the probability of survival of 
the neonate to the point of viability, and any risk is the least possible for 
achieving that objective, or, the purpose of the research is the development of 
important biomedical knowledge which cannot be obtained by other means 
and there will be no added risk to the neonate resulting from the research
     
E. Nonviable Neonates
Complete this checklist if the subject population will include nonviable neonates.
Provide justification for each of the following:
1. Where scientifically appropriate, preclinical and clinical studies have been 
conducted and provide data for assessing potential risks to neonates.
     
2. Each individual providing consent is fully informed regarding the reasonably 
foreseeable impact of the research on the neonate.
     
3. Individuals engaged in the research will have no part in determining the 
viability of a neonate.
     
4. The purpose of the research is the development of important biomedical 
knowledge that cannot be obtained by other means.
     
Verify each of the following:
5. Vital functions of the neonate will not be artificially maintained
 True
 False
6. The research will not terminate the heartbeat or respiration of the neonate
 True
 False


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7. There will be no added risk to the neonate resulting from the research
 True
 False
F. Biomedical and Behavioral Research Involving Prisoners
Complete this checklist if the subject population will include prisoners.
Note: Minimal risk for research involving prisoners is the probability and magnitude 
of physical or psychological harm that is normally encountered in the daily lives, or 
in the routine medical, dental, or psychological examination of healthy persons.
1. Select and justify which allowable category of research involving prisoners 
this research falls within:
 Study of the possible causes, effects, and processes of incarceration, and of 
criminal behavior, provided that the study presents no more than minimal 
risk and no more than inconvenience to the subjects
     
 Study of prisons as institutional structures or of prisoners as incarcerated 
persons, provided that the study presents no more than minimal risk and 
no more than inconvenience to the subjects
     
 Research on conditions particularly affecting prisoners as a class (for 
example, vaccine trials and other research on hepatitis which is much 
more prevalent in prisons than elsewhere; and research on social and 
psychological problems such as alcoholism, drug addiction, and sexual 
assaults)
     
 Research on practices, both innovative and accepted, which have the intent 
and reasonable probability of improving the health or well-being of the 
subject
     
 Epidemiologic studies in which the sole purpose is to describe the 
prevalence or incidence of a disease by identifying all cases or to study 
potential risk factor associations for a disease, the research presents no 
more than Minimal Risk and no more than inconvenience to the subjects, 
and Prisoners are not a particular focus of the research.
     


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2. Provide justification for each of the following regulatory criteria:
a) Any possible advantages accruing to the prisoner through his or her 
participation in the research, when compared to the general living 
conditions, medical care, quality of food, amenities and opportunity 
for earnings in the prison, are not of such a magnitude that his or her 
ability to weigh the risks of the research against the value of such 
advantages in the limited choice environment of the prison is impaired
     
b) The risks involved in the research are commensurate with risks that 
would be accepted by nonprisoner volunteers
     
c) Procedures for the selection of subjects within the prison are fair to all 
prisoners and immune from arbitrary intervention by prison authorities 
or prisoners. Unless justification is provided, control subjects must be 
selected randomly from the group of available prisoners who meet the 
characteristics needed for that particular research project
     
d) The information is presented in language which is understandable to 
the subject population
     
e) Adequate assurance exists that parole boards will not take into account 
a prisoner's participation in the research in making decisions regarding 
parole, and each prisoner is clearly informed in advance that 
participation in the research will have no effect on his or her parole
     
f)
When appropriate, adequate provision has been made for follow up 
examination or care after research participation, taking into account 
the varying lengths of individual prisoners' sentences, and for 
informing participants of this fact
     
III.Medical Devices
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  
If more than one medical device is being evaluated, provide the requested information for each.


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A. Device Name:  Lipogems System
B. Manufacturer:  Lipogems International S.p.A.
C. Does the research involve a Significant Risk Device under an IDE?
 Yes. 
 No
D. Is the research IDE-exempt?
 Yes.
Lipogems is marketed as an autologous adipose tissue transfer system. It has been 
cleared by the FDA twice, most recently on November 4th, 2016. In the most recent 
clearance, Lipogems has been approved for harvest, concentration, and transfer of 
autologous adipose tissue for use in orthopaedic and arthroscopic procedures. Thus, it 
is considered on-label for those applications. The term “stem-cell” is not used as the 
device does not separate cells and tissue and all original components of the adipose 
tissue are present in the final concentrate after processing. In the clearance, it is stated 
that the cells and tissue microarchitecture are preserved, constituting a minimally 
manipulated product. With the existing FDA clearance, injection into the knee for 
arthritis or pain relief is considered within the scope of Lipogems.
 No
E. Does the research involve a Non-Significant Risk (NSR) Device?
 Yes.
Lipogems is marketed as an autologous adipose tissue transfer system. It has been 
cleared by the FDA twice, most recently on November 4th, 2016. In the most recent 
clearance, Lipogems has been approved for harvest, concentration, and transfer of 
autologous adipose tissue for use in orthopaedic and arthroscopic procedures. Thus, it 
is considered on-label for those applications. The term “stem-cell” is not used as the 
device does not separate cells and tissue and all original components of the adipose 
tissue are present in the final concentrate after processing. In the clearance, it is stated 
that the cells and tissue microarchitecture are preserved, constituting a minimally 
manipulated product. With the existing FDA clearance, injection into the knee for 
arthritis or pain relief is considered within the scope of Lipogems.
 No
* This FDA guidance includes a description for when a device study is exempt from the 
IDE requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf 


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**This FDA guidance includes information on how to differentiate between Significant 
Risk and Non-Significant Risk device studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf 


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1. Goldring, M.B. and Goldring, S.R. (2010) ‘Articular cartilage and subchondral bone in 
the pathogenesis of osteoarthritis’, Annals of the New York Academy of Sciences, 
1192(1), pp. 230–237. [PubMed: 20392241]
2. Richmond, J., Hunter, D., Irrgang, J., Jones, M.H., Snyder-Mackler, L., Van Durme, 
D., Rubin, C., Matzkin, E.G., Marx, R.G., Levy, B.A., Watters, W.C., Goldberg, M.J., 
Keith, M., Haralson, R.H., Turkelson, C.M., Wies, J.L., Anderson, S., Boyer, K., Sluka, 
P., St Andre, J. and McGowan, R. (2010) ‘American academy of Orthopaedic surgeons 
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3. Taylor, N. (2017) ‘Nonsurgical management of osteoarthritis knee pain in the older 
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4. Jüni, P., Hari, R., Rutjes, A.W., Fischer, R., Silletta, M.G. and Reichenbach, S. (1996) 
‘Intra-articular corticosteroid for knee osteoarthritis’, Cochrane Database of Systematic 
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5. McAlindon, T.E., Bannuru, R.R., Sullivan, M.C., Arden, N.K., Berenbaum, F., Bierma-
Zeinstra, S.M., Hawker, G.A., Henrotin, Y., Hunter, D.J., Kawaguchi, H., Kwoh, K., 
Lohmander, S., Rannou, F., Roos, E.M. and Underwood, M. (2014) ‘OARSI guidelines 
for the non-surgical management of knee osteoarthritis’, Osteoarthritis and Cartilage, 
22(3), pp. 363–388. [PubMed: 24462672]
6. Sophia Fox, A.J., Bedi, A. and Rodeo, S.A. (2009) ‘The basic science of Articular 
cartilage: Structure, composition, and function’, Sports Health: A Multidisciplinary 
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B.J. and Musahl, V. (2016) ‘Biologic treatments for sports injuries II think tank--current 
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12. Bianchi, F., Maioli, M., Leonardi, E., Olivi, E., Pasquinelli, G., Valente, S., Mendez, 
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intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
randomized, placebo controlled study”
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PROTOCOL TITLE: “Evaluating the efficacy of micro-fragmented adipose tissue and 
intra-articular corticosteroid injections for symptomatic knee osteoarthritis: a 
randomized, placebo controlled study”
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Version Date: March 29, 2018
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ICF_001.pdf: 
                                                     Page 1 of 5                                    Version Date: 11/07/2019
The University of New Mexico Health Sciences Center
Consent to Participate in Research
Evaluating the efficacy of micro-fragmented adipose tissue and intra-articular corticosteroid 
injections for symptomatic knee osteoarthritis: a randomized, placebo controlled study
11/07/2019
Purpose and General Information
You are being asked to participate in a research study that is being done by Dustin Richter, MD, who is the 
Principal Investigator, and his associates.  This research is being done to evaluate the efficacy of 
corticosteroids and Lipogems injections for knee osteoarthritis in comparison to placebo. Corticosteroids 
are one of the current standard of care options to treat knee osteoarthritis. Lipogems is an FDA approved 
device for use in orthopaedics and arthroscopy procedures. You are being asked to participate because 
you have symptomatic osteoarthritis of the knee.  Approximately 75 people will take part in this study at the 
University of New Mexico. Lipogems will be donating kits for this study.
This form will explain the study to you, including the possible risks as well as the possible benefits of 
participating.  This is so you can make an informed choice about whether or not to participate in this study.   
Please read this Consent Form carefully. Ask the investigators or study staff to explain any words or 
information that you do not clearly understand. 
What will happen if I participate? 
If you agree to be in this study, you will be asked to read and sign this Consent Form. After you sign the 
Consent Form, the following things will happen:  You will be enrolled in the study, which requires six 
activities: one procedure, two brief follow-up appointments, and three sets of online surveys. Upon 
enrollment, you will be randomized to receive one of three treatment options: Lipogems, steroid injection, 
or placebo. Participants who are assigned to receive Lipogems will know, because this procedure requires 
a lipoaspiration (fat tissue removal) from the abdomen followed by reinjection into your knee. Participants 
who are assigned to receive either a steroid injection or a placebo injection will not know whether they are 
getting a steroid or placebo until the end of the study. After you are assigned to a group, you will be 
scheduled for your procedure. At the procedure, you will fill out three surveys about the pain in your knee 
and how it affects your daily life and a medication log. You will then receive your injection. You will be 
scheduled for two follow-up appointments: six weeks later and six months later. You will be asked to 
complete the same three surveys at each follow-up visit. You will be emailed these same surveys and 
medication log again two weeks after your injection, three months after, and one year after. After 
completion of your one year questionnaire, you will be told what group you were assigned to. If you were 
assigned to receive placebo, you may elect to have a corticosteroid injection at this time. Your participation 
in the study will be complete after your one year follow-up visit.   
Participation in this study will take a total of up to a maximum of eight hours over a period of one year.
What are the possible risks or discomforts of being in this study?
Every effort will be made to protect the information you give us.  However, there is a small risk of loss of 
privacy and/or confidentiality. Although a breach in patient confidentiality is unlikely to occur and should 


                                                     Page 2 of 5                                    Version Date: 11/07/2019
not negatively impact your health or overall well-being, the necessary precautions will be taken to minimize 
this risk. 
Otherwise, Intra-articular knee injections, such as corticosteroids and Lipogems, are employed in routine 
clinical practice to treat knee osteoarthritis. With any injection, including steroid injections, there is a risk 
of local adverse reaction such as an allergic reaction, increased pain or swelling, and a risk of infection that 
may be deep in the joint and lead to septic arthritis. Other risks of steroid injections include a higher sugar 
concentration in your blood for up to 3 days, skin discoloration, thinning of the layer of fat cells under your 
skin, and facial flushing. Some patients have weakening of the tendons or ligaments that may lead to them 
breaking. In addition to an injection in the knee, Lipogems involves a lipoaspiration procedure, which is 
the removal of fat cells like what is done during a liposuction, from the patient’s stomach. Some risks of 
lipoaspiration include the development of a fluid pocket or collection of blood in the area that may need 
to be drained, infections, and changes to the skin such as a scar, an area of darker skin compared to the 
surrounding skin, or a small area of skin hardening. Very rarely, more serious complications may arise, 
including but not limited to irritation of skin tissues leading to death of the cells or a localized toxic reaction 
to the anesthetic medication that is used to make the stomach numb for the removal of fat cells. 
How will my information be kept confidential?
Your name and other identifying information will be maintained in locked files, available only to authorized 
members of the research team, for the duration of the study.  For any information entered into a computer, 
the only identifier will be a unique study identification (ID) number. Any personal identifying information 
and any record linking that information to study ID numbers will be destroyed two years after data 
collection has ended for the entire study. Your paper documents will be shredded and disposed of, and 
any computerized files will be deleted.  Information resulting from this study will be used for research 
purposes and may be published; however, you will not be identified by name in any publications.
Information from your participation in this study may be reviewed by the investigators, federal and state 
regulatory agencies, and by the UNM Human Research Review Committee (HRRC) which provides 
regulatory and ethical oversight of human research. There may be times when we are required by law to 
share your information. However, your name will not be used in any published reports about this study.
What are the benefits to being in this study?
There may or may not be direct benefit to you from being in this study. Some patients may experience 
reduced pain or increased joint functionality of the affected knee after injection. However, your 
participation may help find out which knee injection is the superior treatment for other patients with knee 
osteoarthritis.
What other choices do I have if I don’t participate?
Taking part in this study is voluntary so you can choose not to participate. You and your clinician can still 
discuss other options for treatment of your knee pain. There are a variety of different treatment options 
available to explore and the choice depends on your medical history, your desires, and your clinician’s 
medical expertise. Some options include: NSAIDs (like aspirin or ibuprofen), steroid injections, other 
forms of injections that are not steroids, or a total knee replacement surgery. If you choose not to 
participate, your clinician will still review your medical history, your current complaints, and other medical 
information available to them to help you choose a treatment option.
Will I be paid for taking part in this study?


                                                     Page 3 of 5                                    Version Date: 11/07/2019
You will be compensated up to $80 via reloadable gift card for participating in the study. A $25 gift card 
will be distributed at each in-office follow-up visit and each completion of the online survey compensates 
$10.
What will happen if I am injured or become sick because I took part in this study?
If you are injured or become sick as a result of this study, UNMHSC will provide you with emergency 
treatment, at your cost. 
No commitment is made by the University of New Mexico Health Sciences Center (UNMHSC) to provide 
free medical care or money for injuries to participants in this study. 
In the event that you have an injury or illness that is caused by your participation in this study, 
reimbursement for all related costs of care will be sought from your insurer, managed care plan, or other 
benefits program. If you do not have insurance, you may be responsible for these costs. You will also be 
responsible for any associated co-payments or deductibles required by your insurance. 
It is important for you to tell the investigator immediately if you have been injured or become sick because 
of taking part in this study. If you have any questions about these issues, or believe that you have been 
treated carelessly in the study, please contact the Human Research Review Committee (HRRC) at the (505) 
272-1129 for more information.
How will I know if you learn something new that may change my mind about participating?
You will be informed of any significant new findings that become available during the course of the study, 
such as changes in the risks or benefits resulting from participating in the research or new alternatives to 
participation that might change your mind about participating.
Can I stop being in the study once I begin?
Yes.  You can withdraw from this study at any time without affecting your access to further healthcare.
The investigators have the right to end your participation in this study if they determine that you no longer 
qualify to take part, if you do not follow study procedures, or if it is in your best interest or the study’s best 
interest to stop your participation.  
HIPAA Authorization for Use and Disclosure of Your Protected Health Information (HIPAA)
As part of this study, we will be collecting health information about you. This information is “protected” 
because it is identifiable or “linked” to you.
Protected Health Information (PHI)
By signing this Consent Document, you are allowing the investigators and other authorized personnel to 
use your protected health information for the purposes of this study.  This information may include:  parts 
of your medical record, including results of physical exams, information about your osteoarthritis 
symptoms, and x-ray results obtained to evaluate your knee.   
In addition to researchers and staff at UNMHSC and other groups listed in this form, there is a chance that 
your health information may be shared (re-disclosed) outside of the research study and no longer be 
protected by federal privacy laws.  Examples of this include disclosures for law enforcement, judicial 
proceeding, health oversight activities and public health measures. 


                                                     Page 4 of 5                                    Version Date: 11/07/2019
Right to Withdraw Your Authorization
Your authorization for the use and disclosure of your health information for this study shall not expire 
unless you cancel this authorization.  Your health information will be used as long as it is needed for this 
study.  However, you may withdraw your authorization at any time provided you notify the UNM 
investigators in writing.  To do this, please send a letter notifying them of your withdrawal to:
Dustin Richter, MD
MSC 10-5600
1 University of New Mexico
Albuquerque New Mexico 87131
Please be aware that the research team will not be required to destroy or retrieve any of your health 
information that has already been used or shared before your withdrawal is received.
Refusal to Sign
If you choose not to sign this consent form and authorization for the use and disclosure of your PHI, you 
will not be allowed to take part in the research study.
What if I have questions or complaints about this study?
If you have any questions, concerns or complaints at any time about the research study, Dustin Richter, 
MD, or his associates will be glad to answer them. Please call Leorrie Atencio Monday-Friday from 8-5pm 
at 505-272-3573.  If you would like to speak with someone other than the research team, you may call the 
Human Research Review Committee (HRRC) at (505) 272-1129.  The HRRC is a group of people from 
UNMHSC and the community who provide independent oversight of safety and ethical issues related to 
research involving human participants.
  
A description of this study clinical trial will be available on http://www.ClinicalTrials.gov
as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of results. You can search this website at any time.
What are my rights as a research participant?
If you have questions regarding your rights as a research participant, you may call the Human Research 
Protections Office (HRPO) at (505) 272-1129 or visit the HRPO website at 
https://hsc.unm.edu/research/hrpo/Consent and Authorization
You are making a decision whether to participate in this study. Your signature below indicates that you 
read the information provided (or the information was read to you). By signing this Consent Form, you are 
not waiving any of your legal rights as a research participant.
I have had an opportunity to ask questions and all questions have been answered to my satisfaction. By 
signing this Consent Form, I agree to participate in this study and give permission for my health information 
to be used or disclosed as described in this Consent Form. A copy of this Consent Form will be provided 
to me.
/
Name of Adult Participant (print) 
  
     
 Signature of Adult Participant     
          Date


                                                     Page 5 of 5                                    Version Date: 11/07/2019
I have explained the research to the participant and answered all of his/her questions. I believe that he/she 
understands the information in this consent form and freely consents to participate. 
/
Name of Research Team Member                           Signature of Research Team Member          Date