All Cohorts:
To be eligible to participate in this study, a subject must meet all the following
criteria.
Inclusion Criteria-ALL Cohorts:
1. Men and women age 18 or older. 2. Clinical and radiographic diagnosis of OA in one of the following areas: Ankle, Hip,
Knee, Shoulder, or Wrist. 3. Continued OA pain in the targeted joint despite conservative measures (per treating
provider's discretion)
4. Average daily VAS Pain Score ≥3. 5. Understand and provide written informed consent and Health Insurance Portability and
Accountability Act (HIPAA) authorization prior to initiation of any study-specific
procedures. 6. On physical exam. subject appears to have adequate adipose tissue for liposuction. 7. Subject must also meet additional inclusion criteria specific to the targeted joint
cohort. Ankle Cohort:
1. Currently Kellgren-Lawrence Grade II, III or IV in the ankle based on X-ray
(weight-bearing mortise views with 20⁰ internal rotation)
2. Ankle pain for at least 6 months, despite conservative treatment or inability to
tolerate the side effects of medications. 3. Normal activity level, not bedridden or confined to a wheelchair, able to walk 30
meters without the aid of a walker, crutches or cane. Hip Cohort:
1. Hip OA diagnosed on x-ray and/or Magnetic Resonance Imaging (MRI) (Tӧnnis grade 1, 2, or
3)
Knee Cohort:
1. Kellgren-Lawrence system of Grade II, III, or
Subject may have concomitant patellofemoral but they must have stage II or higher
generalized knee OA. Shoulder Cohort:
1. Grades 1, 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto
classification system as confirmed by X-ray (axillary view and true anterior-posterior
view)
2. Subjects who have failed standard non-surgical management of their shoulder arthritis
who would benefit from a shoulder arthroplasty. Failed medical management will be
defined as persistent pain and disability despite adequate standard non-operative
management for 6 months. Medical management will be defined as:
1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs. 2. Activity modification. Wrist Cohort:
1. Clinical symptoms consistent with wrist OA. Exclusion Criteria- ALL Cohorts:
1. Subject cannot meet any of the exclusion criteria listed of the targeted joint cohort. 2. Viscosupplementation within 6 months of screening in the targeted joint. 3. Other Biologic Injection (Platelet Rich Plasma (PRP) or stem cell) within 6 months in
the targeted joint. 4. Surgery in the targeted joint within the past 6 months (either open or scope)
5. Planned/anticipated surgery of the targeted joint during study participation. 6. Systemic or intra-articular injection of corticosteroids in any joint within 3 months
before screening (re-screening allowed once this criteria is met)
7. Females of childbearing age who have not used or do not plan to use acceptable birth
control measures, for the duration of the study. Oral, injected or implanted hormonal
contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine
device, surgical sterilization, transdermal delivery, congenital sterility or sexual
abstinence are considered acceptable forms of birth control. If sexually active, the
subject must have been using one of the accepted birth control methods at least one
month prior to study entry.
8. Part of a vulnerable population per Office for Human Research Protections (OHRP)
definition (pregnant women and breast-feeding women, cognitively impaired, prisoners,
etc.)
9. Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7
calendar days prior to the procedure. 10. Unwilling to discontinue NSAIDS for 5 calendar days after procedure. 11. Insufficient amount of subcutaneous tissue to allow recovery of at least 100mL of
lipoaspirate. 12. Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal
if not on long term remission (e.g. at least 5 years or negative biopsy at last exam),
except basal cell carcinoma. 13. Have received chronic (more than 7 consecutive days) treatment with systemic
corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to
an injection procedure.
14. Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint. (Nonintervention observational studies are not
exclusionary.)
15. History of, or ongoing, autoimmune disorder that requires treatment with an
immunosuppressive medication. 16. Subjects who have a documented history or presence of inflammatory arthritis,
rheumatoid arthritis, and sepsis in the treatment site. 17. History of bleeding disorders or inflammatory joint disease. 18. Inability to hold anti-platelet therapy according to treating provider prior to
procedure. 19. Any medical condition that could preclude participation in the study in the opinion of
the investigator. 20. Active workers' compensation case in progress with the targeted joint. 21. Daily opioid use for the 3 months prior to screening or anticipated daily use while
participating on study. 22. Psychiatric disorder that may prevent participation in the study in the opinion of the
investigators. 23. A positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid
test. 24. Has a known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA
[qualitative] is detected)
25. Allergy to sodium citrate of any "caine" type of local anesthetic. 26. Hemoglobin less than 10g/dL at the time of screening. 27. Leukocytes <3,000/µL; neutrophils <1,500/µL; lymphocytes <800/µL; platelets
<100,000/µL at the time of screening. 28. Subjects with a known diagnosis of osteoporosis. 29. Diagnosis of liver disease as defined by alanine aminotransferase (ALT) >2x the upper
limit of age-determined normal (ULN) or total bilirubin > 1.5x ULN. Ankle Cohort:
1. Lower leg trauma in a location other than within the ankle. 2. Arthroscopy or open surgery of the ankle joint within 6 months of screening.
3. Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines
Body Mass Index (BMI > 40)
4. Any condition other than OA of the ankle joint which, in the opinion of the
investigator, affects their ability to ambulate to a sufficient degree to interfere
with the assessment of the safety and treatment effects of the study injection.
Hip Cohort:
1. Evidence of hip dysplasia (centre edge angle less than 20⁰)
2. Previous fracture trauma to the affected hip requiring medical or surgical treatment. 3. Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda,
circumferential labral ossification)
4. Infections or skin diseases at target hip joint. 5. Significant medical co-morbidities (requiring daily assistance for activities of daily
living)
6. Any clinically significant or symptomatic vascular or neurologic disorder of the lower
extremities. 7. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
8. Femoral head deformity (perthes or AVN)
Knee Cohort:
1. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)
2. Clinically apparent tense effusion of the targeted knee. 3. Significant valgus/varus deformities (+/- 10⁰)
Shoulder Cohort:
1. Walch B2 glenoid with greater than 10⁰ of retroversion. 2. Active joint or systemic infection. 3. Rotator cuff arthropathy. 4. Significant muscle paralysis. 5. Charcot's arthropathy. Wrist Cohort:
1. Subjects who have a documented diagnosis of active carpal tunnel syndrome
