Clinical trial: A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells (NCT04405297)

Eligibility criteria:
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. 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 IV

          2. 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. Physiotherapy consisting of stretching, strengthening and local modalities
                  (ultrasound, cryotherapy, etc.)

               3. Activity modification

               4. Patients will present with a type of B2 glenoid deficiency, as defined by the
                  Walch classification system, with greater than 10 degrees of retroversion.

        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

          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. Subjects who have active synovitis in the treatment site

         18. History of bleeding disorders or inflammatory joint disease

         19. Inability to hold anti-platelet therapy according to treating provider prior to
             procedure

         20. Any medical condition that could preclude participation in the study in the opinion of
             the investigator

         21. Active workers' compensation case in progress with the targeted joint

         22. Daily opioid use for the 3 months prior to screening or anticipated daily use while
             participating on study

         23. Psychiatric disorder that may prevent participation in the study in the opinion of the
             investigators

         24. A positive screen for human immunodeficiency virus (HIV) by antibodies or nucleic acid
             test

         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 trauma to the affected hip requiring medical or surgical treatment

          3. Previous surgery on the affected hip or contralateral hip

          4. Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda,
             circumferential labral ossification)

          5. Infections or skin diseases at target hip joint

          6. Significant medical co-morbidities (requiring daily assistance for activities of daily
             living)

          7. Any clinically significant or symptomatic vascular or neurologic disorder of the lower
             extremities

          8. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40)

        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 less than 10⁰ of retroversion

          2. Rotator cuff arthropathy

          3. Significant muscle paralysis

          4. Charcot's arthropathy

        Wrist Cohort:

          1. Subjects who have a documented history of chondrocalcinosis in the wrist

          2. Subjects who have a documented diagnosis of active carpal tunnel syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment