A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells

Study Purpose

This is a prospective, multi-location safety and effectiveness study, and data registry of autologous adult ADRCs generated by the Transpose® RT System in subjects with OA in the shoulder, wrist, knee, hip, or ankle.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04405297
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanford Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David A. Pearce, PhD
Principal Investigator Affiliation Sanford Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis, Hip Osteoarthritis, Ankle Osteoarthritis, Shoulder Osteoarthritis, Wrist Osteoarthritis
Additional Details

Subjects who have signed informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization, and are determined to meet all inclusion criteria and no exclusion criteria will be enrolled in this study and receive the ADRC treatment. The subject will have an injection procedure (ADRC treatment) For this study, a licensed physician trained in liposuction must perform the syringe liposuction procedure. The licensed physician who performs the lipoplasty may be the Investigator or a non-Investigator physician (e.g., a plastic surgeon) who is trained on the study protocol. All subjects will undergo a minor syringe liposuction procedure to acquire approximately 100 mL of lipoaspirate for preparation of ADRC using the Transpose® RT System. The removed tissue is processed to extract a cell suspension (the cell product). Once the cell product has been obtained, tested, and found to conform to release criteria, the subject will be treated with the ADRCs.

Arms & Interventions

Arms

: Hip Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected hip joint.

: Knee Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected knee joint.

: Ankle Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected ankle joint.

: Shoulder Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected shoulder joint.

: Wrist Osteoarthritis

Subjects will receive autologous adipose-derived regenerative stem cells into their affected wrist joint.

Interventions

Device: - Adipose-derived regenerative cells

Adipose-derived regenerative cells will be obtained from a small-volume lipoaspirate procedure. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the targeted joint.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sanford Orthopedics and Sports Medicine, Sioux Falls, South Dakota

Status

Address

Sanford Orthopedics and Sports Medicine

Sioux Falls, South Dakota, 57104

Site Contact

Katie Jensen

[email protected]

605-312-6983