Using fat-derived stem cells to treat wrist osteoarthritis
Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells
This study is testing whether injecting fat-derived stem cells can help people with chronic wrist osteoarthritis feel less pain and improve their wrist function compared to a cortisone injection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | InGeneron, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Sioux Falls, South Dakota and 1 other locations) |
| Trial ID | NCT03503305 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of autologous adipose-derived regenerative cells (ADRCs) in treating chronic wrist osteoarthritis. It is a randomized, double-blinded, active-controlled trial comparing the outcomes of a single ADRC injection to a cortisone injection. The hypothesis is that ADRCs will reduce inflammation, accelerate healing, and decrease pain, leading to improved function and strength in the affected wrist. The study involves 40 participants, divided into a treatment group receiving ADRCs and a control group receiving cortisone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with clinically diagnosed wrist osteoarthritis.
Not a fit: Patients with inflammatory arthritis, severe osteoporosis, or those receiving immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve function for patients suffering from wrist osteoarthritis.
How similar studies have performed: While similar approaches using adipose-derived stem cells have shown promise in other conditions, this specific application for wrist osteoarthritis is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females ages: 18 - 75. 2. Clinical symptoms consistent with wrist osteoarthritis. 3. Diagnosed with wrist osteoarthritis on radiographs. 4. The ability of subjects to give appropriate consent or have a legally authorized representative available. Exclusion Criteria: 1. Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist 2. Subjects who have a documented diagnosis of carpal tunnel syndrome. 3. Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate 4. History of systemic malignant or local neoplasms on affected limb within last 5 years 5. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.) 6. Subjects who have received a corticosteroid injection in the treatment site 7. Subjects on an active regimen of chemotherapy 8. Allergy to sodium citrate of any "caine" type of local anesthetic 9. Subjects pregnant or breast feeding 10. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments 11. Subjects who have document allergy to radiographic guidance agents. 12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint 13. History of tobacco use within the last 3 months 14. Subjects with documented with a history of alcohol or drug abuse 15. Subjects who have a documented history of HIV, Hepatitis B, and Hepatitis C 16. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Where this trial is running
Sioux Falls, South Dakota and 1 other locations
- Sanford USD Medical Center — Sioux Falls, South Dakota, United States (Active_not_recruiting)
- HD Research — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Robert Vandermark, MD — Sanford Health
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.