Osteoarthritis of the Wrist Clinical Trial
Official title:
Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells
| Verified date | April 2024 |
| Source | InGeneron, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective, randomized, double-blinded, active controlled, single site safety and efficacy study in subjects suffering from chronic wrist osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the wrist.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | March 31, 2025 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | HD Research | Houston | Texas |
| United States | Sanford USD Medical Center | Sioux Falls | South Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| InGeneron, Inc. | Sanford Health |
United States,
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Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634. Erratum In: Stem Cells. 2017 Jun;35(6):1651-1652. — View Citation
ter Huurne M, Schelbergen R, Blattes R, Blom A, de Munter W, Grevers LC, Jeanson J, Noel D, Casteilla L, Jorgensen C, van den Berg W, van Lent PL. Antiinflammatory and chondroprotective effects of intraarticular injection of adipose-derived stem cells in experimental osteoarthritis. Arthritis Rheum. 2012 Nov;64(11):3604-13. doi: 10.1002/art.34626. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety - Incidence of Treatment-Emergent Adverse Events | Subjects will be monitored for adverse events | 12 months | |
| Secondary | Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits | Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain) | 3, 6 and 12 months | |
| Secondary | Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits | Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty) | 3, 6 and 12 months | |
| Secondary | Efficacy - Change in Function Scores on the QuickDASH at All Follow-up | Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable) | 3, 6 and 12 months |