Active — Not RecruitingNot Applicable

Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

United States40 participantsStarted 2018-11-21

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Males and females ages: 18 - 75.
✓. Clinical symptoms consistent with wrist osteoarthritis.
✓. Diagnosed with wrist osteoarthritis on radiographs.
✓. The ability of subjects to give appropriate consent or have a legally authorized representative available.

Exclusion criteria

✕. Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist
✕. Subjects who have a documented diagnosis of carpal tunnel syndrome.
✕. Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate
✕. History of systemic malignant or local neoplasms on affected limb within last 5 years
✕. 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.)
✕. Subjects who have received a corticosteroid injection in the treatment site
✕. Subjects on an active regimen of chemotherapy
✕. Allergy to sodium citrate of any "caine" type of local anesthetic

What they're measuring

Safety - Incidence of Treatment-Emergent Adverse Events

Timeframe: 12 months

Trial details

NCT IDNCT03503305

SponsorInGeneron, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Osteoarthritis of the Wrist trials