drugset / Trial / NCT05005000

Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis

NCT05005000

Phase 2 Withdrawn NYU Langone Health
RandomizedParallel-groupOpen-labelTreatment

Summary

32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.

Timeline

Start
2022-05-12
Primary completion
2023-05-25
Completion
2023-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Micro Fragmented Adipose Tissue Cell therapy 1 ml Other
Comparator Triamcinolone Acetonide Other / unclassified 1 ml Other
Comparator Triamcinolone Acetonide Other / unclassified 10 mg/ml Other