drugset / Trial / NCT04448106
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).
Timeline
- Start
- 2023-09-25
- Primary completion
- 2024-08-01
- Completion
- 2026-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celltex- AdMSCs | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | Celltex- AdMSCs | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | Celltex- AdMSCs | Cell therapy | 2.86e+06 cells/kg | Intravenous |