drugset / Trial / NCT06431152
Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis
RandomizedParallel-groupOpen-labelTreatment
Summary
The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. The investigators expect to enroll 12 patients in this phase 1 trial open label dose-escalation pilot and the follow-up will be up to 12 months.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2025-06-30
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UC-MSC sEV | Other / unclassified | 2e+09 unknown | Other |
| Subject | UC-MSC sEV | Other / unclassified | 6e+09 unknown | Other |
| Subject | UC-MSC sEV | Other / unclassified | 2e+10 unknown | Other |