drugset / Trial / NCT03602872
Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis
Non-randomizedSequentialOpen-labelTreatment
Summary
The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).
Timeline
- Start
- 2019-08
- Primary completion
- 2020-04
- Completion
- 2020-04
Outcome
Outcome not reported
Stopped: “Sponsor to start with different protocol, postponed due to COVID”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human allogeneic mesenchymal bone marrow derived stem cells | Cell therapy | 2e+07 cells | Other |