drugset / Trial / NCT03589287
Allogeneic Bone Marrow MSC Therapy for Knee Osteoarthritis
Phase 1/2
Completed
18 enrolled
Taipei Veterans General Hospital, Taiwan
Virginia Contract Research Organization Co., Ltd. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The Clinical trial is a phase I/IIa clinical study for treatment of knee osteoarthritis by intra-articular injection of bone marrow derived allogeneic mesenchymal stem cells. Primary endpoint of the study is safety of allogeneic BM-MSCs application on knee OA with single dose IA injection and the MTD. Secondary endpoint is the effect of allogeneic BM-MSCs transplantation including clinical and image observation since the MSCs have multi-lineage differentiation potential such as chondrocyte differentiation, anti-inflammation and immune-modulation.
Timeline
- Start
- 2018-05-02
- Primary completion
- 2019-05-03
- Completion
- 2020-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bone marrow mesenchymal stem cells | Cell therapy | 1e+07 cells | Other |
| Subject | Bone marrow mesenchymal stem cells | Cell therapy | 5e+07 cells | Other |
| Subject | Bone marrow mesenchymal stem cells | Cell therapy | 1e+08 cells | Other |