Allogeneic Bone Marrow MSC Therapy for Knee Osteoarthritis
NCT03589287 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2021-08-19
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.
Conditions
Interventions
- BIOLOGICAL
-
Chondrochymal®
Allogeneic Bone Marrow Derived Mesenchymal Stem Cells
Sponsors & Collaborators
-
Virginia Contract Research Organization Co., Ltd.
collaborator OTHER -
Taipei Veterans General Hospital, Taiwan
lead OTHER_GOV
Principal Investigators
-
Ming-Chau Chang, MD · Taipei Veterans General Hospital, Taiwan
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-02
- Primary Completion
- 2019-05-03
- Completion
- 2020-04-30
Countries
- Taiwan
Study Locations
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