Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Royan Institute
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Knee cartilage defects
Study Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis
Detailed Description
Articular cartilage defects have a weak potential for self-repair because of the reduced mitotic capacity of chondrocytes in vivo. Because some patients with articular cartilage defects may progress to osteoarthritis, such defects need to be repaired even though their exact natural course remains obscure. Traditional methods for repair, such as micro fracture, perforations, abrasion arthroplasty, have not produced consistent satisfactory long term clinical results. Transplantation of autologous bone marrow MSCs expanded in culture would be a promising approach in the repair of articular cartilage defects in human osteoarthritic knees. This method is clinically straightforward to perform because autologous cells can be readily harvested and expanded in culture without losing their capacity to differentiate into chondrocytes. The purpose of this study was to evaluate the clinical results obtained with autologous MSCs expanded in culture for the treatment of full-thickness chondral defects in human knee.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 45 to 60, inclusive
- •Normal axial alignment
- •Stable knee-previous ligament reconstruction, if stable
- •Intact articular cartilage in posterior meniscal weight-bearing zone
- •Ability to understand and willingness tosign consent from
- •O.C.D or OA calgran classification II,III
Exclusion Criteria
- •Pregnant or lactating
- •Inflammatory arthritis
- •Oral steriod, methotrexate
- •Unable to follow post-operative exercise regimen or return for evaluations
Arms & Interventions
Bone marrow mesenchymal stem cells
Intervention: Bone marrow derived mesenchymal stem cells (Biological)
Outcomes
Primary Outcomes
Knee cartilage defects
Time Frame: 12 months
Secondary Outcomes
- pain(12 months)
