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Clinical Trials/NCT00850187
NCT00850187CompletedPhase 1

Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold

Royan Institute1 site in 1 country6 target enrollmentStarted: August 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Experimental

Intervention: Bone marrow derived mesenchymal stem cells (Biological)

Outcomes

Primary Outcomes

Knee cartilage defects

Time Frame: 12 months

Secondary Outcomes

  • pain(12 months)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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