Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage

Phase 1

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Bone marrow derived mesenchymal stem cells

• Registration Number: NCT00850187
• Lead Sponsor: Royan Institute

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-02-21
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-24
• Status Verified: 2010-04
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Last Update Submitted: 2012-01-02
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone marrow mesenchymal stem cells	Bone marrow derived mesenchymal stem cells	-

Primary Outcome Measures

Name	Time	Method
Knee cartilage defects	12 months

Secondary Outcome Measures

Name	Time	Method
pain	12 months

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of