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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850187
• Other study ID #: Royan - Bone - 001
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2009
• Last updated: January 2, 2012
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Bone marrow derived mesenchymal stem cells
Bone Marrow Aspiration A total volume of 300 ml bone marrow will be aspirated from the iliac crest and are cultured for mesenchymal stem cells

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Royan Institute	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee cartilage defects		12 months	Yes
Secondary	pain		12 months	Yes

External Links

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