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Completed

NCT Number: NCT00850187

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

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

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Key information

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute, Tehran, Tehran Province, Iran

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone marrow derived mesenchymal stem cells

Biological

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

Primary outcomes

  1. Knee cartilage defects

    Time frame: 12 months

Secondary outcomes

  1. pain

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Collaborators

  • Tehran University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 24, 2009
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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