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

This study has been completed.
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT00850187
First received: February 21, 2009
Last updated: January 2, 2012
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Knee Osteoarthritis
Biological: Bone marrow derived mesenchymal stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Knee cartilage defects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone marrow mesenchymal stem cells 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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00850187

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Tehran University of Medical Sciences
Investigators
Study Chair: Hamid gourabi, PhD Chief
Study Director: Mohamadreza Baghaban Eslaminejad, PhD Scientific Board
Principal Investigator: Leila Taghiyar, Msc Researcher
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT00850187     History of Changes
Other Study ID Numbers: Royan - Bone - 001
Study First Received: February 21, 2009
Last Updated: January 2, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Knee cartilage diseases

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014