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

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ClinicalTrials.gov Identifier: NCT00850187
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : January 5, 2012
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Royan Institute

Tracking Information
First Submitted Date  ICMJE February 21, 2009
First Posted Date  ICMJE February 24, 2009
Last Update Posted Date January 5, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Knee cartilage defects [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00850187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
pain [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage
Official Title  ICMJE Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Bone marrow mesenchymal stem cells
Intervention: Biological: Bone marrow derived mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2009)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00850187
Other Study ID Numbers  ICMJE Royan - Bone - 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Tehran University of Medical Sciences
Investigators  ICMJE
Study Chair: Hamid gourabi, PhD Chief
Study Director: Mohamadreza Baghaban Eslaminejad, PhD Scientific Board
Principal Investigator: Leila Taghiyar, Msc Researcher
PRS Account Royan Institute
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP