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

January 2, 2012 updated by: Royan Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee cartilage defects
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 21, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 2, 2012

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan - Bone - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Bone marrow derived mesenchymal stem cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe