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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Bone marrow derived mesenchymal stem cells

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee cartilage diseases

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone marrow mesenchymal stem cells

Arm Description

Outcomes

Primary Outcome Measures

Knee cartilage defects

Secondary Outcome Measures

pain

Full Information

NCT ID

NCT00850187

First Posted

February 21, 2009

Last Updated

January 2, 2012

Sponsor

Royan Institute

Collaborators

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00850187

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

Collaborators

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Knee cartilage diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bone marrow mesenchymal stem cells

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Bone marrow derived mesenchymal stem cells

Intervention Description

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 Outcome Measure Information:

Title

Knee cartilage defects

Time Frame

12 months

Secondary Outcome Measure Information:

Title

pain

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid gourabi, PhD

Organizational Affiliation

Chief

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohamadreza Baghaban Eslaminejad, PhD

Organizational Affiliation

Scientific Board

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Leila Taghiyar, Msc

Organizational Affiliation

Researcher

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://www.royaninstitute.org

Description

Related Info

Learn more about this trial

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

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