Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee

January 7, 2013 updated by: Michel Assor, MD

Pilot Study of A One-Step Procedure for the Use of Autologous Bone Marrow Mesenchymal Stem Cells Stimulated by Proteins Scaffold to Heal Under Arthroscopy Full-Thickness Defects Articular Cartilage and Osteoarthrosis of the Knee.

The purpose of this pilot study is to investigate the efficacy and safety of autologous transplantation, under arthroscopy, of Bone Marrow Mesenchymal stem cells, using, with a cell separator, a fresh non-culture expanded Autologous Bone Marrow derived Mesenchymal Stem, mixed and activated with proteins scaffold in patient with Knee cartilage defects and osteoarthritis. Based on extensive preclinical investigations, the technology of using freshly isolated bone marrow mononuclear cells mixed with proteins seems safe and most effective for a one-step correction of cartilage defect and restoration of the osteochondral complex, because the same mixture can generate cartilage in the vasculature-free knee joint, and bone in the environment of bone defects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Before the implantation of the mesenchymal stem cells, a knee arthroscopy procedure is made for the debridement of the meniscal and cartilage lesions, with microperforation and abrasion, preparation of the osteochondral defect to receive the transplantation, patellar lateral release if necessary.

Then, the investigators use a fresh non-culture expanded autologous bone marrow derived mesenchymal mononuclear stem cells, stimulated with a protein matrix and mixed in a collagen hydroxyapatite scaffold. This cellular paste is transplanted in the prepared defect, under arthroscopy, with injection of platelet rich plasma.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Early 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 Contact

Study Contact Backup

Study Locations

  • France
      • Marseille, France, 13008
        • Recruiting
        • Knee and Lower Limb Institute, Dr Michel Assor
        • Contact:
        • Contact:
          • Michel Assor, MD
          • Phone Number: 0033611950518
        • Principal Investigator:
          • Michel Assor, MD

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

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active patients (30 to 75 years)
  • A localized osteochondral defect of both condyle and/or tibia grade 4 (ICRS classification)
  • with cartilage on the tibial surface no more than grade 3-4, of size < 3-4 cm2, with 3/4 of meniscus present.
  • Stable knee ; previous ligament reconstruction, if stable
  • A defect that is 1 - 4 cm2 or more, up to 6 cm2, located on the femoral condyle and /or less of 4 cm2 for tibial plate, and IKS score <75.
  • Kissing lesions admitted
  • Ability to understand and willingness to sign consent form

Exclusion Criteria:

  • Patients younger than 30 years and older than 75 years
  • Diffuse and advanced articular cartilage degeneration of the joint
  • Axial malalignment, meniscal pathology, and ligamentous instability are relative contraindications that have to be dealt with primarily either concomitantly or before the transplantation during 1 of the 2 stages of the procedure. Refusal of the patient to address these conditions in presence of a cartilage lesion is a criterion for exclusion from the study, to avoid the impact of these knee pathologies on the final results
  • Existing infection in or around the joint & lesions of infectious or oncologic etiology.
  • Debilitated patients.
  • Immunocompromised patients.
  • Patients with autoimmune disorders & systemic inflammatory disease.
  • Preoperative poor neurological or vascular status of the affected limb.
  • Specific contraindications include the use of tobacco and medications that may impair cell proliferation, such as NSAIDs and immunosuppressive drugs. Patients must be nicotine-free (stop smoking) prior to the procedure, as studies have shown that the oxidative effect of smoking impairs cell function and subsequent healing.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKS, International Knee Score
Time Frame: 6 months
measure assess of the knee function
6 months
IKS, International Knee Score
Time Frame: 1 year
measure assess of the knee function
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS, Knee Injury and Osteoarthritis Outcome Score
Time Frame: 6 months
measure assess of the knee function and quality of the new cartilage
6 months
KOOS, Knee Injury and Osteoarthritis Outcome Score
Time Frame: 1 year
measure assess of the knee function and quality of the new cartilage
1 year

Collaborators and Investigators

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

Sponsor

Michel Assor, MD

Investigators

  • Principal Investigator: Michel Assor, MD, Knee and Lower Limb Institute, Marseille, France
  • Study Director: Shimon Slavin, MD, The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel

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

July 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 9, 2010

First Posted (ESTIMATE)

July 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSC- AS3

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.

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