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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Marseille
Sponsor:
Information provided by (Responsible Party):
Michel Assor, MD, University of Marseille
ClinicalTrials.gov Identifier:
NCT01159899
First received: July 6, 2010
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Knee Osteoarthritis
Osteochondritis Dissecans
Osteonecrosis
Procedure: Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University of Marseille:

Primary Outcome Measures:
  • IKS, International Knee Score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    measure assess of the knee function

  • IKS, International Knee Score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    measure assess of the knee function


Secondary Outcome Measures:
  • KOOS, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    measure assess of the knee function and quality of the new cartilage

  • KOOS, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    measure assess of the knee function and quality of the new cartilage


Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
    Transplantation of Activated Bone Marrow Stem Cells in Knee Arthrosis, under arthroscopy, in one-step procedure
    Other Names:
    • mesenchymal stem cells
    • Knee Arthrosis
    • Knee osteochondral defect
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159899

Contacts
Contact: Michel Assor, MD 0033611950518 / 0033609505060 michel.assor@free.fr
Contact: Shimon Slavin, Pr slavin@CTCIcenter.com

Locations
France
Knee and Lower Limb Institute, Dr Michel Assor Recruiting
Marseille, France, 13008
Contact: Michel Assor, MD    0033491221212 / 0033609505060    michel.assor@free.fr   
Contact: Michel Assor, MD    0033611950518      
Principal Investigator: Michel Assor, MD         
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Michel Assor, MD, Sponsor-Investigator, University of Marseille
ClinicalTrials.gov Identifier: NCT01159899     History of Changes
Other Study ID Numbers: MSC- AS3
Study First Received: July 6, 2010
Last Updated: January 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University of Marseille:
Osteoarthritis
knee arthritis
Knee arthrosis
articular cartilage defects
osteochondral defects
mesenchymal stem cells
stem cells
cellules souches,
genou
arthrose genou
PRP platelet rich plasma
thérapie cellulaire
implantation cellules souches mésenchymateuses
régénération cartilage
cicatrisation ménisque
ligament
plasma riche plaquettaire
platelet rich plasma
stem cell
regrowt cartilage
cellules souches
PRP

Additional relevant MeSH terms:
Osteoarthritis
Osteochondritis
Osteochondritis Dissecans
Osteonecrosis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases
Cartilage Diseases
Connective Tissue Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014