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

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ClinicalTrials.gov Identifier: NCT01159899
Recruitment Status : Unknown
Verified January 2013 by Michel Assor, MD, University of Marseille.
Recruitment status was:  Recruiting
First Posted : July 12, 2010
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
Michel Assor, MD, University of Marseille

Tracking Information
First Submitted Date  ICMJE July 6, 2010
First Posted Date  ICMJE July 12, 2010
Last Update Posted Date January 8, 2013
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
  • IKS, International Knee Score [ Time Frame: 6 months ]
    measure assess of the knee function
  • IKS, International Knee Score [ Time Frame: 1 year ]
    measure assess of the knee function
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
  • IKS, International Knee Score [ Time Frame: 6 months ]
    measure assess of the knee function
  • IKS, International Knee Score [ Time Frame: 1 year ]
    mesure assess of the knee function
Change History Complete list of historical versions of study NCT01159899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
  • KOOS, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 6 months ]
    measure assess of the knee function and quality of the new cartilage
  • KOOS, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 1 year ]
    measure assess of the knee function and quality of the new cartilage
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
  • ICRS, International Cartilage Research Society [ Time Frame: 6 months ]
    measure assess of the knee function and quality of the new cartilage
  • ICRS, International Cartilage Research Society [ Time Frame: 1 year ]
    measure assess of the knee function and quality of the new cartilage
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee
Official Title  ICMJE 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.
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Knee Osteoarthritis
  • Osteochondritis Dissecans
  • Osteonecrosis
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 9, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01159899
Other Study ID Numbers  ICMJE MSC- AS3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michel Assor, MD, University of Marseille
Study Sponsor  ICMJE Michel Assor, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Marseille
Verification Date January 2013

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