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

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

Tracking Information

• First Submitted Date: July 6, 2010
• First Posted Date: July 12, 2010
• Last Update Posted Date: January 8, 2013
• Study Start Date: July 2010
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee
• 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.
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Osteoarthritis
• Knee Osteoarthritis
• Osteochondritis Dissecans
• Osteonecrosis

Intervention

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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 9, 2010): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01159899
• Other Study ID Numbers: MSC- AS3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Michel Assor, MD, University of Marseille
• Study Sponsor: Michel Assor, MD
• Collaborators: Not Provided

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

• PRS Account: University of Marseille
• Verification Date: January 2013