Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee
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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. |
- 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
- 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) |
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Procedure: Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
- mesenchymal stem cells
- Knee Arthrosis
- Knee osteochondral defect
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 |
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| Contact: Michel Assor, MD | 0033611950518 / 0033609505060 | michel.assor@free.fr |
| Contact: Shimon Slavin, Pr | slavin@CTCIcenter.com |
| 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 | |
| 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:
|
Osteochondritis Dissecans Osteoarthritis Osteochondritis 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 June 18, 2013