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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis | Procedure | Transplantation of Activated Bone Marrow Stem Cells in Knee Arthrosis, under arthroscopy, in one-step procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| IKS, International Knee Score | measure assess of the knee function | 6 months |
| IKS, International Knee Score | measure assess of the knee function | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS, Knee Injury and Osteoarthritis Outcome Score | measure assess of the knee function and quality of the new cartilage | 6 months |
| KOOS, Knee Injury and Osteoarthritis Outcome Score | measure assess of the knee function and quality of the new cartilage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Assor, MD | Contact | 0033611950518 / 0033609505060 | michel.assor@free.fr | |
| Shimon Slavin, Pr | Contact | slavin@CTCIcenter.com |
| Name | Affiliation | Role |
|---|---|---|
| Michel Assor, MD | Knee and Lower Limb Institute, Marseille, France | Principal Investigator |
| Shimon Slavin, MD | The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knee and Lower Limb Institute, Dr Michel Assor | Recruiting | Marseille | 13008 | France |
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| Label | URL |
|---|---|
| knee stem cell procedures | View source |
| cell therapy and PRP | View source |
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| 1 year |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D010008 | Osteochondritis Dissecans |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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