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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002010-39 | EudraCT Number |
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The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.
To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cultured autologous Mesenchymal Cells | Experimental | Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control. 20x106 cells per cc in a single administration of 7cc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cultured autologous Mesenchymal Cells | Biological | Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control. |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate | Local and general complication rate | 6,12,24,104 weeks |
| Progression of disease to the next stage | 12 months | |
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Inclusion Criteria:
Age 18 to 65, both sexes
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Gomez-Barrena, Prof | Universidad Autonoma de Madrid, Hospital la Paz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedic Surgery, Hôpital Henri Mondor | Créteil | 94000 | France | |||
| Department of Orthopaedic Surgery, CHU Tours |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33535589 | Result | Gomez-Barrena E, Padilla-Eguiluz NG, Rosset P, Hernigou P, Baldini N, Ciapetti G, Gonzalo-Daganzo RM, Avendano-Sola C, Rouard H, Giordano R, Dominici M, Schrezenmeier H, Layrolle P, On Behalf Of The Reborne Consortium. Osteonecrosis of the Femoral Head Safely Healed with Autologous, Expanded, Bone Marrow-Derived Mesenchymal Stromal Cells in a Multicentric Trial with Minimum 5 Years Follow-Up. J Clin Med. 2021 Feb 1;10(3):508. doi: 10.3390/jcm10030508. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 29, 2021 | |
| Reset | Feb 15, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 29, 2021 | Feb 15, 2022 |
| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
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| Amount of necrotic bone in the femoral head in MRI |
| 12 weeks and 52 weeks |
| Pain (VAS) | 6,12,24,52,104 weeks |
| serum levels of bone turnover markers | 12 and 24 weeks |
| Tours |
| 37044 |
| France |
| University Children's Hospital | Tübingen | 72076 | Germany |
| Department of Orthopaedic Trauma, University of Ulm | Ulm | 8907581 | Germany |
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz | Madrid | 28046 | Spain |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |