Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán | OTHER |
| Spanish National Health System | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC seeded onto a phosphate ceramic | Experimental | Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instrumented posterolateral arthrodesis | Procedure | Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight. Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery. |
Inclusion Criteria:
Clinical
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trauma Service. Hospital Universitario de Salamanca | Salamanca | Castille and León | 37007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37038216 | Derived | Gomez-Ruiz V, Blanco JF, Villaron EM, Fidalgo H, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stem cell transplantation for spinal fusion: 10 years follow-up of a phase I/II clinical trial. Stem Cell Res Ther. 2023 Apr 11;14(1):78. doi: 10.1186/s13287-023-03298-4. | |
| 30795797 | Derived | Blanco JF, Villaron EM, Pescador D, da Casa C, Gomez V, Redondo AM, Lopez-Villar O, Lopez-Parra M, Muntion S, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4. |
| Label | URL |
|---|---|
| Spanish cell therapy network (TerCel) | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Salamanca University Foundation | View source |
| Spanish Health Institute Carlos III | View source |
| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
Not provided
Not provided
Not provided