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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007630-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Hospital General Universitario Gregorio Marañon | OTHER |
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Surgical reconstructive procedures for rotator cuff tears present a number of limitations. The few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. Morphologic analysis from the sutures, after different follow-up periods, has not shown satisfactory results.
Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the function compared to cell-free tendon defect treatment.
The investigators will include: Patients with massive tears from the supraspinatus tendon, in which reconstructive surgery is indicated. Patients will be randomly stratified into two groups.
The first group will receive autologous MSCs transplantation included in a collagen type I membrane (OrthADAPT) and the second group will serve as cell-free controls.
The surgical procedure will be performed by arthroscopic and/or combined technique: arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells composite will be put on the sutured area. The radiograms and function will be assessed by independently observers, who will no have knowledge of the study group from which they will have been obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells (MSCs) | Active Comparator | Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT) |
|
| OrthADAPT | Placebo Comparator | Membrane of collagen type I (OrthoADAPT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cells (MSCs) | Biological | 20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant Shoulder Score | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Nuclear Magnetic Resonance (RMN) | 6 months, one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BenjamÃn Fernández-Gutiérrez, PhD | Contact | +34913303615 | 7803 | bfernandez.hcsc@salud.madrid.org |
| Pilar Tornero-Esteban, PhD | Contact | +34913303615 | 7434 | mptornero@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Fernandez-Gutierrez, MD, PhD | Hospital Universitario Clinico San Carlos | Principal Investigator |
| Pilar Tornero-Esteban, Bs, PhD | Hospital Universitario Clinico San Carlos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Clinico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10434073 | Background | Awad HA, Butler DL, Boivin GP, Smith FN, Malaviya P, Huibregtse B, Caplan AI. Autologous mesenchymal stem cell-mediated repair of tendon. Tissue Eng. 1999 Jun;5(3):267-77. doi: 10.1089/ten.1999.5.267. | |
| 12706014 | Background | Awad HA, Boivin GP, Dressler MR, Smith FN, Young RG, Butler DL. Repair of patellar tendon injuries using a cell-collagen composite. J Orthop Res. 2003 May;21(3):420-31. doi: 10.1016/S0736-0266(02)00163-8. |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OrthADAPT | Biological |
|
| Hospital Universitario Clinico San Carlos | Recruiting | Madrid | Madrid | 28040 | Spain |
|
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