| September 11, 2012 |
| September 18, 2012 |
| May 2010 |
| June 2013 (final data collection date for primary outcome measure) |
| Constant Shoulder Score [ Time Frame: up to 1 year ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT01687777 on ClinicalTrials.gov Archive Site |
| Nuclear Magnetic Resonance (RMN) [ Time Frame: 6 months, one year ] [ Designated as safety issue: Yes ] |
| Same as current |
| Not Provided |
| Not Provided |
| |
| Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair |
| Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation. |
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. |
| Interventional |
| Phase 2 |
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment |
| Chronic Disease |
|
|
- Active Comparator: Mesenchymal stem cells (MSCs)
Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)
Intervention: Biological: Mesenchymal Stem Cells (MSCs)
- Placebo Comparator: OrthADAPT
Membrane of collagen type I (OrthoADAPT)
Intervention: Biological: OrthADAPT
|
- 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.
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|
| |
| Recruiting |
| 10 |
| December 2013 |
| June 2013 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subject providing informed consent.
- Comprised subject male/female aged 55-80.
- Subject has a supraspinatus tendon rupture.
- Subject has an unilateral injury.
- Rupture is enough to need medical assistance.
- Subject has an conventional medical treatment fail at least 3 months.
- Subject has a "reparable" injury according to Goutallier´s criteria.
Exclusion Criteria:
- Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.
|
| Both |
| 55 Years to 80 Years |
| No |
|
|
| Spain |
| |
| NCT01687777 |
| EC07/90208, 2007-007630-19 |
| No |
| Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid |
| Hospital San Carlos, Madrid |
| Hospital General Universitario Gregorio Marañon |
| Principal Investigator: |
Benjamin Fernandez-Gutierrez, MD, PhD |
Hospital Universitario Clinico San Carlos |
|
| Study Director: |
Pilar Tornero-Esteban, Bs, PhD |
Hospital Universitario Clinico San Carlos |
|
|
| Hospital San Carlos, Madrid |
| September 2012 |
