Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.

Conditions
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Chronic Disease

Intervention / Treatment
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* Biological: Mesenchymal Stem Cells (MSCs)
* Biological: OrthADAPT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesenchymal stem cells (MSCs)<br>Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT) | Biological: Mesenchymal Stem Cells (MSCs)<br>* 20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.<br>|
| Placebo Comparator: OrthADAPT<br>Membrane of collagen type I (OrthoADAPT) | Biological: OrthADAPT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Shoulder Score |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nuclear Magnetic Resonance (RMN) |  | 6 months, one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraspinatus tendon, Mesenchymal stem cells, OrthADAPT, Rotator cuff