Clinical trial NCT01687777: Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair
Official title: Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Disease
Keywords: Supraspinatus tendon
Mesenchymal stem cells
OrthADAPT
Rotator cuff
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Gregorio Marañon
First posted: 2012-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Constant Shoulder Score
timeFrame: up to 1 year
Secondary outcomes:
measure: Nuclear Magnetic Resonance (RMN)
timeFrame: 6 months, one year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
Study officials:
affiliation: Hospital Universitario Clinico San Carlos
name: Benjamin Fernandez-Gutierrez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Clinico San Carlos
name: Pilar Tornero-Esteban, Bs, PhD
role: STUDY_DIRECTOR
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