Chronic Disease Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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