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

Phase 2

• Conditions: Chronic Disease
• Interventions: Biological: Mesenchymal Stem Cells (MSCs); Biological: OrthADAPT

• Registration Number: NCT01687777
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Study Timeline

• Study Start: 2010-05
• Status Verified: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Study First Posted: 2012-09-19
• Last Update Posted: 2012-09-19
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

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Exclusion Criteria

• Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cells (MSCs)	Mesenchymal Stem Cells (MSCs)	Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)
OrthADAPT	OrthADAPT	Membrane of collagen type I (OrthoADAPT)

Primary Outcome Measures

Name	Time	Method
Constant Shoulder Score	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Nuclear Magnetic Resonance (RMN)	6 months, one year

Trial Locations

Locations (1)

Hospital Universitario Clinico San Carlos; 🇪🇸 Madrid, Spain