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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Hospital San Carlos, Madrid.
Recruitment status was:  Recruiting
Hospital General Universitario Gregorio Marañon
Information provided by (Responsible Party):
Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid Identifier:
First received: September 11, 2012
Last updated: September 18, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Chronic Disease
Biological: Mesenchymal Stem Cells (MSCs)
Biological: OrthADAPT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.

Resource links provided by NLM:

Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:
  • Constant Shoulder Score [ Time Frame: up to 1 year ]

Secondary Outcome Measures:
  • Nuclear Magnetic Resonance (RMN) [ Time Frame: 6 months, one year ]

Estimated Enrollment: 10
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mesenchymal stem cells (MSCs)
Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)
Biological: Mesenchymal Stem Cells (MSCs)
20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
Placebo Comparator: OrthADAPT
Membrane of collagen type I (OrthoADAPT)
Biological: OrthADAPT

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.


Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01687777

Contact: Benjamín Fernández-Gutiérrez, PhD +34913303615 ext 7803
Contact: Pilar Tornero-Esteban, PhD +34913303615 ext 7434

Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Benjamin Fernandez-Gutierrez, MD, PhD    +34913303615 ext 7803   
Contact: Pilar Tornero-Esteban, Bs, PhD    +34913303615 ext 7434   
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Benjamin Fernandez-Gutierrez, MD, PhD    +34913303615 ext 7803   
Contact: Pilar Tornero-Esteban, Bs,PhD    +34913303615 ext 7434   
Sponsors and Collaborators
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
  More Information


Responsible Party: Benjamin Fernandez Gutierrez, Rheumatologist, Hospital San Carlos, Madrid Identifier: NCT01687777     History of Changes
Other Study ID Numbers: EC07/90208
2007-007630-19 ( EudraCT Number )
Study First Received: September 11, 2012
Last Updated: September 18, 2012

Keywords provided by Hospital San Carlos, Madrid:
Supraspinatus tendon
Mesenchymal stem cells
Rotator cuff

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes processed this record on May 24, 2017