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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 because the information has not been verified recently.
Verified September 2012 by Hospital San Carlos, Madrid.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital General Universitario Gregorio Marañon
Information provided by (Responsible Party):
Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT01687777
First received: September 11, 2012
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687777

Contacts
Contact: Benjamín Fernández-Gutiérrez, PhD +34913303615 ext 7803 bfernandez.hcsc@salud.madrid.org
Contact: Pilar Tornero-Esteban, PhD +34913303615 ext 7434 mptornero@gmail.com

Locations
Spain
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Benjamin Fernandez-Gutierrez, MD, PhD    +34913303615 ext 7803    bfernandez.hcsc@salud.madrid.org   
Contact: Pilar Tornero-Esteban, Bs, PhD    +34913303615 ext 7434    mptornero@gmail.com   
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Benjamin Fernandez-Gutierrez, MD, PhD    +34913303615 ext 7803    bfernandez.hcsc@salud.madrid.org   
Contact: Pilar Tornero-Esteban, Bs,PhD    +34913303615 ext 7434    mptornero@gmail.com   
Sponsors and Collaborators
Hospital San Carlos, Madrid
Hospital General Universitario Gregorio Marañon
Investigators
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

Publications:

Responsible Party: Benjamin Fernandez Gutierrez, Rheumatologist, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT01687777     History of Changes
Other Study ID Numbers: EC07/90208, 2007-007630-19
Study First Received: September 11, 2012
Last Updated: September 18, 2012
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines
Spain: Ministry of Health and Consumption

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

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014