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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

September 11, 2012
September 18, 2012
May 2010
June 2013   (final data collection date for primary outcome measure)
Constant Shoulder Score [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01687777 on ClinicalTrials.gov Archive Site
Nuclear Magnetic Resonance (RMN) [ Time Frame: 6 months, one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Disease
  • Biological: Mesenchymal Stem Cells (MSCs)
    20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
  • Biological: OrthADAPT
  • Active Comparator: Mesenchymal stem cells (MSCs)
    Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)
    Intervention: Biological: Mesenchymal Stem Cells (MSCs)
  • Placebo Comparator: OrthADAPT
    Membrane of collagen type I (OrthoADAPT)
    Intervention: Biological: OrthADAPT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
55 Years to 80 Years
No
Contact: Benjamín Fernández-Gutiérrez, PhD +34913303615 ext 7803 bfernandez.hcsc@salud.madrid.org
Contact: Pilar Tornero-Esteban, PhD +34913303615 ext 7434 mptornero@gmail.com
Spain
 
NCT01687777
EC07/90208, 2007-007630-19
No
Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid
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
Hospital San Carlos, Madrid
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP