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

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ClinicalTrials.gov Identifier: NCT01687777
Recruitment Status : Unknown
Verified September 2012 by Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid.
Recruitment status was:  Recruiting
First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Sponsor:
Collaborator:
Hospital General Universitario Gregorio Marañon
Information provided by (Responsible Party):
Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid

Tracking Information
First Submitted Date  ICMJE September 11, 2012
First Posted Date  ICMJE September 19, 2012
Last Update Posted Date September 19, 2012
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
Constant Shoulder Score [ Time Frame: up to 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
Nuclear Magnetic Resonance (RMN) [ Time Frame: 6 months, one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair
Official Title  ICMJE Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Disease
Intervention  ICMJE
  • Biological: Mesenchymal Stem Cells (MSCs)
    20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
  • Biological: OrthADAPT
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01687777
Other Study ID Numbers  ICMJE EC07/90208
2007-007630-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid
Study Sponsor  ICMJE Hospital San Carlos, Madrid
Collaborators  ICMJE Hospital General Universitario Gregorio Marañon
Investigators  ICMJE
Principal Investigator: Benjamin Fernandez-Gutierrez, MD, PhD Hospital Universitario Clinico San Carlos
Study Director: Pilar Tornero-Esteban, Bs, PhD Hospital Universitario Clinico San Carlos
PRS Account Hospital San Carlos, Madrid
Verification Date September 2012

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