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

September 18, 2012 updated by: Benjamin Fernandez Gutierrez, Hospital San Carlos, Madrid

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Clinico San Carlos
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Constant Shoulder Score
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Nuclear Magnetic Resonance (RMN)
Time Frame: 6 months, one year
6 months, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC07/90208
  • 2007-007630-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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