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

NCT01687777 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-09-19

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Mesenchymal Stem Cells (MSCs)

20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.

BIOLOGICAL

OrthADAPT

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Benjamin Fernandez-Gutierrez, MD, PhD · Hospital Universitario Clinico San Carlos

  • Pilar Tornero-Esteban, Bs, PhD · Hospital Universitario Clinico San Carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01687777 on ClinicalTrials.gov