Mesenchymal Stem Cells and Myocardial Ischemia

NCT01076920 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-09-19

No results posted yet for this study

Summary

Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the all damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of injecting MSCs directly into the heart to repair and restore heart function in people who have had a heart attack and who have chronic myocardial ischemia with heart failure.

Conditions

  • Chronic Myocardial Ischemia
  • Left Ventricular Dysfunction

Interventions

GENETIC

Mesenchymal stem cells

60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)

Sponsors & Collaborators

  • French Blood Establishment

    collaborator OTHER
  • Nantes University Hospital

    collaborator OTHER
  • Ministry of Health, France

    collaborator OTHER_GOV
  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • jerome RONCALLI, MD, PhD · University Hospital Of TOULOUSE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-02-28
Completion
2014-09-30

Countries

  • France

Study Locations

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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 NCT01076920 on ClinicalTrials.gov