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| Sponsor: | University Hospital, Toulouse |
|---|---|
| Collaborators: |
French Blood Establishment (Midi-Pyrénées) Nantes University Hospital PHRC, Ministry of Health France |
| Information provided by (Responsible Party): | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01076920 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myocardial Ischemia Left Ventricular Dysfunction |
Genetic: Mesenchymal stem cells |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy |
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Mesenchymal stem cells from the bone marrow can differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue. The aim of the study is in a phase I safety study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.10 patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 24 months follow-up.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: jerome RONCALLI, MD, PhD | +33 561 322 613 | j.roncalli@chu-toulouse.fr |
| France | |
| University Hospital (Rangueil) | Recruiting |
| Toulouse, France, 31059 | |
| Contact: jerome RONCALLI, MD, PhD +33 561 322 613 j.roncalli@chu-toulouse.fr | |
| Principal Investigator: | jerome RONCALLI, MD, PhD | University Hospital Of TOULOUSE |
More Information
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01076920 History of Changes |
| Other Study ID Numbers: | 0505008 |
| Study First Received: | February 10, 2010 |
| Last Updated: | September 15, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Myocardial Ischemia Coronary Artery Disease Ischemia Ventricular Dysfunction, Left Ventricular Dysfunction Heart Diseases |
Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |