Mesenchymal Stem Cells and Myocardial Ischemia (MESAMI)

This study has been completed.
Sponsor:
Collaborators:
French Blood Establishment (Midi-Pyrénées)
Nantes University Hospital
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01076920
First received: February 10, 2010
Last updated: September 18, 2014
Last verified: September 2014
  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 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Evaluate safety and feasibility of transendocardial injection using the NogaStar XP Mapping Catheter with the MyostarTM Left Ventricular Injection Catheter of autologous MSC in subjects with chronic myocardial ischemia and left ventricular dysfunction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in SF-36, VO2max, 6 min walk test, and the NYHA, CCS Classifications Effect related to cardiac function [ Time Frame: 30 days to 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: September 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention arm Genetic: Mesenchymal stem cells
60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. Age 18 to 75
  2. Male or female
  3. NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with)
  4. Chronic coronary artery disease with left ventricular function below 35%
  5. Stable medical therapy for at least one month
  6. Reversible perfusion defects by SPECT
  7. Not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy
  8. Implantable Cardiovertor Defibrillator

Exclusion Criteria:

  1. Acute coronary syndrome, revascularization (PCI or CABG), or cardiac resynchronization during the last 3 months
  2. Sustained ventricular
  3. Further revascularization planned for the next 30 days.
  4. Chronic atrial fibrillation.
  5. A wall thickness in the target region <8 mm as determined by 2D echocardiography (the target region is defined at the time of NOGA® mapping).
  6. An LV thrombus.
  7. Severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
  8. Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the LV.
  9. Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
  10. An active uncontrolled infection.
  11. A prosthetic aortic valve.
  12. A current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
  13. Pregnancy or breastfeeding.
  14. Active participation in other research therapy for cardiovascular repair/regeneration.
  15. Any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
  16. Any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076920

Locations
France
University Hospital (Rangueil)
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
French Blood Establishment (Midi-Pyrénées)
Nantes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: jerome RONCALLI, MD, PhD University Hospital Of TOULOUSE
  More Information

No publications provided

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 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Ventricular Dysfunction
Ventricular Dysfunction, Left
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 30, 2014