Stem cell therapy is an emerging treatment for cardiovascular disease but the best cell type and delivery method remain to be determined. Pre-clinical studies demonstrated improvement of cardiac function by Mesenchymal stem cells (MSC) therapy in particular by their paracrine and immunosuppressive properties. Investigators initiated the MESAMI program by the bicentric pilot phase and highlighted the safety and feasibility of intramyocardial injections of MSCs from bone marrow in patients with chronic ischemic cardiomyopathy and left ventricular dysfunction, guide by the NOGA-XP system. The MESAMI program continues with the phase 2, multicenter, double-blind, randomized, placebo-controlled trial.The aim of this phase 2 study is to demonstrate a functional improvement, measuring peak VO2, at 3 months between the cell therapy group and the placebo group.
Ischemic cardiomyopathies are a leading cause of death in both men and women. During the last decade, treatments for heart failure have evolved, but their purpose is to improve symptoms and prevent aggravation of the disease. Current research is focusing on the development of cell-based therapies using different sources of stem cells which can provide trophic and paracrine support or even replace dying cells with new ones. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. These cells are known for their ability to secrete paracrine factors and their immunosuppressive properties. The MESAMI 2 study will evaluate the efficacy of MSCs injection directly into the heart to repair and restore heart function in people with chronic ischemic heart failure using NOGA-XP system. This phase 2 study is a prospective, multicenter, double-blind, randomized, placebo-controlled trial. A total of 90 patients will be randomized in 2 arms to receive intramyocardial injection of MSCs or placebo. Patients will be followed up for 13 months. Bone marrow will be collected and immediately transported to the French Blood Establishment for MSC isolation and expansion. Patients will receive intramyocardial injection of MSCs or placebo during a left heart catheterization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
After bone-marrow aspiration by an authorized person, MSCs were isolated and cultured during 17±2 days by the French Blood Establishment. Then, patients receive intramyocardial injections of MSCs using the electromechanical NOGA-XP system.
injections of human albumin
University hospital of Henri Mondor
Créteil, France
University hospital of Grenoble
Grenoble, France
University hospital of Lille
Lille, France
University hospital of Nantes
Nantes, France
University hospital of Pitié-Salpêtrière
Paris, France
Cardiology Department of Rangueil Hospital - Rangueil Hospital
Toulouse, France
Change in VO2max
Change in VO2max (or peak VO2) before injection and at 3 months post injection.
Time frame: 3 months
Left ventricular viability
MRI
Time frame: Before injection and at 3, 6 and 12 months
NYHA/CCS class
Change on class
Time frame: Before injection and at 3, 6 and 12 months
Quality of life (Minnesota questionnaire)
Change on quality of life test score
Time frame: Before injection and at 3, 6 and 12 months
VO2 max
Change in VO2max (or peak VO2) at 6 and 12 months post injection.
Time frame: At 6 and 12 months
6'walking-test
Distance to walk test
Time frame: Between 3 and 12 months
Echocardiography
Volume of myocardium and measurement of ejection fraction
Time frame: Before injection and at 3, 6 and 12 months
Myocardial perfusion imaging
Efficacy of the cell therapy on LVEF
Time frame: Before injection and at 3, 6 and 12 months
BNP blood test
Change of the BNP blood test at 3, 6 and 12 months
Time frame: Before injection and at 3, 6 and 12 months
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