Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy (MESAMI2)
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.