Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy (MESAMI2)
Condition: Chronic Myocardial Ischemia
MeSH terms: Cardiomyopathies; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Autologous MSC from bone marrow; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): mesenchymal stem cells; Human Albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells; ischemic cardiomyopathy; NogaStar XP system catheter