Abstract 12345: Intramyocardial Transplantation of Mesenchymal Stromal Cells for Chronic Myocardial Ischemia and Decreased Left Ventricular Function: Results of the MESAMI Phase I Clinical Trial
Background: There are evidences that intramyocardial injections of autologous mesenchymal stromal cells (MSC) are a promising approach to treat ischemic cardiomyopathy. Our aim was to investigate the safety and feasibility of transendocardial injections guided by 3-dimensional NogaStar XP mapping of autologous bone marrow-derived MSC in patients with chronic myocardial ischemia and left ventricular dysfunction.
Methods and Results: The MESAMI 1 trial is a 2-centers phase 1 study, including 10 patients with chronic myocardial ischemia (mean age 57.2±5.8 years; 9 men). The inclusion criteria were: NYHA Class II-IV and/or angina pectoris CCS Class III or IV, chronic ischemic cardiomyopathy with LVEF ≤ 35%, optimal medical and revascularization therapies, and reversible perfusion defect by SPECT. Bone marrow was obtained by aspiration from the iliac crest and MSC were expanded in culture for 17 days. Transendocardial injections (n=14-16) of autologous bone marrow MSC were made into viable muscle in border zones of left ventricular scar. Bone marrow volume was 16.8±2.0 ml, and patients received 61.5*106 MSC. After 1-month follow-up (FU), the primary end-point of safety and feasibility was met since all patients tolerated the procedure with no-adverse events due to the procedure and the cell therapy product. Secondary endpoints between baseline and 3-month follow-up showed that the summed stress score measured by SPECT decreased significantly from 34.1±8 to 25.3±9.5 (p=0.02) and the echocardiographic LVEF improved of about 6% from 31.6±7.7% to 37.4±8% (p=0.16). Others parameters including NYHA, 6 minute walk test, VO2 peak, and Quality of life showed a trend toward improvement at 3 months FU compared to baseline.
Conclusions: This pilot study demonstrated the safety and the feasibility of intramyocardial autologous bone marrow-derived MSC delivered by NogaStar XP system catheter in patients with chronic myocardial ischemia and decreased LVEF. A randomized, double blind, multicenter, placebo-controlled clinical trial (MESAMI 2) will start in the last quarter of 2013 to evaluate the efficiency of this procedure.
Clinical Trial Registration: Unique identifier: NCT01076920
- Stem cell therapy
- Ischemic heart disease
- Interventional cardiology
- Heart failure
- Regenerative medicine stem cells
- © 2013 by American Heart Association, Inc.