Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial
Résumé
Background: The MESAMI 1 trial was a bicentric pilot study designed to test the feasibility and
safety of intramyocardially injected autologous bone marrow-derived mesenchymal stromal cells
(MSCs) for the treatment of ischemic cardiomyopathy.
Methods and Results: The study included 10 patients with chronic myocardial ischemia, left
ventricular (LV) ejection fractions (EFs) of ≤35%, and reversible perfusion defects who were on stable
optimal medical therapy and were not candidates for revascularization. MSCs (mean: 61.5×106 cells
per patient) were injected into 10-16 viable sites at the border of the LV scar via a NOGA-guided
catheter. Both primary endpoints, feasibility (successful harvest, expansion, and injection of
autologous MSCs) and safety (absence of severe adverse events [SAEs]) were met in all 10 patients at
the 1-month follow-up time point, and none of the SAEs reported during the full 2-year follow-up
period were attributable to the study intervention. The results of secondary efficacy endpoint analyses
identified significant improvements from baseline to Month 12 in LVEF (29.4±2.0% versus
35.7±2.5%; p=0.003), LV end-systolic volume (167.8±18.8 mL versus 156.1±28.6 mL; p=0.04), 6-
minute walk test and NYHA functional class.
Conclusions: Our results suggest that autologous MSCs can be safely administered to the hearts of
patients with severe, chronic, reversible myocardial ischemia and impaired cardiac function and may
be associated with improvements in cardiac performance, LV remodeling, and patient functional
status. A randomized, double blind, multicenter, placebo-controlled clinical trial (MESAMI 2) will
evaluate the efficacy of this treatment approach in a larger patient population.
Clinical Trial Registration: Unique identifier: NCT01076920
Domaines
Biologie cellulaire
Origine : Fichiers produits par l'(les) auteur(s)
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