Browsing by Author "Simari, Robert"

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    Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial
    (Elsevier, 2018) Bolli, Roberto; Hare, Joshua M.; Henry, Timothy D.; Lenneman, Carrie G.; March, Keith; Miller, Kathy; Pepine, Carl J.; Perin, Emerson C.; Traverse, Jay H.; Willerson, James T.; Yang, Phillip C.; Gee, Adrian P.; Lima, João A.; Moyé, Lem; Vojvodic, Rachel W.; Sayre, Shelly L.; Bettencourt, Judy; Cohen, Michelle; Ebert, Ray F.; Simari, Robert; Medicine, School of Medicine
    Objectives SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC). Background AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium. Methods The study population is 36 cancer survivors with a diagnosis of AIC, left ventricular (LV) ejection fraction ≤40%, and symptoms of heart failure (NYHA class II-III) on optimally-tolerated medical therapy. Subjects must be clinically free of cancer for at least two years with a ≤ 30% estimated five-year risk of recurrence. The first six subjects participated in an open-label, lead-in phase and received 100 million allo-MSCs; the remaining 30 will be randomized 1:1 to receive allo-MSCs or vehicle via 20 transendocardial injections. Efficacy measures (obtained at baseline, 6 months, and 12 months) include MRI evaluation of LV function, LV volumes, fibrosis, and scar burden; assessment of exercise tolerance (six-minute walk test) and quality of life (Minnesota Living with Heart Failure Questionnaire); clinical outcomes (MACE and cumulative days alive and out of hospital); and biomarkers of heart failure (NT-proBNP). Conclusions This is the first clinical trial using direct cardiac injection of cells for the treatment of AIC. If administration of allo-MSCs is found feasible and safe, SENECA will pave the way for larger phase II/III studies with therapeutic efficacy as the primary outcome.