Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial AMERICAN HEART JOURNAL Bolli, R., Hare, J. M., Henry, T. D., Lenneman, C. G., March, K. L., Miller, K., Pepine, C. J., Perin, E. C., Traverse, J. H., Willerson, J. T., Yang, P. C., Gee, A. P., Lima, J. A., Moye, L., Vojvodic, R. W., Sayre, S. L., Bettencourt, J., Cohen, M., Ebert, R. F., Simari, R. D., Cardiovasc Cell Therapy Res 2018; 201: 54–62

Abstract

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).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.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).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.

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