Abstract 18236: Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC): Six Month Safety and Exploratory Efficacy Results
Background: In the CADUCEUS trial, autologous cardiosphere-derived cells (CDCs) decreased infarct size and increased viable tissue in post-MI subjects. In ALLSTAR Phase I, allogeneic CDCs (CAP-1002) were safe and well-tolerated. The DYNAMIC trial is an open-label dose escalating safety trial of multi-vessel intra-coronary CAP 1002 in subjects with dilated cardiomyopathy.
Methods & Results: Subjects were matched with CAP-1002 cell lines to which they had no donor specific antibodies by single antigen bead testing. Fourteen subjects (mean age 60.6 yr; range 32-76 years) with NHYA Class III symptoms and echo EF ≤35% (Screening Cardiac CT: mean 26.9%; range 16-34%) due to ischemic (n=7) or non-ischemic cause (n=7) were prospectively enrolled. Four escalating total CAP-1002 doses from 37.5M to 75M were infused via a sequential non-occlusive intracoronary catheter technique, divided among the 3 major coronary arteries (LAD, RCA and circumflex). Post-procedural cardiac enzymes (troponin and CKMB) were measured, with no clinically-significant increases observed in the 24 hr post-infusion. No pre-specified primary safety endpoints occurred; (post infusion reduction of TIMI flow for > 3 minutes, VT/VF, sudden death, major adverse cardiac (MACE) events within 72 hours of infusion, or acute myocarditis within 1 month). Further safety data and exploratory efficacy endpoints include BNP, 6 minute walk and VO2max as well as EF and volumes measured by both echo and cardiac CT at 6 and 12 months.
Conclusion: Multi-vessel non-occlusive intracoronary infusion of CAP 1002 in subjects with dilated cardiomyopathy appears to be safe. Six month safety endpoint and adverse event data, as well as exploratory efficacy measures, will be available for presentation November 2015.
Author Disclosures: T. Chakravarty: None. R.R. Makkar: Research Grant; Modest; Edwards Lifesciences, St Jude Medical, Medtronic Inc, Direct Flow Medical, Boston Scientific. Consultant/Advisory Board; Modest; Edwards Lifesciences. M. Kittleson: None. J. Friedman: None. D.S. Berman: None. R. George: None. R. Siegel: None. L. Slipczuk: None. A. Hamer: Employment; Significant; Capricor Therapeutics. R.R. Smith: Employment; Significant; Capricor Therapeutics. S. Smith: Employment; Significant; Capricor Therapeutics. K. Kacena: None. L. Marbán: Employment; Significant; Capricor Therapeutics. Ownership Interest; Significant; Capricor Therapeutics. T.D. Henry: None. E. Marbán: Ownership Interest; Significant; Capricor Therapeutics.
- © 2015 by American Heart Association, Inc.