Interventions for valvular disease and heart failure

Allogeneic cardiosphere-derived cells for the treatment of heart failure with reduced ejection fraction: the Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC) trial

EuroIntervention 2020;16:e293-e300. DOI: 10.4244/EIJ-D-19-00035

Tarun Chakravarty
Tarun Chakravarty1, MD; Timothy D. Henry1, MD; Michelle Kittleson1, MD, PhD; Joao Lima2, MD; Robert J. Siegel1, MD; Leandro Slipczuk1, MD, PhD; Janice M. Pogoda3, PhD; Rachel R. Smith3, MD; Konstantinos Malliaras4, MD; Linda Marbán3, PhD; Deborah D. Ascheim3, MD; Eduardo Marbán1, MD, PhD; Raj R. Makkar1, MD
1. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; 2. Johns Hopkins University, Baltimore, MD, USA; 3. Capricor Therapeutics, Los Angeles, CA, USA; 4. University of Athens, Athens, Greece

Aims: The DYNAMIC trial assessed the safety and explored the efficacy of multivessel intracoronary infusion of allogeneic cardiosphere-derived cells (CDCs) in patients with heart failure and reduced ejection fraction (HFrEF). Here we report the results of the DYNAMIC trial.

Methods and results: We enrolled 14 patients with EF ≤35% and NYHA Class III-IV despite maximal medical and device-based therapy in this single-centre, open-label trial. Intracoronary catheterisation delivered four escalating doses (totalling 37.5-75 million cells) by sequential non-occlusive technique to all three major coronary arteries. The primary safety endpoint was a composite of post-infusion TIMI flow, ventricular tachycardia/fibrillation, sudden death, major adverse cardiac events or acute myocarditis within 72 hours. Twelve patients were male and EF averaged 23.0% (±4.5%). No primary safety endpoints were observed. Two patients died of HFrEF progression nine and 12 months following infusion. Compared to baseline, there was an improvement in EF (26.8% vs 22.9%, p=0.023) and left ventricular end-systolic volume (139.5 vs 177.8 cm3, p=0.03) at six months. Quality of life (QoL) scores and NYHA class (p=0.006) improved at six months. At 12 months, the improvement in EF and QoL remained significant.

Conclusions: Global intracoronary infusion of allogeneic CDCs is safe and feasible. The efficacy of allogeneic CDCs in HFrEF needs to be tested in larger randomised trials.

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Cell-based regenerative therapydepressed left ventricular functiondilated non-ischaemic cardiomyopathyischaemic cardiomyopathy
Interventions for heart failureChronic heart failure
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