The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Allogeneic Cardiosphere-derived Cells for the Treatment of Heart Failure with Reduced Ejection Fraction: Results of the Dilated cardiomYopathy iNtervention with Allogeneic Myocardially-regeneratIve Cells (DYNAMIC) trial

DOI: 10.4244/EIJ-D-19-00035

1. Cedars-Sinai Medical Center, United States
2. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, 90048 USA
3. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, 90048 USA
4. Johns Hopkins University, Baltimore MD 21205 USA
5. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, 90048 USA
6. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, 90048 USA
7. Capricor Therapeutics, Los Angeles, California 90211 USA
8. Capricor Therapeutics, Los Angeles, California 90211 USA
9. University of Athens, Athens, Greece
10. Capricor Therapeutics, Los Angeles, California 90211 USA
11. Capricor Therapeutics, Los Angeles, California 90211 USA
12. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, 90048 USA
13. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, 90048 USA, United States
Disclaimer:

As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention - has been published immediately upon acceptance as it was received. The content of this article is the sole responsibility of the authors, and not that of the journal or its publishers.

To read the full content of this article, please log in to download the PDF.

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). 

Methods and results: We enrolled 14 patients with EF≤35% and NYHA III-IV despite maximal medical- and device-based therapy in this single-center, open-label trial. Intracoronary catheterization delivered four escalating doses (totaling 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 9- 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, p=0.03) at 6 months. Quality of life (QoL) scores and NYHA class (p=0.006) improved at 6 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 randomized trials.

Sign in to read and download the full article

Forgot your password?
No account yet? Sign up for free!
Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Read next article

Quantitative aortography assessment of aortic regurgitation. Insight into a novel technique