@article{453219dea31c452482c3e2babe6d2c8f,
title = "Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial",
abstract = "Background Most cell therapy trials failed to show an improvement in global left ventricular (LV) function measures after myocardial infarction (MI). Myocardial segments are heterogeneously impacted by MI. Global LV function indices are not able to detect the small treatment effects on segmental myocardial function which may have prognostic implications for cardiac events. We aimed to test the efficacy of allogeneic cardiosphere-derived cells (CDCs) for improving regional myocardial function and contractility. Methods In this exploratory analysis of a randomised clinical trial, 142 patients with post-MI with LVEF <45% and 15% or greater LV scar size were randomised in 2:1 ratio to receive intracoronary infusion of allogenic CDCs or placebo, respectively. Change in segmental myocardial circumferential strain (Ecc) by MRI from baseline to 6 months was compared between CDCs and placebo groups. Results In total, 124 patients completed the 6-month follow-up (mean (SD) age 54.3 (10.8) and 108 (87.1%) men). Segmental Ecc improvement was significantly greater in patients receiving CDC (-0.5% (4.0)) compared with placebo (0.2% (3.7), p=0.05). The greatest benefit for improvement in segmental Ecc was observed in segments containing scar tissue (change in segmental Ecc of -0.7% (3.5) in patients receiving CDC vs 0.04% (3.7) in the placebo group, p=0.04). Conclusions In patients with post-MI LV dysfunction, CDC administration resulted in improved segmental myocardial function. Our findings highlight the importance of segmental myocardial function indices as an endpoint in future clinical trials of patients with post-MI. Trial registration number NCT01458405. ",
keywords = "MRI, coronary artery disease, epidemiology",
author = "Ostovaneh, {Mohammad R.} and Makkar, {Raj R.} and Bharath Ambale-Venkatesh and Deborah Ascheim and Tarun Chakravarty and Henry, {Timothy D.} and Glen Kowalchuk and Aguirre, {Frank V.} and Kereiakes, {Dean J.} and Povsic, {Thomas J.} and Richard Schatz and Traverse, {Jay H.} and Janice Pogoda and Smith, {Rachel D.} and Linda Marb{\'a}n and Eduardo Marb{\'a}n and Lima, {Joao A.C.}",
note = "Funding Information: 1Division of Cardiology, Johns Hopkins University, Baltimore, Maryland, USA 2Department of Medicine, Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, USA 3Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angles, California, USA 4Capricor Therapeutics Inc, Los Angles, California, USA 5The Christ Hospital Health Network, Cincinnati, Ohio, USA 6Sanger Heart and Vascular Institute, Charlotte, North Carolina, USA 7Prairie Heart Institute, Springfield, Illinois, USA 8Duke Clinical Research Institute and Duke Medicine, Durham, North Carolina, USA 9Scripps Clinic, La Jolla, California, USA 10Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA 11Cipher Biostatistics and Reporting, Reno, Nevada, USA Contributors MRO, RRM, BA-V, DA, LM, EM and JACL participated in conception, design and interpretation of the data. MRO drafted the initial manuscript and all other authors contributed to revising it and have given final approval of the version to be submitted. MRO and JP were responsible for statistical analysis of the manuscript. TC, TDH, GK, FVA, DJK, TJP, RS, JHT, RDS, LM, EM, JACL contributed to data collection and quality control of the study. Funding This work was supported by the California Institute of Regenerative Medicine and Capricor Therapeutics. Competing interests DA, RDS and LM are employed at Capricor therapeutics. RDS, LM and EM hold stocks at Capricor therapeutics. EM is the founder of Capricor therapeutics. TDH is advisory board member at Capricor therapeutics. The remaining authors have no disclosures. Patient consent for publication Not required. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2021",
month = jul,
day = "7",
doi = "10.1136/openhrt-2021-001614",
language = "English (US)",
volume = "8",
journal = "Open Heart",
issn = "2053-3624",
publisher = "BMJ Publishing Group",
number = "2",
}