Evidence map›Paper›PMID 34233913›Full record

Trial reportOpen heart2021

Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial.

Mohammad R Ostovaneh, Raj R Makkar, Bharath Ambale-Venkatesh, Deborah Ascheim, Tarun Chakravarty, Timothy D Henry, Glen Kowalchuk, Frank V Aguirre, Dean J Kereiakes, Thomas J Povsic and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Open heart, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01458405 (Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With a Myocardial Infarction and Ischemic Left Ventricular Dysfunction), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01458405 phase1 / phase2terminatednot on this map

Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With a Myocardial Infarction and Ischemic Left Ventricular Dysfunction

TypeinterventionalSponsorCapricor Inc.Ran2012 to 2019Enrolled135ConditionsMyocardial InfarctionArmsCAP-1002 Allogeneic Cardiosphere-Derived Cells, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Mohammad R OstovanehDivision of Cardiology, Johns Hopkins University, Baltimore, Maryland, USA.
Raj R MakkarSmidt Heart Institute, Cedars-Sinai Medical Center, Los Angles, California, USA.
Bharath Ambale-VenkateshDivision of Cardiology, Johns Hopkins University, Baltimore, Maryland, USA.
Deborah AscheimCapricor Therapeutics Inc, Los Angles, California, USA.
Tarun ChakravartySmidt Heart Institute, Cedars-Sinai Medical Center, Los Angles, California, USA.
Timothy D HenryThe Christ Hospital Health Network, Cincinnati, Ohio, USA.
Glen KowalchukSanger Heart and Vascular Institute, Charlotte, North Carolina, USA.ORCID 0000-0002-1119-8206
Frank V AguirrePrairie Heart Institute, Springfield, Illinois, USA.
Dean J KereiakesThe Christ Hospital Health Network, Cincinnati, Ohio, USA.
Thomas J PovsicDuke Clinical Research Institute and Duke Medicine, Durham, North Carolina, USA.
Richard SchatzScripps Clinic, La Jolla, California, USA.
Jay H TraverseMinneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.
Janice PogodaCipher Biostatistics and Reporting, Reno, Nevada, USA.
Rachel D SmithCapricor Therapeutics Inc, Los Angles, California, USA.
Linda MarbánCapricor Therapeutics Inc, Los Angles, California, USA.
Eduardo MarbánSmidt Heart Institute, Cedars-Sinai Medical Center, Los Angles, California, USA.
Joao A C LimaDivision of Cardiology, Johns Hopkins University, Baltimore, Maryland, USA jlima@jhmi.edu.ORCID 0000-0001-8756-6995

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost 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.

methodsIn 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.

resultsIn 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).

conclusionsIn 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.

Indexed as

FemaleFollow-Up StudiesHumansMagnetic Resonance Imaging, CineMaleMiddle AgedMyocardial InfarctionMyocardiumMyocytes, CardiacRetrospective StudiesStem Cell TransplantationStroke VolumeTransplantation, AutologousVentricular Dysfunction, LeftVentricular Function, Leftcoronary artery diseaseepidemiologyMRI

Identifiers

PMID34233913
PMCPMC8264869

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.