Evidence map›Paper›PMID 40418635›Full record

Observational studyStem cells translational medicine2025

Long term event-free survival following cell-based therapy in patients with cardiomyopathy: the HYPERION observational cohort.

Russell G Saltzman, Andrew Sundin, Lina V Caceres, Jairo A Tovar, Ana Maria Garzon, Maria A Cabreja, Hossein Shayestehyekta, Jeanette Soto, Dushyantha Jayaweera, Aisha Khan and 3 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Stem cells translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03071835 (A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit.), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT03071835 completednot on this map

A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)

TypeobservationalSponsorUniversity of MiamiRan2016 to 2023Enrolled47ConditionsCardiomyopathies, Heart Diseases, Aging Frailty
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Russell G SaltzmanLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.ORCID 0000-0003-0494-3869
Andrew SundinLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Lina V CaceresLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Jairo A TovarLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Ana Maria GarzonLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Maria A CabrejaLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Hossein ShayestehyektaLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Jeanette SotoLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Dushyantha JayaweeraLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Aisha KhanLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Ivonne H SchulmanLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Raul D MitraniLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.
Joshua M HareLeonard M. Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL 33136, United States.ORCID 0000-0002-7751-5032

Funding

NIH HHS 1R01 HL107110NIH HHS 1R01 HL134558NIH HHS 1R01 HL137355NIH HHS 5R01 CA136387NIH HHS 5UM1 HL113460
6 · The paper itself

Abstract

introductionThere is limited long-term clinical outcome data supporting the use of cell-based therapy to treat heart failure. The HYPERION study (NCT03071835) followed long-term outcomes of patients with ischemic cardiomyopathy (ICM) and non-ischemic cardiomyopathy (NIDCM) who received mesenchymal stromal cells (MSC). We hypothesized that improved cardiac parameters predict longer event-free survival.

methodsWe performed a Kaplan-Meier analysis to examine event-free survival as the primary outcome. Time-to-event information was captured from all eligible participants. Endpoint events were defined as death (all-cause), Left Ventricular Assist Device (LVAD) placement, or Heart Transplant. Subjects were categorized based on increase in Left Ventricular Ejection Fraction (LVEF) or decrease in Left Ventricular End Diastolic Volume (LVEDV) for comparisons within disease etiologies.

resultsThere were 134 men and 21 women, with mean age 60.0 ± 11.0 years. There were 121 (78%) with ICM and 34 (22%) with NIDCM. By the end of long-term follow-up (~13 years), 38 (24.5%) subjects had deceased, 5 (3.2%) received LVAD, and 8 (5.2%) underwent heart transplantation. Post-therapy increase of ≥5% LVEF was associated with longer event-free survival in NIDCM (HR:0.31; 95%CI, 0.11,0.86; P = .025), but not ICM (HR:1.14; 95%CI, 0.47,2.72; P = .776). Conversely, reduction in left ventricular end-diastolic volume (LVEDV) was associated with longer event-free survival in ICM (HR:0.16; 95%CI, 0.05, 0.55; P = .008) but not NIDCM (HR:0.35; 95%CI, 0.1,1.2; P = .098). ICM improvers had LVEDV of 225.7 ± 95.9 mL at baseline and 209.0 ± 100.6 mL by year 5 (P = .046). NIDCM improvers had LVEF of 27.2 ± 8.9% at baseline and 36.1 ± 11.6% by year 5 (P = .018).

conclusionIn this long-term observational cohort analysis, improvement of LVEF and/or reduction in LVEDV was associated with survival benefits among subjects with NIDCM and ICM, respectively. In both etiologies the respective improvements are sustained for up to 5 years, providing evidence that cell-based therapy may be a promising and durable treatment option for patients with heart failure.

Indexed as

CardiomyopathiesCell- and Tissue-Based TherapyMesenchymal Stem Cell TransplantationAgedCohort StudiesDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMaleMiddle AgedHeart failureischemic cardiomyopathymesenchymal stem cellsnon-ischemic dilated cardiomyopathyregenerative medicinesurvival analysis

Identifiers

PMID40418635
PMCPMC12105610

What Socratic holds

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LicenceCC BY-NC
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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.