Evidence map›Paper›PMID 39526355›Full record

ArticleJournal of the American Heart Association2024

Eight-Year Outcomes of Cardiosphere-Derived Cells in Single Ventricle Congenital Heart Disease.

Kenta Hirai, Ryusuke Sawada, Tomohiro Hayashi, Toru Araki, Naomi Nakagawa, Maiko Kondo, Kenji Yasuda, Takuya Hirata, Tomoyuki Sato, Yuki Nakatsuka and 5 more

2 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in Journal of the American Heart Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT01273857 phase1completednot on this map

Phase I Study of Cardiac Progenitor Cell Therapy in Patients With Single Ventricle Physiology

TypeinterventionalSponsorOkayama UniversityRan2011 to 2013Enrolled14ConditionsHypoplastic Left Heart Syndrome, Single Ventricle, Heart FailureArmsAutologous cardiac progenitor cell transplantation, staged shunt procedure
NCT01829750 phase2completednot on this map

Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease

TypeinterventionalSponsorOkayama UniversityRan2013 to 2016Enrolled34ConditionsHypoplastic Left Heart Syndrome, Single Right Ventricle, Single Left VentricleArmsCardiac progenitor cell infusion
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

15 authors.

Kenta HiraiDepartment of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan.ORCID 0000-0003-0299-7791
Ryusuke SawadaDepartment of Pharmacology Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan.ORCID 0009-0002-5355-1204
Tomohiro HayashiDepartment of Pediatrics Kurashiki Central Hospital Okayama Japan.
Toru ArakiDepartment of Pediatrics National Hospital Organization Fukuyama Medical Center Hiroshima Japan.
Naomi NakagawaDepartment of Pediatric Cardiology Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan.ORCID 0000-0002-6357-7582
Maiko KondoDepartment of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan.
Kenji YasudaDepartment of Pediatrics Shimane University Faculty of Medicine Izumo Shimane Japan.ORCID 0000-0001-8379-769X
Takuya HirataDepartment of Pediatrics Kyoto University Graduate School of Medicine Kyoto Japan.ORCID 0009-0004-8857-9607
Tomoyuki SatoDepartment of Pediatrics Jichi Medical University Tochigi Japan.
Yuki NakatsukaDepartment of Data Science, Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan.ORCID 0009-0007-2054-7483
Michihiro YoshidaDepartment of Data Science, Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan.ORCID 0000-0002-9463-9424
Shingo KasaharaDepartment of Cardiovascular Surgery Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan.ORCID 0000-0002-3698-4836
Kenji BabaDepartment of Pediatrics Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama Japan.ORCID 0000-0002-2716-5185
Hidemasa OhDepartment of Regenerative Medicine, Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan.ORCID 0000-0002-9643-6073
TICAP/PERSEUS Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiosphere-derived cell (CDC) infusion was associated with better clinical outcomes at 2 years in patients with single ventricle heart disease. The current study investigates time-to-event outcomes at 8 years. METHODS AND

resultsThis cohort enrolled patients with single ventricles who underwent stage 2 or stage 3 palliation from January 2011 to January 2015 at 8 centers in Japan. The primary outcomes were time-dependent CDC treatment effects on death and late complications during 8 years of follow-up, assessed by restricted mean survival time. Among 93 patients enrolled (mean age, 2.3±1.3 years; 56% men), 40 received CDC infusion. Overall survival for CDC-treated versus control patients did not differ at 8 years (hazard ratio [HR], 0.60 [95% CI, 0.21-1.77];

conclusionsBy 8 years, CDC infusion was associated with lower hazards of late failure and adverse events in single ventricle heart disease. CDC treatment effect on survival was notable by 4 years and showed a durable clinical benefit in patients with heart failure with reduced ejection fraction over 8 years. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01273857 and NCT01829750.

Indexed as

Heart VentriclesChildChild, PreschoolFemaleHeart Defects, CongenitalHeart FailureHumansInfantJapanMalePalliative CareStem Cell TransplantationStroke VolumeTime FactorsTreatment OutcomeUniventricular Heartcardiosphereheart failurerestricted mean survival timesingle ventriclesurvival

Identifiers

PMID39526355
PMCPMC11681388

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.