Evidence map›Paper›PMID 25403163›Full record

ArticleCirculation research2015

Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial.

Shuta Ishigami, Shinichi Ohtsuki, Suguru Tarui, Daiki Ousaka, Takahiro Eitoku, Maiko Kondo, Michihiro Okuyama, Junko Kobayashi, Kenji Baba, Sadahiko Arai and 9 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IControlled Clinical Trial
PubMed Publisher
In one paragraph

Article in Circulation research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 100 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 2% of its field
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
NCT02781922 phase3recruitingnot on this mapstarted 2016, after this paper: background citation

Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study

TypeinterventionalSponsorMetcela Inc.Ran2016 to 2028Enrolled40ConditionsHypoplastic Left Heart Syndrome, Single VentricleArmsAutologous cardiac stem cells (JRM-001)
NCT03129568 phase1completednot on this mapstarted 2017, after this paper: background citation

A Prospective Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy

TypeinterventionalSponsorOkayama UniversityRan2017 to 2020Enrolled5ConditionsDilated CardiomyopathyArmsCDC infusion
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 1 synthesis or guideline pooled it, 179 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. CD34Stem cells translational medicine · 2018
    Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Trial offers hope to children with hypoplastic left heart syndrome.Molecular therapy : the journal of the American Society of Gene Therapy · 2024
    Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Intravenous infusion of cardiac progenitor cells in animal models of single ventricular physiology.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2023
    Article
  20. Article

40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 2 countries.

Shuta IshigamiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Shinichi OhtsukiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Suguru TaruiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Daiki OusakaFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Takahiro EitokuFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Maiko KondoFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Michihiro OkuyamaFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Junko KobayashiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Kenji BabaFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Sadahiko AraiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Takuya KawabataFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Ko YoshizumiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Atsushi TateishiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Yosuke KurokoFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Tatsuo IwasakiFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Shuhei SatoFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Shingo KasaharaFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Shunji SanoFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan.
Hidemasa OhFrom the Departments of Cardiovascular Surgery (S.I., S.T., D.O., M.O., J.K., S.A., T.K., K.Y., A.T., Y.K., S.K., S.S.), Pediatrics (S.O., T.E., M.K., K.B.), Anesthesiology and Resuscitology (T.I.), and Radiology (S.S.), Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan; and Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital (H.O.), Okayama, Japan. hidemasa@md.okayama-u.ac.jp.
Okayama University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleHypoplastic left heart syndrome (HLHS) remains a lethal congenital cardiac defect. Recent studies have suggested that intracoronary administration of autologous cardiosphere-derived cells (CDCs) may improve ventricular function.

objectiveThe aim of this study was to test whether intracoronary delivery of CDCs is feasible and safe in patients with hypoplastic left heart syndrome. METHODS AND

resultsBetween January 5, 2011, and January 16, 2012, 14 patients (1.8±1.5 years) were prospectively assigned to receive intracoronary infusion of autologous CDCs 33.4±8.1 days after staged procedures (n=7), followed by 7 controls with standard palliation alone. The primary end point was to assess the safety, and the secondary end point included the preliminary efficacy to verify the right ventricular ejection fraction improvements between baseline and 3 months. Manufacturing and intracoronary delivery of CDCs were feasible, and no serious adverse events were reported within the 18-month follow-up. Patients treated with CDCs showed right ventricular ejection fraction improvement from baseline to 3-month follow-up (46.9%±4.6% to 52.1%±2.4%; P=0.008). Compared with controls at 18 months, cardiac MRI analysis of CDC-treated patients showed a higher right ventricular ejection fraction (31.5%±6.8% versus 40.4%±7.6%; P=0.049), improved somatic growth (P=0.0005), reduced heart failure status (P=0.003), and lower incidence of coil occlusion for collaterals (P=0.007).

conclusionsIntracoronary infusion of autologous CDCs seems to be feasible and safe in children with hypoplastic left heart syndrome after staged surgery. Large phase 2 trials are warranted to examine the potential effects of cardiac function improvements and the long-term benefits of clinical outcomes. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01273857.

Indexed as

Stroke VolumeVentricular Function, RightChild, PreschoolEchocardiography, DopplerFeasibility StudiesFemaleHeart FailureHumansHypoplastic Left Heart SyndromeInfantInfant, NewbornJapanMagnetic Resonance ImagingMaleMyocytes, CardiacPalliative Carecell therapycongenital heart diseasehypoplastic left heart syndromestem cells

Identifiers

PMID25403163
OpenAlexW2064800079

What OpenQuestion holds

Textmetadata
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.