Evidence map›Paper›PMID 35523485›Full record

ArticleBMJ open2022

Epicardial injection of allogeneic human-induced-pluripotent stem cell-derived cardiomyocytes in patients with advanced heart failure: protocol for a phase I/IIa dose-escalation clinical trial.

He Zhang, Yunxing Xue, Tuo Pan, Xiyu Zhu, Hoshun Chong, Can Xu, Fudong Fan, Hailong Cao, Bomin Zhang, Jun Pan and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03763136 (Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 7% 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.

NCT03763136 phase1 / phase2completednot on this map

Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure

TypeinterventionalSponsorHELP Therapeutics Co., Ltd.Ran2021 to 2024Enrolled20ConditionsHeart FailureArmshPSC-CM Therapy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Biologics for cardiovascular diseases: from bench to bedside.Signal transduction and targeted therapy · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Role of Cx43 in iPSC-CM Damage Induced by Microwave Radiation.International journal of molecular sciences · 2023
    Article
  17. Review
  18. Review
  19. Advances in 3D Organoid Models for Stem Cell-Based Cardiac Regeneration.International journal of molecular sciences · 2023
    Review
  20. 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

14 authors at 2 institutions in 1 country.

He ZhangDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Yunxing XueDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Tuo PanDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Xiyu ZhuDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Hoshun ChongDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Can XuDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Fudong FanDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Hailong CaoDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Bomin ZhangDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Jun PanDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Qing ZhouDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China.
Gang YangHELP Therapeutics, Nanjing, Jiangsu, China.
Jiaxian WangHELP Therapeutics, Nanjing, Jiangsu, China dongjin_wang@126.com wangjx@helptx.com.cn.
Dong-Jin WangDepartment of Cardiothoracic Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China dongjin_wang@126.com wangjx@helptx.com.cn.ORCID 0000-0001-6499-1972
Nanjing Drum Tower Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHeart failure (HF) is a growing global public health burden. However, due to the very limited regenerative capacity of mature cardiomyocytes in the adult mammalian heart, conventional treatments can only improve the symptoms of HF but fail to restore cardiac function. Heart transplantation is limited by a severe shortage of donors. Cell-based transplantation for the treatment of HF has become a promising strategy. Human-induced-pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) have been tested in animal models to assess safety and efficacy. This study aims at evaluating the safety and efficacy of epicardial injection of hiPSC-CMs in patients with advanced HF during coronary artery bypass grafting (CABG) surgery.

methodsThis study is a dose-escalation, placebo-controlled, single-centre phase I/IIa clinical trial. Dose escalation will be guided by a modified 3+3 design for three doses (1×10 ETHICS AND DISSEMINATION: The study protocol has been approved by the Institutional Ethical Committee of Nanjing Drum Tower Hospital (No. SC202000102) and approved by National Health Commission of the PRC (MR-32-21-014649). Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. TRIAL REGISTRATION NUMBER: NCT03763136.

Indexed as

Heart FailureHematopoietic Stem Cell TransplantationInduced Pluripotent Stem CellsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicCoronary Artery BypassHumansMyocytes, CardiacRandomized Controlled Trials as TopicCoronary heart diseaseHeart failureSURGERY

Identifiers

PMID35523485
PMCPMC9083430
OpenAlexW4229069980

What OpenQuestion 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 OpenQuestion graph.