Evidence map›Paper›PMID 40036154›Full record

ArticleeLife2025

Autologous P63+ lung progenitor cell transplantation in idiopathic pulmonary fibrosis: a phase 1 clinical trial.

Shiyu Zhang, Min Zhou, Chi Shao, Yu Zhao, Mingzhe Liu, Lei Ni, Zhiyao Bao, Qiurui Zhang, Ting Zhang, Qun Luo and 3 more

Erratum issuedAbstract readClinical Trial, Phase I
In one paragraph

Article in eLife, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Separation of Human P63Analytical chemistry · 2026
    Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Shiyu Zhang *Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Min Zhou *Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Chi Shao *Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Yu Zhao *Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Mingzhe LiuShanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Lei NiDepartment of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Zhiyao BaoDepartment of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Qiurui ZhangDepartment of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ting ZhangSuper Organ R&D Center, Regend Therapeutics, Shanghai, China.
Qun LuoDepartment of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Jieming QuDepartment of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Zuojun XuDepartment of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Wei ZuoShanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.ORCID https://orcid.org/0000-0002-4460-0337

Funding

Jiangsu Province Science and Technology Special Project (Key Research and Development Plan for Social Development) Funding BE2023727National Biopharmaceutical Technology Research Project Funding NCTIB2023XB01011National High Level Hospital Clinical Research Funding 2022-PUMCH-B-108National Key Research and Development Plan 2024YFA1108500National Key Research and Development Plan 2024YFA1108900Non-profit Central Research institute Fund of Chinese Academy of Medical Science 2020-PT320-005
6 · The paper itself

Abstract

Background: In idiopathic pulmonary fibrosis (IPF) patients, alveolar architectures are lost and gas transfer function would decline, which cannot be rescued by conventional anti-fibrotic therapy. P63+ lung basal progenitor cells are reported to have potential to repair damaged lung epithelium in animal models, which need further investigation in clinical trials. Methods: We cloned and expanded P63+ progenitor cells from IPF patients to manufacture cell product REGEND001, which were further characterized by morphology and single-cell transcriptomic analysis. Subsequently, an open-label, dose-escalation autologous progenitor cell transplantation clinical trial was conducted. We treated 12 patients with ascending doses of cells: 0.6x, 1x, 2x and 3.3x10 Results: P63+ basal progenitor cell was safe and tolerated at all doses, with no dose-limiting toxicity or cell therapy-related severe adverse events observed. Patients in three higher dose groups showed significant improvement of lung gas transfer function as well as exercise ability. Resolution of honeycomb lesion was observed in patients of higher dose groups. Conclusions: REGEND001 has high safety profile and meanwhile encourages further efficacy exploration in IPF patients. Funding: National High Level Hospital Clinical Research Funding (2022-PUMCH-B-108), National Key Research and Development Plan (2024YFA1108900, 2024YFA1108500), Jiangsu Province Science and Technology Special Project Funding (BE2023727), National Biopharmaceutical Technology Research Project Funding (NCTIB2023XB01011), Non-profit Central Research Institute Fund of Chinese Academy of Medical Science (2020-PT320-005), and Regend Therapeutics. Clinical trial number: Chinese clinical trial registry: CTR20210349.

Indexed as

Idiopathic Pulmonary FibrosisLungStem CellsStem Cell TransplantationAgedFemaleHumansMaleMiddle AgedTransplantation, AutologousTreatment Outcomecell therapyhumanidiopathic pulmonary fibrosisregenerative medicinestem cellstransplantation

Identifiers

PMID40036154
PMCPMC11879106

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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.