Evidence map›Paper›PMID 41053831›Full record

Trial reportJournal of translational medicine2025

Topical application of a placental mesenchymal stem cell-embedded biomaterial hydrogel accelerates the repair of radiation-induced skin damage: a double-blind randomized phase II clinical trial.

Linghan Tian, Zhibo Han, Ming Jiang, Yi Yang, Yunhe Ju, Ming Zhang, Yan Chen, Iaming Gu, Ying Song, Lei Bao and 6 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Journal of translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Review
  2. 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

16 authors.

Linghan Tian *Department of Yunnan Tumor Research Institute, Yunnan Provincial Key Laboratory of Cell Therapy Technology Translational Medicine, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Zhibo Han *Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceuticals, National Engineering Research Center of Cell Products, AmCellGene Co., Ltd., Tianjin, 300457, China.
Ming Jiang *Department of Yunnan Tumor Research Institute, Yunnan Provincial Key Laboratory of Cell Therapy Technology Translational Medicine, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Yi YangDepartment of Radiation Oncology, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Yunhe JuDepartment of Radiation Oncology, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Ming ZhangDepartment of Radiation Oncology, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Yan ChenDepartment of Yunnan Tumor Research Institute, Yunnan Provincial Key Laboratory of Cell Therapy Technology Translational Medicine, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Iaming GuDepartment of Yunnan Tumor Research Institute, Yunnan Provincial Key Laboratory of Cell Therapy Technology Translational Medicine, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Ying SongKunming Maternal and Child Health Hospital of Yunnan Province, Obstetrics, Kunming, 650118, China.
Lei BaoKunming Maternal and Child Health Hospital of Yunnan Province, Obstetrics, Kunming, 650118, China.
Qian SongDepartment of Yunnan Tumor Research Institute, Yunnan Provincial Key Laboratory of Cell Therapy Technology Translational Medicine, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Lu YuanDepartment of Yunnan Tumor Research Institute, Yunnan Provincial Key Laboratory of Cell Therapy Technology Translational Medicine, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China.
Zongjin LiBeijing Engineering Laboratory of Perinatal Stem Cells, Beijing Health & Biotech Stem Cell Technology Co., Ltd, Beijing, 100176, China.
Jundong GuTianjin Key Laboratory of Engineering Technologies for Cell Pharmaceuticals, National Engineering Research Center of Cell Products, AmCellGene Co., Ltd., Tianjin, 300457, China.
Zhongchao HanBeijing Engineering Laboratory of Perinatal Stem Cells, Beijing Health & Biotech Stem Cell Technology Co., Ltd, Beijing, 100176, China. hanzhongchao@health-biotech.com.
Jian DongDepartment of Yunnan Tumor Research Institute, Yunnan Provincial Key Laboratory of Cell Therapy Technology Translational Medicine, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, 650118, China. Dongjian1@kmmu.edu.cn.ORCID 0000-0003-2955-0770

Funding

Development of mesenchymal stem cell stemness standards and therapeutic product development (202402AA310265)Key Laboratory of Cell Therapy Technology Transformation Medicine of Yunnan Province, Grant/Award 2015DG034
6 · The paper itself

Abstract

backgroundRadiation-induced skin injury (RSI) is a common complication of radiation therapy, that severely reduces the quality of life of patients, and there is currently no gold standard for treatment. Placental mesenchymal stem cells (PMSCs) have emerged as a promising therapeutic approach due to their regenerative and anti-inflammatory properties, and biomaterials can serve as cell scaffolds to prolong cell survival time. This study is the first to evaluate the safety and efficacy of the a topical application of PMSCs-embedded alginate hydrogel (PMSCs gel) in cancer patients suffering from RSI. MATERIALS AND

methodsThis study was a double-blind, randomized, placebo-controlled phase II clinical trial conducted at Yunnan Cancer Hospital (Chinese Clinical Trial Registry, Approval Number: ChiCTR2400094739) involving participants with grade II or higher radiation-induced skin injuries. The participants were randomly assigned to either the PMSCs gel treatment group or the placebo control group and treated topically for six consecutive days. The primary outcomes included skin injury grade, pain assessment and wound healing rate, whereas the secondary outcomes focused on biomarker changes and quality of life assessments. Statistical analyses were performed using intention-to-treat (ITT) principles.

resultsThis study included 66 patients, 23 males, and 43 females, with a mean radiation-induced skin injury area of 779 mm

conclusionsOur study has demonstrated for the first time that PMSCs hydrogel have significant potential for accelerating the repair of radiation-induced skin damage and reducing skin pain.

trial registrationThis retrospectively registered Chinese Clinical Trial Registry identifier: ChiCTR2400094739 ( https://www.chictr.org.cn/bin/project/edit?pid=250420 ).

Indexed as

Biocompatible MaterialsHydrogelsMesenchymal Stem CellsMesenchymal Stem Cell TransplantationPlacentaRadiation InjuriesSkinAdministration, TopicalAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPregnancyQuality of LifeBiocompatible MaterialsHydrogelsPlacental mesenchymal stem cells hydrogelRadiation-induced skin injuryRandomized controlled trialSafety and efficacyStem cell therapy

Identifiers

PMID41053831
PMCPMC12502358

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Registered trials

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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.