Evidence map›Paper›PMID 32005282›Full record

ArticleTrials2020

Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial).

Xian Wu, Yunqiu Xia, Ou Zhou, Yan Song, Xianhong Zhang, Daiyin Tian, Qubei Li, Chang Shu, Enmei Liu, Xiaoping Yuan and 9 more

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

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03601416 (Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 9% 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.

NCT03601416 phase2unknown statusnot on this map

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children

TypeinterventionalSponsorChildren's Hospital of Chongqing Medical UniversityRan2019 to 2021Enrolled57ConditionsBronchopulmonary DysplasiaArmsTransplantation of mesenchymal stem cell, No Transplantation of Mesenchymal Stem Cell
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
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  8. Article
  9. Mesenchymal stromal/stem cells and bronchopulmonary dysplasia.Frontiers in cell and developmental biology · 2023
    Review
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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

19 authors at 3 institutions in 1 country.

Xian WuPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Yunqiu XiaPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Ou ZhouPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Yan SongPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Xianhong ZhangPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Daiyin TianPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Qubei LiPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Chang ShuPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Enmei LiuPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Xiaoping YuanPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Ling HePediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Chengjun LiuPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Jing LiPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Xiaohua LiangPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Ke YangPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Zhou FuPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Lin ZouPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.
Lei BaoPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China. cqxinshenger@163.com.
Jihong DaiPediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China. danieljh@163.com.
Chongqing Medical University · CNChildren's Hospital of Chongqing Medical University · CNChina International Science and Technology Cooperation · CN

Funding

Ministry of Science and Technology of the People's Republic of China 2016YFA0101300National Natural Science Foundation of China NSFC 81570142National Natural Science Foundation of China NSFC 81670018National Natural Science Foundation of China NSFC 81870126
6 · The paper itself

Abstract

backgroundBronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors and one of the most common chronic lung diseases. It has a poor prognosis, especially in preterm infants. However, effective therapies for this disease are lacking. Stem-cell therapy is a promising way to improve lung injury and abnormal alveolarization, and the human umbilical cord (hUC) is a good source of mesenchymal stem cells (MSCs), which have demonstrated efficacy in other diseases. We hypothesized that intravenously administered allogeneic hUC-MSCs are safe and effective for severe BPD.

methodsThe MSC-BPD trial is a randomized, single-center, open-label, dose-escalation, phase-II trial designed to investigate the safety and efficacy of hUC-MSCs in children with severe BPD. In this study, 72 patients will be enrolled and randomly divided into two intervention groups and one control group. Patients in the intervention groups will receive a low dose of hUC-MSCs (n = 24; 2.5 million cells/kg) or a high dose of hUC-MSCs (n = 24; 5 million cells/kg) in combination with traditional supportive treatments for BPD. The patients in the control group (n = 24) will be treated with traditional supportive treatments alone without hUC-MSCs. The primary outcome measures will be cumulative duration of oxygen therapy. Follow-up assessments will be performed at 1, 3, 6, 12, and 24 months post intervention, and the key outcome during follow-up will be changes on chest radiography. Statistical analyses will evaluate the efficacy of the hUC-MSC treatment. DISCUSSION: This will be the first randomized controlled trial to evaluate the safety and efficacy of intravenously administered hUC-MSCs in children with severe BPD. Its results should provide a new evidence-based therapy for severe BPD.

trial registrationClinicalTrials.gov, ID: NCT03601416. Registered on 26 July 2018.

Indexed as

LungAdministration, IntravenousBronchopulmonary DysplasiaClinical Trials, Phase II as TopicCord Blood Stem Cell TransplantationFemaleHumansInfantInfant, NewbornInfant, PrematureMaleMesenchymal Stem CellsOutcome Assessment, Health CareOxygen Inhalation TherapyRadiography, ThoracicRandomized Controlled Trials as TopicBronchopulmonary dysplasiaClinical trialHuman umbilical cord-derived mesenchymal stem cellsProtocol

Identifiers

PMID32005282
PMCPMC6995070
OpenAlexW3005313807

What OpenQuestion holds

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LicenceCC BY
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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.