Evidence map›Paper›PMID 24508444›Full record

ArticleThe Journal of pediatrics2014

Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial.

Yun Sil Chang, So Yoon Ahn, Hye Soo Yoo, Se In Sung, Soo Jin Choi, Won Il Oh, Won Soon Park

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in The Journal of pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 223 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
223citing papers in PubMed, 13 pooled it
30.9field-weighted citation impact, top 1% 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.

NCT03558334 phase1unknown statusnot on this mapstarted 2018, after this paper: background citation

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia in Premature Infants

TypeinterventionalSponsorChildren's Hospital of Chongqing Medical UniversityRan2018 to 2022Enrolled12ConditionsBronchopulmonary DysplasiaArmsTransplantation of mesenchymal stem cell, No transplantation of mesenchymal stem cell
NCT03774537 phase1 / phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Premature Infants Ａt High Risk For Bronchopulmonary

TypeinterventionalSponsorChildren's Hospital of Chongqing Medical UniversityRan2019 to 2021Enrolled20ConditionsBronchopulmonary DysplasiaArmsTransplantation of hUC-MSCs, No transplantation of hUC-MSCs
NCT03873506 phase1unknown statusnot on this mapstarted 2018, after this paper: background citation

Follow-Up Study of Safety and Efficacy of Mesenchymal Stem Cells in Preterm Infants With Moderate or Severe Bronchopulmonary Dysplasia

TypeinterventionalSponsorChildren's Hospital of Chongqing Medical UniversityRan2018 to 2020Enrolled30ConditionsBronchopulmonary DysplasiaArmstransplantation of hUC-MSCs
NCT04062136 phase1completednot on this mapstarted 2019, after this paper: background citation

Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia

TypeinterventionalSponsorVinmec Research Institute of Stem Cell and Gene TechnologyRan2019 to 2020Enrolled10ConditionsBronchopulmonary DysplasiaArmsstem cell transplantation
3 · Its place in the literature

Who cites it

223 citing papers in PubMed, 13 syntheses or guidelines pooled it, 459 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Yun Sil ChangDepartment of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
So Yoon AhnDepartment of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Hye Soo YooDepartment of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Se In SungDepartment of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Soo Jin ChoiBiomedical Research Institute, MEDIPOST Co, Ltd, Seoul, Korea.
Won Il OhBiomedical Research Institute, MEDIPOST Co, Ltd, Seoul, Korea.
Won Soon ParkDepartment of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Electronic address: wonspark@skku.edu.
Sungkyunkwan University · KRMedipost (South Korea) · KRSamsung Medical Center · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the safety and feasibility of allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation in preterm infants. STUDY

designIn a phase I dose-escalation trial, we assessed the safety and feasibility of a single, intratracheal transplantation of hUCB-derived MSCs in preterm infants at high risk for bronchopulmonary dysplasia (BPD). The first 3 patients were given a low dose (1 × 10(7) cells/kg) of cells, and the next 6 patients were given a high dose (2 × 10(7) cells/kg). We compared their adverse outcomes, including BPD severity, with those of historical case-matched comparison group.

resultsIntratracheal MSC transplantation was performed in 9 preterm infants, with a mean gestational age of 25.3 ± 0.9 weeks and a mean birth weight of 793 ± 127 g, at a mean of 10.4 ± 2.6 days after birth. The treatments were well tolerated, without serious adverse effects or dose-limiting toxicity attributable to the transplantation. Levels of interleukin-6, interleukin-8, matrix metalloproteinase-9, tumor necrosis factor α, and transforming growth factor β1 in tracheal aspirates at day 7 were significantly reduced compared with those at baseline or at day 3 posttransplantation. BPD severity was lower in the transplant recipients, and rates of other adverse outcomes did not differ between the comparison group and transplant recipients.

conclusionIntratracheal transplantation of allogeneic hUCB-derived MSCs in preterm infants is safe and feasible, and warrants a larger and controlled phase II study.

Indexed as

BiomarkersBronchopulmonary DysplasiaCord Blood Stem Cell TransplantationCytokinesFeasibility StudiesFemaleHepatocyte Growth FactorHumansInfant, NewbornInfant, PrematureLogistic ModelsMaleMesenchymal Stem Cell TransplantationSeverity of Illness IndexTracheaTransplantation, HomologousBiomarkersCytokinesHepatocyte Growth FactorHGF protein, humanVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID24508444
OpenAlexW2005962589

What OpenQuestion holds

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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.