Evidence map›Paper›PMID 42409407›Full record

ArticleBMJ open2026

Helping Underdeveloped Lungs with Cells (HULC-2): mesenchymal stromal cells in extreme preterm infants at risk of developing bronchopulmonary dysplasia - a study protocol of a phase 2 multicentre double blind randomised controlled trial in Canada.

Laurent Renesme, Emanuela Ferretti, Chantal Horth, Rebecca Grimwood, Liam Da Sylva, Viviane Olson, Chanele Cyr-Depauw, Daniel Freund, Mario Rüdiger, Marius A Möbius and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07058025 (Mesenchymal Stromal Cells in Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia - A Phase 2 Multi-Centre Double Blind Randomized Controlled Trial), which is not on this 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.

NCT07058025 phase2not yet recruitingnot on this map

Mesenchymal Stromal Cells in Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia - A Phase 2 Multi-Centre Double Blind Randomized Controlled Trial

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2025 to 2038Enrolled168ConditionsBronchopulmonary Dysplasia (BPD), ELGAN (22-28SA)ArmsHuman Allogenic Umbilical Cord Mesenchymal Stromal Cells, Sham procedure control
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

15 authors.

Laurent RenesmePediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada laurenesme@toh.ca.ORCID http://orcid.org/0000-0001-6848-3617
Emanuela FerrettiPediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.ORCID http://orcid.org/0000-0003-1741-4333
Chantal HorthRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Rebecca GrimwoodRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Liam Da SylvaRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Viviane OlsonRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Chanele Cyr-DepauwRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Daniel FreundGood Manufacturing Practice Facility, Center for Regenerative Therapies Dresden, Technische Universität Dresden, Dresden, Germany.
Mario RüdigerNeonatology and Pediatric Intensive Care, University Hospital Carl Gustav Carus, Dresden, SN, Germany.
Marius A MöbiusGood Manufacturing Practice Facility, Center for Regenerative Therapies Dresden, Technische Universität Dresden, Dresden, Germany.
Samantha HodginsRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Saad KhanRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
David CourtmanRegenerative Medicine, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Dean A FergussonUniversity of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada.ORCID http://orcid.org/0000-0002-3389-2485
Bernard ThebaudPediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.ORCID http://orcid.org/0000-0003-1844-7145

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBronchopulmonary dysplasia (BPD) remains a major complication among extremely low gestational age (ELGA) infants, with long-term respiratory and neurodevelopmental consequences. Despite advances in neonatal care, effective therapies to prevent BPD are lacking. Mesenchymal stromal cells (MSCs), particularly those derived from umbilical cord (UC-MSC), offer promise due to their pleiotropic effects. Preclinical and early-phase clinical studies have demonstrated safety and potential efficacy of MSC in neonatal lung injury. The Helping Underdeveloped Lungs with Cells (HULC)-2 trial aims to evaluate whether multiple intravenous doses of human allogenic UC-MSC can reduce mechanical ventilation duration and improve the respiratory outcome in ELGA infants at high risk of developing BPD. METHODS AND ANALYSIS: HULC-2 is a multicentre, double-blind, randomised controlled Phase II trial conducted in Canadian Neonatal Intensive Care Units. ELGA infants (gestational age <28 weeks) who remain ventilator-dependent between 4 and 14 days of life will be randomised to receive either 3 weekly intravenous doses of UC-MSC (10×10 ETHICS AND DISSEMINATION: The study was approved through Clinical Trials Ontario by the Ottawa Health Science Network Research Ethics Board. Results will be disseminated via peer-reviewed publications, conferences and public engagement platforms. Parent partners are actively involved in study design and dissemination to ensure relevance and transparency. TRIAL REGISTRATION NUMBER: NCT07058025.

Indexed as

Bronchopulmonary DysplasiaInfant, Extremely PrematureLungMesenchymal Stem Cell TransplantationCanadaClinical Trials, Phase II as TopicDouble-Blind MethodFemaleGestational AgeHumansInfant, NewbornIntensive Care Units, NeonatalMulticenter Studies as TopicRandomized Controlled Trials as TopicRespiration, ArtificialMesenchymal Stem CellsNeonatal intensive & critical careNEONATOLOGYRandomized Controlled Trial

Identifiers

PMID42409407
PMCPMC13343066

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.