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Bronchopulmonary Dysplasia (BPD)Phase 2HULC-2NCT07058025

Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants

A Phase 2 study testing Human Allogenic Umbilical Cord Mesenchymal Stromal Cells in people with Bronchopulmonary Dysplasia (BPD) and ELGAN (22-28SA), run by Ottawa Hospital Research Institute at 8 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth. Read more about this study

Who is it for?
Ages 4 to 14 days
What is being tested?
Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
8 sitesCanada
Study dates
1 Oct 2025to 30 Sep 2038
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 14 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Gestational age (GA) less than 28+0 weeks
  • Post-natal age between 4 and 14 days of life
  • Invasive ventilation with oxygen requirement:
  • On mechanical ventilation: intubated patient with any of the following ventilation modes: conventional, HFO or Jet ventilation:
  • With requirement of FiO2: FiO2 >= 30% and for at least 12 hours over 24 hours (i.e. flowsheets, FiO2 histogram)

Who cannot join

  • Congenital anomaly:
  • Genetic and chromosomal syndromes (e.g., Trisomy 13, Trisomy 18, Trisomy 21): either patient with high suspicion (antenatal findings, clinical features) or documented syndrome by genetic testing.
  • Major congenital anomalies including cardiac (i.e., congenital heart defects, NB. PDA is not considered an exclusion criterion), neurological (e.g., holoprosencephaly, anencephaly), gastrointestinal (e.g., gastroschisis, omphalocele), pulmonary (e.g., congenital diaphragmatic hernia) anomalies.
  • Inborn errors of metabolism.
  • Hemodynamic instability (shock):
  • Hemodynamic instability with impaired end-organ perfusion (metabolic acidosis with increased lactate and/or decreased urine output).
Show all 18Show fewer
  • Requirements for fluid bolus, inotrope or vasopressor medication
  • Severe sepsis:
  • Signs of hemodynamic instability and requiring at least one fluid bolus.
  • And a positive blood or cerebrospinal fluid culture.
  • Pneumothorax: Pneumothorax with a chest tube in place
  • Severe pulmonary hemorrhage:
  • Active pulmonary hemorrhage (i.e., frank blood coming from the endotracheal tube.
  • And at least one of the following criteria: a)hemodynamic instability. b) blood product transfusion (packed red blood cells, platelets, fresh frozen plasma)
  • Extubation: If Extubation planned within the next 24 hours (post first uc-MSC administration/sham procedure).
  • Patient is not expected to survive:
  • Redirection of care.
  • Patient is moribund

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bernard Thébaud, MD, PhD contact

613-737-8899 ext. 73905

bthebaud@toh.ca

Chantal Horth contact

chorth@cheo.on.ca

8 sites in 1 country

Canada8 sites

  • Royal Alexandra Hospital/Stollery Children's Hospital

    Edmonton, Alberta, T5H 3V9

    Georg Schmölzer, MD, PhD, 780-735-4660, georg.schmoelzer@me.com

    Georg Schmölzer, MD, PhD

  • McMaster Children's Hospital

    Hamilton, Ontario, L8Z 3Z5

    Amit Mukerji, 905-521-2100, mukerji@mcmaster.ca

    Amit Mukerji

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Anne-Monique Nuyt, 514 345-4931 ext. 4673, anne.monique.nuyt@umontreal.ca

    Anne-Monique Nuyt

  • McGill Montreal Children's Hospital

    Montreal, Quebec, H4A 3J1

    Marc Beltempo, MD, M.Sc., FRCPC, (514) 412-4400, marc.beltempo@mcgill.ca

    Marc Beltempo, MD, M.Sc., FRCPC

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Université Laval

    Québec, Quebec, G1V 0B4

    Mireille Guillot, MD, 418-656-2131, mireille.guillot.1@ulaval.ca

    Mireille Guillot

  • Sunnybrook Health Sciences Ctr

    Toronto, Ontario, M4Y 3M5

    Maher Shahroor, MD, RCPSC, 416-480-6100, maher.shahroor@sunnybrook.ca

    Maher Shahroor, MD, RCPSC

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

    Prakesh Shah, 416-586-4761, prakeshkumar.shah@sinaihealth.ca

    Prakesh Shah, MD

Other trials in Canada

About this study

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

This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.

Study participants will receive either multiple intravenous doses (total of 3 doses) of MSC derived from human donor umbilical cord tissue (intervention group) or no uc-MSC injection (control group) to confirm the safety of IV MSC in extreme preterm infants and evaluate the potential benefit of MSC therapy on their respiratory health as well as on other complications related to preterm birth.

Read the detailed description

Include Background...

Being tested
Human Allogenic Umbilical Cord Mesenchymal Stromal Cells, Sham procedure control
Keywords
Phase II clinical trial, Mesenchymal stromal cell, Cell therapy, Preterm infant, Bronchopulmonary Dysplasia, Extremely low gestational age neonates
Medical subject headings
Bronchopulmonary Dysplasia, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Allogenic Umbilical Cord Mesenchymal Stromal CellsBiological

    Also called UC-MSC, Umbilical Cord Mesenchymal Stromal Cells, Mesenchymal Stromal Cells

    IV administration of uc-MSC every 7 days ± 1 day for 3 weeks. Randomized double blinded

  • Sham procedure controlOther

    Sham procedure (mimic IV catheter insertion adn cell product infusion behing a screen). Repeated weekly for 3 weeks

Study groups in NCT07058025
Study groupRoleWhat they receive
Intervention group will receive multiple IV doses of UC-MSCsExperimental* Dose: each dose consists of 10 million cells/kilograms of bodyweight. * Administration protocol: weekly (7 days ± 1 day) IV dose of UC-MSCs for 3 weeks (Total of 3 doses) * Route of administration: IV infusion on peripheral intravenous catheter. The UC-MSC solution will be infused using a syringe pump over 15 minutes, and after the UCMSC infusion, an additional volume of normal saline will be infused over 15 minutes.
Receives: Biological: Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
Control groupSham comparatorParticipants allocated in the control group will receive a sham procedure weekly for 3 weeks. A syringe of normal saline brought to bedside, but it will not be administered. The physician and bedside nurse will perform the sham procedure behind a screen (they will mimic IV catheter insertion and cell product injection)
Receives: Other: Sham procedure control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of mechanical ventilation-free days accounting for mortality

    The study primary outcome is the number of mechanical ventilation-free days accounting for mortality. Mechanical ventilation is defined by artificial ventilation using an endotracheal tube. For study purpose, this outcome will be measured at 120 days after randomization. To account for mortality, any death within 120 days post randomization will be counted as "0" mechanical ventilation-free day (worse outcome).

    Measured: 120 days

Secondary outcomes (11)

  1. Effects of uc-MSCs on the date of extubation for participants.

    This respiratory outcome will be measured to determine if uc-MSCs have an effect on the date of extubation for participants

    Measured: From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months

  2. Effects of uc-MSCs on the rate of survival without moderate or severe BPD at 36 weeks corrected age.

    This will assess if uc-MSCs impact survival with moderate or severe Bronchopulmonary dysplasia.

    Measured: BPD severity will be assessed for each participant at 36 weeks of corrected age

  3. Effects of uc-MSCs on the Number of Participants receiving open-label dexamethasone for severe chronic lung disease

    This will help us determine if the intervention reduces use of dexamethasone for the treatment of severe chronic lung disease.

    Measured: From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months

  4. Effects of uc-MSCs on the duration of respiratory support.

    Since ventilation damages underdeveloped lungs, determining the duration of ventilation is important to monitor as an outcome of uc-MSCs.

    We will collect the total number of days on mechanical ventilation, non-invasive ventilation, and oxygen therapy during the NICU hospitalization for each participant

    Measured: From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months

  5. Effects of uc-MSCs on the levels of respiratory support at 36 weeks CA, 40 weeks CA and at hospital discharge.

    The different levels of intensity of ventilation will help us determine if uc-MSCs reduce ventilation days.

    The respiratory support being used are the following (Room air being the least intensive and best for participant health outcome.):

    mechanical ventilation vs. Continuous Positive Airway pressure/High Flow Nasal Canula, vs. Low Flow Nasal Canula vs. room air

    Measured: From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months

  6. Effects of uc-MSCs on the occurrence of pulmonary hypertension related to severe BPD

    This will help us determine the therapeutic properties of UC-MSCs in reducing the occurrence of pulmonary hypertension related to severe BPD.

    Participants will be screened by echocardiography for pulmonary hypertension at 36 weeks of corrected age. Medication for chronic pulmonary hypertension will be collected.

    Measured: From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months

  7. Neurodevelopment and health outcomes at 24 months corrected age (Bayleys)

    The neurodevelopmental assessment will be scheduled at 24 months CA with a window of +/- 6 months (i.e., between 18 to 30 months CA). Participants will be evaluated in the Neonatal Follow-Up clinic for high-risk infants. An assessment of general health and growth will be performed, and the most recent audiology and ophthalmology results will be recorded. The Bayley Scales of Infant Develpment-4th edition will be performed by a qualified professional to further evaluate the neurodevelopment of the participant.

    Measured: Assessment will be scheduled at 24 months corrected age.

  8. Evaluation of safety of IV administration of UC-MSCs: Dose Limiting toxicity

    Dose-limiting toxicity, defined as one of the following events, occurring within 24-hour post UC-MSC injection:

    • Death
    • Anaphylaxis
    • Increase need for respiratory support define by increase FiO2 >30% from baseline and/or increase in mean airway pressure > 5 cmH2O from baseline
    • Medications to support hemodynamic status (including management of cardiac arrest) including fluid boluses, inotropes, or vasopressors
    • Any SAE not expected in this patient population for which there is no alternative explanation but the IV administration of UC-MSCs and occurring within 1 week after UC-MSCs injection.

    Measured: 24-hours post uc-MSC injection

  9. Evaluation of safety of IV administration of UC-MSCs: potential adverse event

    Any Serious Adverse Event (SAE) not expected in this patient population for which there is no alternative explanation but the IV administration of UC-MSCs and occurring within 1 week after UC-MSCs injection.

    Measured: within 1 week post uc-MSC injection

  10. Long-term participant safety follow-up

    We plan to have annual parental interviews via telephone until the participant is 10 years old. This is to assess the respiratory status and any new diagnoses of study participants.

    Measured: From enrollment until participant is 10 years of age.

  11. Complications of prematurity (assessed at time of hospital discharge)

    The complications of prematurity assessed are the following:

    • BPD.
    • Patent Ductus Arteriosus requiring medical, surgical or device closure.
    • Intra-ventricular hemorrhage ≥ grade 3 according to Papille's classification.
    • Periventricular leukomalacia.
    • Necrotizing enterocolitis ≥ stage 2 according to Bell's classification.
    • Retinopathy of prematurity requiring treatment
    • Late-onset sepsis

    Measured: From date of randomization until the date of discharge home or date of death from any cause, whichever came first, assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention group: Participants allocated in the intervention group will receive multidose of UC-MSCs as follow: * Dose: each dose consists of 10x106 cells/kilograms of bodyweight. * Administration protocol: weekly IV dose of UC-MSCs for 3 weeks (total of 3 doses) * Route of administration: IV infusion on peripheral intravenous catheter. The UC-MSC solution will be infused using a syringe pump over 15 minutes, and after the UCMSC infusion, an additional volume of normal saline will be infused using a syringe pump over 15 minutes. Control group: Participants allocated in the control group will receive a sham procedure weekly for 3 weeks. A syringe of normal saline brought to bedside, but it will not be administered. The physician and bedside nurse will perform the sham procedure behind a screen (they will mimic IV catheter insertion and cell product injection)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07058025
Sponsor's protocol ID
HULC-2
Acronym
HULC-2
Status last verified
Jul 2025
First submitted
26 May 2025
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Renesme L, Ferretti E, Horth C, Grimwood R, Da Sylva L, Olson V, Cyr-Depauw C, Freund D, Rudiger M, Mobius MA, Hodgins S, Khan S, Courtman D, Fergusson DA, Thebaud B. 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. BMJ Open. 2026 Jul 6;16(7):e112385. doi: 10.1136/bmjopen-2025-112385.

    PubMed 42409407

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Human Allogenic Umbilical Cord Mesenchymal Stromal Cells in people with Bronchopulmonary Dysplasia (BPD) and ELGAN (22-28SA), run by Ottawa Hospital Research Institute at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bernard Thébaud, MD, PhD (613-737-8899 ext. 73905, bthebaud@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of mechanical ventilation-free days accounting for mortality (time frame: 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07058025, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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