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ClinicalTrials.gov ID

NCT07058025

Lead Sponsor

Ottawa Hospital Research InstituteOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

168Estimated

Last Update Posted

Jul 10, 2025Actual

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2038Estimated

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

Brief 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.

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.

Detailed Description

Include Background...

• Bronchopulmonary Dysplasia (BPD)
• ELGAN (22-28SA)

• Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
• Sham procedure control

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

1. 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.

2. Hemodynamic instability (shock):

   • Hemodynamic instability with impaired end-organ perfusion (metabolic acidosis with increased lactate and/or decreased urine output).
   • Requirements for fluid bolus, inotrope or vasopressor medication

3. Severe sepsis:

   • Signs of hemodynamic instability and requiring at least one fluid bolus.
   • And a positive blood or cerebrospinal fluid culture.

4. Pneumothorax: Pneumothorax with a chest tube in place

5. 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)

6. Extubation: If Extubation planned within the next 24 hours (post first uc-MSC administration/sham procedure).

7. Patient is not expected to survive:

   • Redirection of care.
   • Patient is moribund

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Ottawa Hospital Research InstituteOTHER

Collaborators

Canadian Institutes of Health Research (CIHR)OTHER_GOV

Stem Cell NetworkOTHER

prakeshkumar.shah@sinaihealth.ca416-586-4761

anne.monique.nuyt@umontreal.ca514 345-4931 ext. 4673

mireille.guillot.1@ulaval.ca418-656-2131