🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in Canada / NCT07058025
Starting soon Phase 2

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

NCT07058025 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2025-10-01
Last updated
2025-07-10

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Human Allogenic Umbilical Cord Mesenchymal Stromal CellsSham procedure control

Human Allogenic Umbilical Cord Mesenchymal Stromal Cells: IV administration of uc-MSC every 7 days ± 1 day for 3 weeks. Randomized double blinded

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

Study 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.

Eligibility

Sex
ALL
Min age
4 Days
Max age
14 Days
Healthy volunteers
No
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 outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Royal Alexandra Hospital/Stollery Children's Hospital Edmonton Alberta
McMaster Children's Hospital Hamilton Ontario
The Ottawa Hospital Ottawa Ontario
Sunnybrook Health Sciences Ctr Toronto Ontario
Mount Sinai Hospital Toronto Ontario
CHU Sainte-Justine Montreal Quebec
McGill Montreal Children's Hospital Montreal Quebec
Université Laval Québec Quebec

More Ottawa Hospital Research Institute trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07058025 on ClinicalTrials.gov ↗ ← All trials in Canada