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)
Number of mechanical ventilation-free days accounting for mortality — 120 days 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).
Trial sites (8)
Facility
City
Region
Status
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
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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.
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