Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants
NCT ID: NCT07058025
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
168 participants
INTERVENTIONAL
2025-10-01
2038-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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)
PREVENTION
QUADRUPLE
Study Groups
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Intervention group will receive multiple IV doses of UC-MSCs
* 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.
Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
IV administration of uc-MSC every 7 days ± 1 day for 3 weeks. Randomized double blinded
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)
Sham procedure control
Sham procedure (mimic IV catheter insertion adn cell product infusion behing a screen). Repeated weekly for 3 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Days
14 Days
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Stem Cell Network
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Bernard Thébaud, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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Royal Alexandra Hospital/Stollery Children's Hospital
Edmonton, Alberta, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Ctr
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
McGill Montreal Children's Hospital
Montreal, Quebec, Canada
Université Laval
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HULC-2
Identifier Type: -
Identifier Source: org_study_id
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