Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-14
SponsorOttawa Hospital Research Institute
About this 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.
Eligibility criteria
Qualifiers
Gestational age (GA) less than 28+0 weeks
Post-natal age between 4 and 14 days of life
With requirement of FiO2: FiO2 >= 30% and for at least 12 hours over 24 hours (i.e. flowsheets, FiO2 histogram)
Disqualifiers
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 with impaired end-organ perfusion (metabolic acidosis with increased lactate and/or decreased urine output).
Trial design
Treatments tested in this trial
- Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
- Sham procedure control
Treatment groups
168 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ottawa Hospital Research Institute
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Stem Cell Network
Collaborator
Source ClinicalTrials.gov