None listed
Conditions
Brief summary
Preterm infants, especially those born before 28 weeks of gestation, are at high risk of complications related to their brain and development. In this international research study conducted at multiple sites, cells (including stem cells) extracted from the baby’s own cord blood will be infused back to them. Babies will be randomised to treatment. It means half of the babies in the trial will receive their cord blood derived cells in the first two weeks of life (in some cases two infusions) in addition to routine neonatal intensive care, while the other half will only receive placebo treatment in the newborn intensive care unit. A randomised study is the most scientific way of assessing whether a treatment is beneficial. Further whether the baby receives the intervention will not be known to the parents, or the treating team. The main outcome studied in this trial will be baby’s survival at two years without major disability related to the brain. We expect that cord blood cell therapy may increase the baby’s chances of survival without any major disability, and if proven to be true at the end of this study, it may offer a new therapy for these vulnerable infants.
Interventions
One to two intravenous infusions of autologous umbilical cord blood derived cells (UCBCs) at a dose of 50 million total nucleated cells per kg given over 1 hour
Cord blood collected from baby's own umbilical cord, processed, UCBCs characterized, cryopreserved, and then infused when all testing confirms cell product is safe to use.
Infusion between Day 10-15 - one or two infusion depending on number of UCBCs extracted
Administered in participating neonatal units under site investigator supervisi
One to two intravenous infusions of autologous umbilical cord blood derived cells (UCBCs) at a dose of 50 million total nucleated cells per kg given over 1 hour Cord blood collected from baby's own umbilical cord, processed, UCBCs characterized, cryopreserved, and then infused when all testing confirms cell product is safe to use. Infusion between Day 10-15 - one or two infusion depending on number of UCBCs extracted Administered in participating neonatal units under site investigator supervision by a registered nurse using an intravenous pump. Standard operating procedures will be harmonized across sites, with regular coordinating centre input and feedback.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Extremely preterm infants born less than 28 weeks completed gestation
Exclusion criteria
Extremely preterm infants where parental consent could not be obtained, or where a major brain malformation was known antenatally.
Outcome results
None listed