None listed
Conditions
Brief summary
We propose that i) collection of sufficient cord blood will be feasible in infants with antenatally diagnosed fetal stroke, and ii) (multiple) autologous intravenous administration of processed umbilical cord blood derived cells in these infants in the newborn period will be safe. This phase I trial will be the first study in the translational pipeline for this neurological condition, and will test the feasibility of cord blood collection, sufficient cell availability and safety of cell administration in this vulnerable group. Following successful completion of this study, an efficacy trial will be planned to determine the efficacy of autologous UCB cell administration in fetal stroke.
Interventions
Autologous umbilical cord blood derived cell administration in babies with known antenatal fetal stroke
- intervention delivered by doctors/ nurses
- dose 25-50 million cells/ kg - up to 3 infusions
- infusion lasting 1 hour- repeat infusion after 5 days
- under direct supervision of research team
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
Infants with brain injury associated with fetal stroke after confirmation of brain injury on postnatal imaging (Cranial ultrasound, MRI brain) soon after birth. Whilst there is no gestational age cut off, it is expected most infants will be born at or near term gestation.
Exclusion criteria
Infants who are likely to have redirection of care (palliation) for any reason.
Outcome results
None listed