NCT03635450.

Study name	Study of hCT‐MSCs in newborn infants With moderate or severe HIE
Methods	Phase 1, open‐label, non‐randomised, parallel assignment
Participants	Sample size = 6 Inclusion criteria 36 0/7th weeks' gestation or older at the time of delivery Able to receive 1 dose of hCT‐MSCs in the first 48 postnatal hours Willingness to return for 1‐year assessments Signs of encephalopathy within 6 hours of age
Interventions	First cohort of 3 subjects enrolled: will receive a single dose of hCT‐MSC in the first 48 postnatal hours  Second cohort of 3 subjects enrolled: will receive 2 doses, with the first dose of hCT‐MSC given in the first 48 postnatal hours and the second dose of hCT‐MSC given approximately 2 months after the first dose.
Outcomes	Primary outcomes Incidence of infusion reactions within 24 h after each infusion (defined as anaphylactic or anaphylactoid reactions with clinical signs inclusive of skin rashes, bronchospasm, angioedema, myocardial infarcts, arrhythmias, and acute lung injury). Incidence of Infections post‐infusion within 2 weeks after administration of hCT‐MSC (defined as bacterial, viral or fungal infections identified by culture or molecular methodologies). Secondary outcomes Survival [time frame: up to 6 months] Death prior to discharge from initial hospitalisation Neurodevelopmental Assessments [time frame: up to 16 postnatal months] 1 year (12 to 16 postnatal months) Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III) assessments in cognitive, language and motor development. Moderate to Severe CP will be assigned with cognitive score, 70, motor score, 70 and with Gross Motor Function Classification System ≥ 2.
Starting date	December 2018
Contact information	Principal Investigator: Michael Cotton, MD; Duke University
Notes	Study sponsor: Joanne Kurtzberg, MD