NCT02455830.

Study name	clinicaltrials.gov/ct2/show/record/NCT02455830?term=NCT02455830&rank=1
Methods	Prospective, case‐control, observational study
Participants	Sample size = 18 Inclusion criteria: Infants are eligible if they meet all the following inclusion criteria except 4. ≥ 36 weeks' gestation Either a 10‐minute Apgar score ≤ 5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH < 7.0 or base deficit ≥ 16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth Moderate to severe encephalopathy (Sarnat II to III) A moderately or severely abnormal background amplitude‐integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored Up to 24 hours of age A person with parental authority must have consented for the study.
Interventions	Autologous cord blood cell therapy The neonates receive their own non‐cryopreserved volume‐ and red blood cell‐reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12 to 24, 36 to 48, and 60 to 72 hours after the birth.
Outcomes	Primary outcome: changes in serum levels of cytokines and trophic factors within 10 days after birth. Secondary outcomes: association with neuroimaging (not specified) at 12 months  and neurodevelopmental functional outcome (not specified)  at 18 months
Starting date	April 2015
Contact information	Study Director: Haruo Shintaku, MD, PhD; Osaka City University Graduate School of Medicine
Notes	Study sponsor: Neonatal Encephalopathy Consortium, Japan