A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy

The purpose of this phase II study is to assess the safety and efficacy of up to two
intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical
cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing
hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley
III scores in all three domains equal to or greater than 85. This will be a randomized,
double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for
cooling.

Inclusion Criteria:

1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria

2. Mothers must have consented or given verbal assent for cord blood collection at
delivery, and cord blood must be available for volume and red blood cell reduction
before 45 hours of age

3. The infant must be able to receive at least one dose of autologous cord blood before
48 hours of age

4. All infants must have signs of encephalopathy within 6 hours of age

Exclusion Criteria:

1. Major congenital or chromosomal abnormalities

2. Severe growth restriction (birth weight <1800 g)

3. Opinion by attending neonatologist that the study may interfere with treatment or
safety of subject

4. Moribund neonates for whom no further treatment is planned

5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have
active syphilis or CMV infection in pregnancy

6. Infants suspected of overwhelming sepsis

7. ECMO initiated or likely in the first 48 hours of life