Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy

The primary aim of this study is to determine the safety, tolerability and feasibility of
intravenous administration of autologous cord blood (CB) and autologous human placental
derived stem cells (HPDSC) in neonates with severe hypoxic-ischemic encephalopathy (HIE). It
is hypothesized that the administration of autologous CB and autologous HPDSC will be safe
and well tolerated in neonates with severe HIE.

Additionally, postnatal neuro-developmental outcomes in neonates with HIE after autologous CB
and HPDSC therapy will be measured; HIE injury to the neonate/infant brain post autologous CB
and HPDSC therapy by imaging will be characterized; the pluripotent stem cell properties of
CB and HPDSC will be characterized; serum levels of selected circulating cytokine and
neurotrophic factors in neonates with HIE before and after autologous CB and HPDSC therapy
will be compared and immune cell phenotype and function in neonates with HIE before and after
autologous CB and HPDSC therapy will be compared.

Inclusion Criteria:

- Gestational age ≥ 36 weeks

- Birth weight ≥ 1800 grams

- Postnatal age after birth of less than 6 hours

- Autologous cord blood and HPDSCs available for infusion

- Plus one or more of the following criteria: Apgar ≤ 5 at 10 minutes of postnatal age,
or Continued need for resuscitation ≥10 min after birth, or Acidosis-cord blood pH or
arterial blood pH within 60 minutes of birth ≤ 7.0 pH, or Base deficit ≥ minus 16mEq
in cord blood and within 60 min of birth.

- Plus Moderate to Severe Altered State of Consciousness, by one or more of the
following: Hypotonia, or Abnormal reflexes, or Absent/weak suck.

Exclusion Criteria:

- Major life-threatening or surgical anomalies

- Polycythemia (hematocrit > 65%)

- Congenital infection based on antenatal diagnosis of TORCH infection

- Parental refusal for study

- Infant expected to live < 24h, medical care is considered futile and no additional
therapy will be offered by the attending neonatologist