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

• Status: Withdrawn
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and effectiveness of autologous human placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates with severe hypoxic-ischemic encephalopathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Collaborator: Celgene

Criteria

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