Autologous Cord Blood Cells for HIE

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

 

Cooling only improves neurologic outcomes in about 50% of HIE babies. Up to 30% of survivors of HIE are diagnosed with cerebral palsy. Animal studies and early human trials have shown that cooling and autologous stem cell transfusions reduce neuronal inflammation/cell death and improve neuronal repair after an HIE event.

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.

This study is coordinated through Duke University. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.

Outcomes will be measured at 22-26 months by neurodevelopment assessment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85.

Investigator(s):

Intervention(s):

  •  Infusion of autologous cord blood
  •  Placebo

Phase: Phase II

 

Eligibility Criteria:


Age Eligible: Up to 6 hours of age

Sexes Eligible: All

Inclusion Criteria:


  • NICHD Neonatal Research Network Hypothermia Trial inclusion criteria
  • 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
  • The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
  • All infants must have signs of encephalopathy within 6 hours of age

Exclusion Criteria:


  • Major congenital or chromosomal abnormalities
  • Severe growth restriction (birth weight <1800 g)
  • Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
  • Moribund neonates for whom no further treatment is planned
  • Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
  • Infants suspected of overwhelming sepsis
  • ECMO initiated or likely in the first 48 hours of life

External Links:


ClinicalTrials.gov