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

M

Michael Cotten

Status and phase

Completed
Phase 2

Conditions

Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns

Treatments

Biological: Placebo
Biological: Infusion of autologous cord blood

Study type

Interventional

Funder types

Other

Identifiers

NCT02612155
Pro00066647

Details and patient eligibility

About

This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.

Full description

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.

Enrollment

35 patients

Sex

All

Ages

Under 6 hours old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

35 participants in 2 patient groups, including a placebo group

Intervention cell recipients
Experimental group
Description:
Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
Treatment:
Biological: Infusion of autologous cord blood
Placebo recipients
Placebo Comparator group
Description:
Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
Treatment:
Biological: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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