Phase 2 N=35 Randomized Quadruple-blind Treatment

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

Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns

Bottom Line

View on ClinicalTrials.gov: NCT02612155 ↗

Enrolled (actual)

Serious AEs

8.6%

Results posted

Aug 2020

Primary outcome: Primary: Survival at One Year — 16; 17 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Infusion of autologous cord blood (Biological); Placebo (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Michael Cotten
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Survival at One Year	16; 17	—
PRIMARY Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85	12; 6	0.06
SECONDARY Mortality Rate	5.88; 5.56	—
SECONDARY Number of Subjects Who Experience Seizures	6; 6	—
SECONDARY Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use	3; 2	—
SECONDARY Number of Subjects Who Require ECMO	0; 0	—
SECONDARY Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding	2; 3	—
SECONDARY Number of Subjects Who Are Discharged on Anti-epileptic Medication	2; 1	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02612155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.