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NCT Number: NCT02612155

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

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.

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Key information

Conditions

Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemic and Lymphatic Diseases Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

0 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infusion of autologous cord blood

Biological

Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.

Placebo

Biological

Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.

Primary outcomes

  1. Survival at One Year

    Time frame: 1 year

    Number of participants alive at one year.

  2. Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85

    Time frame: 1 year

    The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15.

Secondary outcomes

  1. Mortality Rate

    Time frame: 1 year

    (Number of participants who died/total number of participants) x 100

  2. Number of Subjects Who Experience Seizures

    Time frame: During hospitalization, approximately 4-92 days

  3. Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use

    Time frame: During hospitalization, approximately 4-92 days

  4. Number of Subjects Who Require ECMO

    Time frame: During hospitalization, approximately 4-92 days

    ECMO (extracorporeal membrane oxygenation) is a technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life.

  5. Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding

    Time frame: During hospitalization, approximately 4-92 days

  6. Number of Subjects Who Are Discharged on Anti-epileptic Medication

    Time frame: At hospital discharge, approximately 4-92 days

Sponsors and collaborators

Lead sponsor

Michael Cotten

Other

Collaborators

  • The Robertson Foundation

Registry information

Official study title

A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)

Acronym: (HIE)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2015
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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