Skip to main content
OpenTrials
Completed

NCT Number: NCT01649648

Autologous Cord Blood Cells for Brain Injury in Term Newborns

This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxic Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KK Women's and Children's Hospital, Singapore

Loading trial locations.

About this study

The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Autologous umbilical cord blood available
  • >36 weeks gestation
  • Brain injury that satisfies criteria for therapeutic hypothermia
  • Parental informed consent

Exclusion criteria

  • Inability to enroll by 3 postnatal days of age.
  • Presence of known chromosomal anomaly.
  • Presence of major congenital anomalies.
  • Severe intrauterine growth restriction
  • Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
  • Parents refuse consent.
  • Attending neonatologist refuses consent.
  • Failure to collect the infant's cord blood and/or laboratory unable to process cord blood

Treatment and study plan

Autologous cord blood

Biological

Baby's own umbilical cord blood

Primary outcomes

  1. Safety

    Time frame: 1-3 days of age

    Adverse event rates occurring in the recipients

Secondary outcomes

  1. Neurodevelopment

    Time frame: 1 month-2 years old

    Peabody tests, Bayley Scales of Infant Development

  2. Brain imaging

    Time frame: 1 week-6 months

    MRI brain at 1-2 weeks old and 4-6 months old

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study title

Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Jul 25, 2012
Registry last updated
Jan 26, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.