Autologous Cord Blood Cells for Brain Injury in Term Newborns

This study is currently recruiting participants.
Verified April 2012 by National University Hospital, Singapore
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01649648
First received: July 23, 2012
Last updated: July 24, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Hypoxic Ischemic Encephalopathy
Biological: Autologous cord blood
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Safety [ Time Frame: 1-3 days of age ] [ Designated as safety issue: Yes ]
    Adverse event rates occurring in the recipients


Secondary Outcome Measures:
  • Neurodevelopment [ Time Frame: 1 month-2 years old ] [ Designated as safety issue: No ]
    Peabody tests, Bayley Scales of Infant Development

  • Brain imaging [ Time Frame: 1 week-6 months ] [ Designated as safety issue: No ]
    MRI brain at 1-2 weeks old and 4-6 months old


Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Autologous cord blood cells arm
Biological: Autologous cord blood
Baby's own umbilical cord blood

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Autologous umbilical cord blood available
  2. >36 weeks gestation
  3. Brain injury that satisfies criteria for therapeutic hypothermia
  4. Parental informed consent

Exclusion Criteria:

  1. Inability to enroll by 3 postnatal days of age.
  2. Presence of known chromosomal anomaly.
  3. Presence of major congenital anomalies.
  4. Severe intrauterine growth restriction
  5. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
  6. Parents refuse consent.
  7. Attending neonatologist refuses consent.
  8. Failure to collect the infant's cord blood and/or laboratory unable to process cord blood
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649648

Contacts
Contact: Jiun Lee, MBBS 67725075 lee_jiun@nuhs.edu.sg
Contact: Michelle Lim 67725075 michelle_ms_lim@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Principal Investigator: Jiun Lee, MBBS         
Singapore General Hospital Recruiting
Singapore, Singapore
Principal Investigator: Cheo Lian Yeo, MBBS         
KK Women's and Children's Hospital Recruiting
Singapore, Singapore
Principal Investigator: Samuel Rajadurai, MBBS         
Sponsors and Collaborators
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Jiun Lee, MBBS National University Hospital, Singapore
Principal Investigator: Samuel Rajadurai, MBBS KK Women's and Children's Hospital
Principal Investigator: Cheo Lian Yeo, MBBS Singapore General Hospital
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01649648     History of Changes
Other Study ID Numbers: NMRC/EDG/1032/2, EDG09nov061
Study First Received: July 23, 2012
Last Updated: July 24, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Hypoxic ischemic encephalopathy
Autologous cord blood

Additional relevant MeSH terms:
Hypoxia-Ischemia, Brain
Hypoxia, Brain
Brain Ischemia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on April 22, 2014