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Autologous Cord Blood Cells for Brain Injury in Term Newborns

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649648
First Posted: July 25, 2012
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety

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

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


Secondary Outcome Measures:
  • Neurodevelopment [ Time Frame: 1 month-2 years old ]
    Peabody tests, Bayley Scales of Infant Development

  • Brain imaging [ Time Frame: 1 week-6 months ]
    MRI brain at 1-2 weeks old and 4-6 months old


Enrollment: 2
Actual Study Start Date: September 2011
Study Completion Date: November 2015
Primary Completion Date: November 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649648


Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
KK Women's and Children's Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
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

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01649648     History of Changes
Other Study ID Numbers: NMRC/EDG/1032/2, EDG09nov061
First Submitted: July 23, 2012
First Posted: July 25, 2012
Last Update Posted: January 26, 2017
Last Verified: April 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Ischemia
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain


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