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

July 23, 2012
July 24, 2012
September 2011
September 2013   (final data collection date for primary outcome measure)
Safety [ Time Frame: 1-3 days of age ] [ Designated as safety issue: Yes ]
Adverse event rates occurring in the recipients
Same as current
Complete list of historical versions of study NCT01649648 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Autologous Cord Blood Cells for Brain Injury in Term Newborns
Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety

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).

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypoxic Ischemic Encephalopathy
Biological: Autologous cord blood
Baby's own umbilical cord blood
Experimental: Intervention
Autologous cord blood cells arm
Intervention: Biological: Autologous cord blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
September 2015
September 2013   (final data collection date for primary outcome measure)

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
Both
up to 3 Days
No
Contact: Jiun Lee, MBBS 67725075 lee_jiun@nuhs.edu.sg
Contact: Michelle Lim 67725075 michelle_ms_lim@nuhs.edu.sg
Singapore
 
NCT01649648
NMRC/EDG/1032/2, EDG09nov061
No
National University Hospital, Singapore
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
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
National University Hospital, Singapore
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP