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Autologous Cord Blood Cells for Brain Injury in Term Newborns

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.
 
ClinicalTrials.gov Identifier: NCT01649648
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE July 23, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date January 26, 2017
Actual Study Start Date  ICMJE September 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Safety [ Time Frame: 1-3 days of age ]
Adverse event rates occurring in the recipients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01649648 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Cord Blood Cells for Brain Injury in Term Newborns
Official Title  ICMJE Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety
Brief Summary 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypoxic Ischemic Encephalopathy
Intervention  ICMJE Biological: Autologous cord blood
Baby's own umbilical cord blood
Study Arms  ICMJE Experimental: Intervention
Autologous cord blood cells arm
Intervention: Biological: Autologous cord blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
10
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649648
Other Study ID Numbers  ICMJE NMRC/EDG/1032/2, EDG09nov061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE National Medical Research Council (NMRC), Singapore
Investigators  ICMJE
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
PRS Account National University Hospital, Singapore
Verification Date April 2012

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