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Autologous Cord Blood Cells for Brain Injury in Term Newborns

Primary Purpose

Hypoxic Ischemic Encephalopathy

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Autologous cord blood
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy focused on measuring Hypoxic ischemic encephalopathy, Autologous cord blood

Eligibility Criteria

1 Day - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University Hospital
  • KK Women's and Children's Hospital
  • Singapore General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Autologous cord blood cells arm

Outcomes

Primary Outcome Measures

Safety
Adverse event rates occurring in the recipients

Secondary Outcome Measures

Neurodevelopment
Peabody tests, Bayley Scales of Infant Development
Brain imaging
MRI brain at 1-2 weeks old and 4-6 months old

Full Information

First Posted
July 23, 2012
Last Updated
January 25, 2017
Sponsor
National University Hospital, Singapore
Collaborators
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01649648
Brief Title
Autologous Cord Blood Cells for Brain Injury in Term Newborns
Official Title
Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National Medical Research Council (NMRC), Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic Ischemic Encephalopathy
Keywords
Hypoxic ischemic encephalopathy, Autologous cord blood

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Autologous cord blood cells arm
Intervention Type
Biological
Intervention Name(s)
Autologous cord blood
Intervention Description
Baby's own umbilical cord blood
Primary Outcome Measure Information:
Title
Safety
Description
Adverse event rates occurring in the recipients
Time Frame
1-3 days of age
Secondary Outcome Measure Information:
Title
Neurodevelopment
Description
Peabody tests, Bayley Scales of Infant Development
Time Frame
1 month-2 years old
Title
Brain imaging
Description
MRI brain at 1-2 weeks old and 4-6 months old
Time Frame
1 week-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiun Lee, MBBS
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Rajadurai, MBBS
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheo Lian Yeo, MBBS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
KK Women's and Children's Hospital
City
Singapore
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Autologous Cord Blood Cells for Brain Injury in Term Newborns

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