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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

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:

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

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

NCT ID

NCT01649648

First Posted

July 23, 2012

Last Updated

January 25, 2017

Sponsor

National University Hospital, Singapore

Collaborators

National Medical Research Council (NMRC), Singapore

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

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

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

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Autologous Cord Blood Cells for Brain Injury in Term Newborns

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