NCT01649648

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 26, 2017

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

July 23, 2012

Last Update Submit

January 25, 2017

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic ischemic encephalopathyAutologous cord blood

Outcome Measures

Primary Outcomes (1)

  • Safety

    Adverse event rates occurring in the recipients

    1-3 days of age

Secondary Outcomes (2)

  • Neurodevelopment

    1 month-2 years old

  • Brain imaging

    1 week-6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Autologous cord blood cells arm

Biological: Autologous cord blood

Interventions

Autologous cord bloodBIOLOGICAL

Baby's own umbilical cord blood

Intervention

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Autologous umbilical cord blood available
  • \>36 weeks gestation
  • Brain injury that satisfies criteria for therapeutic hypothermia
  • Parental informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National University Hospital

Singapore, 119074, Singapore

Location

KK Women's and Children's Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 25, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2015

Last Updated

January 26, 2017

Record last verified: 2012-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(3)