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:
National University Hospital, Singapore
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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoxic Ischemic Encephalopathy |
Biological: Autologous cord blood |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety |
Resource links provided by NLM:
Further study details as provided by National University Hospital, Singapore:
Primary Outcome Measures:
- Safety [ Time Frame: 1-3 days of age ] [ Designated as safety issue: Yes ]Adverse event rates occurring in the recipients
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Autologous cord blood cells arm
|
Biological: Autologous cord blood
Baby's own umbilical cord blood
|
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.
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649648
Contacts
| Contact: Jiun Lee, MBBS | 67725075 | lee_jiun@nuhs.edu.sg |
| Contact: Michelle Lim | 67725075 | michelle_ms_lim@nuhs.edu.sg |
Locations
| Singapore | |
| National University Hospital | Recruiting |
| Singapore, Singapore, 119074 | |
| Principal Investigator: Jiun Lee, MBBS | |
| Singapore General Hospital | Recruiting |
| Singapore, Singapore | |
| Principal Investigator: Cheo Lian Yeo, MBBS | |
| KK Women's and Children's Hospital | Recruiting |
| Singapore, Singapore | |
| Principal Investigator: Samuel Rajadurai, MBBS | |
Sponsors and Collaborators
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | National University Hospital, Singapore |
| ClinicalTrials.gov Identifier: | NCT01649648 History of Changes |
| Other Study ID Numbers: | NMRC/EDG/1032/2, EDG09nov061 |
| Study First Received: | July 23, 2012 |
| Last Updated: | July 24, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Keywords provided by National University Hospital, Singapore:
|
Hypoxic ischemic encephalopathy Autologous cord blood |
Additional relevant MeSH terms:
|
Brain Ischemia Ischemia Brain Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Hypoxia-Ischemia, Brain Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |
Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013