Hypoxic Ischemic EncephalopathyPhase 1NCT01649648
Autologous Cord Blood Cells for Brain Injury in Term Newborns
A Phase 1 study testing Autologous cord blood in people with Hypoxic Ischemic Encephalopathy, run by National University Hospital, Singapore at 3 sites in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy
- What is being tested?
- Autologous cord blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesSingapore
- Study dates
- Sep 2011to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autologous umbilical cord blood available
- >36 weeks gestation
- Brain injury that satisfies criteria for therapeutic hypothermia
- Parental informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
National University Hospital
Singapore, 119074
KK Women's and Children's Hospital
Singapore
Singapore General Hospital
Singapore
About this study
Official title: Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety
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).
Read the 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.
- Conditions
- Hypoxic Ischemic Encephalopathy
- Being tested
- Autologous cord blood
- Keywords
- Hypoxic ischemic encephalopathy, Autologous cord blood
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cord bloodBiological
Baby's own umbilical cord blood
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Autologous cord blood cells arm Receives: Biological: Autologous cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse event rates occurring in the recipients
Measured: 1-3 days of age
Secondary outcomes (2)
Neurodevelopment
Peabody tests, Bayley Scales of Infant Development
Measured: 1 month-2 years old
Brain imaging
MRI brain at 1-2 weeks old and 4-6 months old
Measured: 1 week-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Jiun Lee, MBBS, Principal investigator, National University Hospital, SingaporeSamuel Rajadurai, MBBS, Principal investigator, KK Women's and Children's HospitalCheo Lian Yeo, MBBS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649648
- Sponsor's protocol ID
- NMRC/EDG/1032/2, EDG09nov061
- Status last verified
- Apr 2012
- First submitted
- 23 Jul 2012
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety
- ClinicalTrials.gov ID
- NCT01649648
- Acronym / sponsor ID
- NMRC/EDG/1032/2, EDG09nov061
- Conditions
- Hypoxic Ischemic Encephalopathy
- Keywords
- Hypoxic ischemic encephalopathy, Autologous cord blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Sep 2011 (actual)
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: Autologous cord bloodAutologous cord blood cells arm |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Autologous umbilical cord blood available
- >36 weeks gestation
- Brain injury that satisfies criteria for therapeutic hypothermia
- Parental informed consent
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous cord bloodBaby's own umbilical cord blood | Biological | Intervention |
Primary outcome
Safety
Time frame: 1-3 days of age
Adverse event rates occurring in the recipients
2 secondary outcomes
Neurodevelopment
Time frame: 1 month-2 years old
Brain imaging
Time frame: 1 week-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Hypoxic Ischemic Encephalopathy
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The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiun Lee, MBBS principal investigator
National University Hospital, Singapore
Samuel Rajadurai, MBBS principal investigator
KK Women's and Children's Hospital
Cheo Lian Yeo, MBBS principal investigator
Singapore General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous cord blood in people with Hypoxic Ischemic Encephalopathy, run by National University Hospital, Singapore at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 1-3 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.