Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
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|ClinicalTrials.gov Identifier: NCT00593242|
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : March 21, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hypoxic Ischemic Encephalopathy||Biological: infusion of autologous cord blood Other: Neurodevelopmental outcomes||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
infants who arrive at the study site within the first 14 postnatal days and had a history of moderate to severe hypoxic ischemic encephalopathy, and have cells available for infusion that pass Carolinas Cord Blood Bank Quality checks Outcomes will be measured at 22-26 months fby neurodevelopment assessment
Biological: infusion of autologous cord blood
infants who meet study enrollment criteria for history of moderate to severe hypoxic ischemic encephalopathy in the neonatal period will receive up to 4 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells. The dose for each infusion is 5x10e7 cells/kg
Infants who had moderate to severe hypoxic ischemic encephalopathy in the neonatal period but did not receive autologous cord blood cells.
Other: Neurodevelopmental outcomes
historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood
- Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. [ Time Frame: during infusions: first 18 postnatal days ]
- Secondary endpoints of this pilot study will include preliminary efficacy as measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age [ Time Frame: 1 year ]
- neuroimaging results will be collected and compared with available results from prior trials of therapies in this population, and from a previously collected set of images from normal term newborns through the first year of life. [ Time Frame: 6 months ]
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|Ages Eligible for Study:||up to 14 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Mothers must have consented for cord blood collection at delivery
- cord blood must be available for extraction of stem cells.
- >34 weeks gestation
- cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
- either a 10 minute Apgar < 5 or continued need for ventilation.
- All infants must have signs of encephalopathy within 6 hours of age.
- Inability to enroll by 14 days of age.
- Presence of known chromosomal anomaly.
- Presence of major congenital anomalies.
- Severe intrauterine growth restriction (weight <1800g)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593242
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Charles M Cotten, MD MHS||Duke University|
Publications of Results:
|Responsible Party:||Michael Cotten, Associate Professor of Pediatrics, Duke University|
|Other Study ID Numbers:||
|First Posted:||January 14, 2008 Key Record Dates|
|Last Update Posted:||March 21, 2017|
|Last Verified:||March 2017|
autologous cord blood cells
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory