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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00593242 |
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood if the baby is born with signs of brain injury.
Condition | Intervention | Phase |
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Neonatal Hypoxic Ischemic Encephalopathy |
Other: autologous cord blood Other: autologous cord blood cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety. |
Estimated Enrollment: | 12 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1A: Experimental
infants who arrive at a study site at < 6 hours of postnatal life and are treated with induced whole body hypothermia by 6 postnatal hours (Group 1A)
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Other: autologous cord blood
A maximum of 4 aliquots of volume-reduced autologous cord blood cells, with the first dose given in the first 8 postnatal hours, and then subsequent doses at 24, 48 and 72 hours postnatally.The number of doses will be determined by the amount of available cord blood cells. The dose for each infusion is 5x10e7 cells/kg
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1B: Experimental
infants who arrive after 6 postnatal hours but before 24 postnatal hours and will not be cooled (Group B).
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Other: autologous cord blood cells
A maximum of 4 aliquots of volume-reduced autologous cord blood cells, with the first dose given in the first 24 postnatal hours, and then subsequent doses at 24, 48 and 72 hours postnatally.The number of doses will be determined by the amount of available cord blood cells. The dose for each infusion is 5x10e7 cells/kg. If the first dose is given between 12 and 24 postnatal hours, only 3 doses will be given (first dose, dose 2 at 48 hours, dose 3 at 72 hours).
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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 whose mothers have previously consented to providing cord blood cells for the Carolinas Cord Blood Bank or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, who have adequate cord blood collected, and have signs of moderate to severe encephalopathy will be given cells in addition to current therapies used at the study institution, Duke. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months at Duke's Special Infant Care Clinic. MRI's will be obtained between postnatal weeks 1 and 4, and, for study purposes at 4 - 6 postnatal months.
Ages Eligible for Study: | up to 24 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kimberley A Fisher, PhD | 919-681-4913 | kimberley.fisher@duke.edu |
Contact: Charles M Cotten, MD MHS | 919-681-6024 | cotte010@mc.duke.edu |
United States, California | |
Oakland Children's Hospital | Not yet recruiting |
Oakland, California, United States, 94609 | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Kimberley A Fisher, PhD 919-681-4913 kimberley.fisher@duke.edu |
Principal Investigator: | Charles M Cotten, MD MHS | Duke University |
Responsible Party: | Duke University ( Charles Michael Cotten MD MHS ) |
Study ID Numbers: | Pro00000412, Duke NPRI01 |
Study First Received: | January 2, 2008 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00593242 |
Health Authority: | United States: Institutional Review Board |
hypoxic-ischemic encephalopathy autologous cord blood cells newborn infants |
Liver Diseases Neurotoxicity Syndromes Hypoxia, Brain Brain Damage, Chronic Disorders of Environmental Origin Brain Diseases Cerebrovascular Disorders Signs and Symptoms Hypoxia-Ischemia, Brain Mental Disorders Brain Ischemia Brain Injuries Dementia Neurobehavioral Manifestations Delirium |
Hepatic Insufficiency Liver Failure Metabolic Diseases Neurotoxicity syndromes Poisoning Vascular Diseases Central Nervous System Diseases Confusion Ischemia Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Pathologic Processes Nervous System Diseases Central Nervous System Viral Diseases Cardiovascular Diseases |