Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Cord Blood for Neonatal Hypoxic-Ischemic Encephalopathy
This study is currently recruiting participants.
Verified by Duke University, January 2008
Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00593242
  Purpose

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
Neonatal Hypoxic Ischemic Encephalopathy
Other: autologous cord blood
Other: autologous cord blood cells
Phase I

U.S. FDA Resources
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.

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls from the Network Hypothermia study. [ Time Frame: during infusions: first 4 postnatal days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
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)
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
1B: Experimental
infants who arrive after 6 postnatal hours but before 24 postnatal hours and will not be cooled (Group B).
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).

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 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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers must have consented for cord blood collection at delivery
  • cord blood must be available for extraction of stem cells.
  • >36 weeks gestation
  • cord or neonatal pH<7.0 or base deficit>16 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.

Exclusion Criteria:

  • Inability to enroll by 24 hours 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593242

Contacts
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

Locations
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    
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Charles M Cotten, MD MHS Duke University
  More Information

Carolinas Cord Blood Bank web page  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by Duke University:
hypoxic-ischemic encephalopathy
autologous cord blood cells
newborn infants

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Central Nervous System Viral Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009