Clinical Trial: Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy Study 1. Phase I Study of Feasibility and Safety.

Brief Summary: This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.

Detailed Summary: 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 whose mothers have previously consented to providing cord blood cells for the Carolinas Cord Blood Bank or other public or private bank that uses accepted standards for collection and handling of cells, or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood cells if an adequate number of cells that meet Carolinas Cord Blood Bank Quality standards are available in the first 14 postnatal days. 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 per clinical routine and results will be analyzed and described in study reports.
Sponsor: Michael Cotten

Current Primary Outcome: 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 ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: January 2, 2008
Date Started: January 2008
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017