Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Michael Cotten, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00593242
First received: January 2, 2008
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Neonatal Hypoxic Ischemic Encephalopathy
Biological: infusion of autologous cord blood
Other: Neurodevelopmental outcomes
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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. [ Time Frame: during infusions: first 18 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: 25
Study Start Date: January 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: infusions
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
historical control
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

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 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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
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.
  • >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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 919-681-4844 cotte010@mc.duke.edu

Locations
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   
Sub-Investigator: Joanne Kurtzberg, MD         
Sub-Investigator: Allen Song, PhD         
Sub-Investigator: Ricki Goldstein, MD         
Sub-Investigator: Ronald Goldberg, MD         
Sub-Investigator: James Provenzale, MD         
Sponsors and Collaborators
Michael Cotten
Investigators
Principal Investigator: Charles M Cotten, MD MHS Duke University
  More Information

Additional Information:
Publications:

Responsible Party: Michael Cotten, Associate Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00593242     History of Changes
Other Study ID Numbers: Pro00000412, Duke NPRI01
Study First Received: January 2, 2008
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Hypoxia, Brain
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014