Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 2 of 3 for:    cord blood hypoxia duke

A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy ((HIE))

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Duke University
Sponsor:
Collaborator:
The Robertson Foundation
Information provided by (Responsible Party):
Michael Cotten, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT02612155
First received: November 19, 2015
Last updated: June 17, 2016
Last verified: June 2016
  Purpose
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.

Condition Intervention Phase
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
Biological: Infusion of autologous cord blood
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Survival at one year [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Percentage of subjects with Bayley III scores in all three domains > or equal to 85 [ Time Frame: One year ] [ Designated as safety issue: No ]
    The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15.


Secondary Outcome Measures:
  • Mortality rate [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Percentage of subjects who experience seizures [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Percentage of subjects who require iNO use [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Percentage of subjects who require ECMO [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Percentage of subjects who require G-tube feeding [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Percentage of subjects who are discharged on anti-epileptic meds [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention cell recipients
Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
Biological: Infusion of autologous cord blood
Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.
Placebo Comparator: Placebo recipients
Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
Biological: Placebo
Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.

Detailed Description:
The purpose of this phase II study is to assess the safety and efficacy of up to two intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.
  Eligibility

Ages Eligible for Study:   up to 6 Hours   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria
  2. Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age
  3. The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
  4. All infants must have signs of encephalopathy within 6 hours of age

Exclusion Criteria:

  1. Major congenital or chromosomal abnormalities
  2. Severe growth restriction (birth weight <1800 g)
  3. Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
  4. Moribund neonates for whom no further treatment is planned
  5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
  6. Infants suspected of overwhelming sepsis
  7. ECMO initiated or likely in the first 48 hours of life
  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: NCT02612155

Contacts
Contact: Kimberley A Fisher, PhD (919) 681-4913 kimberley.fisher@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kimberley A Fisher, PhD    919-681-4913    kimberley.fisher@duke.edu   
Contact: Charles M Cotten, MD         
Sponsors and Collaborators
Michael Cotten
The Robertson Foundation
Investigators
Principal Investigator: Michael Cotten, MD Duke University
  More Information

Publications:
Responsible Party: Michael Cotten, Associate Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT02612155     History of Changes
Other Study ID Numbers: Pro00066647 
Study First Received: November 19, 2015
Last Updated: June 17, 2016
Health Authority: United States: Federal Government
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:
Hypoxia-Ischemia, Brain
Hypoxia, Brain
Ischemia
Brain Diseases
Brain Ischemia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016