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

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ClinicalTrials.gov Identifier: NCT02612155
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
The Robertson Foundation
Information provided by (Responsible Party):
Michael Cotten, Duke University

Brief Summary:
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 or disease Intervention/treatment Phase
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns Biological: Infusion of autologous cord blood Biological: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Survival at one year [ Time Frame: One year ]
  2. Percentage of subjects with Bayley III scores in all three domains > or equal to 85 [ Time Frame: One year ]
    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 :
  1. Mortality rate [ Time Frame: One year ]
  2. Percentage of subjects who experience seizures [ Time Frame: One year ]
  3. Percentage of subjects who require iNO use [ Time Frame: One year ]
  4. Percentage of subjects who require ECMO [ Time Frame: One year ]
  5. Percentage of subjects who require G-tube feeding [ Time Frame: One year ]
  6. Percentage of subjects who are discharged on anti-epileptic meds [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Michael Cotten, Associate Professor, Duke University
ClinicalTrials.gov Identifier: NCT02612155     History of Changes
Other Study ID Numbers: Pro00066647
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Cotten, Duke University:
Hypoxic-ischemic encephalopathy
autologous cord blood cells
newborn infants

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