NCT02612155|CompletedPhase 2ResultsDMCFDA Drug
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(HIE)
A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
Sponsor study identifier
interventional
35
1 country
1
Study Start
March 30, 2017
Actual (reported)Primary Completion
August 5, 2019
Actual (reported)Study Completion
August 5, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 5, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2015
Actual (reported)November 23, 2015
Actual (reported)March 30, 2017
Actual (reported)August 5, 2019
Actual (reported)August 5, 2019
Actual (reported)August 25, 2020
Actual (reported)Survival at One Year
Number of participants alive at one year.
1 year
Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85
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.
1 year
Mortality Rate
1 year
Number of Subjects Who Experience Seizures
During hospitalization, approximately 4-92 days
Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use
During hospitalization, approximately 4-92 days
Number of Subjects Who Require ECMO
During hospitalization, approximately 4-92 days
Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding
During hospitalization, approximately 4-92 days
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
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
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.
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.
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cotten CM, Murtha AP, Goldberg RN, Grotegut CA, Smith PB, Goldstein RF, Fisher KA, Gustafson KE, Waters-Pick B, Swamy GK, Rattray B, Tan S, Kurtzberg J. Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. J Pediatr. 2014 May;164(5):973-979.e1. doi: 10.1016/j.jpeds.2013.11.036. Epub 2013 Dec 31.
Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. doi: 10.1056/NEJMcps050929.
Michael Cotten, MD
Duke University
35 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2015
First Posted
November 23, 2015
Study Start
March 30, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Escolar ML, Poe MD, Provenzale JM, Richards KC, Allison J, Wood S, Wenger DA, Pietryga D, Wall D, Champagne M, Morse R, Krivit W, Kurtzberg J. Transplantation of umbilical-cord blood in babies with infantile Krabbe's disease. N Engl J Med. 2005 May 19;352(20):2069-81. doi: 10.1056/NEJMoa042604.
Primary Completion
August 5, 2019
Actual (reported)Study Completion
August 5, 2019
Actual (reported)Last Updated
May 16, 2024
Results First Posted
August 25, 2020
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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