Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

NCT00593242 | Completed Phase 1

• 2 other identifiers: Pro00000412Duke NPRI01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Keywords

hypoxic-ischemic encephalopathy; autologous cord blood cells; newborn infants

Outcome Measures

Primary Outcomes (1)

• Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls.

  during infusions: first 18 postnatal days

Secondary Outcomes (2)

• 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

  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.

  6 months

Study Arms (2)

infusions

EXPERIMENTAL

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

historical control

OTHER

Infants who had moderate to severe hypoxic ischemic encephalopathy in the neonatal period but did not receive autologous cord blood cells.

Other: Neurodevelopmental outcomes

Interventions

infusion of autologous cord blood BIOLOGICAL

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

infusions

Neurodevelopmental outcomes OTHER

historical controls, no experimental intervention, standard therapies of hypoxic ischemic encephalopathy in the newborn period with autologous cord blood

historical control

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Cotten: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

• Martin PL, Carter SL, Kernan NA, Sahdev I, Wall D, Pietryga D, Wagner JE, Kurtzberg J. Results of the cord blood transplantation study (COBLT): outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with lysosomal and peroxisomal storage diseases. Biol Blood Marrow Transplant. 2006 Feb;12(2):184-94. doi: 10.1016/j.bbmt.2005.09.016.

  PMID: 16443516 BACKGROUND

• Kurtzberg J, Lyerly AD, Sugarman J. Untying the Gordian knot: policies, practices, and ethical issues related to banking of umbilical cord blood. J Clin Invest. 2005 Oct;115(10):2592-7. doi: 10.1172/JCI26690.

  PMID: 16200191 BACKGROUND

• 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.

  PMID: 15901860 BACKGROUND

• Staba SL, Escolar ML, Poe M, Kim Y, Martin PL, Szabolcs P, Allison-Thacker J, Wood S, Wenger DA, Rubinstein P, Hopwood JJ, Krivit W, Kurtzberg J. Cord-blood transplants from unrelated donors in patients with Hurler's syndrome. N Engl J Med. 2004 May 6;350(19):1960-9. doi: 10.1056/NEJMoa032613.

  PMID: 15128896 BACKGROUND

• McGraw P, Liang L, Escolar M, Mukundan S, Kurtzberg J, Provenzale JM. Krabbe disease treated with hematopoietic stem cell transplantation: serial assessment of anisotropy measurements--initial experience. Radiology. 2005 Jul;236(1):221-30. doi: 10.1148/radiol.2353040716.

  PMID: 15987975 BACKGROUND

• 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.

  PMID: 24388332 RESULT

Related Links

• Carolinas Cord Blood Bank web page

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles M Cotten, MD MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 14, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)