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Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

NCT00593242 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-05-16

No results posted yet for this study

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

Interventions

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

OTHER

Neurodevelopmental outcomes

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

Sponsors & Collaborators

  • Michael Cotten

    lead OTHER

Principal Investigators

  • Charles M Cotten, MD MHS · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593242 on ClinicalTrials.gov