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

NCT02612155 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-05-16

Study results available
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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.

Conditions

  • Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns

Interventions

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.

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.

Sponsors & Collaborators

  • The Robertson Foundation

    collaborator OTHER

  • Michael Cotten

    lead OTHER

Principal Investigators

  • Michael Cotten, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2019-08-05
Completion
2019-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02612155 on ClinicalTrials.gov