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Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

NCT03327467 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-01-23

No results posted yet for this study

Summary

This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.

Conditions

  • Cerebral Palsy
  • Hydrocephalus
  • Apraxia of Speech
  • Hypoxia Ischemia, Cerebral
  • Drowning; Anoxia

Interventions

BIOLOGICAL

Cord Blood Infusion

IV infusion of umbilical cord infusion (sibling, autologous, or unrelated donor)

Sponsors & Collaborators

  • Joanne Kurtzberg, MD

    lead OTHER

Principal Investigators

  • Joanne Kurtzberg · Duke University

  • Jessica Sun · Duke University

Eligibility

Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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 NCT03327467 on ClinicalTrials.gov