Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries
1 other identifier
expanded_access
N/A
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedJanuary 23, 2026
August 1, 2025
October 25, 2017
January 22, 2026
Conditions
Interventions
IV infusion of umbilical cord infusion (sibling, autologous, or unrelated donor)
Eligibility Criteria
You may qualify if:
- Age at Consent:
- Autologous: 0-26 years
- Sibling: 6 months - 26 years
- Unrelated Donor (Duke only): 6 months - 26 years
- Diagnosis
- Autologous and Sibling: Cerebral palsy, Hypoxic brain injury, Stroke, Hydrocephalus, Apraxia (without autism), Other brain injury
- Unrelated Donor (Duke only): Motor impairment secondary to: Hypoxic brain injury, Periventricular leukomalacia, Stroke/bleed, Congenital hydrocephalus
- Functional Status:
You may not qualify if:
- Unrelated Donor (Duke only): GMFCS level I-IV (age ≥2)
- No clinically significant abnormalities in blood counts and basic chemistries for age.
- Absolute Lymphocyte Count:
- for African American participants
- for all other participants
- Availability of a qualified autologous or Sibling CB Unit
- Autologous or Sibling: available
- Unrelated Donor (Duke only): N/A
- Written informed consent obtained from the parent or legal guardian.
- Documented HIV or Hepatitis or other disease transmittable through the blood.
- A cord blood unit that fails to meet specifications
- Refusal of consent
- Uncontrolled seizure disorder
- Uncontrolled infection
- Diagnosed with a genetic or metabolic disorder related to the neurologic condition
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rutgers Cancer Institutute
New Brunswick, New Jersey, 08901, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Kurtzberg
Duke University
- PRINCIPAL INVESTIGATOR
Jessica Sun
Duke University
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
October 25, 2017
First Posted
October 31, 2017
Last Updated
January 23, 2026
Record last verified: 2025-08