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

Status:

AVAILABLE

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

Lead Sponsor:

Joanne Kurtzberg, MD

Conditions:

Cerebral Palsy

Hydrocephalus

Eligibility:

All Genders

Up to 26 years

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 disorde...

Detailed Description

The primary purpose of this protocol is to enable access to autologous (a person's own) or allogeneic (someone else's) umbilical cord blood infusion for children with various brain disorders. Children...

Eligibility Criteria

Inclusion

Under this protocol, participants may be eligible for infusion of autologous, sibling, and/or unrelated donor CB cells (Duke only). Some eligibility criteria vary based on CB source. For all participants, eligibility is predicated on the availability of a qualifying CB unit To be eligible, patients must:
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:
Autologous and Sibling: See exclusion criteria
Unrelated Donor (Duke only): GMFCS level I-IV (age ≥2)
Have baseline blood counts and basic chemistries within normal for age.
Have a normal absolute lymphocyte count (ALC) for age on baseline blood count and differential.
Availability of a qualified autologous or Sibling CB Unit
Autologous or Sibling: available
Unrelated Donor (Duke only): not available
Written informed consent obtained from the parent or legal guardian.

Exclusion

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
History of an immune deficiency
History of treatment with chemo or immunosuppressive therapy
History of previous allogeneic cell therapy outside of participation in a Duke clinical trial
Need for mechanical ventilation or chronic O2 support
Unstable airway
Eligible for an active clinical trial of cellular therapy at Duke. If previously enrolled on another Duke cell therapy protocol the participant may still be considered for enrollment on this study after the follow-up period for the clinical trial is completed.
Pregnant or breastfeeding
Umbilical Cord Blood Criteria
Participant enrollment is dependent on the availability of a banked unit of autologous or sibling CB that has been stored at a private or public bank, or, if enrolling at Duke, availability of a publicly banked unrelated donor unit. Units must meet the following criteria:
Precryopreservation:
TNCC ≥2x107/kg
Sterility cultures performed and negative
Viability ≥70%
At least haploidentical HLA match for sibling units and at least a 4/6 HLA match for unrelated donor units
Donor screening testing performed and negative
CBU Test sample
Segment or test vial available
Identity confirmed via HLA typing of test sample and donor
Viability testing recommended, but not required

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03327467

Last Update

August 15 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

Rutgers Cancer Institutute

New Brunswick, New Jersey, United States, 08901