Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries (NCT03327467) | Clinical Trial Compass
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Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries
United States
Plain-language 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.
Who can participate
Age range
26 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is listed as an 'Expanded Access' protocol rather than a standard clinical trial — what does that mean for my child, and does it affect what safety and effectiveness data will be collected about them?
2Since this protocol covers a range of brain injury causes including cerebral palsy, hypoxic-ischemic injury, and near-drowning — does my child's specific diagnosis and how long ago the injury happened make them a good or poor candidate to discuss with the treating team?
3Umbilical cord blood infusions require a matched or banked cord blood unit — should we be asking about whether my child's own stored cord blood could be used, or would donor blood be needed, and how does that difference affect risk?
4Given that this is an expanded access program rather than a Phase 1, 2, or 3 trial, what is currently known about the safety of cord blood infusions in children with brain injuries, and are there any side effects we should specifically ask the team to walk us through?
5Are there standard rehabilitative therapies or other treatment approaches my doctor would recommend we try alongside or before pursuing something like this expanded access protocol, so we can make a fully informed comparison?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.