Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries (NCT03327467) | Clinical Trial Compass
AVAILABLENot Applicable
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 range26 Years
SexALL
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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