Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
AgeUp to 26
SponsorJoanne Kurtzberg, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Autologous: 0-26 years
Sibling: 6 months - 26 years
Unrelated Donor (Duke only): 6 months - 26 years
Diagnosis
Disqualifiers
Unrelated Donor (Duke only): GMFCS level I-IV (age ≥2)
No clinically significant abnormalities in blood counts and basic chemistries for age.
1200 for African American participants
1500 for all other participants
Trial design
Treatments tested in this trial
Cord Blood Infusion
Biological/VaccineIV infusion of umbilical cord blood (sibling, autologous, or unrelated donor)
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Joanne Kurtzberg, MD
Lead sponsor
Duke University
Sponsor institution
Source ClinicalTrials.gov