Expanded Access Protocol: Umbilical Cord Blood Infusions for Children with Brain Injuries
This protocol is designed to enable access to treatment with intravenous infusions of banked autologous or sibling 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 autism will be eligible if they have normal immune function and do not qualify for 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.
- Rutgers Cancer Institute of New Jersey
Patients with documented cerebral palsy, hypoxic brain injury, stroke, hydrocephalus,
apraxia or other brain injuries will be eligible. In addition, patients who have competed
participation in a prior Duke cell therapy study (CP-AC, Duke ACT, CPSib, ACCeNT-CP, TACT,
IMPACT) and who have an eligible/qualified autologous or sibling cord blood unit are
eligible. To be eligible, patients must:
Inclusion Criteria
1. Have a qualifying sibling or autologous cord blood unit
2. Be < 26 years of age at the time of consent.
3. Have given written informed consent according to FDA guidelines (or consent of
parent/legal guardian as applicable).
4. Have baseline blood counts and basic chemistries within normal for age.
5. Have a normal absolute lymphocyte count (ALC) for age on baseline blood count and
differential.
Exclusion Criteria
1. Documented HIV or Hepatitis or other disease transmittable through the blood.
2. A cord blood unit that fails to meet specifications
3. Refusal of consent
4. Uncontrolled seizure disorder
5. Uncontrolled infection
6. Diagnosed with a genetic or metabolic disorder related to the neurologic condition
7. History of an immune deficiency
8. History of treatment with chemo or immunosuppressive therapy
9. History of previous allogeneic cell therapy outside of participation in a Duke
clinical trial
10. Need for mechanical ventilation or chronic O2 support
11. Unstable airway
12. Eligible for an active clinical trial of cellular therapy at Duke. If previously
enrolled on another Duke cell therapy protocol the subject can still be considered for
enrollment on this study after the follow-up period for the clinical trial is
completed.
13. Pregnant or breastfeeding
Umbilical Cord Blood Criteria
Patient enrollment is dependent on the availability of a banked unit of autologous or full
or partially (at least half) matched allogeneic sibling CB that has been stored at a
private or public bank and meets the following criteria:
Precryopreservation:
1. TNCC ≥2x107/kg
2. Sterility cultures performed and negative
3. Viability ≥70%
4. At least haploidentical HLA match for sibling units
5. Donor screening testing performed and negative
CBU Test sample
1. Segment or test vial available
2. Identity confirmed via HLA typing of test sample and donor
3. Viability testing recommended, but not required
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.