Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 12:29 AM
NCT ID:
NCT03327467
Eligibility Criteria:
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:
Inclusion Criteria:
1. Age at Consent:
1. Autologous: 0-26 years
2. Sibling: 6 months - 26 years
3. Unrelated Donor (Duke only): 6 months - 26 years
2. Diagnosis
1. Autologous and Sibling: Cerebral palsy, Hypoxic brain injury, Stroke, Hydrocephalus, Apraxia (without autism), Other brain injury
2. Unrelated Donor (Duke only): Motor impairment secondary to: Hypoxic brain injury, Periventricular leukomalacia, Stroke/bleed, Congenital hydrocephalus
3. Functional Status:
1. Autologous and Sibling: See exclusion criteria
2. Unrelated Donor (Duke only): GMFCS level I-IV (age ≥2)
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.
6. Availability of a qualified autologous or Sibling CB Unit
1. Autologous or Sibling: available
2. Unrelated Donor (Duke only): not available
7. Written informed consent obtained from the parent or legal guardian.
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 participant may 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
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:
1. TNCC ≥2x107/kg
2. Sterility cultures performed and negative
3. Viability ≥70%
4. At least haploidentical HLA match for sibling units and at least a 4/6 HLA match for unrelated donor 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
Sex:
ALL
Maximum Age:
26 Years
Study:
NCT03327467
Study Brief:
Protocol Section:
NCT03327467