Cerebral Palsy Clinical Trial
Official title:
Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries
NCT number | NCT03327467 |
Other study ID # | Pro00083888 |
Secondary ID | |
Status | Available |
Phase | |
First received | |
Last updated |
The purpose of this protocol is to enable access to intravenous infusions of banked autologous (a person's own) or sibling umbilical cord blood (CB) for children with various brain disorders. This is an expanded access protocol intended for patients who are unable to participate in a clinical trial involving their own or their sibling's cord blood. 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. The cord blood is thawed and then administered as an intravenous infusion. Recipients do not receive chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.
Status | Available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 26 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | Rutgers Cancer Institutute | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Joanne Kurtzberg, MD |
United States,
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