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:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT01700166
Eligibility Criteria:
Inclusion Criteria:
1. Between 6 weeks and 6 years of age on the day of study cord blood infusion.
2. MRI documented single arterial distribution infarction.
3. Initial injury occurring in the pre-natal or perinatal period.
4. Ability of caregivers to understand and speak English
5. Ability of child and caregiver to travel to Houston, and stay for at least 4 days, and to return for all Follow-up visits (patient is responsible for cost of travel and lodging while in Houston)
Exclusion Criteria:
Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation - must be sent to research team at least 14 days prior to scheduled study cord blood treatment.
1. Recent radiographic evidence (imaging performed within past 2 weeks) of extensive stroke as evidenced by \>100ml lesion.
2. Multifocal infarctions on screening MRI.
3. Evidence of hypoxic-ischemic encephalopathy on screening MRI.
4. Uncorrected coagulopathy during the baseline period defined as INR \> 1.4; PTT\> 35 sec; PLT \< 100,000.
5. Known history of:
1. Recently diagnosed infection (within past 2 weeks) requiring treatment and/or medical intervention.
2. Renal disease or altered renal function as defined by serum creatinine \> 1.5 mg/dL at admission.
3. Hepatic disease or altered liver function as defined by SGPT \> 150 U/L, and/or T. Bilirubin \>1.3 mg/dL at enrollment.
4. Malignancy.
5. Immunosuppression as defined by WBC \< 3 (10x3) at admission.
6. HIV, Hepatitis B, Hepatitis C.
6. Pneumonia, or chronic lung disease requiring oxygen.
7. Cord blood sample contamination.
8. Participation in a concurrent intervention study.
9. Desire for organ-donation in the event of death.
10. Unwillingness or inability to stay for at least four days following cord blood infusion (should any problems arise following the infusion) and to return for 6 month, 1 year, and 2 year follow-up visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
6 Years
Study:
NCT01700166
Study Brief:
Protocol Section:
NCT01700166