Umbilical Cord Blood in the Treatment of Stroke in Children. (NCT01700166) | Clinical Trial Compass
WithdrawnPhase 1
Umbilical Cord Blood in the Treatment of Stroke in Children.
Stopped: Principal Investigator relocated; Study may resume in Fl Hosp. for Children, Orlando FL
United States0Started 2012-09
Plain-language summary
The specific aims of this study are:
1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS).
2. To determine if late functional outcome, physiologic response, and anatomic findings are changed following hUCB infusion in children with perinatal AIS.
Who can participate
Age range6 Weeks – 6 Years
SexALL
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Inclusion criteria
✓. Between 6 weeks and 6 years of age on the day of study cord blood infusion.
✓. MRI documented single arterial distribution infarction.
✓. Initial injury occurring in the pre-natal or perinatal period.
✓. Ability of caregivers to understand and speak English
✓. 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
✕. Recent radiographic evidence (imaging performed within past 2 weeks) of extensive stroke as evidenced by \>100ml lesion.
✕. Multifocal infarctions on screening MRI.
✕. Evidence of hypoxic-ischemic encephalopathy on screening MRI.
✕. Uncorrected coagulopathy during the baseline period defined as INR \> 1.4; PTT\> 35 sec; PLT \< 100,000.
✕. Known history of:
✕. Recently diagnosed infection (within past 2 weeks) requiring treatment and/or medical intervention.
✕. Renal disease or altered renal function as defined by serum creatinine \> 1.5 mg/dL at admission.