Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke (NCT02460484) | Clinical Trial Compass
SuspendedPhase 1/2
Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke
Stopped: Restructuring Cell Lab
United States10 participantsStarted 2015-04
Plain-language summary
Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to children who have suffered from a Perinatal Arterial Ischemic Stroke. The aim is to determine if hUCB infusion is safe, if late functional outcome is improved, if hUCB treatment improves physiologic response in the child's SSEP \& EEG, and the effect of hUCB infusion in altering anatomic findings on MRI.
Who can participate
Age range6 Weeks ā 6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Between 6 weeks and 6 years of age on the day of study cord blood infusion.
ā. MRI documented single arterial distribution infarction.
ā. Initial injury occurring in the prenatal or perinatal period
ā. Ability of child and caregiver to travel to Orlando, 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 Orlando)
Exclusion criteria
ā. 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 FHFC research team 14 days prior to scheduled study cord blood treatment. Need brain MRI with flair sequence \<2 weeks old.
ā. Recent radiographic evidence (imaging performed within past 2 weeks) of extensive stroke as evidenced by \>100ml lesion
ā. Multifocal infarctions on screening MRI.
ā. Evidence of hypoxic-ischemic encephalopathy on screening MRI.