drugset / Trial / NCT03004976

Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke

NCT03004976

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or myeloablative medications prior to the infusion. Subjects will be followed for one year post infusion for safety and efficacy. Assessments will examine safety and tolerability of the infusion, change in neurological symptoms, change in quality of life, and emotional and cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and 365 days post infusion.

Timeline

Start
2017-03-14
Primary completion
2020-07-17
Completion
2021-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine 5e+06 cells/kg Intravenous
Subject Influenza Virus Vaccine Vaccine 5e+07 cells/kg Intravenous