drugset / Trial / NCT03735277

Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects With Acute Ischemic Stroke

NCT03735277

Phase 1 Unknown 10 enrolled BHI Therapeutic Sciences
NaSingle-groupOpen-labelTreatment

Summary

This is a phase one study investigating the safety and efficacy profile of allogeneic cord blood hematopoietic progenitor cells (HPC, Cord Blood), when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Treatment period consisting of 3 sessions of both intravenous infusion and intrathecal injection (or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection). Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 3 months, 6 months and 12 months will include a neurological exam, MRI, and clinical laboratory tests/urinalysis.

Timeline

Start
2021-03-06
Primary completion
2022-07
Completion
2022-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine 2.5e+07 cells/kg Intravenous
Subject Influenza Virus Vaccine Vaccine 1.5e+09 cells Intravenous

Indications