Chronic Ischemic Stroke Clinical Trial
Official title:
A Double-Blind, Controlled Phase 2b Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke
This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection
of SB623 cells in patients with fixed motor deficits from ischemic stroke. The study will be
conducted at approximately 65 sites in the United States.
Two cohorts, Group 1 (2.5 and 5 million SB623 cells combined) and Group 2 (sham placebo),
will be included in this study. Subjects who are randomized into this study will receive
either 2.5 million SB623 cells, 5 million SB623 cells or sham surgery at a 1:1:1
randomization ratio. Randomization will be performed via an interactive web/voice response
system (IXRS), stratified by Screening mRS score (recorded in the IXRS at the clinical site).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Phase 1 | |
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||
| Completed |
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Phase 1/Phase 2 |