At a glance
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A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Traumatic Brain Injury (TBI)
In Brief
A Phase 2 clinical trial evaluating SB623 cells and Sham Control for Traumatic Brain Injury. Completed, enrolled 63 participants across 36 sites in 3 countries.
Detailed Summary
The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.
Study Details
Timeline
Interventions
SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
Sham Surgery