At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 163 enrolled
Drug / intervention
SB623 Implant (2.5M) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SB623 Implant (2.5M), SB623 Implant (5.0M), and 1 other intervention for Chronic Ischemic Stroke. Completed, enrolled 163 participants across 65 sites.
Detailed Summary
Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Ischemic Stroke
CountriesUnited States
CollaboratorsSumitomo Pharma America, Inc.
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartMar 2016
Primary CompletionDec 2018
TodayJul 2026
First PostedMay 19, 2015
Enrollment StartMar 8, 2016
Primary CompletionDec 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.1 years ago
Interventions
SB623 Implant (2.5M)biological
2.5 million SB623 cells
SB623 Implant (5.0M)biological
5 million SB623 cells
Sham surgeryprocedure