Trials / Completed
CompletedNCT02448641
Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 163 (actual)
- Sponsor
- SanBio, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SB623 Implant (2.5M) | 2.5 million SB623 cells |
| BIOLOGICAL | SB623 Implant (5.0M) | 5 million SB623 cells |
| PROCEDURE | Sham surgery |
Timeline
- Start date
- 2016-03-08
- Primary completion
- 2018-12-05
- Completion
- 2018-12-05
- First posted
- 2015-05-19
- Last updated
- 2020-10-08
- Results posted
- 2020-04-17
Locations
65 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02448641. Inclusion in this directory is not an endorsement.