A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke

Status: Completed
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The primary purpose of the clinical study is to determine the safety of a modified stem cell SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke patients must be between 6 and 60 months after their stroke, and with only this one prior stroke, and with no further improvement from physical therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Documented history of one completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement

• Between 6 and 60 months post-stroke, and having a motor neurological deficit

• No significant further improvement with physical therapy/rehabilitation

• Able and willing to undergo computed tomography (CT), magnetic resonance imaging (MRI), and positron-emission tomography (PET) scans of the head

Locations
United States
Alabama
University of Alabama
Birmingham
California
Stanford University School of Medicine
Stanford
Georgia
Emory University
Atlanta
Illinois
Northwestern University Feinberg School of Medicine
Chicago
Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh
Time Frame
Start Date: 2011-01
Completion Date: 2015-08
Participants
Target number of participants: 18
Treatments
Experimental: SB623 Implant (2.5M)
2.5 million SB623 cells
Experimental: SB623 Implant (5.0M)
5 million SB623 cells
Experimental: SB623 Implant (10.0M)
10 million SB623 cells
Related Therapeutic Areas
Sponsors
Leads: SanBio, Inc.

This content was sourced from clinicaltrials.gov