About the Study
This website was developed by researchers at the University of California, San Francisco (UCSF) in order to identify and pre-screen potential participants for ACTIsSIMA, a stem cell research study for stroke, and for future clinical research studies of therapies for stroke.
The research study is a Phase IIb clinical trial of a modified stem-cell therapy for stroke. Phase IIb is the FDA's (Food and Drug Administration) classification of this research study. Phase IIb studies are designed to test the safety of interventions as well as to assess whether the intervention works to treat stroke symptoms.
The research study will involve a neurosurgical procedure to administer modified stem cells directly to the injured brain and approximately seven follow-up visits over a twelve month period to assess safety and efficacy using CT and MRI scans, questionnaires, video recordings, and examinations.
Although this website (stemcellstudy.ucsf.edu) and the online eligibility questionnaire at (redcap.ucsf.edu) are developed and maintained at UCSF, all other study procedures for the actual stem cell study, including actual enrollment, consent, administration of the stem-cell therapy, and follow-up visits will occur at designated sites throughout the United States. All transportation and study-related costs for participation will be paid for by the study sponsor.
Additional information about the current research study is available at clinicaltrials.gov/ct2/show/study/NCT01287936, a service of the U.S. National Institutes of Health. ClinicalTrials.gov Identifier: NCT01287936.
Funding: The research study and as well as this eligibility questionnaire website are sponsored by SanBio, Inc.(www.san-bio.com).
How do I find out more about this research study?
If your questions are not answered on this website, click Contact Us
to find out more.
How do I find out if I might be eligible for this research study?
to take the Eligibility Questionnaire.