Double-blind, controlled Phase 2b study of the safety and efficacy of modified stem cells (SB623) in patients with chronic motor deficits from ischemic stroke
Brain & Nerve
Leonid Groysman, MD
UC Irvine Medical Center; UCI Institute for Clinical and Translational Science (ICTS), Orange Campus; ICTS, Irvine Campus (Hewitt Hall)
This study is being conducted to determine the safety and efficacy of a cell suspension of SB623 cells administered by injection into the brain around the area of the stroke. This is a one-time administration during a single surgery.
Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; the study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study.
You can participate in this study if you:
- Are between the ages of 18-75 years
- Have a documented history of stroke confirmed by Magnetic Resonance Imaging (MRI) scan, between 6 and 90 months ago
- Have reduced movement in your arm or leg due to your stroke
- Are able and willing to have MRI and computed tomography (CT) scans
- Agree that you will not take blood thinners and other drugs that may thin your blood after your surgery until your study doctor advises you it is safe to do so
- Have had physical therapy before entering the study and are willing to continue to the extent possible
- Are willing to discontinue herbal or non-traditional medicines for 1 week before and 1 week after the surgical procedure
- Are able to understand and sign an informed consent form
You cannot participate in this study if you:
- Have any significant conditions or situation that the study doctor believes may interfere with your safety or the intent and conduct of the study
- Have had a stroke above a certain size as measured by MRI (150 cubic centimeters)
- Have had a heart attack in the past six (6) months
- Have had any seizures in the last three (3) months
- Have substantially reduced mobility in your joints
- Have abnormal lab tests that might signify a significant illness or cancer, unless in remission for more than five (5) years
You will undergo up to 12 weeks of screening before having a single surgery that will require you to spend at least 24 hours in the hospital following the operation. After that, the researchers will ask you to visit the office for follow-up exams for at least six (6) visits over a period of about 12 months.
The primary goal of this study is to establish the safety and efficacy of SB623 cell implantation rather than to maximize the chance for improvement. Accordingly, you should not expect to receive benefit from participation in this study. As a participant in this study, your condition may improve, stay the same, or worsen. Taking part in this study may or may not make your health better. While researchers hope the experimental drug, SB623, will be effective in reducing motor deficit after stroke, there is no proof of this yet.
Subjects will receive token items as expressions of appreciation for their participation in the study. These items are intended to be of use to the subject during the study. For example, tote bags will be provided to the subject and accompanying caregiver prior to the hospital stay to facilitate the subject bringing personal items to the hospital. A fleece travel blanket and portable electronic device charger will be also provided to the subject. Of nominal value, the items will express appreciation for the subjects’ participation without possibility of coercion. The total value of these items is approximately $42.
INT - Drug
Veronica Martin, Department of Neurology, 949-824-3465 or Carol Baird, Stem Cell Research Center, 949-824-3990.