A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (TBI)
June 23, 2017
Brain Injury - Traumatic
Leonid Groysman, MD
Study visits will take place at Hewitt Hall on the UC Irvine campus and at UC Irvine Medical Center in Orange. The surgery will take place at UC Irvine Medical Center.
The UCLA‐UC Irvine Alpha Stem Cell Clinic and Department of Neurology at UC Irvine is seeking participants for a study to evaluate the safety and efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from traumatic brain injury (TBI). Eligible subjects will be assigned to one of four treatment groups. Three groups will receive stem cells administered during a surgical procedure. One group will undergo a surgical procedure alone, but no modified stem cells will be implanted in this group.
You may be eligible to participate in this study if you:
- Are between the ages of 18-75 years
- Have a documented history of TBI confirmed with MRI scan or CT scan, at least 12 months ago
- Have reduced movement in your arm or leg due to your TBI
- Have had physical therapy before entering the study and are willing to continue to the extent possible
- Are able and willing to have MRI and CT scans
- 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 any seizures in the last three months
- Have substantially reduced mobility in your joints
- Have abnormal lab tests that might signify a significant illness or cancer
- Have participated in any other experimental study within 4 weeks of this study
- Have a substance abuse disorder
- Are pregnant or nursing a baby
Please note: The above entries are not a complete list of inclusion and/or exclusion criteria.
There are 10 study visits with 2 visits prior to surgery, 2 visits for the surgery and 6 visits over the next 12 months after surgery. Each visit will last about 2 to 4 hours.
The primary goal of this study is to establish the safety and efficacy of SB623 stem cell implantation. While researchers hope the experimental SB623 cells will be effective in reducing motor deficit after TBI, there is no proof of this yet.
Subjects will receive token items as an expression of appreciation for participation in the study. These items are intended to be of use to the subject during the study.
Carol Baird, RN, MSN