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
Steven Cramer, 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 purpose of this research study is to evaluate an investigational therapy that hopes to improve motor function that was affected due to a traumatic brain injury (TBI). This study will test the safety and effectiveness of a suspension of stem cells administered by injection around the area of injury in your brain. Eligible patients will be randomly assigned (like a flip of a coin) 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. Only the neurosurgeon will know whether stem cells were administered.
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
- Are able and willing to have MRI and CT scans
- Agree that you will not take blood thinners and other drugs that may thin your blood before and after your surgery until your study doctor advises you it is safe to do so
- Willing to discontinue herbal or non-traditional medicines for 1 week before and 1 week after the surgical procedure
- 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 3 months
- Have substantially reduced mobility in your joints
- Have abnormal lab tests that might signify a significant illness or cancer
- Have uncontrolled blood pressure
- Have participated in any other experimental study within 4 weeks of this study
- Have had treatments for tightness or stiffness of the muscles within the last 4 months
- Are using herbal or other non-traditional drugs and unable to discontinue them for the surgery
- Have a substance abuse disorder
- Cannot undergo CT scan or MRI
- Are pregnant or nursing a baby
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 approximately 2 – 4 hours.
The primary goal of this study is to establish safety and efficacy of stem cell implantation rather than to maximize the chance for improvement. Accordingly, you should not expect to receive benefit from participation in this study. While researchers hope the experimental drug will be effective in reducing motor deficit after TBI, there is no proof of this yet.
You will receive token items as expressions of appreciation for your participation in the study. These items are yours to keep.
Carol Baird, RN, MSN