Qualified patients with chronic motor deficits after traumatic brain injury have the opportunity to participate in a new study exploring the use of non-embryonic stem cells as a potential treatment option.
Craig Hospital is a recruitment center for the STEMTRA study (A Study of Modified Stem Cells in Traumatic Brain Injury). Dr. Alan Weintraub, medical director of the Brain Injury Program at Craig, is the principal investigator at the Craig site.
The study is being conducted to determine the safety and efficacy of surgically implanting modified stem cells, derived from adult bone marrow, into the brain and to determine if these stem cells can repair and regenerate regions of the brain that have been damaged, helping patients regain lost motor skills.
In a previous clinical trial with patients with chronic stroke, the modified stem cell treatment demonstrated statistically-significant improvement of neurological function and no adverse events related to the stem cells.
“Patients who have persistent motor deficits including partial paralysis or weakness of one side of their body may benefit from this study intervention,” says Dr. Weintraub. “Rather than this being a rehabilitation technique solely focused on strengthening the weak extremity, this research trial explores the role of biologically turning on internal brain wire regenerative mechanisms.”
Craig is one of 35 centers worldwide recruiting patients for the study.
To qualify for the study, patients must be between 18-75 years of age, be at least one-year post-TBI, be their own legal decision maker, and have specific impairment affecting motor function of one arm and/or leg. Patients may live anywhere in the country, but must be willing to travel to out-of-state for a surgical procedure, and be able to come to Craig Hospital for multiple assessments over the course of a year. Travel expenses are covered and a stipend is provided for each assessment. Participants do not need to have completed their initial rehab at Craig.
Interested patients who meet the inclusion criteria will be pre-screened by Dr. Weintraub and the Craig research team. Initial assessments include an MRI, chest x-ray, ECG, blood work, a physical therapy assessment with a Craig therapist and more. Appropriate patients will travel to a regional hospital where they will undergo a surgical procedure that will inject stem cells into the brain surrounding the area of injury. Following the procedure, the participants will return to Craig periodically for monitoring and will commit to simple daily exercises like walking, squatting reaching, and gripping. Participants will also wear an activity tracker for the course of the 12-month study.
According to the double-blind study design, one in four participants will receive a sham surgery with no stem cells, while the other groups of participants will receive either a small, medium or high dose of the cells.
“It’s exciting for Craig to foray into this type of work,” says Clare Morey, the clinical research coordinator for the study at Craig. “It presents patients with an opportunity to contribute to this developing field of knowledge, while potentially experiencing an improvement in their function.”
To learn more about the STEMTRA study, contact Clare Morey, clinical research coordinator, at 303-789-8621 or firstname.lastname@example.org.