Minimizing Secondary Damage In Spinal Cord Injuries
This clinical trial has the potential to affect the way clinicians treat people with acute SCIs in the future. With over 17,000 new SCI cases each year in the United States alone, an effective therapy has the potential to improve functional outcomes and quality of life for many people around the world
(June 2020) If you were to ask someone with a spinal cord injury (SCI), “How were you injured?” the response will probably describe the initial cause of the injury, such as a car accident, fall, dive, or violent event. However, there is another aspect of SCI that contributes to the damage within the spinal cord. After the initial trauma, or primary injury, the body signals for its natural defender, the immune system, to activate and clear out the debris (dead cells, blood, etc.) from the spinal cord, as well as preserve healthy tissue and cells. While these efforts are essential, they can also destroy healthy cells and leave behind irreversible additional damage. We call this “secondary damage”. Reducing secondary damage in spinal cord injuries could lead to better recovery and better functional outcomes, by preserving healthy cells within the spinal cord.Scientists have been exploring different drugs that may improve survival of neurons in the central nervous system after SCI. SCI researchers identified a neuroprotective drug, Riluzole, which is approved by the United States Food and Drug Administration (FDA) and has been safely used in the treatment of amyotrophic lateral sclerosis (ALS) for over 20 years. Early Riluzole studies done with animals with spinal cord injuries showed that this drug preserves neurological tissue and improves neurological and functional recovery. In 2011, a phase 1 safety trial was completed, which evaluated the safety of efficacy of Riluzole in 30 participants with acute SCI. Based on those positive safety results, an exciting new study began in 2014 at over 20 sites around the world. The Miami Project to Cure Paralysis as one of the study sites, with Dr. James Guest, clinical professor and expert in SCI clinical trials, as the principal investigator. This is a phase IIB/III randomized, double-blinded, multicenter trial, designed to evaluate the effectiveness of Riluzole in people with acute SCI. With a target enrollment of 350 participants, the study is expected to be completed in 2025.
Dr. George Jimsheleishvili, the coordinator for this clinical trial, is on call 24/7, since participants must be consented, screened, and provided the first does of Riluzole within 12 hours of injury. Participants must have a traumatic, cervical-level 4 (C4) to 8 (C8) SCI caused by blunt trauma with no other major injuries (such as traumatic brain injury). Subsequent doses of Riluzole are administered for the following 13 days after injury. From the first few hours after injury and for the following year, Dr. Jimsheleishvili follows up with the participants at various time points to track their recovery. During each follow-up visit, he assesses the participant’s neurological function, quality of life, and functional outcomes. Since the study is double-blinded, neither the participant nor the researchers know whether Riluzole or a placebo was given, ensuring that the researchers, including Drs. Guest and Jimsheleishvili, are not biased during the evaluations.
This clinical trial has the potential to affect the way clinicians treat people with acute SCIs in the future. With over 17,000 new SCI cases each year in the United States alone, an effective therapy has the potential to improve functional outcomes and quality of life for many people around the world. The Miami Project is proud to be a part of this important study and to contribute towards the development of treatments and therapies aimed at improving the lives of people affected by SCI.