Collaboration and Partnership are Key in Advancing Research of Acute Spinal Cord Injuries
The pipeline to research participation often begins before transferring to Shepherd Center.
No one can prepare for a spinal cord injury. In the frantic early hours after a spinal cord injury, often spent in the emergency department or intensive care unit (ICU) of a trauma hospital, patients and families are likely not thinking about research.
But researchers at Shepherd Center are.
Fortunately, even with the unpredictable nature of spinal cord injuries, Shepherd Center has long had collaborations with trauma centers and industry partners in place to connect newly injured patients with clinical trials to participate in and advance research – even weeks or months before a patient arrives at Shepherd Center for rehabilitation. In two recent studies, Shepherd Center is partnering with trauma centers and industry sponsors to advance research that aims to catch patients early in their recovery from spinal cord injury.
AbbVie, Inc. sponsored and launched one such study in 2020, “A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury.” Shepherd Center is one of 30+ institutions participating worldwide in this Phase 2 clinical trial using the drug Elezanumab – a monoclonal antibody – in people with acute (new/recent) traumatic cervical (neck region of the spine) spinal cord injury. Monoclonal antibodies are human-made proteins that behave like human antibodies. In previous studies in animals, Elezanumab was shown to promote neurorestoration and regeneration.
The goal is to enroll 54 newly injured people with spinal cord injury in the trial at trauma centers. Once deemed eligible, participants will receive their first intravenous (IV) infusion of Elezanumab or placebo within 24 hours of injury. Participants then receive monthly doses of Elezanumab or placebo every four weeks for a total of 13 doses. Shepherd Center recently provided this study’s first participant with three study infusions and ongoing research follow-up. Shepherd Center is uniquely suited to participate in studies like this because of its ability to provide a high level of rehabilitation care for patients in the earliest stages of recovery, including those who are still using a ventilator to breathe.
“Partnerships with trauma centers are critical because they allow us to enroll patients in acute SCI studies in those critical early hours and days after injury,” says Michael Yochelson, M.D., MBA, chief medical officer of Shepherd Center and principal investigator for the study. “Not only can Shepherd Center provide highly specialized rehabilitation for patients, but we also offer patients the opportunity to participate in cutting-edge research that we hope will make a difference in patients’ lives earlier in their course of rehabilitation and provide treatment options for generations to come.”
Participants will be followed for approximately one and half years post-injury to assess for the safety and effectiveness of Elezanumab.
Launched in 2021, “A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects with Acute Traumatic Cervical Spinal Cord Injury,” sponsored by Mitsubishi, is evaluating the use of MT-3921, a humanized monoclonal antibody to repulsive guidance molecule A (RGMa). Animal studies of MT-3921 demonstrated improved locomotor function and increased recovery of manual dexterity.
Participating trauma centers will enroll people who meet eligibility criteria, including having an acute, traumatic C4-C7 spinal cord injury, AIS A-C and being able to receive the first infusion of MT-3921 or a placebo within 48 hours of sustaining a spinal cord injury. After the first dose within 48 hours of injury, participants receive infusions of the study drug or placebo on day 15 post-injury, and then monthly through month six. Once a study participant transfers to Shepherd Center from their referring trauma center, Shepherd Center provides acute inpatient rehabilitation and administers the study medication according to the research schedule. Shepherd research staff also monitor the safety and function of the participant for the duration of their care at Shepherd Center.
“While Shepherd Center is known for our life-restoring rehabilitation for spinal cord injuries, through partnerships with our colleagues at trauma centers and industry sponsors, we’re setting the stage now for therapies that have the possibility to change the course of acute spinal cord injuries,” says Donald Peck Leslie, M.D., the study’s principal investigator.
Participants will be followed for nine months post-injury to assess for the safety and effectiveness of MT-3921.
When patients are enrolled in these research studies at the time of injury at participating trauma centers, they have the option of selecting Shepherd Center for both world-class rehabilitation, if they meet eligibility criteria for admission, and ongoing research participation.
You can learn more about research at Shepherd Center here.
By Kerry Ludlam
Shepherd Center provides world-class clinical care, research, and family support for people experiencing the most complex conditions, including spinal cord and brain injuries, multi-trauma, multiple amputations, stroke, multiple sclerosis, and pain. Ranked by U.S. News as one of the nation’s top 10 hospitals for rehabilitation and the best in the Southeast, Shepherd Center treats more than 850 inpatients and 7,600 outpatients annually with unmatched expertise and unwavering compassion to help them begin again.