PI: Ray
Protocol ID: M16-077
Short study title: Elezanumab for Acute Traumatic Cervical SCI (AbbVie)
Sponsor: AbbVie Pharmaceutical
Short description: Multi-center, randomized, double-blinded, placebo-controlled study. Elezanumab is a monoclonal antibody to repulsive guidance molecule A (RGMa). RGMa is a potent inhibitor of neurite outgrowth and negatively impacts neuroplasticity after injury. Elezanumab may lead to neuroregeneration, neuroprotection, and promote neurorestoration. It has been shown to be neuroprotective and neurorestorative in several animal models of acute and chronic neurologic injury with long-term benefits observed with early administration after acute injury. No evidence of drug-related toxicity in animal studies and in Phase 1 clinical studies. Primary endpoint is upper extremity motor function. Labs will also be drawn for identification of biomarkers.
Key eligibility criteria:
- Any sex, age 18 through 70
- ASIA A or B with isolated acute, traumatic cervical spinal cord injury
- Neurologic level anywhere C4 through C7, consistent with MRI
- Drug must be administered within 24h of injury
- Excludes: penetrating injury, clinically significant abnormality on head CT, immobilized upper extremity(s), COVID-19 infection within 14 days of screening, pregnancy
Contact person: Linda Koester, 314-362-7368
Enrollment period: September 6th 2020 – April 1st, 2022
For more information: https://clinicaltrials.gov/ct2/show/NCT04295538
PI: Ray
Protocol ID: MT-3291-A01
Short study title: MT-3291 for Acute Traumatic Cervical SCI
Sponsor: Mitsubishi Tanube Pharma Development America, Inc
Short description: Phase 2a multi-center, randomized, double-blinded, placebo-controlled study. MT-3291 is a monoclonal antibody to the repulsive guidance molecule A (RGMa). RGMa is a potent inhibitor of neurite outgrowth and negatively impacts neuroplasticity after injury. MT-3291 may prevent inflammation, demyelination, and neurodegeneration. It has been shown to be neuroprotective and neurorestorative in several animal models (rats and monkeys) of acute and chronic neurologic injury with long-term motor benefits observed with early administration after acute injury. No evidence of drug-related toxicity in animal studies and in human studies (Japan, 2019-2020). Primary endpoint is upper extremity motor function. Serum and/or CSF (CSF at 1 week) will also be drawn for identification of biomarkers.
Key eligibility criteria:
- Any sex, age 18 through 70
- BMI < 40
- ASIA A, B, or C with isolated acute, traumatic cervical spinal cord injury
- Neurologic level anywhere C4 through C7
- If C4 level, must be at least 1/5 between C5 and C7
- Must receive study drug/placebo within 48h of injury
- Excludes: penetrating injury, TBI with GCS < 14 (non-intubated) or GCS < 10 (intubated), immobilized upper extremity(s), significant polytrauma with ISS > 25, patients receiving steroids for purpose of SCI treatment, positive COVID-19 test, pregnancy
Contact person: Linda Koester, 314-362-7368
Enrollment period: August 2021 – January 2023
For more information: https://clinicaltrials.gov/ct2/show/NCT04683848
PI: Ray
Protocol ID: HSC-MS-19-0258
Short study title: Discovery of Biomarkers Prognostic for Neuropathic Pain after Acute SCI (BSCIP)
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Short description: Multi-center observational study. It is not known why certain patients with SCI (40-70%) develop debilitating neuropathic pain while others are spared from this chronic condition. An autoimmune response can be triggered after SCI due to breakdown of the blood-spinal cord barrier leading to inflammation, hindering recovery, and promoting chronic pain. Discovering biomarker(s) predictive of neuropathic pain is important in developing safe and effective pain therapies. Several candidate antigens have been identified in animal models of SCI, but their relationship to human SCI is not known. The aim of this study is to identify serum autoantibodies in patients in the acute SCI setting that are prognostic for neuropathic pain 6 months after SCI when compared to healthy volunteers.
Key eligibility criteria:
- Any sex, age 18 and up
- Acute traumatic ASIA A through D
- Serum collection within 24h of injury (OK to collect first then obtain consent)
- K2EDTA and sodium heparin tubes (Study team will supply the tubes for collection)
- Excludes: penetrating injury, TBI where patients cannot complete questionnaires and sensory testing, other chronic pain (i.e., diabetic neuropathy, MS), cancer diagnosis or treatment in last 5 years
Contact person: Linda Koester, 314-362-7368
Enrollment period: September 1st, 2019 – July 31st, 2022
For more information: https://reporter.nih.gov/project-details/9829265
PI: Ray
Short study title: Repurposing Operating Room Specimens in Spine and Peripheral Nerve Surgery
Short description: Human specimens are critical to studying nerve regeneration and neuropathic pain. Our previous work using primarily cadaver tissue has revealed important mechanisms behind pain and itch sensations. However, cadaver specimens are limited and are complicated by tissue degradation, which ultimately limits our understanding of the environments present in the human body. During spinal fusion and peripheral nerve surgeries, it is sometimes necessary to remove some or all of specific nerves or dorsal root ganglions (DRGs), which is usually discarded. This study proposes repurposing the otherwise discarded tissue for translational research purposes.
Key eligibility criteria:
- Age 18 through 75
- Patients scheduled to undergo any of the following spine procedures: C1-2 posterior instrumentation/fusion, posterior thoracic corpectomy (T3-T12), vertebral column resection
- Patients scheduled to undergo any of the following peripheral nerve procedures: nerve transfer, brachial plexus reconstruction, distal peripheral nerve reconstructions
- Excludes: patients with neurologic or psychiatric disorder that would preclude accurate evaluation (e.g., Parkinson’s disease, Alzheimer’s disease)
Contact person: Linda Koester, 314-362-7368 or Alex Chamessian (Gereau Lab), 314-356-2270
Enrollment period: March 2021 – Current
PI: Ray/Molina
Protocol ID: 2021.01.10/1.2
Short study title: Intraspinal Pressure Monitoring for Acute Spinal Cord Injury
Short description: CSF diversion from the thecal sac after acute SCI using lumbar drain may provide benefits by relieving intraspinal pressure and improving spinal cord ischemia. This rationale is similar to the use of ventriculostomy catheters in acute hydrocephalus or TBI. Spinal cord perfusion pressure (SCPP) can be monitored and managed by using the intraspinal pressure (ISP) similar to how ICP and CPP are used. Preliminary studies have shown that ISP and SCPP during the first week of injury after SCI correlates with ASIA score at 9-12 months, and maintaining SCPP > 50mmHg correlated with a greater likelihood of patient recovery from baseline after injury. The goal of this study is to study the safety and outcomes of using lumbar drain after SCI in hopes of developing a management protocol. The aim is to keep the LD in place for 120 hours (5 days).
Key eligibility criteria:
- Any sex, age 18 through 70
- ASIA A through C
- Surgery within 48 hours of SCI, LD to be placed immediately after surgery
- If no surgery is indicated, LD to be placed within 24 hours of presentation
- Ability to undergo reliable neurologic exams
- Excludes: penetrating injury, pre-existing coagulopathy, evidence of increased ICP, skin infection at LD site
Contact person: Residents will take an active role in screening but should also notify Miguel Ruiz Cardozo, 314-827-9436, miguelr@wustl.edu
Enrollment period: January 2021 – Current
PI: Ray and Molina
Short study title: Augmedics XVision Surgical Navigation System
Short description: A new technology, Augmedics XVision Surgical Navigation System, is a 3D augmented-reality headset that the surgeon wears in order to integrate all intraoperative imaging into a real-time stereoscopic 3D image of the patient’s anatomy. As such, it addresses the drawback of a surgeon needing to look away from the patient in order to view intraoperative imaging. Our previous cadaveric study demonstrated a 96.7% open and 98.9% percutaneous pedicle screw placement accuracy with Augmedics, which was shown to be non-inferior to robotic-assisted computer-navigated information and superior to conventional, fluoroscopically-guided manual placement of pedicle screw instrumentation. The aim of this study is to evaluate the accuracy of pedicle screw placement by the Augmedics XVision Surgical Navigation System and report on outcomes including pedicle wall breaches, radiologic degrees of deformity correction, complications, pain, cost, and patient satisfaction.
Key eligibility criteria:
- Age 18 and up
- Patients scheduled to undergo spine surgery with pedicle screw insertion with the use of the XVS headset
Patients will be enrolled at the discretion of the treating physician
Enrollment period: June 2020 – Current