Penn neurosciences clinical trials
After the devastating effects of a stroke, subarachnoid hemorrhage (SAH), cardiac arrest or traumatic brain injury, the clinical challenge is daunting: “Our immediate goal is to stop the cascade of secondary neurological damage which results in severe or even fatal injury to a patient’s nervous system,” explains Andrew Kofke, MD, NeuroICU coDirector, Professor, Anesthesiology and Critical Care.
Currently, we have clinical trials that test drugs and monitoring devices aimed to prevent, or alert team members to secondary events that can lead to catastrophic functional disability. What we don’t have are the tools to prevent secondary injury — yet,” says Eileen Maloney, MSN, ACNP, Director of Clinical Research for Penn Neurosurgery. Penn Medicine is deeply involved in interdisciplinary research to improve the morbidity and mortality associated with neurocritical conditions. Equally important, Penn is internationally recognized for its excellence in neurocritical clinical care.
Reducing the devastating effects of vasospasm
Limiting vasoconstriction and vasospasm after a SAH is critical for preventing irreversible brain damage,” says David K. Kung, MD, Assistant Professor of Neurosurgery. Dr. Kung is the Principal Investigator for a Phase 3, multinational, randomized, double-blind placebo-controlled study which examines the efficacy of using oral Nimodipine, the standard of care for reducing vasospasm, versus the delivery of a single, targeted, long-acting dose of Nimodipine directly to the site of the brain injury — and potentially offering new hope to patients.
Pioneering a new paradigm for multimodality brain monitoring (MMM)
Penn is one of a just a handful of hospitals in the country that offers multimodality brain monitoring after a brain injury — a technology that requires placing a catheter directly in the brain.
In searching for a non-invasive MMM technology, Penn physicists have developed an innovative MMM option using near-infrared spectroscopy. “We are always pushing the envelope to find better ways of monitoring the neurological progress of neurocritical patients,” says Dr. Kofke.
Dr. Kofke is a Principal Investigator for an NIH-sponsored study that compares non-invasive MMM to traditional MMM, and examines how well each modality provides data for parameters that include cerebral blood flow, intracranial pressure, metabolic oxygen rates and metabolites.
Stem cells for chronic stroke
An ischemic stroke can leave otherwise healthy people with life-altering, chronic functional deficits,” says Gordon H. Baltuch, MD, Professor of Neurosurgery, and Director, Center for Functional and Restorative Neurosurgery. Now, new hope is on the horizon for these patients.
Dr. Baltuch is leading Penn’s participation in a large, multi-center, Phase 2B, double-blind study that examines whether injecting bone marrow-derived stem cells into the stroke cavity can help repair damaged neural circuits. In a Phase 1 study, using the same active therapy, some significant functional improvements were seen.
Glioblastoma is a highly complex, aggressive tumor with a poor prognosis,” explains Donald M. O’Rourke, MD, Associate Professor of Neurosurgery, and Director, Human Brain Tumor Tissue Bank. “Penn is at the forefront of battling this dreaded disease.
At the Penn Brain Tumor Center, patients with suspected, newly diagnosed or recurrent glioblastoma meet with Penn neurosurgeons within 24 to 48 hours of an initial referral. Patients benefit from the strengths of Penn's renowned multidisciplinary neurosurgical and cancer expertise and innovation, and have access to an unparalleled forum of innovative clinical trials.
A glioblastoma breakthrough?
Pioneered at Penn, Chimeric Antigen Receptor T (CAR T) Cell Therapy was a game changer for treating incurable leukemias. Building on this immunotherapy work, Dr. O’Rourke, and a team of Penn researchers, have initiated an open label, Phase 1 Pilot study using CAR T therapy for patients with a specific mutated glioblastoma antigen. The study explores whether ex vivo engineered T cells, when injected back into patients, will trigger an immunotherapeutic response.
Penn is also one of six institutions in the country chosen to form the newly created Parker Institute for Cancer Immunotherapy – an unprecedented collaboration between top immunologists and physicians developing new therapies for glioblastoma and other cancers.
Glowing tumors guide the surgeon’s hand
A Penn-generated procedural technique that shows great promise uses indocyanine green and near-infrared light in the OR. This technique allows the surgeon to visualize more defined tumor margins in real-time — one that literally glows — for a more precise resection of glioblastoma, and other malignant and benign brain tumors. The method is also being examined in Dr. Kofke’s non-invasive MMM project.
New hope for acute spinal cord injury
A young, healthy life can be destroyed in seconds when someone suffers an acute spinal cord injury from a car crash or fall,” says James Schuster, MD, Associate Professor, Neurosurgery at Penn Medicine. “Research is needed to salvage these lives.”
Dr. Schuster is a Principal Investigator in a study which examines the use of Riluzole within 12 hours of an acute spinal cord injury. This multi-center, randomized, placebo-controlled, double-blind study explores whether Riluzole, an FDA-approved drug for ALS, will offer patients a neuroprotective benefit.
Another study in which Dr. Schuster is involved is INSPIRE. It involves implanting an investigational spinal scaffold at the site of a complete thoracic spine injury (ASIA A) to aid in healing. This is performed during the initial surgical procedure to stabilize the damage.
Advanced damage control
After a catastrophic brain injury, the question always is: Will a patient walk out with a walker, or will the ensuing neurological damage cause someone not to walk out at all?
Every patient benefits from the vast collaborative teamwork of Penn specialists working with Penn researchers to develop personalized treatment plans based on a comprehensive, multidisciplinary review of all of the available diagnostic information.
The Penn Neurocritical Care team brings state-of-the-art techniques and conducts research on a broad range of conditions including super-refractory status epilepticus, ischemic stroke, intracerebral hemorrhage, traumatic brain injury, traumatic spinal cord injury, brain tumors and cardiac arrest. This interdisciplinary effort involving experts from Neurosurgery, Neurology, Anesthesiology, Physics, Oncology and Biostatistics, and focuses their combined expertise on patients with a broad range of neurologic diseases.
Answering the critical call: 24/7 neuro-emergency transfers at 877-937-7366
Transferring a neuro-emergency patient only takes one phone call. Experienced coordinators of Penn Neuro-Emergency Transfer facilitate ground or air transportation to Penn’s world-class neurointensive ICU for transfer patients.