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Clinical Trials Currently Underway at The Miami Project / University of Miami - Part Two


As continue to navigate the Investigational New Drug (IND) application process to gain approval from the Food and Drug Administration (FDA) to begin the Phase I human Schwann cell transplantation clinical trial to determine safety, many are surprised to learn that there are currently over 20 other clinical trials in spinal cord injuries (SCI) and traumatic brain injuries (TBI) underway.  Miami Project clinicians and researchers are taking a leading role in bringing these new therapies to people suffering from the devastation of SCI and TBI.

This week we highlight a few of these additional ongoing trials:

Rolipram for acute spinal cord injury

The Miami Project is conducting pre-clinical studies to identify the optimal methods for delivering Rolipram as a neuroprotective therapy for acute spinal cord injury. The goal of these studies is to determining the best dose, route, and timing of administration of Rolipram to achieve maximal tissue protection. These studies are producing critical data needed to submit an Investigational New Drug application to the Food and Drug Administration to request approval to begin a Phase 1/2 clinical trial to test Rolipram’s safety and efficacy in acute human spinal cord injury.

Therapeutic hypothermia for acute spinal cord injury and traumatic brain injury

The Miami Project and UM Department of Neurological Surgery recently completed a Phase I clinical trial to learn if inducing hypothermia (cooling) within the first few hours of traumatic spinal cord or brain injury is neuroprotective and makes a difference in the severity of injury. When a person with a new injury is brought to the trauma center, doctors place a cooling catheter in a large blood vessel (vena cava) that allows them to cool the body a few degrees to 33 degrees Celsius (or 92 degrees Fahrenheit). The cooling is maintained for a 48 hour period and then the participant is slowly re-warmed at 0.1°C per hour. The researchers followed the participants for one year to compare outcomes. The details of the cooling method have been published in the Journal of Neurotrauma and the details of the clinical outcomes have recently been published in the journal Neurosurgery.  In addition to this single center trial, the neurosurgeons have launched an initiative to study hypothermia treatment for acute traumatic spinal cord injury (SCI) in a multicenter clinical trial. For hypothermia to become a standard in acute SCI care, a randomized, prospective trial involving multiple centers will be needed to prove that hypothermia is safe and effective. University of Miami neurosurgeons have submitted the trial proposal to the Neurological Emergencies Treatment Trials group (NETT) for consideration. The NETT is a network of 17 academic medical centers with emergency care clinicians available to conduct large multicenter clinical trials.

Learn more about additional clinical trials underway.


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