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Scott P. Roy

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Clinical Trials Currently Underway at The Miami Project / University of Miami

As you have been hearing for some time now, one of The Miami Project’s most anticipated clinical trials will involve testing human Schwann cell transplants in humans with acute and chronic SCI. We continue to navigate the Investigational New Drug (IND) application process to gain approval from the Food and Drug Administration (FDA) to begin this Phase I clinical trial to determine safety.  At the same time, 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 and 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.

Over the coming weeks we will highlight a few of the trials that are ongoing, and of course update you on new ones as they are approved and begin enrolling participants.  Some of them are listed below:

Biomarkers for acute traumatic brain injury and spinal cord injury
Miami Project neurosurgeons are conducting crucial observational studies to identify biological markers for early diagnosis of SCI or TBI. Currently, there are no simple blood tests that enable physicians to identify the presence and severity of SCI or TBI in the emergency setting. In these trials, cerebrospinal fluid and blood serum samples are analyzed in people immediately post-injury and compared with brain injury/spinal injury severity and outcome. The goal of this study is to identify biomarkers of SCI or TBI to facilitate earlier diagnosis and, thus, earlier intervention and management.

Riluzole for acute spinal cord injury

The Miami Project, in collaboration with NACTN, will conduct a clinical trial of the drug Riluzole.  Riluzole has been approved for use in people diagnosed with amyotrophic lateral sclerosis (ALS). When Riluzole was tested in preclinical experimental SCI, it had a neuroprotective effect by blocking sodium from entering damaged nerve cells, which may prevent them from swelling and dying. The first subject in this multi-center study was enrolled on April 12, 2010 at a different site.  The Miami Project/UM has received IRB approval for this Phase I trial and will soon begin enrolling research subjects.


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