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CLINICAL TRIALS INITIATIVE UPDATE
Clinical Trials Pipeline - Where are we and where are we going? And the ever-burning question...when will we get there?
As everyone knows, repairing the damaged spinal cord is no simple task. There are multiple types of nerve cells and glial cells that are damaged or lost, there are ascending and descending nerve fibers that are interrupted, there are local spinal circuits that are lost or begin functioning abnormally, there is demyelination and remyelination, there are inhibitory molecules, and there is scar tissue. And that’s not including the changes that occur in the muscles as a result of paralysis. During the 25 year existence of the Miami Project, however, significant progress has been made in understanding how to begin to repair the injured spinal cord. Four key components to developing cures for SCI involve neuroprotection, cell replacement, regeneration, and rehabilitation. Miami Project scientists are currently translating 3 of these 4 components as part of the Clinical Trials Initiative (neuroprotection, cell replacement, and rehabilitation) and are diligently moving forward with the fourth component (regeneration). Each of the 3 components being translated is described in the links below along with updated progress.
Schwann Cell IND Progress
YEAR
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ACCOMPLISHMENTS
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December 2007
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Started organizing Schwann Cell (SC) clinical trial team
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January 2008
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Wrote first draft of SC clinical trial
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February 2008
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Discussed SC clinical trial draft with External Consultants
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Feb - April 2008
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Obtained additional guidance with FDA consultants
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August 2008
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Held pre-pre-IND discussion with the FDA
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2008-2009
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Developed GMP cell processing & manufacturing procedures for human SCs
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2008-2009
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Obtained supportive data from chronically injured non-human primate studies
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2009-2010
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Conducted toxicology & tumorigenicity experiments in rodent models, xenografts
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2009-2010
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Performed SCI studies in pig model to determine safest cell injection procedure
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December 2009
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Additional guidance from FDA consultants
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July 2010
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Held pre-IND discussion with the FDA
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2010-2011
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Conducted toxicology & tumorigenicity studies in rodents, allografts
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2010-2011
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Used pig model to determine safest dose/volume for clinical protocol
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2010-2011
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Initiated autologous SC transplantation studies in pig model
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2010-2011
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Finalized CMC qualifications & optimization on human SCs
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April 2011
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Held External Advisory Board meeting
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May 2011
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Held Data Safety Monitoring Board meeting
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September 2011
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IND application submitted to FDA
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July 2012
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IND approval by FDA
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October 2012
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Approval obtained by UM Institutional Review Board
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November 2012
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1st subject enrolled in trial
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