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Therapeutic Hypothermia

The experimental use of hypothermia in people with nervous system trauma came about after years of laboratory research conducted by W. Dalton Dietrich, Ph.D., and his colleagues.  Their work, beginning in the 1980s, showed that cooling the body temperature a couple of degrees resulted in improved recovery of walking in paralyzed rats.  Currently, they continue their work to gain a better understanding of the biochemical, histological and physiological effects of hypothermia.
It took some years to begin testing this therapy in people partly because reliable methods to cool patients still needed to be developed.  By the year 2000, several companies had developed devices to control a patient’s temperature.  An initial goal of using cooling devices was to counteract fever in patients with stroke, heart attacks, head trauma and spinal cord injury. Fever is common in these patients and studies by various investigators, including Helen Bramlett, Ph.D., at The Miami Project, report that small increases in body temperature can worsen neurological outcome.

Today’s very sophisticated cooling devices now allow clinicians to accurately record and manipulate a patient’s body temperature.  With this degree of control, it appears possible to safely cool injured patients and, with further study, potentially give them a chance for better neurological recovery.


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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.



 Components currently being translated:

Neuroprotection - Therapeutic hypothermia

Cell replacement - Schwann cell transplantation

Rehabilitation - SCI Boot Camp

Investigational New Drug Process

IND Submission

IND Approval



Schwann Cell IND Progress




December 2007

Started organizing Schwann Cell (SC) clinical trial team

January 2008

Wrote first draft of SC clinical trial

February 2008

Discussed SC clinical trial draft with External Consultants

Feb - April 2008 

Obtained additional guidance with FDA consultants

August 2008

Held pre-pre-IND discussion with the FDA


Developed GMP cell processing & manufacturing procedures for human SCs


Obtained supportive data from chronically injured non-human primate studies


Conducted toxicology & tumorigenicity experiments in rodent models, xenografts


Performed SCI studies in pig model to determine safest cell injection procedure

December 2009

Additional guidance from FDA consultants

July 2010

Held pre-IND discussion with the FDA


Conducted toxicology & tumorigenicity studies in rodents, allografts


Used pig model to determine safest dose/volume for clinical protocol


Initiated autologous SC transplantation studies in pig model


Finalized CMC qualifications & optimization on human SCs

 April 2011

Held External Advisory Board meeting

 May 2011

Held Data Safety Monitoring Board meeting

 September 2011

IND application submitted to FDA

 July 2012

IND approval by FDA

 October 2012

Approval obtained by UM Institutional Review Board

November 2012 

1st subject enrolled in trial





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