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MIAMI PROJECT TO CURE PARALYSIS / UNIVERSITY OF MIAMI RESEARCHERS PUBLISH FIRST PAPERS THAT SHOW MILD HYPOTHERMIA TO BE BOTH SAFE AND EFFECTIVE IN ACUTE SPINAL CORD INJURIES

 

Allan D.O. Levi, M.D., Ph.D.April 7, 2010Dr. Allan Levi, clinical researcher from The Miami Project to Cure Paralysis at the University of Miami and chief of the neurospine service at Jackson Memorial Hospital and colleagues have published two papers which provide the first evidence that the use of mild hypothermia is both a safe and effective strategy in acute spinal cord injury (SCI).  The first paper was published in the March 2009 issue of the Journal of Neurotrauma and the second in the April 2010 issue of Neurosurgery.


Most recent clinical reports have focused on the use of cooling for head injury, stroke, and cardiac arrest, but until now clinically relevant data were not available to support its use for spinal cord injuries.  There are currently no established standards of care for the use of modest hypothermia in the acute SCI setting, but significant focus has recently been placed on its use in treating SCI and the need to prove its effectiveness in protecting spinal cord tissue from secondary damage.  Much of the pre-clinical investigative data, pioneered by Miami Project / University of Miami researchers, have revealed that the treatment is not only safe, but can be extremely neuroprotective, which means that it can result in a decrease in the severity of injury and an increase in function.

“Our study included 14 participants and dealt with the most serious cases of cervical spinal cord injury in the acute setting and has shown that the treatment is safe and improved outcomes compared to historical outcomes for similar injuries without cooling,” said Dr. Levi.  “We feel these results should encourage other institutions to take a closer look at the use of modest hypothermia in acute SCI cases so we can quickly and safely determine if this should be used more widely.”

Years of extensive laboratory experience under the supervision of Dr. Dalton Dietrich at The Miami Project, and through other research groups, provided the impetus to take the therapy to humans.  The clinical protocols were created by Miami Project / University of Miami clinicians and researchers and currently The University of Miami/ Jackson Memorial Hospital is in the only institution in the world doing regimented hypothermia treatment and follow up for patients with acute spinal cord injury.

The Neurosurgery paper was the follow up of the earlier manuscript published by Dr. Levi and colleagues in the Journal of Neurotrauma that dealt with the techniques and time frames to be used in the procedure.  The papers represented the largest modern study in the administration of modest hypothermia and demonstrated that the use of systemic intravascular cooling was safe, with a similar number of complications as the control group, and provided the much needed baseline data in terms of safety and window of opportunity for cooling acutely injured patients.

The compiled data strongly suggests that additional trials, including multiple medical centers, should be undertaken so more information can be compiled.  With a multi-center trial, the ability to enroll a larger number of participants is drastically increased and determination of the benefits of treatment is accelerated.

Dr. Levi, holding both a M.D. and Ph.D., has a perspective into the problem of spinal cord injury research and treatment that not many can boast.  He spent a great deal of his career in the laboratory as a researcher obtaining his Ph.D. and his extensive experience as a neurosurgeon allows him to create and direct his research staff to conduct studies that apply to humans in real world situations.  “The benefit of seeing the clinical issues faced by spinal cord injured patients and their doctors allows us to develop clinically relevant studies and ensure discoveries are directed at solving the problems associated with the SCI population,” added Dr. Levi.


 

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