Atlanta researchers to launch clinical trial of progesterone for treatment of brain injury

Researchers from Emory University and Morehouse School of Medicine soon will begin enrolling patients in the world's first clinical trial of the hormone progesterone as a treatment for moderate to severe traumatic brain injury, which annually claims the lives of 50,000 Americans and disables 80,000 more, at an estimated cost of $56 billion. Currently, there is little that doctors can do for this condition beyond providing supportive care.

The three-year pilot study is called "ProTECT", which stands for Progesterone for Traumatic brain injury, Experimental Clinical Treatment. The study has been approved by the U.S. Food and Drug Administration and is funded by the National Institutes of Health (NIH). It will be based at Grady Memorial Hospital, where physicians from Emory will work side-by-side with colleagues from Morehouse to evaluate a treatment that has proved effective in animal models but has not yet been tested in humans.

Researchers, led by Emory University neurobiologist Donald Stein, PhD, have found in a series of experiments that male and female rats with brain injury develop less brain swelling and recover more completely when they are treated with progesterone shortly following injury. The hormone seems to moderate the inflammation that frequently leads to dangerous brain swelling following head injury. Progesterone also seems to slow or block a cascade of damaging chemicals known as free radicals that are unleashed by traumatic injury, leading to the wholesale death of brain cells. Progesterone occurs naturally in small amounts in the brains of male and females, both in animals and in humans.

"Progesterone has been safely used for decades to treat medical conditions in both women and men, sometimes for months or even years at a time," said Arthur Kellermann, MD, MPH, chairman of emergency medicine at Emory and principal investigator of the new study. "Furthermore, progesterone has been safely given intravenously to hum

Contact: Kathi Ovnic
Emory University Health Sciences Center

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