A Forty Year Quest Leads to An Answer for Brain Injury Outcomes

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Donald Stein, PhD. has worked for over forty years to identify a treatment for traumatic brain injury which could improve survivability and lead to improved clinical outcomes. Starting in animal research in the 1960's  Dr. Stein has toiled for years to identify an agent which could help heal an injured brain. Dr. Stein's research has gone unnoticed for most of the past forty years as his interest in the hormone progesterone, a female hormone, did not attract the attention of the research monies coming from the big pharmaceutical companies. Finally, in 1999, while working as an administrator at Emory University, Dr. Stein working with emergency medicine physicians, Arthur Kellerman, MD and David Wright, MD, received a $2.2 million NIH grant to study the effect of progesterone on people who had received traumatic brain injuries. The study focused on 100 individuals with traumatic brain injury who were treated at Grady Memorial Hospital in Atlanta.Some patients received the standards brain injury protocol while others received intravenous progesterone at triple the highest levels found at the end of pregnancy. The 2005 study yielded positive results, the death rate was 13% vs 30% for the standard protocol.Progesterone also showed no negative effects.Dr. Stein published the results in the Annals of Emergency Medicine reporting that "Moderate traumatic brain injury survivors who received progesterone were more likely to have a moderate to good outcome than those randomized to placebo." Dr. Stein's research with animals had led to this small study involving humans which has been replicated in dozens of other studies at numerous research institutions. Dr. Stein has applied for NIH funds for a 1000 patient study and has received $229,000 in grant planning funds.Emory University hasn't applied for the research grant yet, however the technology transfer office at the university is "optimistic" about developing and marketing progesterone for the treatment of brain injury.

Studies of this type are very important to improving survivability and outcome for individuals with traumatic brain injury. Dr. Stein's dedication to research in this area in spite of funding and support difficulties may finally pay off for the 1 million people who experience a TBI each year.

A discussion with researchers at Emory University about progesterone treatment for traumatic brain injury can be found at WSJ.com/video.

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