Hormone research offers hope for those with head injuries
About 1.5 to 2 million people in the United States suffer from head injuries each year, leading to 50,000 deaths and 80,000 new cases of long-term disability, according to the Centers for Disease Control and Prevention (CDC). Currently there is no affective drug treatment for brain injury, but that may soon change because of the research of neuroscientist Donald Stein.
Stein, a researcher at Emory University in Atlanta, Georgia, has developed a safe and effective drug therapy to treat traumatic brain injury using the female hormone progesterone. Progesterone is a hormone produced in the body that helps to regulate a women's menstrual cycle. Studies suggest that progesterone, naturally present in small amounts in the brain of females and males, protects damaged brain tissue and is critical for the development of neurons. (To find out more about progesterone watch the video above)
Stein and his staff gave progesterone to male and female rats within the first 24 hours of brain injury. The treated animals showed no signs of brain swelling. Many of them showed cognitive, sensory and motor improvement within a month of injury.
His research caught the eye of clinicians at Emory who felt strongly that Stein's treatment might work on humans. In 2001, with funding from the National Institutes for Health (NIH), they conducted a Phase I and II clinical trial at Grady Memorial Hospital in Atlanta, a Level 1 trauma center that regularly receives cases of traumatic brain injury. While the trial only enrolled 100 patients (all adults), the results were astonishing. Fewer than half of the patients receiving progesterone had died compared with those on the placebo. There were no side effects and functional outcomes and level of disability were significantly improved among the patients with severe to moderate brain injury.
Encouraged with the findings, the doctors received $28 million in funding from the NIH to conduct a larger Phase III trail that will enroll 1,140 patients in 15 states and 17 Level 1 trauma centers. Currently over 100 patients have been enrolled and doctors tell Stein they are ahead of schedule. Also, the University of Michigan is planning a clinical trial for pediatric patients.
In the meantime, Stein's lab continues its work on progesterone. Stein is interested in how the hormone can help those who have suffered a stroke. His animal studies suggest progesterone is effective in reducing the size of blood clots.
It has been a long road for Stein, who started his work on progesterone 27 years ago. At 72 you'd assume he's looking to retire and pass the baton. Not the case. He has no interest in spending his days playing golf. "This is a very exciting time for us," he says, adding "I can't walk away now."
In the lab: Behavioral study tests rats' gait
In this video, Stein's rats walk across a glass platform so researchers can study their gait. The information can be used to compare the effects of progesterone on the animals before and after treatment.
Stein discusses in detail the Phase I, II and III clinical trials
Stein's work with progesterone to treat head injuries is currently being tested on humans in a nationwide Phase III clinical trial. Find out about this trial and the Phase I and II trials that lead to it.