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Miracle Drug in Final Stage Testing for Severe TBI

People with severe TBI from high velocity head impacts often have skull fracture with extreme brain swelling. If the brain swelling is not rapidly contained and reversed the patient is likely to die or end up in a permanent vegetative coma. Several decades ago Don Stein and other scientists noticed that female rats recovered better and more quickly from TBI than male rates when their progesterone hormone levels were at their highest. When they injected male rats with progesterone (a female hormone) they recovered from TBI equally well as the female rats.

In June of 2010 BHR Pharma, LLC, started testing its proprietary formula of progesterone (called BHR-100) on patients with severe TBI in a double blind study – one in which neither the patient’s family nor the treating doctor knew if the patient was receiving a placebo or the experimental drug. Ultimately 154 sites and 1,180 patients have participated in the trial which is now in stage 3. Some of the patient recoveries have been utterly remarkable, bordering on the miraculous when compared to historic outcomes for patients with severe brain swelling.

One well publicized example is that of Andrea Vellinga, a 30 year old mother, who suffered severe TBI with extreme brain swelling in August 2011 when struck on the head by a falling tower at a county fair. Although the exact mechanisms are still be elucidated, what is known so far is that progesterone has a “neuro-protective” effect on brain cells which have been traumatized.