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

  1. #1
    Senior Member Max's Avatar
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    Atlanta researchers to launch clinical trial of progesterone for treatment of brain injury

    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 humans at much higher doses than that planned in our study, which will limit progesterone treatment to only three days."

    When corticosteroids, which were once prescribed to control brain swelling, were found to be ineffective, emergency physicians and trauma surgeons were left with no effective therapy for blunt force trauma to the brain. Although barbiturates, mannitol, and surgery are sometimes used in an attempt to relieve pressure inside the skull that can occur when a victim's brain swells, they are measures of last resort that may or may not work.

    "In contrast to the many options available to treat other types of injuries," Dr. Kellermann notes, "brain injury remains the final frontier. We want to take the crucial next step and determine whether giving progesterone to victims of moderate to severe traumatic brain injury will save lives and preserve mental function."

    The new study will begin on May 28th and will enroll up to 100 victims of traumatic brain injury over the next two years. Four out of five patients (80%) will be administered progesterone by intravenous infusion for three days. One out of five patients (20%) will be administered a placebo, consisting of intravenous fluid without progesterone. Patients will be evaluated for mental functioning on discharge from the hospital and at one month following injury. Neither the patients, their families, the doctors or nurses treating them, nor the study team will know who received progesterone and who did not until the end of study.

    When progesterone is administered to men, it temporarily suppresses the level of the male hormone testosterone in the blood. However, when progesterone wears off, testosterone levels return to normal. Although progesterone may slightly increase the risk of thromboembolism (blood clots) in the legs or lungs, researchers believe the risk is minimal compared to the potential benefits for victims of brain injury.

    Most study participants will be victims of an automobile or motorcycle crash, a fall, or an assault with a blunt object such as a baseball bat. The study will not enroll victims of gunshots or other penetrating head wounds.

    The study will be open to all races and both sexes. Pregnant women and individuals suffering from soybean or egg allergies or cancer of the breast or reproductive organs will not be eligible. Because the tests used to evaluate recovery have only been validated among English-speaking patients, enrollment will be limited to adult English speakers. Since brain-injured patients cannot think clearly, consent must be granted on their behalf by a family member or legal representative. To gain entry into the study, patients must arrive at Grady and a family member must be found to grant consent within 10 hours of injury -- the sooner, the better. If a family member cannot be located within that time frame, the patient cannot be enrolled in the study.

    Patients will be monitored closely in the Surgical or Neuro intensive care unit at Grady or in a new NIH-funded area of Grady called the General Clinical Research Center. An independent safety committee appointed by the NIH will oversee the project. This group has the power to end the study early if it is clear that one treatment group is doing better than the other. If the results of the pilot phase study are promising, the researchers anticipate that the study will be extended to additional level I trauma centers in other U.S. cities in future years.

    Rates of traumatic brain injury are considerably higher in Georgia and in metro Atlanta than in the country as a whole. In 1999, DeKalb County reported 110 deaths from traumatic brain injury and Fulton County 193 deaths, ranking them in the 75th to 90th percentiles nationally among all US counties. In 1999, traumatic brain injury was responsible for 56 deaths at Grady, out of 429 brain injury patients presenting to the emergency department, and in 2000, 53 deaths, out of 568 brain injury patients.

    "Traumatic brain injury is one of the most devastating and debilitating injuries anyone can suffer, and it inflicts its damage disproportionately in metro Atlanta," said Dr. Kellermann. "We are tremendously excited by the prospect that through this clinical trial, we may be able to offer hope to those devastated by brain injury."


    ###
    CONTACT:
    Sharon Getties, 404/616-8754, sgetties@gmh.edu
    Alicia Lurry, 404/616-6389, alurry@emory.edu

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    Senior Member Max's Avatar
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    Wise,

    Did anybody tried this on sci?

  3. #3
    Max, here's Dr. Young's comment regarding progesterone and spinal cord injury.

    http://carecure.org/forum/showthread.php?t=15600

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    Senior Member Max's Avatar
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    Health Alert: progesterone for brain injuries

    Health Alert: progesterone for brain injuries

    (Columbia) Sept. 2, 2003 - One clear day in October, 1996, Sandy Teepen and her husband Tom were walking to the movies, but, Sandy says, they never made it into the theater, "A car hit me, and the impact of the car ... sent me into the air."

    After a year-and-a-half of rehabilitation Sandy is getting her life back. Doctor David Wright of Emory University says not all patients are as lucky, "Traumatic brain injury causes a lot of death, a lot of morbidity, a lot of mortality in this country, and there's no treatment for it."

    He is hoping to change that with the hormone progesterone, "What this drug does is it targets that secondary pathway. By targeting those, we now have a drug, potentially, that could halt the process of cell death."

    Progesterone seems to control inflammation that can lead to dangerous brain swelling. It also appears to slow or block the release of damaging chemicals in the brain, "We haven't seen any deleterious effects of it, and what we're seeing in the patients looks promising."

    Sandy is now back to doing hobbies that were a struggle after the accident.

    Though progesterone may slightly increase the risk of blood clots in the legs or lungs, doctors believe the risk is minimal compared to the potential benefits. If it works, researchers say progesterone could become a treatment for strokes, spinal cord injuries and other neurological conditions.

    by Dawn Mercer

    posted 12:45pm by Chris Rees
    http://www.wistv.com/global/story.as...Type=Printable

  5. #5
    Senior Member Max's Avatar
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    Progesterone Studied To Relieve Dangerous Brain Swelling

    Progesterone Studied To Relieve Dangerous Brain Swelling

    UPDATED: 3:06 p.m. EDT September 17, 2003

    ATLANTA -- Approximately 5.3 million people in the United States live with a disability from a head injury, and no current treatment could have prevented the damages.

    Drugs and surgery are sometimes used to relieve pressure inside the skull, but they don't always work.

    One clear day in October 1996, Sandy Teepen and her husband, Tom, were walking to the movies, but they never made it to the theater.

    "A car hit me, and the impact of the car administered me -- or sent me into the air," Sandy Teepen said.

    After a 18 months of rehabilitation, Teepen is getting her life back. Dr. David Wright, an emergency physician at Emory University in Atlanta, said it's not always that way. "Traumatic brain injury causes a lot of death, a lot of morbidity, a lot of mortality in this country, and there's no treatment for it," Wright said.

    Wright is hoping to change that with the hormone progesterone.

    "What this drug does is, it targets that secondary pathway. By targeting those, we now have a drug, potentially, that could halt the process of cell death," Wright said.

    Progesterone seems to control inflammation that can lead to dangerous brain swelling. It also appears to slow or block the release of damaging chemicals in the brain.

    "We haven't seen any deleterious effects of it, and what we're seeing in the patients looks promising," Wright said.

    So promising, that Teepen is now doing hobbies that were a struggle after the accident.

    Though progesterone may slightly increase the risk of blood clots in the legs or lungs, doctors believe the risk is minimal, compared to the potential benefits.

    If it works, researchers said progesterone could be a treatment for strokes, spinal cord injuries and other neurological conditions.
    Copyright 2003 by Ivanhoe Broadcast News.

  6. #6
    Senior Member Max's Avatar
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    Protecting the Brain

    Protecting the Brain





    ATLANTA (Ivanhoe Newswire) -- Nearly 5.3 million people in the United States live with a disability from a head injury, and no current treatment could have prevented the damages. Drugs and surgery are sometimes used to relieve pressure inside the skull, but they don't always work. Now, doctors are studying a drug that may help those patients can lead more normal lives.

    One clear day in October 1996, Sandy Teepen and her husband Tom were walking to the movies, but they never made it to the theater.

    "A car hit me, and the impact of the car administered me or sent me into the air," Sandy tells Ivanhoe. She is lucky. After a year and a half of rehabilitation, she is getting her life back. But emergency physician David Wright, M.D., says it's not always this way. "Traumatic brain injury causes a lot of death, a lot of morbidity, a lot of mortality in this country, and there's no treatment for it."

    Dr. Wright, of Emory University in Atlanta, is hoping to change that with the hormone progesterone. He says: "What this drug does is it targets that secondary pathway. By targeting those, we now have a drug, potentially, that could halt the process of cell death."

    Progesterone seems to control inflammation that can lead to dangerous brain swelling. It also appears to slow or block the release of damaging chemicals in the brain.

    "We haven't seen any deleterious effects of it, and what we're seeing in the patients looks promising," Dr. Wright says.

    Sandy is now back to doing hobbies that were a struggle after the accident. "It's like a room full of therapy for me," she says -- Therapy she's thankful for.

    Though progesterone may slightly increase the risk of blood clots in the legs or lungs, doctors believe the risk is minimal, compared to the potential benefits. If it works, researchers say progesterone could be a treatment for strokes, spinal cord injuries, and other neurologic conditions.

    This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

    If you would like more information, please contact:

    David Wright, M.D.
    Emory University
    dwwrigh@emory.edu



    Last Updated: September 24, 2003

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