Possible brain drug test

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  • NFL group, company hope to conduct new trial

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NFL alumni take stance on front line of effort to treat brain injuries

Newark Star Ledger

Newark Star Ledgerhttp://www.nj.com/jets/index.ssf/2013/04/nfl_alumni_take_stance_on_fron.html

Craig Wolff/The Star-Ledger

on April 25, 2013 at 4:30 AM

Wayne Clark

From time to time, Wayne Clark, once a backup quarterback in the NFL, pulls out his old team photo. San Diego Chargers. 1972.

His eyes fall to the young faces of long-ago teammates, and he is reminded that many of them ended up dying from the same cause.

Dementia, dementia, dementia, he finds himself muttering, a morbid chronicling of friends passing on, and, for Clark, a foreboding exercise. While no symptoms have appeared, last year Clark also was diagnosed with a disease that could one day rob him of memory and cognition and lead to profound depression — consequences that by now seem endemic to years of absorbing blows on the football field.

Learning that scientists wanted to enlist former NFL players for a clinical trial of a powerful new drug that could potentially reverse the course of certain brain injuries, Clark reacted without hesitation.

“I’d be willing to participate in anything,” he said. “And I’d expect all of us, no matter our present condition, would do the same.”

He is not alone.

Three weeks ago, the NFL Alumni Association, based in Newark and independent from the league and the NFL Players Association, sent a letter to thousands of old-timers, alerting them to the study of the drug, known for now as NSI-189. The drug holds the promise, its inventors say, of not merely treating the depression but regenerating parts of the brain that have suffered damage and even atrophied.

The responses from former players came in immediately: Count us in.

Amid a pitched legal battle with the NFL, these men say they are looking for answers not just from lawyers but from scientists. They are also mindful that a number of former players in the throes of depression and other mental disorders have committed suicide and their families have donated their brains for research.

Some of the players who committed suicide, including Junior Seau a year ago and Dave Duerson in 2011, shot themselves in the chest. Duerson seemed to think he could advance knowledge of chronic traumatic encephalopathy, known as CTE, from the grave. He left behind a suicide note requesting that his brain be used for research.

These new tests, the old players say, present a chance for former players to do a novel thing — assist the research while they are still alive.

Erectile dysfunction prevents men from leading a normal canada sildenafil sex life. Treatment services vary based on particular viagra price uk situations of the individuals. There are purchase levitra online certain Cheap Erectile Dysfunction Drugs Canada is an important site for providing relief to the affected people. Kamagra is not only a substance that enhances sexual desire but also create stimulation that is cheap viagra no rx required to develop erection. “What I’m excited about is that we are not placing blame,” said Lee Nystrom, who had a brief professional career with the Packers in the 1970s and is a former head of the alumni association. He has grown tired in recent years, he said, of players reduced to grousing about what they see as the league’s inaction over head injuries.

“I’m a positive person, and for once this is something positive we can do,” he said. “And it can help everyone, not just football players.”

The NFL faces a class-action lawsuit from more than 4,000 former players and their wives, who say that over years the league deliberately withheld findings which point to the affects on the brain from a violent game.

NFL spokesman Greg Aiello said the league has given millions to research into brain injuries, including $30 million to the National Institutes of Health.

“We have no issue with this,” Aiello said. “A lot of people are engaged in this. We support any research that would advance the understanding of concussion.”

The drug was created by Neuralstem, a Rockville, Md., company. The drug appears to help the hippocampus part of the brain replenish its own neurons. The hippocampus is vital for memory and a range of cognitive skills. Autopsies performed on former football players and others have found damage to this area of the brain.

Richard Garr, the research company’s president, said the new drug was given the go-ahead for the clinical trials by the Food and Drug Administration and already has passed through a first level of clinical trials. The players would be part of a second phase of tests. He said that unlike traditional antidepressants that address chemical imbalances, the new drug was found to reverse atrophy in laboratory animals.

The letter from the alumni group steered former players to Garr, who said he has received a stream of e-mails and phone calls.

“It’s pitiful,” he said. “Guys who are out there who have to program their addresses into their cars.”

Nystrom, he said, “wakes up every morning scared to death he won’t be able to remember his wife.”

Clark, the former backup quarterback, is 65. He found out he had CTE as part of a study last year at UCLA. Like many former players, he has come to appreciate the Rorschach-like images produced from brain images. He is thankful, he said, that he has not developed symptoms, but apprehensive about what the future may hold.

In all, he said, seven members of the 1972 Chargers suffered from dementia and other brain traumas. Two have died in the past year, he said.

“Is that the natural part of life?” he wondered. “Is that normal, or is playing football the reason? That’s why these tests are important.”

©  NJ.com. All rights reserved.

 

Drug which could reverse depression symptoms draws interest of NFL Alumni Association

http://www.nj.com/sports/index.ssf/2013/04/nfl_alumni_association_to_invi.html

Drug which could reverse depression symptoms draws interest of NFL Alumni Association

Craig Wolff/The Star-Ledger
on April 24, 2013 at 9:47 AM

The NFL Alumni Association announced today that it has invited thousands of former players to take part in a test for a powerful new drug which holds the promise of reversing major depression symptoms and even regenerating damaged parts of the brain.

Amid a class action lawsuit over the effects of years of heavy hitting on the football field, the old-timers say they are now looking for answers not just from lawyers but from scientists. They are also mindful that a number of former players in the throes of depression have committed suicide, careful to avoid shooting themselves in the head, and that their families have donated their brains for research. These tests then, they said, present a chance for former players to assist the research while they are still alive.

Teenagers and their careless driving is a topic of speculation since cialis in uk online forever. Choosing the best online service provider will order viagra from india never ever make you disappoint in any aspect. Free of cost consultation services are available online because there is a risk of side effects if they are properly used at the suitable surface treatment levels, resurfacing action of Fraxel boost the cell proceeds and causes extrusion of the melanin pigment from the skin, as a result skin get rejuvenated appearance due to smoother touch and even pigmentation. 100mg viagra online He is a brilliant sexologist, known to provide the Best treatment at his penis enlargement clinic in cialis samples Delhi. “What I’m excited about is that we are not placing blame,” said Lee Nystrom, a former Green Bay Packer and until recently the head of the alumni group. He said he has grown tired in recent years of players simply grousing about what they see as the league’s inaction over the problem.

“This has the potential of not just helping players, but also everyone suffering from major depression.

The drug, known as NSI-189, was created by Neuralstem, a Maryland research company. The drug, still in early clinical trials, the researchers say, do something typical antidepressants do not — regenerate parts of the brain that have suffered damage and even atrophied. It can, they say, not only reverse depression symptoms but also the loss of cognitive abilities.

Richard Garr, the company’s president, said he hopes that former players will enlist for what are known as Phase 2 trials.

“Most antidepressants,” Garr said, “work on the balance of chemicals in the head.”

The new drug, he said, reverses the course of atrophy that may have been caused by trauma and injury.

NFL Alumni Back New Drug to Keep Brain-Injuries From “Destroying Quality of Life”

 

http://www.latinospost.com/articles/17434/20130424/nfl-alumni-back-new-drug-keep-brain-injuries-destroying-quality.htm

NFL Alumni Back New Drug to Keep Brain-Injuries From “Destroying Quality of Life”

By Erik Derr | First Posted: Apr 24, 2013 04:13 PM EDT

(Photo : Reuters)

There may soon be a medication to counter the effects of sports- related head injuries.

Neuralstem Inc., a company that specializes in cell therapy technology, has developed a drug in pill form designed to stimulate neurons in the area of the brain that handles depression and may be a factor in major brain injuries.

The drug, currently designated “NS1-189,” is already going through a clinical trial for depression treatment.
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During studies on animal subjects, researchers saw how the drug seemed to stimulate the growth of brain cells, prompting the company to pursue additional examination of the potential use of the medication for concussion treatment.

Neuralstem today announced it will be working with the NFL Alumni Association to begin clinical trials of NSI-189 with former players.

The National Football League has expressed great concern over the development of neurological disorders in former players.

The increase in the league’s awareness of the issue follows a series of suicides linked to concussions players sustained during their careers — including that of Pro-Bowl linebacker Junior Seau, who took his life three years after retiring from a 13 years playing in the NFL.

“The National Football League Alumni Association is focused on this serious health issue, which is destroying quality of life and has tragically led to several high-profile suicides just this past year among our members,” said Lee Nystrom, Chairman of the Board, Emeritus of the NFL Alumni Association and a former Green Bay Packer. “The NFL Alumni Association is excited to be working with Neuralstem on this cutting-edge technology. We are committed to pursuing both basic research into traumatic brain injury as well as pushing the envelope to create therapies that can improve the quality of life for our members afflicted with these diseases.”

Said Richard Garr, Neuralstem’s president and CEO: “These injuries can result in long-term and serious loss of cognitive function, depression, a shorter life span and, sadly, death by suicide in some cases…In addition to finding ways to better prevent such injuries, it is imperative that we provide new and improved ways to treat those with such neurological trauma.”

NS1-189 has already received support from the Defense Advanced Research Projects Agency, as well as and the National Institutes of Health.

Neuralstem, NFL Alumni Association To Test Feasibility Of Traumatic Brain Injury Treatment

Neuralstem, NFL Alumni Association To Test Feasibility Of Traumatic Brain Injury Treatment

04/24/13 09:51 AM ET EDT

http://www.huffingtonpost.com/2013/04/24/neuralstem-nfl-brain-injury-treatment-_n_3148796.html

 
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NEW YORK — A potential treatment for traumatic brain injuries may be tested in retired professional football players, who are the focus of concern over blows to the head.

Neuralstem, Inc., of Rockville, Md., said Wednesday it is working with the National Football League Alumni Association to study the feasibility of such a test, which would need government approval. It would involve a drug that’s now in an early human trial for treating depression. In animal studies, the drug appeared to stimulate creation of brain cells.

Concern has mounted about brain injuries and disease in former NFL players, driven in part by some high-profile suicides. Thousands of former players are suing the league and its teams, saying that for years the NFL did not do enough to protect players from concussions.

Football and Concussions: New Drug To Be Tested On NFL Alumni

Medical Daily

http://www.medicaldaily.com/articles/14870/20130424/football-concussions-new-drug-tested-nfl-alumni-ns1-189-neuralstem.htm

Medical Daily

April 24, 2013 12:52 PM EDT

Football and Concussions: New Drug To Be Tested On NFL Alumni

Technology company Neuralstem Inc. is partnering with the NFL to begin testing of concussion medication on human subjects.

By Justin Caba

NFL

Finally, a possible solution to contact sport related head injuries.

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The National Football League (NFL) has expressed a great deal of concern lately when it comes to former player’s development of neurological disorders. The increase in awareness of the issue comes after a series of suicides were linked to concussions sustained during a player’s career, most notably Pro-Bowl linebacker Junior Seau, who took his life three years after retiring from a 13 year NFL career.

“These injuries can result in long-term and serious loss of cognitive function, depression, a shorter life span and, sadly, death by suicide in some cases, said Neuralstem’s president and CEO, Richard Garr. “In addition to finding ways to better prevent such injuries, it is imperative that we provide new and improved ways to treat those with such neurological trauma.”

The drug, currently called “NS1-189.” is already in Phase lb clinical trial for treatment of depression; however, in further studies on animal subjects researchers noticed the drug seemed to promote the growth of brain cells, prompting them to pursue additional studies in its potential use for concussion treatment.

On Wednesday, Neuralstem announced that it will be working with the NFL Alumni Association to begin clinical trials on NSI-189 with former players.

“The National Football League Alumni Association is focused on this serious health issue, which is destroying quality of life and has tragically led to several high-profile suicides just this past year among our members,” said Lee Nystrom, Chairman of the Board, Emeritus of the NFL Alumni Association, and former Green Bay Packer. “The NFL Alumni Association is excited to be working with Neuralstem on this cutting-edge technology. We are committed to pursuing both basic research into traumatic brain injury as well as pushing the envelope to create therapies that can improve the quality of life for our members afflicted with these diseases.”

NS1-189 has already received backing from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).

NFL group, company teaming up for brain drug test

http://pro32.ap.org/article/nfl-group-company-teaming-brain-drug-test

Apr. 24 9:51 AM EDT

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Neuralstem, Inc., of Rockville, Md., said Wednesday it is working with the National Football League Alumni Association to study the feasibility of such a test, which would need government approval. It would involve a drug that’s now in an early human trial for treating depression. In animal studies, the drug appeared to stimulate creation of brain cells.

Concern has mounted about brain injuries and disease in former NFL players, driven in part by some high-profile suicides. Thousands of former players are suing the league and its teams, saying that for years the NFL did not do enough to protect players from concussions.

NFL Group, Company Teaming Up For Brain Drug Test

NFL Group, Company Teaming Up For Brain Drug Test

http://www.npr.org/templates/story/story.php?storyId=178784991

by The Associated Press

April 24, 2013 9:52 AM
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NEW YORK (AP) — A potential treatment for traumatic brain injuries may be tested in retired professional football players, who are the focus of concern over blows to the head.

Neuralstem, Inc., of Rockville, Md., said Wednesday it is working with the National Football League Alumni Association to study the feasibility of such a test, which would need government approval. It would involve a drug that’s now in an early human trial for treating depression. In animal studies, the drug appeared to stimulate creation of brain cells.

Concern has mounted about brain injuries and disease in former NFL players, driven in part by some high-profile suicides. Thousands of former players are suing the league and its teams, saying that for years the NFL did not do enough to protect players from concussions.

Mich. university joins Lou Gehrig’s clinical trial

USAToday

USATodayhttp://www.usatoday.com/story/news/nation/2013/04/18/lou-gehrigs-disease-clinical-trial/2094867/

Mich. university joins Lou Gehrig’s clinical trial

Robin Erb, April 18, 2013

Study is only one if its kind because neural stem cells are injected into the spinal cord.

(Photo: Kimberly P. Mitchell, Detroit Free Press)

Story Highlights

  • University of Michigan joins Emory University in Atlanta in the clinical trial
  • In the study, human neural cells are injected directly into patients’ spinal cord
  • Currently, there is no cure for amyotrophic lateral sclerosis or ALS

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A clinical trial using human neural stem cells to halt or even reverse the deadly effects of Lou Gehrig’s disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights, Mich., said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, and told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl Murray. “She left us room to cry. She said, ‘Take whatever time you need.'”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

Feldman and others theorize that these new cells, once in the spinal cord, act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The cells were derived from a cell line that dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said.

U-M may recruit ALS patients for stem cell clinical trial

Detroit Free Press
Detroit Free Presshttp://www.freep.com/article/20130417/NEWS06/304170160/U-M-may-recruit-ALS-patients-stem-cell-clinical-trialDr. Eva Feldman is overseeing the clinical trial. / Detroit Free Press

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By Robin Erb
Read the full article by clicking here

A clinical trial using human neural stem cells — injected into the spinal cord — to halt or even reverse the deadly effects of Lou Gehrig’s Disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl. “She left us room to cry. She said ‘Take whatever time you need.’ ”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

Feldman and others theorize that these new cells, once in the spinal cord, act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The cells were derived from a cell line that dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said. “This isn’t even about a cure. People would be happy with the treatment.”

Contact Robin Erb: 313-222-2708 or rerb@freepress.com.

Kofi Myler

What’s next?

■A University of Michigan Institutional Review Board will review the protocols for the trial, considering the ethics and science of the experimental procedure.
■ The university cannot begin recruiting until the the board OKs the trial. The approval process could take months.
■ Once approval is given, the research team, made up of doctors, nurses, researchers and others, may begin recruiting. Because the trial will likely involve fewer than 15 patients at U-M, it’s unclear how they will be recruited.
■U-M most likely will post recruiting information on its clinical trials website,www.umclinicalstudies.com. For general information for ALS patients wishing to take part in U-M research, e-mail jkballar@umich.edu.

Kofi Myler
Kofi Myler