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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell …

Posted: Published on October 18th, 2012

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM). "There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner. Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for … Continue reading

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Hope for Muscular Dystrophy Patients

Posted: Published on October 18th, 2012

Although he made it to 29 years old with Duchenne muscular dystrophy, Jason Williams was not expected to survive more than another year. But this week, doctors announced that Williams no longer has an expiration date. Thanks to a groundbreaking surgery that's never been performed on a Duchenne patient in the United States before, there's no telling how many more birthdays -- and Cincinnati Reds seasons -- he'll be around for. "The most important thing this device has given him is hope, because without it, we know what's going to happen," said heart surgeon Dr. David Morales, who implanted Jason's Left Ventricular Assist Device, or LVAD, on Sept. 5 with a team of doctors at Cincinnati Children's Hospital. Duchenne muscular dystrophy is an inherited disease characterized by progressive muscle weakness because of a mutated protein gene. It only affects boys, and usually sets in when the child is between 2 and 6 years old, first confining the child to a wheelchair and ultimately weakening his heart and killing him by his late teens or early 20s. "He's going to be with us longer than we ever anticipated he would be," said Williams's mother, Karen Jones, as she stood next to … Continue reading

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New fruit fly model of epilepsy reveals mechanisms behind fever-induced seizures

Posted: Published on October 18th, 2012

ScienceDaily (Oct. 17, 2012) UC Irvine and Brown University researchers have created a new fruit fly model of inherited epilepsy that's providing insights into the mechanisms underlying temperature-dependent seizures while establishing a platform from which to develop therapies for these disorders. In the Oct. 10 issue of The Journal of Neuroscience, Diane O'Dowd of UCI, Robert Reenan of Brown and colleagues report their method for placing a gene mutation that causes human fever-induced seizures into drosophila fruit flies. As a result, the mutant flies experience heat-induced seizures. This represents the first time a human genetic disease mutation has been "knocked in" to the equivalent location in the fruit fly genome. The drosophila knock-in model provides a rapid and low-cost basis for defining the neural mechanisms contributing to inherited seizure disorders. "We can also use this genetic model of human epilepsy in fruit flies to look for new treatments for the disease," said O'Dowd, professor and chair of developmental & cell biology at UCI. Fever-induced, or febrile, seizures are most commonly seen in children. Only about one in 100 children with febrile seizures develops epilepsy, and most outgrow them by age 5. In contrast, individuals who have the inherited disorder -- … Continue reading

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Epilepsy drug shows promise as weight-loss aid

Posted: Published on October 18th, 2012

By Alan Mozes HealthDay Reporter MONDAY, Oct. 15 (HealthDay News) -- A prescription medication originally developed to treat epilepsy may help obese adults shed weight when combined with routine nutritional counseling, researchers say. Patients who took 400 milligrams of the anti-seizure drug zonisamide daily for a year lost nearly 7.5 pounds more on average than those assigned to dietary and lifestyle changes alone, the new study found. But they also suffered more side effects than patients not taking the medication. "The question was to see if more weight loss could be achieved if we provided decent quality lifestyle intervention, mostly dietary counseling, along with this medication," said study lead author Dr. Kishore Gadde, director of the Obesity Clinical Trials Program at Duke University Medical Center in Durham, N.C. "And the answer was yes," Gadde said. The research, funded by the U.S. National Institutes of Health, appears online Oct. 15 in the journal Archives of Internal Medicine. For obese men and women who can't control their weight through diet and lifestyle changes, nonsurgical options are limited, the study authors noted. Just a few prescription medications are approved in the United States for long-term treatment of obesity, including orlistat (brand name Xenical) … Continue reading

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Epilepsy drug leads to weight loss, side effects

Posted: Published on October 18th, 2012

NEW YORK (Reuters Health) - A drug approved to prevent seizures may also help obese people lose a few pounds when it's added to therapy and nutritional guidance, a new small trial suggests. But people who took zonisamide also reported more side effects, from nausea and vomiting to anxiety and depression. And two researchers not involved in the study questioned how much the drug would actually help people in the real world. Although zonisamide is only approved by the U.S. Food and Drug Administration for seizures, doctors can prescribe it "off-label" for non-approved purposes. Prior small trials and anecdotal evidence suggested it might help heavy people shed extra pounds. "There is a little bit of weight loss with this drug when it is given for treatment of epilepsy," said lead researcher Dr. Kishore Gadde, from Duke University Medical Center in Durham, North Carolina. That could be because of its effects on serotonin and dopamine, he said. Those two neurotransmitters are known to effect motivation and reward pathways in the brain, including those related to food. Gadde said his team wanted to see if zonisamide could produce weight loss in people without epilepsy, and with the added help of a behavioral … Continue reading

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Blind stroke victim Colin Farmer shot in the back with 50,000-volt taser by police who mistook his white stick for a …

Posted: Published on October 18th, 2012

Retired company director Colin Farmer, 61, was shot as he walked to meet friends in Chorley, Lancashire The unnamed officer then handcuffed Mr Farmer - a two-time stroke victim - as he fell to the ground after being hit with the stun-gun The frightened grandfather, who is blind and partially paralysed down one side of his body, feared he was being attacked by a mugger Mr Farmer has called for the officer responsible to be 'sacked, charged and locked-up' following the incident Lancashire Constabulary has said it 'deeply regrets' the blunder, and has launched an urgent investigation By Nazia Parveen and James Tozer PUBLISHED: 05:04 EST, 17 October 2012 | UPDATED: 19:32 EST, 17 October 2012 Police were accused last night of behaving like thugs with weapons after firing a 50,000-volt Taser into the back of a blind man. An officer mistook stroke victim Colin Farmers white stick for a samurai sword and discharged the stun gun leaving the retired architect writhing in agony on the ground. No disciplinary action is being taken against the officer. The extraordinary blunder is the latest illustration of the soaring number of controversial incidents with the weapons, which can be fatal. 'Terrified': Blind pensioner … Continue reading

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Simple ways to prevent stroke

Posted: Published on October 18th, 2012

Each year in the United States, 785,000 people suffer a stroke. It is the fourth leading cause of death and its consequences are among the top causes of disability in the U.S. The good news is that there are preventative measures you can take to reduce your risk of stroke, and most of them are simple lifestyle modifications. 1. Control your diabetes. People with diabetes are at an increased risk for stroke; in fact, the risk of cardiovascular disease as a whole is 2.5 times higher in people with diabetes than those without. According to the American Diabetes Association, 2 out of 3 people with diabetes die from stroke or heart disease. Keeping your diabetes in check, either via medication, diet or weight loss, is the first step in reducing your risk of stroke. 2. Quit smoking. Smokers have twice the risk for stroke compared to non-smokers because of the effects on the heart, blood and arteries. Smoking reduces the amount of oxygen in the blood, resulting in the heart having to work harder and facilitating the formation of blood clots. Smoking also facilitates the buildup in the walls of the arteries, which may block blood flow to the brain, … Continue reading

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New Stroke Unit at North York General Hospital Provides Patients with Best Quality Care

Posted: Published on October 18th, 2012

TORONTO, Oct. 17, 2012 /CNW/ - Over 50,000 strokes strike Canadians every year, making stroke the third leading cause of death in this country. Every minute counts after a stroke because treatment delays can cause significant negative neurological effects on a patient. The newly designated Neurology and Stroke Unit at North York General Hospital (NYGH) means people in our community, suspected of having a stroke, will have access to the best quality stroke care that follows the best available evidence. As part of the Neurology and Stroke Unit's official designation, 10 beds have been dedicated as stroke beds, a roving Stroke Assessment and Treatment Team (SATT) is available, across the hospital, to assess patients suspected of having a stroke, and four additional Holter monitors have been purchased. "With a designated Stroke Unit and SATT, we can assess stroke patients faster so their treatment can begin sooner, giving stroke patients a better chance of a meaningful recovery after they are discharged from the Hospital," said Dr. Kuldeep Sidhu, Chief of Emergency Medicine at NYGH. Patients at NYGH now have access, seven days a week, to an interdisciplinary SATT, comprised of nurses, occupational therapists, physiotherapists and speech language pathologists, experienced in the … Continue reading

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New technology advances stroke treatment

Posted: Published on October 18th, 2012

KUSA - When it comes to treating strokes, doctors frequently say that "time is brain." This is because the sooner a stroke is treated the less damage is done to the brain. Currently, medications are used at a hospital to try and break up any clots causing an ischemic stroke, where the blood supply to part of the brain has been cut off. This medication needs to be given within a small time window and has some potentially serious side effects. Even so, this medication has saved many lives and improved the recovery of many stroke victims. But newer technology is allowing more advanced stroke treatments. One of these technologies is a device known as the MAX System of Reperfusion Catheters manufactured by Penumbra, Inc. Swedish Medical Center, located in Englewood, Colo., is the first advanced care center in the state to use what they call a "simple, fast technology" on stroke patients. This device consists of a small catheter that is used in a leg artery. The catheter is moved up to the affected part of the brain and the blood clot causing the stroke is located. Using the Max system the doctor then uses the catheter to gently … Continue reading

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Quadriplegic to share her breast cancer survival story

Posted: Published on October 18th, 2012

Photo by Joni Eareckson Tada Joni Eareckson Tada Being a quadriplegic, Joni Eareckson Tada never thought she would get cancer. "I was too busy tending to all the challenges of being a spinal cord injury survivor, and so my last mammogram was nine years ago," said Tada, 63, of Calabasas, who was injured in a diving accident at age 17. After a needle biopsy in June 2010, followed by a mastectomy the next week, "I was told I had stage 3 breast cancer ... a 3-inch tumor and several lymph nodes affected. Then it was an arduous treatment of chemotherapy." Because Tada thought cancer only happened to other women, she decided to be the keynote speaker at the 16th annual Breast Cancer Awareness Seminar. Sponsored by Los Robles Hospital & Medical Center, the event will take place from 8 a.m. to 1p.m. Saturday at the Ronald Reagan Presidential Library in Simi Valley. "I wanted to speak at this event to alert every woman of the growing statistics impacting one in eight women," said Tada, whose ministry, Joni and Friends International Disability Center, is in Agoura Hills. "In last week's Newsweek magazine, the National Cancer Institute stated that one in every … Continue reading

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