Femto Medicine - Part 5932

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Regenerative medicine and cell therapy industry in 2012 | Stem Cell …

Posted: Published on December 30th, 2012

As usual, at the end of the year, I overview the most interesting and important events in cell therapy and Regen industry. The list of top 10 events reflects solely my opinion. 1. Debate on regulation of adult stem cells as drugs I think, it was the most important and interesting debate in 2012. In July, the lawsuit of Regenerative Sciences versus FDA got a new turn US Federal court ruled in favor of FDA regulation cultured adult stem cells as drugs. This ruling and ongoing debate has far-reaching implications for cell therapy industry as a whole. Based on court decision, FDA has a power to regulate stem cell clinics, which attempt to offer autologous adult stem cells (AASC) as a medical procedure on the US market. Yet another notable provocative event was an inspection of CellTex facility with following warning letter. FDA consistently and persistently says that almost all of AASC should be regulated as drugs or any other biologics, means via clinical trials (IND) and BLA (Biologics License Application). Federal court ruling and CellTex inspection triggers a lot of good and productive debates among cell therapy industry professionals, patient advocates, academics and physicians. But, it also polarized community … Continue reading →

Posted in FDA Stem Cell Trials | Comments Off

2013: Year of the Stem Cell

Posted: Published on December 30th, 2012

Researchers have already safely injected stem cells into patients with neurodegenerative diseases and spinal cord injuries -- and they've seen the potential to vastly improve lives. Knut Olstad in August 2011, 20 minutes before the accident that left him paralyzed below the waist Marcus Hilton has probably been going blind since he was born, though he didn't really begin to notice that something was wrong until he was seven or eight. Several years after that, he was officially diagnosed with Stargardt disease, the leading cause of juvenile blindness. Thirty-four years of decline later, his retinas irreparably damaged, he is unable to drive, read fine print, or recognize people from a distance. For Knut Olstad, devastation came much more suddenly. Having quit smoking and taken up cross-country skiing and bicycling in an early mid-life crisis, he was 45 years old and on what he described as the vacation of his life, conquering 25 mountains on the Tour de France route. On the last descent of the twenty-fifth mountain, on what might even have been the final turn of the entire trip, a car veered into his lane. He swerved out of the way, squeezed just a little too hard on the … Continue reading →

Posted in Stem Cell Human Trials | Comments Off

Acorda Therapeutics to Present at the 31st Annual J.P. Morgan Healthcare Conference

Posted: Published on December 29th, 2012

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Ron Cohen, M.D., President & CEO, will present at the upcoming 31st Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2013 at 11:00 a.m. Pacific Time at the Westin St. Francis Hotel in San Francisco, CA. A live audio webcast of the presentation can be accessed under Investor Events in the Investor section of the Acorda website at http://www.acorda.com or you may use the link: http://jpmorgan.metameetings.com/webcasts/healthcare13/directlink?ticker=ACOR Please log in 5 minutes before the scheduled time of the presentation to ensure a timely connection. An archived version of the webcast will be available until February 7, 2013 on the Acorda website in the Investor Relations section. About Acorda Therapeutics Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with MS, spinal cord injury and other neurological conditions. Acorda markets AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, in the United States as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed. AMPYRA is marketed outside the United States as FAMPYRA (prolonged-release fampridine tablets) by Biogen Idec under a licensing … Continue reading →

Posted in Spinal Cord Injury Treatment | Comments Off

Brain injury post cardiac arrest may have proved fatal for Delhi gang-rape victim

Posted: Published on December 29th, 2012

New Delhi, Dec 29 (ANI): The Delhi gang-rape victim, whose assault in the national capital triggered nationwide protests, died in a Singapore hospital on Saturday of injuries suffered to her brain from the cardiac arrest she suffered at the Safdarjung Hospital on Tuesday night. The victim underwent three surgeries at the Safdarjung Hospital in Delhi, where she remained on ventilator support during most part of the treatment. The 23-year-old victim, who was severely beaten, raped and thrown out of a moving bus in New Delhi, was flown to Singapore by the Indian government on Wednesday (December 26) for specialist treatment The Delhi gang-rape victim had significant brain injury, infection in lungs and abdomen, the Mount Elizabeth Hospital said on Friday. "Our medical team's investigations upon her arrival at the hospital on Thursday showed that in addition to her prior cardiac arrest, she also had infection of her lungs and abdomen, as well as significant brain injury," said Dr Kelvin Loh, Chief Executive Officer, Mount Elizabeth Hospital. In a statement, Dr Loh said, "The patient is currently struggling against the odds, and fighting for her life. As at 28 December, 11 am (8:30 IST) the patient continues to remain in an … Continue reading →

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National MS Society Reports Sweeping Advances Made in MS Research During 2012

Posted: Published on December 29th, 2012

Part 2: Overview, Progress Toward Restoring Function and Ending MS NEW YORK, Dec. 27, 2012 /PRNewswire-USNewswire/ -- The National MS Society supported new and ongoing initiatives to propel efforts to restore function to people with MS through its Discovery and Fast Forward research programs. (Logo: http://photos.prnewswire.com/prnh/20090302/DC77093LOGO) PROGRESS TOWARD RESTORING FUNCTION LOST TO MS Other important 2012 results toward restoring function include: Nervous System Protection and Repair First trial of experimental anti-LINGO to stimulate myelin repair This first human phase I trial of BIIB033 (Biogen Idec), an immune antibody that inhibits LINGO-1, involved 64 healthy adult volunteers and 42 people with relapsing or secondary-progressive MS. There were no serious adverse events; headache was the most frequently adverse event reported. The authors concluded that the results support advancing this myelin repair strategy into a phase II clinical trial. Reported at the American Academy of Neurology annual meeting http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=6377 Trial of patients' own adult stem cells appear safe and hints of benefit Researchers in the UK published results of a small clinical trial involving 10 people with secondary-progressive MS, reporting that injecting a person's own bone marrow stem cells appeared safe and possibly beneficial in helping to protect the nervous system from injury. … Continue reading →

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