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FDA Approves Stemedica Phase II Clinical Trial for Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem …

Posted: Published on October 2nd, 2012

SAN DIEGO, Calif., Oct. 2, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the clinical effects of Stemedyne-MSC (Stemedica's human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with a myocardial infarct. The Phase IIa double-blinded randomized clinical trial will study approximately forty (40) patients. All patients will initially receive standard care including percutaneous transluminal coronary angioplasty (PTCA) and stenting and, upon completion, will be randomized to receive Stemedyne-MSC intravenously or placebo. The clinical trial will address the prevalence of cardiovascular disease estimated to carry a global disease burden in excess of $400 billion each year. More than one million patients undergo PTCA and stenting in the Untied States annually; another 800,000 have the procedures each year in Europe. Nabil Dib, M.D., MSc., F.A.C.C., Director of Cardiovascular Research at Mercy Gilbert and Chandler Regional Medical Centers, and an Associate Professor of Medicine and Director of Clinical Cardiovascular Cell Therapy at the University of California, San Diego, will serve as the principal investigator of the FDA-approved … Continue reading →

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Cedars-Sinai study sheds light on bone marrow stem cell therapy for pancreatic recovery

Posted: Published on October 2nd, 2012

Public release date: 2-Oct-2012 [ | E-mail | Share ] Contact: Sandy Van sandy@prpacific.com 808-526-1708 Cedars-Sinai Medical Center LOS ANGELES (Oct. 2, 2012) Researchers at Cedars-Sinai's Maxine Dunitz Neurosurgical Institute have found that a blood vessel-building gene boosts the ability of human bone marrow stem cells to sustain pancreatic recovery in a laboratory mouse model of insulin-dependent diabetes. The findings, published in a PLOS ONE article of the Public Library of Science, offer new insights on mechanisms involved in regeneration of insulin-producing cells and provide new evidence that a diabetic's own bone marrow one day may be a source of treatment. Scientists began studying bone marrow-derived stem cells for pancreatic regeneration a decade ago. Recent studies involving several pancreas-related genes and delivery methods transplantation into the organ or injection into the blood have shown that bone marrow stem cell therapy could reverse or improve diabetes in some laboratory mice. But little has been known about how stem cells affect beta cells pancreas cells that produce insulin or how scientists could promote sustained beta cell renewal and insulin production. When the Cedars-Sinai researchers modified bone marrow stem cells to express a certain gene (vascular endothelial growth factor, or VEGF), pancreatic recovery … Continue reading →

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Despite Tory carping, Canadians value the United Nations

Posted: Published on October 2nd, 2012

Two years ago Prime Minister Stephen Harpers Conservatives cared enough about the United Nations to lobby for a Security Council seat. Now, after being jilted, they seem to be in a cranky funk. Unlike U.S. President Barack Obama, who spoke eloquently on freedom of speech to this years General Assembly, Harper couldnt be bothered to attend. He was in New York last week, but only to accept a world statesman award as he turned his back on most of it. Canada has no interest in trying to court every dictator with a vote at the United Nations, Harper told the award dinner. Or just going along with every emerging international consensus, no matter how self-evidently wrong-headed. Foreign Affairs Minister John Baird then hectored the General Assembly. Canada cannot and will not participate in endless, fruitless inward-looking exercises, he said. The UN spends too much time on itself. It must now look outward. Granted, the UN has more than its share of flaws. The Security Council has failed so far to thwart Irans nuclear ambitions or stop Syrias bloodshed. (It has also been accused of impotency on the Palestinian issue, though Ottawa has no complaint about that.) Despotic regimes get a … Continue reading →

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FDA warns public of risks of online pharmacies

Posted: Published on October 2nd, 2012

The Food and Drug Administration is warning U.S. consumers that the vast majority of Internet pharmacies are fraudulent and likely are selling counterfeit drugs that could harm them. The agency on Friday launched a national campaign, called BeSafeRx, to alert the public to the danger, amid evidence that more people are shopping for their medicine online, looking for savings and convenience. Instead, they're likely to get fake drugs that are contaminated, are past their expiration date or contain no active ingredient, the wrong amount of active ingredient or even toxic substances such as arsenic and rat poison. They could sicken or kill people, cause them to develop a resistance to their real medicine, cause new side effects or trigger harmful interactions with other medications being taken. "Our goal is to increase awareness," FDA Commissioner Dr. Margaret Hamburg said, "not to scare people away from online pharmacies. We want them to use appropriate pharmacies." That means pharmacies that are located in the U.S., are licensed by the pharmacy board in the patient's state and have a licensed pharmacist available to answer questions. In addition, the pharmacy must require a valid doctor's prescription for the medicine. Online drugstores that claim none is … Continue reading →

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FDA Approves Stemedica Phase II Clinical Trial for Acute Myocardial Infarction With Ischemia Tolerant Mesenchymal Stem …

Posted: Published on October 2nd, 2012

SAN DIEGO, Calif., Oct. 2, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the clinical effects of Stemedyne-MSC (Stemedica's human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with a myocardial infarct. The Phase IIa double-blinded randomized clinical trial will study approximately forty (40) patients. All patients will initially receive standard care including percutaneous transluminal coronary angioplasty (PTCA) and stenting and, upon completion, will be randomized to receive Stemedyne-MSC intravenously or placebo. The clinical trial will address the prevalence of cardiovascular disease estimated to carry a global disease burden in excess of $400 billion each year. More than one million patients undergo PTCA and stenting in the Untied States annually; another 800,000 have the procedures each year in Europe. Nabil Dib, M.D., MSc., F.A.C.C., Director of Cardiovascular Research at Mercy Gilbert and Chandler Regional Medical Centers, and an Associate Professor of Medicine and Director of Clinical Cardiovascular Cell Therapy at the University of California, San Diego, will serve as the principal investigator of the FDA-approved … Continue reading →

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Blind Mice Get Experimental Stem Cell Treatment For Blindness

Posted: Published on October 2nd, 2012

April Flowers for redOrbit.com Your Universe Online Columbia University ophthalmologists and stem cell researchers have developed an experimental treatment for blindness using the patients skin cells, which has improved the vision of blind mice in testing. The findings of this research, published online in the journal Molecular Medicine, suggest that induced pluripotent stem cells (iPS) could soon be used to improve vision in people with macular degeneration and other eye retina diseases. iPS cells are derived from adult human skin cells but have embryonic qualities. With eye diseases, I think were getting close to a scenario where a patients own skin cells are used to replace retina cells destroyed by disease or degeneration, says Stephen Tsang, MD, PhD, associate professor of ophthalmology and pathology & cell biology. Its often said that iPS transplantation will be important in the practice of medicine in some distant future, but our paper suggests the future is almost here. Scientists were very excited by the advent of human iPS cells when they were discovered in 2007, as they provide a way to avoid the ethical complications of embryonic stem cells. Another advantage is that the iPS cells are created from the patients own skin, eliminating … Continue reading →

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Nuvilex Subsidiary Austrianova Singapore to Participate in AusBiotech 2012

Posted: Published on October 2nd, 2012

SILVER SPRING, Md. and SINGAPORE, Oct. 2, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today its wholly-owned subsidiary, Austrianova Singapore Pte Ltd (ASPL) will attend this year's AusBiotech event. The annual AusBiotech event this year will be held from October 30 - November 2 at the Melbourne Convention and Exhibition Centre, Melbourne, Australia. It has earned a reputation as the industry's premier biotechnology conference for the Asia Pacific region and has successfully expanded its relevance to the Australian and International Biotechnology industries by attracting more than 1100 participants from over 20 countries. Dr Brian Salmons, CEO of ASPL said, "AusBiotech has grown in stature over the past several years. In prior years, we entered agreements with companies and found it to be one of the most valuable events for networking with new contacts. We anticipate meeting with companies with proprietary therapeutic cells, such as stem cells, that can leverage their technology with our Cell-in-a-Box(R) delivery system. We believe the new contacts we make will expand our customer base and increase the use of cell and gene therapy for making therapeutic products and treating diseases. We will also be promoting … Continue reading →

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Histogenics Honored as a 2012 “Fierce 15” Company by FierceMedicalDevices

Posted: Published on October 2nd, 2012

WALTHAM, Mass.--(BUSINESS WIRE)-- Histogenics, a regenerative medicine company combining cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration, announced today that it has been named to the FierceMedicalDevices Fierce 15 list, designating it as one of the leading medical device and diagnostic companies of 2012. FierceMedicalDevicesEditors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this years winners based on their top management teams, notable financial backing, and promising technologies and market opportunities. We have worked hard over the past year, securing $49 million in financing and adding key new staff, investors and board members, so that we are now in the position to focus our full attention on continued successful clinical and regulatory execution for NeoCart cartilage regeneration implant, which is currently enrolling patients into the Phase 3 IND clinical study, and the EU regulatory development of our VeriCart cartilage repair scaffold, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. We believe our product candidates have the potential to transform the treatment of cartilage injury with the goal of returning some of the estimated 1.8 million patients each year in the U.S. … Continue reading →

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NeoStem to Present at Multiple Conferences in October

Posted: Published on October 2nd, 2012

NEW YORK, Oct. 2, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that Company management and management of its subsidiary, Progenitor Cell Therapy ("PCT"), have been invited to present at multiple conferences in October. RetailInvestorConferences.com The RedChip 15th Annual Fall Small-Cap Conference Regenerative Medicine Foundation 2012 Conference 2012 Stem Cell Meeting on the Mesa, 2nd Annual Investor and Partnering Forum About NeoStem, Inc. NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve … Continue reading →

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Viagra Without Prescriptions Canada

Posted: Published on October 2nd, 2012

SAN JUAN (AP) El gobernador Luis Fortuo dej el lunes la puerta abierta para que parejas del mismo sexo puedan adoptar menores en Puerto Rico. El mandatario afirm que no es necesario que la nueva ley de adopcin que discute la Asamblea Legislativa entre en asuntos como la preferencia sexual del padre o la madre adoptante. "La ley no mira qu t haces en tu privacidad, la ley lo que tiene que mirar es si esta persona o personas son una alternativa de vida para un nio, eso es lo que tiene que mirar", sostuvo en conferencia de prensa tras participar en una actividad en Juncos. "Para un proyecto que es un proyecto de amor, un proyecto de dar una alternativa de vida a una nia o a un nio, no tenemos que entrar a esas discusiones que nos dividen", aadi. Fortuo afirm que apoya "completamente" el proyecto de ley de adopcin tal y como fue aprobado en la Cmara de Representantes y dijo esperar que el mismo se discuta a fondo a partir del 17 de agosto. El presidente del Senado, Thomas Rivera Schatz, ha sealado que enmendar el proyecto para buscar que la nueva ley de adopcin tenga … Continue reading →

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