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Research and Markets: Developments in Tissue Engineered and Regenerative Medicine Products: A Practical Approach

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/9xf3cb/developments_in) has announced the addition of Woodhead Publishing Ltd's new book "Developments in tissue engineered and regenerative medicine products: A practical approach" to their offering.

Developments in Tissue Engineered and Regenerative Medicine Products summarizes recent developments in tissue engineering and regenerative medicine with an emphasis on commercialization and product development. Features of current cell therapy and tissue engineered products which have facilitated successful commercialization are emphasized. Roadblocks to successful product development are also highlighted. Preclinical and clinical testing of tissue engineered and regenerative medicine products, regulatory, quality control, manufacturing issues, as well as generating and securing intellectual property and freedom to operate considerations are presented.

This book represents a complete 'how-to' manual for the development of tissue engineered and regenerative medicine products from conceptualization to clinical trial to manufacturing.

Key Topics Covered:

- Overview of tissue engineering/regenerative medicine

- Cells

- Biomaterials for TE/RM products

- Neo-Bladder: A foundational technology platform for tubular organ regeneration

- Neo-Urinary Conduit

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Research and Markets: Developments in Tissue Engineered and Regenerative Medicine Products: A Practical Approach

Recommendation and review posted by sam

Leading bone marrow transplant expert recommends significant change to current practice

ScienceDaily (Oct. 17, 2012) One of the world's leading bone marrow transplant experts is recommending a significant change to current transplant practice for patients who need marrow or adult stem cells from an unrelated donor to treat hematologic malignancies. Fred Appelbaum, M.D., director of the Clinical Research Division at Fred Hutchinson Cancer Research Center, asserts that bone marrow -- not circulating, peripheral blood, which is the current norm -- should be the source for unrelated donor adult stem cells for most patients who require a transplant. The reason: because there is less incidence of chronic graft-versus-host disease (GVHD), which can be a debilitating side effect of transplantation.

Appelbaum called for the change in an Oct. 18 editorial in The New England Journal of Medicine in response to a new study, published in the same issue, which compared survival rates and side effects of treating patients with hematopoietic adult stem cells derived from bone marrow versus circulating peripheral blood. The study found a higher incidence of chronic GVHD -- 53 percent when peripheral blood was the source of stem cells for transplant -- versus 41 percent when bone marrow is the source.

"For the majority of unrelated transplants following a standard high-dose preparative regimen, bone marrow should be used since survival is equivalent with the two sources but the incidence of chronic graft-versus-host disease, which can be a debilitating complication, is significantly less with marrow," Appelbaum wrote.

GVHD is a common side effect in people who receive cells from an unrelated donor. It occurs when the transplanted cells recognize the recipient's tissues as foreign and attack the tissues. This can cause a variety of problems, including skin rashes, liver problems and diarrhea. Chronic GVHD can develop any time between three months and three years after the transplant and can range from mild to serious in intensity.

Appelbaum said that stem cells derived from peripheral blood should only be used for the minority of patients in whom the benefits outweigh the risks. These include patients in need of rapid engraftment, such as those with life-threatening infections, or patients at high risk for graft rejection, such as those who receive reduced-intensity conditioning that does not include intensive chemotherapy.

For the past 10 years peripheral blood has been the norm as a source of matched related and matched unrelated adult stem cells for transplant because, despite the higher risk of GVHD, they are easier to harvest from the donor, they can be stimulated to grow in large numbers prior to harvesting, and they engraft, or set up shop, quickly inside the recipient's body.

The potential impact if such a practice change were widely implemented is large. Currently, about 75 percent of unrelated donor transplants are done using stem cells that are collected from the peripheral blood of donors. About 70 percent of all patients who undergo a life-saving transplant to treat blood cancers such as leukemia require an unrelated donor. Collecting adult stem cells from bone marrow is a more invasive process than collecting them from the bloodstream.

According to Appelbaum, about 5,500 unrelated donor transplants were performed in the United States last year. More than 20 million potential unrelated donors are typed and listed in registries in the Americas, Europe and Asia.

The study that compared the two sources of adult stem cells was the first randomized trial of its kind to compare the two sources of cells. It was led by former Hutchinson Center transplant physician Claudio Anasetti, M.D., who is now at the H. Lee Moffitt Cancer Center in Tampa, Fla. It found no difference in two-year survival, faster engraftment and less graft failure, but a significant increase in chronic GVHD, when patients were transplanted with stem cells derived from peripheral blood.

"While this study should change practice, it will be interesting to see if it really does," Appelbaum wrote. "The benefits of peripheral blood are seen early, under the watchful eyes of the transplant physician, while the deleterious effects occur late, often after the patient has left the transplant center."

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Leading bone marrow transplant expert recommends significant change to current practice

Recommendation and review posted by Bethany Smith

Parkinson's cells

The nuclei of brain stem cells in some Parkinson's patients become misshapen with age. The discovery opens up new ways to target the disease.

Nubby nucleus: Brain cells from a deceased Parkinsons patient have deformed nuclei (bottom) compared with normal brain cells from an individual of a similar age. Merce Marti and Juan Carlos Izpisua Belmonte

Stem cells in the brains of some Parkinson's patients are increasingly damaged as they age, an effect that eventually diminishes their ability to replicate and differentiate into mature cell types. Researchers studied neural stem cells created from patients' own skin cells to identify the defects. The findings offer a new focus for therapeutics that target the cellular change.

The report, published today in Nature, takes advantage of the ability to model diseases in cell culture by turning patient's own cells first into so-called induced pluripotent stem cells and then into disease-relevant cell typesin this case, neural stem cells. The basis of these techniques was recognized with a Nobel Prize in medicine last week.

The authors studied cells taken from patients with a heritable form of Parkinson's that stems from mutations in a gene. After growing several generation of neural stem cells derived from patients with that mutation, they saw the cell nuclei start to develop abnormal shapes. Those abnormalities compromise the survival of the neural stem cells, says study coauthor Ignacio Sancho-Martinez of the Salk Institute for Biological Studies in La Jolla, California.

Today's study "brings to light a new avenue for trying to figure out the mechanism of Parkinson's," says Scott Noggle of the New York Stem Cell Foundation. It also provides a new set of therapeutic targets: "Drugs that target or modify the activity [of the gene] could be applicable to Parkinson's patients. This gives you a handle on what to start designing drug screens around."

The strange nuclei were also seen in patients who did not have a known genetic basis for Parkinson's disease. The authors suggest this indicates that dysfunctional neural stem cells could contribute to Parkinson's. While that conclusion is "highly speculative," says Ole Isacson, a neuroscientist at Harvard Medical School, the study demonstrates the "wealth of data and information that we now can gain from iPS cells."

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Parkinson's cells

Recommendation and review posted by Bethany Smith

Stem Cells Reveal Defect in Parkinson's Cells

The nuclei of brain stem cells in some Parkinson's patients become misshapen with age. The discovery opens up new ways to target the disease.

Nubby nucleus: Brain cells from a deceased Parkinsons patient have deformed nuclei (bottom) compared with normal brain cells from an individual of a similar age. Merce Marti and Juan Carlos Izpisua Belmonte

Stem cells in the brains of some Parkinson's patients are increasingly damaged as they age, an effect that eventually diminishes their ability to replicate and differentiate into mature cell types. Researchers studied neural stem cells created from patients' own skin cells to identify the defects. The findings offer a new focus for therapeutics that target the cellular change.

The report, published today in Nature, takes advantage of the ability to model diseases in cell culture by turning patient's own cells first into so-called induced pluripotent stem cells and then into disease-relevant cell typesin this case, neural stem cells. The basis of these techniques was recognized with a Nobel Prize in medicine last week.

The authors studied cells taken from patients with a heritable form of Parkinson's that stems from mutations in a gene. After growing several generation of neural stem cells derived from patients with that mutation, they saw the cell nuclei start to develop abnormal shapes. Those abnormalities compromise the survival of the neural stem cells, says study coauthor Ignacio Sancho-Martinez of the Salk Institute for Biological Studies in La Jolla, California.

Today's study "brings to light a new avenue for trying to figure out the mechanism of Parkinson's," says Scott Noggle of the New York Stem Cell Foundation. It also provides a new set of therapeutic targets: "Drugs that target or modify the activity [of the gene] could be applicable to Parkinson's patients. This gives you a handle on what to start designing drug screens around."

The strange nuclei were also seen in patients who did not have a known genetic basis for Parkinson's disease. The authors suggest this indicates that dysfunctional neural stem cells could contribute to Parkinson's. While that conclusion is "highly speculative," says Ole Isacson, a neuroscientist at Harvard Medical School, the study demonstrates the "wealth of data and information that we now can gain from iPS cells."

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Stem Cells Reveal Defect in Parkinson's Cells

Recommendation and review posted by Bethany Smith

2012 U.S. Conference on Rare Diseases and Orphan Products: Shaping the Future Now

HORSHAM, Pa., Oct. 17, 2012 /PRNewswire/ --The 2012 U.S. Conference on Rare Diseases and Orphan Products will bring together the rare disease and orphan product communities to collaborate on and advance product research, drug development and access to treatments to help the 30 million Americans suffering from rare diseases. Sponsored by DIA and the National Organization for Rare Disorders (NORD), the conference will be held Oct. 22-24 at the Capital Hilton hotel in Washington, D.C.

Among the conference's influential speakers and moderators will be keynote speaker John J. Castellani, president and CEO of Pharmaceutical Research and Manufacturers of America, who will discuss special challenges in rare diseases, and Stephen C. Groft, director of the National Institutes of Health Office of Rare Diseases Research, who will moderate several panel discussions including one on gene therapy and genome sequencing.

Two influential journalists also will play a part in the sessions. Wall Street Journal reporter Thomas Burton will moderate a discussion about the environment surrounding investments in orphan products, and Steve Usdin, Washington editor of BioCentury and co-host of "BioCentury This Week," will moderate panel discussions about the ethical challenges of genetic testing and internationalization of the rare disease community.

Participants and other presenters will include representatives of patient organizations and drug and medical device companies, researchers, investors, thought leaders and regulatory officials.

Other conference sessions to be featured are Well-Designed and Well-Conducted Clinical Trials; Challenges of Reimbursement for the Rare Disease Patient; Comparative Effectiveness Research and Health Technology Assessments; and Role of Academic Centers in Orphan Product Development.

Another unique component of the 2012 conference will be an inspiring panel discussion on Oct. 22 featuring patients who have a rare disease and their advocates, who will talk about how nonprofit associations for rare diseases are playing a key role in the development of orphan products.

Visit http://www.diahome.org to learn more about the conference and register.

ABOUT DIA: DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and lifecycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo; Mumbai, India; and Beijing.

ABOUT NORD: NORD is a nonprofit organization representing U.S. patients and families affected by rare diseases. NORD was established in 1983 by leaders of rare disease patient organizations who worked together for the enactment of the Orphan Drug Act. Today, NORD provides programs and services that include advocacy, education of patients and medical professionals, support for research and patient assistance programs to help patients access lifesaving therapies.

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2012 U.S. Conference on Rare Diseases and Orphan Products: Shaping the Future Now

Recommendation and review posted by Bethany Smith

Barley gene work 'can boost crops'

New research which has unravelled the barley genome could help produce better varieties of the crop - a vital part of the beer and whisky industries.

Scientists said the breakthrough is a critical step towards developing barley varieties able to cope with the demands of climate change.

The study, funded by the Biotechnology and Biological Sciences Research Council (BBSRC) and the Scottish Government, should also help in the fight against cereal crop diseases which cause millions of pounds of losses annually.

Researchers said barley is the second most important crop in UK agriculture, and malting barley, some 30% of the total, underpins the beer and whisky sector which is worth around 20 billion to the UK economy.

The UK team behind the international research was led by Professor Robbie Waugh, of Scotland's James Hutton Institute, who worked with researchers at the Genome Analysis Centre in Norwich.

He said: "Access to the assembled catalogue of gene sequences will streamline efforts to improve barley production through breeding for varieties better able to withstand pests and disease, and deal with adverse environmental conditions such as drought and heat stress.

"It will accelerate research in barley, and its close relative, wheat. Armed with this information, breeders and scientists will be much better placed to deal with the challenge of effectively addressing the food security agenda under the constraints of a rapidly changing environment."

As well as being used in the beer and whisky industry, barley is also a major component of the animal feed for the meat and dairy industries, while barley straw is used for animal bedding in the winter, and for frost protection in horticulture.

Unravelling the sequence of barley's DNA has proved a major challenge as the barley genome is almost twice the size of that of humans. Scientists from the International Barley Genome Sequencing Consortium (IBSC) managed to construct a high-resolution draft DNA sequence assembly which contains the majority of barley genes in linear order.

Published in the journal Nature, the sequence provides a detailed overview of the functional portions of the barley genome, revealing the order and structure of most of its 32,000 genes and a detailed analysis of where and when genes are switched on in different tissues and at different stages of development.

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Barley gene work 'can boost crops'

Recommendation and review posted by Bethany Smith

Casey Analyst Forecasts Explosive Biotech Growth

Submitted by The Life Sciences Report as part of our contributors program .

This interview was conducted by The Life Sciences Report (10/11/12)

The myth of technology, whether for smartphones or cancer treatments, is that the next big thing appears suddenly and magically. Casey Research Analyst Alex Daley sets the record straight in this exclusive interview with The Life Sciences Report . While the science of genetic medicine has accelerated the process of turning magical thinking into practical medicine, Daley cautions investors in biotech and medical device companies to be patient, and names companies with innovative technologies poised for explosive growth.

The Life Sciences Report: At Casey Research's "Navigating the Politicized Economy" summit, you talked about the difference between the speed of science and the speed of technology, and how quickly the time to market and cost of products in the life sciences space is decreasing. Can you provide some examples?

Alex Daley: Many technologies, like the touch-screen tablets and smartphones that now dominate the market, seem to come out of nowhere, perpetuating the myth of technology as almost magical. But you only have to look as far as the as-yet-unfulfilled promises of recent years to see the slow development curve that leads to explosive growth. This has been most noticeable in the advent of genetic medicine.

We all remember the sequencing of the human genome as a scientific milestone. Announced in 2000, just at the turn of the millennium, it was followed by much media fanfare about the dawn of genetic medicine. Every untreatable disease was going to be cured. Every person was going to receive medicine tailored to his or her unique makeup.

Yet, more than a decade later, that promise remains almost entirely unfulfilled. It's not that the science has stood still. Quite the opposite: It has been moving forward at blazing speed. The original human genome project, which sequenced a single person's genome to 92%?including everything but some particularly difficult areas?took 13 years and cost more than $3 billion ($3B). It was a monumental advancement, but not practical for everyday use.

Over the last decade the cost of genome sequencing has fallen far faster than many predicted. We've gone from taking 13 years to taking just about one day to sequence a whole genome. And the cost has fallen from billions to thousands of dollars. We've now sequenced tens of thousands of genomes for scientific research, and with the falling price that number is skyrocketing. We have built an amazing scientific base for study, and driven down costs to make it viable for mainstream use. All of that had to happen before genetic medicine could even begin to crawl forward?precisely what is happening now, with the advent of the first U.S. Food and Drug Administration (FDA)-approved antisense drug and other genetic milestones just being reached.

Just as the plasma TV (invented in the 1930s), the LED light (1960s), the industrial robot (also a child of the '60s), the touch-screen interface for computers (early 1980s) and other inventions we think of as thoroughly modern took decades to go from the lab into our everyday lives, it will take considerable time for genetic medicine to fully develop. But the pace is ever-increasing and advances happen at an astounding rate. The decrease in time needed for gene-sequencing, for instance, far outpaced the development of computer chips in terms of cost/speed, as in the famous Moore's law (predicting a doubling of circuit capacity every two years).

TLSR: What is the role of FDA in that race to market? Is it a speed bump, a safety crew or something else?

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Casey Analyst Forecasts Explosive Biotech Growth

Recommendation and review posted by Bethany Smith

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

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 Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."

"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.

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

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Genomind Executive to Speak at Open Minds Technology & Informatics Institute

General Manager, Nancy Grden to speak on cutting edge technology.

Chalfont, PA (PRWEB) October 17, 2012

The session titled Genetics, Neurotech & Personalized Medicine: Using Emerging Science to Improve Treatment of Cognitive Disorders, will discuss the advancements in personalized medicine and how this changing facet of the health care industry will affect how patients and medical professionals approach diagnosis and treatment in the future. Grden will share the recent success Genomind has made with the companys Genecept Assay, which analyzes patient saliva for biomarkers and genes that may have impact on treatments for psychiatric disorders. She will also weigh in on the implications of such advancements on service providers, and future breakthroughs that may be on the horizon. The session will take place at 9:30 am.

Grden is an experienced executive in numerous industries, and was instrumental in Genominds formation and launch. As general manager she is responsible for all aspects of Genominds development, commercialization, and future strategy.

OPEN MINDS Technology & Informatics Institute (ww.openminds.com/tii) will run October 17-18 at the Baltimore Convention Center. It is the only event of its kind that focuses on the latest advancements in technology and informatics for the health care field and how they will impact the public.

About Genomind

Genomind is a personalized medicine company, comprised of innovative researchers and expert leaders in psychiatry and neurology. Genomind is committed to discovery of the underlying causes of neuropsychiatric disorders and supports the development of personalized medicine that improves patients lives. Genomind was founded by Ronald I. Dozoretz, MD, a psychiatrist who has devoted his career to improving mental health. Jay Lombard, DO, a neurologist and co-founder of Genomind, is a critically acclaimed author and nationally recognized thought leader in neuropsychiatry practice and research. Learn more at http://www.genomind.com.

About the Genecept Assay

The Genecept Assay is a comprehensive, simple-to-use tool for understanding genetic and biological markers that best inform response to different psychiatric treatments. The Assay is Genominds core product, and contains a proprietary panel of biomarker tests, an analytic report, and a psychopharmacologist consultation. The Assay can be used for a range of psychiatric conditions including depression, bipolar disorder, schizophrenia, anxiety disorders, OCD and ADHD. For more information on the Assay, including information about the specific genes in the panel, please visit http://www.genomind.com/products/assay.

Doreen Korba Genomind, LLC 215.396.5596 Email Information

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Genomind Executive to Speak at Open Minds Technology & Informatics Institute

Recommendation and review posted by sam

Quadriplegic to share her breast cancer survival story

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 three women will develop some sort of cancer," Tada said. "It's a growing problem, and I'm grateful I've been offered a platform from which to share my story."

Each year, the seminar has a nonmedical guest speaker address topics that are not clinically related to breast cancer, said Kris Carraway-Bowman, vice president of marketing and public relations for the hospital.

"As if her handicap wasn't enough to deal with, she was diagnosed with breast cancer three years ago," Carraway-Bowman said. "Instead of hiding it, she had her journey to fight breast cancer documented on film to share with other women fighting the disease so that they may find strength together."

Originally posted here:
Quadriplegic to share her breast cancer survival story

Recommendation and review posted by sam

Bioheart Extends Licenses of Electrical Stimulation Patents With Airspeed

SUNRISE, FL--(Marketwire - Oct 17, 2012) - Bioheart, Inc. ( OTCQB : BHRT ) today announced that they have agreed to extend the license agreement with Airspeed for four separate Bioheart patents.The patents include methods of electrical stimulation and biological pacing, which are marketed under the MyoStim product line.Airspeed holds exclusive rights to these patents and all products associated with the patents and pays Bioheart milestone payments and royalties based on future sales of products.MyoStim is pursuing initial safety and efficacy trials in both wound care and heart failure using the Wound Healing and Regeneration Accelerator units (MWHA-1).

Mike Tomas, President and CEO, said, "Bioheart is currently focused on our core assets for heart failure patients and is enthusiastic about Airspeeds ability to bring Bioheart's electrical stimulation technologies to market."

Alan Remen, Airspeed Holdings' Managing Director and MyoStim's Co-Founder and CEO, said, "This technology may help to stimulate the body's own bio-electric 'homing' signal to recruit stem cells to the site of injury and grow new blood vessels, which can be an effective therapy for critical wounds and heart failure."

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

About Airspeed Holdings, LLC

Headquartered in San Diego, Airspeed is a private investment, entrepreneurial capital management firm and leading edge, multi-project business development enterprise that creates and nurtures new technology companies.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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Bioheart Extends Licenses of Electrical Stimulation Patents With Airspeed

Recommendation and review posted by Bethany Smith

New blood-vessel-generating cells with therapeutic potential discovered

Washington, October 17 (ANI): Researchers believe they have discovered stem cells that play a decisive role in new blood vessel growth.

If the researchers at the University of Helsinki, Finland, learn to isolate and efficiently produce these stem cells found in blood vessel walls, the cells offer new opportunities in the treatment of cardiovascular diseases, cancer and many other diseases.

The growth of new blood vessels, also known as angiogenesis, is needed in adults when repairing damaged tissue or organs.

Unfortunately, malignant tumours are also capable of growing new blood vessels to receive oxygen and nutrients. In other words, the treatment of diseases would benefit from two types of methods - ones that help launch the process of angiogenesis and ones that make it possible to prevent the process.

Medications that prevent the growth of new blood vessels have already been introduced, but their effectiveness and long-term efficacy leave much to be desired.

For more than a decade, Adjunct Professor Petri Salven from the University of Helsinki has studied the mechanisms of angiogenesis to discover how blood vessel growth could be prevented or accelerated effectively.

He has examined the birth and origin of endothelial cells, which form the thin layer that lines the interior surface of blood vessels. Endothelial cells are necessary for new blood vessel growth. Where do these highly diversified cells come from? Can their production be prevented or increased?

For a long time, it was assumed that new cells in the blood vessel walls of an adult originate in the bone marrow. In an article published in the PNAS journal in 2008, Salven's research team showed that such stem cells were not found in bone marrow.

Now Salven is ready to reveal where these mysterious stem cells originate.

"We succeeded in isolating endothelial cells with a high rate of division in the blood vessel walls of mice. We found these same cells in human blood vessels and blood vessels growing in malignant tumours in humans. These cells are known as vascular endothelial stem cells, abbreviated as VESC. In a cell culture, one such cell is able to produce tens of millions of new blood vessel wall cells," Salven said.

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New blood-vessel-generating cells with therapeutic potential discovered

Recommendation and review posted by Bethany Smith

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

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 Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."

"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.

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

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

NEW YORK, Oct. 17, 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 it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").

On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.

"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."

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 our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

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Brain plaques may be worse than carrying Alzheimer's gene

A new study comparing risk factors for Alzheimers disease has found that having a high amount of beta amyloid plaques in the brain is associated with greater mental decline in healthy, older people than carrying a gene thought to increase peoples risk for the disease.

According to study author Yen Ying Lim, at the University of Melbourne in Victoria, Australia, prior research has shown that carrying the Alzheimers gene, called the APOE 4 allele, and plaques have both been associated with increased risk of cognitive decline and the eventual development of Alzheimers disease. The gene also increases the risk of plaques.

Therefore, Lim and her colleagues originally thought that having both the gene and a high amount of plaques together would result in greater cognitive decline.

However, the data suggested that while both plaques and the gene were associated with decline in healthy people, the main driver of this decline was the amyloid plaque, Lim told FoxNews.com.

In a study of 141 healthy people with an average age of 76, the researchers found people who had more plaques at the start of the study had up to 20 percent greater cognitive decline over the next year and a half than those who had fewer plaques.

While people who carried the Alzheimers gene also showed greater decline than people without the gene, the gene did not affect the decline in memory caused by the plaques.

Though the evidence indicates plaques may be a more important factor in determining Alzheimers risk or other brain-related diseases, there are challenges to scanning people for plaques rather than the APOE 4 allele.

The main challenge is cost scans are very expensive, and the number of scanners are very few, Lim said. Further, this is the first time such a relationship between amyloid and cognitive decline has been observed.

If the results are replicated in future studies, Lim added, it could help direct future researchers on how to potentially treat or prevent Alzheimers disease.

It provides us with a platform to begin to investigate whether in healthy people with high levels of plaques, pharmaceutical therapies designed to halt or alter plaque accumulation can prevent the disease from progressing to the more severe stages, Lim said.

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Progress in Cell-SELEX compound screening technology reviewed in BioResearch Open Access

Public release date: 17-Oct-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, October 17, 2012SELEX is a rapid, efficient, and iterative high-throughput method for screening large libraries of molecules to identify those with the potential to be developed as drug compounds or research tools. Advances in SELEX technology that have enabled screening in live cells, called Cell-SELEX, are explored in a comprehensive Review article published in BioResearch Open Access, a bimonthly peer-reviewed open access journal from Mary Ann Liebert, Inc. The article is available free on the BioResearch Open Access website.

Cell-SELEX uses live cells as targets for binding of molecules called aptamers, comprised of short chains of nucleic acids. Aptamers share many of the qualities that have made antibodies such successful drugs, but offer additional advantages such as stability, short length, and ease of manufacturing. Shoji Ohuchi, University of Tokyo, Japan, examines the ongoing progress in developing and refining this useful process for drug compound screening in the Review article "Cell-SELEX Technology."

"This review summarizes the progress and application of Cell-SELEX technology, providing an excellent resource for beginners to the field and experts alike," says Editor-in-Chief Jane Taylor, PhD, MRC Centre for Regenerative Medicine, University of Edinburgh, Scotland.

###

About the Journal

BioResearch Open Access is a bimonthly peer-reviewed open access journal that provides a new rapid-publication forum for a broad range of scientific topics including molecular and cellular biology, tissue engineering and biomaterials, bioengineering, regenerative medicine, stem cells, gene therapy, systems biology, genetics, biochemistry, virology, microbiology, and neuroscience. All articles are published within 4 weeks of acceptance and are fully open access and posted on PubMedCentral. All journal content is available on the BioResearch Open Access website.

About the Publisher

Mary Ann Liebert, Inc. is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Assay and Drug Development Technologies, Tissue Engineering, Stem Cells and Development, Human Gene Therapy and HGT Methods, and AIDS Research and Human Retroviruses. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc. website.

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Progress in Cell-SELEX compound screening technology reviewed in BioResearch Open Access

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Are young people who join social media protests more likely to protest offline too?

Public release date: 17-Oct-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, October 17, 2012Among adults who use social media such as Facebook, YouTube, Twitter, and blogs for political purposes, 42% are under the age of 30. A case study of the controversial Budget Repair Bill in Wisconsin explored whether young adults who use social media are more likely to engage in offline protests, and the results are published in an article in Cyberpsychology, Behavior, and Social Networking, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free online on the Cyberpsychology, Behavior, and Social Networking website.

In the article entitled "Killing the Bill Online?: Pathways to Young People's Protest Engagement via Social Media ," Timothy Macafee, University of Wisconsin-Madison, compared the relationship between information-seeking behaviors online versus expressive engagement online (defined as using social media as a "soapbox" to share personal views and political events and issues) and actual participation in political protests.

"Individuals use social media primarily for informational and expressive purposes," Macafee concludes. College students used social media to gain information related to the protests in this case study, but that activity did not affect their offline behavior; whereas, "expressive" political social media use encouraged offline protest participation.

"Using social media for information gathering has quite different implications for real world behavior than does use of social media to express oneself (through blogs, tweets, etc.)," says says Brenda K. Wiederhold, PhD, MBA, BCIA, Editor-in-Chief of Cyberpsychology, Behavior, and Social Networking, from the Interactive Media Institute, San Diego, CA. "As young people utilize social media for information gathering more than traditional means, such as television or newspapers, those wishing to influence opinion and individual behavior should pay heed."

###

About the Journal

Cyberpsychology, Behavior, and Social Networking is an authoritative peer-reviewed journal published monthly in print and online that explores the psychological and social issues surrounding the Internet and interactive technologies. Complete tables of content and a sample issue may be viewed online on the Cyberpsychology, Behavior, and Social Networking website.

About the Publisher

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Are young people who join social media protests more likely to protest offline too?

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Seattle Genetics Announces Initiation of Phase II Trial of ADCETRIS® as Front-line Therapy for Hodgkin Lymphoma …

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced the initiation of a phase II clinical trial evaluating ADCETRIS (brentuximab vedotin) as a front-line therapy for patients age 60 or older with newly diagnosed Hodgkin lymphoma (HL). The trial is designed to assess the efficacy and tolerability of ADCETRIS as a monotherapy for older HL patients who have received no prior treatment. Seattle Genetics is the leader in the field of antibody-drug conjugates (ADCs) and ADCETRIS is an ADC directed to CD30 for relapsed HL and systemic anaplastic large cell lymphoma (sALCL).

The current standard of care for the treatment of front-line HL is a combination of multiple chemotherapeutic agents and has not changed in more than three decades. Some older HL patients are not able to tolerate the significant side effects associated with these regimens, and there is a significant need to identify effective and tolerable treatment options for these patients, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer at Seattle Genetics. We believe the response rate associated with single-agent use of ADCETRIS in the relapsed HL setting supports the evaluation of single-agent ADCETRIS in older patients who have received no prior therapy.

The phase II single-arm, open-label clinical trial will evaluate the efficacy and tolerability of ADCETRIS as front-line monotherapy in patients age 60 or older with HL. The trial is enrolling patients who are newly diagnosed and have received no prior HL treatment. The primary endpoint of the trial is to assess the objective response rate (ORR), with key secondary endpoints of safety and tolerability, duration of response, complete remission (CR) rate and progression-free survival (PFS). The study is expected to enroll up to 20 patients at multiple centers in the United States.

More information about the trial, including enrolling centers, will be available by visiting http://www.clinicaltrials.gov.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

ADCETRIS is not approved for use outside the United States. The marketing authorization application for ADCETRIS in relapsed or refractory HL and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency (EMA) in June 2011. In July 2012, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion for the conditional approval of ADCETRIS, supporting an approval decision in the European Union.

Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

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Seattle Genetics Announces Initiation of Phase II Trial of ADCETRIS® as Front-line Therapy for Hodgkin Lymphoma ...

Recommendation and review posted by Bethany Smith

Nanoparticles seen as gene therapy advance

Published: Oct. 16, 2012 at 8:30 PM

EVANSTON, Ill., Oct. 16 (UPI) -- U.S. scientists say they've discovered how to control the shape of nanoparticles that can move DNA through the body to treat cancer and other diseases.

A gene therapy technique utilizing nanoparticles is significant in that it does not use a virus to carry DNA into cells, as some gene therapy strategies relying on viruses have posed health risks, researchers at Northwestern University and John Hopkins University reported.

"These nanoparticles could become a safer and more effective delivery vehicle for gene therapy, targeting genetic diseases, cancer and other illnesses that can be treated with gene medicine," John Hopkins material science Professor Hai-Quan Mao said.

Mao, who has been developing non-viral nanoparticles for gene therapy for a decade, said a major breakthrough is the ability to "tune" the particles in three shapes, resembling rods, worms and spheres, which mimic the shapes and sizes of viral particles.

The nanoparticles carry healthy snippets of DNA within protective polymer coatings and are designed to deliver their genetic payload only after they have moved through the bloodstream and entered the target cells, prompting the cells to produce functional proteins that combat disease.

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Nanoparticles seen as gene therapy advance

Recommendation and review posted by Bethany Smith

Research firm reaped stem cell funds despite panel’s advice

StemCells Inc. has a history not much different from those of dozens, even hundreds, of biotech companies all around California.

Co-founded by an eminent Stanford research scientist, the Newark, Calif., firm has struggled financially while trying to push its stem cell products through the research-and-development pipeline. It collects about $1 million a year from licensing patents and selling cell cultures but spends well more than $20 million annually on R&D, so it runs deeply in the red.

On the plus side, StemCells Inc. has had rather a charmed relationship with the California stem cell program, that $3-billion taxpayer-backed research fund known formally as the California Institute for Regenerative Medicine.

The firm ranks first among all corporate recipients of approved funding from CIRM, with some $40 million in awards approved this year. That's more than has gone to such established California nonprofit research centers as Cedars-Sinai Medical Center, the Salk Institute for Biological Studies, and the Sanford-Burnham Medical Research Institute.

The record of StemCells is particularly impressive given that one of the two proposals for which the firm received a $20-million funding award, covering a possible Alzheimer's treatment, was actually rejected by CIRM's scientific review panel twice. Nevertheless, the stem cell agency's governing board went ahead and approved it last month.

What was the company's secret? StemCells says it's addressing "a serious unmet medical need" in Alzheimer's research. But it doesn't hurt that the company also had powerful friends going to bat for it, including two guys who were instrumental in getting CIRM off the ground in the first place.

There's nothing improper about the state stem cell agency funding private enterprise; that's part of its statutory duties, and potentially valuable in advancing the goals of research. In part that's because CIRM is in a good position to help biotech firms leapfrog the "valley of death" the territory between basic research and the much more expensive and speculative process of moving a technology to clinical testing and, hopefully, the marketplace. Unfortunately, that's also the point where outside investment often dries up.

But private enterprise is new territory for CIRM, which has steered almost all its grants thus far to nonprofit institutions. Those efforts haven't been trouble-free: With some 90% of the agency's grants having gone to institutions with representatives on its board, the agency has long been vulnerable to charges of conflicts of interest. The last thing it needed was to show a similar flaw in its dealings with private companies too.

That brings us back to StemCells Inc. First, consider the firm's pedigree. Its co-founder was Irving Weissman, director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine and a stem cell research pioneer. Weissman was one of the most prominent and outspoken supporters of Proposition 71, the 2004 ballot initiative that established the stem cell agency.

He's also been a leading beneficiary of CIRM funding, listed as the principal researcher on three grants worth a total of $24.5 million. The agency also contributed $43.6 million toward the construction of his institute's glittering $200-million research building on the Stanford campus. As of mid-April Weissman was still listed as a shareholder of StemCells, where his wife, Ann Tsukamoto, is an executive. Weissman, who is traveling in Africa, could not get back to me by deadline to talk about his relationship with the company.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

NEW YORK, Oct. 17, 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 it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").

On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.

"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."

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 our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

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Quake Prep Tips for Angelenos With Disabilities

"OK/Help" Signs Could Save Time, Lives in Quake Aftermath

Seismologist Dr. Lucy Jones says future earthquakes in California are inescapable, but safety officials say what can be controlled is how Angelenos and first responders communicate in the aftermath of the Big One. About 50,000 signs with the word OK on one side and HELP on the other were distributed across the San Fernando Valley on Monday in an effort to get aid where its needed in case of an emergency. Officials say the latest method could save time and lives. Stephanie Elam reports from Chatsworth for the NBC4 News at 5 p.m. on Oct. 15, 2012.

Nine years ago, Deserie Ortiz suffered a spinal cord injury in a car crash. Now, she works with disabled youth and admits she needs to better prepare herself for the Big One, the massive earthquake experts predict will strike Southern California sooner rather than later.

I know you are supposed to drop, cover and hold on and things like that but if I drop on the floor, I'm not going to be able to get back up on my wheelchair, Ortiz said.

I just have to do it now. Especially since I am an advocate of my own life and I'm an advocate for others, I need to be an example, she said.

MORE:"OK/Help"Earthquake Safety Initiative | Quake Maps, Apps and Pets Preps

For the wheel-chair bound, safety officials advise dropping, covering and holding on the best way they can modified instructions with the same urgency.

They should lock the wheelchair in place so that it does not move, said Jeff Reeb, access and functional needs coordinator for LA County Office of Emergency Management.

If residents are in bed when an earthquake hits, experts advise to use the linens, bedding and paddings to their advantage.

I didn't know what I was going to do but I did stay on my bed and that I was not going to move until I felt secure to get on to my wheelchair, Ortiz said.

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Quake Prep Tips for Angelenos With Disabilities

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Researchers discover new blood vessel-generating cell with therapeutic potential

Public release date: 16-Oct-2012 [ | E-mail | Share ]

Contact: Bryan Ghosh bghosh@plos.org 44-122-344-2837 Public Library of Science

Researchers at the University of Helsinki believe they have discovered stem cells that play a decisive role in the growth of new blood vessels. If researchers learn to isolate and efficiently produce these stem cells found in blood vessel walls, the cells could offer new opportunities for developing therapeutics to treat diseases, such as cardiovascular disease and cancer. The study reporting the discovery of these stem cells is published in the open access journal PLOS Biology on October 16.

The growth of new blood vessels, known as neoangiogenesis, occurs during the repair of damaged tissue and organs in adults. However, malignant tumours also grow new blood vessels in order to receive oxygen and nutrients. As such, neoangiogenesis is both beneficial and detrimental to health, depending on the context, requiring therapeutic approaches that can either help to stimulate or prevent it. Therapeutics that aim to prevent the growth of new blood vessels are already in use, but the results are often more modest than predicted.

Adjunct Professor Petri Salvn and his team, from the University of Helsinki, now report that these stem cells can be found among the cellsso-called endothelial cellsthat line the inside of blood vessel walls. He explains, "we succeeded in isolating endothelial cells with a high rate of division in the blood vessel walls of mice. We found these same cells in human blood vessels and blood vessels growing in malignant tumours in humans. These cells are known as vascular endothelial stem cells, abbreviated as VESC. In a cell culture, one such cell is capable of producing tens of millions of new blood vessel wall cells".

From their studies in mice, the team are able to show that the growth of new blood vessels weakens, and the growth of malignant tumours slows, if the amount of these cells is below normal. Conversely, new blood vessels form where these stem cells are implanted.

"The identification and isolation of an entirely new adult stem cell type is a significant discovery in stem cell biology." explains Salvn. "Endothelial stem cells in blood vessels are particularly interesting, because they offer great potential for applications in practical medicine and the treatment of patients."

If an efficient method of vascular endothelial stem cell production could be developed, it could offer new treatment opportunities in situations where damaged tissue or diseases call for new blood vessel growth, or where the constriction or dysfunction of blood vessels deprives tissues of oxygen, for example in cardiac disease. These cells also offer new opportunities for developing therapeutics that seek to prevent new blood vessel growth in malignant tumours.

###

Funding: The work was supported by the Finnish Academy of Sciences. The funders had no role in study design, data collection and analysis, decision to publish,or preparation of the manuscript.

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Researchers discover new blood vessel-generating cell with therapeutic potential

Recommendation and review posted by Bethany Smith

New blood-vessel-generating cell with therapeutic potential discovered

ScienceDaily (Oct. 16, 2012) Researchers at the University of Helsinki, Finland, believe they have discovered stem cells that play a decisive role in new blood vessel growth. If researchers learn to isolate and efficiently produce these stem cells found in blood vessel walls, the cells offer new opportunities in the treatment of cardiovascular diseases, cancer and many other diseases.

The study will be published Oct. 16, 2012 in the online journal PLOS Biology.

The growth of new blood vessels, also known as angiogenesis, is needed in adults when repairing damaged tissue or organs. Unfortunately, malignant tumours are also capable of growing new blood vessels to receive oxygen and nutrients. In other words, the treatment of diseases would benefit from two types of methods: ones that help launch the process of angiogenesis and ones that make it possible to prevent the process. Medications that prevent the growth of new blood vessels have already been introduced, but their effectiveness and long-term efficacy leave much to be desired.

For more than a decade, Adjunct Professor Petri Salvn from the University of Helsinki has studied the mechanisms of angiogenesis to discover how blood vessel growth could be prevented or accelerated effectively. He has examined the birth and origin of endothelial cells, which form the thin layer that lines the interior surface of blood vessels. Endothelial cells are necessary for new blood vessel growth. Where do these highly diversified cells come from? Can their production be prevented or increased?

For a long time, it was assumed that new cells in the blood vessel walls of an adult originate in the bone marrow. In an article published in the Proceedings of the National Academy of Sciences (PNAS) in 2008, Salvn's research team showed that such stem cells were not found in bone marrow.

Now Salvn is ready to reveal where these mysterious stem cells originate. His team's new study will be published in the PLOS Biology journal on 16 October 2012.

"We succeeded in isolating endothelial cells with a high rate of division in the blood vessel walls of mice. We found these same cells in human blood vessels and blood vessels growing in malignant tumours in humans. These cells are known as vascular endothelial stem cells, abbreviated as VESC. In a cell culture, one such cell is able to produce tens of millions of new blood vessel wall cells," Salvn explains.

"Our study shows that these important stem cells can be found as single cells among ordinary endothelial cells in blood vessel walls. When the process of angiogenesis is launched, these cells begin to produce new blood vessel wall cells."

The effects of new endothelial stem cells have also been tested in mice. The results show that the growth of new blood vessels weakens and the growth of malignant tumours slows if the amount of these cells in the organism is below normal. Correspondingly, a high number of new blood vessels quickly emerge where new stem cells are implanted.

Identifying stem cells among other blood vessel wall cells is challenging and time-consuming. Salvn and his team managed to identify a few molecular surface structures that make it easier to trace these stem cells. However, the efficiency of the identification process needs to be enhanced.

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New blood-vessel-generating cell with therapeutic potential discovered

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New life for the dead: Stem cells from corpse scalp

By Charles Choi, LiveScience contributor

Death will come for us all one day, but life will not fade from our bodies all at once. After our lungs stop breathing, our hearts stop beating, our minds stop racing, our bodies cool, and long after our vital signs cease, little pockets of cells can live for days, even weeks. Now scientists have harvested such cells from the scalps and brain linings of human corpses and reprogrammed them into stem cells.

In other words, dead people can yield living cells that can be converted into any cell or tissue in the body.

As such, this work could help lead to novel stem cell therapies and shed light on a variety of mental disorders, such as schizophrenia, autism and bipolar disorder, which may stem from problems with development, researchers say.

Making stem cells Mature cells can be made or induced to become immature cells, known as pluripotent stem cells, which have the ability to become any tissue in the body and potentially can replace cells destroyed by disease or injury. This discovery was honored last week with the Nobel Prize.

Past research showed this same process could be carried out with so-called fibroblasts taken from the skin of human cadavers. Fibroblasts are the most common cells of connective tissue in animals, and they synthesize the extracellular matrix, the complex scaffolding between cells. [ Science of Death: 10 Tales from the Crypt ]

Cadaver-collected fibroblasts can be reprogrammed into induced pluripotent stem cells using chemicals known as growth factors that are linked with stem cell activity. Reprogrammed cells could then develop into a multitude of cell types, including the neurons found in the brain and spinal cord. However, bacteria and fungi on the skin can wreak havoc on the culturing processes used to grow cells in labs, making the process tricky to successfully carry out.

Now scientists have taken fibroblasts from the scalps and the brain linings of 146 human brain donors and grown induced pluripotent stem cells from them as well.

"We were able to culture living cells from deceased individuals on a larger scale than ever done before," researcher Thomas Hyde, a neuroscientist, neurologist and chief operating officer at the Lieber Institute for Brain Development in Baltimore, told LiveScience. Previous studies had only grown fibroblasts from a total of about a half-dozen cadavers.

The bodies had been dead up to nearly two days before scientists collected tissues from them. The corpses had been kept cool in the morgue, but not frozen.

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New life for the dead: Stem cells from corpse scalp

Recommendation and review posted by Bethany Smith


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