AUSTIN, Texas, Oct. 12th, 2012 /PRNewswire-USNewswire/ -- Prominent stem cell scientists, physicians, and advocates from leading medical facilities and research institutions across Texas and California will highlight the 3rd Annual Stem Cell Research Symposium: Spotlight on Texas, on October 19, 2012, at the Texas State Capitol.

This free, public symposium, produced and co-hosted by the Austin-based nonprofit Texas Cures Education Foundation (Texas Cures), is designed to educate the public about the exciting stem cell research andclinical trials currently under way in Texas.The event will also include a discussion of recent Texas laws affecting stem cell research, the potential economic impact of stem cell research and highlight the current progress in one of the most promising areas of medicine.

This year, more than a dozen local and national advocacy groups, institutions and foundations showed their support for the efforts of the hosting organizations Texas Cures and Texans for Stem Cell Research including the Genetics Policy Institute, Alliance for Regenerative Medicine and Texans for Advancement of Medical Research.

The symposium begins at 8:30 a.m. in the Capitol Extension Auditorium (E1.004), located at the Texas State Capitol Building. Admission is free and open to the public.Registration is recommended.

This program unites the diverse stem cell research and regenerative medicine community to provide a unified voice for promising science that holds unmatched potential to benefit patients. Leading speakers at the event will include:

For additional details about the program and presentation topics, please visit TexasCures.org.

The 3rd Annual Stem Cell Research Symposium: Spotlight on Texas is an official World Stem Cell Awareness Day Event. Follow @TexasCures and #stemcellday for live Twitter updates and announcements.

Texas Cures Education Foundation (Texas Cures) TexasCures.orgis a non-partisan, nonprofit 501(c)3] organization based in Austin, Texas. It was founded for the purpose of advancing knowledge of the life-saving work that doctors and researchers perform every day on behalf of patients and their families. Texas Cures facilitates stem cell public education for the betterment of healthcare and the growth of companies, research hospitals, and institutions, charities, and volunteer patient group organizations that include a broad range of regenerative medicine stakeholders. Texas Cures advocates for responsible public policy and encourages legislative and regulatory proposals that expand access to stem cell clinical applications.

SOURCE Texas Cures Education Foundation

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Leading Researchers to Unite at Texas State Capitol for Regenerative Medicine and Stem Cell Research

Recommendation and review posted by sam

Newswise WINSTON-SALEM, N.C. While it is well known that starfish, zebrafish and salamanders can re-grow damaged limbs, scientists understand very little about the regenerative capabilities of mammals. Now, researchers at Wake Forest Baptist Medical Centers Institute for Regenerative Medicine report on the regenerative process that enables rats to re-grow their bladders within eight weeks.

In PLOS ONE, a peer-reviewed, online publication, the scientists characterize this unique model of bladder regeneration with the goal of applying what they learn to human patients.

A better understanding of the regenerative process at the molecular and cellular level is a key to more rapid progress in applying regenerative medicine to help patients, said George Christ, Ph.D., senior researcher and professor of regenerative medicine at Wake Forest Baptist.

In a previous study by Christs team, research in rats showed that when about 75 percent of the animals bladders were removed, they were able to regenerate a complete functional bladder within eight weeks. The current study focused on how the regeneration occurs.

There is very little data on the mechanisms involved in organ regeneration in mammals, said Christ. To our knowledge, bladder regeneration holds a unique position there is no other mammalian organ capable of this type of regeneration.

The ability of the liver to grow in size when lobes are removed is sometimes referred to as regeneration, but this is a misnomer, said co-author Bryon Petersen, Ph.D., who was a professor of regenerative medicine at Wake Forest Baptist during the period the research occurred. Instead, through a proliferation of cells, the remaining tissue grows to compensate for the lost size. In contrast, the hallmark of true regeneration is following natures pattern to exactly duplicate size, form and function, Petersen said.

If we can understand the bladders regenerative process, the hope is that we can prompt the regeneration of other organs and tissues where structure is important from the intestine and spinal cord to the heart, said Petersen.

The current study showed that the animals bodies responded to injury by increasing the rate at which certain cells divided and grew. The most notable proliferative response occurred initially in the urothelium, the layer of tissue that lines the bladder.

As the proliferative activity in the bladder lining waned, it continued elsewhere: in the fibrous band (lamina propria) that separates the bladder lining from the bladder muscles and in the bladder muscle itself.

The researchers have several theories about how the process works, said Christ. One possibility is that cells in the bladder lining transition and become a type of stem cell that can proliferate throughout the bladder. Other theories are that cells in the bladder lining signal other cells to replicate and that injury prompts stem cells to arrive through the blood stream to repair the bladder damage.

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Scientists Identify Mammal Model of Bladder Regeneration

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Friday, Oct. 12, 2012

Harvard University said neither it nor Massachusetts General Hospital have ever authorized any iPS-related clinical studies by Hisashi Moriguchi, who claims to have achieved the first clinical application using the revolutionary stem cell technology.

"No clinical trials related to Moriguchi's work have been approved by institutional review boards at either Harvard University or Massachusetts General Hospital," a statement issued by Harvard and related institutes said Thursday.

The statement confirmed that Moriguchi "was a visiting fellow at Massachusetts General Hospital from 1999-2000," but added that he "has not been associated with (the institution) or Harvard since that time."

Moriguchi, a researcher at University of Tokyo Hospital, claimed to be a visiting lecturer at Harvard and to have conducted clinical trials at Massachusetts General Hospital with other researchers to transplant artificial cardiac muscle cells developed from iPS cells into six patients with heart disease.

The claim came just after Shinya Yamanaka of Kyoto University and a British scholar were jointly awarded this year's Nobel Prize in physiology or medicine for their research on iPS cells. Yamanaka and John Gurdon were credited with the discovery that mature human cells can be reprogrammed as immature cells capable of developing into all types of body parts.

"Research has been conducted after going through due procedures, such as consultations with a university ethics committee," Moriguchi claimed. "I have been told my method of creating iPS cells is different from the one used by Yamanaka (and Gurdon), but I have been doing it my way and no problems have been identified after transplants."

Moriguchi, who is thought to have asked a heart surgeon to carry out cell transplants, unveiled details about the treatment at a meeting of annual stem-cell research conference at Rockefeller University in New York held Wednesday and Thursday.

But the event's organizer, the nonprofit New York Stem Cell Foundation, subsequently said it "has received information from Harvard University that raises legitimate questions concerning a poster presentation" by Moriguchi, and has withdrawn it from the conference.

Moriguchi graduated from Tokyo Medical and Dental University with a degree in nursing science and does not have a license to practice medicine, according to a professor who taught him as an undergraduate.

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Doubt cast on clinical stem cell tests

Recommendation and review posted by Bethany Smith

ScienceDaily (Oct. 11, 2012) Early results of a Phase II intra-arterial stem cell trial for ischemic stroke showed no adverse events associated with the first 10 patients, allowing investigators to expand the study to a targeted total of 100 patients.

The results were presented October 11 by Sean Savitz, M.D., professor of neurology and director of the Stroke Program at The University of Texas Health Science Center at Houston (UTHealth), at the 8th World Stroke Congress in Brasilia, Brazil.

The trial is the only randomized, double-blind, placebo-controlled intra-arterial clinical trial in the world for ischemic stroke. It is studying the safety and efficacy of a regenerative therapy developed by Aldagen Inc., a wholly-owned subsidiary of Cytomedix, Inc., that uses a patient's own bone marrow stem cells, which can be administered between 13 and 19 days post-stroke.

The therapy, called ALD-401, consists of stem cells that are identified using Aldagen's proprietary technology to isolate cells that express high levels of an enzyme that serves as a marker of stem cells. Pre-clinical studies found that these cells enhance recovery after stroke in mice. The cells are administered into the carotid artery. Patients are followed for 12 months to monitor safety and to assess mental and physical function.

"We have been approved by the Data Safety Monitoring Board (DSMB) to move the study into the next phase, which will allow us to expand the number of sites in order to complete enrollment," said Savitz, senior investigator for the multi-center study. As per the protocol for the trial, the Food and Drug Administration required a review by the DSMB prior to advancing to the next phase.

Preclinical research, including research at the UTHealth Medical School, has suggested that stem cells can promote the repair of the brain after an ischemic stroke, which is caused by a blood clot in the brain. Stroke is a leading cause of disability and the fourth-leading cause of death in the United States, according to 2008 statistics reported by the Centers for Disease Control and Prevention.

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The above story is reprinted from materials provided by University of Texas Health Science Center at Houston.

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Safety results of intra-arterial stem cell clinical trial for stroke presented

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ScienceDaily (Oct. 12, 2012) Scientists at Wake Forest Baptist Medical Center have taken the first steps to create neural-like stem cells from muscle tissue in animals.

Details of the work are published in two complementary studies published in the September online issues of the journals Experimental Cell Research and Stem Cell Research.

"Reversing brain degeneration and trauma lesions will depend on cell therapy, but we can't harvest neural stem cells from the brain or spinal cord without harming the donor," said Osvaldo Delbono, M.D., Ph.D., professor of internal medicine at Wake Forest Baptist and lead author of the studies.

"Skeletal muscle tissue, which makes up 50 percent of the body, is easily accessible and biopsies of muscle are relatively harmless to the donor, so we think it may be an alternative source of neural-like cells that potentially could be used to treat brain or spinal cord injury, neurodegenerative disorders, brain tumors and other diseases, although more studies are needed."

In an earlier study, the Wake Forest Baptist team isolated neural precursor cells derived from skeletal muscle of adult transgenic mice (PLOS ONE, Feb. 3, 2011).

In the current research, the team isolated neural precursor cells from in vitro adult skeletal muscle of various species including non-human primates and aging mice, and showed that these cells not only survived in the brain, but also migrated to the area of the brain where neural stem cells originate.

Another issue the researchers investigated was whether these neural-like cells would form tumors, a characteristic of many types of stem cells. To test this, the team injected the cells below the skin and in the brains of mice, and after one month, no tumors were found.

"Right now, patients with glioblastomas or other brain tumors have very poor outcomes and relatively few treatment options," said Alexander Birbrair, a doctoral student in Delbono's lab and first author of these studies. "Because our cells survived and migrated in the brain, we may be able to use them as drug-delivery vehicles in the future, not only for brain tumors but also for other central nervous system diseases."

In addition, the Wake Forest Baptist team is now conducting research to determine if these neural-like cells also have the capability to become functioning neurons in the central nervous system.

Co-authors of the studies are Tan Zhang, Ph.D., Zhong-Min Wang, M.S., Maria Laura Messi, M.S., Akiva Mintz, M.D., Ph.D., of Wake Forest Baptist, and Grigori N. Enikolopov, Ph.D., of Cold Spring Harbor Laboratory.

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Neural-like stem cells from muscle tissue may hold key to cell therapies for neurodegenerative diseases

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Public release date: 12-Oct-2012 [ | E-mail | Share ]

Contact: Marguerite Beck marbeck@wakehealth.edu 336-716-2415 Wake Forest Baptist Medical Center

WINSTON-SALEM, N.C. Oct. 12, 2012 Scientists at Wake Forest Baptist Medical Center have taken the first steps to create neural-like stem cells from muscle tissue in animals. Details of the work are published in two complementary studies published in the September online issues of the journals Experimental Cell Research and Stem Cell Research.

"Reversing brain degeneration and trauma lesions will depend on cell therapy, but we can't harvest neural stem cells from the brain or spinal cord without harming the donor," said Osvaldo Delbono, M.D., Ph.D., professor of internal medicine at Wake Forest Baptist and lead author of the studies.

"Skeletal muscle tissue, which makes up 50 percent of the body, is easily accessible and biopsies of muscle are relatively harmless to the donor, so we think it may be an alternative source of neural-like cells that potentially could be used to treat brain or spinal cord injury, neurodegenerative disorders, brain tumors and other diseases, although more studies are needed."

In an earlier study, the Wake Forest Baptist team isolated neural precursor cells derived from skeletal muscle of adult transgenic mice (PLOS One, Feb.3, 2011).

In the current research, the team isolated neural precursor cells from in vitro adult skeletal muscle of various species including non-human primates and aging mice, and showed that these cells not only survived in the brain, but also migrated to the area of the brain where neural stem cells originate.

Another issue the researchers investigated was whether these neural-like cells would form tumors, a characteristic of many types of stem cells. To test this, the team injected the cells below the skin and in the brains of mice, and after one month, no tumors were found.

"Right now, patients with glioblastomas or other brain tumors have very poor outcomes and relatively few treatment options," said Alexander Birbrair, a doctoral student in Delbono's lab and first author of these studies. "Because our cells survived and migrated in the brain, we may be able to use them as drug-delivery vehicles in the future, not only for brain tumors but also for other central nervous system diseases."

In addition, the Wake Forest Baptist team is now conducting research to determine if these neural-like cells also have the capability to become functioning neurons in the central nervous system.

Link:
Stem cells from muscle tissue may hold key to cell therapies for neurodegenerative diseases

Recommendation and review posted by Bethany Smith

TOKYO: Shinya Yamanaka, fresh from the Nobel Prize for medicine, states that science and ethics must go hand in hand. Interviewed by the Mainichi Shimbun after the award, he said: "I would like to invite ethical experts as teachers at my laboratory and work to guide iPS [induced pluripotent stem] cell research from that direction as well. The work of a scientific researcher is just one part of the equation. "

Yamanaka, 50, found that adult cells can be transformed into cells in their infancy, stem cells (iPS), which are, so to speak, the raw material for the reconstruction of tissue irreparably damaged by disease. For regenerative medicine the implications of Yamanaka's discovery are obvious. Adult skin cells can for example be reprogrammed and transformed into any other cell that is desired: from the skin to the brain, from the skin to the heart, from the skin to elements that produce insulin.

"Their discovery - says the statement of the jury that awarded him the Nobel Prize on October 8 - has revolutionized our understanding of how cells and organisms develop. Through the programming of human cells, scientists have created new opportunities for the study of diseases and development of methods for the diagnosis and therapy ".

These "opportunities" are not only "scientific", but also "ethical". Much of the scientific research and global investment is in fact launched to design and produce stem cells from embryos, arriving at the point of manipulating and destroying them, facing scientists with enormous ethical problems.

" Ethics are really difficult - Yamanaka explainsto Mainichi - In the United States I began work on mouse experiments, and when I returned to Japan I learned that human embryonic stem cells had been created. I was happy that they would contribute to medical science, but I faced an ethical issue. I started iPS cell research as a way to do good things as a researcher, and I wanted to do what I could to expand the merits of embryonic stem cells. If we make sperm or eggs from iPS cells, however, it leads to the creation of new life, so the work I did on iPS cells led to an ethical problem. If we don't prepare debates for ethical problems in advance, technology will proceed ahead faster than we think.. "

The "ethical question" Yamanaka pushed to find a way to "not keep destroying embryos for our research."

Speaking with his co-workers at the University of Kyoto, immediately after receiving the award, Yamanaka showed dedication and modesty.

"Now - he said - I strongly feel a sense of gratitude and responsibility" gratitude for family and friends who have supported him in a demanding journey of discovery that lasted decades; responsibility for a discovery that gives hope to millions of patients. Now iPS cells can grow into any tissue of the human body allowing regeneration of parts so far irretrievably lost due to illness.

His modesty also led him to warn against excessive hopes. To a journalist who asked him for a message to patients and young researchers awaiting the results of his research heresponded: "The iPS cells are also known as versatile cells, and the technology may be giving the false impression to patients that they could be cured any day now. It will still take five or 10 years of research before the technology is feasible. There are over 200 researchers at my laboratory, and I want patients to not give up hope"

"Dozens of times - he continued - I tried to get some results and I have often failed in the experiments .... Many times I was tempted to give up or cry. Without the support of my family, I could not have continued this search. From now on I will be facing the moment of truth. I would like to return to my laboratory as quickly as possible. "

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Hisashi Moriguchi presented his work at the New York Stem Cell Foundation meeting this week.

AP/Press Association

From the beginning, it seemed too good to be true. Days after Kyoto University biologist Shinya Yamanaka won a Nobel prize for his 2006 discovery of induced pluripotent stem (iPS) cells (see 'Cell rewind wins medicine Nobel'), Hisashi Moriguchi a visiting researcher at the University of Tokyo claimed to have modified that technology to treat a person with terminal heart failure. Eight months after surgical treatment in February, said a front-page splash in the Japanese newspaper Yomiuri Shimbun yesterday, the patient was healthy.

But after being alerted to the story by Nature, Harvard Medical School and Massachusetts General Hospital (MGH), where Moriguchi claimed to have done the work, denied that the procedure had taken place. No clinical trials related to Dr Moriguchi's work have been approved by institutional review boards at either Harvard University or MGH, wrote David Cameron, a spokesman for Harvard Medical School in Boston, Massachusetts. The work he is reporting was not done at MGH, says Ryan Donovan, a public-affairs official at MGH, also in Boston.

A video clip posted online by the Nippon News Network and subsequently removed showed Moriguchi presenting his research at the New York Stem Cell Foundation meeting this week.

If true, Moriguchis feat would have catapulted iPS cells into use in a wide range of clinical situations, years ahead of most specialists' predictions. I hope this therapy is realized in Japan as soon as possible, the head of a Tokyo-based organization devoted to helping children with heart problems told Yomiuri Shimbun.

But there were reasons to be suspicious. Moriguchi said he had invented a method to reprogram cells using just two chemicals: microRNA-145 inhibitor and TGF- ligand1. But Hiromitsu Nakauchi, a stem-cell researcher at the University of Tokyo, says that he has never heard of success with that method. He adds that he had also never heard of Moriguchi before this week.

Moriguchi also said that the cells could be differentiated into cardiac cells using a 'supercooling' method that he had invented. Thats another weird thing, says Nakauchi.

The article in which Moriguchi presented his two-chemical method, published in a book1 describing advances in stem-cell research, includes paragraphs copied almost verbatim from other papers. The section headed 2.3 Western blotting, for example, is identical to a passage from a 2007 paper by Yamanaka2. Section 2.1.1, in which Moriguchi describes human liver biopsies, matches the number of patients and timing of specimen extractions described in an earlier article3, although the name of the institution has been changed.

When contacted by Nature, Moriguchi stood by his publication. We are all doing similar things so it makes sense that wed use similar words, he says. He did admit to using other papers as reference.

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Stem-cell transplant claims debunked

Recommendation and review posted by Bethany Smith

Regenevda recently opened its brand new flagship facility in Beverly Hills, specializing in cutting edge anti-aging treatments such as Stem Cell Therapy.

Beverly Hills, CA (PRWEB) October 12, 2012

Dr. Thom Lobe is an internationally respected surgeon and has been in practice for over 30 years. Consistently pioneering advances in medicine, Dr. Lobe was one of the first doctors to ever separate conjoined twins. Consistently working to help make advances in medicine, Dr. Lobe also has over 200 publications to his credit.

Overseeing the business aspect of Regenevda is Lindsey Combs. She is responsible for sales, staff, accounting, facility management, and business development. A graduate of the University of California, Los Angeles, Ms. Combs has been working in the anti-aging field for over 10 years and has been a California Licensed Esthetician since 2003.

Being one of the very few physicians in the country to hold the most advanced board certification (FAARM), Dr. Lobe is able to offer Stem Cell Therapy at the Regenevda clinic. Inside each persons own body, there are special cells in nearly every organ and tissue that have the ability to help heal damage. These special cells are called Stem Cells and this therapy works by harvesting these cells from a persons own blood, bone marrow, or fat and can help with different conditions. Some examples of procedures that use Stem Cell Therapy are: Stem Cell Facelifts, Stem Cell Breast Augmentation, and Stem Cell Joint Therapy. Stem Cell treatments are safe, non-invasive, and are done under local anesthesia.

Intravenous Nutrition Therapy (or IV Vitamin Therapy) is another anti-aging and rejuvenation treatment that can also help patients prevent migraines, lose weight, fight chronic infections like hepatitis, candida, lyme disease, as well as fight acute infections like the flu and mono. IV Therapy works by using intravenous solutions to deliver vitamins and minerals directly to the body cells. This bypasses the digestive system and provides a more direct method of delivery, which ensures that all of the nutrients required are delivered, allowing the patient to feel an improvement in condition almost immediately.

Human Growth Hormone (HGH) Therapy is another advanced treatment offered at Regenevda. HGH is secreted by the Pituitary gland and fuels cell growth and reproduction. This production peaks at adolescence. Over time, due to the effect of aging, the production of HGH slows down dramatically. As production declines, it makes it more difficult for the body to recover from physical and mental exertion. HGH Therapy acts as a supplement for HGH deficient adults to lessen body fat, boost lipid lineament, improve memory, promote bone density, as well as decrease risk factors that involve cardio-vascular conditions. If used at the onset of the decrease in HGH production, HGH Therapy can help curtail early aging and even be used as preventive measure against osteoporosis. A complete analysis of the patients sex hormones, evaluation of glucose regulation and functions of the adrenal gland, thyroid gland, and pancreas are performed before the treatment is administered for optimal results.

Combining decades of medical experience with the most cutting edge advances in medical technology, the Regenevda clinic looks to pave the way for the future of anti-aging treatments. The Regenevda Beverly Hills Institute of Cellular Therapy is located at 50 North La Cienega Boulevard. For any inquiries, they can be reached at 855-734-3638, or visit http://www.regeneveda.com.

About Regenevda :

Regeneveda, home of The Beverly Hills Institute of Cellular Therapy, provides state-of-the-art Stem Cell Therapy. Stem Cell Therapy is an effective treatment for chronic conditions such as Arthritis, Diabetes, Chronic Sports Injuries, and Chronic Pain, but is also revolutionizing anti-aging treatments such as Breast Enhancement, Erectile Dysfunction, and Facial Aging.

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Regenevéda Opens Flagship Stem Cell Therapy Clinic in Beverly Hills

Recommendation and review posted by Bethany Smith

DALLAS, October 12, 2012 /PRNewswire/ --

The report "Autologous Cell Therapy Market(2012 - 2017)", published by MarketsandMarkets (http://www.marketsandmarkets.com), would be the first global and exclusive report on ACT market. It also gives clear information about the complete industry, approved products and potential market size; it also identifies driving and restraining factors for the global ACT market with analysis of trends, opportunities and challenges. The market is segmented and revenue is forecasted on the basis of major regions such as USA, Europe and Rest of the World (ROW). Further, market is segmented and revenues are forecasted on the basis of potential application areas of ACT.

Browse ACT market research data tables/figures spread through 111 slides and in-depth TOC on"Autologous Cell Therapy (ACT) Market (2012 - 2017)". http://www.marketsandmarkets.com/Market-Reports/autologous-cell-therapy-market-837.html Early buyers will receive 10% customization on reports.

There is a wide market potential and favorable landscape for adoption across many geographical locations of the world. During the forecast period, these technologies are expected to revolutionize the area of bio-pharma and personalized medicine. High incidence and lack of effective treatment for several diseases will drive the ACT technology in developed and developing nations.

Investment activities, for past five years are actively held in research and developments, attracting interests of cell therapy industry firms, medical centers and academic institutions. ACT potential can be demonstrated by mergers, collaborations, acquisitions and partnerships that happened actively between the ACT technology developing companies in past three years. Development of sophisticated automation devices for cell expansion and culture process for use in the treatment is one of the emerging trends of ACT market.

The global ACT market is valued around $650 million by 2011 with a CAGR of 21%. Several products and technologies of ACT are in pipeline which is expected to hit the market during the forecast period, which will result in increased growth rate.

About MarketsandMarkets

MarketsandMarkets is a global market research and consulting company based in the U.S. We publish strategically analyzed market research reports and serve as a business intelligence partner to Fortune 500 companies across the world. MarketsandMarkets also provides multi-client reports, company profiles, databases, and custom research services.

MarketsandMarkets covers thirteen industry verticals; including advanced materials, automotives and transportation, banking and financial services, biotechnology, chemicals, consumer goods, energy and power, food and beverages, industrial automation, medical devices, pharmaceuticals [ http://www.marketsandmarkets.com/pharmaceutical-market-research-3.html ], semiconductor and electronics, and Telecommunications and IT.

We at MarketsandMarkets are inspired to help our clients grow by providing apt business insight with our huge market intelligence repository. To know more about us and our reports, please visit our website http://www.marketsandmarkets.com.

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Global Autologous Cell Therapy Market worth $2.2 Billion by 2017

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DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/vgdk75/gtxs_capesaris) has announced the addition of the "GTx's Capesaris - A novel medical castration method" report to their offering.

Capesaris is an oral selective estrogen receptor modulator (SERM) that GTx is developing as a first-line androgen deprivation therapy (ADT) in advanced prostate cancer. By utilizing this approach, GTx hopes that use will be devoid of many of the adverse effects of historical medical castration products such as diethylstilbestrol (DES, an estrogen replacement therapy), and the luteinizing hormone receptor hormone (LHRH) agonists that form the current standard of care. This report explores the validity of that premise, the probability of phase III success, the regulatory path to approval, and the market into which it will launch, if successful.

Key Topics Covered:

INTRODUCTION AND BACKGROUND

1. Prostate cancer

- Epidemiology

- Clinical presentation, diagnosis, and staging

- Current treatments

2. GTX-758 (CAPESARIS)

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Research and Markets: GTx's Capesaris - A Novel Medical Castration Method

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Variant linked to increased risk for long-term organ failure

Highlights In the largest study of its kind, a variant within the multidrug resistance 1 (MDR-1) gene in kidney transplant donors was linked to a 69% increased risk for long-term failure of transplanted organs. This variant affects the expression of the protein that the MDR-1 gene encodes, which pumps drugs out of cells. (Immunosuppressant drugs are critical for preventing organ rejection but are also toxic to the kidneys.)

Newswise Washington, DC (October 11, 2012) A single genetic variant in kidney donors cells may help determine whether their transplanted organs will survive long term, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN). The findings provide new information that might be used to improve transplant longevity by revealing that the genetic make-up of kidney transplant donors affects the survival of transplanted organs.

A transplant recipient must take lifelong immunosuppressive drugs to prevent rejection of the new organ, but these drugs can have serious side effects, including kidney damage. So, ironically, the very drugs needed to prevent kidney rejection can also be toxic to the kidneys. Research suggests that how well certain proteins pump these drugs out of kidney cells may influence the drugs kidney toxicity.

Richard Borrows, MB (Queen Elizabeth Hospital Birmingham, in the UK) and his colleagues looked to see if variants in the genes that encode such pumps might influence the health of transplanted kidneys. They investigated the links between donor and recipient gene variants with kidney outcome among 811 immunosuppressant-treated kidney transplant recipients.

Among the major findings: One particular variant within the multidrug resistance 1 (MDR-1) gene in donors was linked to a 69% increased risk for long-term failure of transplanted organs. The researchers validated the link in another 3,660 donors, making this the largest study of its kind. This variant affects the expression of the protein that the MDR-1 gene encodes, the drug transporter P-glycoprotein. No other genetic variants in donors or recipients were linked with organ survival or failure.

The study of donor, as opposed to recipient, gene variation is relatively uncommon in the field of transplantation, and it certainly warrants more attention, said Dr. Borrows. He added that a single genetic variant probably has limited effect on its own, but when combined, multiple genetic variants may play an important role in transplant longevity.

Study co-authors include Jason Moore, MBBS, Amy Jayne McKnight, PhD, Bernd Dhler, PhD, Matthew Simmonds, PhD, Aisling Courtney, PhD, Oliver Brand, PhD, David Briggs, PhD, Simon Ball, PhD, Paul Cockwell, PhD, Christopher Patterson, PhD, Alexander Maxwell, PhD, Stephen Gough, PhD, and Gerhard Opelz, PhD.

Disclosures: The authors reported no financial disclosures.

The article, entitled Donor ABCB1 Variant Associates with Increased Risk for Kidney Allograft Failure, will appear online at http://jasn.asnjournals.org/ on October 11, 2012, doi: 10.1681/ASN.2012030260.

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Single Gene Variant in Donors May Affect Survival of Transplanted Kidneys

Recommendation and review posted by Bethany Smith

When a patient in need of a kidney transplant finally receives their new organ, their health problems may not necessarily be over. For some kidney recipients, their bodies may ultimately reject the foreign kidney leading to the organs removal and another long wait for a new donor.

However, new research out of the Queen Elizabeth Hospital Birmingham in the U.K. may help prevent this kind of painful rejection in the future. Scientists have discovered a single gene variant in kidney transplant donors that may predict whether or not the transplanted kidney will survive in the recipient.

The gene- the multidrug resistance 1 (MDR-1) gene was originally identified by the researcher of having a potential impact on kidney rejection and survival, because the protein the gene encodes helps to pump drugs out of cells.

In order for a transplanted kidney to successfully adapt and adhere to a new bodys system, the kidney recipient must take a number of immunosuppressive drugs to prevent rejection often including a class of drugs called calcineurin inhibitors (CNIs). Unfortunately, these kinds of medications can also come with serious side effects.

We wanted to look at a link between the genotype of the donor and the risk of transplant failure to CNI toxicity, Dr. Richard Borrows, in the department of nephrology and kidney transplantation at University Hospital Birmingham and the studys lead author, told FoxNews.com. Although they have revolutionized kidney transplantation, they are inherently toxic to the transplanted kidney. Theres a train of thought that that toxicity in turn leads to transplant failure.

Borrows and his team examined three different cohorts of pairs of kidney recipients and their donors. In the first group of 811 individuals, they looked for 52 gene variants in both the donors and the recipients. Only one gene appeared to be associated with kidney failure a particular variant of MDR-1.

Overall, the variant was linked with a 69 percent increased risk for long-term transplant failure. Two additional groups of a combined 3,660 donors confirmed the results.

The MDR-1 gene variant affects the expression of the protein that the gene encodes the drug transporter P-glycoprotein. Donor kidney cells with this kind of variant ultimately have more P-glycoprotein. Originally, the researchers believed that less P-glycoprotein would increase CNI toxicity and thus increase the chances of organ failure but instead the opposite was found to be true.

Borrows and his team have a few ideas as to why the increase of P-glycoprotein would potentially lead to kidney transplant failure, but did not test them.

The presence of P-glycoprotein seems to promote cellular damage by cholesterol and cholesterol esters, Borrows said. Also, in animal models, the presence of P-glycoprotein is associated with an increased likelihood of kidney damage when blood supply to the kidney is interrupted. So on one hand, this protein seems to be involved in the transport of CNI inhibitors, and on the other hand it seems to be involved in many other biological processes as well. So we need to tease each of these out.

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Single gene variant may affect transplanted kidney survival

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HEIDELBERG, GERMANY and BUDAPEST, HUNGARY--(Marketwire - Oct 12, 2012) - Genetic Immunity ( OTCBB : PWRV ), a leader in immunotherapy technology product development, and DKFZ (German Cancer Research Center, Heidelberg, Germany) signed a collaborative agreement to develop a DNA-based vaccine for the treatment of Human Papilloma Virus (HPV) infection that causes cervical cancer and other cancers of the anus, penis, vulva, vagina, and oropharynx. Present HPV vaccines (Cervarix, Gardasil) have no therapeutic effect on HPV-related diseases, so they will not treat existing diseases or conditions caused by HPV.

The Division of Genome Modifications and Carcinogenesis led by Prof. Dr. Lutz Gissmann will initiate a preclinical research program to evaluate the therapeutic efficacy of the DKFZ's HPV-specific plasmid DNA using Genetic Immunity's nanomedicine formulation and Langerhans cell-targeting administration technologies. DKFZ is a world leading research center in tumor virology. Harald zur Hausen was awarded the Nobel Medicine Prize for his work on HPV-caused cancer of the cervix. Zur Hausen, former Scientific Director of the German Cancer Research Center, is recognized for finding that cervical cancer is caused by viral infections. His research made it possible to develop a vaccine against one of the most frequent cancers in women. Zur Hausen shared the Nobel Prize for Medicine with Franoise Barr-Sinoussi and Luc Montagnier for discovering HIV, the virus that causes AIDS.

"There is a huge unmet medical need for such cancer vaccine, because vaccines we have developed earlier do not provide protection against cancer when used for treatment of existing conditions caused by HPV. Our goal is to provide protection against cancer for patients after the onset of sexual activity, after they might be exposed to HPV," said Dr. Julianna Lisziewicz, CEO of Genetic Immunity.

Genetic Immunity has successfully tested in clinical trials DermaVir, a candidate immunotherapy for the cure of HIV. This new collaboration is using the clinically proven technology expanding the pipeline to another deadly viral disease that causes cancer. The partners will test whether HPV-specific memory T cells induced by Genetic Immunity's nanomedicine products could protect against cancer after infection has occurred.

"We found that Genetic Immunity technology is unique to target the vaccine DNA into the nucleus of the Langerhans cells. We believe that it will provide a breakthrough in cancer immunotherapy. We pioneered HPV prophylactic vaccines with new innovations and we would like to expand this tradition to therapeutic setting," said Dr. Prof. Gissmann of DKFZ.

Genetic Immunity is a wholly owned subsidiary of Power of the Dream Ventures, Inc. ( OTCBB : PWRV ).

About Genetic Immunity

Genetic Immunity, part of Power of the Dream Ventures, Inc. (PWRV), is a clinical stage technology company committed to discovering, developing, manufacturing and commercializing a new class of immunotherapeutic biologic drugs for the treatment of viral infections, cancer and allergies. Our Langerhans cell-targeting nanomedicines are exceptional in both safety and immune modulating activity boosting specific Th1-type central memory T cells. These are essential to eliminate infected cells or cancerous cells, and balance the immune reactivity in response to allergens.

In 1988 Drs. Lisziewicz and Lori founded Genetic Immunity in the US after they described the 1st patient whose immune system was boosted to control HIV after treatment interruption (Lisziewicz et al. New England Journal of Medicine 1999) that lead to the invention of DermaVir. The Company's innovative technology team directed by Dr. Lisziewicz, a champion of immune boosting therapies, is now headquartered in Budapest, Hungary. She has been invited into the Scientific Advisory Board of the HIV Cure Initiative led by Francoise Barre-Sinoussi Nobel Prize Laureate for her HIV research in 2009. For more information please visit http://www.geneticimmunity.com

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DKFZ and Genetic Immunity Sign Collaboration Agreement to Develop HPV Therapeutic Vaccine

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ScienceDaily (Oct. 11, 2012) Researchers at the University of Illinois Hospital & Health Sciences System have identified a genetic signature that distinguishes patients with complicated sarcoidosis, an inflammatory lung disease that can be fatal, from patients with a more benign form of the disease. The gene signature could become the basis for a simple blood test.

Their findings are reported online in the journal PLOS ONE.

In sarcoidosis, tiny clumps of abnormal tissue form in organs of the body. These clusters of immune cells, called granulomas, cause inflammation. Sarcoidosis can occur in the lymph nodes, liver, eyes, skin or other tissues, but almost always also in the lungs. The cause of the disease is unknown. African Americans are at higher risk for the disease and for more severe cases.

"One of the perplexing aspects of this disease is that two thirds of the people who get sarcoidosis get better with only minimal therapy," says Dr. Joe G.N. "Skip" Garcia, vice president for health affairs at the University of Illinois and principle investigator on the study.

But one third of patients go on to develop complicated sarcoidosis -- neurologic sarcoidosis, cardiac sarcoidosis and progressive lung disease, Garcia said. Complicated sarcoidosis can leave patients with lung damage, and in a small percentage of cases the disease can be fatal.

The challenge, Garcia says, is that there is no difference in the clinical presentation between patients with simple sarcoidosis and those who will go on to develop more serious disease.

The researchers took blood from patients with simple and complicated sarcoidosis as well as patients without the disease to look for a pattern of gene expression unique to complicated sarcoidosis.

They were able to identify a distinct 20-gene pattern of gene expression that could reliably identify those most likely to progress to complicated sarcoidosis.

A 31-gene expression signature had been identified previously, but a smaller panel of genes makes the new test less expensive and more useful clinically, said Garcia.

"We are dedicated to looking for new insights as well as new therapies for sarcoidosis and hope to someday be able to identify people at risk for it ahead of time," Garcia said.

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New gene test flags risk of serious complications in sarcoidosis

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Public release date: 12-Oct-2012 [ | E-mail | Share ]

Contact: Megan Fellman fellman@northwestern.edu 847-491-3115 Northwestern University

Researchers from Johns Hopkins and Northwestern universities have discovered how to control the shape of nanoparticles that move DNA through the body and have shown that the shapes of these carriers may make a big difference in how well they work in treating cancer and other diseases.

This study, to be published in the Oct. 12 online edition of the journal Advanced Materials, is also noteworthy because this gene therapy technique does not use a virus to carry DNA into cells. Some gene therapy efforts that rely on viruses have posed health risks.

"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," said Hai-Quan Mao, an associate professor of materials science and engineering in Johns Hopkins' Whiting School of Engineering.

Mao, co-corresponding author of the Advanced Materials article, has been developing nonviral nanoparticles for gene therapy for a decade. His approach involves compressing healthy snippets of DNA within protective polymer coatings. The particles are designed to deliver their genetic payload only after they have moved through the bloodstream and entered the target cells. Within the cells, the polymer degrades and releases DNA. Using this DNA as a template, the cells can produce functional proteins that combat disease.

A major advance in this work is that Mao and his colleagues reported that they were able to "tune" these particles in three shapes, resembling rods, worms and spheres, which mimic the shapes and sizes of viral particles. "We could observe these shapes in the lab, but we did not fully understand why they assumed these shapes and how to control the process well," Mao said. These questions were important because the DNA delivery system he envisions may require specific, uniform shapes.

To solve this problem, Mao sought help about three years ago from colleagues at Northwestern. While Mao works in a traditional wet lab, the Northwestern researchers are experts in conducting similar experiments with powerful computer models.

Erik Luijten, associate professor of materials science and engineering and of applied mathematics at Northwestern's McCormick School of Engineering and Applied Science and co-corresponding author of the paper, led the computational analysis of the findings to determine why the nanoparticles formed into different shapes.

"Our computer simulations and theoretical model have provided a mechanistic understanding, identifying what is responsible for this shape change," Luijten said. "We now can predict precisely how to choose the nanoparticle components if one wants to obtain a certain shape."

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Scientists discover that shape matters in DNA nanoparticle therapy

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ScienceDaily (Oct. 12, 2012) Researchers from Johns Hopkins and Northwestern universities have discovered how to control the shape of nanoparticles that move DNA through the body and have shown that the shapes of these carriers may make a big difference in how well they work in treating cancer and other diseases.

This study, published in the Oct. 12 online edition of Advanced Materials, is also noteworthy because this gene therapy technique does not use a virus to carry DNA into cells. Some gene therapy efforts that rely on viruses have posed health risks.

"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," said Hai-Quan Mao, an associate professor of materials science and engineering in Johns Hopkins' Whiting School of Engineering.

Mao, co-corresponding author of the Advanced Materials article, has been developing nonviral nanoparticles for gene therapy for a decade. His approach involves compressing healthy snippets of DNA within protective polymer coatings. The particles are designed to deliver their genetic payload only after they have moved through the bloodstream and entered the target cells. Within the cells, the polymer degrades and releases DNA. Using this DNA as a template, the cells can produce functional proteins that combat disease.

A major advance in this work is that Mao and his colleagues reported that they were able to "tune" these particles in three shapes, resembling rods, worms and spheres, which mimic the shapes and sizes of viral particles. "We could observe these shapes in the lab, but we did not fully understand why they assumed these shapes and how to control the process well," Mao said. These questions were important because the DNA delivery system he envisions may require specific, uniform shapes.

To solve this problem, Mao sought help about three years ago from colleagues at Northwestern. While Mao works in a traditional wet lab, the Northwestern researchers are experts in conducting similar experiments with powerful computer models.

Erik Luijten, associate professor of materials science and engineering and of applied mathematics at Northwestern's McCormick School of Engineering and Applied Science and co-corresponding author of the paper, led the computational analysis of the findings to determine why the nanoparticles formed into different shapes.

"Our computer simulations and theoretical model have provided a mechanistic understanding, identifying what is responsible for this shape change," Luijten said. "We now can predict precisely how to choose the nanoparticle components if one wants to obtain a certain shape."

The use of computer models allowed Luijten's team to mimic traditional lab experiments at a far faster pace. These molecular dynamic simulations were performed on Quest, Northwestern's high-performance computing system. The computations were so complex that some of them required 96 computer processors working simultaneously for one month.

In their paper, the researchers also wanted to show the importance of particle shapes in delivering gene therapy. Team members conducted animal tests, all using the same particle materials and the same DNA. The only difference was in the shape of the particles: rods, worms and spheres.

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Shape matters in DNA nanoparticle therapy

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ScienceDaily (Oct. 12, 2012) Researchers from Johns Hopkins and Northwestern universities have discovered how to control the shape of nanoparticles that move DNA through the body and have shown that the shapes of these carriers may make a big difference in how well they work in treating cancer and other diseases.

This study, to be published in the Oct. 12 online edition of the journal Advanced Materials, is also noteworthy because this gene therapy technique does not use a virus to carry DNA into cells. Some gene therapy efforts that rely on viruses have posed health risks.

"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," said Hai-Quan Mao, an associate professor of materials science and engineering in Johns Hopkins' Whiting School of Engineering.

Mao, co-corresponding author of the Advanced Materials article, has been developing nonviral nanoparticles for gene therapy for a decade. His approach involves compressing healthy snippets of DNA within protective polymer coatings. The particles are designed to deliver their genetic payload only after they have moved through the bloodstream and entered the target cells. Within the cells, the polymer degrades and releases DNA. Using this DNA as a template, the cells can produce functional proteins that combat disease.

A major advance in this work is that Mao and his colleagues reported that they were able to "tune" these particles in three shapes, resembling rods, worms and spheres, which mimic the shapes and sizes of viral particles. "We could observe these shapes in the lab, but we did not fully understand why they assumed these shapes and how to control the process well," Mao said. These questions were important because the DNA delivery system he envisions may require specific, uniform shapes.

To solve this problem, Mao sought help about three years ago from colleagues at Northwestern. While Mao works in a traditional wet lab, the Northwestern researchers are experts in conducting similar experiments with powerful computer models.

Erik Luijten, associate professor of materials science and engineering and of applied mathematics at Northwestern's McCormick School of Engineering and Applied Science and co-corresponding author of the paper, led the computational analysis of the findings to determine why the nanoparticles formed into different shapes.

"Our computer simulations and theoretical model have provided a mechanistic understanding, identifying what is responsible for this shape change," Luijten said. "We now can predict precisely how to choose the nanoparticle components if one wants to obtain a certain shape."

The use of computer models allowed Luijten's team to mimic traditional lab experiments at a far faster pace. These molecular dynamic simulations were performed on Quest, Northwestern's high-performance computing system. The computations were so complex that some of them required 96 computer processors working simultaneously for one month.

In their paper, the researchers also wanted to show the importance of particle shapes in delivering gene therapy. Team members conducted animal tests, all using the same particle materials and the same DNA. The only difference was in the shape of the particles: rods, worms and spheres.

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Shape matters in DNA nanoparticle therapy: Particles could become a safer, more effective delivery vehicle for gene ...

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ScienceDaily (Oct. 11, 2012) Early results of a Phase II intra-arterial stem cell trial for ischemic stroke showed no adverse events associated with the first 10 patients, allowing investigators to expand the study to a targeted total of 100 patients.

The results were presented October 11 by Sean Savitz, M.D., professor of neurology and director of the Stroke Program at The University of Texas Health Science Center at Houston (UTHealth), at the 8th World Stroke Congress in Brasilia, Brazil.

The trial is the only randomized, double-blind, placebo-controlled intra-arterial clinical trial in the world for ischemic stroke. It is studying the safety and efficacy of a regenerative therapy developed by Aldagen Inc., a wholly-owned subsidiary of Cytomedix, Inc., that uses a patient's own bone marrow stem cells, which can be administered between 13 and 19 days post-stroke.

The therapy, called ALD-401, consists of stem cells that are identified using Aldagen's proprietary technology to isolate cells that express high levels of an enzyme that serves as a marker of stem cells. Pre-clinical studies found that these cells enhance recovery after stroke in mice. The cells are administered into the carotid artery. Patients are followed for 12 months to monitor safety and to assess mental and physical function.

"We have been approved by the Data Safety Monitoring Board (DSMB) to move the study into the next phase, which will allow us to expand the number of sites in order to complete enrollment," said Savitz, senior investigator for the multi-center study. As per the protocol for the trial, the Food and Drug Administration required a review by the DSMB prior to advancing to the next phase.

Preclinical research, including research at the UTHealth Medical School, has suggested that stem cells can promote the repair of the brain after an ischemic stroke, which is caused by a blood clot in the brain. Stroke is a leading cause of disability and the fourth-leading cause of death in the United States, according to 2008 statistics reported by the Centers for Disease Control and Prevention.

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The above story is reprinted from materials provided by University of Texas Health Science Center at Houston.

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Safety results of intra-arterial stem cell clinical trial for stroke presented

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TOKYO: Shinya Yamanaka, fresh from the Nobel Prize for medicine, states that science and ethics must go hand in hand. Interviewed by the Mainichi Shimbun after the award, he said: "I would like to invite ethical experts as teachers at my laboratory and work to guide iPS [induced pluripotent stem] cell research from that direction as well. The work of a scientific researcher is just one part of the equation. "

Yamanaka, 50, found that adult cells can be transformed into cells in their infancy, stem cells (iPS), which are, so to speak, the raw material for the reconstruction of tissue irreparably damaged by disease. For regenerative medicine the implications of Yamanaka's discovery are obvious. Adult skin cells can for example be reprogrammed and transformed into any other cell that is desired: from the skin to the brain, from the skin to the heart, from the skin to elements that produce insulin.

"Their discovery - says the statement of the jury that awarded him the Nobel Prize on October 8 - has revolutionized our understanding of how cells and organisms develop. Through the programming of human cells, scientists have created new opportunities for the study of diseases and development of methods for the diagnosis and therapy ".

These "opportunities" are not only "scientific", but also "ethical". Much of the scientific research and global investment is in fact launched to design and produce stem cells from embryos, arriving at the point of manipulating and destroying them, facing scientists with enormous ethical problems.

" Ethics are really difficult - Yamanaka explainsto Mainichi - In the United States I began work on mouse experiments, and when I returned to Japan I learned that human embryonic stem cells had been created. I was happy that they would contribute to medical science, but I faced an ethical issue. I started iPS cell research as a way to do good things as a researcher, and I wanted to do what I could to expand the merits of embryonic stem cells. If we make sperm or eggs from iPS cells, however, it leads to the creation of new life, so the work I did on iPS cells led to an ethical problem. If we don't prepare debates for ethical problems in advance, technology will proceed ahead faster than we think.. "

The "ethical question" Yamanaka pushed to find a way to "not keep destroying embryos for our research."

Speaking with his co-workers at the University of Kyoto, immediately after receiving the award, Yamanaka showed dedication and modesty.

"Now - he said - I strongly feel a sense of gratitude and responsibility" gratitude for family and friends who have supported him in a demanding journey of discovery that lasted decades; responsibility for a discovery that gives hope to millions of patients. Now iPS cells can grow into any tissue of the human body allowing regeneration of parts so far irretrievably lost due to illness.

His modesty also led him to warn against excessive hopes. To a journalist who asked him for a message to patients and young researchers awaiting the results of his research heresponded: "The iPS cells are also known as versatile cells, and the technology may be giving the false impression to patients that they could be cured any day now. It will still take five or 10 years of research before the technology is feasible. There are over 200 researchers at my laboratory, and I want patients to not give up hope"

"Dozens of times - he continued - I tried to get some results and I have often failed in the experiments .... Many times I was tempted to give up or cry. Without the support of my family, I could not have continued this search. From now on I will be facing the moment of truth. I would like to return to my laboratory as quickly as possible. "

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Friday, Oct. 12, 2012

NEW YORK A team of researchers has transplanted artificial cardiac muscle cells developed from multipurpose stem cells into six patients in the United States in the world's first clinical application of iPS cells, one of the researchers said Wednesday.

Shinya Yamanaka, who won this year's Nobel Prize in medicine or physiology for his development of iPS cells, declined comment on the transplants, while other experts said details about the medical performance should be carefully evaluated.

The researchers developed the muscle cells from induced pluripotent stem cells produced from the patients' livers and transplanted them to the patients, said Hisashi Moriguchi, a visiting professor at Harvard University.

A 34-year-old American male patient who was the first to receive the transplant in February now has normal heart functions and has been discharged from the hospital, Moriguchi said.

The patient suffered from liver cancer and received a liver transplant in February 2009. He developed ischemic cardiomyopathy this February, prompting the researchers to conduct the heart surgery.

The researchers took cells from the patient's original liver, which was kept after removal for the 2009 transplant, and developed iPS cells by adding protein and other medical agents from which they produced cardiac muscle cells. The muscle cells were placed in 30 locations in the patient's heart.

No rejection or cancer development was found in the heart, and his heart function gradually recovered to normal levels 10 days after the surgery, they said.

"We need to improve the efficacy and safety of such medical treatment . . . and think of ways to reduce economic burden on patients," Moriguchi said.

The researchers used an improved technique to produce iPS cells developed by Yamanaka, the professor from Kyoto University who jointly won this year's Nobel with John Gurdon of Britain. Such cells have the potential to grow into any type of body tissue.

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U.S. marks first iPS clinical applications

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ScienceDaily (Oct. 11, 2012) Researchers at Dana-Farber Cancer Institute have developed a novel method for determining how ready acute myeloid leukemia (AML) cells are to die, a discovery that may help cancer specialists to choose treatments option more effectively for their patients who have AML.

In a study published in the Oct. 12 issue of the journal Cell, the researchers report that their findings may lead to improved tests to predict which patients successfully treated for AML can continue in remission with standard chemotherapy alone, and which patients are likely to relapse despite additional treatment, but might benefit from a bone marrow transplant.

Anthony Letai, MD, PhD, senior author of the paper, said the study's results also help to explain the "therapeutic index" of AML chemo drugs: That is, how a patient's normal blood-forming stem cells can survive chemotherapy doses that kill the leukemia cells. Unlike current predictive tools, the new method determines the degree to which an individual patient's AML cells are "primed to die" by apoptosis, or programmed cell death. Chemotherapy is more effective when the cancer cells are well along the path to self-destruction, while patients with less-primed leukemia cells are more likely to suffer fatal relapse without a bone marrow transplant, said the researchers.

"Our data suggest that applying our assay in addition to conventional indicators yields a much better predictive tool," said Letai. "We plan to confirm this in independent experiments, and then test its performance prospectively in clinical trials to see if we can use it to do a better job of assigning individualized therapy in AML."

According to the American Cancer Society, an estimated 13,780 cases of AML will be diagnosed in the United States this year, and more than 10,000 people are expected to die from AML, making it the most lethal form of leukemia in the U.S.

Currently, clinicians try to predict an AML patient's outcome by assessing the cancer cells' pathological features and whether the cells contain certain mutations that suggest a poorer response. But these indicators do not provide a biological explanation for patients' differing responses to treatment, noted Letai.

The method described in the new study takes a different approach, first described by Letai in 2011 paper. It employs a technique called "BH3 profiling" to measure the readiness of mitochondria -- tiny organelles within the cell -- to unleash chemical compounds that cause the cell to destroy itself. The self-destruction process, called apoptosis, is triggered by "death molecules," whose mission is to eliminate unneeded or dangerously damaged cells from the body. The study's authors called this readiness for apoptotic self-destruction "mitochondrial priming."

BH3 profiling involves exposing cancer cells to BH3 molecules, which mimic the protein death signals in the body. If the cancer cells' mitochondria membrane is rapidly and easily disrupted, then the cells are considered to be highly primed for death. If the mitochondria strongly resist the disruption, the leukemia cells are further from self-destruction and less likely to respond to chemotherapy.

Applying the method to stored AML patient samples, "We found that mitochondrial priming measured by BH3 profiling was a determinant of initial response to induction [initial] chemotherapy, relapse following remission, and requirement for allogeneic bone marrow transplantation," the authors wrote.

Moreover, knowing whether a patient is likely to have a complete response to chemotherapy would be also very useful in personalizing chemotherapy decisions even when bone marrow transplant is not a consideration. "In elderly patients with AML, chemotherapy can be very toxic with an increased risk of fatal complications," said Letai. "You don't want to give chemotherapy unless you know whether it will benefit. Now we can predict who will benefit from it and who won't -- and should receive an alternative treatment."

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New tool determines leukemia cells' 'readiness to die,' may guide clinical care

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Robin Roberts has returned home from the hospital, following a bone marrow transplant she received with stem cells from her sister last month.

"There's no place like home. After 30 days in the hospital I'm home," Roberts Tweeted on October 11. "Praise God from whom all blessings flow. Thank YOU and bless YOU."

The 51-year-old "Good Morning America" anchor was being treated for myelodysplastic syndrome (MDS), a rare blood and bone marrow disorder. Roberts revealed her ailment in June, saying it was caused in part by treatments she had undergone for breast cancer five years ago. Her older sister, Sally-Ann, was her bone marrow donor.

Check out 9 facts about Robin Roberts, her MDS and bone marrow transplant.

Roberts went on medical leave a day early than she had initially planned in late August in order to visit her ailing mother, Lucimarian Tolliver Roberts. Lucimarian died on August 30 at the age of 88 and Robin Roberts made it back just in time to see her mother.

In the recent blog post, Roberts detailed her difficulties with chemotherapy and how her co-workers' visit helped lift her spirits.

"Today is what I like to call 'Thankful Thursday, aka Friday Eve,'" Roberts wrote in a post on October 4. "I have been in the hospital 25 days now. My bone marrow transplant took place exactly two weeks ago. The only numbers that matter are my blood counts and they are... GREAT! My sister Sally-Ann's stem cells apparently feel right at home in my body -- an answer to so many prayers."

"My doctors and rock star nurses are very pleased with my progress and I could not be more thankful for the excellent care I am receiving," she added. "I have had some extremely painful days and it's still difficult for me to eat because of all the chemo."

Roberts also mentioned a visit she had with fellow "Good Morning America" co-workers Josh Elliott and Sam Champion, which can be seen in the photo above, as well as an upcoming visit from a childhood pastor.

"I continue to learn so much on this journey, especially when it comes to true friendship and love. My friends near and far -- like Sam and Josh who came to visit yesterday -- have been lifting my spirits," Roberts wrote. "My childhood pastor (who delivered Momma's eulogy) is coming from down South to see me tomorrow. I am hopeful that I MAY be well enough to continue my recovery at home next week and my sisters plan to come back to NYC for that milestone in my journey."

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Robin Roberts returns home from hospital following bone marrow transplant

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ScienceDaily (Oct. 11, 2012) The generation of functional thyroid tissue from stem cells could allow the treatment of patients, which suffer from thyroid hormone deficiency due to defective function, or abnormal development of the thyroid gland. The team of Sabine Costagliola at the IRIBHM (Universit Libre de Bruxelles) recently developed a protocol that allowed for the first time the efficient generation of functional thyroid tissue from stem cells in mice and published the results of their studies in the scientific journal Nature.

Thyroid hormones are a class of iodide-containing molecules that play a critical role in the regulation of various body function including growth, metabolism and heart function and that are crucial for normal brain development. The thyroid gland, an endocrine organ that has been specialized in trapping iodide, is the only organ where these hormones are produced. It is, however, of note that one out of 3000 human newborns is born with congenital hypothyroidism, a condition characterized by insufficient production of thyroid hormones. In the absence of a medical treatment with thyroid hormones -- initiated during the first days after birth -- the child will be affected by an irreversible mental retardation. Moreover, a life-long hormonal treatment is necessary in order to maintain proper regulation of growth and general metabolism.

By employing a protocol in which two important genes can be transiently induced in undifferentiated stem cells, the researchers at IRIBHM were able to efficiently push the differentiation of stem cells into thyrocytes, the primary cell type responsible for thyroid hormone production in the thyroid gland.

A first exciting finding of these studies was the development of functional thyroid tissue already within the culture dishes. As a next step, the team of Sabine Costagliola transplanted the stem-cell-derived thyrocytes into mice lacking a functional thyroid gland. Four weeks after transplantation, the researchers observed that transplanted mice had re-established normal levels of thyroid hormones in their blood and were rescued from the symptoms associated with thyroid hormone deficiency. These findings have several important implications. First, the cell system employed by the IRIBHM group provides a vital tool to better characterize the molecular processes associated with embryonic thyroid development. Second, the results of the transplantation studies open new avenues for the treatment of thyroid hormone deficiency but also for the replacement of thyroid tissue in patients suffering from thyroid cancer.

The researchers are currently developing a similar protocol based on human stem cells and explore ways to generate functional human thyroid tissue by reprogramming pluripotent stem cells (iPS) derived from skin cells.

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The above story is reprinted from materials provided by Universit Libre de Bruxelles, via AlphaGalileo.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

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Generation of functional thyroid tissue from stem cells

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Friday, Oct. 12, 2012

Stem cells derived from a mouse's skin won Shinya Yamanaka the Nobel Prize in physiology or medicine on Monday. Now researchers in Japan are seeking to use his pioneering technology for an even greater prize: restoring sight.

Scientists at the Riken Center for Developmental Biology in Kobe plan to use induced pluripotent stem (iPS) cells in a human trial using patients with macular degeneration, a disease in which the retina becomes damaged and results in loss of vision, Yamanaka, a Kyoto University professor, told reporters the same day in San Francisco.

Companies including Pfizer Inc. are already planning trials of stem cells derived from human embryos, but Riken's will be the first to use a technology that mimics the power of embryonic cells while avoiding the ethical controversy that accompanies them.

"The work in that area looks very encouraging," John B. Gurdon, 79, a professor at the University of Cambridge who shared this year's Nobel Prize with Yamanaka, said in an interview in London.

Yamanaka and Gurdon split the 8 million Swedish kronor (about 94 million) award for experiments 50 years apart demonstrating that mature cells in latent form retain all of the DNA they had as immature stem cells, and that they can be returned to that potent state.

Their findings offer the potential for a new generation of therapies against hard-to-treat diseases like macular degeneration.

In a study published in 1962, Gurdon took a cell from a tadpole's gut, extracted the nucleus and inserted it into the egg cell of an adult frog whose own nucleus had been removed. The reprogrammed egg cell developed into a tadpole with the genetic characteristics of the original tadpole, and subsequent trials yielded adult frogs.

Yamanaka, 50, built on Gurdon's work by adding four genes to a skin cell from a mouse, returning it to its immature state as a stem cell with the potential to become any cell in the body.

He dubbed them induced pluripotent stem cells.

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Riken to test iPS cells in human trial

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