StemCell Therapy

June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.

"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."

With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.

"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.

"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.

In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.

Pixuvri is currently available in the EU through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

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Cell Therapeutics Appoints New Chief Medical Officer

By Makiko Kitamura - 2012-06-13T22:30:00Z

The first vein grown from a patients own stem cells was successfully transplanted into a 10-year-old girl, potentially offering a way for those lacking healthy veins to undergo dialysis or heart bypass surgery.

A team led by Michael Olausson of the University of Gothenburg took a 9-centimeter (3.5-inch) segment of vein from a human donor and removed all living cells, the Swedish researchers wrote in a study in The Lancet medical journal today. The resulting protein scaffolding was injected with stem cells from the girls bone marrow, and two weeks later was implanted in the patient, who had a blockage in the vein that carries blood from the spleen and intestines to the liver.

The result points to what may be a safer source of stem cells, the building blocks of life which can grow into any type of tissue in the body. Using cells from the patient may limit the risk that the immune system would attack the transplant, which can occur with tissue taken from healthy people and given to the sick. The girl hasnt developed signs of rejection, even without taking drugs to suppress her immune system, the researchers said.

The successful procedure establishes the feasibility and safety of a novel paradigm for treatment, the researchers wrote in the study. Our work opens interesting new areas of research, including trying to reproduce arteries for surgical use in patients.

The recipient had no complications from the operation, and a year later, has grown 6 centimeters and gained 5 kilograms (11 pounds) in weight.

Olausson and colleagues report suggests that tissue- engineered vascular grafts are promising, but one-off experiences such as the procedure they describe need to be converted into full clinical trials in key target populations, Martin Birchall and George Hamilton, professors at the University College London, wrote in a commentary accompanying the Lancet publication.

The study was funded by the Swedish government.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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First Vein Grown From Human Stem Cells Transplanted

13 June 2012 Last updated at 08:31 ET

Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize.

His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body.

Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine.

He was joint-winner with Linus Torvalds, who created a new open source operating system for computers.

This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award.

My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases.

The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki.

Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit humanity in the future.

"The innovations of both this year's winners embody that principle.

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Stem cell scientist wins award

ScienceDaily (June 13, 2012) Human-derived stem cells can spontaneously form the tissue that develops into the part of the eye that allows us to see, according to a study published by Cell Press in the 5th anniversary issue of the journal Cell Stem Cell. Transplantation of this 3D tissue in the future could help patients with visual impairments see clearly.

"This is an important milestone for a new generation of regenerative medicine," says senior study author Yoshiki Sasai of the RIKEN Center for Developmental Biology. "Our approach opens a new avenue to the use of human stem cell-derived complex tissues for therapy, as well as for other medical studies related to pathogenesis and drug discovery."

During development, light-sensitive tissue lining the back of the eye, called the retina, forms from a structure known as the optic cup. In the new study, this structure spontaneously emerged from human embryonic stem cells (hESCs) -- cells derived from human embryos that are capable of developing into a variety of tissues -- thanks to the cell culture methods optimized by Sasai and his team.

The hESC-derived cells formed the correct 3D shape and the two layers of the optic cup, including a layer containing a large number of light-responsive cells called photoreceptors. Because retinal degeneration primarily results from damage to these cells, the hESC-derived tissue could be ideal transplantation material.

Beyond the clinical implications, the study will likely accelerate the acquisition of knowledge in the field of developmental biology. For instance, the hESC-derived optic cup is much larger than the optic cup that Sasai and collaborators previously derived from mouse embryonic stem cells, suggesting that these cells contain innate species-specific instructions for building this eye structure. "This study opens the door to understanding human-specific aspects of eye development that researchers were not able to investigate before," Sasai says.

The anniversary issue containing Sasai's study will be given to each delegate attending the 2012 ISSCR meeting in Yokohama, Japan. To highlight the ISSCR meeting and showcase the strong advances made by Japanese scientists in the stem cell field, the issue will also feature two other papers from Japanese authors, including the research groups of Akira Onishi and Jun Yamashita. In addition, the issue contains a series of reviews and perspectives from worldwide leaders in stem cell research.

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The above story is reprinted from materials provided by Cell Press, via EurekAlert!, a service of AAAS.

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Scientists see new hope for restoring vision with stem cell help

LONDONFor the first time doctors have successfully transplanted a vein grown with a patient's own stem cells, another example of scientists producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. Last March, the girl's doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 9-centimeter (3 1/2-inch) section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girl's bone marrow, scientists grew millions of cells to cover the vein, a process that took about two weeks. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

"This is the future for tissue engineering, where we can make tailor-made organs for patients," said Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors.

She and colleagues published the results of their work online Thursday in the British medical journal Lancet. The work was paid for by the Swedish government.

The science is still preliminary and one year after the vein was transplanted, it needed to be replaced with another lab-grown vein when doctors noticed the blood flow had dropped. Experts from University College London raised questions in an accompanying commentary about how cost-effective the procedure might be, citing "acute pressures" on health systems that might make these treatments impractical for many patients.

Sumitran-Holgersson estimated the cost at between $6,000 and $10,000.

Similar methods have already been used to make new windpipes and urethras for patients. Doctors in Poland have also made blood vessels grown from donated skin cells for dialysis patients.

Patients with the girl's condition are usually treated with a vein transplant from their own leg, a donated vein, or a liver transplant. Those options can be complicated in children and using a donated vein or liver also requires taking anti-rejection medicines.

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Doctors make new vein with girl's own stem cells

Nation & World briefing

LONDON -- For the first time doctors have successfully transplanted a vein grown with a patient's own stem cells in another example of producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. In March, the girl's doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 31/2-inch section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girl's bone marrow, scientists grew millions of cells to cover the vein, a two-week process. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors, and her colleagues published the results of their work online Thursday, June 14, in the British medical journal Lancet. The work was paid for by the Swedish government.

Bishops continue to fight mandate

ATLANTA -- The nation's Roman Catholic bishops on Wednesday promised steadfast opposition to President Barack Obama's mandate that birth control be covered by health insurance, saying it is one

Bishops insisted repeatedly that they had no partisan agenda. They said they were forced into action by state and federal policies that they said would require them to violate their beliefs in order to maintain the vast public-service network the church has built over a century or longer.

"It is not about parties, candidates or elections as others have suggested," said Baltimore Archbishop William Lori, chairman of the bishops' religious-liberty committee. "The government chose to pick a fight with us."

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Vein grown with patient's stem cells is transplanted

Salk researcher's findings suggest a potentially favorable time to harvest stem cells for therapy and may reveal genes crucial to tissue production

LA JOLLA, CA----With their potential to treat a wide range of diseases and uncover fundamental processes that lead to those diseases, embryonic stem (ES) cells hold great promise for biomedical science. A number of hurdles, both scientific and non-scientific, however, have precluded scientists from reaching the holy grail of using these special cells to treat heart disease, diabetes, Alzheimer's and other diseases.

In a paper published June 13 in Nature, scientists at the Salk Institute for Biological Studies report discovering that ES cells cycle in and out of a "magical state" in the early stages of embryo development, during which a battery of genes essential for cell potency (the ability of a generic cell to differentiate, or develop, into a cell with specialized functions) is activated. This unique condition, called totipotency, gives ES cells their unique ability to turn into any cell type in the body, thus making them attractive therapeutic targets.

"These findings," says senior author Samuel L. Pfaff, a professor in Salk's Gene Expression Laboratory, "give new insight into the network of genes important to the developmental potential of cells. We've identified a mechanism that resets embryonic stem cells to a more youthful state, where they are more plastic and therefore potentially more useful in therapeutics against disease, injury and aging."

ES cells are like silly putty that can be induced, under the right circumstances, to become specialized cells-for example, skin cells or pancreatic cells-in the body. In the initial stages of development, when an embryo contains as few as five to eight cells, the stem cells are totipotent and can develop into any cell type. After three to five days, the embryo develops into a ball of cells called a blastocyst. At this stage, the stem cells are pluripotent, meaning they can develop into almost any cell type. In order for cells to differentiate, specific genes within the cells must be turned on.

Pfaff and his colleagues performed RNA sequencing (a new technology derived from genome-sequencing to monitor what genes are active) on immature mouse egg cells, called oocytes, and two-cell-stage embryos to identify genes that are turned on just prior to and immediately following fertilization. Pfaff's team discovered a sequence of genes tied to this privileged state of totipotency and noticed that the genes were activated by retroviruses adjacent to the stem cells.

Nearly 8 percent of the human genome is made up of ancient relics of viral infections that occurred in our ancestors, which have been passed from generation to generation but are unable to produce infections. Pfaff and his collaborators found that cells have used some of these viruses as a tool to regulate the on-off switches for their own genes. "Evolution has said, 'We'll make lemonade out of lemons, and use these viruses to our advantage,'" Pfaff says. Using the remains of ancient viruses to turn on hundreds of genes at a specific moment of time in early embryo development gives cells the ability to turn into any type of tissue in the body.

From their observations, the Salk scientists say these viruses are very tightly controlled-they don't know why-and active only during a short window during embryonic development. The researchers identified ES cells in early embryogenesis and then further developed the embryos and cultured them in a laboratory dish. They found that a rare group of special ES cells activated the viral genes, distinguishing them from other ES cells in the dish. By using the retroviruses to their advantage, Pfaff says, these rare cells reverted to a more plastic, youthful state and thus had greater developmental potential.

Pfaff's team also discovered that nearly all ES cells cycle in and out of this privileged form, a feature of ES cells that has been underappreciated by the scientific community, says first author Todd S. Macfarlan, a former postdoctoral researcher in Pfaff's lab who recently accepted a faculty position at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. "If this cycle is prevented from happening," he says, "the full range of cell potential seems to be limited."

It is too early to tell if this "magical state" is an opportune time to harvest ES cells for therapeutic purposes. But, Pfaff adds, by forcing cells into this privileged status, scientists might be able to identify genes to assist in expanding the types of tissue that can be produced.

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"Magical State" of Embryonic Stem Cells May Help Overcome Hurdles to Therapeutics

News

Article date: February 27, 2012

By Stacy Simon

Someone being treated for cancer often needs a lot of help at home, too. Usually a spouse, partner, adult child, or close friend becomes the primary caregiver who provides transportation, keeps house, prepares meals, provides emotional support, and communicates with other relatives and friends. The caregiver may also help feed, dress and bathe the patient, give drugs, manage side effects, report problems, and manage financial and insurance issues.

The physical and emotional toll of these tasks often leads to a lot of stress and a negative impact on the caregivers own health. In fact, the level of distress for the caregiver can sometimes be as high as it is for the patient. Caregivers have less time for their own needs, and often spend less time on leisure activities, have less contact with family and friends, dont get as much sleep or exercise, and ignore their own physical health concerns.

There may also be a financial impact. Caregivers may work fewer hours, take a leave of absence, or move closer to the patient.

Researchers from the National Institutes of Health say health care providers should devote some attention to caregivers, in addition to the patients theyre caring for, to help relieve some of this burden. The researchers detailed the case of one caregiver in a recent article published in the Journal of the American Medical Association.

The caregiver was a 53-year-old woman whose husband had an aggressive bone marrow cancer called acute myeloid leukemia. He was hospitalized to undergo a stem cell transplant, a complicated procedure that can often have major side effects. His hospital stay and recovery was prolonged because of complications that included fluid around the heart, kidney failure, pneumonia, and graft vs. host disease. During the next several weeks, he was readmitted twice for additional complications including heart failure. He died during his last hospital stay.

During the time she cared for her husband, the wife, like many caregivers, complained little to the health care team, not wanting to take the focus away from the person being cared for. But when asked, she reported symptoms of stress that included anxiety, depression, loneliness, emotional distress, fatigue, lack of energy, trouble sleeping, and difficulty staying focused. Financial concerns added to her stress level. The transplant center was 143 miles away, so the couple had to move into temporary housing near the center. Both were unemployed due to disability, yet she was also supporting her father, mother and aunt.

The stresses associated with caregiving can increase the risk of illness in the caregiver. And like many caregivers, the wife in the case study already had a history of health problems and was dealing with additional stressful events. She had had heart bypass surgery and arthritis, and she was a smoker. Four months after her husbands death, her father died. Shortly after that, she had a heart attack and needed a pacemaker.

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Case Study: When You Care for Someone with Cancer

Last year Peyton Manning flew to Europe on a private jet, not for tea and crumpets or to see the Louvre, but for an experimental stem-cell treatment on his injured neck.

The procedure, one that isn't even legal in the United States, allegedly took his own fat cells and used them to try to regrow damaged neck tissue:

"There are many proposed therapies that are being tested in clinical trials, and there are more to come," Dr. Lawrence Goldstein, director of the stem cell program at the University of California, San Diego, told ABC News. "But in the absence of reliable evidence, it is impossible to know whether the 'treatment' will make Manning better or worse or merely financially poorer."

TheNFL doesn't have any rules specifically banning illegal procedures that an athlete can have done in foreign locales. Kobe Bryant, the NBA's aging lion, had similarly cutting-edge treatment on his arthritic knee in Germany. It's called "Biologic Medicine,"and in addition to Bryant, super-agent Ari Emanueland the late Pope John Paul II were ardent believers.

There are a ton of controversial treatments possible where science collides with loose regulation. Bone marrow injections filled with those miracle-working stem cells can be injected into the body. Blood can be heated up, spun and spun in an incubator, the healing agents isolated and injected. The 34-year-old Bryant felt like a new man after first undergoing the procedure, like Manning's one not approved by the FDA:

He even recommended the treatment to Alex Rodriguez, which led the baseball star to undergo the same treatment on his knee late last year. Bryant hasn't commented publicly on the treatment, but A-Rod has described the feelings of his friend.

Bryant "was really adamant about how great the procedure was for him," Rodriguez told reporters."I know that he was hurting before, almost even thinking about retirement, that's how much pain he was under. And then he said after he went to Germany he felt like a 27-year-old again. I was still a little apprehensive about it, and he kept staying on me about it."

Athletes at the highest levels will do almost anything to maintain that edgeto feel younger, sprier and as explosive as they did in their primes. And with the right money and resources, they are extending their careers further than any of their predecessors would have dared dream. Is it any wonder athletes in mixed martial arts are doing the same?

Frank Mir on TRT

In that sport, some of the UFC's top aging stars have undergone Testosterone Replacement Therapy (TRT), looking to bring their bodies' natural level of testosterone back to the levels they enjoyed in their 20s. Top contenders like Dan Henderson (41), Chael Sonnen (35) and Frank Mir (33)have all undergone the procedure. Former middleweight champion Rich Franklin (37)is considering it.

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The UFC's Supposed Testosterone Epidemic: Critics Living in the Past

The proposed new platform for the Republican Party of Iowa touches on abortion, agriculture, budgeting, business, criminal justice, education, elections, energy, environment, family values, foreign policy, government, gun rights, health care, homeland security, human services, immigration, marriage, religious freedom, the Republican Party, right to work, taxation and transportation.

Iowa Gov. Terry Branstad said most people dont read the platform, which is controlled by the most ardent activists. The candidates stances are more important, he said.

At the end of the day, the platform is a grassroots a document as developed by the delegates, Branstad told the Des Moines Register Tuesday. But whats more important, in my mind, is the candidates that really articulate their stand on the issues. Thats really the important thing and thats what goes to the voters. Most people dont read the party platforms and you can take either party platform and you find that parties tend to be controlled by the more ardent left or right and that doesnt really reflect where the candidates are going to come down.

Heres the proposed 2012 platform, which delegates will vote on Saturday during the state convention in downtown Des Moines:

Preamble: We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable rights, that among these are life, liberty, and the pursuit of happiness. That to secure these rights, governments are instituted among men, deriving their just powers from the consent of the governed. That whenever any form of government becomes destructive of these ends, it is the right of the people to alter or to abolish it, and to institute new government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their safety and happiness.

As Republicans, we seek a world of liberty; a world in which all individuals are sovereign over their own lives and are never deprived of property or forced to sacrifice ones values for the benefit of others. We believe that respect for individual rights is the essential precondition for a free and prosperous world, and that only through freedom can peace and prosperity be realized. Consequently, we defend each persons right to engage in any activity that is peaceful and honest, and welcome the diversity that freedom brings. We defend the right of each individual to be free and to follow their own dreams in their own ways, unless the exercise of their freedoms infringes upon the valid rights of others.

In the following pages we have set forth our basic principles and enumerated various policies derived from those principles. Let it be clear that these specific policies are not our end goal. Our goal is nothing more nor less than a world set free, and it is to this end that we stand together.

Where two planks might seem to be contradictory, the platform should be interpreted as favoring the goal of the plan providing the least government while protecting basic rights and responsibilities of individuals. Some planks may appear redundant or in conflict, but upon closer evaluation you should see that sufficient nuance exists to include each plank. Any redundancy from one section of this Platform to another was deliberately adopted for emphasis and because government actions often impact more than one area of life. All planks should be read and understood in the context of related issues, events, and circumstances.

Other planks are supported as possible steps toward the goal of limited, responsible, Constitutional, Republican Government. It has taken many years to move away from Constitutional Government and it is unlikely that we will be able to return to the vision of our illustrious Founding Fathers overnight.

A Right to Life 1.1 We believe in the sacred gift of life from conception to natural death. On day one a babys genetic code and DNA are formed. That is the beginning of life. We affirm that the unborn child is a living human being, with rights separate from those of its mother regardless of gestational age or dependency. 1.2 We oppose infanticide, euthanasia, and assisted suicide. 1.3 We advocate the appointment of judges who respect the sanctity of life and who understand their limited role in government. 1.4 We disagree with Roe vs. Wade and Doe vs. Bolton as settled law. Under the Tenth amendment, these Supreme Court decisions have no authority over the states. 1.5 We support a personhood amendment to the US Constitution that states, Personhood and life begins at Conception and that no person shall be deprived of life, liberty, and property, according to the 14th amendment with-out due Process of Law and shall hold all officials accountable to enforce it. 1.6 We oppose the use of public revenues for abortion, and call for elimination of government funding for all organizations, such as Planned Parenthood, which advocate or support abortion. 1.7 We support a ban of RU-486 (morning after pill) and all abortion-inducing drugs. 1.8 We support legislation requiring a parent or legal guardians consent before an abortion or any reproductive surgery is performed on a minor child. 1.9 We believe in conscience-clause legislation so that no physician, pharmacist, or other health care provider can be penalized for refusing to prescribe, dispense, or participate in the procurement of abortion or anything contrary to the conscience of the health care provider. 1.10 We support an Iowa Womans Right to Know Law requiring informed consent including a three day waiting period with a mandatory ultrasound before any elective abortion services may be provided. Informed Consent means that abortionists must offer to the pregnant woman, prior to the abortion, complete factual information about the complications of abortion, the biological development of the unborn, fetal pain, and the availability of alternatives to abortion. 1.11 We call for confidential statistical reporting of abortion procedures to the State Health Department by all doctors and health facilities performing abortions. 1.12 Facilities performing abortions should be subject to the same health and safety standards as hospitals. 1.13 We call for the end of tele-med abortions. 1.14 We support legislation that would prohibit organizations, such as Planned Parenthood, from entering public school facilities for the purpose of promoting abortion. 1.15 We call for banning partial birth abortions. 1.16 We support agencies that do not refer for or perform abortions and encourage Positive Alternatives, for pregnancy counseling. We support adoption and aid to unwed mothers during pregnancy. All funding must come from the private sector. 1.17 We support the use of non-embryonic stem cells to advance modern medical research. We oppose somatic cell nuclear transfer (human cloning), embryonic stem cell research, human fetal-tissue research from induced abortions, and the commercial use or sale of fetal parts. 1.18 We oppose the selling, brokering, or marketing of fetal and aborted tissue. We oppose the use of aborted fetal tissue in vaccines. This should be illegal.

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Iowa governor downplays GOP party platform; here's the whole document

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed

LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models.

"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies."

Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials.

Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments.

"The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues," adds Jyothikumar. "As a result, market prices for various products may be affected."

Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies," cautions Jyothikumar. "Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics."

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New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan

Newswise Cell-based therapies have yet to reach their full potential in repairing damaged tissue because of the hostile environment the cells face once injected into the body. A patients inflammatory response normally causes the majority of these therapeutic cells to die or migrate away from the area in need of repair.

To address this problem, a startup company based on technology developed at the Georgia Institute of Technology is creating an efficient, safe and repeatable delivery method that protects cells from death and migration from the treatment site. Using microbead technology developed in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, SpherIngenics is producing protective capsules for the delivery of cell-based therapies.

Supported by a broad range of Georgia Tech initiatives, the company recently received a two-year $730,000 Phase II Small Business Innovation Research (SBIR) grant from the U.S. Department of Defense to continue development of the technology.

When damaged tissue is being repaired by a cell-based therapy, our microbead technology ensures that cells travel to and remain in the targeted area while maintaining continued viability, said SpherIngenics CEO Franklin Bost, who is also a professor in the Coulter Department. This technology has the potential to reduce the cost of treatment by eliminating the need for multiple therapeutic procedures.

Bost and Coulter Department Professors Barbara Boyan and Zvi Schwartz founded the company in 2007. They worked with the Georgia Tech Research Corporation to license five patents from Boyans lab for technology originally developed in the Georgia Tech/Emory Center for the Engineering of Living Tissue (GTEC), which was funded by a grant from the National Science Foundation. Then they secured $450,000, which included a Phase I SBIR grant from the U.S. Department of Defense and grants from the Georgia Research Alliance and the Coulter Foundation.

During Phase I of the SBIR grant, the researchers confirmed that as many as 250 human adult stem cells could remain viable in culture if they were encapsulated in a 200-micron-diameter bead made of natural algae materials and that they could release factors that enhance tissue regeneration.

For the Phase II SBIR grant, were going to examine whether delivering microbeads full of stem cells can enhance cartilage repair and regeneration of craniofacial defects in an animal model, said Boyan, who is the companys chief scientific officer. Boyan is also the associate dean for research and innovation in the Georgia Tech College of Engineering, the Price Gilbert, Jr. Chair in Tissue Engineering at Georgia Tech, and a Georgia Research Alliance Eminent Scholar.

The company will perform this research in its laboratory space located in the Advanced Technology Development Center (ATDC) biosciences incubator.

The companys ultimate goal is to commercialize the microbead technology for use in hospitals and by cell therapy companies. To help reach this goal, a group of students wrote a business plan for SpherIngenics last year through the Georgia Tech College of Managements Technological Innovation: Generating Economic Results (TI:GER) program.

The team -- which included Coulter Department doctoral student Christopher Lee, Georgia Tech MBA students Chris Palazzola and Eric Diersen, and Emory University law students Bryan Stewart and Natalie Dana -- won third place in the 2011 Georgia Tech Business Plan Competition. The competition, while largely an education experience, provided students an opportunity to develop their venture ideas and present them to a panel of highly experienced judges in the venture capital, technology transfer and legal fields.

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Georgia Tech Cell Delivery Startup Secures Defense Funding

Stem cells were encouraged to form a structure known as the optic cup

By Daily Mail Reporter

PUBLISHED: 10:55 EST, 13 June 2012 | UPDATED: 10:55 EST, 13 June 2012

Scientists have taken a major step towards restoring vision for blind people with the help of stem cells.

Human-derived stem cells can spontaneously form the tissue that develops into the part of the eye which allows us to see, according to a new study.

Researchers say transplantation of this tissue in the future could help patients with visual impairments see clearly.

The stem cells formed two layers of the optic cup, including a layer containing a large number of photoreceptors

Senior study author Doctor Yoshiki Sasai, of the RIKEN Centre for Developmental Biology in Japan, said: 'This is an important milestone for a new generation of regenerative medicine.

'Our approach opens a new avenue to the use of human stem cell-derived complex tissues for therapy, as well as for other medical studies related to pathogenesis and drug discovery.'

Read the original:
Blindness breakthrough as scientists turn stem cells into the tissue that allows humans to see

This is a human ES cell-derived optic cup generated in our self-organization culture (culture day 26). Bright green, neural retina; off green, pigment epithelium; blue, nuclei; red, active myosin (strong in the inner surface of pigment epithelium). Credit: Nakano et al. Cell Stem Cell Volume 10 Issue 6

Human-derived stem cells can spontaneously form the tissue that develops into the part of the eye that allows us to see, according to a study published by Cell Press in the 5th anniversary issue of the journal Cell Stem Cell. Transplantation of this 3D tissue in the future could help patients with visual impairments see clearly.

"This is an important milestone for a new generation of regenerative medicine," says senior study author Yoshiki Sasai of the RIKEN Center for Developmental Biology. "Our approach opens a new avenue to the use of human stem cell-derived complex tissues for therapy, as well as for other medical studies related to pathogenesis and drug discovery."

During development, light-sensitive tissue lining the back of the eye, called the retina, forms from a structure known as the optic cup. In the new study, this structure spontaneously emerged from human embryonic stem cells (hESCs)cells derived from human embryos that are capable of developing into a variety of tissuesthanks to the cell culture methods optimized by Sasai and his team.

The hESC-derived cells formed the correct 3D shape and the two layers of the optic cup, including a layer containing a large number of light-responsive cells called photoreceptors. Because retinal degeneration primarily results from damage to these cells, the hESC-derived tissue could be ideal transplantation material.

Beyond the clinical implications, the study will likely accelerate the acquisition of knowledge in the field of developmental biology. For instance, the hESC-derived optic cup is much larger than the optic cup that Sasai and collaborators previously derived from mouse embryonic stem cells, suggesting that these cells contain innate species-specific instructions for building this eye structure. "This study opens the door to understanding human-specific aspects of eye development that researchers were not able to investigate before," Sasai says.

The anniversary issue containing Sasai's study will be given to each delegate attending the 2012 ISSCR meeting in Yokohama, Japan. To highlight the ISSCR meeting and showcase the strong advances made by Japanese scientists in the stem cell field, the issue will also feature two other papers from Japanese authors, including the research groups of Akira Onishi and Jun Yamashita. In addition, the issue contains a series of reviews and perspectives from worldwide leaders in stem cell research.

More information: Nakano et al.: "Self-Formation of Optic Cups and Storable Stratified Neural Retina from Human ESCs." DOI 10.1016/j.stem.2012.05.009

Journal reference: Cell Stem Cell

Provided by Cell Press

Original post:
Scientists see new hope for restoring vision with stem cell help

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed

LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models.

"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies."

Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials.

Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments.

"The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues," adds Jyothikumar. "As a result, market prices for various products may be affected."

Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies," cautions Jyothikumar. "Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics."

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New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan

13 June 2012 Last updated at 08:31 ET

Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize.

His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body.

Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine.

He was joint-winner with Linus Torvalds, who created a new open source operating system for computers.

This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award.

My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases.

The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki.

Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit humanity in the future.

"The innovations of both this year's winners embody that principle.

Excerpt from:
Stem cell scientist wins award

MANILA, Philippines -- "The Buzz" host Boy Abunda is going to Europe this weekend with his mother, who is suffering from dementia and Alzeimers disease.

In an interview with ABS-CBN News on Tuesday afternoon, Abunda said he will bring his mother to Germany to try stem cell therapy.

"Ako ay pupunta sa Europe hindi para magbakasyon. Dadalhin ko po ang aking ina para magpagamot sa Germany. Ito po 'yung fresh stem cell therapy. Maganda 'yung dini-diretso na dahil napag-uusapan ito," Abunda said.

While Abunda is in Germany, Kris Aquino will take his place on ABS-CBN's entertainment talk show "The Buzz."

In the interview, Abunda also said he's proud of Aquino, who's now open to doing extreme adventures, while continuing to be a good mother to her two sons.

"Ang daming nagbago kay Kris. May mga bagay na hindi ko inakala na gagawin ni Kris like 'yung diving, zipline at marami pang iba. Natutuwa ako that she has become more open to many things. She has become more adventurous. She has retained being the doting mother that she is pero mas malalim ang halakhak niya ngayon sa buhay. She's just so joyful. Natutuwa ako habang pinapanood ko ang kanyang adventure sa 'KrisTV,'" Abunda said.

Abunda said he's also hoping to do a new project with Aquino.

"I'm hoping na someday ay muli kaming magtagpo sa isang palabas dahil marami ang humihiling na kami ay magsama sa isang palabas. Sigurado ako sa puso ko na kami ay gagawa at gagawa dahil magkadugtong ang aming pusod," he said.

More:
Abunda to try stem cell therapy for mom

June 12, 2012

The use of stem-cells building-block cells that are harvested from embryos or adults to treat heart disease could rely on faith as much as it does science, after billions of dollars in research has not produced the results that researchers have been looking for.

Questions and concerns on the topic arose during the recent opening of the multi-million-dollar Scottish Center for Regenerative Medicine (SCRM) in Edinburgh, chaired by Sir Ian Wilmut, the renowned scientist whose Dolly the sheep clone in 1996, was a groundbreaking step in stem cell technology.

During the opening ceremonies of the Center, Christine Mummery of the Leiden University Medical Center in the Netherlands discussed how a 2001 claim, based on mice experimentation, indicated that bone-marrow cells could mend heart damaged by coronary disease, caused a mad rush of people to the clinics looking for a cure-all.

With nothing in the way of systematic research in animals, the first patients were being treated within a year, prematurely by Mummerys account. She argued that the paper that launched the mass stampede was completely wrong, and subsequent studies proved that. But despite the findings, the 2001 paper has never been withdrawn.

Norwegian professor Harald Arnesen in 2007 voiced his concerns over those heart trials as well. He concluded that they were not convincing and that one German team had achieved striking results only because the control group had done particularly badly. Arnesen called for a moratorium on this kind of stem-cell therapy, based on that research.

But neither Arnesen, nor Mummery, could deter clinicians. Another trial, the largest to date, began in January 2012 and included 3,000 heart-attack patients recruited from across Europe. The trial was funded by the European Union as well.

The idea behind the trials is straightforward. During a heart attack, a clogged blood vessel starves heart muscle of oxygen. Up to a billion heart muscle cells, called cardiomyocytes, can be damaged, and the body responds by replacing them with relatively inflexible scar tissue, which can lead to fatal heart failure.

What is notably surprising, explained Mummery, is that stem cells come in many different forms: Embryonic stem cells are the building-blocks of the body and have the potential to turn into all 200 cell types found in the human body. Adult stem cells, however, are limited in what they can do. For example, bone marrow stem cells only generate blood cells.

So, the 2001 study claiming that bone marrow stem cells could turn into healthy heart muscle was a surprising and exciting claim, although a bold move.

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Some Stem-Cells May Not Be The Answer For Heart Disease

2012-06-13 08:31

Paris - Some stem cells can lay dormant for more than two weeks in a dead person and then be revived to divide into new, functioning cells, scientists in France said on Tuesday.

The research, published in the journal Nature Communications, unlocks further knowledge about the versatility of these cells, touted as a future source to replenish damaged tissue.

"Remarkably, skeletal muscle stem cells can survive for 17 days in humans and 16 days in mice, post mortem well beyond the one to two days currently thought," they said in a statement.

The stem cells retained their ability to differentiate into perfectly functioning muscle cells, they found.

"This discovery could form the basis of a new source, and more importantly new methods of conservation, for stem cells used to treat a number of pathologies," the statement said.

Stem cells are infant cells that develop into the specialised tissues of the body.

They have sparked great excitement as they offer hopes of rebuilding organs damaged by disease or accident.

The study led by Fabrice Chretien of France's Pasteur Institute found that to survive in adverse conditions, skeletal muscle stem cells lower their metabolism to enter a dormant state, using less energy.

The team then also looked at stem cells taken from bone marrow, where blood cells are produced.

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Stem cells harvested long after death

Science is social, but when political ideology takes precedence over experimental evidence the results can be fatal.

"Eduard Kolchinsky" by Nathaniel Gold

The United States is in the midst of a partisan political battle over science. Whether the issue is evolution, global warming, stem cell research, or HPV vaccines, conservative politicians either disregard the evidence that would undermine their position or remain proudly ignorant of scientific reality. For example, in the lead up to the mid-term elections, Republican House Majority Leader Eric Cantor (VA-7) singled out the National Science Foundation as part of his YouCut Citizen Review that asked conservative voters to sift through a list of already approved federal science grants and contact their Congressperson about wasteful spending that should be cut. This, in addition to the ongoing battles to stop the teaching of evolution, and prevent the evidence of global warming from informing energy policy, has made science the subject of political attacks today more than during any other period in U.S. history.

The goal, as Republican strategist Frank Luntz famously wrote in a leaked memo, is entirely ideological. There is still a window of opportunity to challenge the science, he wrote, referring to global warming. A compelling story, even if factually inaccurate, can be more emotionally compelling than a dry recitation of the truth. This is the backdrop to the so-called Climategate scandal in which hacked e-mails written by climate scientists became the justification for right-wing attacks upon, not only the science they rejected, but also the integrity of the scientists themselves.

History offers compelling examples of what can go wrong when science is sidelined in favor of political ambition. Perhaps the most extreme case would be that of the Soviet Union where biologists, in particular, were censored, arrested, or even executed because their evidence contradicted the official Party line. Under the influence of the charismatic agronomist Trofim Lysenko, who claimed that genetics was a fraud and that environment alone influenced heredity, Russian biology became stunted for a generation. His promise of unprecedented agricultural yields coincided with a Soviet ideology that believed human nature could be moulded to support the interests of the state. Those scientists who challenged the results of his highly flawed experiments, particularly after the August, 1948 session of VASKhNIL (the Lenin All-Union Academy of Agricultural Sciences), were singled out as critics not only of Lysenkoism but of Soviet ideology itself.

Eduard Izrailevich Kolchinsky grew up in the generation after Lysenkos downfall and has worked for more than forty years to bring the previously censored history of evolutionary biology to light in his native Russia. Born on September 16, 1944, at the same time that Allied forces were entering Germany in World War II, Kolchinsky has been fascinated with the intersection between biology and politics throughout his career. Receiving his PhDs in Philosophy of Biology and the History of Science, his first book, The Evolution of Evolution (1977) co-written with Kirill Zavadsky, became highly influential and continues to be cited to this day. Among Kolchinskys many international honors he was recently invited to be a Fellow in the Linnaean Society of London. He is currently the director of the St. Petersburg branch of the Institute for the History of Science and Technology (IHST) in the Russian Academy of Sciences as well as a professor of Philsophy at St. Petersburg State University.

I recently arrived in Russia to begin my fellowship with the Institute and to present my research at an international conference being held later this week. I had the opportunity earlier to sit down with Professor Kolchinskyalong with Marina Loskutova, IHST senior researcher, who assisted with translationto ask him about the dangers of mixing science with politics and what lessons can be learned by exploring this previously unknown history of the Soviet Union.

Eduard Izrailevich Kolchinsky, January 2012. Image courtesy of the Institute for the History of Science and Technology, RAS.

Eric Michael Johnson: Readers of Scientific American are certain to have an idea of what it was like to live in the Soviet Union. Some of these ideas may be accurate, others not. But few will have any idea about what it was like to be an evolutionary scientist during the Soviet period. What were the major issues that scientists had to deal with then and what, in your opinion, are the greatest misconceptions about this time?

The rest is here:
The Failed Synthesis: Eduard Kolchinsky on the Dangers of Mixing Science and Politics