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FDA Cracks Down on Stem Cell Clinics But Patients Are Still at Risk – TIME

Posted: August 29, 2017 at 4:49 pm

On Monday, the U.S. Food and Drug Administration (FDA) announced that the agency is targeting clinics that offer unproven stem cell therapies, calling such offices "unscrupulous clinics" selling "so-called cures." The FDA seized materials from one clinic in California, and sent a warning letter to another in Florida.

The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work," said FDA Commissioner Dr. Scott Gottlieb in a statement.

The agency announced that on Friday, Aug. 25th, U.S. Marshals seized five vials of a vaccine that is intended for people at a high risk for smallpox (for example, people in the military) from StemImmune Inc. in San Diego, California. The FDA says it learned that StemImmune was using the vaccines as well as stem cells from body fat to create an unapproved stem cell therapy. On its website, StemImmune says "The patients own (autologous, adult) stem cells, armed with potent anti-cancer payloads, function like a Trojan Horse, homing to tumors and cancer cells, undetected by the immune system." The stem cell treatment was injected into the tumors of cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

MORE: Three People Are Nearly Blind After Getting a Stem Cell Treatment

The FDA also sent a warning later to U.S. Stem Cell Clinic in Sunrise, Florida. The company recently came under public scrutiny when a March report revealed that three people had severe damage to their vision one woman went blindafter they were given shots of what the company said were stem cells into their eyes during a study sponsored by the clinic. The FDA says that an inspection of U.S. Stem Cell Clinic revealed that the clinic was using stem cells to treat diseases like Parkinson's, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. According to the FDA, there are currently only a limited number of stem cell therapies approved by the agencyincluding ones involving bone marrow, for bone marrow transplants in cancer care, and cord blood for specific blood-related disorders. There are no approved stem cell treatments for other diseases.

The FDA says U.S. Stem Cell Clinic also attempted to interfere with the FDA's most recent inspection by refusing to allow FDA investigators to enter without an appointment, and denied the agency access to its employees. "Refusing to permit entry or FDA inspection is a violation of federal law," the FDA says.

Action by the FDA on clinics promoting unproven stem cell therapies is "a long time coming," says Sean Morrison, former president of the International Society for Stem Cell Research (ISSCR) and d irector of the Childrens Research Institute at UT Southwestern. "C linics are preying on the hopes of desperate patients claiming they can cure all manner of diseases with stem cells that have not been tested in clinical trials, and in some cases, are flat out impossible."

In the past, medical experts were concerned over Americans traveling to countries with less medical regulation for stem cell therapies, but Morrison says such clinics have been popping up stateside over the last five years. "It's not a few companies in the U.S. making claims about therapies with stem cells," says Morrison. "It's scores of companies. The problem has exploded in the U.S."

Morrison blames the lack of FDA crackdown in the past for the growing problem. "At some point people made the calculation that the FDA didnt seem to be enforcing these laws," he says. "The margins are huge. They charge people tens of thousands of dollars."

Since stem cell therapy is still an active and legitimate area of scientific research, it can be hard for Americans to figure out what is safe and effective and what is not. Even when it comes to clinical trials, the scientific soundness is murky. A July 2017 paper reported that 18 U.S. companies have registered "patient-sponsored" stem cell studies on ClinicalTrials.gov. That means that the patients receiving the treatment paid for them, which isn't the case in more legitimate studies. None of these were gold standard studies: meaning the people were not randomly assigned to receive the treatment or not, so the participants knew they were receiving the therapy that could bias the results. Only seven of the studies disclosed upfront that patients had to pay to join the study, and none revealed that the costs ranged from $5,000 to $15,000 a treatment, Wired reports.

While Morrison says he's glad the FDA has taken action, he says it's not enoughat least not yet. "The FDA has to show that there is really a sustained commitment to enforcement," he says. "When the FDA wasnt bringing actions against these companies, I think people thought this meant that it was a gray area and that they could get away with it."

Undoing that damage could be a long process, and one that Morrison says needs consistent attention by the agency. In a letter released on Monday, FDA commissioner Gottlieb said the agency is stepping up enforcement of stem cell therapies and regenerative medicine. "Ive directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health," said Gottlieb. Whether those efforts have an impact remains to be seen.

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Trendsetter: Why Doug Baldwin went to England for stem-cell therapy – The News Tribune (blog)

Posted: August 29, 2017 at 4:49 pm

RENTON Turns out, Doug Baldwin started this current Seahawks fad of traveling outside the teams normal medical coverage to get far-flung treatment using body cells.

The Seahawks No. 1 wide receiver told me Monday he went overseas before this season -- to England, to be exact -- for pre-emptive, preventative treatment to maintain healthy knees.

I had mine in the offseason. I did stem-cell, Baldwin said, drenched in sweat in the hallway outside the teams locker room just after completing Mondays practice.

I mean, I dont have any ailments. Im trying to find every edge I can get.

Baldwin, Seattles $46 million receiver, tied Bobby Engrams 2007 franchise record with 94 receptions last season. He earned his first Pro Bowl selection. In 2015, the season that led to his contract extension, he co-led the NFL with 14 touchdown catches.

He said hed been looking into stem-cell therapy for years.

Transplanting or using bone marrow is the most widely used stem-cell therapy to treat or prevent a condition or disease. The U.S. Food and Drug Administration further explains stem cells may also help repair the body by dividing to replenish cells that are damaged by disease, injury, or normal wear.

So why London for Baldwin?

The FDA, as stated on its website, has not approved any stem cell-based products for use in this country other than using human umbilical cord blood forming stem cells for certain diseases.

There was a company wed be speaking to, Baldwin said of the London place he got treatment, without wanting to disclose many details. Did my research. Took my two years to finally decide.

In the last two weeks, seven Seahawks have gone away and outside the teams regular medical treatment to get a debated blood-re-injection process called regenokine to treat aching joints and/or aid in recovery from surgery. The treatment was founded in Germany, where its known as orthokine.

K.J. Wright returned last week from regenokine treatment, the re-injection of ones blood after it is heated and spun in a centrifuge to enhance its anti-inflammatory properties. The Pro Bowl outside linebacker played in Seattles exhibition last Friday against Kansas City.

D.J. Alexander the Pro Bowl special-teams player the Seahawks acquired this summer in a trade with Kansas City, went for regenokine treatment last week.

On Monday, coach Pete Carroll said wide receiver and kick returner Tyler Lockett, Pro Bowl defensive ends Michael Bennett and Cliff Avril, starting left guard Luke Joeckel and starting outside linebacker Michael Wilhoite are away from the team getting the same treatment Wright and Alexander had. Carroll said the team expects all those players to be ready for the opening game Sept. 10 at Green Bay.

That process reportedly costs $10,000. That doesnt count the travel and hotel costs of flying to get the therapy, of course. The FDA has yet to approve regenokine for use in the U.S., largely because its still unproven and reportedly because the agency has issues with the heating of the blood.

That is probably why Carroll said this on Thursday: Ive never had the OK that I can talk about it; I dont even know if I can talk about it. I was always afraid I wouldnt pronounce it right. But what I know its called is regenokine.

Dr. Peter Wehling in Germany, the man who founded the procedure known there as orthokine, was said in 2013 to have treated 30 to 40 NFL players with it. At that time the treatment process took four days, which could explain why Wright and his Seahawks successor have been missing a week of practices and games this month for it.

LifeSpan Medicine, clinic in Santa Monica, California, with offices also in New York and Dallas, lists regenokine as one the regenerative therapies it practices -- again, without FDA approval for use in this country.

Carroll said this on Monday:

Baldwin turns 29 next month. The opening at the Packers will begin the second season of the four-year, $46 million extension he signed in the summer of 2016. He looked ready for the 2017 season in Seattles most recent preseason game, Friday against Kansas City. He had two catches for 45 yards in 2 1/2 quarters, racing across the field and away from Chiefs defenders.

Hes only missed two games in his six-year career. Those absences were in his second season, 2012, after Seattle signed him as one of the leagues most successful undrafted free agents of the last decade.

Now, hes one of the trend-setters among eight Seahawks whove received alternative therapy.

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Gilead Makes Long-Awaited Splash With $12B Bet on Kite, Cell Therapy – Xconomy

Posted: August 29, 2017 at 4:49 pm

Xconomy San Francisco

Investors have been waiting for years for Gilead Sciences to make another big splash. This morning, it finally did, agreeing to buy Kite Pharma for close to $12 billion in a significant bet on the success of an emerging, cutting edge type of cancer immunotherapy known as CAR-T.

Gilead (NASDAQ: GILD), of Foster City, CA, is paying $180 per share in cash for Santa Monica, CA-based Kite (NASDAQ: KITE), a 29 percent premium to the companys $139.10 per share closing price on Friday and a deal that values the company at $11.9 billion. Kite shares promptly climbed 16 percent, to $162 apiece, early Monday. The agreement was first reported by the Wall Street Journal. It is expected to close during the fourth quarter. Kites lead product, to treat desperate cases of non-Hodgkin lymphoma, is expected to get FDA approval by the end of 2017.

For Gilead, the acquisition shows a renewed effort by the big drugmaker to make a dent in the oncology field. Gilead is known for its HIV drugs and more recently hepatitis C treatments, thanks to an $11 billion buyout of Pharmasset in 2011 that gave it the mega-blockbuster drugs sofosbuvir (Sovaldi) and sofosbuvir-ledipasvir (Harvoni). But over the years, Gilead has also steadily made a series of business development moves in oncology, among them an acquisition of Calistoga Pharmaceutials that gave the company its first, and to this point, only marketed cancer drug, idelalisib (Zydelig). In 2016, the drug generated $168 million in sales.

Gilead has been hoping for much more than that in cancer, and the pressure for the company to do something significant to generate excitement about its future has been building over the past few years as competing hepatitis C treatments have arrived and eroded its market share. Shares of Gilead are down almost 40 percent from their all-time highs in the summer of 2015 as calls for Gilead to use its pile of cashit had $36.6 billion on hand at the end of Juneon a transformative deal have intensified.

Will the Kite buyout be the jumpstart Gilead has been searching for? The deal is a gamble on a field of high promise, but substantial risk: a type of cancer immunotherapy treatment known as CAR-T, in which a patients immune cells are removed, modified, and re-infused into the body to find and kill cancer. The approach has shown promise in certain forms of blood cancer, in some cases wiping out leukemias or lymphomas in patients at deaths door, and is close to its first FDA approval. Novartis (NYSE: NVS) could bring the first CAR-T product, CTL019, to market later this year, and Kites axicabtagene ciloleucel (or axi-cel for short) could follow close behind. Kite has also filed for approval of axi-cel in Europe; a decision is expected next year.

The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers, said Gilead president and CEO, John Milligan, in a statement.

Milligan added that the cell therapy field has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients. And Gilead appears to be going all in, saying in its statement that it wants to build an industry-leading cell therapy franchise. But there are lingering questions about CAR-Ts overall potential. It comes with safety risks, namely figuring out how to harness the altered cells without causing the body significant harm in the process. A common reaction to treatment, for instance, is an immune system reaction called cytokine release syndrome that has proven deadly in some cases. Kite and Seattle competitor Juno Therapeutics (NASDAQ: JUNO) have also seen certain instances of brain swellingJuno had to abandon its most advanced treatment after the side effect led to multiple deaths in clinical testing.

In addition, CAR-T treatments havent yet worked in solid tumors, which include more prevalent cancers of the breast and lung. They also involve a complex manufacturing process and are likely to be very expensive; their commercial prospects are uncertain.

We are encouraged that Gilead has finally executed an acquisition and we think that the Kite deal is a major strategic positive, wrote Barclays analyst Geoff Meacham, in a research note. [T]he question will be if Kite will be big enough to move the needle and re-accelerate earnings growth to Sovaldi/Harvoni-launch levels.

Heres more on CAR-Ts promise and the questions that lie ahead for its developers.

Gilead will hold a conference call this morning to discuss the deal.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com

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Gilead Makes Long-Awaited Splash With $12B Bet on Kite, Cell Therapy - Xconomy

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CSL snags a preclinical stem cell therapy in $416M Calimmune … – Endpoints News

Posted: August 29, 2017 at 4:49 pm

Louis Breton, Calimmune

CSL Behring has bagged the stem cell gene therapy player Calimmune for $91 million and another $325 million in milestones for the years-long clinical journey ahead.

CSL is acquiring two therapeutic tech platforms in the deal, which involve developing and delivering stem cell therapies. CSLs main pipeline interest is in Calimmunes preclinical sickle cell disease and -thalassemia, which the buyer sees as a big plus for its work in hematology.

CSL, though, plans to let go of control of Calimmunes lead, clinical program on HIV as soon as possible. In a follow-up to a query, a company spokesperson replied:

We are currently evaluating our options for developing this pipeline candidate, which could include licensing or partnering. Given our areas of focus, it is unlikely that we will develop this candidate on our own.

Paul Perreault

CSLs plans to development the preclinical program acknowledges that this will be a lengthy process. In their statement CSL notes that it expects to take eight years to push through the clinical program.

Calimmune has research work underway in Australia and California, where the company has gained support for the California Institute for Regenerative Medicine.

Calimmune shares in our promise and focus to improve the lives of patients with rare and serious medical conditions, said CSL CEO Paul Perreault. The acquisition represents another important step in the execution of our strategy for sustainable growth.

Calimmune CEO Louis Breton added:We are excited to become part of CSL Behring. They are an established global industry leader in protein-replacement therapies and have a proven track record of driving innovations through the development pipeline and delivering differentiated products to the global marketplace. Together, we are well positioned to take our achievements to the next level.

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Global Cartilage Repair Market 2017-2021 – Gene Therapy and Stem Cell Therapy is the latest Market Trend Making … – Business Wire (press release)

Posted: August 29, 2017 at 4:49 pm

DUBLIN--(BUSINESS WIRE)--The "Global Cartilage Repair Market 2017-2021" report has been added to Research and Markets' offering.

The global cartilage repair market to grow at a CAGR of 11.59 % during the period 2017-2021.

The treatment of articular cartilage has evolved tremendously in the past decade. Reparative and restorative methods have been developed to address the significant source of morbidity in the young and active patients. Articular cartilage injury can be focal, which is localized or systemic. Procedures are being developed not only to alleviate the symptoms associated with articular cartilage defects but also to limit the progression of cartilage damages into degenerative diseases.

According to the report, one of the major drivers for this market is Rising incidence of accidental injuries. Globally, the road traffic injuries are increasing, with post complicated symptoms such as weakening of tendons, cartilage tear, and orthopedic issues.

The latest trend gaining momentum in the market is Gene therapy and stem cell therapy. Gene therapy is one of the promising fields in the cartilage repair. Many clinical studies have been performed for cartilage repair. The researchers are trying to develop gene therapy for cartilage repair and currently been investigated for clinical application.

Further, the report states that one of the major factors hindering the growth of this market is Product side effects. Surgeons use cartilage repair products such as tissue scaffold to improve the recovery. These products once grafted in the body may cause serious complications, resulting in their increased scrutiny for safety and efficacy. In many autologous chondrocyte implantation, there were common complications such as graft rejection, symptomatic hypertrophy, disturbed fusion and delamination.

Key vendors

Other prominent vendors

Key Topics Covered:

For more information about this report visit https://www.researchandmarkets.com/research/rjx284/global_cartilage

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Global Cartilage Repair Market 2017-2021 - Gene Therapy and Stem Cell Therapy is the latest Market Trend Making ... - Business Wire (press release)

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6 arrested over unauthorized stem cell therapy using cord blood – Kyodo News Plus

Posted: August 29, 2017 at 4:49 pm

Police on Sunday arrested a doctor and five others suspected of involvement in unauthorized stem cell therapies using blood from umbilical cords and placenta after childbirth.

The doctor who heads a clinic in Tokyo and people involved in cord blood sales are suspected to have administered cord blood to seven patients to treat cancer and as a beauty treatment. Each treatment is said to have cost 3 million to 4 million yen ($27,400-$36,600).

While hopes are high over the use of cord blood in the field of regenerative medicine to treat a number of diseases as it contains stem cells, the health ministry is concerned over the spread of costly medical services provided without clear scientific evidence and without ensuring sufficient safety.

The arrests were the first of anyone suspected of violating a law on regenerative medicine that came into force in 2014. The transplantation of cells could involve the risk of graft rejection and infection.

Medical institutions using stem cells are required to submit treatment plans beforehand for review by the health ministry, except for treating designated diseases such as leukemia.

The six suspects allegedly conducted the treatments without notifying the authorities.

Those arrested include Shinsuke Shuto, a 40-year-old doctor in Tokyo, and Tsuneo Shinozaki, 52, who runs a Tsukuba, Ibaraki Prefecture company selling cord blood, and Shusuke Tsubo, 60, who runs a clinic in the city of Kyoto.

Shuto is among those who allegedly administered cord blood to four patients at his clinic between July last year and this April without reporting the treatment to the government. Shinozaki and Tsubo are suspected of involvement in the unauthorized treatment of three people from around February last year to April.

The police have not made clear how the six suspects have responded to the allegations.

The seven patients included one minor and others ranging in age from the 40s to 70s. Six lived in different prefectures in Japan and one was a Chinese, the police said.

According to the police investigation, Shinozaki's company was selling cord blood it took over from a private cord blood bank in Tsukuba, which went under in 2009. It had enough cord blood to treat more than 1,000 people.

Between May and June this year, the health ministry ordered a total of 12 clinics in Tokyo and other cities, including Shuto's clinic, to suspend treatment after they were found to have administered cord blood for cosmetic therapy or cancer treatments without notification. The effectiveness and safety of such therapy has not been proven.

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Asymmetrex Introduces New Contract Service For Producing … – PR Web (press release)

Posted: August 29, 2017 at 4:48 pm

Two years in the making, Asymmetrex's stem cell counting technology now improves manufacturing of therapeutic stem cells.

Boston, MA (PRWEB) August 29, 2017

Today, Asymmetrex, the Massachusetts based stem cell biotechnology innovator, begins offering a new contract service to support the cell therapy industrys production of therapeutic adult tissue stem cells. Stem cells are a small sub-population of specialized cells that function to renew and repair the organs and tissues of children and adults. Stem cells from a healthy donor can be transplanted to restore or repair diseased or damaged organs and tissues in patients who are sick or injured.

Stem cell transplant treatments do not require expansion of donor stem cells when a donor with a compatible immune system is available for a patient. However, in general, there are many more patients in need of a transplant than there are immune compatible donors. So, the future ability of stem cell medicine to address the full degree of medical need depends on developing the ability to expand initial donor stem cell populations into larger numbers without loss of their curative properties. Expanded numbers of quality adult tissue stem cells are also needed to support statistically sound clinical trials for continued development of stem cell transplant therapies.

Asymmetrexs new advance for cell therapy suppliers is the result of the companys unique proprietary expertise in adult tissue stem cell culture. Its recently patented AlphaSTEM Test technology, which is a means to count adult tissues stem cells specifically for the first time, is based on the earlier discovery that during expansion in culture, ironically, adult tissue stem cells are lost as a result of their intrinsic tissue renewal property. Under typical culture conditions, stem cells continuously produce non-stem cells that subsequently undergo significant, though limited, multiplication. However, as in the body, stem cells do this while not multiplying their own number. The result of these continued natural processes in culture is progressive dilution and loss of the stem cells with each subsequent expansion culture.

Recently, Asymmetrex demonstrated that not only can its AlphaSTEM Test technology be used to count and certify the quality of adult tissue stem cells, but it can also be used to establish unique culture conditions projected to reduce stem cell dilution significantly during expansion. Asymmetrexs Director, James L. Sherley, M.D., Ph.D., shares, Two years ago when we achieved specific counting, I expected that we would be able to find conditions for increasing stem cell number, too; but even I didnt anticipate the projected huge savings in production costs! The companys projections indicate that it can achieve production of twice as many stem cells as several companies have reported, but require only 5% or less of their production cost. The required culture time is also reduced significantly.

The new service has been developed first for human mesenchymal stem cells, which are found in a variety of tissues including bone marrow, adipose (fat), umbilical cord, and amniotic fluid. These cells are an ideal first focus, as there are many companies worldwide working on their production to supply hundreds of stem cell transplantation clinical trials each year. Asymmetrex plans to also investigate application of the method to other types of adult tissue stem cells, which have been largely dismissed for expansion because their donor populations are not as proliferative as mesenchymal stem cells. Sherley says that blood stem cells are a very important member of this latter group on the Asymmetrex horizon.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrexs founder and director, James L. Sherley, M.D., Ph.D., is an internationally recognized expert on the unique properties of adult tissue stem cells. The companys patent portfolio contains biotechnologies that solve the two main technical problems quantification and production that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells for disease research purposes. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the AlphaSTEM Test) for use in stem cell transplantation therapies and in pre-clinical assays for drug safety. The same technology underpins Asymmetrex's contract service for optimizing manufacturing processes for therapeutic adult tissue stem cells.

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Genetic Counseling Program Overview – School of Medicine

Posted: August 29, 2017 at 4:48 pm

IMPORTANT: APPLICATION DEADLINE IS NOWDECEMBER 15THGENETIC COUNSELING TRAINING PROGRAMIntroduction and Program Goals

The Genetic Counseling Training Program, leading to a Master of Science degree in Genetic Counseling, is a two-year academic program comprised of didactic course work, laboratory exposure, research experience and extensive clinical training. The program, directed by Anne L. Matthews, R.N, Ph.D., is an integral component of the teaching and research programs in the Department of Genetics and Genome Sciences (G&GS) at CWRU under the leadership of Dr. Anthony Wynshaw-Boris, MD. Ph.D., chairman of G&GS. Program leadership also includes Rebecca Darrah, MA, MS, PhD, Associate Director and the program's medical director, Shawn McCandless M.D., Associate Professor of G&GS and Pediatrics and Director of the Center for Human Genetics, University Hospitals Cleveland Medical Center. The Program is accredited by the Accreditation Council for Genetic Counseling (ACGC) and graduates of the program are eligible to apply for Active Candidate Status and sit for the American Board of Genetic Counseling certification examination.

The overall objective of the Genetic Counseling Program is to prepare students with the appropriate knowledge and experiences to function as genetic counselors in a wide range of settings and roles. With unprecedented advances in our understanding of the genetic and molecular control of gene expression and development, and in our ability to apply this knowledge clinically, the Program strives to train students who can interface between patients, clinicians and molecular and human geneticists. Students gain insightful and multifaceted skills that will enable them to be effective genetic counselors, aware of the many new technical advances and often-difficult ethical, legal and social issues that have surfaced in the light of the Human Genome Project. Graduates of the Program will be prepared to work in a variety of settings including both adult and pediatric genetics clinics, specialty clinics such as cancer genetics, cardiovascular genetics and metabolic clinics, and prenatal diagnosis clinics, as well as in areas of research or commercial genetics laboratories relevant to genetic counseling and human genetics.

A unique aspect of the Genetic Counseling Training Program that it is housed within Case Western Reserve's Department of Genetics and Genome Sciences that is internationally known for both its clinical expertise and cutting edge research in molecular genetics, model organisms and human genetics. Thus, the Department of G&GS at CWRU provides an interface between human and medical genetics with basic genetics and provides an exciting atmosphere in which to learn and develop professionally. The direct access to both clinical resources and advanced technologies in human and model organisms affords students with an unparalleled environment for achievement. The Graduate Program in Genetics in the Department of Genetics and Genome Sciences provides an interactive and collaborative environment for both pre (genetic counseling and PhD students) - and post-doctoral trainees to come together in a collegial atmosphere. By fostering interactions between pre- and post-doctoral trainees in genetic counseling, medical genetics, and basic research at an early stage of their careers, it is anticipated that graduates will be well-rounded professionals with an understanding of the importance of both clinical and basic research endeavors. Moreover, such resources as the Department of Biomedical Ethics, the Center for Genetic Research, Ethics and Law, the Mandel School of Applied Social Sciences, and the Law-Medicine Center provide for an enriched learning experience for students.

The curriculum consists of 40 semester hours: 22 semester hours of didactic course work and 7 semester hours of research. Additionally, there are four 8-week clinical rotations, one 3-week laboratory rotation and one 6-week summer clinical rotation required of all students, which provide an additional 11 credit hours. Courses include material covering basic genetics concepts, embryology, medical genetics, biochemical genetics, molecular genetics, cytogenetics, genomics, cancer genetics, population genetics, genetic counseling principles, human development, psychosocial issues, interviewing techniques, and ethical and professional issues in genetic counseling.

Clinical rotations include one intensive three-week laboratory rotation in diagnostic cytogenetics and clinical molecular genetics as well as the Maternal Serum Screening program. There are four 8-week clinical rotations during year 2 during which students obtain clinical experience in General Genetics (children and adults) including Specialty Clinics such as Marfan Clinic, Prader-Willi Clinic and Craniofacial Clinic; Prenatal Diagnosis Clinic, and Cancer Genetics Clinic. These rotations take place at The Center for Human Genetics at University Hospitals Cleveland Medical Center, the Genomic Medicine Institute at the Cleveland Clinic and MetroHealth Medical Center. Students also will have the opportunity to pursue an elective rotation with specialty clinics or intern with genetic counselors in such areas as commercial testing companies. Additionally, there is one off-site rotation - a 6-week clinical rotation which is held at Akron Children's Hospital in Akron Ohio during the summer. Moreover, students rotate through the Cleveland-based institutions for weekly observational experiences starting early in year 1 of the program.

Students are also required to attend and participate in a number of other activities such as weekly Clinical Patient Conferences, Genetics Grand Rounds, Departmental Seminars and Journal Club. Students also participate with the doctoral graduate students in the Department of Genetics and Genome Sciences' annual retreat and present their research projects during the poster sessions. In addition, counseling students present their research during the programs Research Showcase. Students also have an opportunity to give educational talks to local schools, participate in DNA Day at local high schools and other groups when available.

Tuition for the 2017-2018 academic year is $1,827.00 per semester hour. Currently, other fees include student health insurance ($986 per semester) and a student activity fee of $14.00 per semester.

The Department of Genetics is unable to provide financial aid or research/teaching assistantships to students; however, it does award some scholarship funding in the form of a monthly stipend to genetic counseling students. The amount of the stipend is determined yearly and will be shared with applicants at the time of their interviews. In addition, the costs of the on-line embryology course as well as the CWRU Technology fee of $852.00 per year are covered by the Department. Moreover, students receive funds to cover the costs associated with their research projects and second year students receive funds to travel to the National Society of Genetic Counselors' annual education conference held in the fall.

Financial aid is available to graduate students. The university has extensive information regarding financial aid and scholarship opportunities to assist students in funding their education. For additional information or assistance, please contact the Office of University Financial Aid at http://case.edu/stage/admissions/financialaid.html or (216) 368-4530.

Clarice Young at (216) 368-3431 or email: clarice.young@case.edu

OR

The Program Director:

Please Note: The Direct Application link will take you to the School for Graduate Studies webpage. Go to Prospective Students - Admissions Information - Graduate Program Applications. You will see a link on the right hand side of the page entitled Application Log In to begin your application.

The application includes:

Fulfillment of the requirements for admission to the School of Graduate Studies at Case Western Reserve University must be met as well as those required by the Genetic Counseling Training Program. An applicant having graduated with excellent academic credentials (minimum undergraduate grade point average of 3.0 on a 4.0 scale) from a fully accredited university or college. Complete credentials must be on file with the School of Graduate Studies.

The Genetic Counseling Training Program at Case Western Reserve University is participating in the Genetic Counseling Admissions Match through National Matching Services (NMS) beginning with admissions for Fall 2018. The GC Admissions Match has been established to enhance the process of placing applicants into positions in masters-level genetic counseling programs that are accredited by the Accreditation Council for Genetic Counseling (ACGC). The Match uses a process that takes into account both applicants' and programs' preferences. All applicants must first register for the Match with NMS before applying to participating genetic counseling graduate programs. At the conclusion of all program interviews, both applicants and programs will submit ranked lists of preferred placements to NMS according to deadlines posted on the NMS website. The binding results of the Match will be released to both applicants and programs simultaneously in late April.

Please visit the NMS website at (https://natmatch.com/gcadmissions) to register for the match, review detailed information about the matching process, and to view a demonstration of how the matching algorithm works.

Important: After you have registered with NMS, you will need to put your NMS ID number at the top of your CV/Resume and/or at the top of your personal statement.

The average GPA for matriculating students is 3.5 and GRE mean scores are approximately, 60-70th percentiles and above. However, we take a holistic view of the applicant's complete file in determining admission, which means we look at everything the applicant has submitted. A high GPA or GRE score will not automatically lead to admission; neither will low scores automatically lead to a denial.*While the CWRU application form asks for your GRE scores, please include the percentile score as well.

The Personal Statement is extremely important and applicants need to pay specific attention to how they present themselves in their Personal Statement. Aspects to remember include: Is the applicant's Personal Statement grammatically sound, and does it give us a clear picture as to who the applicant is? Applicants' should emphasize those experiences which have directly assisted them in becoming aware of and knowledgeable about the genetic counseling profession. Genetic counselors are highly motivated and hardworking individuals. Thus, the Admissions Committee looks for applicants who demonstrate initiative, self-direction, excellent communication skills and who have "gone the extra mile" to show their passion for becoming a genetic counselor.

Letters of recommendation should be written by individuals who can provide an accurate picture of your academic capabilities, your communication skills (both written and spoken) and your potential to successfully complete graduate education. At least two referees should be faculty from your past institutions. Other excellent referee sources include genetic counselors you have shadowed or supervisors of internships or advocacy experiences which you have had. Recommendation letters from friends or family members are discouraged. Please note, while CWRU provides an on-line recommendation form for referees to complete, your referee should also provide a personal letter to accompany the form.

While the number of applications received by the Program varies from year to year, in general we receive approximately 60 - 70+ applications each year. At this time, the Program is able to accept 8 students per year.

December 15th of each year is the application deadline. It is important that all required materials such as GRE scores (including their percentiles), transcripts from all institutions in which you have completed coursework and letters of reference be submitted by the application deadline if you wish to have your application reviewed by the Admissions Committee. If you will be taking a prerequisite course or courses in the upcoming semester that will not be reflected on your current transcripts, please let us know in your personal statement (or Resume) which course or courses you will be taking to meet the pre-requisites. Also, please submit a current CV or resume along with your personal statement. The Program only admits one class per year -- in fall semester. Because of the intensive nature of the Program, all students must be full time, we are unable to accommodate part-time students.

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Americans OK with GMs for health care, but still wary about food – Medical Xpress

Posted: August 29, 2017 at 4:48 pm

More than three-quarters of Americans would accept release of genetically modified mosquitoes to decrease risk of the Zika virus, but fewer than half accept genetic modification (GM) of animals, grain crops and produce, according to a Purdue University study.

Nicole Olynk Widmar, associate professor of agricultural economics, and Wally Tyner, the James and Lois Ackerman Professor of Agricultural Economics, led the study to understand attitudes toward genetic engineering in the wake of last year's heightened coverage of the Zika virus. The results suggest people are far more accepting of genetic modifications that benefit human health but are still somewhat wary of modifications to food.

"Whenever you have a newly perceived health risk, there are calls for technology to solve the problem. If you think about the Ebola virus, everybody said, 'Where's an Ebola vaccine?' They wanted technology to mitigate the risk," Widmar said. "Food is an everyday choice. In some ways, I can understand why people may be more cautious about what they're ingesting on an ongoing basis."

Data also show that acceptance of genetic modification may be related to sex, education, income and awareness of GM technology.

Zika, a virus spread primarily through mosquito bites, can cause severe birth defects including microcephaly and fetal brain defects. The virus was especially prevalent in Brazil during the 2016 Summer Olympics in Rio de Janeiro, and mosquito carriers have been reported in parts of Florida and Texas.

Mechanisms developed to control virus include the release of genetically modified mosquitoes that will breed with females to produce eggs that won't hatch or offspring that die before reaching sexual maturity. Widmar and Tyner wanted to assess public opinion of the technologies and understand what drives acceptance of some genetic modifications but not others.

Findings are based on 964 Americans surveyed with a goal of selecting respondents that matched 2014 census estimates for age, gender, income, education and region of residence. The margin of error was about 3 percent, and results were published in the journal PLoS One.

The survey revealed that 78 percent would support release of genetically modified mosquitoes in the United States. Acceptance of genetic modification is 44 percent for livestock production; 49 percent for grain production; 48 percent for fruit and vegetable production; 62 percent for human medicine; and 68 percent for human health.

Males were more likely to accept genetic modification across all categories. Younger respondents also accepted at higher rates in everything except for human health reasons, in which there was no significant difference amongst age groups.

Higher income groups were more likely to agree with genetic modification for grain, fruit and vegetables, and livestock production than lower income groups. Those with college degrees were more accepting of genetic modification.

Finally, the findings show that those aware of genetically modified mosquito technology were more likely to be accepting of genetic modification in all areas assessed.

Widmar said she expected respondents to be more accepting of genetic modification for health and medicine, and she suspects it may have to do with how those technologies have been released. In the case of mosquitoes, Zika was all over the news, as was coverage of companies seeking regulatory permission to release their modified insects for trials. Americans were likely less informed about the release of genetically modified crops and found out about them after they were already a significant part of the food chain.

"The perception of choice matters," Widmar said. "If you need it to stay healthy, you would probably use it. But if you feel like you were given GMOs and told about it later, that might upset you."

Tyner said there may be a lesson in the data for those who want to develop future GMO technologies. While GMO crops have often been lauded for reducing inputs and lowering costs for growers, people may be more receptive to information about how those same crops allow use of less toxic pesticides.

"If we can highlight health and environmental benefits, rather than just focusing on the bottom line that might have a positive effect on the public attitude toward GMOs," Tyner said. "If you look back, things might have gone differently if we had the first releases in the medical field rather than the food field."

Widmar and Tyner plan to continue work related to the impacts of GMOs on society. Widmar continues to assess consumer acceptance, and demand for, various technologies impacting the human condition through food production and health care.

Explore further: Survey: Public supports use of GMO mosquitoes to fight Zika virus

More information: Nicole J. Olynk Widmar et al. When is genetic modification socially acceptable? When used to advance human health through avenues other than food, PLOS ONE (2017). DOI: 10.1371/journal.pone.0178227

Journal reference: PLoS ONE

Provided by: Purdue University

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This Last-Resort Test Saved 2 Women From CancerAnd It Could Save You, Too – Prevention.com

Posted: August 29, 2017 at 4:48 pm

But despite rounds of surgery and radiation and chemotherapy, the cancer kept coming back. Eventually, her prognosis shifted from very hopeful to very dim, Christine says. (Here are 8 things every woman needs to know about ovarian cancer.)

I had two young children and I was being told, basically, to get my affairs in order, she says. I was not given much hope. In fact, Christine was told she had around a month of "good-quality life" left to live.

It was around this time, early 2014, that her doctor at Cancer Treatment Centers of America proposed genomic testing. I had never heard of this form of testing before, she says. It was completely new to me. Considering the bleakness of her prognosis, she was excited to hear she had a hopeful new option.

Considering where I was, to be able to live a normal life and look forward to watching my kids grow up is amazing.

Her doctors sent her tumor cells to the labs of Foundation Medicine. Their tests identified mutations within the DNA of Christines tumor cells that indicated she might respond well to a targeted drug therapy called everolimus (trade name Antifor), which is normally used to treat renal (or kidney) cancer. She started on everolimus in 2014.

(Reverse chronic inflammation and start healing your body from the inside out with The Whole Body Cure.)

It was a drug interventionI take a pill every day with a glass of water, she says. After three years on the drug, her cancer has retreated: Ive had completely clear scans and my cancer is in remission."

I never would have thought this was possible, she adds of the seemingly miraculous outcome. Considering where I was, to be able to live a normal life and look forward to watching my kids grow up is amazing.

What Is Genomic Testing?Every cell in your body contains 20,000 to 30,000 genes. By examining those genes for abnormalities or mutations, genetic testing can determine if the makeup of your DNA puts you at greater risk for certain types of cancer. (This is what it's like to be tested for the breast cancer gene.)

The test offered by Foundation Medicine and other genomic testing companies is slightly different in that it also examines the genetic makeup of tumor cells.

By sequencing the genes within a persons tumor cells, the test can in some cases identify mutations that may respond to new and more-targeted treatment options, says Kojo Elenitoba-Johnson, MD, a professor of pathology and laboratory medicine and director of the Center for Personalized Diagnostics at the University of Pennsylvania Perelman School of Medicine.

MORE: 7 Warning Signs Of A Brain Tumor You Should Know

Genomic testing can also eliminate treatment optionsan outcome Elenitoba-Johnson says is also useful. This can prevent wasteful and counterproductive treatment courses, and it saves critical time that may be wasted in applying the wrong therapy, he explains.

Watch this moving video of strangers talking about their metastatic breast cancer:

It's important to note that, while drug companies are developing new treatments all the time, drugs do not exist for every genetic mutation, he adds. There are many more mutations than there are therapies at this point. Whether or not insurance will pay for the test or treatments also depends on the specifics of your situation and coverage.

PREVENTION PREMIUM: The One Thing That Got Me Through Cancer And A Divorce

Another Success StoryLike Christine Schmidt, Colleen Farrell was youngjust 33when she was first diagnosed with cancer.

In the summer of 2014, Id started feeling run down, she recalls. I started napping every day, which was totally unlike me, and I had discomfort in my lower back.

Doctors initially pegged her discomfort as a pulled muscle. But by that fall, they had identified a tumor. Colleen had advanced colorectal cancer. (Every woman should know these 5 signs of colorectal cancer.)

I was Stage 4, so it was bad, she recalls. It wasnt quite, Go home and plan your funeral, but it was, Be aware that you might have to soon.

MORE:7 Things That Surprised Me About Going Through Chemotherapy

Despite radiation and chemo, the cancer soon spread to her liver and both her lungs. I was blown awayjust devastated, she says. Things were very grim.

The images came back showing that not only had the tumors not grown, but theyd started to recede.

Her doctors told her about genomic testing, and that it could open doors to new treatment options. They told me some people were having success, but there were a lot of unknowns, she recalls. I asked what my odds were without it, and they told me a couple of months, so I obviously wanted to try it.

The results her doctors got back from Foundation Medicine indicated her cancer might respond to immunotherapy (here's how it works). I started it in March of 2016, she says. Eight weeks later, I had my first scan, and the images came back showing that not only had the tumors not grown, but theyd started to recede.

She says her doctor was floored. Back when her rectal tumor had first been discovered, it had measured 12 centimeters. After just one course of the new treatment, it had shrunk to 7 cm. My doctor couldnt believe how well it was working, she says.

MORE: 11 Women Share The Surprising Ways They Discovered They Had Cancer

In fact, the new medication almost worked too well. I ended up having three massive hemorrhages and almost died because my tumor shrank so quickly that all the blood vessels and organs that were smushed up suddenly started pumping blood again, she says. So that tells you how quickly it worked.

Colleen says shes not completely out of the woods. But I never thought Id be where I am today, she adds. I think all the time how lucky I was to have benefited from thisthat I could try itbecause not everybody can.

Whos A Candidate For Genomic Testing?As recently as a few years ago, the type of gene sequencing performed during this test would have cost millions of dollars and taken years, not days, to complete, Elenitoba-Johnson says.

Because the genomic testing platform is so newand many of the associated treatment options are still in clinical trialsgenomic testing may only be appropriate when conventional approaches like chemotherapy have failed, he says. (Here are 5 misconceptions you probably still have about chemo.) It really depends on the type of cancer a person has.

For some forms of leukemia, the knowledge of the disease response is pretty mature, and so the first-line management is receiving this test and one of these new targeted therapies, he explains. In other cases, drugs [targeting the mutations] have only recently become available, and knowledge of their effectiveness and side effects is not as well-understood.

He mentions lung cancer, colorectal cancer, and melanoma as other forms of cancer for which genomic testing may be appropriate. But again, it depends on the individual patient and the specifics of their cancer.

MORE: 7 Skin Cancer Symptoms You Can't See

Needless to say, the science of cancer diagnostics and treatment has entered a new and exciting phase. Genomic testing, coupled with newer, more-targeted therapies, is already saving lives.

The future is here, and it is bright. But theres a lot more work to be done.

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This Last-Resort Test Saved 2 Women From CancerAnd It Could Save You, Too - Prevention.com

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