Myriad Genetics Inc. (MYGN), a provider of gene tests for breast cancer, fell to its lowest value in almost two years after the U.S. proposed cutting reimbursements for the diagnostic service by almost half.

Myriad dropped 16 percent to $20.26 at 10:21 a.m. New York time after declining to $20.02, its lowest intraday price since Jan. 5, 2012. The shares had lost 11 percent in the 12 months through Dec. 27.

The Centers for Medicare and Medicaid Services will hold a public comment period through Jan. 27 on the proposed lower rates, Myriad said in a filing today. The Salt Lake City-based company will have trouble getting high reimbursements for the tests from the U.S. and other payers, said Peter Lawson, an analyst with Mizuho Securities Co.

Negative pricing overhangs have increased beyond our comfort level, Lawson said in a note to clients today. He reduced his rating on the stock to hold from buy.

Medicare, the U.S. health-insurance program for the elderly and disabled, will pay $1,438 next year for sequencing of the BRCA1 and BRCA2 genes, which are associated with breast cancer, the company said in a filing today. That figure is down from a government determination in September to pay $2,795 for the test. Medicare makes up about 10 percent of Myriads BRCA testing sales, Lawson said.

Myriad held a U.S. monopoly over the BRCA tests until June, when the U.S. Supreme Court invalidated parts of its gene patents. Afterward, Quest Diagnostics Inc. (DGX), Ambry Genetics Corp. and another closely held company said they were entering the BRCA market.

Mutations in the BRCA1 and BRCA2 genes, the most common cause of hereditary breast and ovarian cancer, are present in about one in 400 women and indicate an elevated risk.

To contact the reporter on this story: Drew Armstrong in New York at darmstrong17@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Myriad Genetics Drops After U.S. Cuts Rate for Gene Test

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Plantar fasciitis, a chronic pain condition involving the sole of the foot, is now being treated using regenerative medicine like stem cell therapy, and offering the first form of real relief for many sufferers.

Plantar fasciitis affects millions of Americans, and is a condition in which the plantar fascia the thick tissue covering the sole of the foot is inflamed, causing severe pain on the bottom of the foot, and impeding activities such as running and walking.

The plantar fascia tissue is what connects the heel bone to the toes, thus creating the arch of the foot.

Traditional treatments for the debilitating injury have offered some relief in recent years through the use of physical therapy, NSAIDS, and steroid injections. However, these types of pain relief develop slowly over time, and are not an effective way to truly treat the problem. Stem cell therapy is going beyond these typical treatments, treating the root cause of the issue, and are often able to alleviate pain more quickly and with longer-lasting results.

Clinics in Arizona and California are just two examples of offices now offering stem cell injections of adult bone marrow and both fat- and amniotic-derived materials. Board certified pain management doctors at the Arizona Pain Stem Cell Institute, in Phoenix, and TeleHealth, in southern California, are giving patients suffering from the condition a low risk, outpatient alternative to corrective surgery.

Many other U.S. states now have pain treatment centers offering the plantar fasciitis stem cell therapy, as well.

Main image courtesy Nevit Dilmen via Wikimedia Commons.

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Plantar Fasciitis Now Being Treated With Stem Cells

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Rasu Shrestha, MD on Personalized Medicine
Applied Radiology speaks with Dr. Rasu Shrestha on his thoughts how informatics is and will continue to play a major role in reaching the goal of personalize...

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The Skin Gun
Currently when treating a burn victim, it can take weeks to generate an autologous skin graft when one is necessary to treat the affected areas. However, a t...

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Dec. 23, 2013 New findings suggest the oxytocin receptor, a gene known to influence mother-infant bonding and pair bonding in monogamous species, also plays a special role in the ability to remember faces. This research has important implications for disorders in which social information processing is disrupted, including autism spectrum disorder. In addition, the finding may lead to new strategies for improving social cognition in several psychiatric disorders.

A team of researchers from Yerkes National Primate Research Center at Emory University in Atlanta, the University College London in the United Kingdom and University of Tampere in Finland made the discovery, which will be published in an online Early Edition of Proceedings of the National Academy of Sciences.

According to author Larry Young, PhD, of Yerkes, the Department of Psychiatry in Emory's School of Medicine and Emory's Center for Translational Social Neuroscience (CTSN), this is the first study to demonstrate that variation in the oxytocin receptor gene influences face recognition skills. He and co-author David Skuse point out the implication that oxytocin plays an important role in promoting our ability to recognize one another, yet about one-third of the population possesses only the genetic variant that negatively impacts that ability. They say this finding may help explain why a few people remember almost everyone they have met while others have difficulty recognizing members of their own family.

Skuse is with the Institute of Child Health, University College London, and the Great Ormond Street Hospital for Children, NHS Foundation Trust, London.

Young, Skuse and their research team studied 198 families with a single autistic child because these families were known to show a wide range of variability in facial recognition skills; two-thirds of the families were from the United Kingdom, and the remainder from Finland.

The Emory researchers previously found the oxytocin receptor is essential for olfactory-based social recognition in rodents, like mice and voles, and wondered whether the same gene could also be involved in human face recognition. They examined the influence of subtle differences in oxytocin receptor gene structure on face memory competence in the parents, non-autistic siblings and autistic child, and discovered a single change in the DNA of the oxytocin receptor had a big impact on face memory skills in the families. According to Young, this finding implies that oxytocin likely plays an important role more generally in social information processing, which is disrupted in disorders such as autism.

Additionally, this study is remarkable for its evolutionary aspect. Rodents use odors for social recognition while humans use visual facial cues. This suggests an ancient conservation in genetic and neural architectures involved in social information processing that transcends the sensory modalities used from mouse to man.

Skuse credits Young's previous research that found mice with a mutated oxytocin receptor failed to recognize mice they previously encountered. "This led us to pursue more information about facial recognition and the implications for disorders in which social information processing is disrupted." Young adds the team will continue working together to pursue strategies for improving social cognition in psychiatric disorders based on the current findings.

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Gene that influences the ability to remember faces identified

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Seinfeld - Season 05, Episode 01 - About plants genetics 🙂

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Let #39;s Play The Sims 3 - Perfect Genetics Challenge - Episode 34
My Sims 3 Page: http://mypage.thesims3.com/mypage/Llandros2012 My Blog: http://Llandros09.blogspot.com My Facebook: https://www.facebook.com/Llandros09?ref=t...

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DNA Genetics / Big Buddha / True Canna Genetics / Greenhouse Seeds Seminar PART 2 Cannabis Cup 2013
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Harnessing the Potential of Stem Cells For New Medicines: Doug Melton at TEDxBeaconStreet
Doug Melton talks about the potential of stem cell biology for regenerative medicine, with a focus on finding new treatments for diseases such as diabetes. D...

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EDMONTON-In the flurry of news reports that followed the revelation that Angelina Jolie underwent a double mastectomy, many left out a crucial detail: the gene mutation that led to the actress decision to undergo surgery is relatively rare.

Thats the finding of a University of Alberta researcher currently working on a book about how celebrities impact peoples health and other lifestyle decisions.

Sixty-eight per cent of articles did not discuss the rarity of the gene, which is very important since her situation is actually tremendously rare, said Timothy Caulfield, Canada Research Chair in Health Law and Policy.

The good news is they did a fairly good job when they talked about the science and talked about the risks associated with preventive mastectomy.

Jolie revealed her decision in a piece published in the May 14, 2013 edition of the New York Times. She wrote that her mother had died of breast cancer at the age of 56 and she had inherited a mutation in the BRCA 1 gene. Doctors had estimated she had an 87-per-cent risk of breast cancer. She underwent a preventive double mastectomy, which reduced her breast cancer risk to less than five per cent.

Jolie herself wrote that, Only a fraction of breast cancers result from an inherited gene mutation.

Alberta researchers say 95 per cent of women who have breast cancer never test positive for the gene mutation.

In their research, Caulfield and two others analyzed 103 news and opinion pieces published in major American, British and Canadian newspapers, including the New York Times, the Globe and Mail and the Guardian.

The study did not include the Edmonton Journal or Calgary Herald, which ran locally written articles about Jolies mastectomy that mentioned the rarity of her condition.

The researchers combed through the articles, looking for various themes such as the cost and drawbacks of preventive mastectomies or mentions of alternatives to surgery for breast cancer prevention. From there, more analysis was done to identify the tone of the articles.

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Rarity of Angelina Jolie’s gene mutation condition under-reported, says researcher

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Lets Play The Sims 3 Perfect Genetics Ch Baby #1 arrives

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stem cell therapy in chandigarh
Performing a hair transplant is as much about craftsmanship and design as it is about microsurgery. Each case is different and a successful result depends on...

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Thirteen-year-old Julia Jenkins saved all three of her brothers by donating bone marrow twicewithout which her siblings could not have survived a rare blood disorder.

In 2008, Julias two-year-old brother was diagnosed with Burkitts lymphoma, a rare cancer.

"I had asked the Lord, Please don't let it be cancer.' But then when it turned to be cancerous, I had to change my perspective and say, Thank you that's it's curable. If you get it in time, it's curable, you can fight it,'" said their mother, Christy Jenkins.

Then, Julias six-year-old brother John began suffering from severe stomach problems. Exactly two years later after Will's diagnosis, while he was undergoing chemotherapy, John was diagnosed with the same cancer.

While Berkitts lymphoma is not usually genetic, a specialist had the boys tested for XLP, a genetic immune disorder that caused similar symptoms. Both bothers tested positive for it as did their two-year-old brother Matthew.

"Here I was approached with the plate of, 'All three boys need a bone marrow transplant to possibly survive,'" said Christy Jenkins.

Julia, who did not have the disease, was tested for a bone marrow match.

"I remember getting my blood tested, like sticking a needle in my arm," Julia said.

Despite the odds, Julia's bone marrow matched perfectly with all three of her brothers. At eight years old, though, Julia didnt know what a transplant would entail.

"But, I said yes, because they're my brothers," said Julia.

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Girl Saves Three Brothers With Bone Marrow Transplants

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Lockport Union-Sun & Journal Dr. Andrew Cappuccino was finishing a round of golf on Labor Day weekend this year when he got a call from his friend and personal doctor.

The call was to tell to come in for a bone marrow biopsy.

I thought it was a joke at first, Cappuccino said. Within 48 hours I was admitted into the hospital to begin chemotherapy.

Cappuccino was diagnosed with acute myeloid leukemia. The orthopedic spine surgeon, known for treating Buffalo Bills tight end Kevin Everett for his cervical spine injury, was thrown for a loop.

Id never been sick a day in my life, Cappuccino said.

Cappuccino and his wife, Helen, had just dropped their youngest of six children off at NYU to begin college. With all of the kids out of the house, Helen told him it was time to get himself a long overdue physical.

Tests showed that two genetic mutations in Cappuccinos red blood cells caused the cancer to proliferate, putting him in a lower percentile to be cured. Luckily, one of the Lockport surgeons brothers was a perfect match for bone marrow stem cells.

After 5 and a half months of treatments at Roswell Park, theres an 80 percent chance that Cappuccinos leukemia has been cured.

Cappuccinos wife Helen, a surgical oncologist at Roswell Park, was able to be with him both emotionally and physically throughout his ordeal. Since family members are permitted to stay with Roswell patients, Helens commute to work became much shorter during her husbands hospital stay.

I only had to take the elevator downstairs, Helen said.

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Healing a healer

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A release from the University of California-Los Angleles written by Shaun Mason reports that researchers at UCLA's Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research have discovered a mechanism by which certain adult stem cells suppress their ability to initiate skin cancer during their dormant phase an understanding that could be exploited for better cancer-prevention strategies. The study, led by Andrew White and William Lowry, was published online Decemeber 15th 2013 in the journal Nature Cell Biology.

The release notes that hfollicle stem cells, the tissue-specific adult stem cells that generate the hair follicles, are also the cells of origin for cutaneous squamous cell carcinoma, a common skin cancer. These stem cells cycle between periods of activation during which they can grow and quiescence (when they remain dormant).

White and Lowry applied known cancer-causing genes to hair follicle stem cells of laboratory mice and found that during the cells dormant phase, they could not initiate skin cancer. Once the cells were in their active period, however, they began growing cancer.

The release quotes White as saying, "We found that this tumor suppression via adult stem cell quiescence was mediated by PTEN, a gene important in regulating the cell's response to signaling pathways. Therefore, stem cell quiescence is a novel form of tumor suppression in hair follicle stem cells, and PTEN must be present for the suppression to work."

The team believes that understanding cancer suppression through quiescence could better inform preventative strategies for certain patients, such as organ transplant recipients, who are particularly susceptible to squamous cell carcinoma, and for those taking the drug vemurafenib for melanoma, another type of skin cancer. The study also may reveal parallels between squamous cell carcinoma and other cancers in which stem cells have a quiescent phase.

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Dormant Adult Stem Cells Suppress Cancer

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In a book packed with fascinating anecdotes, its hard to pick out highlights from David EpsteinsThe Sports Gene.

However, pushed to do exactly that, this writer cannot overlook the story of Superbaby. Sometime around the year 2000, a baby was born in a Berlin hospital, but not any normal baby. Doctors noticed the childs bulging biceps, his chiseled calves and glutes that [y]ou could bounce nickel off.

By the tender age of four Superbaby had no trouble holding 6.6-pound [3kg] dumbbells suspended horizontally at arms length. The boy looked normal with his clothes on but underneath, his muscles were roughly double the size of similarly aged male children.

Epstein continues to explain how a lack of the protein myostatin part of the GDF-8 gene can result in this remarkable genetic abnormality, before delving into similar examples in mice and whippets. The chapter concludes by suggesting some of the lessons we can take from the science, a trait throughout the book.

Epstein is a Columbia University graduate who has become universally-regarded for his investigative reporting for Sports Illustrated in the US. He co-authored the revelation that Alex Rodriguez, the baseball star, had tested positive for steroids in 2003, the same year he was named the American Leagues Most Valuable Player award.

The byline ofThe Sports Gene reads, Inside the Science of Extraordinary Athletic Performance. Its very self-explanatory, with Epstein drawing together mountains of scientific research into sporting achievement to reveal the physical, genetic traits that certain athletes possess.

The joy of this book is its balance; Epstein continually acknowledges that practice can be vital in producing world-class performers, even if it is on occasion unnecessary. Many commentators see The Sports Gene as a response to the so-called 10,000-hour rule, which burst into the mainstream after Malcolm Gladwell provided an incomplete overview of it in his 2008 book Outliers: The Story of Success.

Gladwell is seen as one of the main drivers of a widely accepted, but highly debatable, notion that talent doesnt matter, 10,000 hours of deliberate practice will make anyone an expert in anything they desire to do. While there are certainly positives in people believing that, it doesnt tell the whole story.

Thats where Epsteins work comes in, providing us with thrillingly readable scientific fact about what physically makes the best sporting performers. However, he balances that utterly with the repeated statement that training is important too, although not necessarily 10,000 hours of it.

Epsteins own fascination with the subject matter is infectious, making The Sports Gene such a pleasure to read. The former 800 metres runner believes that the study of genetics can help us to improve selection of athletes for particular sports. A persons body shape may mean that they can never be sprinter, but those same physical elements might mean they have potential in swimming, for example.

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‘The Sports Gene’ should be top of your post-Christmas book list

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A genetic risk factor for type 2 diabetes commonly found in the DNA of Mexican and Latin American people was likely inherited from Neanderthals when they interbred with humans some 50,000 years ago, according to an exhaustive new analysis.

Scientists at the Broad Institute, a Cambridge genomic research center, worked with colleagues to compare more than 9 million spots in the genomes of 8,000 Latin Americans and found a version of a gene that increased a persons risk for the disease by about 20 percent. The research, published Wednesday in the journal Nature, was supported by Mexican billionaire Carlos Slim Hel, who visited the Broad Institute this fall to announce a $74 million gift for continued genetics research in Latin American populations.

At the time, Eric Lander, director of the Broad Institute, pointed to this resultwhich was not yet publishedas an example of the importance of studying the genomes of diverse populations, because genetic risk factors for diseases may not be the same.

It had been missed in all the studies of European patients, and yet it turns out to be one of the most powerful genes that is known to affect diabetes, Lander said then. The abstract idea that studying Mexican populations would lead to discoveries that are being missed turns out to be right.

Mexican and Latin American people have about twice the rate of diabetes as non-Hispanic white people in the U.S., leading researchers to wonder whether there were different genetic risk factors. By comparing the same 9.2 million spots in the DNA of Mexican and Latin American people with and without diabetes, they were able to identify a number of versions of genes more common in people with the disease. Many of those had already been identified in previous genetic studies of the disease, which have typically been done in European populations. But they were especially intrigued by one new gene strongly associated with the disease, with changes to five letters in a gene called SLC16A11.

That version of the gene was nearly absent from African populations and rarely seen in Europeans. It was found in about 10 percent of Asians, and in about half of Native Americans, raising the suggestion that it entered the human gene pool after humans left Africa.

We were intrigued, and it eventually dawned on us that archaic interactioncrossbreeding with Neanderthalsmight be the source of this, said Amy Williams, a post-doctoral researcher at the Broad and Harvard Medical School. Williams and colleagues got access to a new Neanderthal genome sequence and found it there, suggesting that the version of the gene entered the human population when the two species interbred.

That doesnt suggest that Latin Americans have any more or less Neanderthal DNA than the rest of us. Studies have found that people outside Africa have roughly the same small amount2 percent of Neanderthal. Williams said analyses suggest that the gene was not adaptive or subject to natural selection, but rose in frequency due to chancerandom genetic drift.

The task ahead for the team now is to better understand the role the gene may play in causing the disease. Initial studies revealed that it is active in fat metabolism in the liver, and researchers at the Broad hope to understand the biology to help inform the hunt for therapies.

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Diabetes risk factor common in Latin Americans likely inherited from Neanderthals

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By Traci Pedersen Associate News Editor Reviewed by John M. Grohol, Psy.D. on December 28, 2013

A genetic variant known to make some people hypersensitive to stress is also linked to a 38 percent increased risk of heart attack or death in patients with heart disease, according to researchers at Duke Medicine.

Weve heard a lot about personalized medicine in cancer, but in cardiovascular disease we are not nearly as far along in finding the genetic variants that identify people at higher risk, said senior author Redford B. Williams Jr., M.D., director of the Behavioral Medicine Research Center at Duke University School of Medicine.

Here we have a paradigm for the move toward personalized medicine in cardiovascular disease.

The researchers built on previous work at Duke and elsewhere that identified a variation in a DNA sequence, known as a single nucleotide polymorphism (SNP), where one letter in the genetic code is swapped for another to change the genes function. The team focused on a particular SNP that occurs on the gene that makes a serotonin receptor and causes a hyperactive reaction to stress.

In a previous study, researchers found that men with this genetic variant had twice as much cortisol in their blood when exposed to stress, compared to men without the variant.The stress hormonecortisol is produced in the adrenal gland to support the bodys biological response when reacting to a situation that causes negative emotions.

It is known that cortisol has effects on the bodys metabolism, on inflammation and various other biological functions, that could play a role in increasing the risk of cardiovascular disease, said lead author Beverly H. Brummett, Ph.D., associate professor of psychiatry and behavioral sciences at Duke.

It has been shown that high cortisol levels are predictive of increased heart disease risk. So we wanted to examine this more closely.

The exciting part to me this is that this genetic trait occurs in a significant proportion of people with heart disease, Brummett said. If we can replicate this and build on it, we may be able to find ways to reduce the cortisol reaction to stress either through behavior modification or drug therapies and reduce deaths from heart attack.

Researchers used a database to run a genetic analysis of more than 6,100 white participants, two-thirds of whom were men, and one-third women. About 13 percent of this group had the genetic variation for the overactive stress response.

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Stress Reaction Gene Tied to Heart Attacks

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silent hill - savage genetics remix

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MrReaplos Dienstag - Advanced Genetics Mod Review [1.6.4]
Das Spiel : Minecraft Webseite : http://www.minecraft.net Texturepack : ...

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Advanced Genetics Mod Review- Part 1
How amazing! It #39;s wonderful what the scientists in the lab can whip up with now adays, allow you to extract DNA from and animal, and inject it into yourself?...

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Cosmic Log

Alan Boyle, Science Editor NBC News

19 hours ago

Genetics isn't just for the living, as the past year's scientific revelations have demonstrated. Whether it's identifying King Richard III's long-lost bones or tracing humanity's tangled family tree, DNA analysis is shedding new light on mysteries that have lain buried for ages.

New technologies addressed longstanding questions in other contexts during 2013. Here are five of the year's leading themes, plus five bonus scientific highlights and links to five additional end-of-the-year roundups.

DNA unravels history's mysteries: In February, genetics clinched the case for King Richard III's remains, which British archaeologists recovered from beneath a parking lot in Leicester. Richard III was famous as one of Shakespeare's best-known villains, but the chroniclers lost track of his bones soon after his defeat and death on Bosworth Field in 1485. Analyses of his rediscovered remains proved the truth of what Shakespeare said with regard to a different English king: "Uneasy lies the head that wears the crown." Forensic analysis found that the poor royal suffered from scoliosis, roundworms and other ailments. And Richard's troubles aren't over yet: Interested parties in Leicester and York are still fighting over who has rightful custody of his bones. On other fronts, genetics is being applied to the mysteries surrounding the fates of French King Henry IVand England's Alfred the Great.

DNA points to complexity in human origins: This month, scientists announced that they deciphered 400,000-year-old DNA extracted from bones found in a Spanish cave. That technical achievement set a record, but it also turned up something unexpected: genetic linkages to a mysterious population of human ancestors in Siberia, known as Denisovans. Other studies have pointed to interbreeding among Neanderthals, Denisovans and ancient representatives of our own species, Homo sapiens. DNA signatures even hint at humanlike populations yet to be identified. Such findings support the view that our family tree isn't organized into clear-cut roots and branches, but instead consists of bushy, messy tangles.

Lost cities uncovered: Laser scanning, aerial imaging and other high-tech tools have revealed a previously uncharted ancient settlement in Cambodia that predated Angkor Wat, ruins in Peru that predated the Inca culture, andstructures in Honduras that might have inspired conquistadors' tales of a treasure-laden city. The methods available to archaeologists today would make Indiana Jones green with envy. "I go out and do archaeology with a ray gun," the University of Sheffield's Ellery Frahm told LiveScience. "It doesn't get more sci-fi than that."

Discoveries from Antarctica's depths: Antarctica may seem like a frozen wasteland, but it can be a wonderland for the right kinds of research. In January, Russian scientists brought up fresh samples of ice from Lake Vostok, a body of water that lies hidden beneath a 2-mile-deep layer of ice. In July, they reported that the ice contained samples from a wide assortment of life forms, even though the lake has seemingly been cut off from the rest of the world for millions of years. Meanwhile, detectors buried in Antarctica's ice were used to make a completely different kind of discovery: the first signs of high-energy neutrinos from beyond our solar system. Those detectors, part of the international IceCube experiment, could point the way to an entirely new kind of astronomy, based on neutrinos instead of old-fashioned photons.

Clarity about climate change: Atmospheric readings of carbon dioxide exceeded 400 parts per million this year, raising fresh warnings about the greenhouse-gas effect. Climate-change skeptics tried to make the case that global warming has stalled, based on temperature readings from recent years, but researchers came up with a different explanation: Right now, much of the planet's excess heat is being soaked up by the ocean rather than the atmosphere. Such findings were factored into the Intergovernmental Panel on Climate Change's latest report, which suggested establishing a cumulative cap on carbon emissions.

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Year in science: Old bones yield new revelations about kings and genes

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Sleeping After a Spinal Cord Injury
In this video I talk about my bed and how I sleep. I also discuss getting in and out of bed and rolling to avoid pressure sores.

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Dr. Aidan R. Raney performs a checkup on heart attack patient Mark Athens, 52, on Tuesday, Dec. 17, at Scripps Green Hospital in La Jolla. Athens received a stem cell treatment to help his heart recover as part of a clinical trial to determine the treatments safety and effectiveness.

A new stem cell treatment may help heart attack patients do something once thought medically impossible regenerate dead heart muscle.

Scripps Health in La Jolla is one of three centers testing the therapy from Capricor, a Los Angeles biotech company. The cardiac stem cells are meant to boost the hearts natural ability to perform minor repairs. If it works, scars should shrink and functional heart muscle should grow.

Capricor gets the cells from donor hearts, grows them into the amount needed for treatment, then sends them to doctors taking part in what is called the Allstar trial. Doctors inject the cells into the coronary artery, where they are expected to migrate to the heart and encourage muscle regrowth.

The trial has successfully completed Phase 1, which mainly evaluates safety. On Dec. 17, Capricor said it had received permission to begin Phase 2, which will examine efficacy in about 300 patients who will get the treatment or a placebo. More information can be found at clinicaltrials.gov under the identifier NCT01458405.

The Allstar trial is funded with a $19.7 million disease team grant from the California Institute for Regenerative Medicine, or CIRM, the states stem cell agency.

This is a highly significant announcement for us at CIRM as its the first time weve funded a therapy into a Phase 2 clinical trial, Chairman Jonathan Thomas said in a Dec. 23 statement.

About 600,000 Americans die of heart disease annually, making it the leading cause of death, according to the Centers for Disease Control and Prevention in Atlanta. Even those surviving may be left permanently impaired, if the heart is severely damaged. These are the patients Capricor seeks to help.

Mark Athens received Capricors treatment on Sept. 25, about a month after having a moderate heart attack. The Encinitas resident was the last treated under Phase 1, said Scripps cardiologist Richard Schatz, who performed the procedure. It will take about six months to know whether the treatment worked, Schatz said.

Unlike many trials, Phase 1 was not placebo-controlled, so Athens knows he got the therapy. He appeared cheerful, smiling and bantering with his examining doctor during a Dec. 17 checkup at Scripps Green Hospital.

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Stem cells tested to repair hearts

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PUBLIC RELEASE DATE:

26-Dec-2013

Contact: Mary Beth O'Leary moleary@cell.com 617-397-2802 Cell Press

Stem cell-based gene therapy holds promise for the treatment of devastating genetic skin diseases, but the long-term clinical outcomes of this approach have been unclear. In a study online December 26th in the ISSCR's journal Stem Cell Reports, published by Cell Press, researchers evaluated a patient with a genetic skin disorder known as epidermolysis bullosa (EB) nearly seven years after he had undergone a gene therapy procedure as part of a clinical trial. The study revealed that a small number of skin stem cells transplanted into the patient's legs were sufficient to restore normal skin function, without causing any adverse side effects.

"These findings pave the way for the future safe use of epidermal stem cells for combined cell and gene therapy of epidermolysis bullosa and other genetic skin diseases," says senior study author Michele De Luca of the University of Modena and Reggio Emilia.

EB is a painful condition that causes the skin to be very fragile and to blister easily, and it can also cause life-threatening infections. Because there is no cure for the disease, current treatment strategies focus on relieving symptoms. To evaluate stem cell-based gene therapy as a potential treatment, De Luca and his colleagues previously launched a phase I/II clinical trial at the University of Modena and recruited an EB patient named Claudio. The researchers took skin stem cells from Claudio's palm, corrected the genetic defect in these cells, and then transplanted them into Claudio's upper legs.

In the new study, De Luca and his team found that this treatment resulted in long-term restoration of normal skin function. Nearly seven years later, Claudio's upper legs looked normal and did not show signs of blisters, and there was no evidence of tumor development. Remarkably, a small number of transplanted stem cells was sufficient for long-lasting skin regeneration.

Even though Claudio's skin had undergone about 80 cycles of renewal during this time period, the transplanted stem cells still retained molecular features of palm skin cells and did not adopt features of leg skin cells. "This finding suggests that adult stem cells primarily regenerate the tissue in which they normally reside, with little plasticity to regenerate other tissues," De Luca says. "This calls into question the supposed plasticity of adult stem cells and highlights the need to carefully chose the right type of stem cell for therapeutic tissue regeneration."

###

Stem Cell Reports, De Rosa et al.: "LONG-TERM STABILITY AND SAFETY OF TRANSGENIC CULTURED EPIDERMAL STEM CELLS IN GENE THERAPY OF JUNCTIONAL EPIDERMOLYSIS BULLOSA."

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Gene therapy for human skin disease produces long-term benefits

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