Young Kids With Hip, Thigh Fractures Heal Well With Single-Leg Casts

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Mouse Study Suggests Certain Fats Could Trigger Crohn's, Colitis

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Sleep Apnea Treatment Might Boost Men's Sex Lives

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Vein grown from stem cells saves 10-year-old girl

Reuters – 4 hrs ago LONDON (Reuters) - Doctors in Sweden have replaced a vital blocked blood vessel in a 10-year-old girl using the first vein grown in a lab from a patient's own stem cells.

The successful transplant operation, reported online in The Lancet medical journal on Thursday, marks a further advance in the search for ways to make new body parts.

It could open the door to stem cell-based grafts for heart bypass and dialysis patients who lack suitable blood vessels for replacement surgery, and the Swedish team said it is now working with an undisclosed company to commercialize the process.

"I'm very optimistic that in the near future we will be able to get both arteries and veins transplanted on a large scale," said Suchitra Sumitran-Holgersson, professor of transplantation biology at the University of Gothenburg, and a member of the team that performed the operation in March 2011.

The advantage of using tissue grown from a patient's own cells is that there is no risk of organ rejection and hence no need for lifelong immunosuppressive drugs.

Four years ago, a 30-year-old woman received the world's first transplant of a tailor-made windpipe, grown in a similar way by seeding a stripped-down donor organ with her own stem cells. Other such trachea operations have followed since.

The latest case involved a young girl with an obstructed hepatic portal vein, which drains blood from the intestines and spleen to the liver. Its blockage can be fatal.

The team from the University of Gothenburg took a 9 cm (3.5 inch) section of groin vein from a deceased donor and removed all the living cells, leaving just a protein scaffold tube. Stem cells extracted from the girl's bone marrow were then injected onto the tube and two weeks later the graft was implanted.

The new blood vessel immediately restored normal blood flow, the doctors said, although after a year it narrowed and a second stem cell-based graft was needed.

Martin Birchall and George Hamilton of University College London said in a commentary in The Lancet that the Swedish doctors had spared the young girl the trauma of having veins harvested from deep in her neck or leg and avoided the need for a liver transplant.

But they cautioned the technique now needed to be tested in clinical trials and developed into a straightforward quality-controlled production process.

Sumitran-Holgersson said her team had already simplified the process and was now able to harvest stem cells from blood rather than bone marrow. She aims to test the technique with arteries later this year.

"You are going to see more and more of these personalized grafts in future," she said in a telephone interview.

The university has also linked up with a Swedish company, which Sumitran-Holgersson declined to identify, to explore how to commercialize the technique. This could involve offering "off-the-shelf" scaffolds from which tailor-made blood vessels could then be built.

Around the world, scientists in the emerging field of regenerative medicine are working to engineer many different human organs and tissues in the lab, including lungs and hearts.

Building such complex organs is a lot more challenging than making blood vessels, however, since veins are relatively simple hollow structures with few engineering demands.

(Editing by Alessandra Rizzo)

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FDA panel backs broader use of Edwards heart valve

A panel of heart experts said Wednesday that the government should expand approval of the first artificial heart valve designed to be implanted without major surgery, despite limited information about some long-term side effects.

The Food and Drug Administration's panel of outside cardiologists voted 11-0 with one abstention that the benefits of broader approval for Edwards Lifesciences' Sapien valve outweigh the risks.

The valve is currently approved for patients who aren't healthy enough to undergo the more invasive open-heart surgery, which has been used to replace the aortic valve for decades.

If FDA follows the group's advice, the implant will be approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.

The FDA is not required to follow the panel's advice, though it often does. A decision is expected later this year.

Edwards Lifesciences Corp. presented data from a pivotal trial showing that patients implanted with its heart valve survived about as long as those who underwent surgery. One year after the operation, 76 percent of patients implanted with the heart valve were still alive, compared with 73 percent of those who had undergone open-heart surgery.

The numbers were close enough to meet the study's goal of showing that Sapien's survival rate was at least as good as surgery. But panelists raised a number of concerns about the valve's side effects and the accuracy of the company's trial results.

Patients who got the Sapien valve had a higher rate of stroke immediately following the procedure when compared to surgery, though rates evened out over time. Additionally, more than half of patients had leaking from the aortic heart valve, a potentially dangerous condition in which blood flows backward into the heart's ventricle chamber.

Elsewhere, panelists noted that the death rate among men was more than 3 percent higher than that for women with the Sapien valve.

In each case, panelists said more follow-up data would be needed to define the scope and severity of these issues.

Irvine, Calif.-based Edwards plans to conduct two follow-up studies to evaluate long-term safety as well as differences in gender outcomes.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA.

Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Sapien valve is usually threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. An alternate procedure inserts the valve through a small incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve.

In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

Shares of Edwards Lifesciences Corp. fell 27 cents Wednesday to close at $90.54. They rose 59 cents to $91.13 in extended trading following news of the panel's vote.

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Rhode Island passes bill to guarantee rights of homeless people

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U.S. advisers back Edwards valve for wider group

Reuters – 4 hrs ago GAITHERSBURG, Maryland (Reuters) - An artificial heart valve from Edwards Lifesciences Corp that can be inserted without cracking open the chest for surgery won the support of U.S. advisers on Wednesday for use in a wider group of patients.

A panel of outside advisers to the U.S. Food and Drug Administration voted unanimously, with one abstention, that the benefits of the Sapien device outweigh its risks for people who need a new heart valve but face a higher risk of dying from open-heart surgery.

The FDA usually follows panel recommendations, although it is not required to, and will make a final decision in the future.

Shares of Edwards edged up 0.5 percent to $91 in post-market trading, as analysts said a positive recommendation had largely been factored into the share price before the meeting.

The valve is widely considered to be Edwards' most important new product, and was already approved last year for those deemed too sick to have the open-heart surgery.

Devices like Sapien, as well as sophisticated non-surgical techniques, are seen as the next frontier in the battle against heart disease as drugmakers produce fewer new medicines to fight the world's leading cause of death.

The Sapien device is meant for people with aortic stenosis, when the aortic valve that allows blood to leave the heart does not fully open, decreasing blood flow and potentially preventing it from reaching the brain and the rest of the body.

About 250,000 Americans have severe symptoms of the disease, and about two-thirds of them undergo surgery to treat it.

A bad aortic valve commonly requires open-heart surgery, during which the ribs are sawed open, the heart is stopped and a new valve is sewn in place. But thousands of people each year are considered too sick to get the surgery, or have other health conditions that make it risky.

With an Edwards' Sapien transcatheter heart valve -- the first such device in the United States -- a catheter guides the new valve to the heart through the femoral artery in the groin or a small incision between the ribs. The valve costs about $30,000 and is made of cow tissue and polyester supported with a stainless steel mesh frame.

Doctors say this and a similar device being developed by Medtronic Inc will eventually become the standard of care.

In pivotal clinical trials, Edwards said the Sapien led to a slightly lower death rate and dramatically shorter recovery times and hospital stays than chest-cracking open-heart surgery.

However, FDA advisers were concerned about higher stroke risk with the device compared to the traditional surgery, as well as an issue known as aortic leakage, when the valve does not seal properly and can send blood back into the heart.

"I think we are in belief that the totality of the data demonstrate a reasonable assurance of safety and efficacy," said Dr. Warren Laskey, the panel chair and a cardiologist at the University of New Mexico School of Medicine.

"There are questions that remain unaddressed, but they don't seem to impede our acceptance of the totality of the data."

The panelists were also worried about clinical trial data that showed people who had the device inserted through the ribs -- known as a transapical procedure -- had a higher mortality rate after one year compared to an insertion through an artery in the leg.

The advisory panel voted 10 to 2 that the device was safe, and 12 to 0 that it was effective.

Sapien is considered to be one of the most important growth drivers for Edwards, especially if the company gets approval for the broader use, potentially doubling the number of eligible patients, analysts say.

Analysts have pegged the worldwide market for transcatheter aortic valves at more than $2 billion a year.

"A broader indication for high-risk patients would enable multi-disciplinary heart teams to choose the approach best suited to their patients' needs, including for the first time a transapical delivery option," Edwards' chairman and chief executive Michael Mussallem said in a statement.

(Reporting by Anna Yukhananov; Editing by Bernard Orr)

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Diabetes drug may help fight cancer, but no proof yet

Reuters – 1 hr 41 mins ago (Reuters) - A cheap and relatively safe diabetes drug, metformin, might have cancer-fighting properties, according to an international study - but findings fall short of proving it actually can stave off cancer.

Researchers, whose findings were published in the Journal of Clinical Oncology, found that women with diabetes who took the medication had a 25 percent lower risk of developing breast cancer over more than a decade of follow-up.

"Metformin use in postmenopausal women with diabetes was associated with lower incidence of invasive breast cancer," wrote lead researcher Rowan Chlebowski, at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center.

"These results can inform future studies evaluating metformin use in breast cancer management and prevention."

Metformin, also sold under the brand name Glucophage, has been on the market for many years and is generally considered safe, although five to 10 percent of patients experience side effects like nausea and bloating.

It is used by millions of type 2 diabetics every day to help control their blood sugar, and studies have shown it also shrinks lung and breast tumors in mice. Several reports show people taking it for diabetes appear to develop cancer less often.

The new study used data from about 68,000 postmenopausal women who took part in the U.S. government-funded Women's Health Initiative clinical trials.

Over nearly 12 years of observation, there were more than 3,200 new cases of breast cancer among the women.

Every year, 0.42 percent of women without diabetes developed breast cancer, compared to 0.40 percent of diabetics on metformin and 0.47 percent of diabetics taking other drugs.

After taking into account risk factors for breast cancer, the gap between women without diabetes and diabetics on drugs other than metformin vanished. But diabetics on metformin turned out to have a 25 percent lower cancer risk than their diabetes-free peers.

"This is an area of great excitement," said Pamela Goodwin, a breast cancer expert at Mount Sinai Hospital in Toronto, Canada, who wrote an editorial that appeared with the study.

"The evidence is coming together that metformin may actually have a clinically-relevant effect, but none of this is good enough to chance clinical practice just yet."

But she added that while the study is the best of its kind so far, it relies on observations instead of an actual experiment in which women are randomly selected to take metformin or not.

Goodwin and her colleagues are currently running a trial to test whether metformin can help ward off new tumors in women getting breast cancer treatment. Results are expected in three to four years. SOURCE: http://bit.ly/L86p7l

(Reporting from New York by Frederik Joelving at Reuters Health; editing by Elaine Lies and Bob Tourtellotte)

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FDA reviews safety of innovative heart valve

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Freezer damages brain samples used to study autism

A freezer malfunctioned at a Harvard-affiliated hospital that oversees the world's largest collection of autistic brain samples, damaging a third of the scientifically precious specimens and casting doubt on whether they can be used in research.

The director of the Harvard Brain Tissue Resource Center said the loss was "devastating," particularly in light of the increasing demand for brain samples among scientists searching for the cause of autism and potential treatments.

"Over the last 10 years, the autism tissue program has been working very hard to get the autism community to understand the importance of brain donation," Dr. Francine Benes said. Now many of those samples have been compromised.

The freezer failed sometime late last month at the center, which is housed at McLean Hospital in the Boston suburb of Belmont. At least 54 samples earmarked for autism research were harmed. Many of them turned dark with decay.

However, an initial review indicates that the DNA in the samples is intact and can still be used for genetic research. It's unclear, however, whether the samples could be used for the full range of neuroscience needs.

Thirty-two of the brains had been cut in half, with one side placed in a formaldehyde solution and the other placed in the freezer. The samples in the solution remain available for all research projects, the hospital said.

The frozen tissue samples are normally maintained at about minus 80 degrees Celsius, but the temperature had reached about 7 degrees

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Noisy hospitals need Rx for quiet as patients rest

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Stem cells can be harvested long after death: study

"Stem cells are fed at the University of Connecticut's Stem Cell Institute in 2010. 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 say. (AFP Photo/Spencer Platt)" title

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