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Buffalo teacher a key advocate in breakthrough diabetes drug – Buffalo News

May 19th, 2017 2:44 pm

Eric Fenar is a Type 1 diabetic whoexercises regularly,rigorously measures his blood sugar levels and takes othersteps to stayhealthy.

Still, he says,"In life, it's tough to eat tofu and salad and grilled chicken every day."

He likes Asian food, pizza and beer too much for that.

This is why Fenar has become one of the biggest volunteer pitchmen in the country for an inhalable insulin drug called Afrezza a drug that has helped the 34-year-old Buffalo public school teacher reach the most stable blood glucose levels he's had since he was diagnosed at age 10.

"There is a little bit of a learning curve," he said, "but now I have the power to fight those high blood sugars. Life is much more flexible."

Fenar discovered Afrezza during one of his routine online searches about better diabetes management. He testified at a 2014 federal Food and Drug Administration hearing to tout the promise of Afrezza for those like himself before he'd even tried the drug. He met Al Mann, the creator, before the billionaire businessman died in February 2016.

Fenar grew up in Lancaster. He remembers the weekend he was diagnosed with Type 1 diabetes, because he watched on a hospital television set on Oct. 23, 1993 as Joe Carter hit a home run to help the Toronto Blue Jays win the World Series.

His diagnosis meant that his body produced no insulin to help him break down food. It also meant a lifetime of insulin injections and great sacrifices as he kept vigilant watch on his blood sugar levels or so it seemed at the time.

"I want people to be aware of this option," Eric Fenar says. "This is what I needed: a faster insulin."

"My family has always been up to date on the latest technologies," he said. "I was up to date on the shots for two years and mom read about the insulin pump. Back then it was only for people 18 and over. At this point, I was about 12."

His mother, Susan, a nurse, convinced doctors and health insurers that Fenar was capable of using a pump to monitor his glucose levels and give himself insulin without dispensing a potentially fatal overdose.

Years later, he started to use a Dexcom, a bluetooth-compatible device that reads blood sugar without the need to do a finger-prick blood test. This allowed him to use his pump, or an injection, to push the correct amount of insulin into his bloodstream.

The challenge, Fenar said, is the lag time that comes with injectable insulin. It can take 45 minutes to an hour for the effect to take hold causing damage from high blood sugar and running the risk of an insulin crash or overflow, particularly an hour or so before or after meals.

"The thing that got me is Afrezza starts to work in 12 to 15 minutes," he said.

Dr. Howard Lippes, a Williamsville endocrinologist, assistant clinical professor with the University at Buffalo medical school and owner of R&B Medical Group, prescribes the inhalable drug to about 15 to 20 percent of his Type 1 adult diabetic patients.

Some use it regularly, others intermittently "to correct high glucose," he said. "There are pros and cons. It's not better. It's different."

Lippes doesn't count Afrezza's inhalability as a big advantage, "given the ease of today's insulin pen devices, which are simple and painless," he said. But he and patients who use it appreciate the speed in which it can control blood sugar levels.

For example, those like Fenar who enjoy pizza. When someone without diabetes eats pizza, or other food or drink loaded with carbs, the pancreas starts making insulin right away to compensate for the spike in blood sugar, which can cause inflammation and damage the cardiovascular system.

"If you're diabetic and eat a meal, you've got to give the insulin a running start if you want to catch the blood sugar before it goes up," Lippes said. "The timing of the meal can be a bit daunting. The Afrezza works really quickly, so that is an advantage for some patients."

It also has a shorter "tail" than injectable insulins, leaving the bloodstream faster so the danger of a lingering low blood sugar reaction diminishes, the doctor said.

Lippes prescribes Afrezza almost exclusively for those with Type 1 diabetes. It costs about the same as injectable insulin and is covered by most health insurance plans, he said.

Those with a cough or cold may not want to use it, Lippes said, and it is not recommended for those with asthma or chronic lung diseases like COPD. Its use is discouraged by those who smoke, "not that any diabetic should do that," Lippes said.

A small percentage of patients who try Afrezza get a throat irritation or cough, though the majority of patients tolerate it well.

Despite its advantages, the inhalable drug has yet to reach a critical mass in the diabetes drug industry.

Mann ran 17 companies that helped improve pacemakers, cochlear implantsand insulin pumps. He put $1 billion of his own money into Afrezza before he died, at age 90, and also was at work on developing an artificial retina.

Lippes blamed lagging Afrezza sales on the relative small size of the drug-making company, MannKind, as well as the first inhalable drug, Exubera, which Pfizer introduced more than a decade ago, then pulled from the market in 2007. In that case, the inhalation device was so big, it couldn't fit into a purse and looked like something you'd use to smoke illegal drugs. It proved too cumbersome for most who tried it, Lippes said.

He described the Afrezza inhaler as "a little whistle device," which dispenses powdered insulin in 4-, 8- and 12-unit doses.

The Afrezza inhaler is a whistle-like device, which dispenses powdered insulin in 4-, 8- and 12-unit doses.

Fenar needs a basal insulin injection once a day, to keep his sugar levels stable while he sleeps. Otherwise, he has found reliability in the drug and delivery method he advocates.

"With Afrezza, I was able to get off my insulin pump," he said. "I used to carry what I called a diabetic man purse," with extra pump supplies and extra insulin. "Now, when I leave the house, I have a tenth of what I used to carry.I'm not connected to anything. And for my insulin needs, I take Afrezza.

"I want people to be aware of this option. This is what I needed: a faster insulin."

For Lippes, the drug represents one of several exciting new changes in diabetes treatment.

The next, he said, is the sensor augmented insulin pump. Medtronics Corp. which recently hit the market with its variety, the 670G Pump refers to it as "the artificial pancreas."

"It's not quite there yet," Lippes said, "but we're on the threshold of big changes with these new glucose sensor devices that can tell the insulin pump what to do in real time. I have patients lined up to get it."

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New strategies to assess the risk of diabetes-related vision loss – ModernMedicine

May 19th, 2017 2:44 pm

A colleague recently told me that eye doctors should stay within the lines of traditional eye care because we barely have enough time as it is to do our jobs. My response was that today more than half of our adult patients have either diabetes or prediabetes,1 so our job now requires we go outside the lines to avoid the leading cause of preventable blindness.2

The incidence of severe vision loss caused by proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME) appear to have declined significantly over the last 40 years due to improvements in blood glucose control, improved surveillance of diabetes patients, and widespread use of effective interventional therapies like photocoagulation and anti-VEGF injections.3

Nonetheless, diabetic retinopathy (DR) and DME remain hugely important causes of vision impairment and blindness and remain the leading causes of vision loss in Americans of working age.2

Previously from Dr. Chous:How diabetes is linked to gut bacteria

Increased prevalence of DR and DME is linked to increasing prevalence of diabetes and reduction in macrovascular mortality achieved with better treatment regimens. Ironically, improved longevity allows patients with diabetes to live long enough for development of vision-threatening complications.4

With recent estimates showing more than 12 percent of all U.S. adults having diabetes, it is becoming increasingly important to identify and remediate patients at highest risk for progression to clinical diagnosis of diabetes and all of its attendant complications, including vision loss.5

Additionally, identifying diabetes patients at highest risk for developing sight-threatening retinopathy (STR) and attempting earlier intervention will play an increasingly important role as we strive to improve public health outcomes and reduce medical expenditures.

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New strategies to assess the risk of diabetes-related vision loss - ModernMedicine

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Is Autologous Heamatopoietic Stem Cell Transplantation Still Viable for MS? – LWW Journals

May 19th, 2017 2:42 pm

FitzGerald, Susan

doi: 10.1097/01.NT.0000520472.01901.8f

Features

Two new reports on autologous hematopoietic stem cell transplantation (AHSCT) for multiple sclerosis (MS) indicate that the therapy may benefit some MS patients. But whether AHSCT is viable is a matter of debate among some MS experts, who contend that the regimen could be toxic, leading to infection and death.

Two new reports on autologous hematopoietic stem cell transplantation (AHSCT) for multiple sclerosis (MS) indicate that the therapy may benefit some MS patients. But whether AHSCT is viable is a matter of debate among some MS experts, who contend that the regimen, which uses a combination of cytotoxic drugs to ablate the immune system in an attempt to reset the immunological memory could be toxic, leading to infection and death.

Experts who were not involved with the study said that newer, second generation MS drugs may be safer options, though few studies comparing the method with these drugs have been undertaken.

The first new report, published in the April 28 online edition of Neurology, provided a meta-analysis of 15 studies involving 764 MS patients who underwent AHSCT. The report found that the risk-benefit profile of the therapy makes it best suited for patients who have aggressive, relapsing-remitting MS who have not yet become highly disabled.

The second report, which provided long-term outcomes for 281 MS patients from an observational, retrospective study, found that almost half of the patients remained free from neurological progression five years after AHSCT. The study, published in the April edition of JAMA Neurology, reported that younger age, relapsing form of MS, fewer prior immunotherapies, and lower baseline EDSS [Expanded Disability Status Scale] score were factors associated with better outcomes.

Maria Pia Sormani, PhD, professor of biostatistics at the University of Genoa in Italy, and lead author of the report in Neurology, told Neurology Today that skepticism about the treatment approach is likely due to multiple factors.

MS is not a lethal disease, and this procedure is very invasive and has a non-negligible mortality risk, said Dr. Sormani, who also was a study author on the JAMA Neurology study. The lack of data from a rigorous clinical trial of AHSCT for MS has also been problematic.

To gain a clearer picture of what the current evidence shows, her team's meta-analysis pooled data from 15 studies, mostly open label, from January 1991 to July 2016. The researchers found that treatment-related mortality (TRM) declined during the period covered by the review, likely a result of improvements in transplant techniques, more clinical experience, and better patient selection, Dr. Sormani said. Overall TRM was 2.1 percent, but after 2005 it was 0.3 percent.

The meta-analysis found that the rate of disease progression in patients was 17.1 percent at two years following AHSCT and 23.3 percent at five years. The analysis also found that 83 percent of patients had no evidence of disease activity (NEDA) at two years, and 67 percent had no evidence at five years. Doing the transplant earlier, before the patient develops much disability seems advantageous, Dr. Sormani said.

The meta-analysis had the usual limitations of such reviews, she noted. The original studies were not all designed or executed in the same way, patient selection and study methodology were not uniform, and transplant techniques and protocols varied.

Even with advanced immunotherapy, such as natalizumab or alemtuzumab, only 32-39 percent maintained NEDA at two years in the phase II clinical trials, wrote Joachim Burman, MD, PhD, of Uppsala University in Sweden and Robert Fox, MD, of the Cleveland Clinic, in the editorial accompanying the paper. They agreed with the research team that the approach is more likely to benefit those with RRMS, not those with progressive forms of MS.

The report in JAMA Neurology included data on 281 patients from 25 centers who underwent AHSCT between January 1995 and December 2006. Seventy-eight percent of the patients had progressive forms of MS. The median follow-up was 6.6 years, with some patients followed for as long as 16 years

The five-year probability of progression-free survival was 46 percent and overall survival was 96 percent, the research team headed by Paolo A. Muraro, MD, a clinical reader in neuroimmunology and deputy head of the division of brain sciences at Imperial College London.

Factors associated with neurological progression after transplant were older age, progressive (versus relapsing) form of MS, more than two previous disease-modifying therapies, and higher baseline EDSS scores.

An accompanying editorial coauthored by Michael K. Racke, MD, professor of neurology and neuroscience at Ohio State University, noted that while the transplant therapy appears to favor those with RRMS with aggressive breakthrough disease, it Z

Dr. Racke told Neurology Today in an interview that he is currently planning a multicenter randomized controlled trial, which will include 55 RRMS patients in each arm. The study will compare AHSCT using what is considered a medium-intensity myelobation (BEAM) technique to best available drug treatment (whatever treatment a given patent is taking).

Dr. Racke said one question that needs to be further considered is, When is the best time to do a transplant? He said drug therapies need to be given a chance, but earlier might be better than later because once you start getting damage to the central nervous system we can't really fix that.

He said the upcoming trial will likely include cost analyses to compare the cost of long-term drug therapy to the mostly upfront costs of transplant, which is thought to be a once-and-done procedure.

Commenting on the two studies, Timothy L. Vollmer, MD, FAAN, professor of neurology at University of Colorado Health Sciences Center and co-director of the Rocky Mountain MS Clinic at Anschutz Medical Center, expressed skepticism about using AHSCT, particularly in light of effectiveness of the second-generation MS drugs that have come into use, such as natalizumab for JCV negative patients, fingolimod, dimethyl fumarate, and ocrelizumab.

Dr. Vollmer said most studies of AHSCT for MS were done before the newer drugs were available. He is concerned about both the immediate risks (infection, death) and potential long-term consequences of undergoing a toxic regimen to eradicate the immune system, noting that it could cause brain atrophy, already a concern for MS patients.

Mark S. Freedman, MD, professor of neurology at the University of Ottawa, senior scientist at The Ottawa Hospital Research Institute, and director of the Multiple Sclerosis Research Unit at The Ottawa Hospital-General Campus, is more sanguine about the procedure.

In a 2016 report in The Lancet, he and a colleague described outcomes for 24 RRMS patients who underwent transplant after failing drug therapy. Dr. Freedman said he has done about 25 more cases since the study came out. He said no patient has experienced a clinical relapse following transplant, none has evidence of new brain lesions on MRI, and none requires disease-modifying medication.

Dr. Freedman said there is a high level of interest in the procedure among MS patients, but it isn't for everyone. Patients must be carefully selected for the procedure, and undergo an aggressive chemotherapy regimen to eliminate their immune system, he said, noting that those with a high inflammatory component to their disease are ideal. Harvested stem cells undergo a special sorting technique at his center before being infused into the body to make sure that no previous disease-causing lymphocytes are accidentally included.

We're taking away immunologic memory, Dr. Freedman said. The new immune system is learning all over again what it should and shouldn't be doing.

He said that while the procedure is only done in patients who have not fared well with drug therapy, the best timing for this treatment would be as early as possible, when disability is minimal.

Probably doing it within five years from the onset of illness would give the optimal results, he said.

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Is Autologous Heamatopoietic Stem Cell Transplantation Still Viable for MS? - LWW Journals

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Face blindness test: Do you have the same condition as Brad Pitt? – Express.co.uk

May 19th, 2017 2:41 pm

GETTY

The inability to recognise faces is a surprisingly common, but fairly unknown, condition.

Those who suffer have to use clothes, hairstyles, voice or walking manner to identify a person.

It means that they often remove themselves from social situations so that they dont embarrass or offend others.

Many people are unaware they are affected, and may just think they have a bad memory.

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Some people with face blindness struggle to recognise their family and friends, and this can have a negative impact on their lives."

Punit Shah

However a new simple test to diagnose face blindness has been presented in research published in the The Quarterly Journal of Experimental Psychology.

They looked at whether an online questionnaire could accurately reveal face recognition ability.

Punit Shah, lead study author and lecturer in psychology at Anglia Ruskin University, said: Some people with face blindness struggle to recognise their family and friends, and this can have a negative impact on their lives.

Face blindness has been recognised by the NHS since 2016 and it is important to establish how many people are affected in order that they receive the assistance they need.

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Little Geeta, three, and her younger brother Lukeshwar, one, suffer from severe skin condition epidermolysis bullosa - an inherited mutation that makes skin fragile.

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In the questionnaire, the participants were asked how much they agreed or disagreed with particular statements, such as I often mistake people I have met before for strangers or I sometimes find movies hard to follow because of difficulties recognising characters.

Shah explained: Psychologists interested in face blindness have been hesitant to use questionnaires, but our new study suggests that using a well-designed questionnaire is helpful in recognising the condition and is suitable to be used on a large scale.

We are now adapting this questionnaire as there is evidence that prosopagnosia exists in children. It could help to explain why some children struggle to make close friends, and the problem could be more acute in schools where uniforms are worn.

Early detection may be beneficial as training programmes to improve face recognition, which are known to work in adults, may be even more successful in children given that they have a more plastic brain. There is still a lot to learn about prosopagnosia, but this research into identifying the condition using questionnaires is hopefully a step in the right direction.

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One of the most well known sufferers of prosopagnosia is the actor Brad Pitt.

He has spoken in the past about how the condition makes him seem egotistical.

According to the NHS, the condition often affects people from birth.

They are unable to recognise family, friends and partners, and have to use other clues to identify them.

This can be difficult if a sufferer sees someone out of context, and can cause distress.

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Scientists have reversed age-related blindness by deliberately … – ScienceAlert

May 19th, 2017 2:41 pm

A small and preliminary clinical trial has found that injecting a common cold-like virus into the eyes of age-related macular degeneration (AMD) patients - one of the leading causes of blindness in the US - can halt and even reverse the progression of the disease.

The results will need to be replicated in a much larger group of patients, but the early signs suggest that a single injection of the specially engineered virus can kick the body's natural immune response into gear, and clear out the fluid that causes permanent vision loss.

The approach, trialled by researchers at Johns Hopkins Medicine in Maryland, targeted a protein called vascular endothelial growth factor (VEGF), which is overactive in people with wet AMD - a rare and more severe form of the disease, which causes new blood vessels to grow beneath the retina and leak blood and fluid into the eye.

This build-up of fluid causes permanent damage to light-sensitive retinal cells, prompting them to progressively die off, leaving blind spots in the centre of a person's vision. Wet AMD affects around 10 percent of all AMD patients.

While treatments do currently exist for wet AMD, they involve getting injections in the eye once every four weeks - and if you want to maintain the benefits, you have to keep up those monthly injections for the rest of your life.

Side effects of current medications include eye infections and a heightened risk of stroke.

What the team at Johns Hopkins has demonstrated in a handful of patients is that, in some cases, there could be a way to halt and even reverse the progression of wet AMD with a single injection.

"This preliminary study is a small but promising step towards a new approach that will not only reduce doctor visits and the anxiety and discomfort associated with repeated injections in the eye, but may improve long-term outcomes," says one of the team, Peter Campochiaro.

"[P]rolonged suppression of VEGF is needed to preserve vision, and that is difficult to achieve with repeated injections because life often gets in the way."

The phase 1 clinical trial involved 19 men and women, who were 50 years or older, with advanced wet AMD.

They were divided into five groups that received increasing doses of a viral vector called AAV2 - a common cold-like virus that's been genetically engineered to penetrate the patients' retinal cells and deposit a gene that prompts the production of a protein called sFLT01.

"After the virus deposited the gene, the cells began secreting sFLT01 which bound to VEGF and prevented it from stimulating leakage and growth of abnormal blood vessels," the team explains.

"The goal is for the retinal cells infected by the virus to produce enough sFLT01 to permanently stop the progression of AMD."

Previous research has shown that sFLT01 can inactivate VEGF, but until now, scientists had struggled to get the body to produce it on its own - instead, they've had to regularly inject VEGF-suppressing proteins to keep it at bay.

The first three groups were given the lowest doses of the AAV2 virus, and after they showed no negative side effects, the final two groups were given the maximum dose. No severe side effects were observed in either group.

"Even at the highest dose, the treatment was quite safe. We found there were almost no adverse reactions in our patients," says Campochiaro.

The 19 participants were all selected based on their lack of response to all other standard treatment options - eight of which were unlikely to respond even to their new treatment.

Of the remaining 11, four showed dramatic improvements after a single viral injection, with the amount of fluid in their eyes reducing from severe to "almost nothing", the team reports. Two more patients experienced a partial reduction in the amount of fluid in their eyes.

The remaining five patients weren't so lucky, experiencing no improvement in vision after the injection, but for good reason - the researchers realised that their bodies naturally produced antibodies that attack the AAV2 virus.

And therein lies the rub, because the researchers suspect that these natural antibodies could be widespread in the US at least, becauseadeno-associated viral infections - a relative of the AAV2 virus - are quite common.

It will take a much larger clinical trial to figure out if the almost 50-50 chance of success in this study is an accurate indication of how the wider population will respond to their new treatment, but it's a promising development.

With advanced age-related macular degeneration expected to increase fromapproximately 2.07 million Americans in 2010 to 5.44 million in 2050, treatment that works for only half of wet AMD patients could still change hundreds of thousands of lives.

The research has been published in The Lancet.

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Could eating a low GI diet prevent blindness as you get older … – Express.co.uk

May 19th, 2017 2:41 pm

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New research has discovered that switching from a high-glycemic (GI) diet to a low-glycemic diet can stop the progression of age-related macular degeneration (AMD).

The study by Tufts University found that for the same amount of total carbohydrate, high GI foods release sugar into the bloodstream more rapidly than low GI foods.

This can affect your eyesight by causing damage to the retina.

High GI foods include potatoes, white bread and rice, while examples of low GI foods are whole grains, lentils and fruit.

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The researchers discovered that a high GI diet triggered the development of many features of AMD.

The researchers discovered that a high GI diet triggered the development of many features of AMD.

These included the loss of function of cells at the back of the eye, and of the cells that capture light.

However, eating a low GI diet did not.

Interestingly, switching from a high GI diet to a low GI diet could repair this damage to the retina.

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10 things to eat to live past 100

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Sheldon Rowan, scientist at Tufts University and lead study author, said: "We were genuinely surprised that the retinas from mice whose diets were switched from high- to low-glycemic index diets midway through the study were indistinguishable from those fed low-glycemic index diet throughout the study.

We hadn't anticipated that dietary change might repair the accumulated damage in the RPE so effectively.

Our experimental results suggest that switching from a high-glycemic diet to a low-glycemic one is beneficial to eye health in people that are heading towards developing AMD.

AMD happens gradually over time - in the early stages it causes blurred vision, while later on it can develop into blindness.

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There is currently no cure, making these new findings of particular interest.

The researchers also believe theyve found potential biomarkers of AMD which can be used to predict when a person is at risk for this disease.

Allen Taylor, scientist at Tufts University and senior study author, said: "Currently, there are no early biomarkers to anticipate the disease. Our findings show an interaction between dietary carbohydrates, the gut microbiome, specific biochemical molecules, and AMD features.

This work should lead to new approaches to understand, diagnose and treat early AMD - perhaps before it affects vision.

Already anticipated by our human epidemiologic studies, the findings imply that we can develop dietary interventions aimed at preventing the progression of AMD, a disease which impacts millions and costs billions worldwide.

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Diabetes sufferers could REVERSE blindness with new drug – Express.co.uk

May 19th, 2017 2:41 pm

GETTY

In rare cases of uncontrolled diabetes, sufferers can turn blind.

One the most common forms of diabetic eye disease is diabetic retinopathy.

Its caused by having higher than normal levels of blood glucose for a long period of time which can damage the small blood vessels within the retina.

These are the light-sensitive layer at the back of the eye that converts light into signals for the brain.

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A new drug has just been approved by the FDA to treat all forms of the diabetic eye disease.

Until recently, theres been no way to reverse it.

However, a drug has just been approved by the US Food and Drug Administration (FDA) to treat all forms of the diabetic eye disease.

Previously the drug, Lucentis, had been available for use in the US to manage patients with diabetic macular edema (DME), and was given the go-ahead for its use in the UK in 2013.

Now it can be used to treat diabetic retinopathy in patients with or without DME.

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People should be aware signs and symptoms of diabetes are not always obvious and the condition is often diagnosed during GP check ups.

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Sandra Horning, chief medical officer and head global product development at Genentech, the developers of Lucentis, said: "Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the US between the ages of 20 and 74.

We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME.

Currently the main way to treat the condition is with laser eye surgery, which works by preventing fresh blood vessel growth and improving the nutrient and oxygen supply to the retina.

Prior to the FDAs approval, research compared Lucentis directly with laser surgery.

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In the study, the drug was shown to significantly improve diabetic retinopathy among the 300 patients who trialled it.

Its the first vascular endothelial growth factor (VEFG) inhibitor to be approved for treating all forms of diabetic retinopathy.

VEGF sends new blood vessels to help affected tissues, but this can actually make sight worse.

There are two ways vision loss due to diabetes can occur.

Either weak, abnormal blood vessels can develop on the surface of the retina, leaking fluid onto the centre of the eye, and blurring vision.

Alternatively, fluid can leak from the blood vessels into the central area of the retina that provides our central vision, and cause it to swell.

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Diabetes sufferers could REVERSE blindness with new drug - Express.co.uk

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Color blindness epidemic in NM – Albuquerque Journal

May 19th, 2017 2:41 pm

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While hanging out at A Better U, the word on the streets is that during UNMs search for a new head mens basketball coach not one black coach was included within the list of potential candidates. And furthermore, that no black administrators or faculty were even casually offered the opportunity to provide input within the selection process of a program manned more than 50 percent by African American students. Two questions were posed that merit mention: (1) Would this have occurred if there were more African Americans working within the UNM Athletics Department and/or mens basketball? (2) Is UNM, which still does not have a black person sitting on its board of regents, making greater efforts to eradicate institutional racism on its campus as the school promised following hazing incidents aimed at black students two years ago? Sorry, my bad, thats right, like the Bernalillo Democratic Party and the New Mexico State Democratic Party, youre color blind.

Has anyone noticed that a great amount of the ART project construction emphasis is near and around the Confederate monuments in Old Town? The same monuments that Mayor Richard Berry promised the Albuquerque African American community he would remove or modify over two years ago. And while some still insist these monuments represent New Mexicos heritage, the fact remains that this commemoration is sponsored by the Sons of Confederate Veterans (SCV), an organization that has been directly tied to the Ku Klux Klan and other white supremacist organizations throughout its history. Yet, when completed, ART will bring all visitors and residents of the state right to a commemoration of one of this nations most atrocious acts against humanity: slavery of black people. Oh, Im sorry, my bad, like Bernalillo Democratic Party, New Mexico State Democratic Party and the University of New Mexico, the Mayors Office and city of Albuquerque are also color blind.

With the APS 20162017 (school year) coming to a close over the next few weeks headlined by high school and middle school graduations, many in the African American community are interested in the plans of the APS Board (of Education) to address discriminatory disciplinary practices throughout the schools in the district prior to the beginning the next school year. Many groups, including Black Parents of New Mexico, have been urging the APS Board to look into the disproportionate number of as well as the severity of expulsions and suspensions administered to African American students.

Throughout the nation this practice is the catalyst of the prison pipeline that plagues the family and youth while deteriorating life at large for all of society.

This past February a more progressive mindset appeared to have been elected to the board, a mindset that should embrace the belief that everyone deserves a fair shot at a decent, fulfilling and economically secure life. However, I must note that traditionally progressives do not believe race is endemic to the American experience, and furthermore, there is not one black person sitting on the school board.

Oh, Im sorry, my bad, like the Bernalillo Democratic Party, the New Mexico State Democratic Party, the University of New Mexico, the Mayors Office and city of Albuquerque, and joining the list, APS, youre all so, so, color blind.

Link:
Color blindness epidemic in NM - Albuquerque Journal

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China agrees to review US biotechnology applications – Chemical & Engineering News

May 19th, 2017 2:41 pm

China will evaluate eight pending U.S. agricultural biotechnology product applications by the end of May, potentially opening the door for sales by Dow AgroSciences, DuPont Pioneer, Monsanto, and Syngenta.

China agreed to conduct the evaluations as part of an agreement unveiled by the White House on May 12. The two countries reached the trade deal after a meeting in April between U.S. President Donald J. Trump and Chinese President Xi Jinping.

U.S. officials have prodded China for years to speed up its lengthy process for deciding whether to approve the import of new genetically modified (GM) crops. It typically takes six years to win Chinese clearance of a GM variety, twice as long as other major nations take.

Under the new deal, Chinas National Biosafety Committee will meet by the end of May to assess the safety of eight products made by four major U.S. agrochemical companies.

Dow AgroSciences is seeking approval for its corn and soybean seeds, while Syngenta and DuPont Pioneer have each applied to sell a GM corn variety in China. Monsanto makes four of the products pending approval, including herbicide-tolerant corn, soybeans, and two alfalfa varieties that have been under review for nearly six years.

The Biotechnology Innovation Organization (BIO), an industry trade group, wants to make sure China lives up to its commitment.

The ultimate test of success will be for China to follow its process and quickly approve the eight pending biotechnology applications and establish a synchronized, timely, and predictable process going forward, says Joseph Damond, senior vice president for international affairs at BIO.

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Bucks commissioners OK state award of $2 million for Pa. Biotechnology Center expansion – The Intelligencer

May 19th, 2017 2:41 pm

The Bucks County commissioners unanimously approved a $2 million state grant that will aid the expansion of the Pennsylvania Biotechnology Center in Buckingham.

With their vote Wednesday, the commissioners accepted the agreement between the biotechnology center and the state, and agreed to act as the facilitator for the Redevelopment Assistance Capital Program (RACP).

"Every entity that applies for the RACP grant has to have a cooperation agreement with one of the governments to move forward," said Lynn Bush, executive director of the Bucks County Planning Commission. "We are basically the go-between for the company and the state agency."

Plans have been in motion for years to add more laboratory and office space to the Biotechnology Center. The state grant and a $4.6 million federal grant will contribute to the overall costs of the project, estimated between $12 million and $13 million. The remainder willbe financed with a conventional loan awarded by Univest Bank.

"We're thrilled to continue our partnership with the biotechnology center and allow them the opportunity to grow and expand in that area," said Bucks County Commissioner Robert Loughery. "The center has become a real success story for the county and the region."

A groundbreaking ceremony for the expansion was held in April, but actual construction has yet to begin. Before work could begin in earnest, Bush said Thursday afternoon the plans need to go before the Buckingham Board of Supervisors for final land development approval.

The Biotechnology Center is credited with contributing approximately $1.8 billion to the local economy and supporting more than 700 jobs since its creation in 2007. A partnership with the Hepatitis B Foundation and Delaware Valley University started the initiative, but disagreements on the center's management ended the relationship.

The Hepatitis B Foundation bought out the university's interests in the center for $2 million in October, ending the disagreement and restarting the stalled expansion plans.

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Reasons to Add Puma Biotechnology (PBYI) to Portfolio Now – Zacks.com

May 19th, 2017 2:41 pm

On May 16, 2017, we issued an updated report on Puma Biotechnology, Inc. (PBYI - Free Report) .

Puma Biotechnology is a development-stage biopharmaceutical company focused on the development and commercialization of innovative treatments that enhance cancer care.

The company posted narrower-than-expected loss in the first quarter of 2017. Reported loss of $1.97 per share was also narrower than year-ago figure of $2.19. With no approved products in its portfolio at the moment, the company does not generate revenues yet. The company reported first-quarter results on May 10, 2017.

So far this year, Pumas shares have outperformed Zacks classified Medical-Biomed/Genetics industry. The companys shares have gained 4.1% while the industry registered an increase of 2.2%.

Puma has made significant progress with its lead candidate, neratinib. The candidate is currently under review in both the U.S. and the EU for HER2+ breast cancer. An approval would be a huge boost for the company given the immense commercial potential in the target market.

We note that several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway. During the quarter, Puma presented encouraging data from several ongoing studies on neratinib at the annual meeting of the American Association for Cancer Research (AACR).

Puma also expects to achieve several milestones in the second quarter of 2017. These include additional data from the phase III study on neratinib in third-line HER2-positive metastatic breast cancer patients and data from a phase II study on neratinib in HER2-positive metastatic breast cancer patients with brain metastases.

However, dependence on the successful development of a single candidate may hurt the companys growth prospects in case of any adverse development or regulatory setback.

Moreover, lack of partnership deals could hamper progress of the candidate as the company has no sales, marketing or distribution capabilities.

Zacks Rank & Key Picks

Puma currently carries a Zacks Rank #2 (Buy). Other stocks in the health care sector that warrant a look include Aeglea BioTherapeutics (AGLE - Free Report) , VIVUS, Inc. (VVUS - Free Report) and MEI Pharma, Inc. (MEIP - Free Report) . While Aeglea carries a Zacks Rank #2, VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy). You can see the complete list of todays Zacks #1 Rank stocks here.

Aegleas loss per share estimates narrowed from $3.64 to $2.48 for 2017, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 20.75%.

VIVUSs loss per share estimates narrowed from 50 cents to 39 cents for 2017, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.

MEI Pharmas posted positive earnings surprises in three of the four trailing quarters with an average beat of 66.56%. The companys shares gained 16% so far this year.

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Digging Up the Facts on Puma Biotechnology, Inc. (PBYI) – StockNewsJournal

May 19th, 2017 2:41 pm

GuruFocus.com
Digging Up the Facts on Puma Biotechnology, Inc. (PBYI)
StockNewsJournal
Puma Biotechnology, Inc. (PBYI) is an interesting player in the Healthcare space, with a focus on Biotechnology. The stock has been active on the tape, currently trading at $36.25, up from yesterday's close by 13.46%. Given the stock's recent action ...
Coherus Biosciences Inc (CHRS) Given a $43.00 Price Target by Maxim Group AnalystsBNB Daily (blog)

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Global Biotechnology Congress 2017 – Corporate Registration … – Business Wire (press release)

May 19th, 2017 2:41 pm

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global Biotechnology Congress 2017 - (5th in the Series) Corporate" conference to their offering.

The 'Global Biotechnology Congress 2017' would provide eminent scientists the opportunity to present their cutting edge researches in the field of biotechnology and its applications in medicine. A number of Nobel Laureates and leading researchers are expected to participate in this important conference.

This unique international conference provides a platform for researchers and decision makers in biotechnology to present their latest findings and learn about all the important developments in biotechnology. Many Nobel Laureates and world's renowned experts will participate in the conference.

The conference will cover the translational nature of biotechnological research, with emphasis on both the basic science as well as its applications in industry and academia. Presentations will include major research advances in biotechnology, business development, strategic alliances, partnering trends, product opportunities, growth business models and strategies, licensing and pharmaceutical biotechnology (e.g. vaccines, CNS, cancer, antibodies), medical biotechnology, industrial biotechnology, bioprocess engineering, protein engineering, plant and environmental technologies, transgenic plant and crops, bioremediation, and microbial diversity research.

Throughout the course of the four day conference, you will have the opportunity to both network and hear leaders from the international academic and corporate biotechnology communities.

Benefits of Attending

- Exchange ideas and network with leading biotechnologists and decision makers.

- Bring together top international biotechnology professionals presenting cutting-edge discoveries, research and opportunities for new biotech business practices and partnerships.

- Participants can gain direct access to a core audience of biotechnology professionals and decision makers, and have increased visibility through branding and networking at the conference.

- Obtain a global roundup of Pharmaceutical research capabilities and opportunities.

- The conference will feature a commercial exhibition and poster sessions.

For more information about this conference visit http://www.researchandmarkets.com/research/k2mmsx/global

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Puma Biotechnology, Inc. (PBYI): Some of the key technical areas – USA Commerce Daily

May 19th, 2017 2:41 pm

USA Commerce Daily
Puma Biotechnology, Inc. (PBYI): Some of the key technical areas
USA Commerce Daily
With all other things going on, Puma Biotechnology, Inc. (NASDAQ:PBYI) has been on a free fall declining -4.23 percent in just three months. It looks like traders are not happy with the stock. On the other side, analysts now consider Puma ...

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Planda Biotechnology’s Upcoming Clinical Trial Could Strengthen Case for Phytofare in Treatment of Diabetes – Markets Insider

May 19th, 2017 2:41 pm

NEW YORK, NY--(Marketwired - May 18, 2017) - Planda Biotechnology (OTCQB: PLPL) announced that it will conduct a human clinical trial to study the effectiveness of using its highly bioavailable green tea extract, Phytofare Catechin Complex, to regulate blood glucose levels in type 2 diabetics. If the positive data that was recently published in the Journal of Human Nutrition and Dietetics is any indicator, Planda should expect to receive its own positive data. The two studies could complement one another, and Planda's study could further strengthen the case for using green tea catechins in improving the health of type 2 diabetics.

According to an industry report, the market for diabetes drugs alone was valued at $30.95 billion in 2016, and it's expected to grow at an exponential rate and become a $44.53 billion market by 2021, at a CAGR of about 7.5%.

Obviously Planda would like to carve out its own space in this industry, and with a recently published study showing success with a green tea supplement that only contained 1 of the tea plant's 8 catechins, Planda has to feel pretty confident it can produce even better data given it can deliver all 8 catechins with its Phytofare extract.

Catechins are known as antioxidants, and antioxidants protect the body from free radicals that are thought to play a role in everything from heart disease to cancer. Catechins are found in the greatest abundance in the leaves of the tea plant.

And we already know that Planda produces a product (Phytofare) that contains all 8 of the catechins found in the tea plant. But, more importantly, Planda's product has proven in human clinical trials that it can deliver 10 times more of the catechins into the bloodstream and keep those antioxidants there at therapeutic levels for more than 24 hours.

Now, let's fast forward to the data from a study that was just published in the Journal of Human Nutrition and Dietetics and how Planda can add to that data with its clinical trial in diabetes. In that clinical trial, over 400 pregnant women, all of whom were in their third trimester and were diagnosed with gestational diabetes mellitus or "GDM," participated in investigating the effects of the catechin "epigallocatechin 3-gallate" (EGCG) on GDM in terms of both maternal and neonatal treatment outcomes.

Data from the study suggests that mothers with GDM, who were given EGCG as a supplement during the third trimester of their pregnancy, had significantly improved maternal diabetic parameters, and fewer cases of neonatal complications, compared to similar women given a placebo supplement.

One of the trial's authors, H. Zhang, said of the study, "Our current clinical trial is the first to report the potential therapeutic value of the natural compound EGCG in GDM, which is able to both alleviate maternal diabetic symptoms and reduce the incidence of neonatal complications."

A point that we can't emphasize enough from the GDM study that could benefit Planda greatly is that participants were given a supplement that contained only 1 of the 8 catechins, and we don't even know how bioavailable the supplement was. During Planda's clinical trial however, participants will be given Phytofare, which we know will deliver all 8 catechins into the bloodstream of each participant in the study. So we expect that Planda's data could be extremely positive and further strengthen the research done in the GDM study.

Given how potent Phytofare is, and how Planda is able to enhance the already highly bioavailable extract even more by entrapping it in liposomes, positive data from Planda's upcoming clinical trial in type 2 diabetes could thrust the company into the conversation, and become a real solution for how we're treating/managing type 2 diabetes worldwide.

About Stock Market Media Group

Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles.

We may from time to time include our own opinions about our featured companies, their businesses, markets and opportunities. Any opinions we may offer are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers and viewers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any company are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: http://www.sec.gov. We also recommend as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.

We are not a registered broker, dealer, analyst, or adviser. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications are not a recommendation to buy or sell a security.

Section 17(b) of the 1933 Securities and Exchange Act requires publishers who distribute information about publicly traded securities for compensation, to disclose who paid them, the amount, and the type of payment. In order to be in full compliance with the Securities Act of 1933, Section 17(b), we are disclosing that SMMG is compensated $5,000 per month by Plandai Biotechnology for content development. Neither SMMG nor anyone associated with it owns shares in PLPL.

For more information: http://www.stockmarketmediagroup.com.

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‘Doctors on Call’ show to focus on arthritis – WVU Medicine (press release)

May 19th, 2017 2:41 pm

Posted on 5/19/2017

When

5/25/2017 8:00 PM

MORGANTOWN, W.Va. Knees, hips, fingers, shoulders arthritis can cause pain in joints all over the body, and it affects millions of people. What can be done about it? Find out on the next Doctors on Call at 8 p.m. on Thursday, May 25, on West Virginia Public Broadcasting.

During live interviews, Mollie Cecil, M.D., WVU Medicine family medicine specialist, will share her experience with Lyme disease. Ghulam Abbas, M.D., director of surgical thoracic oncology at the WVU Cancer Institute, will discuss the importance of screening for lung cancer, and George Sokos, D.O., director of advanced heart failure at the WVU Heart and Vascular Institute, will dispel some myths about being an organ donor. WVU Medicine pharmacist Charles Ponte, Pharm.D., and director of outpatient pain services Richard Vaglienti, M.D., will appear back to back to discuss both medications and alternatives to medicine to relieve chronic pain.

Dont miss the story of Randy Ash, who experienced a severe hunting accident and was rushed to the Jon Michael Moore Trauma Center at J.W. Ruby Memorial Hospital.

DOC Talk, the call-in portion of the show, will provide viewers with the opportunity to ask questions about arthritisof two WVU Medicine experts rheumatologist Bruce Rothschild, M.D., and orthopaedic surgeonMatthew Dietz, M.D.

Its summer! That means cook-outs and picnics, and DOC in the Kitchen will show you how to practice food safety while you enjoy summer treats. Summer can also bring allergies, and the DOC List has the most common allergy triggers. The DOC Demo will show you some warm-water exercises in the pool that can relieve arthritis pain, and Its No Big Deal will show you how easy it is to become an organ donor.

WVU Medicine physicians John Phillips, M.D., and Kathy Moffett, M.D., will host the show. Highlights will be tweeted live on Thursday evening (@DOCWVU). Viewers can also get updates, suggest topics, and provide feedback anytime on Facebook (facebook.com/DoctorsOnCallWVU).

Now in its 25th season, Doctors on Call is an hour-long magazine-style show that airs quarterly.

To see previous episodes, visit wvumedicine.org/DOC.

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Steroid Shots For Knee Pain May Worsen Arthritis – Daily Hornet

May 19th, 2017 2:41 pm

Steroid shots are the go-to treatment for people with painful knee arthritis. Patients typically receive injections of corticosteroid drugs directly into the knee joint every few months at an outpatient clinic.

However, a new study has found that steroid shots do not work any better than salt-water, and they may actually worsen cartilage loss.

The researchers randomly assigned 140 men and women over 45 years old to receive injections of either salt-water or a steroid shot. The patients were injected every 12 weeks for two years.

All of the patients had knee arthritis with inflammation of the synovial membrane, making them ideal patients for treatment with the anti-inflammatory corticosteroid triamcinolone.

At the end of the study, there was no overall difference between the two groups in terms of pain, stiffness, ability to stand from a seated position, or walk. Bone and joint scans also showed no differences.

The only major difference was that patients who got steroid shots had twice the amount of cartilage loss in their knees 0.21 millimeters for the steroid shot group, vs. 0.10 millimeters for the salt-water group.

The results were surprising because the researchers thought steroid shots might reduce inflammation, or at least slow down the progression of cartilage damage. Instead, they found steroid shots had the opposite effect.

Dr. Timothy E. McAlindon, chief of rheumatology at Tufts Medical Center in Boston, Massachusetts, said steroid shots may be useful for treating short-term pain associated with flareups of arthritis, but not as a long-term treatment strategy:

Theres a lot of excitement about treating inflammation to influence this disease, but this study is a test of that notion, and its negative. So we really have to question whether its correct.

Osteoarthritis, also known as degenerative joint disease, affects 30 million adults in the United States. It is caused by the breakdown of cartilage, which is the pad of tissue between the knee bones. It is extremely painful when the bones scrape together.

Steroid shots temporarily relieve pain, but the effects wear off in about two months. The long-term trade-off is faster degeneration of cartilage in the knees and progressive joint damage.

Source: Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis JAMA (May 2017)

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Steroid Shots For Knee Pain May Worsen Arthritis - Daily Hornet

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Walking to battle arthritis – Austin American-Statesman

May 19th, 2017 2:41 pm

Austin American-Statesman
Walking to battle arthritis
Austin American-Statesman
Buckner Villas, a senior living community in North Austin, recently held a community walk where residents and their families hit the track to exercise and raise money for the Arthritis Foundation. Shown here are Holly Jones, left, and Jean Jenkens ...

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Walking to battle arthritis - Austin American-Statesman

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Mouse study looks at safety of stem cell therapy for early menopause – Medical Xpress

May 19th, 2017 2:40 pm

May 18, 2017

Now that we know that egg-making stem cells exist in adult rodents and humans and that these cells can be transplanted into mice with premature ovarian failure to produce offspring, the next question is to assess whether the offspring from the egg-making stem cells of a single adult mouse are biologically normal compared to natural births. On May 18 in the journal Molecular Therapy, researchers in China show that female mice with early menopause that receive egg-making stem cells from another mouse are capable of producing healthy pups 2 months later with no observable genetic malfunctions.

"One of our aims is to cure the disease of premature ovarian failure using female germline stem cells," says senior author Ji Wu, a reproductive biologist at Shanghai Jiao Tong University. "Before this treatment can be applied to humans, we need to know the mechanism of female germline stem cell development and safety after transplantation of single mouse female germline stem cells."

Premature ovarian failure, also called early menopause, is the loss of normal ovarian function, and thereby the release of eggs, before the age of 40. The condition is rare, affecting 200,000 women in the United States per year, and is incurable, although it can be treated with hormone supplements. Multiple groups are now looking at whether stimulating tissue regeneration or using stem cell transplants could help.

In the Molecular Therapy study, Wu and her colleagues isolated and characterized female germline stem cells from a single transgenic mouse with cells that show green fluorescence when activated by a blue laser. This allowed the researchers to observe and analyze the development of the transplanted stem cells, which were introduced to the ovaries of other mice using a fine glass needle.

Wu and colleagues found that the transplanted egg-producing stem cells exhibited a homing ability and began to differentiate into early-stage oocytes when they reached the edge of the ovary. The oocytes spent a few weeks maturing and yielded offspring within 2 months. The researchers then demonstrated that the developmental mechanisms of eggs derived from transplanted germline stem cells were similar to that of normal eggs.

"The results are exciting because it's not easy to get offspring from female germline stem cells derived from a single mouse," Wu says.

Wu's lab is also working to establish female egg-producing stem cell lines from scarce ovarian tissues derived from follicular aspiratesthe leftover cells gathered when a clinician searches a patient for oocytesthat are produced and discarded in in vitro fertilization centers worldwide. These aspirates can yield stem cells that differentiate into eggs in the lab, with the potential to be transplanted. The study not only provides a new approach to obtain human female germline stem cells for medical treatment, but also opens several avenues to investigate human oogenesis in vitro.

Explore further: Making sperm from stem cells in a dish

More information: Molecular Therapy, Wu et al.: "Tracing and characterizing the development of transplanted female germline stem cells in vivo" http://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(17)30180-6 , DOI: 10.1016/j.ymthe.2017.04.019

Journal reference: Molecular Therapy

Provided by: Cell Press

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Artificial pancreas helping people with diabetes – FOX13 Memphis

May 18th, 2017 3:45 am

by: Darrell Greene Updated: May 17, 2017 - 10:40 PM

MEMPHIS, Tenn. - Diabetes is attacking younger Americans more often than ever before.

According to new research released by the New England Journal of Medicine, cases of both type 1 and type 2 diabetes rose dramatically between 2002 and 2012.

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Those new diagnoses crossed all racial boundaries in young people through age 20.

While a cure is still distant on the horizon according to researchers, new treatments are helping diabetics live longer and better lives.

Emily Fonville is your average 15-year-old learning to drive, playing high school sports, and of course dressing up for the prom.

What you can't see in her pictures, is her daily fight against type 1 diabetes.

"It's like the hidden disease," Emily said.

But that fight is becoming more and more winnable.

Just three weeks ago, Emily became the first person in the Mid-South and one of the first in the nation to begin wearing the artificial pancreas.

It's true name, Medtronic is the hybrid closed loop system.

It's comprised of an insulin pump which attaches to the patient's skin, and a sensor which monitors in real time the patient's blood sugar.

The sensor sends those readings to the pump and when the patient's blood sugar is high, the pump gives the patient a precisely measured dose of insulin.

If the patient's blood sugar is too low, it has the ability to suspend delivery of insulin automatically.

"It is a game changer," Emily exclaimed when asked about the new tool.

Dr. Kashif Latif is Emily's doctor. He's one of the leading endocrinologists in the nation.

"There's a lot of technology going on, but this breakthrough has been the best thing ever for people with type 1 diabetes," said Latif who operates the first insulin pump center in nation out of his practice in Bartlett.

And while he admits this is not a cure, he said it's the next best thing to come along to date.

"It kind of matches what our body or our pancreas does for us. It's a more physiologic delivery of insulin for high glucose or low glucose," said Latif.

That means a lot less worry about diabetes for Emily.

"I think it is life changing. Being on this pump I feel like a normal person. I don't have to pull out a shot and give it in the middle of a restaurant.

I can just look down, press a button, and it's done."

FOX13 spoke to representatives of Medtronic who said the company was somewhat taken off guard.

They applied to the FDA for approval of the system in 2015, understanding that the approval process can take years.

But the human trials of the system went so well, the hybrid closed loop system was approved late last year.

Medtronic is making the systems as quickly as they can to fill the need.

2017 Cox Media Group.

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