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New Partnership to Advance Production Standards in Biomanufacturing – Research Horizons

Posted: February 20, 2017 at 4:42 pm

Posted February 20, 2017 Atlanta, GA

The Georgia Institute of Technology will play a key role in a new public-private partnership to help establish best practices and eventual industry-wide standards for the production of therapies using living cells to treat a range of conditions.

The new partnership aims to advance techniques to process, measure and analyze cell, gene, tissue-engineered, and regenerative medicine products, as well as cell-based drug discovery products.

We are poised to make a significant impact in how cells and regenerative medicine products are manufactured across the world through this new strategic partnership, said Krishnendu Roy, Robert A. Milton Chair and professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

Roy will serve as one of the Charter Board Members for the new International Standards Coordinating Body (SCB), which was recently established in coordination with National Institute of Standards and Technology (NIST) and Alliance for Regenerative Medicine (ARM).

Georgia Tech has already taken a leadership role in development of best practices and analytical standards that will impact biomanufacturing and innovation through the national roadmap on cell manufacturing developed by the National Cell Manufacturing Consortium (NCMC) and the newly established Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M), Roy said.

Compared to traditional pharmaceuticals, which are made primarily through chemical processes, biological medicines, also known as biopharmaceuticals, are much more challenging to produce. With medicines like cell-therapies, gene therapies and engineered tissues, finding ways to produce larger quantities at a time while ensuring high-quality and safety is a key challenge.

The SCBs long-term mission is to efficiently and effectively support sector standards development to accelerate product development and scalability, and streamline regulatory submission review and approval, said Robert A. Preti, chairman of ARM and president of cell manufacturing industry partner PCT, a Caladrius Company.

The new standards initiative comes on the heels of the establishment of two National Manufacturing Innovation Institutes announced last December. One, the Institutes for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), which the U.S. Department of Commerce is supporting with a five-year, $70 million grant is a consortium of more than 150 companies, academic institutions and other organizations focused towards working on improving the way biopharmaceuticals are produced, with a goal of bringing down costs and finding ways to get the drugs into the hands of clinicians and patients faster. The second, Advanced Regenerative Manufacturing Institute (ARMI) is funded by the Department of Defense and focuses on biofabrication of engineered tissues as replacement of damaged and diseases organs as well as for therapeutics development. Georgia Tech is poised to play key roles in these initiatives as well.

These synergistic national and international activities further establish Georgia Tech as a leading academic institution in the biopharmaceutical area, Roy said. In January 2016, Georgia Tech announced the Marcus Center as a research center devoted to developing processes and techniques to manufacture living cells. The center was made possible by a $15.7 million grant from the Atlanta-based Marcus Foundation. This center intends to work closely with NIIMBL and ARMI to further leverage these unique private-public partnerships and develop transformative technologies to bring cell-based therapies and regenerative medicines to clinic faster and at a lower cost.

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Stem Cell Company Combining Stem Cell Therapy with Hyperbaric Oxygen Treatment – Yahoo Finance

Posted: February 20, 2017 at 4:41 pm

TAMPA, Fla., Feb. 20, 2017 /PRNewswire/ -- StemedixInc., a U.S. based stem cell therapy group that specializesin the use of stem cells to treat patients with degenerative conditions, announced today that they are offering their patients a powerful treatment combination; Hyperbaric Oxygen Therapy (HBOT) and Stem Cell Therapy. According to research, the benefit of having HBOT treatments in conjunction with stem cell therapy is increasing the synthesis of nitric oxide, which signals the release of stem cells.

A recentstudyby researchers fromNeural Regeneration Researchfound results showing test subjects that underwent bothmesenchymalstem cell transplantation and HBOT had better neurological outcomes and better cognitive performance scores than subjects that endured only one type of treatment. Anotherstudyat the University of Pennsylvania School of Medicine, led by researcher StephenThom, MD, PhD, found that HBOT increases stem cell activity. After one treatment, the stem cell concentration doubled and after 20 treatments, they increasedeightfold.

Based on the growing interest and success, Fred Palmer, director of operations, at Stemedixsaid, "We are very proud to be working with the most recent and advanced technologies in the industry today. This combination of hyperbaric oxygen and stem cell therapies is progressively becoming the recommended treatment from our physicians and the selected treatment of our patients. Studies coupled with our own results we have seen thus far have been very impressive and supportive to our decision to offer this adjoining treatment."

Stemedix is now combining their stem cell therapy treatments with HBOT which allows for healing to occur that enables fibroblasts (tissue cells), capillaries (circulatory), osteoblasts (bone cells) andstem cellsto be stimulated. Without appropriate levels of oxygen in the tissue, healing cannot take place. With HBOT, oxygen is dissolved into all of the body's fluids, plasma, central nervous system fluids, lymph, and bone. In addition, the areas of the body that are lacking oxygen will begin to receive oxygen again.

To learn more about StemedixHBOT and stem cell therapy, contact Stemedixat 800-531-0831.

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Stem Cell Company Combining Stem Cell Therapy with Hyperbaric Oxygen Treatment - Yahoo Finance

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Stem Cell therapy is future of anti-ageing – Bangalore Mirror

Posted: February 20, 2017 at 4:41 pm

Chronological aging shows the natural life cycle of the cells as opposed to cells that have been unnaturally replicated multiple times or otherwise manipulated in a lab.

In order to preserve the cells in their natural state, Penn researchers developed a system to collect and store them without manipulating them, making them available for this study. They found stem cells collected directly from human fat -- called adipose-derived stem cells (ASCs) -- can make more proteins than originally thought. This gives them the ability to replicate and maintain their stability, a finding that held true in cells collected from patients of all ages.

Our study shows these cells are very robust, even when they are collected from older patients, said Ivona Percec, MD, director of Basic Science Research in the Center for Human Appearance and the studys lead author. It also shows these cells can be potentially used safely in the future, because they require minimal manipulation and maintenance.

Stem cells are currently used in a variety of anti-aging treatments and are commonly collected from a variety of tissues. But Percecs team specifically found ASCs to be more stable than other cells, a finding that can potentially open the door to new therapies for the prevention and treatment of aging-related diseases.

Unlike other adult human stem cells, the rate at which these ASCs multiply stays consistent with age, Percec said.

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Local vet taking part in stem cell therapy study for dogs – Story … – ABC Action News

Posted: February 20, 2017 at 4:41 pm

TARPON SPRINGS, Fla. - Cosby just doesnt get around like he used to.

We have six dogs and hes always the one thats the last to get up. The last to get out, said his owner Brian Cirillo.

And for Cirillo, its sad to see.

I hate it. Its always like he always on his tippy topes on his back legs. So its heartbreaking.

But a new trial study that is about to start at the St. Francis Pet Care Center in Tarpon Springs, could be just what Cosby needs.

Veterinarian Mike Amsberry is offering stem cell therapy for dogs.

They are seeing that its very, very safe. And very effective.

This study is focused specifically on four-legged friends with arthritis.

But in the past hes seen stem cell treatments work wonders for other ailments.

Its cells treating the body, rather than then some foreign substance. Some medication.

In this trial, the stem cells come from umbilical cords of donor dogs.

Not only can qualified pets get the treatment for free, but owners are paid too.

Cosby seems like the perfect candidate.

I think thats where everything seems to be going with regard to medicine. So to be on the leading edge of that to potential help him without having to put him on a bunch of medicine is definitely a plus, said Cirillo.

The hope is one day Cosby will be able to keep up with the rest.

And lead the way to help thousands of other dogs.

For more information on the trial study go to petstemcells.org.

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AJ Foyt planning to undergo stem cell therapy – USA TODAY

Posted: February 20, 2017 at 4:41 pm


USA TODAY
AJ Foyt planning to undergo stem cell therapy
USA TODAY
Foyt, 82, told IndyCar.com Saturday during a Verizon IndyCar Series test at Phoenix International Raceway that he plans to undergo stem cell therapy, likely in Cancun, Mexico, with injections into both ankles and shoulders as well as his blood. Foyt ...
Local Physician Offers Latest in Stem Cell TherapyPR Leap (press release)
New Nanofiber Stem Cell Therapy Developed By Kyoto UniversityUniversity Herald
Stem Cell Therapy Market Is Expected to Reach USD 60.94 Billion by 2022Satellite PR News (press release)
Digital Journal
all 12 news articles »

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Where are all the new diabetes drugs? – STAT

Posted: February 20, 2017 at 4:40 pm

A

s oncologists race forward with new treatments verging on science fiction and biotech companies press onwith drugs for once-hopeless rare disorders, one of the worlds most pervasive diseases looks like its been left behind.

There are few new drugs on the horizon for diabetes, which affects about 29 million Americans. Most of the treatments in late-stage development are simply improved versions of whats out there taken weekly versus daily, or orally instead of by injection.

So has pharma run out of ideas in diabetes?

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Not exactly. But whether its ideas will ever get to market is another question. Theres plenty of promising science in the early stages of research. Available drugs, however, work pretty well. Given the cost of development and a high bar for approval, pharma can only afford to advance true-blue breakthroughs, and those are hard to come by.

There are unmet needs, but its going to take a really good drug, said Dr. John Buse, director of the Diabetes Center at the University of North Carolina, Chapel Hill. Its not like 10 years ago where you could market acarbose, a drug you have to take three times a day that makes you fart. Now that profile would never make it into Phase 2.

The risky bet behind the first artificial pancreas for diabetes patients

And the economics can be unforgiving. Oral insulin has long been considered a Holy Grail in diabetes research, potentially freeing patients from routine injections in favor of an easy-to-take pill. But late last year, Danish drug maker Novo Nordisk backed away from such a project not because it failed in clinical trials, but because developing it would be too expensive to get a sure return on investment.

That logic frustrates patients and their advocates.

My wish would be that people thinking like that would spend time with the people who face the challenges of Type 1 diabetes, said Derek Rapp, CEO of JDRF, which funds and advocates for research in the field.

But diabetes has become a tough and crowded market. Industry leaders Sanofi, Novo Nordisk, and Eli Lilly have all issued grim sales forecasts in recent years, as pricing pressure makes their past discoveries less and less lucrative.Novo Nordisks CEO abruptly decided to resign last year amid a surprise dip in projected revenue.

Clearly the bar has gone up, said Dr. Philip Larsen, Sanofis head of diabetes research. The larger companies are now in what you could call a thinking-outside-the box mode.

A Novo Nordisk diabetes drug may save lives, but Wall Street shrugs

That means betting on early-stage efforts that could truly move the needle, albeit withhigh odds of failure.

Scientists at Sanofi, for instance, noted that gastric bypass surgery can have remarkable effects on Type 2 diabetes, even sending some patients into remission. Their question: Can that be replicated with a drug? Theyve got a drug, now in mid-stage development, that seeks to copy the cocktail of endocrine events that happens in the aftermath of surgery, Larsen said. The goal:create an injection that spares the need for a knife.

Drug makers are also at work on so-called smart insulin, which would switch on when blood glucose is too high and then harmlessly switch off once it had normalized, reducing the risk of hypoglycemia. Others are digging into the gut microbiome, a network of trillions of microbes, in hopes of finding a way to ameliorate diabetes.

We dont want to add new classes just to have new classes, said Dr. Ruth Gimeno, vice president of diabetes research at Eli Lilly. We want to really make a difference. Were giving ourselves a little more time rather than saying lets just fill the pipeline with incremental things.

And pharma has gradually widened its aperture to include novel technology, examining how wearable devices, glucose monitors, and advanced insulin pumps can work alongside drugs to improve patients lives.

There are some exciting and promising things that are being looked at, but I think the scope of diabetes management is getting a bit wider to be not strictly pharmaceuticals, said Dr. Robert Gabbay, chief medical officer of Harvard Universitys Joslin Diabetes Center. Devices are becoming increasingly important.

For some doctors, the key isnt more new products. Its education to teach themhow to use whats already on the market

Drugs called GLP-1 agonists, introduced more than a decade ago, have proved both to lower patients blood sugar and cut the risk of long-term cardiovascular problems. The same goes for SGLT2 inhibitors, introduced in 2013, which have been shown to reduce the risk of death by 32 percent for Type 2 diabetics.

And yet theyre not being widely used.

Thats in part because most primary care physicians dont know how to use them, said Dr. Athena Philis-Tsimikas, who leads the Scripps Whittier Diabetes Institute in California. The other issue is paperwork: Doctors have to go through a ridiculous number of steps to get patients health plans to cover those new drugs, Philis-Tsimikas said.

Its not like were desperate for something that is additionally innovative, she said. Were not using what we have.

Damian Garde can be reached at damian.garde@statnews.com Follow Damian on Twitter @damiangarde

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Diabetes could cause up to 12% of US deaths – Futurity: Research News

Posted: February 20, 2017 at 4:40 pm

The proportion of deaths attributable to diabetes in the US is as high as 12 percentthree times higher than estimates based on death certificates suggesta new analysis shows.

For a new study, published inPLOS ONE, researchers used two large datasets that included more than 300,000 people to estimate the fraction of deaths attributable to diabetes among people ages 30 to 84 between 1997 and 2011. To come up with the estimates, researchers calculated the prevalence of diabetes in the population, as well as excess mortality risk among people with diabetes over five years of follow up.

The proportion of deaths attributable to diabetes was estimated to be 11.5 percent using one datasetthe National Health Interview Study (NHIS)and 11.7 percent using the otherthe National Health and Nutrition Examination Survey (NHANES). Among the subgroups examined, the attributable fraction was highest among individuals with obesity (19.4 percent).

The proportion of deaths overall was significantly higher than the 3.3 to 3.7 percent of deaths in which diabetes is identified on death certificates as the underlying cause.

The frequency with which diabetes is listed as the underlying cause of death is not a reliable indicator of its actual contribution to the national mortality profile, writes Andrew Stokes, assistant professor of global health at Boston University School of Public Health, and Samuel Preston, professor of sociology and a researcher with the Population Studies Center at the University of Pennsylvania.

They say their analysis indicates that diabetes was the third leading cause of death in the US in 2010, after diseases of the heart and malignant neoplasms.

Diabetes is associated with a number of diseases and disabilities, including ischemic heart disease, renal disease, and visual impairment. Its prevalence has risen rapidly in the US and worldwide in the last 20 years.

Our results demonstrate that diabetes is a major feature on the landscape of American mortality, and they reinforce the need for robust population-level interventions aimed at diabetes prevention and care, Stokes says.

The study notes that the sensitivity and specificity of death certificate assignments of diabetes as an underlying cause of death are lowfar below those of administrative records or surveys.

When both diabetes and heart disease are mentioned on a death certificate, the researchers add, the decision about whether diabetes is listed as the underlying cause is highly variable.

The NHIS dataset is based on self-reports of diabetes diagnoses, while the NHANES data contains both self-reports and HbA1c levels, a preferred biomarker for the presence of diabetes. Individuals in both datasets were linked to the National Death Index through December 2011 to calculate mortality over five years.

The National Institute on Aging and the National Center for Health Statistics funded the work.

Source: Boston University

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Watching Your Sugar: Area YMCAs Launch Diabetes Prevention Program – wnep.com

Posted: February 20, 2017 at 4:40 pm

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The Wilkes-Barre and Greater Scranton YMCAs are launching a diabetes prevention program.

The two nonprofits are starting to sign people up now for these classes that begin on March 15.

Newswatch 16's Ryan Leckey visited the Wilkes-Barre YMCA on Monday tolearn more about the program and how you can sign up.

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Several other YMCAs across northeastern and central Pennsylvania have already started similar programs or plan to in the months to come including the YMCA in Carbondale.

If you don't live in the Wilkes-Barre or Scranton area, you're encouraged to call your local YMCA to see if the facility is offering the program.

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To find learn more about the yearlong program, how to sign up, and to take the test to see if you're at risk for Type II diabetes, head here!

For furtherquestions, contact Shadia Lahlou, the Senior Director of Chronic Disease Programs. Her email is slahlou@greaterscrantonymca.org and her phone is570-342-8115.

Take a look at this live Q & A about the program from Ryan Leckey's Facebook page.

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Women with diabetes are especially prone to developing heart … – Washington Post

Posted: February 20, 2017 at 4:40 pm

By Marlene Cimons By Marlene Cimons February 19

Women typically dont develop heart disease or high blood pressure, one of its major risk factors until after menopause. But if you have diabetes, that rule no longer applies, says Christine Maric-Bilkan, a program officer in the vascular biology and hypertension branch of the National Heart, Lung, and Blood Institute.

Diabetes dramatically increases the risk of heart disease at any age overall, people with diabetes are twice as likely to have heart disease or a stroke as are other people and its impact tends to be greater in women than in men, she says. Diabetes, a disease in which the body either doesnt produce enough insulin (Type 1) or cannot use it properly (Type 2), can cause spikes in blood sugar. Over time, these spikes can damage nerves and blood vessels, putting diabetics at elevated risk of heart disease and stroke.

Uncontrolled diabetes also contributes to vision loss, kidney failure and amputations, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

[What you need to know about those new, deadly heart-surgery infections]

People with diabetes are up to four times as likely to develop cardiovascular disease as are people who do not have diabetes, according to the Cleveland Clinic. Women with diabetes are twice as likely to suffer a second heart attack and four times as likely to suffer heart failure as are women who do not have the disease, according to the American Diabetes Association.

The risk of developing hypertension doubles in men and quadruples in women if you have diabetes, Maric-Bilkan says. (Hypertension is a major contributor to heart disease.)

There is something about diabetes that takes away the protective factor against heart disease that premenopausal women seem to have, something probably related to estrogen, she says. Women are not impacted by heart disease as much as men at younger ages, but once they have diabetes, that protection is lost and diabetes has an overall greater impact on women, compared with men, at all ages.

In 2011, Maric-Bilkan tested a small group of premenopausal Finnish women with Type 1 diabetes and found that they all had lower-than-normal estrogen levels.

[Diabetes was once a problem of the rich. Now it belongs to the poor.]

I dont know if they got diabetes because their estrogen levels were reduced, or the reverse, she says. One thought is that its the estrogen that gives protection, but men with diabetes, who also have a greater risk of heart disease, have high estrogen and low testosterone, the opposite of women. So the high estrogen doesnt protect men. Diabetic women have more testosterone than non-diabetic women, so it may have to do with the balance of hormones.

She stresses that the risk of death from heart disease is exceptionally high in women with early-onset [Type 1] diabetes compared with women in the general population, according to a study she authored.

Women with diabetes need to understand that the risk of getting heart disease is significant, and they need to be aware of it, she says.

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Tiny, poor, diabetes-wracked Pacific island nations want to ban junk food, despite risk of WTO retaliation – Boing Boing

Posted: February 20, 2017 at 4:40 pm

In the poor, remote island nations of the South Pacific, the Type-II diabetes rate ranges from 19% to 34%, a devastating health statistic that is challenging the countries' economies and wellbeing.

Some of these countries have tried taxing sugar or sweetened beverages, but Vanuatu is set to go further, banning imported food from government and tourist institutions altogether. It's the first step to a comprehensive ban on all junk food importation -- something that has been unsuccessfully tried in the region, as when Samoa passed a ban on high-fat "turkey tails," only to have it reversed by the World Trade Organization.

Public health experts who study the island nations of the Pacific welcomed the ban, saying that bold measures were necessary for an impoverished and isolated region of 10 million people one where the cost of sending legions of patients abroad for dialysis treatment or kidney transplants is untenable.

Imagine if 75 million Americans had diabetes thats the scale of the epidemic were talking about in Vanuatu, Roger Magnusson, a professor of health law and governance at Sydney Law School in Australia, said in an email.

Can anyone seriously say that Vanuatu doesnt have the right to exercise its health sovereignty in every way possible to protect its population from an epidemic of that scale? he added.

Experts say the regions health crisis is primarily driven by a decades-long shift from traditional diets based on root crops toward ones that are high in sugar, refined starch and processed foods.

As Obesity Rises, Remote Pacific Islands Plan to Abandon Junk Food [Mike Ives/New York Times]

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