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PressTV-Biotechnology in Iran – Press TV

Posted: April 6, 2017 at 1:45 am

Iran has made a considerable breakthrough in biotechnology inasmuch as it is able to produce GM foods and Up until 2013 it has produced 18 different kinds of recombinant medicines.

The modern biotechnology has been established nearly nine decades ago in Iran, started with vaccine production in Pasteur and Razi Institutes in 1920 and 1925. National Institute of Genetic Engineering and Biotechnology institute of Iran was established in 1989. Iranian scientists are active in various spheres of agriculture in this institute and work on medicinal plants with the aim of using their metabolites or increasing their tolerance to non-biological changes such as salinity or drought. One of the uses of biotechnology is in production of genetically modified foods; however, there are many opposing voices claiming that they are harmful for health.

Simply said, biotechnology harnesses cellular and bi molecular processes and puts them to work for us. It is used for production of GM foods and treating diseases with genetic technologies and many other fields. Biotechnology is an efficient, up-to-date and effective tool in agricultural field. Biotechnology helps you to improve plants' resistance to a considerable amount. Iran is among pioneering countries in this field. Up until 2013, 18 different kinds of recombinant drugs have been produced in Iran. This number is against 50 recombinant drugs produced globally. With the help of biotechnology and recombinant drugs, Iran has seen a 30% drop in its drug export and 50% inflation growth has been controlled.

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Europe’s biotechnology potential hindered by investment fears – EurActiv

Posted: April 6, 2017 at 1:45 am

In terms of pure biotechnology, Europe has embraced innovation. However, it cannot compete with the US yet because it cannot drive private investment in the field, as well as open up the market to new products, a pharmaceutical executive told EURACTIV.com in Lyon.

Despite the EUs consistent growth in the biotech business, the EBE claims that the industry is not receiving enough support from investors, universities or research institutions, thus limiting the EUs ability to keep pace with the US in biotechnology.

The EU is lagging behind due to challenges in translating scientific innovations into successful businesses, a European Biopharmaceutical Enterprises (EBE) report claims.

Biotechnology is the use of living systems or organisms in the creation of industrial products. The growth of the biotechnology industry is important for Europe and created 10,000 new jobs and 93 medicines recommended for market authorisation by the European Medical Agency in 2015, according to the EBE.

Biotechnology could help patients across Europe gain access to innovative therapies, for example, against rare diseases. Proponents of bio-medicines also claim that precision therapy, because it is more efficient, will ease the burden on member states ailing healthcare systems.

The EBE suggests that steps should be taken to create a stronger investor community for biotech products to prevent places other than Europe from benefitting economically from technology invented and developed in Europe.

License to fail

The paper suggests that European entrepreneurs may be more adverse to risk because they have no license to fail, citing the lack of a strong culture of institutions or individuals seeking useful application of their work, taking out patents and creating start-up companies.

On the other hand, universities in the US often empower scientists to be knowledgeable in business and management.

The paper recommends that European institutions improve their support of scientists in marketing their technologies through better investment in Technical Transfer Offices (TTOs). The current lack of funding for TTOs at European universities means it is difficult for them to attract and train experienced staff.

Although Europe has public research funding organisations, such as the Innovative Medicines Initiative (IMI) and the European Commissions Horizon 2020, the lack of mature biotech companies makes the investment ecosystem fragile and makes it difficult for Europe to compete with the US for funding, the paper says.

Europe needs to build a bigger and better capital market for biotech companies to overcome the funding gap that prevents the needed growth of the biotech sector, it reads. The EBE suggests the European Commission create a single capital market for biotech companies and the creation of tax incentives for investment in biotechnology.

Being successful in the US

Didier Hoch, chairman of the Biovision 2017- The World Life Sciences Forum in Lyon, told EURACTIV that there are several reasons why biotechnology can flourish more easily in the US than in Europe.

According to Hoch, in terms of pure biotechnology, Europe is not lagging behind the US, as its sufficiently innovative. Where we are lagging behind is to drive investment in the field and attract private investors and open up the market to new products, he noted.

In fact, in the US the norm is to have a connection between the science, universities and private investors [] which is not yet the case in Europe, where there is a kind of fear when you are in the public sector to go private said Hoch, adding that another hindrance is the lack of trust between the public and private sector

Another difference between Washington and Brussels is the source of money. Hoch explained that money invested in the US biotech sector was coming from private investors, while in Europe, it comes from venture capital funds mainly funded by the EU institutions.

Even venture capitals are funded from EU money. This regime could eventually be thestrength for Europe, as in a way it can be competitive against private US money, he emphasised.

However, Hoch insisted that Europe still needed to convince more private sector entities to invest in biotechnology. It might be a long-term and risky field, but in the US the private sector invests in its potential, he said.

Hoch stressed that currently a biotech product could be considered successful if it has accessed the US market.

If you have a biotech company you should have in mind first to succeed in the US, even if you are based in Europe, he explained, explaining that in terms of the market, 70% of a new products success is in the US.

If you dont get your product there you will face difficulties, he said, emphasising that its mainly a political decision to have the US as an attracting market.

Last but not least, Hoch pointed out that its easier to get to the US market because there is a clear way to access and not like 27 different in the Europe, which have a country-based approach.

Making Europe innovative

In February, the centre-right European Peoples Party (EPP) presented its vision for the future of the Economic and Monetary Union (EMU) and emphasised the need for anew framework on access to financing in order for innovative companies to be encouraged to invest in Europe.

EPP President Joseph Daul told EURACTIV that the EU should become an innovation hub as this is the key to future growth and help it compete with the US.

This is where we need to concentrate our efforts to make Europe the worlds best talent hub. We should embrace radical innovations and make our continent the birthplace of the next Facebook or Apple, he told EURACTIV.

The EPP recognises that Europe was lagging behind compared to the US regarding innovative companies and, therefore, suggested the creation of an environment that will help new talents flourish.

We must understand that this follows partly from structural factors in our continent compared to our partners on the other side of the Atlantic. Venture Capital Funds in the EU are on average small. We need to support creating Funds of Funds, and we must look into existing regulations to make sure that investing in private equity funds is not discouraged by regulations and capital rules, the paper reads.

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UF biotechnology institute named Incubator of the Year – The Independent Florida Alligator

Posted: April 6, 2017 at 1:45 am

The UF business incubator Sid Martin Biotechnology Institute was named the 2017 Top Global Incubator of the Year.

The International Business Innovation Association recognized the institute March 28, said Mark Long, the institutes director. The institute received $1,500 for winning the award out of 30 other incubators.

The biotechnology institute provides lab space, equipment, business and legal advice at a low cost for new biotech companies, Long said.

Scientists need help understanding business and addressing the market, he said. Were here to help them out with that.

The institutes 40,000 square foot facility is at Progress Park in Alachua. Its used as office and laboratory space thats rented out to new companies unable to afford commercial space.

Getting an award like this is a real marketing tool in attracting new companies and investors for these companies, Long said.

He said since the institute started in 1995, businesses theyve served have a 78 percent success rate, meaning 78 percent of businesses stay open after the first five years. Since 2003, the success rate has improved to 93 percent.

Meekah Chaderton, a manager at the startup food development company Captozyme, said the institute helped improve the companys business.

Chaderton said Captozyme plans to move out of the institute and into their own space in June.

Small companies cant afford to buy a lot of equipment and lab space, so renting affordable space from Sid Martin has made us more competitive, Chaderton said.

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Ovarian cancer: Effective immunotherapy steps closer with new T … – Medical News Today

Posted: April 6, 2017 at 1:45 am

At a scientific meeting this week, researchers report some progress in developing an immunotherapy for ovarian cancer. However, they also outline the considerable challenges that remain before the treatment can be made effective for this and other cancers that have solid tumors.

The researchers - from the Fred Hutchinson Cancer Research Center (Fred Hutch) in Seattle, WA - presented the findings at the annual meeting of the American Association of Cancer Research in Washington, D.C.

Estimates from the American Cancer Society suggest that, in the United States, around 22,440 women will be diagnosed with ovarian cancer and approximately 14,000 will die from the disease during 2017.

The cancer begins in cells of the ovaries - reproductive glands found only in women. Each woman normally has two ovaries, situated on each side of the uterus inside the pelvis. The ovaries produce eggs that travel to the uterus through the fallopian tubes. If an egg is fertilized by male sperm, it develops into a fetus.

Dr. Kristin Anderson, an immunotherapy researcher at Fred Hutch who presented the findings at the meeting, says that while ovarian cancer is not as common in the U.S. as other cancers with solid tumors, it has a low rate of survival and a high rate of relapse. The main reason is that the cancer does not cause obvious symptoms and is often advanced by the time it is diagnosed.

Immunotherapy is a relatively new area of medicine that is showing promising results in the treatment of cancer. The approach uses the patient's own immune system to fight disease.

The new study concerns a method called adoptive T cell transfer. In this approach, immune cells called T cells are taken from the patient's own blood and trained to target and destroy cancer cells. Then, after multiplying in the laboratory, the primed cells are returned to the patient's body. Sometimes donor cells are used instead.

Fast facts about ovarian cancer

Learn more about ovarian cancer

Fred Hutch have a number of teams researching immunotherapy cancer treatments. In particular, Dr. Anderson and colleagues have reported success in using adoptive T cell transfer to treat blood cancers.

In her meeting presentation, Dr. Anderson reported progress on applying lessons learned from that work to the treatment of solid tumors.

The researchers found that ovarian cancer cells overproduce two proteins - WT1 and mesothelin - and showed that T cells engineered to target them can kill mouse and human ovarian cancer cells in the laboratory.

They also found that the engineered T cells significantly increased survival in a mouse model of ovarian cancer.

However, Dr. Anderson cautions that there is still some way to go before adoptive T cell transfer is ready for clinical trials in human patients.

The team discovered that, compared with treating blood cancers, it is much harder to apply T cell therapy to solid tumors like breast, ovarian, lung, and pancreatic cancers.

In leukemia and lymphoma, the engineered T cells can be infused directly into the bloodstream to target the blood cancer. However, access to solid tumors that are tucked away inside the body poses some major challenges. Among these are issues concerning the tumor microenvironment - a mixture of noncancerous cells, molecules, and extracellular matrix in and around the tumor.

Dr. Anderson outlines three particular challenges posed by the tumor microenvironment that they are working on. One is the fact that there are cells and proteins in the tumor microenvironment that send signals to the T cells that tell them to shut down or simply ignore the tumor cells.

The team suggests that there are some existing drugs called checkpoint inhibitors that they could explore to tackle this problem. Another approach could be to engineer the T cells to block these particular signals.

The second challenge is that ovarian tumor cells and neighboring blood vessels send self-destruct signals to the T cells, causing them to commit suicide before they can attack cancer cells.

The Fred Hutch team is already working on a solution to this second challenge in the form of a fusion protein that boosts the T cells' anticancer activity when they receive these self-destruct signals.

The third challenge that the researchers have identified in the solid tumor microenvironment is the problem of low sugar. To grow as rapidly as they do, ovarian cancer cells devour sugar, which they get from their environment.

However, the engineered T cells also need this sugar to fuel their journey to, and attack on, the cancer cells. The researchers at Fred Hutch are looking for a way to engineer the T cells so that they use a different source of energy.

Dr. Anderson says that while they are currently focusing on ovarian cancer, they believe that these solutions will also help to make progress on using adoptive T cell transfer with other solid tumors.

"If we can solve some of the issues that really plague us with these hard ones, then we can more readily apply [the solutions] to cancers that have fewer of these hurdles," she explains, as she concludes:

"Tumor microenvironment issues come hand-in-hand with working on solid tumors."

The team hopes to start a human clinical trial of adoptive T cell transfer for ovarian cancer in the next few years.

Learn about 12 newly discovered genetic variants that raise the risk of ovarian cancer.

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Nerve cells actively repress alternative cell fates | News Center … – Stanford Medical Center Report

Posted: April 6, 2017 at 1:45 am

Until now, researchers have focused only on identifying these types of single-lineage repressors, said Wernig. The concept of an everything but repressor is entirely new.

In 2010, Wernig showed that it is possible to convert skin cells into functional neurons over the course of three weeks by exposing them to a combination of just three proteins that are typically expressed in neurons. This direct reprogramming bypassed a step called induced pluripotency that many scientists had thought was necessary to transform one cell type into another.

One of the proteins necessary to accomplish the transformation of skin to neurons was Myt1l. But until this study the researchers were unaware precisely how it functioned.

Usually we think in terms about what regulatory programs need to be activated to direct a cell to a specific developmental state, said Wernig. So we were surprised when we took a closer look and saw that Myt1l was actually suppressing the expression of many genes.

These genes, the researchers found, encoded proteins important for the development of lung, heart, liver, cartilage and other types of non-neuronal tissue. Furthermore, two of the proteins, Notch and Wnt, are known to actively block neurogenesis in the developing brain.

Blocking Myt1l expression in the brains of embryonic mice reduced the number of mature neurons that developed in the animals. Furthermore, knocking down Myt1l expression in mature neurons caused them to express lower-than-normal levels of neural-specific genes and to fire less readily in response to an electrical pulse.

Wernig and his colleagues contrasted the effect of Myt1l with that of another protein called Ascl1, which is required to directly reprogram skin fibroblasts into neurons. Ascl1 is known to specifically induce the expression of neuronal genes in the fibroblasts.

Together, these proteins work as a perfect team to funnel a developing cell, or a cell that is being reprogrammed, into the desired cell fate, said Wernig. Its a beautiful scenario that both blocks the fibroblast program and promotes the neuronal program. My gut feeling would be that there are many more master repressors like Myt1l to be found for specific cell types, each of which would block all but one cell fate.

Wernig is a member of Stanfords Cardiovascular Institute, Child Health Research Institute, Cancer Institute, Neurosciences Institute and Bio-X.

Other Stanford co-authors of the paper are postdoctoral scholars Soham Chanda, PhD, Bo Zhou, PhD, Xuecai Ge, PhD, and Philip Brennecke, PhD; graduate students Cheen Ang, Thomas Vierbuchen and Daniel Fuentes; research assistant Sarah Grieder; undergraduate student Brandon Walker; professor of genetics Lars Steinmetz, PhD; and professor of molecular and cellular biology Thomas Sudhof, MD.

The research was supported by the German Research Foundation, the National Institutes of Health (grant R01MH092931), the California Institute for Regenerative Medicine, the New York Stem Cell Foundation, the Howard Hughes Medical Institute, the Swedish Research Council, the Swedish Government Initiative for Strategic Research Institute, the Department of Health and Human Services and Spectrum Child Health.

Stanfords Department of Pathology also supported the work.

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Discovering how insulin-producing cells show their age – Medical Xpress

Posted: April 6, 2017 at 1:45 am

April 5, 2017 Susan Bonner-Weir, Ph.D., is Senior Investigator in the Islet Cell And Regenerative Biology Section at Joslin Diabetes Center, and Professor of Medicine at Harvard Medical School. Credit: John Soares

Diabetes researchers have puzzled for decades about why insulin-producing beta cells in one pancreatic islet often look and behave quite differently than their counterparts in the same islet or in nearby islets. Using newly identified cellular markers of aging, Joslin Diabetes Center scientists now have shown that this diversity may be driven at least in part by differently aged beta cell populations within the pancreas.

Additionally, the Joslin team demonstrated that the aging of beta cells, with associated losses of their insulin secretion, can be accelerated by insulin resistance, a condition that can lead toward type 2 diabetes.

"This research opens up an entirely new set of questions about the development of type 2 diabetes," says Susan Bonner-Weir, a Joslin Senior Investigator and corresponding author on a paper describing the work in the journal Cell Metabolism. The disease worsens over time as beta cells die off or perform less effectively, for reasons that are not well understood.

Scientists have long known that beta cells change significantly over time, says Bonner-Weir, who is also Professor of Medicine at Harvard Medical School (HMS). Back in 2011, for example, her lab demonstrated that beta cells in newborn rats are immature cells with very different gene expression and function than adult beta cells.

Her lab's most recent work, led by HMS Instructor Cristina Aguayo-Mazzucato, started instead with very old mice, created for another experiment, whose beta cells emitted fluorescent signals. The investigators could compare the insulin-producing beta cells from these mice with those from younger, genetically identical mice to examine the characteristics of the cells across the mouse lifespan.

As they did so, Aguayo-Mazzucato and her colleagues were struck by dramatic difference in the genes expressed by beta cells in animals of various ages. The researchers followed up to identify markers of aging in these cells, using several mouse modelsone with impaired glucose tolerance (a contributor to type 2 diabetes progression) and another that shows markers of rapid aging.

The scientists identified several markers of aging beta cells, including one protein called IGF1R that is an important player in cell survival. The markers highlighted the striking diversity of beta cell aging, and functional decline, both within and between islets in both mouse and human pancreases.

This diversity of age among beta cells may be responsible at least in part for the striking heterogeneity that has been observed in both mice and humans. "We showed that this heterogeneity may be based on different populations of different-aged beta cells," Bonner-Weir says. "Even in young animals, where many beta cells are still immature, you may have other beta cells that are at the end of their lifespan. Each life stage may have a different phenotype (different gene expression and function) than the other stages."

The heterogeneity may reflect typical lifespans of these cells. "There's a lot of growth in beta cells up until puberty or even young adulthood, but after that, there's a very slow turnover," she says. "A few cells reach the end of their life span and die, and a few other cells are created."

The Joslin team went on to study the effect of metabolic stress on signs of aging. In one set of experiments, when the scientists boosted insulin resistance by giving mice a compound that cuts insulin signaling, they saw increased expression of several markers of aging in beta cells.

In another effort, examining human pancreas specimens, the scientists found that two of the aging markers were significantly increased among people with type 2 diabetes. The researchers also detected surprising numbers of aged beta cells in people as young as 20.

"We will follow up using more human islets and trying to understand how many of these functions translate from animal models to humans," says Bonner-Weir, who notes that human islets are far more diverse than those in lab animals.

Her group also will probe further into their findings, including pinpointing factors that boost aging in beta cells, examining whether this aging is reversible and finding potential ways to reduce related metabolic stresses.

Additionally, the Joslin team will study why nearby pancreatic islets can display such dramatic differences in beta cell aging. One hypothesis is that beta cells in some islets may remain dormant until needed, and thus not age as quickly, Bonner-Weir says. Another, more controversial, is that new islets may grow in new pancreatic lobes appearing in adulthood.

The research also may help to suggest answers to some puzzles in type 1 diabetes, she says, including why some cells seem to be more resistant to the autoimmune attack that causes the disease and how beta cells can be found in some people who have had the condition for decades.

Explore further: New type of insulin-producing cell discovered

More information: Cristina Aguayo-Mazzucato et al, Cell Aging Markers Have Heterogeneous Distribution and Are Induced by Insulin Resistance, Cell Metabolism (2017). DOI: 10.1016/j.cmet.2017.03.015

In people with type I diabetes, insulin-producing beta cells in the pancreas die and are not replaced. Without these cells, the body loses the ability to control blood glucose. Researchers at the University of California, ...

If you become resistant to insulin, a condition that is a precursor to type 2 diabetes, your body tries to compensate by producing more of the "beta" cells in the pancreas that produce the critical hormone. Researchers have ...

A Yale-led research team identified how insulin-producing cells that are typically destroyed in type 1 diabetes can change in order to survive immune attack. The finding may lead to strategies for recovering these cells in ...

Joslin researchers have identified immune cells that promote growth of beta cells in type 1 diabetes. This study provides further evidence of a changed role for immune cells in type 1 diabetes pathology. The study appears ...

Researchers at the Ume Center for Molecular Medicine have created the first 3D spatial visualization of an obese mouse pancreas showing the distribution dynamics of insulin producing beta cells. The results show significant ...

Eating a high fat and high sugar diet when pregnant leads to metabolic impairments in both the mother and her unborn child, which may "program" them for potential health complications later in life, researchers have shown.

Diabetes researchers have puzzled for decades about why insulin-producing beta cells in one pancreatic islet often look and behave quite differently than their counterparts in the same islet or in nearby islets. Using newly ...

Research led by the University of Otago, Wellington has found that a 'home-grown' naturally occurring probiotic reduces the risk of developing diabetes during pregnancy (gestational diabetes) and lowers fasting blood sugar.

Americans of South Asian descent are twice as likely as whites to have risks for heart disease, stroke and diabetes, when their weight is in the normal range, according to a study headed by Emory University and UC San Francisco.

Scientists may have found a new tool for studyingand maybe even treatingType 2 diabetes, the form of diabetes considered responsible for close to 95 percent of cases in the United States.

With a series of new grants, Saint Louis University researchers will tackle the twin epidemics of diabetes and obesity by tapping into the potential of two nuclear receptors that control muscle metabolism. The scientists ...

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Study: heart failure stem cell therapy safe, shows early signs of effectiveness – The San Diego Union-Tribune

Posted: April 6, 2017 at 1:44 am

A stem cell treatment for heart failure patients is safe and shows early signs of effectiveness, according to a study published Wednesday.

The study was conducted by Japanese researchers in 27 patients, who received transplants of stem cells taken from their own thigh muscles. There were no major complications, and most patients showed considerable improvement in their symptoms.

The study was published in the open-access Journal of the American Heart Association. Dr Yoshiki Sawa of Osaka University Graduate School of Medicine was the senior author. It can be found at j.mp/stemheart.

However, two San Diego cardiologists who do stem cell research on heart disease cautioned that similar clinical trials have shown promise over the years, only to fail at the end for various reasons. There is no approved stem cell therapy for heart failure.

So while the trial itself appears to be well-conducted, the researchers are very far from actually proving their treatment is effective, said Dr. Richard Schatz of Scripps Health and Dr. Eric Adler of UC San Diego School of Medicine.

For one thing, the trial was small, they said, and larger trials are where the most rigorous scientific evaluations are made.

These early trials have looked beneficial in the past, Adler said. When we do the larger trials, the results are more equivocal.

Adler said the signs of efficacy in this trial are modest. For example, the change in ejection fraction, a measurement of efficiency in pumping blood, rose from 27 percent to 30 percent in 15 of the 27 patients. Their heart failure was associated with a lack of blood flow, or ischemia. The remaining non-ischemic patients actually had a slight decline.

The entire field of stem cell and regenerative therapy for heart disease has been a disappointment to date, Schatz said.

Weve been at it for 20 years now, and we dont have a product or a positive (late-stage) trial, so that tells you pretty much everything you need to know, he said. Its not for lack of trying or billions of dollars invested. Its just very, very difficult.

The cardiac field has had more success with other technologies, such as cardiac stents. Schatz is the co-inventor of the first stent.

In the study, the researchers acknowledge that previous attempts had only been modestly effective. They devised a method of producing sheets of muscle stem cells and attaching them to the inner layer of the sac that encloses the heart, a layer that rests directly on the heart surface.

The stem cell sheets stimulate healing by producing chemicals that stimulate cardiac regeneration, the study said. The cells themselves dont survive in the long term, but by the time they die they have served their purpose.

Loss of function

Heart failure is a progressive disease in which the heart gradually loses its ability to pump blood. This can be triggered by a heart attack or any other cause that damages the heart muscle.

When damaged heart muscle is replaced with scar tissue, as often happens, the heart loses pumping capacity. It becomes overstressed, and its output of blood declines. This limits the patients ability to engage in intensive physical activity. In advanced cases, patients may become bedridden.

Existing treatments include drugs and LVAD units, which take over some of the hearts function to relieve stress. Some drugs may help the heart work more efficiently, but none have been shown to improve heart failure by actually regenerating lost heart muscle.

Stem cell therapy is tested in patients who havent responded well to other treatments. Trials have been and are being conducted in San Diego area hospitals.

Scripps Health has been testing a cardiac stem cell therapy from Los Angeles-based Capricor. The cells, taken from donor hearts, are injected into the coronary artery, where they are expected to settle in the heart and encourage regrowth.

UC San Diego is testing a heart failure therapy from Teva Pharmaceutical Industries. It consists of bone marrow derived mesenchymal precursor cells. These can give rise to several different cell types, including muscle cells.

And many other trials are going on throughout the country and internationally.

Adler and Schatz said theres reason for optimism in the long run, as technologies improve.

Just because the other trials have been negative doesnt mean this technique wont be beneficial, Adler said. Its just too early to tell.

That said, Schatz emphasized that the nature of the three-phase clinical trial process means that the show-stoppers for a treatment typically appear late.

Tighter standards needed

Clean trials trials where we all agree that this is the patient population we want to look at, are needed, he said.

For example, heart failure comes in two types, he said. Ischemic heart failure is caused by heart attacks and blocked arteries, which impede blood flow. Non-ischemic heart failure can be caused by damage from diseases, such as a virus.

Non-ischemics can be younger people, in their 20s and 30s, while the ischemic patients are older. Mixing those patient groups in a single trial is a mistake, he said.

Theyre different animals, Schatz said.

Another pitfall is failing to screen carefully enough to enroll only patients likely to benefit, Schatz said.

You can have a patient who has chest pain, and coronary disease just incidentally, he said.

His shoulder or chest pain is from a virus. So he goes into the trial and gets a placebo injection in his arm of cortisone, and his arm pain goes away. And because hes in that placebo group, hes counted as a success the pain went away. It has nothing to do with his heart. Thats an extreme example, but we actually saw that happen.

In a failed gene therapy trial for heart disease, some patients apparently had received the injection in the wrong location, missing the heart muscle, Schatz said.

You assume they got the gene, but they didnt, Schatz said. The study was negative, and thats why I think it was negative.

Such errors dont show up in Phase 1 trials, Adler and Schatz said, because theyre focused on evaluating safety. And these early trials dont have many patients, there arent enough to comfortably determine the therapy is really effective.

By the last stage of the trial, these sources of error have often been identified and trial standards have tightened up. And thats when the faulty assumptions made early appear as the trial ends in failure.

Despite those forbidding hurdles, Adler said research should continue.

This disease is killing a lot of people. Theres not going to be enough hearts to go around for transplant. Theres six million Americans with heart failure, and theres 2,000 heart transplants a year. So coming up with novel regenerative cell-based therapy is something were still excited about.

bradley.fikes@sduniontribune.com

(619) 293-1020

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Stem-cell therapy is poised to disrupt the Tommy John epidemic in baseball – Quartz

Posted: April 6, 2017 at 1:44 am

For about half a decade, its been something of an open secret in baseball that playerspitchers especiallyregularly undergo stem-cell therapy to stave off surgeries and lost playing time. Its a cutting-edge medical procedure, done by everyone from high-school standouts to major-league all-stars. Its rarely discussed by players, or by their coaches, parents, doctors, or employers.

So when the Los Angeles Angels went public in 2016 with the news that first Andrew Heaney and then Garrett Richards were undergoing stem-cell therapy for torn ulnar collateral ligaments (UCLs), it was both anticlimactic and a revelation. For the first time, baseball pitchers and their employers were openly admitting trying this novel procedure that, while fairly well-proven anecdotally, has yet to be validated by any well-designed scientific study.

By now, that so-called Tommy John surgery for a torn or damaged UCL has become a rite of passage for the top-flight professional baseball pitcher is a cliche of sports punditry. Every young arm that can fold and then unfold itself into tortuous patterns that facilitate throwing baseballs at 95 miles per hour or faster is bound for the knife, once those upper body contortions inevitably tear the tissue on the inside of their elbows connecting their upper and lower arms, the UCL.

The first Tommy John surgery (or more properly, UCL reconstruction) was performed in 1974 by the orthopedic surgeon Frank Jobe, then the team physician for the Los Angeles Dodgers, on the eponymous pitcher. It was a great success; Tommy John came back to pitch 14 more years in the pros, racking up 164 wins with four different teams.

TJ surgery is fairly straightforward: the connective tissue that makes up the UCL is either replaced with a tendon taken from elsewhere in the patients own body or from the donated tissue of a cadaver.

Nevertheless through the mid-1970s and into the 80s, TJ was something of a rarity; just a handful of baseball players underwent that particular knife. In the 1990s the numbers started to tick up, and then in the 2000s, they exploded. From 1995 to 2005, there was an average of 28 TJ surgeries per year across all levels of pro baseball; from 2005 to 2015, there was an average of 84 TJ surgeries per year.

Then something strange happened. In 2016, the total number of TJ surgeries performed dropped to 90, from 127 the year before, a 30% decline. Only one other year in Tommy John history, 2008, saw such a precipitous drop from the previous year. By 2009, TJ numbers were back to 2007 levels; obviously it remains to be seen whether 2017 will look more like 2015 or more like last year. But the data suggest that if TJ surgery numbers are in fact starting to trend downward, it might have something to do with the rise of stem-cell therapy.

What makes stem cells unique is that they are whats called undifferentiated; they can become other specialized cells depending on the bodys need at the time. There are two types of human stem cells, embryonic and adult. Embryonic stem cells come from a very early-stage embryo; these are what you likely think of when you hear the term stem cellstheyre at the center of one of most exciting fields of medical science research today. Embryonic stem cells are now used or are being studied for a shockingly wide range of applications, from Alzheimers and autism to vision impairment and infertility. However, thanks to the religious right-driven opposition to the harvesting, study, and use of embryonic stem cells, theyve been mired in controversy in the US.

On the other hand, the use of adult stem cellswhich can be harvested from bone marrow, fat, or blood of any person of any age (the name is a bit misleading)is widely accepted by both the medical community and politicians. They have less range, so to speak, than embryonic stem cells; they are primarily to repair and replace damaged tissue in the area they are found. That makes them just about perfect for repairing a torn UCL.

The first pro baseball player known to have undergone stem-cell therapy for a UCL weakness was Bartolo Colonand he was basically forced into talking about it. Following a long run of success culminating with a Cy Young Award season in 2005, Colon had four frustrating years racked with injury and ended up unsigned after 2009. He took a year off to recuperate and in spring of 2011, he was back, signed with the New York Yankees and feeling good. Serge Kovaleski, an investigative reporter with the New York Times, started digging into how Colon had made his comeback, and uncovered the name of Joseph Purita, an orthopedic surgeon and stem-cell therapy pioneer.

As Purita tells it, there was nothing illegal or nefarious about the work hed done on Colon; there was just never a plan to broadcast it, either. Then, he recalls, the Times called me up and said were going to write a story whether or not. So, Purita offered details. In April 2010, he told the paper, a team of Dominican doctors used stem-cell therapy to help repair Colons ligament damage and torn rotator cuff.

Colons recovery was a resounding success. Hes been an all-star twice, is the current active leader in major league wins, and, at age 44, is signed to a $12.5 million contract to be the Atlanta Braves number two starter for the 2017 season.

I cant give names but there are some professionalsBut instead of thrusting stem-cell therapy into the mainstream, the Colon incident forced it to stay underground. The treatment was not well understood at that point, and the circumstancesthat it was done offshore, that it was unearthed by investigative reporting, and that, in 2012, Colon was suspended for 50 games for testing positive for testosterone useclouded public opinion on it. Many were convinced Colon had gotten performance-enhancing drugs in the Dominican Republic. Purita denies this vociferously, and MLB inquiries back him up.

The upshot is that every doctor I spoke to who studies and performs stem-cell therapy for torn-ligament repair says some version of the same thing: I cant give names but there are some professionals who have come in for treatment, says Joshua Dines, an orthopedic surgeon at New Yorks Hospital for Special Surgery, and an assistant team physician for the New York Mets.

Purita says that since Colon, hes worked with some players that had team approvaland some just come on their own, but none wanted to go public about the procedure.

If use of your arm is mostly limited to spreadsheet jockeying and lifting forkfuls of pasta or salad from plate to maw, TJ is no big dealin that case, youre ready to go back to work in six weeks. But if you throw a ball at top speed past another pro athlete for a living, youre going to be out of commission for 18 months or more as you regain strength in your money arm.

And money is the (post) operative word. In 2016 alone, MLB teams lost nearly $60 million in player value because they had to fulfill dozens of contracts of players recovering from Tommy John. Thats nearly enough to field an entire pro teamdefinitely enough to roster a top-of-league pitching staff. And that $60 million doesnt come close to accounting for the losses suffered by players who had to undergo the knife during the last year of a contract, and found themselves released by their previous teams with no new offers on the table while they recovered.

There was never going to be a way to prevent the need for Tommy John surgeries. Baseball players throw far too hard, with far more breaking pitches, starting at far too young an age, to realistically stop UCLs from tearing (though all sports medicine experts do now warn coaches and parents to keep kids and teens at low pitch counts). The alternative was always going to be something that could cure ligament tearsbut better than TJ surgery, with a faster recovery time.

Everything weve seen in the past decade or so suggests stem-cell therapy is exactly that. At this point, platelet-rich plasma (PRP) injections are common first-line defenses against UCL injuries. The procedure entails harvesting PRP from the player and injecting it into the injured part of the body. PRP is dense with proteins specialized for injury repair.

You can think of these injections as a precursor to stem-cell therapy; both are considered biologic treatments and entail wielding the bodys own weapons against injury. Many of the doctors now doing stem-cell therapy started off with PRP procedures. When baseball players have a torn ligament, they typically try PRP first. If that fails, its Tommy John time.

Everyone in the field says that at this point PRP is last decades technologyExcept, everyone in the field says that at this point PRP is last decades technology, more than ready to be replaced by stem-cell therapy, which does much the same thing but better. Adult stem cells essentially are there for the very purpose of tissue repair. Why not take them from a part of the body thats all good, and send them to a region where reinforcements are desperately needed?

Dines says that in his own practice, hes been able to cut down the need for Tommy John surgery by about a third, thanks to his reliance on stem-cell therapy. He doesnt believe that the procedure will lower the number of players that have to have TJ, but it will limit the number of overall TJ surgeriesbecause at this point, many pitchers have to get the surgery twice in their career. Dines says stem-cell therapy can get 15- or 16-year-old pitchers through their first partial tear. They may still need to get a full TJ surgery by age 24, but avoiding that first one is still a huge victory. (A growing number of middle-age first-time TJ patients could also explain the overall drop in Tommy John surgeries.)

Purita is even more optimistic. While most orthopedic surgeons say that, right now, stem-cell therapy is effective on partial, but not full, ligament tears, Purita is confident his version can handle any UCL. He sent Quartz a photo showing a patientan MLB pitcher who wishes to remain anonymous, Purita sayswho had a full UCL tear in November 2011 and, after receiving stem-cell therapy at Puritas clinic, made a full recovery by February 2013.

You never say something replaces something else entirely, Purita says. Stem-cell therapy is not going to replace every case [of Tommy John], but it could probably replace the majority of cases.

Talk to anyone who knows the field and theyll rattle off the same reasons why stem-cell therapy for UCL tears isnt already the standard of care: One reason is that, relative to the population, the number of UCL tear patients is extremely small, which means theres only a tiny pool from which to draw potential study participants. Two, a trial for a new medical treatment is typically only considered well-designed if the subjects are blindthat is, they dont know if they are getting the real treatment or a placebo. But what kind of team or player is going to risk a million-dollar arm on a properly designed study where theres a 50% chance that the injury gets a placebo?

Thats not to say that this is some sort of back-alley procedure. Its performed by some of the most prestigious orthopedic surgeons and medical research centers in the US, and the US Food and Drug Administration approves its use: US doctors are allowed to harvest a persons stem cells and use those cells to treat that same person, as long as you dont manipulate (e.g. genetically modify) the cells.

Someone making $20 million a year is not going to do something he hasnt checked out wellThe lack of literature on the procedure hasnt exactly inspired the confidence of players and teams to go public with their decision to pursue it; nor does the fact that the procedure for years had, as Dines puts it, a bad rap[it] would get lumped in with things that were illegal. There was this specter of cheating. But Dines, and others, say thats changing.

The needle is moving towards this being a valid way of treating things, says Purita. People are starting to recognize that someone making [or risking] $20 million a year is not going to do something he hasnt checked out well.

Amadeus Mason, a sports medicine and biologics expert at Emory University, compares stem-cell therapy today to Tommy John in the 1980s. It was, Okay, were going to try this and see, says Mason, who trained with orthopedic surgeon James Andrews. (Andrews is the Michael Jordan of ligament repairhes saved the arms and careers of some of the greatest pitchers in major league baseball history.) There wasnt a big fanfare going in when players started with Tommy John surgeries, Mason says, but when players came back to pitch [there] was. Same thing here.

Mason thinks stem-cell therapy hasnt quite reached the inflection point, but it is near. Here, too, he sees a comparison with Tommy John: It took a while for them to perfect the procedure so that more and more doctors could do the surgery and reproduce the results well.

Right now, Mason says, there is a relatively small handful of doctors who can do stem-cell therapy for UCL tears, but that list is growing rapidly. For example, the annual conference of the Orthobiologic Institutea professional organization for regenerative medicine researchers and practitionersstarted in 2009 with 20 or so doctors; last years event had nearly 1,000.

Some players can throw faster after they have the surgeryThe Angels didnt want to talk to me about why they decided to go public with Heaney and Richards stem-cell therapies. Perhaps thats because Heaneys, on May 2, 2016, was unsuccessful. The 25-year-old former first-round draft pick underwent Tommy John surgery in July of that year after failing to regain strength in his left arm. Hell miss the entire 2017 season, setting back a promising young career.

Richards had his stem-cell procedure just 14 days after Heaney. So far, it seems to have worked. He didnt return to pitch in 2016, but in spring training this year, he was throwing nearly 100 miles per hour. Probably the Angels best starting pitcher, Richards will take the mound on April 5, and all eyes will be on his right throwing armand on his face, to see if it is registering any pain.

If Richards stays healthy this yearand next year, and the year after thathe could become something like the 21st-century Tommy John. Every team will have a stem-cell therapy expert on its medical staff, or at least one on speed dial. Careers will be saved, and so will millions of dollars.

But wider use of stem-cell therapy also will force the MLB to confront an interesting potential side effect of the procedure. Some players can throw faster after they have the surgery, says Purita. By definition, its making the performance better. Right now, major league baseball does not include stem-cell therapy in its list of banned performance enhancers (pdf). But what happens when a baseball player, perhaps a fringe pitching prospect in the low minors, feels some elbow pain one day and gets an MRI, and is diagnosed with nothingbut decides to get stem-cell therapy anyway, since it could give him an extra four miles per hour on his fastball?

The MLB will have a decision to make: To accept potential competitive imbalances to save young arms, or to seek to preserve a level playing field (or even just the fiction of one) at the cost of some of the games best players. The question is all but inevitable.

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Island Animal Hospital Offers Stem Cell Therapy – Beachside Resident

Posted: April 6, 2017 at 1:44 am

No one wants surgery. Dr. Jeffrey Christianson is participating in a study that may provide relief for injured or immune-disordered pets without incisions.

Stem cells can morph into any type of cell needed. The cells are harvested from the animals fat, processed, and reinjected into the pet. These one-size-fits-all cells can be used to replace joint tissue, bone, or other tissues that have worn away or become injured.

Stem cell therapy is a branch of Restorative Medicine helping sick animals restore and improve function. Veterinary medicine has been utilizing Autologous (stem cells from the pet) therapy for well over a decade. It helps animals with arthritis, injuries, inflammatory bowel disease, and other immune-mediated disorders rehabilitate or regain some function.

Dr. Christiansons newest project is a research study to analyze the use of Allogeneic cells (cells from donor pets) in therapy. The clinic is taking part in a double-blinded placebo controlled research study. Half of the patients just get a saline control solution injected into the joint as opposed to a stem cell therapy. He will monitor the results over a six-month period. He wont know until the end of the study who got the control. Some of the pets get a stem cell treatment for free. We do blood work and x-rays, and its all covered by the study.

Its unknown if Allogeneic stem cell therapy is as safe and effective as Autologous therapy. Dr. Christianson noted, The goal of the study is that sick pets could receive stem cell therapy without the pain and discomfort of surgery.

Sick and injured animals recuperating at the Island Animal Clinic have a goodwill ambassador to their lift their spirits. Dr. Ballards dog, Jiminy Cricket (Jim) is a daily visitor. Jim was an injured client. Practice Manager Holly Davis explains, He came in with two broken legs, and it was too much for his owner to handle. Jim was in two casts for months and needed round-the-clock care. Jim now goes to work daily with Dr. Ballard. He runs around the hallways when Dr. Ballard is on break, providing comic relief for recuperating pet patients.

Veterinary medical discoveries are providing a better quality of life and extending the lives of our furry friends. Its exciting that a local animal hospital is at the forefront of these emerging trends. Its also comforting to know recovering pets have Jim for inspiration.

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Diabetes In Mexico: An Epidemic And The No. 1 Killer : Goats and … – NPR

Posted: April 6, 2017 at 1:43 am

A family sells pastries in Mexico City. As Mexicans' wages have risen, their average daily intake of calories has soared. Meghan Dhaliwal/for NPR hide caption

A family sells pastries in Mexico City. As Mexicans' wages have risen, their average daily intake of calories has soared.

Mario Alberto Maciel Tinajero looks like a fairly healthy 68-year-old. He has a few extra pounds on his chest but he's relatively fit. Yet he's suffered for the last 20 years from what he calls a "terrible" condition: diabetes.

"I've never gotten used to this disease," he says. Maciel runs a stall in the Lagunilla market in downtown Mexico City. This market is famous for its custom-made quinceaero dresses and hand-tailored suits.

Diabetes has come to dominate Maciel's life. It claimed the life of his mother. He has to take pills and injections every day to keep it under control.

"I've never gotten used to this disease," says Mario Alberto Maciel Tinajero, at his dress shop in the Lagunilla market. "Imagine not being able to eat a carnitas taco!" Meghan Dhaliwal/for NPR hide caption

"I've never gotten used to this disease," says Mario Alberto Maciel Tinajero, at his dress shop in the Lagunilla market. "Imagine not being able to eat a carnitas taco!"

And because of the disease he's supposed to eat a diet heavy in vegetables that he views as inconvenient and bland. "Imagine not being able to eat a carnitas taco!" he says with indignation. His doctors have told him to stop eating the steaming hot street food that's for sale all around the market tacos, tamales, quesadillas, fat sandwiches called tortas. His eyes light up when talks about the roast pork taquitos and simmering beef barbacoa that he's supposed to stay away from.

"A person who has to work 8 or 10 hours has to eat what's at hand, what's available," he says. "It's difficult to follow a diabetic diet. The truth is it's very difficult."

Diabetes is the leading cause of death in Mexico, according to the World Health Organization. The disease claims nearly 80,000 lives each year, and forecasters say the health problem is expected to get worse in the decades to come. By contrast, in the U.S. it's the sixth leading cause of death, with heart disease and cancer claiming 10 times more Americans each year than diabetes.

Rising rates of obesity combined with a genetic predisposition for Type 2 diabetes has caused a slow steady rise in the condition in Mexico over the last 40 years. Now roughly 14 percent of adults in this country of 120 million are living with what can be a devastating and even fatal health condition. Diabetes poses an increasing burden on the nation's hospitals and clinics. The surge in diabetes threatens the very stability of Mexico's public health care system, according to new reports.

For many people with diabetes in Mexico, like Maciel, managing the condition is a constant and significant challenge.

"I'd say I have it about 50 percent under control," he says, even though he was diagnosed two decades ago. "I take my medicine. I inject my insulin twice a day, in the morning and the night. I try to eat a proper diet as much as I can."

At times he says he can't afford his medications. And trying to cut down on the amount of sugar, salt and fat in his diet, as his doctors tell him he should, is easier said than done.

And Maciel's experience helps explain how Type 2 diabetes has become the leading cause of death in Mexico.

Type 2 diabetes is often considered a lifestyle disease because it's far more likely to develop in people who are overweight. Mexico has seen a rapid increase in obesity, with the number of people categorized as overweight and obese tripling over the last four decades.

The obesity problem is in part a side effect of Mexico's economic progress. As wages have risen, the average daily intake of calories has soared. In 2012 Mexico was the world's top per capita consumer of soda in the world guzzling 176 liters per person per year, according to the Mexican government. That's nearly 500 cans of soda for every man, woman and child. (Mexico was recently overtaken by Argentina, the U.S. and Chile.) Coca-Cola is practically the national drink in Mexico. Type 2 diabetes has skyrocketed as soda consumption has risen.

"In the middle of the 1970s and especially after the '80s, the prevalence of diabetes exploded," says Dr. Carlos Aguilar Salinas, the vice head of the endocrine department at Mexico's National Institute of Medical Sciences and Nutrition in Mexico City.

"Diabetes is now one of the biggest problems in the health system in Mexico," he says. It's the first cause of death. It's the first cause of disability. It's the first cause of early retirement. It's the main cost for the health system."

Diabetes costs the Mexican health care system billions of dollars each year.

The disease can lead to serious eye problems including blindness, nerve damage that requires amputations and kidney failure, among other issues.

Mexico's public health care system attempts to manage the huge number of people with diabetes by trying to get them to manage their blood sugar levels, alter their diet and exercise more.

But there diabetes is typically a lifelong condition. Once someone is diagnosed, the goal is to get the disease under control and keep it from getting worse.

Just around the corner from where Mario Alberto Marciel Tinajero has his dress-making shop, Dr. Rosa Estrella Calvillo Gomez runs a one-room medical clinic in the Lagunilla market.

Dr. Estrella Gomez says her patients don't want to accept that they have a disease for which there is no cure. "Tell me anything but don't tell me I'm a diabetic," they say to her. Meghan Dhaliwal/for NPR hide caption

Dr. Estrella Gomez says her patients don't want to accept that they have a disease for which there is no cure. "Tell me anything but don't tell me I'm a diabetic," they say to her.

The free clinic was set up by the local government. People can come in for any kind of health problem. But Calvillo says roughly half her patients are coming for complications with diabetes.

"Diabetics don't just come in with high blood sugar," Calvillo says sitting behind a desk overflowing with promotional drug samples that she gets from pharmaceutical representatives. "It's about controlling multiple health problems at once," she says, and most of her patients with diabetes don't have the disease under control.

"The problem that I have here first, is the denial and second, the cost of the medication."

Patients don't want to accept that they have a disease for which there is no cure. "Tell me anything but don't tell me that I'm a diabetic,'" she says they tell her. She melodramatically puts her hands over her eyes and shakes her head. "They deny it."

Also, diabetes isn't an easy condition to manage. The public health system treats severe complications like nerve damage or blindness, although dialysis and kidney transplants are not available. For the daily management of diabetes, patients are largely on their own.

Easy access to rich foods, such as those sold at this bakery in a Mexico City Metro station, contributes to Mexico's high rates of obesity and diabetes. Meghan Dhaliwal/for NPR hide caption

Calvillo says a diabetic can easily spend $150 a month out of pocket on insulin injections, blood sugar test strips and medications for hypertension and other complications.

"To get excellent control of diabetes costs a lot of money," she says, "It costs as much as renting an apartment."

Mario Alberto Maciel Tinajero is one of the doctor's patients. He says coping with the disease is a real struggle, and many people with diabetes are desperate.

"The most dangerous thing for diabetics is to fall into the hands of charlatans, swindlers who offer miracle products," he says.

As diabetes took its final toll on his mother, he watched as she spent thousands of pesos on useless he thinks possibly even toxic herbs and injections. After both her feet had been amputated and doctors were only offering palliative care, salesmen came along offering "magical" injections, alleging that they'd give her relief.

"With the promise of a cure, you can be left in the street with nothing," he says. "Absolutely nothing."

Maciel is grateful to have Dr. Calvillo to help him grapple with the condition.

"If this clinic didn't exist," he says, "I would be dead."

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