StemCell Therapy

German oncologists have unveiled that market-approved inhibitors of DNA methyltransferases (DMNTi) and histone deacetylases (HDACi) act through expression of cancer neoantigens. They already have a biomarker test to identify responders.

The findings, reported in Nature Genetics, are good news for drug developers who want to broaden the scope of current immune checkpoint modulators through combination therapies that trigger cancer cells to release immunogenic neoantigens.

Following addition of epigenetic inhibitors to cancer cell cultures thousands of atypical transcripts with altered frameshift were expressed form previously ignored endogenous promotors of retroviral origin, resulting in profound tumour cell death, group leader Plass from German Cancer Centre told European Biotechnology. His team has already a biomarker assay that could identify responders to the treatment as it measures activation of the normally silent treatment induced, not-annotated transcription start sites (TINATs).

Up to now, pharma majors such as Roche/Genentech have largely relied on combination of their checkpoint inhibitors with personalised mRNA cancer vaccines. The new findings might open the avenue to a broader activation of cancer neoantigens than these vaccinesas over 2,500 TINATs have been identified in the human genome by the researchers. The retrotransposons (elements of human endogenous retroviruses, HERVs), which are located in long terminal repeats, have entered the human genome millions of years ago.

However, application of the findings might be hampered by the fact that TINATs, so far, have only been identified in the human genome, which might complicate preclinical in-vivo testing. Its unclear if they also exist in animals, says Plass, who is currently deciphering the exact mechanism that normally stops TINATs from being activated. First findings suggest that acetylation of transcription factors might play an important role.

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Epigenetic drugs set to boost immunoncology - European Biotechnology

The center features a new technologically-advanced laboratory and an additional 180,000 square feet of working space, which is an increase of 145 per cent compared to the former facility.

Eli Lilly and Company has announced completion of a $90 million expansion of its Biotechnology Center in San Diego, California. Lilly's new space will help foster and accelerate the discovery of medicines within the company's core therapeutic areas of immunology, diabetes, oncology and neurodegeneration, as well as the emerging area of pain.

The center features a new technologically-advanced laboratory and an additional 180,000 square feet of working space, which is an increase of 145 per cent compared to the former facility. In addition to the center's established presence in preclinical and clinical immunology research, the new space allows for closer partnership between Lilly experts in biotechnology, discovery chemistry and research technologies while also fostering external collaborations.

As a pioneer in automated organic synthesis, Lilly is creating the Lilly Life Science Studio in San Diego. Building upon Lilly's Automated Synthesis Laboratory in Indianapolis, the new facility will allow researchers across the globe to remotely design, synthesize and screen investigational molecules in an unprecedented manner. Using the power of automation, the Lilly Life Sciences Studio will shape the next generation of drug discovery and expand the reach of individual scientists to test new ideas, while reducing the cost and minimizing the environmental impact of our research activities.

San Diego has long been an important location for Lilly. In 2004 Lilly acquired Applied Molecular Evolution, Inc. before establishing the Lilly San Diego Biotechnology Center in 2009, located near the University of California, San Diego, among other prominent biomedical research institutes. Since its establishment, the center has created more than 100 jobs with more than 200 scientists currently working in various research activities.

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Eli Lilly expands Biotechnology center - BSI bureau (press release)

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Most cases of bone cancer develop in the long bones of the legs or upper arms which can cause symptoms of the disease to be mistaken for arthritis.

The most common symptoms of the disease is a persistent pain which gets worse over time, and like arthritis, can get worse at night.

Other symptoms of bone cancer can include swelling and redness over a bone which can make movement challenging.

This could also be mistaken for gout, an uncomfortable, inflammatory condition that occurs when needle-like crystals of uric acid form within certain joints or soft tissues.

Macmillan Cancer Support said another signs of the disease could be difficulty moving a joint.

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It said: If the cancer is near a joint, this can make it more difficult to move the joint. It can affect the movement of the whole limb.

If the affected bone is in the leg, it may cause a limp. If the tumour is in the spine, it may press on nerves, causing weakness or numbness and tingling in the limbs.

Other symptoms include a high temperature and unexplained weight loss.

Osteosarcoma is the most common form of primary bone cancer in children and young adults, usually affecting people aged 10 to 24 years.

However, there has not been a new treatment for osteosarcoma in almost 40 years, in spite of extensive research.

More than 160 new patients are diagnosed with osteosarcoma in the UK each year, of which around one third cannot be cured.

The current treatment for osteosarcoma is chemotherapy followed by surgery, where the bone tumours are removed.

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Leukaemia 31% - This cancer of the blood is the most common type of childhood cancer

Osteosarcoma is difficult to treat.

Now experts have revealed a subgroup of patients with osteosarcoma could be helped by an existing drug, scientists from the Wellcome Trust Sanger Institute and their collaborators at University College London Cancer Institute and the Royal National Orthopaedic Hospital NHS Trust have suggested.

In the largest genetic sequencing study of osteosarcoma to date, scientists discovered that 10 per cent of patients with a genetic mutation, in particular growth factor signalling genes may benefit from existing drugs, known as IGF1R inhibitors.

In the study, scientists analysed the genome of 112 childhood and adult tumours double the number of tumours studied previously.

Dr Sam Behjati, first author from the Wellcome Trust Sanger Institute and University of Cambridge, said: Osteosarcoma is difficult to treat.

Despite extensive research over the past 40 years, no new treatment options have been found.

In this study we reveal a clear biological target for osteosarcoma that can be reached with existing drugs.

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Professor Adrienne Flanagan, senior author from the Royal National Orthopaedic Hospital NHS Trust and University College London Cancer Institute, said: By sequencing the whole genome of the tumours, we have unpicked the mechanism behind osteosarcoma for the first time.

Dr Peter Campbell, lead author from the Wellcome Trust Sanger Institute, said: Currently, there are no new osteosarcoma treatments on the horizon.

Genomic sequencing has provided the evidence needed to revisit clinical trials of IGF1R inhibitors for the subset of patients that responded in the past.

The mutations of patients tumours may enable clinicians to predict who will, and will not respond to these drugs, resulting in more efficient clinical trials.

The drugs could be effective for 10 per cent of osteosarcoma patients.

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What is bone cancer? Symptoms could be similar to arthritis | Health ... - Express.co.uk

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohns disease stem cell therapy licensed from TiGenix.

Following its acceptance for review by the European Medicines Agency (EMA), Takeda and TiGenix announced this week Swissmedic has accepted for review the file for compound Cx601, an allogeneic expanded adipose-derived stem cell (eASC) therapy for the treatment of complex perianal fistulas in patients with Crohns disease.

The therapy is being made from TiGenix site in Madrid, Spain but CEO Eduardo Bravo told Biopharma-Reporter its partner Takeda which holds the rights for Cx601 in non-US markets following a licensing agreement inked last year will take responsibility for its manufacture from 2021 from a purpose built manufacturing facility in Europe.

Takeda spokesman Luke Willats told this publication: After a transition period for technology transfer during which TiGenix will manufacture Cx601, Takeda will assume responsibility for manufacturing the compound.

But while Willats added the firm is exploring how itcan best meet manufacturing responsibilities for Cx601 following a potential European Commission (EC) approval decision for the compound in 2017, he could not comment further on specific plans or CAPEX investments.

The Japanese pharma firm has its European headquarters in Switzerland, with production sites in Austria, Belgium, Denmark, Estonia, Germany, Ireland, Italy, Norway, Poland and Russia.

Fat chance

Cx601 is produced by TiGenix in plastic flasks in incubators at a one-litre scale, using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons, Bravo told us.

The fat gets sent to our facility in Madrid and is processed to extract the stem cells, which account for about 2% of the material. These are placed in plastic flasks with serum to multiply the number. This is repeated until there is a large population and then the cells are frozen, creating the master cell bank (MCB).

According to Bravo, one liposuction when expanded produces upwards of 360 billion cells, enough to treat 2,400 patients.

While TiGenix is considering using bioreactors for its future pipeline, it will continue making the product as it does now due to not needing to increase volume and the challenges of making production changes in the middle or end of development.

For cell therapies, the process defines the product. Anything you change could change the cells themselves, effectively changing the product.

US deal with Lonza

TiGenix holds the US rights to Cx601 and is discussing with the US Food and Drug Administration (FDA) whether it can file using EMA data, something Bravo said would be decided in the next six-to-eight months.

US trial material will be produced by TiGenixs contract manufacturing organisation (CMO) Lonza , which is undergoing tech transfer at its site in Maryland.

But looking ahead to commercialisation, Bravo said it is not yet decided whether we continue using a CMO or build our own [US] facility.

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Takeda prepping to take over EU production of stem cell therapy from 2021 - BioPharma-Reporter.com

IANS | Mumbai June 23, 2017 Last Updated at 00:16 IST

Raising hopes of new and less painful treatment for burn injuries, a 26-year-old patient with Grade 2 burn injuries was successfully treated using stem cell therapy at a city-based hospital, doctors said on Thursday.

Anand Tiwari suffered burns after accidentally falling in a boiler unit while at work. He sustained Grade 2 and early Grade 3 burns in all parts of the body below his neck.

When admitted to the city based StemRx Bioscience Solutions hospital, he had severe burning sensation and pain all over the body. Blisters and swellings were noticed in many areas of his chest and limbs.

According to doctors, after initial care and stabilisation of the patient, for treatment of burns, a treatment protocol was prepared by Pradeep Mahajan, a regenerative medicine researcher at Stemrx Bioscience Solutions Hospital.

Explaining the treatment procedure, Mahajan said: "This involved the use of growth factors and fibroblasts and collagen based gel. These biological agents stimulate natural healing mechanisms in the body."

"The advantage of these growth factors is that they can be obtained from the patients' own body and hence are safe and effective. Additionally, unlike conventional treatment options, biological agents promote faster recovery," he said.

Under the stem cell therapy, the treatment process has to be repeated continuously so as to get rid of the problem completely and accordingly the procedure was performed.

"During the entire treatment, the patient was not given any closed dressing. He also underwent blood and supplementary fluid transfusion as required to maintain systemic homeostasis," said Mahajan.

He said that changes in the patient were observed as early as two-three days after the initiation of therapy. Drying of superficial burns began and swelling started reducing.

"Gradually, dry crusts started peeling and by the end of the third week, initial healing of most areas was complete. There was no odour or oozing from any wound and he did not complain of pain or burning sensation anymore.

"After a month-long treatment, healthy skin formation is being observed and further healing is progressing at an impressive rate," said Mahajan, adding that in treatment through conventional modalities, it takes more than eight weeks for healing to happen and further several months for patient to be able to regain joint and facial movements.

--IANS

rup/nir

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

Raising hopes of new and less painful treatment for burn injuries, a 26-year-old patient with Grade 2 burn injuries was successfully treated using stem cell therapy at a city-based hospital, doctors said on Thursday.

Anand Tiwari suffered burns after accidentally falling in a boiler unit while at work. He sustained Grade 2 and early Grade 3 burns in all parts of the body below his neck.

When admitted to the city based StemRx Bioscience Solutions hospital, he had severe burning sensation and pain all over the body. Blisters and swellings were noticed in many areas of his chest and limbs.

According to doctors, after initial care and stabilisation of the patient, for treatment of burns, a treatment protocol was prepared by Pradeep Mahajan, a regenerative medicine researcher at Stemrx Bioscience Solutions Hospital.

Explaining the treatment procedure, Mahajan said: "This involved the use of growth factors and fibroblasts and collagen based gel. These biological agents stimulate natural healing mechanisms in the body."

"The advantage of these growth factors is that they can be obtained from the patients' own body and hence are safe and effective. Additionally, unlike conventional treatment options, biological agents promote faster recovery," he said.

Under the stem cell therapy, the treatment process has to be repeated continuously so as to get rid of the problem completely and accordingly the procedure was performed.

"During the entire treatment, the patient was not given any closed dressing. He also underwent blood and supplementary fluid transfusion as required to maintain systemic homeostasis," said Mahajan.

He said that changes in the patient were observed as early as two-three days after the initiation of therapy. Drying of superficial burns began and swelling started reducing.

"Gradually, dry crusts started peeling and by the end of the third week, initial healing of most areas was complete. There was no odour or oozing from any wound and he did not complain of pain or burning sensation anymore.

"After a month-long treatment, healthy skin formation is being observed and further healing is progressing at an impressive rate," said Mahajan, adding that in treatment through conventional modalities, it takes more than eight weeks for healing to happen and further several months for patient to be able to regain joint and facial movements.

--IANS

rup/nir

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

IANS

http://bsmedia.business-standard.com/_media/bs/wap/images/bs_logo_amp.png 177 22

Original post:
Patient with severe burns treated using stem cell therapy | Business ... - Business Standard

June 23, 2017

Imagine being able to take cells from your skin, transform them into other types of cells, such as lung, brain, heart or muscle cells, and use those to cure your ailments, from diabetes to heart disease or macular degeneration. To realise this, however, challenges still remain, Professor Janet Rossant, a pioneer in the field, says.

All across the world, scientists have begun clinical trials to try and do just that, by making use of the incredible power and versatility of stem cells, which are special cells that can make endless copies of themselves and transform into every other type of cell.

While human embryos contain embryonic stem cells, which help them to develop, the use of those cells has been controversial. The scientists are using induced pluripotent stem cells instead, which are other cells that have been reprogrammed to behave like stem cells.

"There are still significant challenges that we need to overcome, but in the long run we might even be able to create organs from stem cells taken from patients. That would enable rejection-free transplants," said Professor Janet Rossant, a pioneer in the field.

The mouse that changed everything

A speaker at the recent Commonwealth Science Conference 2017 held in Singapore and organised by Britain's Royal Society and Singapore's National Research Foundation, Prof Rossant gave an overview of stem cells' origins, history, uses and potential.

Now a senior scientist at The Hospital for Sick Children (also known as Sick Kids) in Toronto, Canada, after a decade as its chief of research, she was the first scientist to demonstrate the full power of stem cells in mice.

In the early 1990s, scientists believed that stem cells could only become certain types of cells and carry out limited functions. Based on her own research and that of others, however, Prof Rossant believed that they were capable of far more.

Working with other scientists, she created an entire mouse out of stem cells in 1992, upending the conventional wisdom. "We went on to create many baby mice that were completely normal, and completely derived from stem cells grown in a petri dish," she said.

"That was an amazing experiment, and it was instrumental in making people believe that human embryonic stem cells could have the full potential to make every cell type in the body," she added.

When scientists learned how to remove stem cells from human embryos in 1998, however, controversy ensued. Many lobbied against the cells' use in medical research and treatment due to the moral implications of destroying even unwanted embryos to gain the cells.

In Canada, Prof Rossant chaired the working group of the Canadian Institutes of Health Research on Stem Cell Research, establishing guidelines for the field. These guidelines helped to keep the field alive in Canada, and were influential well beyond the country's borders.

In 2006, Japanese researchers succeeded in taking skin cells from adult mice and reprogramming them to behave like embryonic stem cells. These revolutionary, induced pluripotent stem (IPS) cells allowed scientists to sidestep the ongoing controversy.

The challenges in the way

While stem cells have been used for medical treatment in some cases bone marrow transplants, for example, are a form of stem cell therapy there are several challenges that need to be overcome before they can be used more widely to treat diseases and injuries.

"We need to get better at turning stem cells into the fully mature cells that you need for therapy. That's going to take more work. Another issue is that of scale-up. If you're going to treat a patient, you need to be able to grow millions of cells," said Prof Rossant.

She added: "Safety is another concern. One of the most exciting things about pluripotent stem cells is that they can divide indefinitely in the culture dish. But that's also one of the most scary things about them, because that's also how cancer works.

"Furthermore, because we need to genetically manipulate cells to get IPS cells, it's very hard to know whether we've got completely normal cells at the end of the day. These are all issues that need to be resolved."

She noted that some scientists are working on making "failsafe" IPS cells, which have a built-in self-destruct option if they become dangerous. "Bringing stem cells into regenerative medicine is going to require interdisciplinary, international collaboration," she said.

In the meantime, stem cells have been a boon to medical research, as scientists can use them to create an endless supply of different cells to study diseases and injuries, and test drugs. "That's the biggest use of IPS cells right now," Prof Rossant said.

Sick kids and how to help them

At SickKids, which is Canada's largest paediatric research hospital, she has been using stem cells to study cystic fibrosis, a frequently fatal genetic disorder that causes mucus to build up and clog some organs such as the lungs. It affects primarily children and young adults.

SickKids discovered the CFTR gene that, when mutated, causes the disease. It was also the first to produce mature lung cells, from stem cells, that can be used to study the disease and test drugs against it.

Even better, Prof Rossant and her team were able to turn skin cells from cystic fibrosis patients into IPS cells and then into lung cells with the genetic mutation specific to each of them. This is critical to personalising treatment for each patient.

"Drugs for cystic fibrosis are extraordinarily expensive, and patients can have the same mutation and yet respond differently to the same drug," Prof Rossant explained. "With our work, we can make sure that each patient gets the right drug at the right time."

In 1998, Prof Rossant also discovered a new type of stem cell in mice, now called the trophoblast stem cell. These surround an embryo and attach it to the uterine wall, eventually becoming the placenta. She is using such cells to study placenta defects and pregnancy problems.

By using IPS cells to create heart cells and other cells, pharmaceutical companies can also test their new drugs' effectiveness and uncover potential side effects, as well as develop personalised medicines.

"There are still huge amounts of opportunities in pluripotent stem cells," said Prof Rossant, who has won numerous awards for her research, including the Companion of the Order of Canada and the 2016 Friesen International Prize in Health Research.

She is also president and scientific director of the Toronto-based Gairdner Foundation, which recognises outstanding biomedical research worldwide, and a professor at the University of Toronto's molecular genetics, obstetrics and gynaecology departments.

"Meetings like the Commonwealth Science Conference are a fantastic opportunity for scientists to come together, learn about each other's work and establish new relationships, which will help to push science forward, including in stem cell research," she said.

She noted: "The world of science is becoming increasingly interdisciplinary, so this kind of meeting of minds across nations, cultures and scientific fields is really the way of the future."

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Stem cells: the future of medicine - Medical Xpress

Sarepta Therapeutics has penned its second DMD gene therapy pact this year as it announces a tie-up with Frances Genethon, a nonprofit R&D org.

The research collaborationwill see the Franco-American pair jointly develop treatments for Duchenne muscular dystrophy and comes after Sareptas first FDA approval for DMD with its controversial med Exondys 51 (eteplirsen).

RELATED: FDA expert lashes out at 'worrisome' Sarepta approval in JAMA

Sarepta is looking to tap into Genethons preclinical microdystrophin gene therapy approach, which can target the majority of patients with DMD. Its current med can only treat certain patients, namely those with the mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13% of the population with DMD.

It is hoping that with new tie-ups, it could produce a gene therapy that could treat many more, if not all, patients with the disease, although this is still some years off. DMD is a rare genetic disorder characterized by progressive muscle deterioration and weakness. The disease primarily affects young boysand occurs in about one out of every 3,600 male infants worldwide.

This builds on the pacts announced at the start of the year at the JPM conference, which saw it sign a deal with the Nationwide Childrens Hospital, which also focuses on the microdystrophin gene therapy program, as well as another form of gene therapy.

An initial phase 1/2a trial for the microdystrophin gene therapy is slated to begin at the end of the year and will be done at Nationwide Childrens. It also penned an exclusive license agreement with Nationwide for their Galgt2 gene therapy program, originally developed by researcher Paul Martin. This early-stage program aims to research a potential surrogate gene therapy approach to DMD, whereby the gene therapy looks to induce genes that make proteins that can perform a similar function as dystrophin. The goal will be to produce a muscle cell that can function normally even when dystrophin is absent, Sarepta said at the time.

Under the terms of its latest collaboration, Genethon will be responsible for the early development work. Sarepta has the option to co-develop Genethons microdystrophin program, which includes exclusive U.S. commercial rights. Financial terms, as is becoming more common with these pacts, have not been disclosed.

RELATED: With Exondys 51 approved, Sarepta chief Ed Kaye to bow out

Our agreement with Genethon strengthens our ongoing commitment to patients and is aligned with our strategy of building the industrys most comprehensive franchise in DMD, said Ed Kaye, Sareptas outgoing chief. This partnership brings together our collective experience in Duchenne drug development and Genethons particular expertise in gene therapy for rare diseases. We look forward to working with Genethon given their knowledge, large infrastructure and state-of the-art manufacturing capabilities to advance next generation therapies for DMD.

Frederic Revah, CEO of Genethon, added: Microdystrophin-based gene therapy is a very promising approach with potential application to a large majority of Duchenne patients. In order to accelerate the development of a treatment, we are very pleased to partner with Sarepta Therapeutics, which has demonstrated commitment and success for innovative therapies for Duchenne muscular dystrophy. This partnership brings together the highly complementary and synergistic expertises of Sarepta and Genethon, to the benefit of the patients.

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Sarepta signs another Duchenne gene therapy pact as it aims for wider treatment - FierceBiotech

San Francisco-based Vineti, a cell and gene therapy software and analytics company, has closed on Series A funding round that pulled together nearly $14 million.

Backing came from General Electric Ventures, Mayo Clinic and new investor Draper Fisher Jurvetson.

The company will use the funds to continue growing its team and to deliver cloud-based software to improve patient access. It also plans to speed its work on life-saving treatment delivery and to promote safety and FDA compliance for individualized cell therapies.

The Vineti platform integrates logistics, manufacturing and clinical data.

Physicians, medical researchers and pharmaceutical companies are working together to develop successful therapies, transitioning from a one-size-fits-all model to individualized treatments for each patient, Vineti CEO Amy DuRoss said in a statement. But, the process for administering these treatments is broken and outdated, restricting access to terminal patients and creating unnecessary risk.

DuRoss added that Vineti developed the platform to ensure treatments reach the patients who need them the most. She added that many patients who are excellent candidates dont have access to the most innovative therapies and discovery timelines are more challenging than necessary.

GE Ventures formed Vineti based on customer requests to bridge the technology gap between individualized cell therapies and production.

Modern technology solutions to address complex production and delivery processes are lacking. GE Ventures, Mayo Clinic and DFJ have invested in Vineti to rectify these problems.

Vineti is led by DuRoss, Chief Strategy Officer Heidi Hagen and CTO Razmik Abnous.

Twitter: @Bernie_HITN Email the writer: bernie.monegain@himssmedia.com

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Vineti to fast-track cell and gene therapy tech with $14 million first ... - Healthcare IT News

SAN FRANCISCO, Calif. Mayo Clinic Ventures has partnered with a California-based company to make cancer-fighting gene therapies available to the public.

Vineti, a pioneering cell and gene therapy software and analytics company, announced Tuesday that it had completed its initial round of funding raising $13.75 million aimed at delivering "the first cloud-based software solution to improve patient access, accelerate life-saving treatment delivery, and promote safety and regulatory compliance for individualized cell therapies."

The funding was provided by Mayo Clinic Ventures, GE Ventures, DFJ and LifeForce Capital. It's just the 15th company that Mayo Clinic Ventures has backed since it was formed, according to Andy Danielson, vice chairman of Mayo Clinic Ventures.

"One thing with Vineti that we liked is that we have a commitment to cell and gene therapies at Mayo," Danielson told TechCrunch.com. "Vineti will make the gene and cell therapy production process more efficient and as a result, less costly. It's all part of the equation of making these therapies more affordable and opening them up to a greater number of people."

The targeted cancer therapy under development by Vineti is part of a thriving field that conducted more than 800 clinical trials in 2016 while investing nearly $6 billion. It's all aimed at positively impacting the oncology field, the largest market in medicine that's expected to grow to $165 billion by 2021.

The first two cell therapies are expected to hit the market later this year.

Vineti touts its plans as one that "integrates logistics, manufacturing and clinical data to improve product performance overall and enable faster, broader access for patients."

"Physicians, medical researchers and pharmaceutical companies are working together to develop successful therapies, transitioning from a one-size-fits-all model to individualized treatments for each patient," said Amy DuRoss, CEO at Vineti. "Now, the process for creating and delivering these treatments can be as innovative as the therapies themselves. We are developing the Vineti platform to help these treatments reach the patients who need them the most, and are confident the partnership between our advances technologies and leading medical research will deliver better outcomes across the globe."

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Mayo Clinic Ventures funds new cancer-fighting cell, gene therapy ... - Post-Bulletin

British drugmaker GlaxoSmithKline made headlines last year when it won approval for its gene therapy Strimvelis in Europe. But, due to a small patient population and high price tag, the drug has only been used once. So far, despite higher levels of safety and efficacy than previous iterations, the new wave of gene therapies still face commercial hurdles.

Spark Therapeutics looks set to be the next company to take on this challenge in the U.S. The biotech is currently awaiting approval of its treatment for a rare genetic form of blindness a potential one-time cure. Yet pricing will be the most closely watched aspect of this therapy, likely serving as an early barometer of what might be sustainable for a pipeline of treatments still in development.

While gene therapy offers the promise of cures and new ways of revolutionizing treatment of genetic diseases, society remains a long way from fully realizing those advances.

After decades of setbacks, a slew of next-gen gene therapies are ready to hit the U.S. market, prompting questions about manufacturing and pricing. Read More >>

A pricing conundrum and ethical decisions are clouding an already hazy path to market for many gene therapy drugs and providers. Read More >>

With an approval of Spark Therapeutics' gene therapy for a rare eye disease rapidly approaching, new questions about pricing are being raised. Read More >>

In a field shaped by small patient populations and eye-popping cost considerations, understanding gene therapy's promise and challenges comes down, in part, to the numbers. Read More >>

While many are optimistic about gene editing's ability to cure disease, it seems not enough realize the more dangerous aspects of treatment. Read More >>

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Gene therapy: What you need to know - BioPharma Dive

[ACCESSWIRE]

SUNRISE, FL / ACCESSWIRE / June 21, 2017 / U.S. Stem Cell (OTCQB: USRM). A scientific paper about intra-articular injection for the treatment of osteoarthritis co-authored by Kristin Comella, Chief Science Officer at U.S. Stem Cell, Inc., a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, was published in the June 20, 2017 issue of the Journal of Translational Medicine.

Comella is a world-renowned expert on regenerative medicine with a focus on adipose derived stem cells. She was named number 24 on Terrapin's list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose.

Entitled, "Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis," the scientific paper was co-authored by Kristin Comella, Himanshu Bansal, Jerry Leon, Poonam Verma, Diwaker Agrawal, Prasad Koka and Thomas Ichim. Below is a link and abstract to the paper: http://bit.ly/2smaM93.

Background: Stromal vascular fraction (SVF) can easily be obtained from a mini- lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. We evaluated the safety and preliminary e?-cacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.

Methods: A total of ten patients underwent a local tumescent liposuction procedure to remove approximately 100 ml of fat tissue from the abdomen. SVF was isolated using an enzyme digestion and resuspended in PRP for intra-articular injection in the knee. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and six-minute walk distance (6MWD) were used to evaluate clinical e?ects and included the measure of patient's subjective assessment of pain, joint mobility, and physical disability. WOMAC score, 6MWD and laboratory tests were repeated at 3 and 6 months and 1, 1.5 and 2 years. XRAY and MRI were completed at 1 year.

Results: The average total WOMAC score was 64 at baseline and signi?cantly reduced to 52 at 3 months, 46 at 6 months, 42 at 1 year, 38 at 1.5 years, and 41 at 2 years. Patients walked an average of 1310 feet at baseline and demonstrated a statistically signi?cant improvement at 3 and 6 months and 1, 1.5, and 2 years post treatment. Cartilage thickness as determined by MRI improved by at least 0.2 mm in six patients, was unchanged in two patients and decreased by at least 0.2 mm in two patients.

Conclusions: Overall, all of the patients were pleased with the treatment results. They reported a reduction in pain levels, especially after 3 months. More importantly, the procedure demonstrated a strong safety pro?le with no severe adverse events or complications reported.

Trial registration NCT03089762; Name of registry: http://www.clinicaltrials.gov.

About U.S. Stem Cell, Inc.

U.S. Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development, and commercialization of cell-based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.

Our business, which includes three operating divisions (U.S. Stem Cell Training, Vetbiologics, and U.S. Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.

Forward-Looking Statements:

Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue," or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.

Media Contact:

U.S. Stem Cell, Inc. 13794 NW 4th Street, Suite 212 Sunrise, Fl 33325 Phone: 954.835.1500 Email: usstemcell@us-stemcell.com

SOURCE: U.S. Stem Cell, Inc.

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Kristin Comella, US Stem Cell's CSO, Co-Authors Scientific Paper on Intra-Articular Injection for Osteoarthritis ... - Baystreet.ca

Dr. CohenFor the first time, the FDA has approved a reusable fat collection and transfer system for plastic and reconstructive surgery.

In March, Millennium Medical Techologies (MMT) was granted clearance of its collection of canisters, lids, luer extension and bags that are used with vacuum and/or cleared pumps, tubing and cannulas for collection and transfer of aspirate fat.

The FDA clearance of these items for grafting permits me to use FDA-validated devices in conjunction with the companys Lipo-Loop for large volume fat grafting, without cost or need for additional processing devices, says Steven R. Cohen, M.D., medical director and owner of FACES+ Plastic Surgery, Skin and Laser Center in San Diego, Calif.

Dr. Cohen tells Cosmetic Surgery Times that he co-developed Lipo-Loop, a sterile closed system for liposuction, to eliminate the confusion around large volume fat grafting. Tumescent anesthesia is more effectively delivered because the device vibrates while instilling the solution, making it very comfortable for the patient.

The fat is gently separated by vibration, yielding more stem and regenerative cells, while loosening up the fat and making it easier and more comfortable to remove, Dr. Cohen explains. Because the fat graft is optimized by the hole size of the harvest cannula, it is already micronized. Then, after rinsing, if even needed, the fat is ready to be reinjected into the patient using an automatic injection with vibration, making the fat graft more uniformly distributed and smoother.

Dr. Cohen says Lipo-Loop is the first commercially available system to make large volume fat grafting predictable, simple and safe. Not only can one obtain macrofat for grafting larger volumes into breasts and buttocks, but one can also modify the fat for full facial rejuvenation in a new procedure I have labeled injectable tissue regeneration.

Related: Best practices for facial fat transfer

The discovery of bioactive and biostimulatory cells and molecules, such as mesenchymal stem cells, pericytes, growth factors, exosomes and other cell signaling factors in fat, are leading to a disruption in not only how we will manage aging in the face, but also how we will manage aging and wear and tear in other body tissues, Dr. Cohen says.

For instance, for early knee injury, instead of injecting a steroid to reduce pain and inflammation, we will be injecting stromal vascular fraction cells and platelet rich plasma into the knee to reduce inflammation and stimulate repair, Dr. Cohen says.

Likewise, for facial aging, we will be treating a woman with full facial fat grafting early in the course of agingto replace what is being lost with biologically active tissues that not only restore appearance, but actually regenerate tissue that has aged, Dr. Cohen says. These new strategies will likely be found to impact us even on the cellular level, where we may for the first time begin to see a deacceleration of the aging process in some tissues treated with these new regenerative approaches.

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Lipo-Loop: A closed system for large-volume fat transfer - ModernMedicine

When we cant see clearly, we grasp at what we can. While we cant correct vision without the help of lenses or surgery, there are some fundamental ways you can improve your eyesight and eye health on your own.

The best way to improve your eyesight naturally is to give your eyes what they need to be healthy. A steady supply of nutritious foods and vitamins keeps your eyes and your body in general at their peak.

Two common vitamins and antioxidants shown to help improve eyesight include:

Lutein is a pigment found in high concentrations in a layer of the retina where pigment-packed cells help shield against excess light. Solid scientific research shows that lutein supplementation aids this process in our eyes to naturally improve vision.

Fortunately, lutein is an antioxidant that occurs naturally in fruits and vegetables such as spinach, kale, and Swiss chard

Many of the vitamins and antioxidants that improve eyesight naturally are found in common foods, including:

Many eye exercises are touted as ways to naturally improve eyesight and overcome nearsightedness. The Bates Method suggests palming, movement and visualization techniques to reshape the eyeball and improve vision. Yan Bao Jian Cao suggests massage and acupressure as ways to relieve strain and eye problems.

However, none of these exercises are verified to have more than anecdotal or placebo results. While vision therapy is a serious area of optometry that addresses problems with alignment, tracking and strain, theres no sound evidence that vision exercises can affect clarity.

We cant correct our vision without professional help, and theres no quick-and-easy fix for eyesight problems. But with tools such as good nutrition and diet, you can still help your eyesight naturally and on your own. As always, please discuss with your eye doctor.

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Improve Eyesight & Vision | Eye Exercises | CooperVision

The beauty truly is in the details. Andrew Airey was born with a genetic disorder known as Stargardt Macular Dystrophy, but wasnt properly diagnosed until he was an adult. As a result, Airey often struggled with his eyesight as a child, but it wasnt until he was in his mid-20s that he pretty much lost his eyesight entirely.

By then, he was already in a relationship with his now-wife, Kelli, whom he calls a covenant wife.

Kelli knew that I had low vision and it was something that she accepted, Airey tells The Knot. I was going to specialists often and it was not until 2006 that I was able to get some real answers about my eye problems I lost my detail vision, color vision, the ability to focus in on items at several distances. I was upset. Kelli knew that there was no cure and my eyesight would get worse. She has been right by my side through this whole endeavor.

When the pair got married in August 2002, Airey remembers he wasnt able to really see Kellis face or any other details from their special daya fact that still haunts him.

I have been out of focus for too long, he says. When you have an eye disease, it is challenging to function at a high level. I am a tenacious individual and I will try to the best of my ability to overcome any challenge that life brings. I was not able to see my wifes face Honestly, the average person has no idea what it is like and lack of awareness is prevalent in our world.

In 2015, then the couple happened upon eSight Corp, a new technology company giving legally blind individuals the gift of sight, after actively searching for possible solutions. From there, Director of Marketing Jeff Fenton reached out to the couple with a once-in-a-lifetime opportunity: to recreate their wedding. This time, Airey would be able to see it all.

The pair, who share three daughters, gathered close friends and family, and, as documented in a viral video shared on eSights Facebook page, they recreated their celebration of love.It was an incredible experience, Airey says. I was able to see Kelli walk down the aisle smiling the whole time. I saw her beautiful face, her dress, and her veil. I will never forget it.

Airey noticed other details too: When my daughters walked down the aisle I could see their sweet faces, their facial features which have been a blur for so long. I remember seeing my daughter Avas ring on her finger and the diamonds in Kellis veil. The details of everyday life, which so many people take for granted, were brought to life for me again that day.

(Photo courtesy of eSight)

(Photo courtesy of eSight)

Now, Airey and his family are excited to experience life with his rediscovered vision, and he tells The Knot that though there are so many things hes excited to see, the one that hes most thankful for is being able to see his three daughters dancing.

One of the most precious moments was seeing each of my daughters in their dance classes, Airey says. All three girls have a passion for dance and have danced at a local studio, Creative Sole, for years. I have missed out on actually being able to see them during some of their happiest moments. As I write this, my girls are preparing for their recital tonight and tomorrow. Words cannot describe how much I am looking forward to watching them dance on stage. This is their sixth dance recital, but for me, it will all be new thanks to my eSight glasses.

(Photo courtesy of eSight)

In retrospect, Airey says he sees the deeper meaning and implications behind his eye disease and his familys love and support through it all. I know there is a greater purpose for our lives, he says. I believe that God chose me to inspire others through this challenge. I have lost my sight, but not my vision.

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Legally Blind Man Finally Sees His Wife For the First Time at Their Second Wedding - The Knot News

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BEHAVIORAL MED & PSYCH CLIN. ENDO. HLTH CR & PUB HLTH COMPLICATIONS DIABETES IN YOUTH EDUCATION EPIDEMIOLOGY & STATISTICS EXERCISE FOOT CARE IMMUNOLOGY, IMMUNOGENETICS NUTRITIONAL SCIENCES & METABOL PREG AND REPRODUCTIVE HEALTH

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American Diabetes Association

Definition

Diabetes mellitus refers to a group of diseases that affect how your body uses blood sugar (glucose). Glucose is vital to your health because it's an important source of energy for the cells that make up your muscles and tissues. It's also your brain's main source of fuel.

If you have diabetes, no matter what type, it means you have too much glucose in your blood, although the causes may differ. Too much glucose can lead to serious health problems.

Chronic diabetes conditions include type 1 diabetes and type 2 diabetes. Potentially reversible diabetes conditions include prediabetes when your blood sugar levels are higher than normal, but not high enough to be classified as diabetes and gestational diabetes, which occurs during pregnancy but may resolve after the baby is delivered.

Diabetes symptoms vary depending on how much your blood sugar is elevated. Some people, especially those with prediabetes or type 2 diabetes, may not experience symptoms initially. In type 1 diabetes, symptoms tend to come on quickly and be more severe.

Some of the signs and symptoms of type 1 and type 2 diabetes are:

Although type 1 diabetes can develop at any age, it typically appears during childhood or adolescence. Type 2 diabetes, the more common type, can develop at any age, though it's more common in people older than 40.

To understand diabetes, first you must understand how glucose is normally processed in the body.

Insulin is a hormone that comes from a gland situated behind and below the stomach (pancreas).

Glucose a sugar is a source of energy for the cells that make up muscles and other tissues.

The exact cause of type 1 diabetes is unknown. What is known is that your immune system which normally fights harmful bacteria or viruses attacks and destroys your insulin-producing cells in the pancreas. This leaves you with little or no insulin. Instead of being transported into your cells, sugar builds up in your bloodstream.

Type 1 is thought to be caused by a combination of genetic susceptibility and environmental factors, though exactly what many of those factors are is still unclear.

In prediabetes which can lead to type 2 diabetes and in type 2 diabetes, your cells become resistant to the action of insulin, and your pancreas is unable to make enough insulin to overcome this resistance. Instead of moving into your cells where it's needed for energy, sugar builds up in your bloodstream.

Exactly why this happens is uncertain, although it's believed that genetic and environmental factors play a role in the development of type 2 diabetes. Being overweight is strongly linked to the development of type 2 diabetes, but not everyone with type 2 is overweight.

During pregnancy, the placenta produces hormones to sustain your pregnancy. These hormones make your cells more resistant to insulin.

Normally, your pancreas responds by producing enough extra insulin to overcome this resistance. But sometimes your pancreas can't keep up. When this happens, too little glucose gets into your cells and too much stays in your blood, resulting in gestational diabetes.

Risk factors for diabetes depend on the type of diabetes.

Although the exact cause of type 1 diabetes is unknown, factors that may signal an increased risk include:

Researchers don't fully understand why some people develop prediabetes and type 2 diabetes and others don't. It's clear that certain factors increase the risk, however, including:

Any pregnant woman can develop gestational diabetes, but some women are at greater risk than are others. Risk factors for gestational diabetes include:

Long-term complications of diabetes develop gradually. The longer you have diabetes and the less controlled your blood sugar the higher the risk of complications. Eventually, diabetes complications may be disabling or even life-threatening. Possible complications include:

Most women who have gestational diabetes deliver healthy babies. However, untreated or uncontrolled blood sugar levels can cause problems for you and your baby.

Complications in your baby can occur as a result of gestational diabetes, including:

Complications in the mother can also occur as a result of gestational diabetes, including:

Prediabetes may develop into type 2 diabetes.

You're likely to start by seeing your primary care doctor if you're having diabetes symptoms. If your child is having diabetes symptoms, you might see your child's pediatrician. If blood sugar levels are extremely high, you'll likely be sent to the emergency room.

If blood sugar levels aren't high enough to put you or your child immediately at risk, you may be referred to a doctor who specializes in diabetes, among other disorders (endocrinologist). Soon after diagnosis, you'll also likely meet with a diabetes educator and a dietitian to get more information on managing your diabetes.

Here's some information to help you get ready for your appointment and to know what to expect.

Preparing a list of questions can help you make the most of your time with your doctor. For diabetes, some questions to ask include:

Examples of questions your doctor may ask, include:

Symptoms of type 1 diabetes often appear suddenly and are often the reason for checking blood sugar levels. Because symptoms of other types of diabetes and prediabetes come on more gradually or may not be evident, the American Diabetes Association (ADA) has recommended screening guidelines. The ADA recommends that the following people be screened for diabetes:

If the A1C test results aren't consistent, the test isn't available, or if you have certain conditions that can make the A1C test inaccurate such as if you're pregnant or have an uncommon form of hemoglobin (known as a hemoglobin variant) your doctor may use the following tests to diagnose diabetes:

If type 1 diabetes is suspected, your urine will be tested to look for the presence of a byproduct produced when muscle and fat tissue are used for energy when the body doesn't have enough insulin to use the available glucose (ketones). Your doctor will also likely run a test to see if you have the destructive immune system cells associated with type 1 diabetes called autoantibodies.

Your doctor will likely evaluate your risk factors for gestational diabetes early in your pregnancy:

Your doctor may use the following screening tests:

Depending on what type of diabetes you have, blood sugar monitoring, insulin and oral medications may play a role in your treatment. Eating a healthy diet, maintaining a healthy weight and participating in regular activity also are important factors in managing diabetes.

An important part of managing diabetes as well as your overall health is maintaining a healthy weight through a healthy diet and exercise plan:

Healthy eating. Contrary to popular perception, there's no specific diabetes diet. You'll need to center your diet on more fruits, vegetables and whole grains foods that are high in nutrition and fiber and low in fat and calories and cut down on animal products, refined carbohydrates and sweets. In fact, it's the best eating plan for the entire family. Sugary foods are OK once in a while, as long as they're counted as part of your meal plan.

Yet understanding what and how much to eat can be a challenge. A registered dietitian can help you create a meal plan that fits your health goals, food preferences and lifestyle. This will likely include carbohydrate counting, especially if you have type 1 diabetes.

Treatment for type 1 diabetes involves insulin injections or the use of an insulin pump, frequent blood sugar checks, and carbohydrate counting. Treatment of type 2 diabetes primarily involves monitoring of your blood sugar, along with diabetes medications, insulin or both.

Monitoring your blood sugar. Depending on your treatment plan, you may check and record your blood sugar as often as several times a week to as many as four to eight times a day. Careful monitoring is the only way to make sure that your blood sugar level remains within your target range. People who receive insulin therapy also may choose to monitor their blood sugar levels with a continuous glucose monitor. Although this technology doesn't yet replace the glucose meter, it can provide important information about trends in blood sugar levels.

Even with careful management, blood sugar levels can sometimes change unpredictably. With help from your diabetes treatment team, you'll learn how your blood sugar level changes in response to food, physical activity, medications, illness, alcohol, stress for women, fluctuations in hormone levels.

In addition to daily blood sugar monitoring, your doctor will likely recommend regular A1C testing to measure your average blood sugar level for the past two to three months. Compared with repeated daily blood sugar tests, A1C testing better indicates how well your diabetes treatment plan is working overall. An elevated A1C level may signal the need for a change in your insulin regimen or meal plan. Your target A1C goal may vary depending on your age and various other factors. However, for most people with diabetes, the American Diabetes Association recommends an A1C of below 7 percent. Ask your doctor what your A1C target is.

Insulin. People with type 1 diabetes need insulin therapy to survive. Many people with type 2 diabetes or gestational diabetes also need insulin therapy.

Many types of insulin are available, including rapid-acting insulin, long-acting insulin and intermediate options. Depending on your needs, your doctor may prescribe a mixture of insulin types to use throughout the day and night.

Insulin can't be taken orally to lower blood sugar because stomach enzymes interfere with insulin's action. Often insulin is injected using a fine needle and syringe or an insulin pen a device that looks like a large ink pen.

An insulin pump may also be an option. The pump is a device about the size of a cellphone worn on the outside of your body. A tube connects the reservoir of insulin to a catheter that's inserted under the skin of your abdomen. A tubeless pump that works wirelessly is also now available. You program an insulin pump to dispense specific amounts of insulin. It can be adjusted to deliver more or less insulin depending on meals, activity level and blood sugar level.

An emerging treatment approach, not yet available, is closed loop insulin delivery, also known as the artificial pancreas. It links a continuous glucose monitor to an insulin pump. The device automatically delivers the correct amount of insulin when the monitor indicates the need for it. There are a number of different versions of the artificial pancreas, and clinical trials have had encouraging results. More research needs to be done before a fully functional artificial pancreas can receive regulatory approval.

However, the first step toward an artificial pancreas was approved in 2013. Combining a continuous glucose monitor with an insulin pump, this system stops insulin delivery when blood sugar levels drop too low. Studies on the device found that it could prevent low blood sugar levels overnight without significantly increasing morning blood sugar levels.

Controlling your blood sugar level is essential to keeping your baby healthy and avoiding complications during delivery. In addition to maintaining a healthy diet and exercising, your treatment plan may include monitoring your blood sugar and, in some cases, using insulin or oral medications.

Your health care provider will also monitor your blood sugar level during labor. If your blood sugar rises, your baby may release high levels of insulin which can lead to low blood sugar right after birth.

If you have prediabetes, healthy lifestyle choices can help you bring your blood sugar level back to normal or at least keep it from rising toward the levels seen in type 2 diabetes. Maintaining a healthy weight through exercise and healthy eating can help. Exercising at least 150 minutes a week and losing 5 to 10 percent of your body weight may prevent or delay type 2 diabetes.

Sometimes medications such as metformin (Glucophage, Glumetza, others) also are an option if you're at high risk of diabetes, including when your prediabetes is worsening or if you have cardiovascular disease, fatty liver disease or polycystic ovary syndrome.

In other cases, medications to control cholesterol statins, in particular and high blood pressure medications are needed. Your doctor might prescribe low-dose aspirin therapy to help prevent cardiovascular disease if you're at high risk. Healthy lifestyle choices remain key, however.

Because so many factors can affect your blood sugar, problems may sometimes arise that require immediate care, such as:

Diabetes is a serious disease. Following your diabetes treatment plan takes round-the-clock commitment. Careful management of diabetes can reduce your risk of serious even life-threatening complications.

No matter what type of diabetes you have:

In addition, if you have type 1 or type 2 diabetes:

If you drink alcohol, do so responsibly. Alcohol can cause either high or low blood sugar, depending on how much you drink and if you eat at the same time. If you choose to drink, do so only in moderation one drink a day for women of all ages and men older than 65, and up to two drinks a day for men age 65 and younger and always with food.

Remember to include the carbohydrates from any alcohol you drink in your daily carbohydrate count. And check your blood sugar levels before going to bed.

Numerous substances have been shown to improve insulin sensitivity in some studies, while other studies fail to find any benefit for blood sugar control or in lowering A1C levels. Because of the conflicting findings, there aren't any alternative therapies that are currently recommended to help with blood sugar management.

If you decide to try an alternative therapy, don't stop taking the medications that your doctor has prescribed. Be sure to discuss the use of any of these therapies with your doctor to make sure that they won't cause adverse reactions or interact with your current therapy.

Additionally, there are no treatments alternative or conventional that can cure diabetes, so it's critical that people who are receiving insulin therapy for diabetes don't stop using insulin unless directed to do so by their physicians.

Living with diabetes can be difficult and frustrating. Sometimes, even when you've done everything right, your blood sugar levels may rise. But stick with your diabetes management plan, and you'll likely see a positive difference in your A1C when you visit your doctor.

Because good diabetes management can be time-consuming, and sometimes overwhelming, some people find it helps to talk to someone. Your doctor can probably recommend a mental health professional for you to speak with, or you may want to try a support group. Sharing your frustrations and your triumphs with people who understand what you're going through can be very helpful. And you may find that others have great tips to share about diabetes management.

Your doctor may know of a local support group, or you can call the American Diabetes Association at 800-DIABETES (800-342-2383) or the Juvenile Diabetes Research Foundation at 800-533-CURE (800-533-2873).

Type 1 diabetes can't be prevented. However, the same healthy lifestyle choices that help treat prediabetes, type 2 diabetes and gestational diabetes can also help prevent them:

Sometimes medication is an option as well. Oral diabetes drugs such as metformin (Glucophage, Glumetza, others) may reduce the risk of type 2 diabetes but healthy lifestyle choices remain essential.

Have your blood sugar checked at least once a year to check that you haven't developed type 2 diabetes.

Last updated: July 31st, 2014

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Diabetes Disease Reference Guide - Drugs.com

Diabetes is a serious disease. People get diabetes when their blood glucose level, sometimes called blood sugar, is too high. The good news is that there are things you can do to take control of diabetes and prevent its problems. And, if you are worried about getting diabetes, there are things you can do to lower your risk.

Our bodies turn the food we eat into glucose. Insulin helps glucose get into our cells, where it can be used to make energy. If you have diabetes, your body may not make enough insulin, may not use insulin in the right way, or both. That can cause too much glucose in the blood. Your family doctor may refer you to a doctor who specializes in taking care of people with diabetes, called an endocrinologist.

There are two main kinds of diabetes.

Diabetes can affect many parts of your body. Its important to keep diabetes under control. Over time, it can cause serious health problems like heart disease, stroke, kidney disease, blindness, nerve damage, and circulation problems that may lead to amputation. People with type 2 diabetes also have a greater risk for Alzheimers disease.

Many people have prediabetes. This means their glucose levels are higher than normal but not high enough to be called diabetes. Prediabetes is a serious problem because people who have it are at high risk for developing type 2 diabetes.

There are things you can do to prevent or delay getting type 2 diabetes. Losing weight may help. Healthy eating and being physically active can make a big difference. Work with your doctor to set up a plan for good nutrition and regular exercise. Make sure to ask how often you should have your glucose levels checked.

Some people with type 2 diabetes may not know they have it. But, they may feel tired, hungry, or thirsty. They may lose weight without trying, urinate often, or have trouble with blurred vision. They may also get skin infections or heal slowly from cuts and bruises. See your doctor right away if you have one or more of these symptoms.

Doctors use several blood tests to help diagnose diabetes:

Your doctor may want you to be tested for diabetes twice before making a diagnosis.

Once youve been told you have diabetes, your doctor will choose the best treatment based on the type of diabetes you have, your everyday routine, and any other health problems you have. Many people with type 2 diabetes can control their blood glucose levels with diet and exercise alone. Others need diabetes medicines or insulin injections. Over time, people with diabetes may need both lifestyle changes and medication.

You can keep control of your diabetes by:

Your doctor may want you to see other healthcare providers who can help manage some of the extra problems caused by diabetes. He or she can also give you a schedule for other tests that may be needed. Talk to your doctor about how to stay healthy.

Here are some ways to stay healthy with diabetes:

Make sure you always have at least 3 days worth of supplies on hand for testing and treating your diabetes in case of an emergency.

Medicare may pay to help you learn how to care for your diabetes. It may also help pay for diabetes tests, supplies, flu and pneumonia shots, special shoes, foot exams, eye tests, and meal planning.

For more information about what Medicare covers, call 1-800-633-4227 (1-800-MEDICARE) or visit their website, http://www.medicare.gov.

American Diabetes Association 1-800-342-2383 (toll-free) askada@diabetes.org (email) http://www.diabetes.org

Centers for Disease Control and Prevention 1-800-232-4636 (toll-free) 1-888-232-6348 (TTY/toll-free) cdcinfo@cdc.gov (email) http://www.cdc.gov/diabetes/home/index.html

National Institute of Diabetes and Digestive and Kidney Diseases 1-800-860-8747 (toll-free) 1-866-569-1162 (TTY/toll-free) healthinfo@niddk.nih.gov (email) http://www.ndep.nih.gov http://www.niddk.nih.gov/health-information/diabetes

Smokefree.gov 1-800-784-8669 (1-800-QUITNOW/toll-free) cancergovstaff@mail.nih.gov (email) http://www.smokefree.gov https://60plus.smokefree.gov

For more information on health and aging, contact:

National Institute on Aging Information Center P.O. Box 8057 Gaithersburg, MD 20898-8057 1-800-222-2225 (toll-free) 1-800-222-4225 (TTY/toll-free) niaic@nia.nih.gov (email) http://www.nia.nih.gov

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National Institute on Aging National Institutes of Health U.S. Department of Health and Human Services

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Diabetes in Older People | National Institute on Aging

Podiatrist Vinaya A.S. has bumped across southern India in a bus-turned mobile clinic for 17 years, going village to village checking feet for the ulcer-causing effects of diabetes. These days, her key to staving off limb amputations comes down to one thing: food.

Millets, to be precise. The ancient grains were a staple in India for thousands of years, but largely spurned since a so-called Green Revolution last century led to cheaper, more abundant supplies of refined rice and wheat flour that can bolster blood-sugar. Now a surge in type-2 diabetes is pushing doctors and government officials to recommend a return towholegrains, like ragi or finger millet, that healthfully sustained previous generations.

Vinaya A.S. with patients at a mobile clinic on the outskirts of Bengaluru

Photographer: Dhiraj Singh/Bloomberg

Food is your medicine you need to eat right, Vinaya, 48, told a group of villagers inDoddaballapur, on the outskirts of Bangalore, last month. Bring the fiber-rich ragi back to your plates, along with fruits and vegetables.

Healthy food choices are becoming critical in India, where diabetes is ripping through the population with deadly consequences. The number of adults living with the disease has risen more than five fold since 1980, though more than half of sufferers arent aware they have it. Left uncontrolled, high blood-sugar levels can damage organs and tissues, including the nerves and blood vessels in the feet, making them susceptible to injuries that fail to heal and eventually turn gangrenous. When that happens, amputations can be life-saving.

Onset of diabetes occurs about a decade earlier in Indians than in North Americans and Europeans. About a third of Indians with the obesity-linked disease are thin, suggesting that too many calories isnt the only diet-related problem, saidK. Srinath Reddy, president of the Public Health Foundation of India.

Modern Indian meals lack fiber, which protects against diabetes, and are high in white rice and other refined carbohydrates, like wheat flour, used to make poori, or deep-fried bread, and samosas, a deep-fried, vegetable-containing pastry. Such energy-dense foods cause spikes in blood-sugar that weaken the bodys response to insulin and, when eaten regularly, can eventually lead to type-2 diabetes.

Traditional staples, like millets, have been replaced by polished rice and refined wheat flour even in rural areas, said Reddy, a cardiologist who is a past president of the World Heart Federation. Traditional Indian diets, not in vogue now, had a protective effect against diabetes.

There were 69.2 million adults living with diabetes in India in 2015, according to the International Diabetes Federation. Complications such as stroke, kidney failure and blood-poisoning from festering sores kill more than 1 million annually and the country will have 123.5 million diabetics by 2040 unless trends in overweight and obesity are curbed, the Brussels-based group predicts.

Health awareness is motivating Indias urban upper crust to seek out so-called superfoods, such as steel-cut oats and quinoa, a type of edible seed from South America, but millets an umbrella term for many small seeded grains have been slower to catch on, said Krishna Byregowda, the agriculture minister of Karnataka state.

Why are we forgetting our own superfoods while buying and adopting imported oats and quinoa? he asked a crowd at a three-day Organics and Millets National Trade Fair in the state capital, Bangalore, last month.

Customers at Vaathsalya Millet Cafe in Bengaluru.

Photographer: Dhiraj Singh/Bloomberg

Byregowda is spearheading a campaign involving chefs, nutritionists, doctors and food businesses to bolster demand for a grain he grew up eating as ragi mudde finger-millet flour cooked and shaped into soft mounds and served with leafy greens in a spiced gravy.

His farmer-ancestors grew it not just for its nutritional benefits: the crop needs a third of the rainfall of rice. Yet, millet and sorghum production have declined by a combined 51 percent in India and rice and wheat output has almost quadrupled since the 1960s, when a Green Revolution introduced modern seeds, chemicals and irrigation to boost harvests and stave off hunger.

Drought-induced crop failures in recent years in southern India have convinced the 44-year-old American University graduate of the need to return to growing millet.

In these times of climate change, it made sense to encourage farmers to switch to climate-smart crops rather than cultivate the water-intensive rice, Byregowda said in an interview. The post-Green Revolution planning left millet farmers, like my family, in the lurch.

The government of the neighboring southern state of Tamil Nadu has allocated 8 billion rupees ($124 million) to subsidize the cultivation of millets and pulses, and restaurants in the capital, Chennai, are catering for a growing appetite for millets. P. Sathiya Moorthi sells biscuits, biscotti and sweets from the grain to customers working at the local Hyundai Motor India Ltd. factory and Cognizant Technology Solutions Corp.s offices.

In Hyderabad in Telangana state, Narayana Peesapaty and his wife Pradnya Keskar have found another culinary use for the grain: edible spoons costing a few cents apiece.

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While millets have gained some international popularity thanks to pop starMadonna and chef Joanne Weir, they are only just gaining traction among health-conscious consumers in the U.S., according to Amrita Hazra. The India-born researcher is part of the Millet Project, a two-year-old University of California, Berkeley program thats working with Californian farmers, chefs and retailers to rediscover the traditions of cultivating and consuming millets.

Ancient grains are making a comeback in peoples diet, and very slowly into the fields, Hazra said.

A farmer cuts millet on the outskirt of Bengaluru.

Photographer: Dhiraj Singh/Bloomberg

A reviewin 2014 of sorghum and millets used as livestock fodder and birdseed in some countries found they contain health-enhancing properties, though more human clinical trials are needed to assess their direct dietary benefits. They contain more fiber, more micro-nutrients and probably have a smaller blood-sugar impact than refined carbohydrates, said Jennie Brand-Miller, professor of human nutrition at the University of Sydney.

As long as the millets are prepared and consumed in traditional ways, I think this is a good suggestion, said Brand-Miller, who is internationally recognized for her research on the bodys absorption of carbohydrates. To maximize the health benefits of millets, consumers need to resist the urge to grind and refine them.

For podiatrist Vinaya, they are much healthier alternative to the fast-foods, sweetened soda drinks and rice more of her patients are consuming. Of the 60 people who turned up for last months free clinicin which her team checks blood flow to the foot, nerve sensitivity and blood-glucose, 27 were found to have diabetes, she said.

Unchecked, that can lead to foot sores that ulcerate. Her hospital in Bangalore does 30 to 35 foot amputations a month because of diabetes. In at least three of these cases, an entire lower limb needs to be amputated to prevent gangrene causing lethal blood poisoning, or sepsis.

Checking for diabetes at a mobile clinic.

Photographer: Dhiraj Singh/Bloomberg

To London-trained Vinaya, who runs the diabetic foot clinic at Bhagwan Mahaveer Jain Hospital, the link between diet and lifestyle changes and the rising incidence of diabetes has strengthened based on data her team has gathered from 2.4 million people in 350,000 households across 1,700 villages the largest such diabetes study in the world.

Even physically active, slender farmers in their 30s and 40s are being afflicted with the disease in India. She tells them how to replace the rice in their favorite dosa pancakes and idli savory cakes with millets. On her repeat rounds to the rural camps, villagers gather round to titter, Doctor-madam has come to conduct cooking classes.

Continued here:
Birdseed Turned Superfood May Help Curb India's Diabetes Scourge - Bloomberg

The American Diabetes Association (ADA) sparked a social media uproar at its annual conference in San Diego earlier this month when it restricted participants from posting photographs of slide presentations on Twitter:

ADA Twitter response to an attendee who posted a photograph from a slide presentation.

The response by conference attendees especially those quite active on social media was brisk, passionate, and hinted at Orwellian censorship. Medscape, who broke the story on the second day of the meeting, mostly focused on the response by physicians.

It would be fair to point out theres some selection bias at play here; after all, the survey was done via social media, and completed by people who use social media. Many like Kevin Campbell MD, a cardiologist in North Carolina with a substantial Twitter following felt the ban was ill-advised for these reasons:

Michelle Litchman PhD, FNP

Whether these rationale hold water or not will likely be debated frequently in the coming years, as more people attending medical conferences turn to social media.

But these arguments center on health care providers.

What about patients? Could such a ban affect the roughly 1 out of 10 Americans with diabetes?

Michelle Litchman is a Utah-based family nurse practitioner who specializes in diabetes care. She was unable to attend the ADA conference but followed it on Twitter so she could bring the latest information back to her patients.

Its impossible to be at every significant conference. There are just too many. Healthcare providers and patients rely on the collective sharing of conference pearls, which include photos, to engage in discussions. These discussions are focused on how to interpret and implement research findings, which in turn inform clinical practice and diabetes management. If we want to elevate healthcare, we need to give clinicians and patients access to up-to-date information.

Amy Tenderich

Amy Tenderich, who has Type 1 diabetes, agrees. I really dont see a downside to sharing openly, as that is also the world we live in now, says Tenderich, who started the popular diabetes advocacy website, DiabetesMine.com, about 12 years ago.

I can tell you that Twitter has definitely given many more people a window into these events. And I believe it helps patients to know what is happening in the field, to have hope, and to be able to look for research studies to potentially be involved in.

If live tweeting from a conference actually creates a pipeline from researchers up-to-date findings, through health care providers, and ultimately to patients this raises two important issues that I did not see brought up in any of the news coverage I saw of the Twitter debate (such as this strongKaiser Health News piece that emphasized possible corporate influence over the ADA policy). First, how often is there truly cutting edge information from medical conferences that needs to be disseminated ASAP? Second, what are the implications of globally disseminating new findings that have not been peer-reviewed or meticulously vetted for publication?

In theory, rapid and early dissemination of new research findings both to the medical community and the lay public may help to get appropriate care to patients sooner, and help important ideas spread, says Michael Hochman MD, an internist and director of the Gehr Family Center for Implementation Science.

In practice, however, it seems that the dissemination of early stage research findings often leads to the cart getting out ahead of the horse. Its hard to know where the optimal balance lies. There are clearly benefits to immediate communication, but there are also real risks that preliminary, un-adjudicated results will be taken out of context. And there are countless examples of new medical treatments and tests becoming widely disseminated before the data support their widespread dissemination.

Michael Hochman MD

Case in point: earlier this month we reviewed several presentations at the worlds largest cancer meeting (ASCO) that generated significant mainstream and social media buzz, but clearly did not live up to the hype. Some of it was downright misleading. Did these findings make their way through social media to ultimately become topics of discussion between patients and providers?

Over the years weve written about many other examples of news from scientific meetings that wasnt ready for prime time:

Clearly, we need to consider the potential consequences of rapidly spreading unfiltered misinformation via social media. Likewise, is there an argument to be made for not tweeting preliminary results and waiting until they are published? Certainly, the possibility of doing harm seems very real.

This Twitter debate at the ADA meeting in San Diego may very well become a bellwether for both the benefits and limitations of social media in broadcasting health care information.

As they stand now the bookends seem to be on one end an ideal of a democratization of access to information that flies in the face of tradition and promises open dialogue, open sharing, and accelerated innovation and on the other a push to protect property rights (doctors, drug companies, and associations) that on the surface, at least, seems to be primarily financially motivated.

The ADA stance centered on unpublished data and intellectual property is a curious one. If the abstracts from the conference are available online, and the data is publicly presented at the meeting, what is it about tweeting the same information that concerns them?

Of note, after the meeting the ADA promised to re-evaluate its social media policy and our legal obligations to the researchers. It was not made clear what those legal obligations were, and if they involved not just the researchers, but also the funders of research.

But I suspect what might become rather neglected as this story evolves is the issue of spreading unvetted findings, and how that can mislead both doctors and patients.

This very well may be the most important consideration of all especially for patients and may not initially appear to be associated with costs, but will ultimately prove very costly in every sense of the word.

Joy Victory is deputy managing editor of HealthNewsReview.org. She tweets as @thejoyvictory. If you feel

"With each passing week he displays the classic symptoms of medium-grade mania in more

Increasingly, I'm becoming more appreciative of, and am on the lookout for, alternative, creative approaches

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American Diabetes Association's Twitter fiasco: Does it matter to patients? - HealthNewsReview.org

With the upcoming watchOS 4 update for Apple Watch slated to bring new features for diabetes management devices, we took some time to speak with Dexcoms CEO Kevin Sayer this week about what it means for users. When Apple revealed watchOS 4 at its Worldwide Developers Conference this month, it featured Dexcom, makers of the G5 Continuous Glucose Monitor (CGM) popular among iPhone users, on stage as an example of an Apple Watch app that will benefit from new features in the release.

Sayer shared details on how exactly Dexcom devices will improve from these new features in watchOS 4, and more specifically why CoreBluetooth support will be a game changer for Apple Watch users with diabetes.

We also learned from Sayer about the next-generation of the companys popular G5 CGM coming soon. And we had to ask about the chatter prior to WWDC that Apple is reportedly developing its own glucose monitoring technology, to find out his thoughts on the possibility of such features being built directly into future Apple Watch models.

Dexcoms G5 CGM already works with both the iPhone and Apple Watch, but currently the G5s signal has to go to the iPhone first before syncing data to Apple Watch. That means the data on Apple Watch is a bit delayed, and it also means you must have your iPhone around if youre on the go and want to continue syncing data. With new support for CoreBluetooth in watchOS 4, the G5 CGM will make a direct connection:

The way we architected our transmitter to transmit this glucose data many years ago is there is two Bluetooth channelsso it could communicate with two devices at the same time because our sensor talks to Android phones as well, it also speaks with certain models of insulin pumps an Apple patient now with this Watch direct connectivity can have a direct Watch connection and a direct connection with another device what that means for our patients, I think its a game changer for them.

People who work out who have diabetes right now always have these fanny packs and if they have a Dexcom system theyre carrying their phone so the datas there If they have an Apple Watch [with CoreBluetooth support], they can leave that phone home, and track their workout real-time. Or if youre in your office if I had a meeting in the boardroom and had diabetes and was tracking my glucose. I could leave my phone in my office so it wouldnt bother my meeting theres a number of places where this direct connection will be useful I think its part of a much longer term strategy to make that wearable more useful in the lives of people who use it.

Apple announces CoreBluetooth support for watchOS 4 at WWDC 2017

Our ultimate goal is to make the on body component, the wearable, the size of about a penny to wear it like a bandaid.

Sayer also confirmed that the current-generation G5 CGM will get the CoreBluetooth support for a direct connection with watchOS 4, although the iPhone will still likely be required for some setup and data entry:

Hardware-wise its ready to go what we will have to do is once the new OS for the Watch comes out, well have to fine tune our app and get it ready and make sure it works Then well submit our app to the FDA for review We absolutely will support the feature.. We will give patients the ability to see their data directly on the Watch for the current G5 system and systems after that

I believe we will continue to have set up with the phone app a patient doesnt have to enter data that often they have to enter a couple calibrations a day Those things are to be worked out during our human factors testing and our discussions with the FDA, in addition to our discussions with Apple.

Apple announces new diabetes management features at WWDC 2017

One report from CNBC back in April, prior to the unveiling of new features for diabetes management with watchOS 4, claimed Apple had a secret team working on optical sensors to allow for noninvasive measuring of glucose levels (and Tim Cook was reportedly spotted wearing a sensor of some kind connected to Apple Watch). Thats something no one else has been able to do, so we asked Sayer his thoughts on the reports and the possibility of integrating the technology directly into a device like a smartwatch:

Right now the way our sensor works is theres a small wire literally about the width of a human hair thats inserted in the subcutaneous tissue, and that wire is coated with several membranes. And thats how glucose is measured is through that sensor thats inserted under the skin for years people have tried to come up with solutions that dont involve any thing under the skin, similar to what the Apple Watch would be with some type of light technology bouncing through the skin and back up people who intensively manage their diabetes really require extremely accurate information, because insulin is a life saving and a life threatening drug. If somebody could solve that problem it would be a boon for diabetes, but we havent seen anything thats better than what we have and we know how hard it is to do what we do

He also told us about the companys ultimate goal to make the on body component, the wearable, the size of about a penny, which in theory could enable a device the size of a bandaid that could be worn underneath or attached directly to a device like Apple Watch:

We experiment with a number of new form factors Our ultimate goal is to make the on body component, the wearable, the size of about a penny, and have you be able to wear it like a bandaid. What our patients want today more than anything else, is to not have that [the CGM] seen if its the size of a penny and like a bandaid sitting on your arm, if it can communicate directly to an Apple Watch thats a wonderful solution for a patient, theyll be thrilled If Apple asked for a collaboration, wed certainly talk about it.

Currently under development and scheduled for a release as soon as next year following watchOS 4, Sayer told us about the next-generation of the companys G5 CGM, which will feature a lower profile design, a new automated insertion system, and other new features:

Gen 6 is the name of the next platform that is a different hardware configuration that will be lower profile and the insertion system will be automated and very, very user-friendly and easy for patients to use, with the same connectivity that we have in our current G5 system. So it will give the patients a much better on body experience, and the sensor we believe is really the next step in our technology evolution as far as making these things more accurate and more consistenttheres a bunch of great features Apple users have that to look forward to next year sometime, we hope to file it with the FDA in September

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Link:
Dexcom CEO talks 'game changer' diabetes management coming to Apple Watch - 9to5Mac