Field notes from a revolution in cancer treatment

Any cancer center, no matter how cutting edge its technology or cheerful its design, is a place where people get bad news.

But theres more good news about cancer treatment than most people think, and the game is changing month by month.

Cancer treatment is swiftly moving toward individualized molecular and genetic tools that Sparrow Cancer Centers director, James Herman, hopes will replace what he calls MOAB (Mother of All Bombs) forms of treatment such as radiation and chemotherapy.

Oncologist Tim McKenna, director of Sparrows breast clinic, has been in practice over 35 years. He said he more optimistic now than he has ever been.

I can see where maybe breast cancer surgeons will be standing on street corners with cardboard signs, McKenna said.

Already, many of McKennas patients never get a mastectomy or lumpectomy. Treatment that combines chemotherapy with monoclonal antibodies that target a patients particular cancer can get rid of a tumor without surgery in many cases.

McKenna said they take a couple of core samples and say, You know what? I guess there isnt any cancer left. Youre done. I predict that in 15 years, 20 years, that will be 90 percent of the cure.

Corrie Bourdon called it a brave new world, amazing and life-saving. As the cancer genetic counselor, a position created a year ago especially for her, Bourdon is Sparrows newest staff member and a herald of that new world.

If you remember the 90s sci-fi movie, Gattaca, its becoming real life, Bourdon said.

Now, when cancer is detected, on cologists ask a whole new set of questions, using a strange new vocabulary. McKenna rattled off a few of the big ones: Is the cancer estrogen receptor positive? Does it overexpress her2/neu? Whats the Oncotype score? Whats the MammaPrint score?

To sample just one spoonful of that jargon stew, MammaPrint is a 70-gene map of the cancer itself, a genetic analysis that helps doctors decide if systemic treatment is warranted, even though they cant prove the cancer might be somewhere else.

It allows us to predict recurrence down the road and take steps now, McKenna said.

Like the genetic engineers of Gattaca, Bourdon tests families for genes that predispose them to cancer. (People sometimes ask Bourdon if she designs babies. She tells them she doesnt.)

If a person carries the mutation, the next step is extra screening or even preventative surgery to keep them from getting the cancer.

The advances are exponentially increasing, she said. Cancer treatment and genetics are converging very, very quickly, if they are not already converged.

Until recently, as Sparrow oncologist Joseph Meunier explained it, many chemotherapy drugs have been designed to treat a particular type of cancer, based on the part of the body affected, such as lung or breast cancer.

But recently, Meunier and his team have been successful doing things they never thought they would do, like treating ovarian cancer with skin cancer drugs.

They wouldnt have thought of trying such a thing five years ago, because no body knew the two forms of cancer had the same genetic mutation in common.

Just the leaps for ward in the last 18 months its been absolutely unbelievable, Meunier said.

A month ago, the FDA approved a chemotherapy type drug for the treatment of a genetic mutation, regardless of the organ of origin.

Thats the first time thats ever happened, Meunier said. I cant even imagine, in the next 10 or 20 years, the way we look at therapy altogether is going to be entirely different.

Genetically tailored treatment is not a silver bullet, though. Bourdon said the environment still plays a huge role in how people get cancer.

Exposures to chemicals, pesticides, or they worked in a factory, Bourdon said. Ive heard a lot about the Dow Chemical Plant in Michigan. Or if someone was in the military, who knows what they were exposed to? But cancers have genes of their own that can be unlocked and, perhaps, manipulated to their distinct disadvantage.

I would not be surprised at all if we actually have a cure for cancer in the next 10, 20 years, or weve at least made such advancements that you just go to your doctor and take a pill to fix your gene and youre cured, Bourdon said.

Gordan Srkalovic, oncologist and director of Sparrows clinical trials program, took a more circumspect view. Srkalovic has been an oncologist for 18 years and did basic oncology research before that. He has been at Sparrow 14 years.

Are we going to conquer cancer? is a loaded question, he said. I dont think we will be able to cure every patient with cancer, at least not in my lifetime.

Its more likely, Srkalovic said, that cancer will be cut down to size, from a deadly, progressive disease to a chronic one that can be treated, comparable to hypertension or high blood pressure, and thats already happening.

The goal at the present is to reduce the burden of disease to the point the patient could have cancer cells, but the cancer is controlled, he said.

Its a more modest prognosis, but still a dramatic leap from cancer outcomes a generation ago.

When I started, you took a Magic Marker and you put an X over where you thought the cancer was, Herman said. Then Id pretend Id know what was going on with the treatment.

The cure rate for cancer has gone from 30 percent to 70 percent since Herman entered the field over 35 years ago.

That means the cancer is gone and they die of something else, he said. You dont hear about that 70 percent. They carry on and live their life. Its a revolution.

So McKenna may end up on a street corner with his cardboard sign after all. It seems perverse to dream of tearing down a building thats brand new, but the Herbert-Herman Cancer Center is a special case.

We love helping patients and curing them, but it would be amazing if we were all out of a job, Bourdon said.

I hope it is the last cancer center, Meunier said. I hope we dont have to build a new one again.

Will we be able to get rid of buildings like this? I hope so, Herman said. Herman is entitled to say that, with his name is on the place and all.

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Cancer treatment is swiftly moving toward individualized molecular and genetic tools that Sparrow Cancer Center's ... - City Pulse

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Firefighter Dustin Luebke puts his life on the line everyday protecting and serving the community. Never did he think his life would be threatened in a different way.

So now in 2017, Im going through it for the third time. So now its again recurring Hodgkins, said Luebke.

It all started in March of 2014. After 12 rounds of chemotherapy and six months in remission, it came back. He needed a stem cell transplant and was able to use his own stem cells.

Shortly after completing a year of chemotherapy after the transplant, it came back for the third time.

Its tough to swallow the first time and the second time. And then with the third time, its frustrating, said Luebke.

This father to three little girls will eventually need a bone marrow transplant.

But with this time, right now Im just doing an immunotherapy and were hoping that brings it back down to a cellular level and I can be on that for as long as until it stops working. So then it would require a stem cell transplant with a donor this time, said Luebke.

Thats where you and I can do our part and become part of the bone marrow registry and potentially be the match and save a life like Luebke's.

You fill out a short questionnaire. It talks about your health history and some personal questions, like how willing would you be to become a donor and then the swabbing process is really simple. We just swab each of your cheeks for a couple of minutes and then youre done, said Jalisa Spittler, transplant coordinator.

Spittler says 70% of patients who need a donor dont have a match in their family making the bone marrow registry their only hope.

We do have a lot of patients here that are waiting for matches that we just cant find for them. So its really helpful if we can create a diverse list with tons of people from here in South Dakota, said Spittler.

I got three little girls to raise and beautiful wife at home so I gotta stick around for a few more years, said Luebke.

Its pretty tough to realize that now youre relying on someone else where before it was all the medicine and just chemotherapy and now youre relying on somebody else with healthy stem cells to keep you going, said Luebke.

Sometimes it takes months to find a match.

Its taxing on them because they have to take more chemotherapy the longer it takes us to find a match for them. And the more chemotherapy they take, the harder it is on their body to get through the transplant. So its really important that we have a huge number of people to look at first, said Spittler.

Theres many ways that you can help out with people lives. And whether its in a fire, on a medical call and even helping somebody with life itself and furthering their life and making it better so they dont have to do chemotherapy anymore, said Luebke.

Luebke is a hero to this family and the community.

The first step to being someones cure is to join Be the Match Registry.

This Tuesday at the Oyate Community Center in Sioux Falls, there will be a bone marrow registry drive from noon to 7PM. It is put on by Avera, the city of Sioux Falls, and Be the Match. Registering takes less than 15 minutes.

For more information, just call 877-AT-AVERA.

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Avera Medical Minute AMcK: Firefighter with recurrent Hodgkin Lymphoma will need bone marrow transplant in future ... - KSFY

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Heres an interesting project: somebody has been growing a human hand in a lab and displaying it for the world to see.

We live in a time where the meaning of impossible needs to be updated.

As we make new discoveries, new possibilities open up to us. And if you want a good example of that, just look at how advanced prosthetics have become in the last decade. Soon, you might be able to grow a humanhand like a Chia pet.

Or take a look at Dr. Sergio Canavero, who plans to perform a full-on head transplant later this year.

But that example may be a little extreme.

See, theres something miraculous about giving something vital like a limb or an organ to someone to needs it. In the past, it couldnt be done, but with the future in sight, were slowly changing our minds on that.

So, the future can be full of hope. And when one of us loses a hand, possibly due to someone we have only just learned is our father, we wont have to worry too hard.

Ok, heres a better example of the kind of future Im talking about.

Artist Amy Karle has an interesting new project that combines 3D printing with stem cell research. The idea is to grow a functional human hand, and if it works she wants to make the design free and open source.

And trust me, that will be one weird-yet-cool day for the people who frequent Instructables.com.

Karle may be an artist, but shes no amateur. She works with nonprofit groups that design 3D printed prosthetic arms, and she has help from a team of scientists.

The project is called Regenerative Reliquary, and it is being displayed in San Franciscos Pier 9 space while it grows. Or, to be more accurate, while part of it grows.

Karle has designed a 3D printed trellis in CAD which was printed using a cellular growth medium called pegda. Over several weeks, the pegda trellis was grown in a bioreactor on display. The next step will be to grow a cell line on the trellis, something Karle is culturing stem cells for now.

The team is using stem cells extracted from bone marrow, and with any luck, the idea will bear fruit and be released to the public.

I like the sound of an open source prosthetic design, especially considering how much more of an option 3D printing is these days. Lose a limb, and you may one day be able to make a replacement within the comfort of your own garage.

For now, though, were still waiting to see if Karles project will work. According to the artist, Well see if the cells have a mind of their own. I like to step back and let the artwork take over.

Now you know how Karle plans to grow a human hand. Lets rewind a bit, back to where I mentioned Dr. Canavero and his upcoming head transplant.

As crazy as it sounds, if Canaveros plan works science will have taken a big step toward manipulating the central nervous system. And thats really, really important. If scientists can connect a head to a spine, and they can grow a limb in a tank, it follows that they may one day be able to attach that limb as a replacement.

And that doesnt just apply to limbs, either. Scientists have been looking into growing replacement organs for years, just look at this article from way back in 2014.

We may be on the verge of the ability to reproduce and replace parts of the human body. And at this rate, who knows what kind of effect this can have on the survivability rate of human beings in the future.

Im sure well never resurrect the dead or anything, but I think the fictional Dr. Frankenstein would be proud.

Creating replacement body parts is something that has been a mainstay of science fiction, and it isnt crazy any longer to think that it may become a reality. So, like I said earlier, we may need to push the goal posts back on the word impossible.

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How to Grow a Human Hand - Edgy Labs (blog)

Recommendation and review posted by Bethany Smith

How many mutations?

By Michael Le Page

As you were. In May, a study claimed that the revolutionary CRISPR gene editing technique can cause thousands of unwanted and potentially dangerous mutations. The authors called for regulators to reassess the safety of the technique.

But doubts were raised about these claims from the very beginning, not least because it was a tiny study involving just three mice. Some critics have called for the paper to be withdrawn. Now a paper posted online on 5 July has proposed a simple and more plausible explanation for the controversial results. If its right, the authors of the original study were wrong.

We strongly encourage the authors to restate the title and conclusions of their originalpaper or provide properly controlled experiments that can adequately support their claims, write the team behind the new study. Not doing so does a disservice to the field and leaves the misleading impression that the strong statements and recommendations found in their paper are adequately supported by the data presented.

The aim of gene editing is to make a precise change in a DNA sequence while leaving the rest of the genome untouched. Gene editing can be used to introduce desirable changes into plants and animals (and perhaps people too one day), and to treat a range of disorders in people.

Gene editing has been around for decades but it remained extremely difficult and expensive until the revolutionary CRISPR technique was discovered in 2013. CRISPR is so cheap and easy that it is already widely used by researchers around the world, and nearly 20 clinical trials in people are already getting underway. The rapid pace of development has been unprecedented.

But have doctors been rushing to use it too soon? When Stephen Tsang of Columbia University Medical Center and colleagues compared the entire genomes of two CRISPR-edited mice with a third one, they found thousands of shared mutations in the two edited mice.

Tsang and co attributed to these mutations to CRISPR, and issued a widely-covered press release that suggested CRISPR is far riskier than dozens of other studies had suggested.

It has always been clear that CRISPR, like other gene-editing techniques, can sometimes make alterations other than the intended one. These off-target changes are most likely to occur when the CRISPR machinery binds to DNA sequences very similar to the target one.

For this reason, studies on the safety of CRISPR have usually looked to see if any sequences resembling the target sequences have been altered. Most have found few unwanted changes, suggesting CRISPR is safe. And some teams have already tweaked the CRISPR machinery to reduce these off-targets effects even more.

Tsang and colleagues claimed that by sequencing the entire genome, they found off-target mutations missed by studies that only looked at sites resembling the target sequence. But there is a much simpler explanation, says the latest study: the two CRISPR-edited mice just happened to be more closely related and thus shared more mutations.

Tsang and colleagues assumed the three mice they studied were essentially genetically identical because their parents were very closely related, but the way the colony of mice was maintained means this was probably not the case, the team, which includes Luca Pinello of Harvard University, say.

This explanation makes sense for another reason, too. The shared mutations in the edited mice were nowhere near DNA sequences resembling the one were targeted for editing, Pinello and colleagues point out, so its far from clear why CRISPR would cause mutations in these same sites in two different mice.

I agree the two mice are indeed more likely to be closely related, says geneticist Gaetan Burgio of the Australian National University, one of the many critics of the original paper. He says its publication in a prominent journal was a failure of peer review.

Journal reference: bioRxiv, DOI: 10.1101/159707

Read more: CRISPR causes many unwanted mutations, small study suggests

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CRISPR gene editing technique is probably safe, study confirms ... - New Scientist

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CRIPSR-Cas is one tool that could help keep pace with the growing demand for more sustainable agricultural solutions.

DuPont Pioneer

When Carmen and I were young, we made our home at the foot of the Sandia Mountains east of Albuquerque. Back then, for a weekend outing on a pleasant summers day, we would avoid Interstate 25 and travel the Turquoise Trail National Scenic Byway, the picturesque backroad that links Albuquerque with Santa Fe through the high country. The Byway is named for the semi-precious, blue-green mineral deposits of hydrated copper and aluminum phosphatesought after by Native Americans for more than a millenniumwhich are found near the northern stretches of the road. Once bustling mining towns, scattered along the way like nuggets of the wild west, may also be discovered and explored; ghost towns such as Golden and Madrid (pronounced MAD-rid, not Ma-DRID).

During one of these trips, we stopped at the Golden General Merchandise Store and struck up a conversation with the proprietors, Vera and Bill Henderson. We learned that in 1962, Bill and Vera purchased the store from her parents. Together they turned the failing store into a thriving arts and crafts trading post featuring Native American jewelry, rugs, Kachina dolls, and pottery for sale.

The Hendersons (both of these dear friends have passed away) were true and devoted connoisseurs and patrons of local and regional artisans. Vera especially wanted customers to share her passion in these handicrafts. If a potential patron showed lackadaisical interest in the artistic qualities of a piece or the artist who made it, she would send them on their way, telling them to take their business to Santa Fe!

I admired Veras spunk and forthrightness. She cared deeply, and she stood up for what she believed. She inspired me to learn the stories told about everyday Pueblo Indian life by silversmiths such as the Kewa Pueblo artist Vidal Aragon.

For example, a silver bracelet we purchased depicted a Pueblo village around which grew stalks of corn. As a kid growing up in the D.C. suburbs, about all I knew of corn was corn flakes. The Hendersons passion for Native American traditions encouraged me to deepen my cultural appreciation of food and agriculture.

The Keresan-speaking tribes of the American Southwest believed in a female corn goddess, whom they called Iyatiku. It is she who led the first people to the surface of the earth from Shipap, her underground realm. To provide for their sustenance and wellbeing, Iyatiku planted pieces of her heart in the fields surrounding their village. These tiny tokens of her body grew into lush fields of life-sustaining corn!

This worldviewthat seeds and plants are sacred gifts available to and shared by allis common among native peoples around the world. This ancient perspective stands in stark contrast to the modern view corporate ag-science offers us. To illustrate, I will use DuPont Pioneers CRISPR-Cas waxy corn as an example.

DuPont Pioneer has recently announced its intentions to commercialize waxy corn hybrids developed in the laboratory using a new and powerful gene editing technique called CRISPR-Cas: clustered regularly interspaced short palindromic repeats-CRISPR-associated system. (Thats not a typo. This two-part acronym incorporates its own acronym!)

Waxy corn produces a high amylopectin starch content, which is milled for a number of everyday consumer food and non-food uses including processed foods, adhesives and high-gloss paper. DuPont Pioneer created this hybrid using CRISPR-Cas advanced gene editing technology to program the plants molecular machinery to synthesize amylopectin starch in abnormally high levels.

According to DuPont Pioneers website and their September 2016 webinar, CRISPR-Cas is a more efficient and targeted plant breeding technology. In the past, genetic engineering of plants often has relied upon transgenic techniques, which modifies the host species by adding genetic material from different species (i.e., GMOs). CRISPR-Cas does not incorporate foreign DNA from other species. Its a continuation of what people have been doing since plants were first domesticatedselecting plants for their desired characteristics like higher yields, disease resistance, longer shelf life or better nutrition.

CRISPR-Cas gene editing technology is likened to word processing, by which scientist delete, edit, or search and replace specific portions of a plants genetic code. CRISPR-Cas uses molecular scissors to cut a specific section of DNA. After the DNA is cut, either a piece is removed and the loose ends are spliced back together eliminating an undesired trait; or a desired trait is inserted into the gap and the DNA is stitched together again.

DuPont Pioneer seeks to further the science and expand the adoption of CRISPR-Cas across all crops, including soybeans, rice, wheat, canola, sunflowers, fruits and vegetables. Agricultural products developed with CRISPR-Cas will be like the ones that we have been producing through conventional plant breeding for generations and will be subject to extensive testing prior to commercialization. As with every technology we apply, we hold ourselves accountable to our core values, to our customers and to consumers.

According to DuPont Pioneer, current Food and Drug Administration law will not require labelling of CRISPR-Cas waxy corn. Even under the newly enacted National Bioengineered Food Disclosure Law of 2016, their genetically edited waxy corn will not meet the definition of bioengineered as written in the law, and would therefore not require disclosure as a bioengineered food.

For much of human history, edible plants were cherished as gifts from the gods. Now, they are becoming high-tech, commercial products of industry. Once seeds were available to all. Now they are becoming proprietary, patented, intellectual property, licensed through end-user agreements.

Are these trends truly more sustainable agricultural solutions as industry claims they are? Are they empowering farmers? Or are corporate monopolies of engineered seeds leading to bondage and dependency for farmers who are getting trapped in debt to pay royalties in the words of Vandana Shiva, philosopher and eco-feminist.

On a personal level, I relish the smell of a freshly picked ear of corn. For me, summer would not be complete without a picnic lunch serving up hot corn-on-the-cob. I wonder, would my body and soul feel as nourished if I knew I was biting into kernels of CRISPR-Cas corn? If not, should I adapt my aesthetic sensibilities to these new agricultural realities by adopting the attitude CRISPR-Cas corn, and I dont care (sung to the antebellum minstrel tune Jimmy Crack Corn)?

J. Dirk Nies

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Science to Live By: CRISPR-Cas Corn - The Crozet Gazette

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The gene-editing tool CRISPR may cause thousands of unintended mutations, but critics say its way too soon to accuse it of infidelity1.

A two-page study, published 30 May in Nature Methods, put biologys hottest technique in the crosshairs, questioning its ability to rewrite DNA with the precision necessary for medicine. The papers findings quickly dominated social media conversations on biology. And the stocks of biotech companies with CRISPR-based projects dipped by as much as 15 percent.

But some researchers are loath to end their love affair with CRISPR. Reports of the methods infidelity, they say, are greatly exaggerated. One reason, they note, is that the study is small just two mice for CRISPR and a single control mouse.

I think its an important finding that we really need to follow up, but its really hard to judge why there are so many [mutations], says Guoping Feng, professor of brain and cognitive sciences at the Massachusetts Institute of Technology. He says another enzyme the team used may in fact have caused the errant mutations.

Two weeks after the papers publication, Nature Methods editors added a note to the paper, saying they are considering the criticism of the results and plan to respond soon.

CRISPR is a molecular scalpel that cuts DNA. It can home in on a specific spot on the molecule using a piece of RNA as a guide. The tool holds significant medical promise because it could help modify or fix genes that cause medical conditions.

In 2016, Alexander Bassuks team reported injecting mouse embryos with CRISPR fused to its usual protein partner, CAS9, which binds to DNA. The researchers targeted a gene called PDE6B that is involved in vision. The experiment was designed to correct a mutation that causes blindness in the mice2. It did.

For the new study, Bassuk and his collaborators looked for off-target effects of the treatment. They sequenced the whole genomes of the two mice and the control mouse. They compared the results from the edited mice against a database that includes genomes of 36 mouse strains.

CRISPR-CAS9 introduced more than 100 unintended mutations and more than 1,600 one-letter swaps in the code of DNA, the researchers found.

None of these changes had any obvious consequences. As far as we can tell, it hasnt affected the mice, says Bassuk, professor of pediatric neurology at the University of Iowa in Iowa City. But the researchers tested only the mices vision and do not know if the mutations affected the animals behavior or perception.

This was not the first time that CRISPR had caused accidental mutations, though previous reports found far fewer mutations3.

Its always been a concern for everyone in the field that this is not a completely clean method, says Anis Contractor, associate professor of physiology at Northwestern University in Chicago. Contractor was not involved in the research but uses CRISPR to make mouse models. This is a big red flag.

Contractor and others say the findings may prompt a change in best practices when using the method. Scientists may need to sequence the genomes of their models an expensive task to uncover any unexpected mutations.

Others, however, are downplaying the results.

I dont think this paper has any merit for CRISPR research, says George Church, professor of genetics at Harvard University. I think its a negative example that we can use as a cautionary tale. Church is co-founder of Editas Medicine, a biotechnology company that is using the technique to develop gene-editing therapies. The company lost 12 percent of its value the day the study was published. (Its stock has since gone up, surpassing its previous value.)

Church and the companys other executives wrote to Nature Methods with a laundry list of concerns about the paper. Their biggest beef, says Church: The studys control mouse likely wasnt genetically identical to the ones that had been edited with CRISPR, so its impossible to know whether the mutations resulted from the method.

Instead, Church argues, its possible that the mutations represent natural genetic variance between the animals. Church stops short of saying the paper should be retracted but calls it a rushed job. Another gene-editing company, Intellia Therapeutics, voiced similar complaints.

The team also used an unusual version of the editing system, says Feng, who is using CRISPR to create animal models of autism. He says the use of extra nickase, an enzyme that can cause breaks in a strand of DNA, could have caused the mutations.

I couldnt figure out what reason youd need to do it this way, he says.

Bassuk points out that the team did the editing work in 2015, early in CRISPRs use.

We used what was available at the time, Bassuk says. Its obviously not what people are using in 2017. He says he is not sure whether the editing system made a difference in the results.

In the past three months, researchers have debuted the first two mouse models of autism created using CRISPR. No one has yet published work on using CRISPR to correct genes in animal models of the condition.

In the short term, the findings will definitely temper the enthusiasm for CRISPR models, says J. Tiago Gonalves, assistant professor of neuroscience at Albert Einstein College of Medicine in New York, who was not involved in the research. But in the end, Im confident the problems will be solved and well figure out whats happening.

Read more:

CRISPR goes wild, and scientists debate its fidelity | Spectrum ... - Spectrum

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LONDON Stem-cell tourism involving patients who travel to developing countries for treatment with unproven and potentially risky therapies should be more tightly regulated, international health experts said on Wednesday.

With hundreds of medical centers around the world claiming to be able to repair damaged tissue in conditions such as multiple sclerosis and Parkinson's disease, tackling unscrupulous advertising of such procedures is crucial.

These therapies are advertised directly to patients with the promise of a cure, but there is often little or no evidence to show they will help, or that they will not cause harm, the 15 experts wrote in the journal Science Translational Medicine.

Some types of stem cell transplant mainly using blood and skin stem cells have been approved by regulators after full clinical trials found they could treat certain types of cancer and grow skin grafts for burns patients.

But many other potential therapies are only in the earliest stages of development and have not been approved by international regulators.

"Stem cell therapies hold a lot of promise, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments," said one of the 15, Sarah Chan of Britain's University of Edinburgh.

The experts called for global action, led by the World Health Organization, to introduce controls on advertising and agree international standards for the manufacture and testing of cell and tissue-based therapies.

"The globalization of health markets and the specific tensions surrounding stem cell research and its applications

have made this a difficult challenge," they wrote. "However, the stakes are too high not to take a united stance."

(Reporting by Kate Kelland, editing by John Stonestreet)

LONDON, July 7 At least three people worldwide are infected with totally untreatable "superbug" strains of gonorrhoea which they are likely to be spreading to others through sex, the World Health Organization (WHO) said on Friday.

(Reuters Health) - Young women who suffer a concussion may be at increased risk of menstrual irregularities, at least for a few months, suggests a new U.S. study.

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'Stem-cell tourism' needs tighter controls, say medical experts - Reuters

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High-tech beauty tools on the market are going futuristic to help you look your best.

Here are some cutting-edge product recommendations:

Typically, only between 1 percent and 10 percent of skin care topicals are absorbed into the skin, and the rest is wasted. The JeNu PLUS Ultrasonic Infuser emits 365,000 pulses of ultrasonic energy per second to push more skin care product into skin for maximum absorption; increasing absorption by up to 75x. Use with a proprietary MicroSphere Gel (sold separately) to maximize skin care product absorption. You can purchase the infuser at https://www.jenu.com/infuser-plus

Create flawless curls and waves at the push of a button with the CHI Spin n Curl. Hair is drawn into the curl chamber with a ceramic rotating barrel, and its timed to create perfect curls. Ceramic heat technology helps distribute heat evenly across the barrel surface to help seal the cuticle, reducing styling damage while locking in moisture. The digital temperature display offers easily adjustable temperature settings each hair texture, creating a customizable styling experience. Available for purchase at http://qvc.co/2tQjEpw

Finally, shapewear for your face! The OMG! Is this Really Me? Instant Face Shaper is a potent gel utilizing natural clay-derived compounds to instantly make skin feel tightened and lifted. Also contains plant-derived stem cell extracts to fight free radicals and reduce the appearance of fine lines and wrinkles. You can purchase the product at http://www.robinmcgrawrevelation.com/products/omg-really-me

myCoolSlim is a natural way to reduce unwanted body fat by delivering a safe and effective cold temperature directly to stubborn areas of fat. Its specially designed based on science to freeze and naturally eliminate fat cells.Wear it for 30 minutes a day no more than that and watch the fat cells shrink away! It's the #1 at home cold contouring solution and a much cheaper alternative to expensive plastic surgery. Available to buy at http://mycoolslim.com

HiMirror is the worlds first smart beauty mirror its like having a virtual beauty consultant! The intuitive, touch-free design gives you a beauty, skin, and health analysis. The Smart Body Scale is an accessory to the HiMirror, and it measures weight, body fat percentage, body mass index, total body water, skeletal muscle mass, bone mass, and basal metabolic rate. All data is displayed on a simple interface. You can purchase the products at https://www.himirror.com/us_en/home

For more beauty tips, tricks and product recommendations, subscribe to Beauty News with Angela Cruz at http://www.youtube.com/AngelaCruzTube.

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High-tech beauty products - WPTV.com

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Equine mesenchymal stromal cells have been shown to have antibacterial properties, raising the possibility they could aid in healing troublesome skin wounds in humans and horses.

Mesenchymal stem cells, or MSCs, are multipotent connective-tissue cells that can differentiate into a variety of cell types, including bone cartilage, muscle and fat.

Chronic skin wounds in humans are common and their treatment is often complicated by pathogenic bacteria. Therefore, safe and innovative treatments to reduce the bacterial load in such wounds are needed.

MSCs have been reported to provide local hormonal signals that promote healing in skin wounds. However, the effects of equine MSCs on the growth of bacteria commonly found in skin wounds has not, until now, been explored.

Researchers from the College of Veterinary Medicine at New Yorks Cornell University have been the first to show that equine MSCs possess antimicrobial properties which stymied the growth of Escherichia coli (E. coli) and Staphylococcus aureus (S. aureus).

The MSCs did so in part by secreting antimicrobial peptides and depolarizing the bacterial cell membranes.

Rebecca Harman, Gerlinde Van de Walle, Steven Yang, and Megan He, writing in the journal Stem Cell Research & Therapy, said they focused on the antibacterial properties of MSCs from horses, as this animal model offered a readily translatable model for therapies in humans.

The study team described the laboratory experiment they set up, in which MSCs were isolated from the blood of healthy horses. The bacteria were cultured in the presence of MSCs and an MSC conditioned medium a processed fluid containing all factors secreted by the cells.

They found that both the MSCs and the MSC conditioning medium inhibited the growth of both bacteria, and that the conditioning medium depolarized the cell membranes of these bacteria.

The conditioning medium was found to contain four antimicrobial peptides, cystatin C, elafin, lipocalin 2, and cathelicidin. These appeared to be at least partially responsible for the antibacterial action.

They also looked for the presence of beta defensin 2 in equine MSCs since it has been found to be secreted by human umbilical cord-derived MSCs. It belongs to a widespread family of antimicrobial peptides found in most mammals, including horses. To the surprise of the research team, they could not detect beta defensin 2 in equine MSCs.

Our results, they concluded, demonstrate that equine MSCs inhibit bacterial growth and secrete factors that compromise the membrane integrity of bacteria commonly found in skin wounds.

There appeared to be a difference in the underlying mechanisms targeting each species, withdifferent secreted factors appearing to target different bacteria.

It will be interesting, they said, to study the effects of the MSC conditioning medium on additional bacterial species commonly found in equine skin wounds. The findings will likely be relevant to human as well as veterinary medicine, they said.

Since we found that equine MSCs secrete a variety of antimicrobial peptides that appear effective against both gram-positive [S. Aureus]and gram-negative [E.Coli] bacteria, these cells may serve as a broad-spectrum treatment to control bacterial growth and kill bacteria, without leading to resistance.

The study team said they now intended to evaluate the effectiveness of equine MSCs in healing both acute and chronic wounds.

Antimicrobial peptides secreted by equine mesenchymal stromal cells inhibit the growth of bacteria commonly found in skin wounds Rebecca M. Harman, Steven Yang, Megan K. He and Gerlinde R. Van de Walle Stem Cell Research & Therapy 2017 8:157 DOI: 10.1186/s13287-017-0610-6

The study, published under a Creative Commons License, can be read here.

Original post:
Mesenchymal stromal cells from horses show potential for healing skin wounds - Horsetalk

Recommendation and review posted by Bethany Smith

A U.S. biomedical researcher believes most babies will be made in the lab instead of the bedroom within the next two to three decades -- a bold prediction that could halt genetic predisposition to certain diseases and introduce a new plane of biological inequality.

Hank Greely, the director of Stanford Law Schools Center for Law and the Biosciences, told attendees at the Aspen Ideas Festival earlier this week that replacing sex as the primary means of baby-making will save women from undergoing fertility treatments, reduce health care costs, and give non-traditional families more avenues to have children.

Greely predicts most prospective parents will soon opt to choose from a range of embryos created by taking female skin samples and using stem cells to create eggs, which are then fertilized with sperm.

The range of embryos would be audited for genetically transmitted diseases such as Huntingtons, and perhaps even DNA indicators for breast cancer and Alzheimers. The process could also allow for the selection of cosmetic features, like hair and eye colour, and even complex traits such as intelligence.

Some of this can already take place through costly pre-implantation genetic diagnostics and in vitro fertilization. But Greely imagines, in the future, such selection will become commonplace as the technology becomes cheaper and perhaps even subsidized due to the offset in other medical costs.

University of Toronto bioethicist Kerry Bowman warns that widespread adoption of multiple embryo selection would be quite a deviation from the status-quo, and would mark a shift that makes longstanding fears about genetic predetermination a reality.

It could lead to inequality. Who could afford such a technique? he asked CTV News Channel on Thursday. When we have some people that are selected to the point of almost being enhanced, weve got more inequality added on top of that.

Beyond the issue of cost and the ethical taboo of so-called designer babies, Bowman points to the moral implications of creating additional embryos with the knowledge that some will be discarded.

What are you going to do with them? He (Greely) seems to be talking about a very large amount of embryos. That is one concern, Bowman said.

With that in mind, however, he expects many people will embrace the rise of scientific intervention in human reproduction for the mere possibility of diminishing the risk of disease.

If you could prevent a child being born into a life of suffering, most people would be very supportive of that, Bowman said. Historically, weve thrown the dice.

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Sex for procreation will be obsolete in 30 years, researcher says - CTV News

Recommendation and review posted by sam

Recently, a kerfuffle in the world of CRISPR illustrated just how easily moneyand our perception of itcan impact science.

In late May, a paper came out questioning how effective the gene-editing technology really is. Working with mice, researchers found that edits made with CRISPR can also result in thousands of unintended changes to a genome. The study cast serious doubt on whether CRISPR is ready for prime time.

The fallout was swift. Stock prices of three CRISPR companiesEditas Medicine, Intellia Therapeutics and CRISPR Therapeuticstumbled. Scientists affiliated with those companies fired back, questioning the studys methodology. Stocks bounced back. The scientific world was set atwitter, questioning not only the validity of the initial study, but how to trust a rebuttal against that study when it came from those who stood to lose the most from its publication.

Conflicts of interest arent a new problem in science. One frequently-cited example is the role that tobacco industry-funded scientists played in distorting the health consequences of smoking. There is a significant body of evidence suggesting financial interests can correlate with favorable results. But, conflicts of interest arent always all bad. Research funding from sources with a vested interest in a topic can sometimes help advance science that otherwise might not get funded at allthink the patient advocacy groups funding cures for little-known diseases.

Whats undoubtedly true is that money plays a significant role in science. And rarely has there been as much money at stake as with CRISPR, the nascent gene-editing technique that promises to cure everything from genetic disease to global famine by allowing researchers to easily cut and paste particular genes. When scientists whose fortune and reputation hinges on a particular technology speak out against a paper questioning that technology, its hard not to wonder how that bias might factor in.

There is this unspoken assumption the people in academia are driven primarily by the quest for knowledge and the science, Josephine Johnston, a bioethicist at The Hastings Institute, told Gizmodo. But in recent history, controversies over things like tobacco and GMOs have begun to erode that perception. When it became clear that more and more scientists have a specific financial stake, it caused a lot of concern, Johnston said.

When it comes to CRISPR, the financial stakes are certainly complicated. Two separate groups of scientists have long been embroiled in a battle over the patent for the technology, with one headquartered at The Broad Institute of MIT and Harvard, and the other at U.C. Berkeley (so far, the US has awarded the patent to Broad but Europe and China have sided with Berkeley). The patent gives the scientists the ability to license the technology. In this case, Broad has licensed the technology to Editas, a company founded by scientists at both Berkeley and Broad. Berkeley licensed its patents Intellia, which Berkeleys Jennifer Doudna is also a founder of, as well as to CRISPR Therapeutics.

Most of the headline-grabbing scientists associated with CRISPR have major financial stakes in publicly traded CRISPR companies, creating a strong incentive across the industry for CRISPR to succeed. The concern is that a CRISPR-favoring bias could potentially cause researchers to misinterpret or skew study results, or forge ahead with human clinical trials before CRISPR is really ready.

Thats not to say that theres necessarily anything wrong with the points industry-affiliated CRISPR scientists raised in their rebuttal to the paper questioning their science. In fact, several other scientists raised similar concerns.

Finances certainly can influence science. Not just companies, but also the premises supporting government grant finances, George Church, an author of the rebuttal paper and founder of Editas, told Gizmodo via email. We were basically raising issues that the original authors can address. This, fortunately, doesnt require perfect unbiased authors. Anyone can point out a potential problem.

Michael Kalichman, director of UC San Diegos research ethics program, pointed out that financial interest isnt the only bias that scientists have to be wary of.

Weve talked about conflicts of interest for many years in science and for many reasons much of that focus has been on financial conflicts. For one, its easy to see, he told Gizmodo. What I find astonishing is that even scientists forget that there are other conflicts that can influence work, like tenure, your reputation or just being excited about an idea.

Kalichman said his biggest concern is less that scientists are actually doing anything unethical, and more that financial conflicts of interest create the perception that they are. The paper that sparked the CRISPR controversy received press in most major news outlets, and the blowback against it has received significant attention, too.

Part of me is worried about the way [this CRISPR fight] is playing out because of the picture it paints of science, he said. We have this battle going on in the pages of scientific journals that creates this perception that this is what science is about when most of science is not about this.

Johnston echoed those concerns.

The introduction of these financial interests muddies the water enough that people dont know who to trust, she said. Whether or not we can see anything wrong with either study, or anyone else can, theres still this suspicion that the financial stakes must have played some role here. Thats a very corrosive thing across science.

In the initial Nature Methods paper, scientists from Stanford and University of Iowa working to cure blindness in mice found that while CRISPR did successfully edit the gene for blindness, it also caused mutations in more than a thousand unrelated genes. The consequences of those off-target effects, far more extensive than previously realized, are largely unknown. This finding warns that CRISPR technology must be further tailored, particularly before it is used for human gene therapy, the researchers wrote.

As mentioned, scientists associated with CRISPR companies were not the only ones, or even the first, to criticize the studys design. Many scientists raised red flags about basic mistakes, such as misidentifying genes, mislabeling genetic defects, and the small number of animals the researchers had included in their research. But other scientists found the reaction against the paper, was written as a brief letter to the editor intended mainly to point to an area where more study might be needed, to be overwrought. Some, like UC Davis professor Paul Knoepfler, suggested the real problem was that the results had been over-interpreted and blown up in the press, setting in motion an out-sized blowback.

Scientists from Intellia and Editas both sent separate letters to Nature Methods, forcing it to eventually add a note to the study about the controversy surrounding the letter. Whats more, in publishing their own study taking down the initial works methodology, scientists associated with Editas opted to publish a pre-print online before it was peer-reviewed, though the initial paper did go through a peer review process. And while the response paper mentions the institutions and companies each author is affiliated with, there is no clear conflict of interest section. (Church said conflicts of interest will be included with journal publication.)

This week, a pre-print of a second paper published by scientists at Intellia that reanalyzed the original papers data and found far fewer off-target edits also appeared online.

In a statement, the Broad Institute said that the peer review process should weed out the impact of any conflict.

Scientific paperswhether making a new claim, or analyzing an existing scientific claimshould always be subject to rigorous evaluation by the scientific community to establish whether the scientific evidence actually supports the argument in the paper, the Broad Institute told Gizmodo. Such review by the community provides protection against incorrect arguments, whether due to a scientific error, financial or reputational interest, or something else.

Most journals and research institutions have a comprehensive conflict of interest policy. In 2010, UNESCO called for journals to adopt a common standard of dealing with the complex and growing financial arrangements that have developed in recent years between vested interests and independent scientists. Even so, sometimes those ties wind up omitted.

Kalichman said more might be needed to address conflicts of interest in the realm of basic science.

In clinical research, you do everything you can to separate financial interests from the people doing the work, Kalichman said. We dont really talk about that in basic research, but maybe we need to do something like that. Maybe if you have a financial interest, youre not the one that looks at the raw data.

Its next to impossible to fully weed out conflict in sciencebe it financial or otherwise. Besides, it makes sense that scientists should be able to make money off of their own work. But its also impossible not to acknowledge that those interests can influence the science. How could they not?

Update: This story has been updated to include mention of the Intellia study.

See the article here:
Gene Editing Controversy Reminds Us Just How Much Money Influences Science - Gizmodo

Recommendation and review posted by simmons

IPSWICH An Ipswich mom has been crowned a Science Super Hero by the Science Channel.

Jocelyn Duff was recognized as the June honoree of the networks monthly initiative for furthering science in her community and encouraging the next generation of innovators and problem solvers.

Duff, a physicians assistant, is the founder and executive director of CureCMT4J, an all-volunteer, nonprofit foundation inspired by her 11-year-old daughter, Talia.

In 2015 Talia was diagnosed with Charcot Marie Tooth Type 4J (CMT4J), a rare disease known to affect approximately 22 people worldwide. The neuro-degenerative disease, like ALS, causes progressive muscle weakness, leading to paralysis and respiratory compromise.

Duff founded CureCMT4J in June 2016 to address an expedited path toward a gene therapy cure. She quickly assembled a scientific team of world experts who began pre-clinical work in October 2016 at Jackson Laboratories, through a grant from the National Institute of Health.

In December 2016, CureCMT4J funded the first viral vector production for CMT4J through the University of North Carolina-Chapel Hill. Duff expects proof of concept results this summer. CureCMT4Js goal is to reach a human clinical trial as quickly as possible to save Talia and help others afflicted with rare diseases.

The Science Channel nominates three Science Super Heroes monthly from any of the following categories: Super Star (CEO or professional), Shooting Star (super fan), and Rising Star (college student). Each Science Super Hero is highlighted on-air on Science Channel the first Thursday of the month and across all Science Channel social platforms for the entire month.

To learn more about CMT4J or to donate towards a cure go to curecmt4j.org.

Mary Markos may be contacted at 978-675-2708 or mmarkos@gloucestertimes.com.

||||

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Ipswich mom honored as Science Super Hero - The Salem News

Recommendation and review posted by Bethany Smith

A hypothetical heterosexual couple living in the US or UK takes tests to learn if they are carriers of the more prevalent recessive diseases. Theyre relieved to find out that cystic fibrosis (CF) isnt something they need worry about passing to their children neither has any of the few dozen mutations the test panel includes.

The couple do not carry the most common 32,106, or even 139disease-causing mutations in the CFTR gene, the number depending upon the testing lab. But that could be a problem a false negative if the woman and man are anything other than non-Hispanic whites.

More than 2,000 variants (alleles) of CFTR are known, and their prevalence varies in different populations. Thats not because DNA recognizes the race or nationality of the person whose cells its in, but because of how we choose our partners.

CF Among Asians

For people of Asian ancestry, the available CF test panels are pretty much useless, according to an article (Ethnicity impacts the cystic fibrosis diagnosis: A note of caution) and an accompanying editorial (Dont judge a book by its cover: the emerging challenge of diagnosing CF in non-Caucasians), in the latest issue of the Journal of Cystic Fibrosis (both unfortunately behind a paywall).

Barbara Bosch, from the University Hospitals Leuven in Belgium and colleagues, compared CF symptoms among 234 Asians represented in the internationalCFTR2database to 53 patients in the UK CFdatabase.

In European whites, CF tends to cause lung congestion (often with Pseudomonas aeruginosa infection), pancreatic insufficiency, salty sweat, and likely one or two copies of the mutation F508del, which deletes one of the proteins 148 amino acids. Asians had been thought to have more severe lung disease than the classic European cases, but it turns out that they have poorer lung function overall, making CF seem worse. Asians also have less salty sweat, much better pancreatic function, and fewer cases of CF-associated male infertility. It isnt surprising that CF cases among Asians can be missed or misdiagnosed.

The most important distinction between European white and Asian populations, for treatment purposes, is the CFTR mutations. While 73% of people recognized to have CF worldwide have at least one copy of F508del and 70% of Europeans with CF have two copies, the mutation accounts for only 12-31% of CF alleles among Asians, and none (so far noted) in Korea, Japan, Thailand, and Vietnam. Last year researchers discovered a CFTR mutation in theChinesenot yet found in other populations. Having F508del or a handful of other specific mutations is a prerequisite for the targeted treatment ivacaftor (Kalydeco) and only F508del for ivacaftor combined with lumacaftor (Orkambi).

Asian roots impact on all 3 CF diagnostic pillars, the researchers conclude, referring to the lung and pancreas symptoms, the salty sweat, and the mutations. To avoid misdiagnosis as something like tuberculosis, which has happened to Chinese children with CF, the investigators suggest a more personalized approach to diagnosing the condition that considers ancestry. But parsing populations to better target genetic tests is running up against genetic admixture diversity at the DNA level when parents are from different backgrounds.

InterrogatingCFTR

In this age of ancestry.com ads everywhere and even dog breed DNA testsavailable at Wal-Mart, shouldnt we gear genetic disease tests to ancestry, restricting the mutations? But theres a catch-22. Returning to the example of CF, if Asians (and presumably other non-whites) are misdiagnosed when their clinical presentations dont match the classic white phenotype, then their mutations wont enter the databases that guide test development.

A better approach than meticulously cataloging ancestors and testing for the few identified mutations in prospective parents, especially given faster and cheaper DNA sequencing, is what the company GenePeeksis pioneering: mining as much information about a gene as possible, and applying it to all patient samples. That means deducing every way that a gene can vary, with extra, missing, and substituted DNA bases. So far theyve interrogated more than 1,000 genes.

For CF, GenePeeks curation process predicts changes in the 188,702 DNA base sequence of CFTR that alter the encoded proteins structure or function in ways that could affect health. F508del entraps CFTR protein in the twists and turns of the cells secretory network, so it cant reach the surface where it should monitor ion (salt) transport. A different mutation might slow the proteins journey to the cell membrane, and another close the ion channels too quickly. For some genotypes, symptoms might be so mild that a clinician not familiar with the diverse guises of CF wouldnt make the diagnosis. Chronic sinusitis or male infertility may be the lone manifestations.

GenePeeks analysis extends to interactions of mutations. For example, their algorithms can pick up when two people have mutations in different parts of the gene that complement, so that together in their child, the protein functions well enough to support lung health. A lab just cataloging mutations without considering how a pair of them might theoretically interact (based on biochemistry) might conclude that the risk of the child inheriting CF is 25%, when its not. In the future, analysis will ideally include gene-gene interactions.

Several recently announced collaborations are bringing GenePeeks expertise to parts of the world where populations are young and more global genetic testing needed: Saudi Arabia, the United Arab Emirates, Oman, Qatar, Bahrain, Kuwait, Lebanon, Jordan, Turkey, India, Pakistan, South Africa, Egypt, Ghana, and Kenya. The desire to protect a future child from serious disease is universal. Were trying to meet that need with better screening tools in markets that have been underserved historically, GenePeeks CEO Anne Morriss recently told me. Whenever the company becomes aware of a clinically important variant of any gene, they add it to their list for anyone not just a member of the population in which the mutation was discovered.

Genetic Testing for All

While genetic testing companies are expanding their offerings, some of them are still not keeping up with admixture. Even recent recommendationsto increase the roster of genes in preconception carrier screens require that a disease have a carrier frequency of at least 1 in 100. But where? Among whom?That criterion might miss a disease thats rare in a larger population yet concentrated in a subgroup.

Thats the case for Steel syndrome, which causes joint pain, hip dislocation, pinching of the spinal cord in the neck, short stature, and characteristic facial features, due to a mutation in a collagen gene. Its much more common among residents of East Harlem in New York City who are of Puerto Rican ancestry than among other groups. Hip surgery, which is done for the same symptoms arising from an injury, could harm a person with Steel syndrome. Because some people who identify as Hispanic may not be aware of Puerto Rican ancestry, adding the Steel syndrome mutation to orthopedic genetic testing panels or collagen panels makes sense. The 1 in 100 carrier frequency rule would miss the disease in East Harlem. (I told the Steel syndrome story here.)

GenePeeks approach celebrates the dynamic complexity of the human gene pool. The protocol recognizes the realities of global migration and diversity. People move they always have and always will. A couple with Middle Eastern ancestry can just as easily walk into a doctors office in LA as Dubai, says Morriss.

Direct-to-consumer genetic testing websites can oversimplify the situation, presenting carrier testing as a yes/no situation: you have a mutation or you dont. If you are starting a family, find out if you are a carrier for certain inherited conditions, advertises 23andme. A carrier can actually mean hundreds if not thousands of different things! We have two copies of each gene (except the X in males), and each gene, because it has thousands of building blocks, comes in many flavors.

So before we all load our genome sequences onto our smartphonesand start doling out dough for analysis to the companies that are now planning this new addictive service, researchers need to learn all there is to know about specific genes in us all.

Who ever knew genetics could be so complicated?

More:
Cystic Fibrosis Among Asians: Why Ethnicity-Based Genetic Testing is Obsolete - PLoS Blogs (blog)

Recommendation and review posted by sam

Genetic testing is expected to grow from a current $3-$4 billion market to $8-$10 billion over the next 5-6 years, asserts biotechnology sector specialist says Bret Jensen, editor of Biotech Gems.

Shares of genetic testing firm Invitae (NVTA) have risen over 20% in the past year. However, the shares have been chopped in half since they became public in early 2015, making the stock a busted IPO, a space we have found some significant investment successes in during the past.

Their specialty is genetic tests for hereditary disorders, amassing them into a single service whose advantage over competitors includes a lower price point, faster turnaround time and improved accuracy.

Management is quick to point out that over 4,000 medically important genetic tests are available today, but many are underutilized due to prohibitively high pricing.

They are building their genetic information platform with the long term in mind, noting that as more and more patients are accurately diagnosed they will be provided with the appropriate therapy earlier resulting in improved outcomes.

Current growth has been promising, with over twenty-six thousand tests accessioned and fourteen quarters of double digit sequential growth.

Other encouraging news has been that the average cost per sample has fallen to $360, representing a 40% improvement over the prior year and a 10% improvement over the prior quarter. Management expects these costs to continue to fall throughout the rest of 2017.

One can imagine the vast potential of the companys technology when they consider that in the future genetic information will play a role throughout a persons life, from newborn screening to having kids, addressing health issues and medical conditions to aging-related conditions and preventative applications.

Thus far this year the company has made a couple key acquisitions, including snapping up software developer Ommdom for $6 million in common stock.

See original here:
Invitae: Growth in Genetic Testing - Moneyshow.com (registration)

Recommendation and review posted by sam

LONDON, July 6, 2017 /PRNewswire/ -- Download the full report: https://www.reportbuyer.com/product/4825304/

The current and future aspects of cancer genomics have covered a long path of advances and the journey is still ongoing.

The technological improvements in genomic sciences had allowed parallel sequencing of both tumors and germline mutations and had provided the weapon of next generation sequencing. Under the supervision of intellectual property laws and appropriate guidelines cancer susceptibility testing has become one of the major assets in medical practice. There appears to be pervasive belief in both scientific and public circles that genetic testing is going to be the cornerstone of much, if not all, of what medicine holds for the future. Besides, what is generally meant is the wide scale testing for susceptibility to common diseases especially for cancer and for responsiveness to drugs has come to be described as genetic profiling.

With the knowledge and acceptance of the fact that the breast cancer is on alarming scale, the major concern has been diverted towards this scenario. As there are 5% to 10% of breasts cancer cases which occur due to the germline mutations and the most common ones are the BRCA1 and BRCA2 mutations. Fortunately, these hereditary cancers can be prevented if diagnosed early or even before its occurrence which includes the susceptibility testing of breast cancer genes.

Breast cancer susceptibility has been in existence since 1966 and had served as the boon for the patients as well as the stakeholders. Certainly, 2013 have been the year of major events in the field of predictive genetic testing as US FDA approved the use of next generation DNA sequencing in clinical practice. Further, the decision of Supreme Court invalidated the BRCA patent held by Myriad genetics. These decisions made the new entries and embraced the competitions in the cancer genetics market.

Leading to the current scenario which is completely changing and the market is now subjected to the direct to consumer BRCA testing kits provided by varied pharmaceuticals. However, the new entrants to the global market will face considerable challenges in persuading physicians to choose them as a test provider. New entrants will need to provide indication of subsequent in meeting the requirements of physicians such as reputation, trust, transparency, and counseling. Some of these aspects cannot be established quickly, and take time to establish.

The future holds up for the precision medicine and cancer predictability will be proving a great deal, as through the aid of breast cancer predictive testing and better counseling measures this regimen can turn out into an effective prophylactic modality for hereditary as well as early stage breast cancer.

The predictive risk calculations will be leading towards the better management and improved survival rates. Over the next decade or two, it seems likely that the technology will screen entire populations or specific subgroups for genetic information in order to target interventions to individual patients that will improve their health and prevent disease. While the evidence base is still growing, genetic services industry leaders strongly believe that emerging testing capabilities will have significant clinical impact in the future.

"Global Breast Cancer Predictive Genetic Testing Market Outlook 2022" Report Highlights: Hereditary Breast Cancer Genes Conceptual of Breast Cancer Susceptibility Predictive Cancer Testing Essentials Economical, Ethical & Social Aspects Global Prevalence of Breast Cancer Market & Cost Analysis of Predictive Testing Insurance Affairs for Breast Cancer Predictive Testing Download the full report: https://www.reportbuyer.com/product/4825304/

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Global Breast Cancer Predictive Genetic Testing Market Outlook 2022 - PR Newswire (press release)

Recommendation and review posted by sam

July 5, 2017 Credit: Cancer Research UK

Cancer patients should have routine access to genetic testing to improve diagnosis and treatment, according to England's chief medical officer.

Despite the UK being a world leader in genomic medicine its full potential is still not being realised, Professor Dame Sally Davies said in a new report.

Davies urged clinicians and the Government to work together and make wider use of new genetic techniques in an attempt to improve cancer survival rates.

Genetic testing can pinpoint the faults in DNA that have led to a cancer forming. Different cancers have different faults, and these determine which treatments may or may not work.

Such testing could lead to patients being diagnosed faster and receiving more targeted or precise treatments.

Davies said that "the age of precision medicine is now" and that the NHS must act quickly to remain world class.

"This technology has the potential to change medicine forever but we need all NHS staff, patients and the public to recognise and embrace its huge potential." said Davies.

Sir Harpal Kumar, Cancer Research UK's chief executive, agreed, saying that it would be a disservice to patients if the UK were slow to respond to innovations in this area.

The report recommends that within 5 years training should be available to current and future clinicians and that all patients should be being offered genomic tests just as readily as they're given MRI scans today.

Davies also called for research and international collaboration to be prioritised, along with investment in research and services so that patients across the country have equal access.

However the report recognises potential challenges such as data protection issues and attitudes of clinicians and the public.

"This timely report from the chief medical officer showcases just how much is now possible in genomics research and care within the NHS," added Sir Kumar.

"Cancer Research UK is determined to streamline research, to find the right clinical trial for cancer patients and to ensure laboratory discoveries benefit patients".

And the design of clinical trials are starting to change. A number of trials are underway, like Cancer Research UK's National Lung Matrix Trial with AstraZeneca and Pfizer, where patients with a certain type of lung cancer are assigned a specific treatment based on the genetic makeup of their cancer.

However, Sir Harpal Kumar stressed that to bring the report's vision to life the Government, the NHS, regulators and research funders need to act together.

Explore further: Adding abiraterone to standard treatment improves prostate cancer survival by 40 percent

Cancer Research UK is partnering with pharmaceutical companies AstraZeneca and Pfizer to create a pioneering clinical trial for patients with advanced lung cancer marking a new era of research into personalised medicines ...

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Does doxycycline treat h pylori ulcers - Shelf life extension program doxycycline - Longboat Key News

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Stem cells have long been used to treat blood cancers and some immune diseases. But some doctors are offering stem cell treatments for diseases still under clinical trial. Photograph: Mauricio Lima/AFP/Getty Images

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks, the authors wrote.

Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldales death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve comorbidities and that stem cells could move from joints to other parts of the body to improve disease in distant sites including lungs and brain, vision, mentation and pain.

In his report into Drysdales death, the coroner Hugh Dillon wrote that he could not say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale.

But regardless of his motivation, Dr Brights performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdales death.

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australias drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. A TGA spokeswoman said the Administration was still examining the options for changes to the legislation to reflect public and industry views. The TGA currently considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

There is a precedent for international regulation of this industry because regulations already exist around drugs the way they are manufactured, she said.

This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

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Stem cell therapies: medical experts call for strict international rules - The Guardian

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Sergey with his wife and son

ABMDR salutes young officer and celebrates its 30th life saved through a transplant

LOS ANGELESThe Armenian Bone Marrow Donor Registry (ABMDR) announced that it has facilitated its 30th bone marrow stem cell transplant, thanks to stem cells harvested from a young ABMDR matched donor. The stem cells of the donor, Sergey, who is a 23 year-old army officer serving on the frontline in Artsakh, were utilized to save the life of a cancer patient in Iran.

On July 3, 2017, Sergey became the 30th ABMDR donor to experience the joy of saving the life of someone he had never met, said ABMDR President Dr. Frieda Jordan.

Dr. Sevak Avagyan, Sergey, Dr. Andranik Mshetsyan

In 2012, Sergey had joined the ranks of ABMDRs donor registry during a recruitment drive at the Vazken Sagsyan Military Institute, in Yerevan. Five years later, he was found to be a perfect match for a patient in Iran who was suffering from leukemia and whose only hope for survival was to receive a bone marrow stem cell transplant from a compatible donor. Sergey turned out to be a perfect match for the patient. He was given a day off to leave the frontline to come to ABMDRs Stem Cell Harvesting Center in Yerevan to donate his stem cells and save a patients life.

Accompanied by his young wife and six-month old son, Sergey was greeted by ABMDR staff at the Stem Cell Harvesting Center. The painless, non-invasive harvesting procedure, performed by Dr. Andranik Mshetsyan, lasted approximately four hours. Also present at the procedure were ABMDR Executive Director Dr. Sevak Avagyan and Medical Director Dr. Mihran Nazaretyan.

Sergey, Dr. Mihran Nazaretyan, and Lab Staff Member

At the conclusion of the harvesting, as staff members performed quality-control analyses of the harvested cells and packed them for the special courier who was waiting to transport the precious gift of life to the patient in Iran, Sergey, a hero in the eyes of all, on the frontlines as well as far away from them, joined his young family while someone in Iran was about to get a second chance at life.

Established in 1999, ABMDR, a nonprofit organization, helps Armenians and non-Armenians worldwide survive life-threatening blood-related illnesses by recruiting and matching donors to those requiring bone marrow stem cell transplants. To date, the registry has recruited over 29,000 donors in 42 countries across four continents, identified over 4,190 patients, and facilitated 30 bone marrow transplants. For more information, call (323) 663-3609 or visit abmdr.am.

Continued here:
Artsakh Soldier Saves Life Of Cancer Patient In Iran - Asbarez Armenian News

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Blanca Romero gave birth to her son, Sebastian, on Feb. 12, 2017, at Houston Methodist Hospital in Katy. At 8 lbs. 9 oz., Sebastian had plump cheeks, big brown eyes and a head full of thick black hair. He was, by all appearances, a perfectly healthy baby boy.

Sebastian was Romeros third child, so she was familiar with the post-delivery drill. She took him to his newborn screening with the pediatrician, but something wasnt quite right with one of his tests. The results showed abnormalities in Sebastians immune system.

It was scary to hear your child has something, but you dont know what it is, Romero said.

Romero and her husband, Emil, met with Sarah Nicholas, M.D., an allergy and immunology specialist at Texas Childrens Hospital, who explained that their son had a rare genetic disorder called severe combined immunodeficiency (SCID). The condition is more commonly known as bubble boy disease, named for David Vetter, who suffered from the same illness and was forced to live his short life in a sterile plastic bubble. Born in 1971, Vetter was also treated at Texas Childrens.

Patients with SCID are born missing their T cells, a type of white blood cell that protects the body from foreign invaders by killing viruses and sending instructions to the rest of the immune system. In some SCID cases, patients may be born without their B cells, a white blood cell that produces antibodies, or natural killer (NK) cells, a white blood cell that kills viruses and tumor cells.

Without the bodys natural defense system, Sebastian and other babies with SCID are at high risk for severe and recurrent infections, such as pneumonia.

Even a slight cold could turn deadly, a rash could turn into an infection and turn deadly, Romero said. Anything could kill him.

But there was hope. With chemotherapy and a bone marrow transplant, Sebastian had a good chance of living in the real world.

Although Sebastian didnt need to live in a plastic chamber like Vetter, the environment he required at home created a bubble of social isolation for Romero and her family.

Soon after his diagnosis, Romeros husband and the couples other two children, Abraham, 7, and Kayla, 5, caught colds.

Romeros instincts kicked in. She began formulating a way to keep Sebastian safe from pathogens and people, including his own family. First, she and her husband disinfected theirentire home, buying four air filters to remove dust, pollen, mold and bacteria from the air.

Then, they transformed the master bedroom into living quarters for her and Sebastian. Romero spent her days alone with the baby, venturing outside the room only for brief moments.

My husband would bring food into the bedroom whenever the kids would leave for school and he would leave for work, Romero said. He would Lysol the entire house so that I could go in the living room or the kitchen to get something to eat, and then Id go right back into the room.

Romero notified her childrens school of Sebastians condition. The classrooms where Abraham and Kayla spent most of their time were sanitized daily. The school also let Romero know when any students were sent home with fevers, so that she could decide whetheror not her children should go to school.

Rather than eating lunch in the cafeteria with the rest of his class, Abraham stayed in the classroom with his teacher and one friend.

When the kids returned home from school, they were required to shower immediately to make sure they didnt carry any outside pollutants or germs into the house.

Even then, the master bedroom was off limits. Although Abraham and Kayla were eager to hold and play with their baby brother, they had to stand far from the door. Romero would hold Sebastian up in the air like in Lion King when theyre showing Simba, she said, sothey could see him.

They went from being able to touch and love the baby to not being able to touch him anymore, Romero said. At first, they didnt understand, so they would cry a lot. We had to explain to them that this was life-threatening and he could die.

The kids were isolated from their mother, as well.

I couldnt hug my kids, Romero said. I couldnt kiss them because I have to protect Sebastian as his main caregiver.

Instead, she would give her two oldest children pretend hugs. She would hug herself and they would hug themselves at the same time, as if they were hugging each other.

I feel guilty, Romero said. Everybody tells me not to because Sebastian is the one who needs us the most right now, but I cant help, as a mother, to feel like Im failing my other two children because they also need me.

On May 14, Mothers Day, Blanca and Emil Romero packed their suitcases and drove Sebastian from their home in Katy to Texas Childrens. They settled into a small room with a metal crib for Sebastian and a sofa that converted into a pull-out mattress. For the next month, this would be their second home.

Currently, the only curative option for patients with SCID is a one-two punch of chemotherapy and a bone marrow transplant using stem cells.

With this treatment, the survival rate at Texas Childrens has been shown to be more than 90 percent for patients with SCID if treated within 3 months of age. Left untreated, however, SCID is almost always fatal from infection within a year of age.

Any time you see your patient go through a difficult procedure you really worry about the risks youre subjecting them to, but SCID is really universally fatal without intervention, Nicholas said. I feel good recommending it to my patients because I know its a lifesaving therapy.

Stem cells are the mother cells of the blood that eventually mature into red blood cells, platelets and white blood cells, explained Caridad Martinez, M.D., Sebastians bone marrowtransplant specialist and associate clinical director of the Pediatric Bone Marrow Transplant Program at Texas Childrens Cancer and Hematology Centers. Healthy white blood cells canfurther divide into various subtypesincluding lymphocytes, which are the bodys B cells, T cells and NK cells.

Since the lymphocytes arise from stem cells that are located in the bone marrow, the only curative option for SCID patients is basically to replace that sick marrow producing abnormallymphocytes with a normal marrow producing functional lymphocytes, Martinez said.

There are three options for patients who need a bone marrow transplant: a sibling donor, an unrelated marrow donor or a cord blood unit. A sibling donor is the preferred option, but only 25 percent of patients who need a bone marrow transplant will have a matched sibling donor.

Patients without a matched sibling require either a transplant from an unrelated marrow donor or a cord blood unitstem-cell-rich blood left in the umbilical cord and placenta after birth that was donated to a public cord blood bank.

But none of these options worked for Sebastian, who is Hispanic. Minoritiesincluding Hispanics, African Americans and Asiansare underrepresented in the bone marrow transplant registry, making it difficult for babies of those ethnic backgrounds to find a good donor match.

Martinez said it was the first time in her 10 years of transplanting SCID babies that she and her team werent able to find a matched sibling or cord blood unit for transplant.

Without many options left, Martinez decided on a different type of transplant, one that had never been performed on a SCID patient at Texas Childrens: a haploidentical transplant. A haploidentical, or half-match, donor can be a patients mother, father or sibling, as long as they havent been exposed to certain viruses, including cytomegalovirus (CMV), a commonvirus that affects 85 percent of adults.

Once a person is exposed to CMV, the virus remains dormant inside the body and can be reactivated.

Those viruses are like common colds, but when they reactivate in the transplant period it can be a problem, Martinez said.

Fortunately, Romero tested negative for those viruses, making her an ideal haploidentical donor for Sebastian.

Martinez administered a drug called granulocyte colony-stimulating factor to stimulate the production of Romeros stem cells and mobilize them out of the bone marrow to the peripheral blood for extraction. After measuring the amount of cells her body was producing, Martinez and her team discovered that Romero had four to five times the amount of stem cells Sebastian needed for his transplant. Romero called them her super cells.

The extracted stem cells were then sent to a lab for graft engineering and T cell depletion, a purification process that separates unmatched T cells to prevent graft-versus-host disease (GVHD).

Finally, on the evening of Thursday, May 25, Martinez and her team walked into Sebastians hospital room carrying a small blood bag full of purified stem cells. They hooked up the bag to the IV pole next to Sebastians bed and began administering 78 milliliters of the super cells.

Romero watched as the pink liquid snaked through the tube into Sebastians central line. An hour and 10 minutes later, his body received the final drops of lifesaving stem cells.

But Sebastian wasnt out of the woods yet. He was still experiencing side effects from chemotherapy.

In preparation for the bone marrow transplant, Sebastian underwent 10 days of chemotherapy to suppress any remaining immune response that might reject the donor cells and to clear space in the bone marrow for the new stem cells to grow and expand. Although this is a necessary part of the treatment, it takes a painful toll on the body.

During the chemo days, he looked fine, but now to see the after effects, I cant do anything and nothing soothes him, Romero said. I try to hold him and its horrible. I cant do anything. It sucks. I wish I could just know what hes feeling.

Monday, May 29, was one of their hardest days yet. Emil Romero sat in the pull-out bed, gently holding Sebastian in his arms, while the slack of catheter tubes attached to Sebastians body trailed around them. Sitting next to her husband, Blanca Romero gazed forlornly at her 3-month-old baby boy and listened to his subdued whimpering.

He has learned that, if he cries, it hurts him more, so he whimpers more than he cries, she said. He doesnt babble as much either because it hurts him.

As she caressed Sebastians head, strands of his hair stuck to her hands, a side effect of chemo. Sebastian inched closer to her and started rubbing her face. Could he sense his mothers pain, or was he just practicing his hand-eye coordination?

There are moments when Im pretty okay and then there are moments when I go into the bathroom and just cry it out, Romero said. Its tough to see your child going through this stuff but hes there fighting and were fighting along with him.

A new immune system takes time to grow and be normal, Martinez said.

You need to wait until that immune system is mature enough to be functional and able to fight viruses or respond to vaccines, she added. That usually happens about nine months to a year after the transplant is done.

On Wednesday, June 14, Sebastians doctors delivered some surprising news: His T cell count in his bone marrow was steadily increasing above optimal levels. He was going to be released that afternoon, ahead of schedule.

It was a mix of emotions, Romero said. You get choked up knowing were ready to go home, but at the same time, super scared because youve been in this environment where everybody knows they have to protect him.

But it was wonderful to have the family back together again. Sebastians two older siblings could finally shower their baby brother with affection. They had been waiting patiently and loving Sebastian from a distance, but now, they could hug and kiss him.

This is the closest theyve all been since he was born, Romero said.

Sebastian will continue to stay in isolation at home for at least three months. He was supposed to leave only for clinic visits three times a week to receive blood or platelet transfusions, but because of a fungal infection he contracted, Romero still takes him to the hospital for treatment every day for four to six hours. Its an exhausting routine traveling back and forth from Katy to the hospital, Romero said, but at least theyre home.

Were so thankful that hes been doing so good, she said, her voice a couple octaves higher, as she nuzzled Sebastians neck and cuddled with him on the sofa in their living room.

Over the past four months, Romero and her familys lives took an unexpected turn because of Sebastians SCID diagnosis. But Romero, ever the optimist, said she hopes Sebastians journey will raise more awareness about SCID and inspire others to become bone marrow or cord blood donors.

I know theres a plan and a purpose. I can see that through sharing our story, she said. If you could go, be a match and sign up, do it. You can save a life. Whats better than that? You can be somebodys hero.

Continue reading here:
Bursting the Bubble - Texas Medical Center (press release)

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STEM CELL THERAPIES BREAKING BARRIERSPhysicians all over the world are increasingly employing stem cell therapies for the treatment of chronic diseases including hypertension, diabetes, chronic kidney disease, neurological disorders, asthma, diabetes, rheumatoid arthritis, spinal cord injuries, female and male sexual dysfunction, joint pain and autoimmune disease. INSET is Dr. David Ikudayisi, of the Glory Wellness and Regenerative Centre PHOTO CREDIT: http://theconversation.com

Technology offers groundbreaking new treatment option for chronic diseases to patients Physicians all over the world are increasingly employing stem cell therapies for the treatment of chronic diseases including hypertension, diabetes, chronic kidney disease, neurological disorders, asthma, diabetes, rheumatoid arthritis, spinal cord injuries, female and male sexual dysfunction, joint pain and autoimmune disease.

A study published last week in the FASEB Journal showed that a new therapy developed through stem cell technology holds promise as a treatment for chronic asthma.

Also, researchers have successfully patched up damaged hearts to treat heart failure, using the patients own muscle stem cells but another study published last week in journal Circulation found that the treatment could be more harmful than helpful if cardiac stem cells are involved.

In another study published in the journal Science Translational Medicine, team of investigators has successfully repaired severe limb fractures in laboratory animals with an innovative technique that cues bone to regrow its own tissue. If found to be safe and effective in humans, the pioneering method of combining ultrasound, stem cell and gene therapies could eventually replace grafting as a way to mend severely broken bones.

Using new gene-editing technology, researchers have rewired mouse stem cells to fight inflammation caused by arthritis and other chronic conditions. According to the study published in the journal Stem Cell Reports, such stem cells, known as SMART cells (Stem cells Modified for Autonomous Regenerative Therapy), develop into cartilage cells that produce a biologic anti-inflammatory drug that, ideally, will replace arthritic cartilage and simultaneously protect joints and other tissues from damage that occurs with chronic inflammation.

Scientists have for the first time created a special type of neuron from human stem cells that could potentially repair spinal cord injuries. The study was published in the Proceedings of the National Academy of Sciences.

Also, early results of a clinical trial suggest that stem cell therapy may be a promising treatment for erectile dysfunction, after the procedure was found to restore sexual function in men with the condition.

Meanwhile, the ANOVA IRM Stem Cell Centre has opened its doors in Frankfurt, Germany offering a groundbreaking new treatment option to patients worldwide.

One of the pioneers of stem cell therapy in Nigeria, Dr. David Ikudayisi, of the Glory Wellness and Regenerative Centre, with clinics in Abuja and Lagos, told The Guardian that there are several thousand clinical trials based on autologous (patients own) Mesenchymal Stem Cells (MSCs). He said these type of stem cells are relatively easy to obtain from a patient via bone marrow blood or fat tissue and have been shown to hold vast healing potential.

Ikudayisi is a United States (U.S.) Board Certified Internist with a strong passion for regenerative aesthetic and cosmetic medicine.

Ikudayisi said ASCT and Platelet Rich Plasma Therapy (PRPT) are under a new specialty of medicine known as regenerative medicine, which is a specialist segment of medicine that helps people to naturally regenerate and rejuvenate their bodies from the different conditions they may be suffering from without using chemicals or the orthodox medicine we are used to.

ASCT may hold answers to many questions and problems that we doctors believed had no solutions, especially neurological disorders. Adult stem cell therapy with or without PRPT revitalizes and regenerates the body organs and systems; it also reverses and repairs many pending subclinical medical problems before they become apparent, including the diseases that are age-related, Ikudayisi said.

He said that ASCT and PRPT are safe as shown by many published research reports and clinical trials done already. He, however, said this does not guarantee that adverse effects cannot occur if physicians that are not properly trained do the treatment.

The US-trained said ASCT has helped a lot of people all over the world to regain their lives back from debilitating ailments and Nigerians are not left behind. He said there are real people in Nigeria that were either wheelchair bound but now walking freely with occasional use of a cane or using a cane before but now walking without one; diabetes patients are able to have restoration of vision in their eyes, and some feel and look younger.

He said ASCT has helped chronic kidney disease patients in Nigeria that are on haemodialysis to either reduce the frequency of haemodialysis per week or like in a patient that was recommended to have kidney transplant a year ago is now off haemodialysis and off diabetic medications, and remain stable for the last six months.

Ikudayisi said men with erectile dysfunction are now feeling like young men again. He further explained: I would be remiss to mention that the type of treatment protocol, the dosage of stem cells used also play a role in the efficacy of the treatment, and not everyone will respond in the same manner. Most of the patients showed improvements after the first treatment, and the few that needed second treatment went on to see great results after more treatments were done; needless to say that they were elated with the results.

The only groups of patients that will always need more than a couple of transplantation sessions are patients with the neurological disorders. The latest researches and evidence-based studies show the number of treatment session needed to get significant clinical results can decreased by adding Exosomes to the treatment sessions.

Ikudayisi said there are some diseases that conventional treatments have no cure for, but ASCT can reverse the symptoms of those diseases, repair, and regenerate the damaged tissues or organs involved. He explained: In some cases, it significantly slows down the progression of the disorder. For example, it can regenerate the bony joints in arthritis, repair and strengthen partial Rotator cuff tears and avascular necrosis of the hip without surgery, revitalize the sexual organs in men and women, regenerate renal cells in kidney diseases, modulate immune system without use of medications that have very serious side effects in conditions like rheumatoid arthritis, lupus, scleroderma, Crohns disease, etc. Another advantage is its application in neurological disorders like Amyotrophic lateral sclerosis (ALS) and spinal cord injury.

Ikudayisi said ASCT can gradually lower diabetic medications dosage and eventually may get the patients off diabetic medications. This is evidenced by stem cells in a hyperglycemic medium differentiating into pancreatic cells; therefore leading to increased development of new blood vessels, secretion of various products of the immune system, and up-regulation of pancreatic transcription factors and vascular growth factor. This aids the pancreas to regenerate and boost its ability to produce insulin. In stroke patients, stem cells activate cells around the suffering brain tissue to catalyze rapid healing and to improve brain function, thereby restoring motor function. Until recently, it was believed that damage to the brain tissue was permanent. This is being challenged by the evidences of re-growth of brain cells and improvements of neurological function documented with the use of adult stem cells, he said.

Ikudayisi said a procedure called P-Shot for Men uses PRPT to resolve challenges relating to erectile dysfunction by regenerating the damaged tissues. It gives treated men the possibility of saving their relationships by increasing stamina, enjoying bigger and harder genitals, and eventually increasing the length and girth. Orgasm-Shot for Women, the regenerative medicine procedure for womens sexual function, leads to increased ability to have orgasm, better arousal from clitoris stimulation, decreased pain during intercourse, tighter vaginal opening, increased sexual desire and natural lubrication, and increased arousal from G-spot stimulation. In addition, because of the O-Shot rejuvenation capabilities, there is help available for women suffering from urinary stress incontinence without the need for invasive surgery, he said.

Ikudayisi said since the stem cells used are autologous, there is no risk of rejection of the stem cell transplant, but as with any procedure, there is a risk of infection, which can be very minimal or non-existent if done under the right conditions. He said adult stem cells transplantation can also be considered by people looking for alternative treatments especially in the areas of diabetes, hypertension, kidney disease, female and male sexual dysfunction, joint pain, neurological disorder and autoimmune disease.

The regenerative medicine expert, however, said: Currently, the cost of treatment varies, and it is not for everyone. However, you cant place a price tag on life just as the saying goes that Health is wealth.

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Stem cell therapies breaking barriers Features The Guardian ... - Guardian (blog)

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This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

The cell-based markets was analyzed for 2016, and projected to 2026. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 306 of these are profiled in part II of the report along with tabulation of 291 alliances. Of these companies, 170 are involved in stem cells. Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 64 Tables and 22 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

Key Topics Covered:

Part I: Technologies, Ethics & Regulations

Executive Summary

1. Introduction to Cell Therapy

2. Cell Therapy Technologies

3. Stem Cells

4. Clinical Applications of Cell Therapy

5. Cell Therapy for Cardiovascular Disorders

6. Cell Therapy for Cancer

7. Cell Therapy for Neurological Disorders

8. Ethical, Legal and Political Aspects of Cell therapy

9. Safety and Regulatory Aspects of Cell Therapy

Part II: Markets, Companies & Academic Institutions

10. Markets and Future Prospects for Cell Therapy

11. Companies Involved in Cell Therapy

12. Academic Institutions

13. References

For more information about this report visit https://www.researchandmarkets.com/research/hpj9sh/cell_therapy

Source: Jain PharmaBiotech

Media Contact:

Laura Wood, Senior Manager press@researchandmarkets.com

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Global Cell Therapy Report 2017 - Technologies, Markets and ... - PR Newswire (press release)

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July 06, 2017 07:00 ET | Source: Shire Pharmaceuticals Group

Shire submits investigational New Drug Application to FDA for Gene Therapy candidate SHP654 for treatment of Hemophilia A

SHP654 aims to deliver sustained protection against bleeds for patients with hemophilia A

Lexington, Mass.-July 6, 2017- Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving people with rare diseases, today announcedthe submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for SHP654, also designated as BAX 888, an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. SHP654 aims to protect hemophilia A patients against bleeds through the delivery of a long-term, constant level of factor expression.1 The IND filing for SHP654 represents the latest step forward for Shire's gene therapy program, which shows promise for both hemophilia A and B populations.

"Shire is leveraging decades of scientific leadership in hemophilia to advance research in gene therapy for this community," said Paul Monahan, M.D., Senior Medical Director, Gene Therapy, Shire. "Drawing from our rich heritage, Shire is well equipped to sustainably support the development of gene therapies that aim to advance current standards of care and minimize the burden of this disease. SHP654 uses a proprietary technology platform designed to produce sustained levels of factor similar to the natural mechanisms of the body. Our goal with gene therapy for hemophilia is to uphold the highest standards for safety and efficacy."

Shire's gene therapy program for hemophilia A uses a recombinant adeno-associated virus serotype 8 (rAAV8) vector, which selectively targets the liver.1,2 It involves the delivery of a functional copy of FVIII to the body's liver to enable its own production of FVIII, rather than relying on a factor-based treatment.1 SHP654 uses the rAAV8 vector to deliver a codon-optimized, B-domain deleted FVIII (BDD-FVIII) specifically to a patient's liver, where FVIII would then be produced and used to manage bleeds.1 The FVIII expression is further controlled in patients by incorporating the liver-specific transthyretin (TTR) promoter/enhancer.1

The IND filing for SHP654 was based on the results of pre-clinical and phase 1 studies demonstrating the potential utility of this candidate, including the following that will be presented at the International Society on Thrombosis and Haemostasis (ISTH) 26th Biennial Congress in Berlin, Germany, from July 8 - 13, 2017:

An IND is a request for FDA authorization to administer an investigational drug to humans.5 Following the FDA's acceptance of the IND for SHP654, Shire will study SHP654 in a global multi-center study evaluating safety and examining the SHP654 doses required to boost factor VIII activity levels and affect hemophilic bleeding and will pursue bringing this innovation to markets worldwide.

About SHP654 Shire is developing SHP654 (BAX 888), which includes technology acquired from Chatham Therapeutics, LLC, a spin-out of Asklepios Biopharmaceutical, Inc. SHP654 is an investigational factor VIII (FVIII) gene therapy intended to treat hemophilia A using a recombinant adeno-associated virus serotype 8 (rAAV8) vector to deliver a codon-optimized, B-domain deleted FVIII (BDD-FVIII) specifically to a patient's liver, where FVIII would then be produced and used to manage bleeds.1,2

About Hemophilia A Hemophilia A, the most common type of hemophilia, is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII in the blood.6 The severity of hemophilia A is determined by the amount of factor in the blood, with more severity associated with lower amounts of factor.7 More than half of patients with hemophilia A have the severe form of the condition.7 Approximately 25-30% of individuals with severe hemophilia A develop inhibitors.8 Inhibitors are a serious medical problem that can occur when a person with hemophilia has an immune response to treatment with clotting factor concentrates.9 Hemophilia primarily affects males, with an incidence of one in 5,000 male births.7,10

References

NOTES TO EDITORS

For further information please contact:

Media

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

http://www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

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Women live longer than men in many countries around the world. In the United States, women outlive men by an average of five years. Scientists have long attributed this divide to genetics and biology, but a physician at Duke University is posing an alternative theory: toxic masculinity.

Haider Warraich is a clinical researcher and cardiology fellow atDuke University Medical Centerwho authored a new article in The Guardian that explores how male attitudes towards their own health may be at the core of the disparity in life expectancy.

Host Frank Stasio talks with clinical researcher and cardiology fellow Haider Warraich about the disparity in life expectancy for men.

Host Frank Stasio speaks with Warraich about why men in the U.S. tend to wait longer to seek physical and psychological help. They also discuss how the idea of manly behaviors, like drinking and smoking, may lead to lowered health outcomes.

INTERVIEW HIGHLIGHTS

On changes in gender-based life expectancy through history: In the start of the 18th century women and men lived for about the same duration, which was surprisingly just to the mid 20s ... But then as we got better at making sure that childbirth wasn't a death sentence, and women were actually able to give birth and not die off prematurely, we started to see a gap emerge. We started to see women consistently, across societies, lived longer than men.

On the persistent gap in male to female life expectancy: That gap in the United States is about five years. In other countries such as Russia it's about 10 years. This is certainly something we have not seen for the expanse of human civilization but certainly something that we now see consistently across most developed societies.

On biological theories that seek to explain why women live longer: The female sex hormone estrogen conveys some protection as far as reducing the risk of heart disease ... Some have postulated that the fact that women have a faster heart rate in general in some ways or somehow simulates the effect of exercise which is why they're able to live longer. And others have said The female birth rate is higher. We have more female children than we have male children, which in some ways suggests that even from an almost embryonic stage women have some type of advantage over men. Those are some of the biological theories that have been postulated.

Why biological theories don't paint a full picture of the life expectancy gap: What we're seeing more and more is that it is male behaviors that are likely driving men dying off earlier than women ... Some of these behaviors just have to do with the fact that men are more likely to take risks than women. Some of that has to do with the fact that the male hormone testosterone drives risk-taking behavior. But a lot of it is a construct of society. Men have a higher rate of smoking pretty much across the world. Men drink more. Men have more road traffic accidents, gunshot wounds et cetera. All of these are things that are driven by male behaviors. Men are less likely to seek the help of a physician if they fall sick. Men who have some type of psychiatric issues such as depression or anxiety, or other things, are less likely to go see a psychiatrist.

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How Masculinity Can Be Bad For Men's Health - WUNC

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An influx of men from the steppe of Central Asia may have swept into India around 3,500 years ago and transformed the population.

The same mysterious people ancient livestock herders called the Yamnaya who rode wheeled chariots and spoke a proto-Indo-European language also moved across Europe more than 1,000 years earlier. Somehow, they left their genetic signature with most European men, but not women, earlier studies suggest.

The new data confirm a long-held but controversial theory that Sanskrit, the ancient language of Northern India, emerged from an earlier language spoken by an influx of people from Central Asia during the Bronze Age. [24 Amazing Archaeological Discoveries]

"People have been debating the arrival of the Indo-European languages in India for hundreds of years," said study co-author Martin Richards, an archaeogeneticist at the University of Huddersfield in England. "There's been a very long-running debate about whether the Indo-European languages were brought from migrations from outside, which is what most linguists would accept, or if they evolved indigenously."

From the earliest days of colonial rule in India, linguists like William Jones and Jakob Grimm (who co-edited "Grimm's Fairy Tales") noticed that Sanskrit shared many similarities with languages as disparate as French, English, Farsi (or Persian) and Russian. Linguists eventually arrived at the conclusion that all these languages derived from a common ancestral language, which they dubbed Indo-European.

But while North Indian languages are predominantly Indo-European, South Indian languages mostly belong to the Dravidian language family. To explain this, scholars proposed the so-called Aryan invasion theory that a group of people from outside India swept in and brought a proto-Sanskrit language to northern India. (The name "Aryans" came from a Sanskrit word for "noble" or "honorable.") In the early 1900s, British archaeologist Mortimer Wheeler proposed that these Aryan people may have conquered, and caused the collapse of, the mysterious Indus Valley Civilization that flourished in what is now India and Pakistan.

The Aryan migration theory eventually became controversial because it was used to justify claims of superiority for different Indian subgroups; was claimed as the basis for the caste system; and in a bastardized form, was incorporated into Nazi ideology that the Aryans were the "master race."

What's more, earlier genetic data did not seem to corroborate the notion of a dramatic Aryan influx into India during the Bronze Age, according to a 2003 study published in the American Journal of Human Genetics.

But past genetic analyses were based on either DNA from mitochondria, which is passed from mothers to daughters, or from genetic mutations found in nuclear DNA, which are inherited from both parents but can be difficult to date.

In the current study, which was reported in March in the journal BMC Evolutionary Biology, Richards and colleagues analyzed modern genetic data from mitochondrial DNA, Y-chromosome DNA which is passed only from father to son and nuclear DNA. By tying all these pieces of data together, the team was able to tie patterns of migration to specific points in time.

The team found evidence that people began colonizing India more than 50,000 years ago and that there were multiple waves of migration into India from the northwest over the last 20,000 years, including waves of people from Anatolia, the Caucasus and Iran between 9,000 and 5,000 years ago.

But evidence for one migration was particularly striking: The genetic makeup of the Y chromosome dramatically shifted about 4,000 to 3,800 years ago, the study found. About 17.5 percent of Indian men carry a Y-chromosome subtype, or haplogroup, known as R1, with the haplogroup more dominant in men in the north compared to the south of India.

This new finding points to an ancient group of people who inhabited the grassland between the Caspian and Black seas from about 5,000 to 2,300 years ago, known broadly as the Yamnaya people. The Yamnaya (and its later subgroup, the Andronovo culture) typically buried their dead in pit graves, drove wheeled horse chariots, herded livestock and spoke an early precursor Indo-European language. About 5,000 years ago, people from this culture almost completely transformed the genetic landscape of Europe, a 2015 Science study suggests.

The genetic signature of the Yamnaya people shows up strongly in the male lineage, but hardly at all in the female lineage, the study found.

One possibility is that a group of horse-riding warriors swept across India, murdered the men and raped or took local women as wives, but not all explanations are that martial, Richards said. For instance, it's possible that whole family units from the Yamnaya migrated to India, but that the men were either able to acquire (or started out with) higher status than local males and thus sired more children with local women, Richards said.

"It's very easy for Y-chromosome composition to change very quickly," Richards told Live Science. "Just because individual men can have a lot more children than women can."

The shift wasn't as dramatic as the genetic transformation of Europe; while up to 90 percent of European men from some countries carry a version of R1, only a minority of men from the Indian subcontinent do, Richards said.

"It's not like a complete wipeout by any means," Richards said.

The study has a limitation: Because the very hot conditions in India don't preserve DNA well, the group lacks ancient DNA to prove that ancient migrants to the region carried the R1 haplogroup, said James Mallory, an archaeologist at Queen's University Belfast in Ireland, who was not involved in the study.

"They're trying to read the history of a people through its modern DNA," Mallory told Live Science. In the past, similarly well-grounded theories have been disproven once people sampled ancient skeletal remains, Mallory added.

The other problem is that there is very little archaeological evidence for a dramatic cultural transformation in India at that time, he added. The Andronovo left behind distinctive artifacts and evidence of their culture in other places, such as their pit burials and unique pottery.

But in India, "We do not really find evidence for these particular cultures," Mallory said.

On the other hand, population studies of the Irish have revealed almost 90 percent of men carry an R1 haplogroup, and yet there's also very little archaeological evidence of a cultural transformation consistent with huge population turnover, he added. So it may simply be that genetics are revealing a lost history of people in the area.

"The genetics are continually giving archaeologists surprises," Mallory said.

Originally published on Live Science.

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Aryan Invasion May Have Transformed India's Bronze-Age Population - Live Science

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