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Kadmon Announces that KD025 Met Primary Endpoint at Interim Analysis of Pivotal Trial in Chronic Graft-Versus-Host Disease – Yahoo Finance

By daniellenierenberg

NEW YORK / ACCESSWIRE / November 11, 2019 / Kadmon Holdings, Inc. (KDMN) today announced positive topline results from the planned interim analysis of ROCKstar (KD025-213), the fully enrolled pivotal trial evaluating KD025 in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy. The trial met the primary endpoint of Overall Response Rate (ORR) at the interim analysis, which was conducted as scheduled two months after completion of enrollment.

KD025 showed statistically significant ORRs of 64% with KD025 200 mg once daily (QD) (95% Confidence Interval (CI): 51%, 75%; p<0.0001) and 67% with KD025 200 mg twice daily (BID) (95% CI: 54%, 78%; p<0.0001). KD025 has been well tolerated and adverse events have been consistent with those expected in the patient population.

"We are extremely pleased with the outcomes of the interim analysis, which showed that KD025 has already greatly exceeded the threshold for success in this pivotal trial," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We look forward to sharing these results with the FDA at a pre-NDA meeting, where we will also discuss the timing for a regulatory filing for KD025 in cGVHD, which we expect to occur in 2020, subject to FDA input."

"KD025 was shown to be a highly active and well-tolerated therapy across the spectrum of this complex, multi-organ disease," said Corey Cutler, MD, MPH, FRCPC, Associate Professor of Medicine, Harvard Medical School; Medical Director, Adult Stem Cell Transplantation Program, Dana-Farber Cancer Institute and a KD025-213 study investigator and Steering Committee member. "The response rates observed are particularly impressive since this study is being conducted in a real-world population with severe disease, supporting the potential role of KD025 in cGVHD patients who are in need of effective and well-tolerated therapies."

"It is highly encouraging to see the positive results from the pivotal trial are in line with those observed in the earlier Phase 2 study of KD025 in this difficult-to-treat disease," said Madan Jagasia, MD, Vanderbilt University, an investigator of the KD025-208 and KD025-213 studies and the KD025-213 Steering Committee chair. "These latest KD025 data continue to underscore the value that KD025 may offer to cGVHD patients."

KD025-213 is an ongoing open-label trial of KD025 in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive KD025 200 mg QD or KD025 200 mg BID, enrolling 66 patients per arm. Statistical significance is achieved if the lower bound of the 95% CI of ORR exceeds 30%, which was achieved in both arms of the trial at the interim analysis.

While the ORR endpoint was met at the interim analysis, the primary analysis of the KD025-213 study will occur in the first quarter of 2020, six months after completion of enrollment. This analysis will include updated safety data and efficacy data, including ORRs and secondary endpoints, such as duration of response, changes in corticosteroid dose and changes in quality of life. Kadmon plans to submit results from the KD025-213 study for presentation at an upcoming scientific meeting.

Conference Call and Webcast

Kadmon will host a conference call and webcast on Monday, November 11, 2019, at 5:00 p.m., Eastern time, to discuss the topline results of the interim analysis of the KD025-213 study.

To participate in the conference call, please dial (866) 762-3021 (domestic) or (703) 925-2661 (international) and reference the conference ID: 6468498. The accompanying slides will be available for download on Kadmon's website beginning at 5:00 p.m. Eastern time.

To listen online via webcast, please visit: https://edge.media-server.com/mmc/p/9b9w8p38. The webcast will be archived and will be available at http://investors.kadmon.com/presentations-and-events.

About KD025

KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. In addition to cGVHD, KD025 is being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209). KD025 was granted Breakthrough Therapy Designation and Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy.

Story continues

About cGVHD

cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are currently living with cGVHD, and approximately 5,000 new patients are diagnosed with cGVHD per year.

About Kadmon

Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.

Forward Looking Statements

This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, including KD025-213, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) our reliance on the success of our product candidates, including KD025; (iv) the timing or likelihood of regulatory filings and approvals, including in connection with KD025-213; (v) our ability to expand our sales and marketing capabilities; (vi) the commercialization of our product candidates, if approved; (vii) the pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations or obtain additional grant funding; (xvi) the rate and degree of market acceptance of our product candidates; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our ability to achieve cost savings and other benefits from our efforts to streamline our operations and to not harm our business with such efforts; (xxi) the use of proceeds from our recent public offerings; (xxii) the potential benefits of any of our product candidates being granted orphan drug designation; (xxiii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; and/or (xxiv) other risks and uncertainties. More detailed information about Kadmon and the risk factors that may affect the realization of forward-looking statements is set forth in Kadmon's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Kadmon assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact Information

Ellen Cavaleri, Investor Relations646.490.2989ellen.cavaleri@kadmon.com

SOURCE: Kadmon Holdings, Inc.

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Ambrosia Is Back to Selling Transfusions of Young People’s Blood – Futurism

By daniellenierenberg

Ambrosia Health is back.

Following a brief shuttering and then a rebranding effort during which it was known as Ivy Plasma the young blood clinic has gone back to its roots: selling plasma sourced from the blood of 16- to 25- year-olds to healthy patients who believe the transfusions can give them ill-defined health benefits.

People really like the Ambrosia name and brand, so Ambrosia is going to continue, Ambrosia founder and young blood advocate Jesse Karmazin told OneZero. The resounding response from people wanting to sign up was, keep things the same. So thats what were going to do.

With the return to its original branding, Ambrosia is also embracing a new business model.

When it was Ivy Plasma, the clinic offered transfusions in San Francisco and Tampa. It since shuttered the clinic in Tampa, but Karmazin told Futurism that Ambrosia will ship plasma directly to any customers doctor so they can get their dose of young blood without having to fly to California.

We use overnight shipping to deliver the plasma to patients doctors offices, and provide training for the doctors to infuse it, Karmazin told Futurism last month. This way, the number of patients we are able to serve has increased dramatically. I dont operate a blood bank.

Ambrosias checkered, on-again-off-again status was spurred by an FDA statement issued in February in which the regulatory agency warned that transfusions of young blood didnt have any of the health benefits especially enhanced youthfulness, improved longevity, or reversedmemory loss that advocates claimed it did.

In slightly more words, the FDA essentially called young blood transfusions dangerous scams.

Because of the FDA warning, Karmazins clinic offered off-label treatments when it resurfaced as Ivy Plasma. That meant that customers could get their treatments if they desired, but they did so at their own risk and then-Ivy Plasma wasnt legally permitted to claim it would do them any good.

That practice continues today in the newly rebranded Ambrosia, according to OneZero. But the clinics updated website includes more details about the treatment.

Our treatment has been found to produce statistically significant improvements in biomarkers related to Alzheimers disease, cancer, inflammation, and stem cells in our clinical trial, the website reads. Patients have reported subjective improvements in athletics, memory, skin quality, sleep, and other areas.

When asked whether the FDAs rules had grown more lenient, Karmazin told Futurism he had consulted with the agency as well as a number of lawyers and wasnt worried about the claims made on his website.

Im comfortable with going ahead and offering this treatment commercially to patients, he told OneZero.

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Oct4, Considered Vital for Creating iPSCs, Actually Isnt Needed – The Scientist

By daniellenierenberg

Since 2006, when Shinya Yamanaka, now the director of the Center for iPS Cell Research and Application at Kyoto University, discovered a method that could guide fully differentiated cells back to their pluripotent state, scientists have been using his recipe to produce induced pluripotent stem cells. The protocol relies on overexpressing the so-called Yamanaka factors, which are four transcription factors: Oct4, Sox2, Klf4, and cMyc (OSKM). While the technique reliably creates iPS cells, it can cause unintended effects, some of which can lead to cells to become cancerous. So researchers have worked to adjust the cocktail and understand the function of each factor.

No one had succeeded in creating iPS cells without forcing the overexpression of Oct4. It was thought that this was the most crucial factor of the four. At least until now.

If this works in adult human cells, it will be a huge advantage for the clinical applications of iPS cells.

Shinya Yamanaka, Kyoto University

Four years ago, Sergiy Velychko, a graduate student at the Max Planck Institute for Molecular Biomedicine in Hans Schlers lab, and his team were studying the role of Oct4 in creating iPS cells from mouse embryonic fibroblasts. He used vectors to introduce various mutations of the gene coding for Oct4 to the cells he was studying, along with a negative controlone that didnt deliver any Oct4. He was shocked to discover that even using his negative control, he was able to generate iPS cells.

Velychkos experiment was suggesting that it is possible to develop iPS cells with only SKM.

We just wanted to publish this observation, Velychko tells The Scientist, but he knew hed need to replicate it first because reviewers wouldnt believe it.

He and his colleagues, including Guangming Wu, a senior scientist in the lab, repeated the experiment several times, engineering vectors with different combinations of the four factors. SKMthe combination that didnt include Oct4was able to induce pluripotency in the cells with about 30 percent of the efficiency of OSKM, but the cells were of higher quality, meaning that the researchers didnt see evidence of common off-target epigenetic effects. They reported their results yesterday (November 7) in Cell Stem Cell.

Efficiency is not important. Efficiency means how many colonies do you get, explains Yossi Buganim, a stem cell researcher at the Hebrew University of Jerusalem, who was not involved in the study. If the colony is of low quality, the chances that eventually the differentiated cells will become cancerous is very high.

Finally, the team employed the ultimate test, the tetraploid complementation assay, in which iPS cells are aggregated with early embryos that otherwise would not have been able to form a fully functional embryo on their own. These embryos grew into mouse pups, meaning that the iPS cells the team created were capable of maturing into every type of cell in the animal.

Whats more is they found that the SKM iPS cells could develop into normal mouse pups 20 times more often than the OSKM iPS cells, suggesting that the pluripotency of iPS cells can be greatly improved by omitting Oct4 from the reprogramming factor cocktail.

The results will need to be verified in human cells, Buganim cautions. His team has developed methods for creating iPSCs that worked well in mouse cells only to be completely ineffective in humans.

Yamanaka himself was enthusiastic about the results, telling The Scientist in an email that his team would definitely try the method in other cell types, especially adult human blood cells and skin fibroblasts. If this works in adult human cells, it will be a huge advantage for the clinical applications of iPS cells.

S.Velychkoet al.,Excluding Oct4 from Yamanaka cocktail unleashes the developmental potential of iPSCs,Cell Stem Cell,doi:10.1016/j.stem.2019.10.002,2019.

Emma Yasinski is a Florida-based freelance reporter. Follow her on Twitter@EmmaYas24.

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Humanity is well on its way to a real-life Terminator uprising – Yahoo Lifestyle

By daniellenierenberg

The recent release of Terminator: Dark Fate saw both Arnold Schwarzenegger and Linda Hamilton reprise their iconic roles and James Cameron's return as a writer and producer. While the sentient killing machines depicted in the Terminator franchise are comprised of CGI and Hollywood special effects, plenty of real world research is going into developing robots with similar capabilities, just without the murderous intent (we hope).

This research spans academia, militaries (though it can be difficult to suss out the actual breakthroughs from government propaganda), and private enterprise. Perhaps the most well known privately-owned robotics developer is Boston Dynamics, makers of the Atlas. You may remember this bipedal robot from September when it showed off its uncanny parkour abilities, which the robot can pull off 80 percent of the time. The Atlas is able to move so fluidly thanks to a novel optimization algorithm that breaks down complex movements into smaller reference motions for its arms, torso, and legs. The Atlas then utilizes a model predictive controller to chain each appendages movements into smoothly flowing movements. However, while Boston Dynamics' Big Dog was developed as a quadrupedal cargo carrier for military operations, the Atlas is strictly for use as an emergency first responder.

But for all of Atlas' fancy footwork, it doesn't look or work very much like the humans it aims to imitate. But, then again, neither did the T-800 from The Terminator and T2: Judgement Day -- at least once stripped of its biological covering. As you can see in the clip below, the T-800's muscles don't operate like a human's. Instead of bundles of contracting fibers, it utilized a complex series of delicate pneumatic compressors to manipulate its movements.

However, building bundles of synthetic muscles is exactly what a number of researchers are currently attempting. These fibers can be made from a variety of materials, from carbon fiber to nylon to exotic polyethylenes. When activated, these materials are capable of lifting up to 1,000 times their own mass (far more than we can) as well as retain a "memory" of their previous shape.

For example, a team of researchers from MIT developed a polymer that can expand 1,000 times its original length and pick up 650 times its own mass. It does this by bonding high-density polyethylene (the stuff used to make recyclable soda bottles) and a stretchy elastomer. This bonded pair naturally coils, like a bedspring. But when heat or cold is applied, the HDPE expands or contracts at five times the rate of the elastomer which lengthens or shortens the coil by as much as 50 percent of its original length.

Similarly, a team from Columbia Engineering recently developed a 3D printed synthetic muscle that not only expands and contracts but also bends, and even twists, on command -- while hauling 1000 times its own mass. This is a big deal because, like the T-800, today's robots are mostly driven by pneumatics, which severely restricts their applications and their overall size. This material, however, can be activated with just 8V of current.

"We've been making great strides toward making robots minds, but robot bodies are still primitive," lead scientist Hod Lipson said in a 2017 statement. "This is a big piece of the puzzle and, like biology, the new actuator can be shaped and reshaped a thousand ways. We've overcome one of the final barriers to making lifelike robots."

Electricity isn't the only potential source of power for these synthetic fibers. Human muscles run on glucose and oxygen, so why not a robot's as well? A research team from Linkping University, Sweden recently did just that and published their findings in the journal, Advanced Materials, this past June.

Their muscle consists of two electroactive polymer sheets sandwiching a non-conductive central membrane. When a positive current is applied to one side (causing it to contract) and a negative current is applied to the other (causing it to expand), the entire thing bends towards the positive charge. But rather than use an electrical current, the Linkping team integrated a naturally occurring enzyme capable of converting chemical energy into electrical energy.

"These enzymes convert glucose and oxygen, in the same way as in the body, to produce the electrons required to power motion in an artificial muscle made from an electroactive polymer. No source of voltage is required: it's enough simply to immerse the actuator into a solution of glucose in water", Edwin Jager, senior lecturer at Linkping University, said in a June statement.

Skin is another sticking point for the T-800 -- it can't travel back in time without an "Edgar Suit" after all -- but modern research is already hard at work on growing human skin in the lab. Don't worry, we're not bringing back Leatherface. It's actually to help eliminate the need for animal testing in the cosmetics industry.

In 2015, cosmetics giant L'Oreal teamed up with 3D printing startup Organovo to begin bioprinting human skin, in half-centimeter square patches. Similarly in 2016, the RIKEN Center for Developmental Biology paired with Tokyo University to grow a nearly complete epidermis -- down to the hair follicles -- that could be transplanted onto live subjects and actually work. The team took cells from the gums of mice and reset them to their stem cell-like iPS state before culturing and then implanting them on other mice, where they grew into integumentary tissue -- that's the layer of cells between the outer and inner skin layers where hairs are developed.

But the skin suit does not make the man -- sit down, Buffalo Bill -- at least when it comes to Terminators. It's their big beautiful AI brains. Obviously, we don't have anything as capable as what sits between the T-800's audio inputs, but that doesn't mean we're not trying. Many of the biggest names in Silicon Valley, including Apple, Huawei, Qualcomm and Alphabet, are racing to develop a new generation of processors specifically designed to handle machine learning tasks. Similar to ARM chips, which pair slower-performing but less energy-intensive cores with more powerful cores with a bigger current draw, the latest generation of "AI chips" integrate cores dedicated to machine learning functions. Image recognition and those sorts of applications -- looking at you Apple Face ID -- are instead routed to the GPU's neural engine.

The T-1000 (portrayed by Robert Patrick in T2 and Byung-hun Lee in Genisys) conveniently didn't require a flesh jacket to get back through time on account of its mimetic poly-alloy "liquid metal" construction. In the movies, these poly-alloys enabled the T-1000 to shrug off immense amounts of damage and change its shape at will. Real-life liquid metals like gallium offer some unique properties of their own like high electrical conductivity and deformability. But there are drawbacks. Most magnetic liquid metals suffer from a high surface tension, limiting their stretchiness to just the horizontal plane. Plus, they typically have to be submerged lest they become a sticky paste when exposed to atmosphere.

To get around these issues, a team of researchers submerged a droplet of gallium-indium-tin alloy in a hydrochloric acid bath. The gallium alloy reacted to the acid, forming a gallium oxide skin on the droplet, which drastically lowered its surface tension and allowed the droplet to be stretched both horizontally and vertically. The results of the team's experiments were published in the journal Applied Materials & Interfaces this past March. But don't worry about getting a finger needle through the eye anytime soon. This research is still in very early development, though it could one day find use in flexible electronics and soft robots.

We're also not likely to see robots melting through gates in the near future, but plenty of robots can already modify their shapes in response to environmental changes. NASA, for example, is working on the Shapeshifter ahead of a proposed expedition to Saturn's moon, Titan.

"We have very limited information about the composition of the surface. Rocky terrain, methane lakes, cryovolcanoes - we potentially have all of these, but we don't know for certain," JPL Principal Investigator Ali Agha said in a statement. "So we thought about how to create a system that is versatile and capable of traversing different types of terrain but also compact enough to launch on a rocket."

The team's answer is a gang of up to 12 small robots, dubbed "cobots," that can Voltron themselves into various configurations depending on the challenge at hand. Each would be capable of autonomous flight. Together they'd be able to daisy chain themselves across gaps or combine into a large wheel for faster overland travel. The team plans to submit their proposal in 2020 for consideration ahead of the next scheduled mission to Titan in 2026.

It may not be able to fully recombine on the other side of a security gate, this tendril-like robot developed by UCSB and Stanford researchers can easily make it between the bars. Taking inspiration from the movements of plant and fungal roots, the inflatable robot can extend up to 72 meters in length. Think of it as one of those balloons that clowns twist into animals, just 236 feet long. By incorporating specialized "control chambers" the robo-tube can also change direction, manipulate objects and even form its own tools, like hooks.

In the third Terminator, T3, Skynet has improved upon the T-1000's poly-alloy design -- this time using it as a protective coating over a super strong endoskeleton -- to create the T-X model. It doesn't just hunt humans, the T-X is a Terminator-killer to boot.

Unfortunately, plenty of research has already been sunk into developing autonomous war machines. In 2016 the US Navy and DARPA collaborated on the Sea Hunter, an autonomous anti-sub system, the US Army is currently accepting proposals for its Advanced Targeting and Lethality Automated System (ATLAS), an AI-powered system able to "acquire, identify, and engage targets at least 3X faster than the current manual process," per the solicitation notice. The Air Force is also exploring the idea of fully autonomous drones as part of its Skyborg project. And those are just a few of the programs we know about.

Whether these systems ever see the light of day -- at least publicly -- remains to be seen given the tremendous public outcry against autonomous weapons. Human Rights Watch is a founding member of the Campaign to Stop Killer Robots and calls for a "preemptive ban on the development, production, and use of fully autonomous weapons." In 2015, robotics researchers and tech luminaries like Steve Wozniak and Stephen Hawking penned an open letter arguing against their development.

"You can't have machines deciding whether humans live or die," Toby Walsh, a professor at the University of New South Wales, told the NYT in July. "It crosses new territory. Machines don't have our moral compass, our compassion and our emotions. Machines are not moral beings."

These pleas have not gone unnoticed. Earlier this month, the Pentagon released draft guidelines regarding AI development. The guidelines demand that AI systems be accountable, avoid bias and be "governable." That is, the systems use an inhibitor function to stop themselves before causing unnecessary harm or damage. Then again, on November 5th, the bipartisan National Security Commission on Artificial Intelligence called for the rapid development and deployment of autonomous weapon systems -- ethical concerns be damned.

"In light of the choices being made by our strategic competitors, the United States must also examine AI through a military lens, including concepts for AI-enabled autonomous operations," the commission's interim report reads.

What could possibly be more terrifying than an unstoppable killing machine? An unstoppable killing machine that can step out of its own skin to become a pair of unstoppable killing machines, that's what. And that's exactly what Sarah Connor has to defeat in Dark Fate. The Rev-9 Terminator builds off of the T-X's endoskeleton-wrapped-in-liquid-metal design except it can separate its halves and fight like those freaky blonde twins from Matrix Reloaded. Our current state of the art swarm technology can't coordinate at that level just yet, but it's getting close.

Drone swarms can actually be quite useful by splitting sensory and processing functions across a group of robots. Lady Gaga would never have been able to pull off her 2017 Super Bowl Halftime Show were it not for a swarm of 300 Intel drones.

This technology has also caught the attention of the US military. The Army, for example, has developed the Perdix system, a hoard of more than 100 microdrones which are launched from a trio of F/A-18 Super Hornets and provide low-altitude surveillance for troops on the ground. The US Navy is developing a similar system, dubbed "swarmbots." These autonomous patrol boats coordinate with one another to investigate suspicious vessels that enter their domain (in this case Chesapeake Harbor) and then relay that information back to a human supervisor. But not all drone swarms wear capes. In 2018, a kidnapping ring leveraged a swarm of drones to buzz an FBI hostage team in the middle of their operation and keep tabs on the Feds' movements.

So even as the military and private enterprises continue to slog towards a future filled with autonomous weapons of war, we can take comfort in knowing that at the current rate of development, we likely won't face a Terminator uprising in our lifetimes. Then again, those maniacal mechanical bastards can time travel.

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Doctor explains what happens to your skin during the menopause and the best products to treat it – RSVP Live

By daniellenierenberg

Hormonal changes can play havoc with our skin as we get older, especially in the perimenopause and menopause years.

These changes aren't the same for every woman, and they don't all begin at once.

During the perimenopause and menopause, the most notable hormonal change is a decline of oestrogen levels.

Oestrogen affects every tissue and organ of the human body, skin included, so the decline of oestrogen in perimenopause and menopause can cause the following symptoms:

Dermatologist and founder of Meder Beauty Science Dr Tiina Meder explained the best way to look after your skin during perimenopause and menopause is a "considered daily skincare routine".

"Using a gentle cleanser will help preserve the skins barrier function and prevent dryness and sensitivity," she said.

"Antioxidant-rich moisturisers, packed with prebiotics, will help keep skin hydrated and protected, simultaneously restoring and preserving the skins microbiome.

"Facial oils will also help to compensate lipid deficiency, while weekly exfoliation will help stimulate skin renewal.

Perimenopausal and menopausal skin is more sensitive to sun exposure.

"The maintenance of melanocytes the cells that manufacture the pigment melanin - is controlled by oestrogen," said Dr Meder.

"During the perimenopause and menopause, the number of melanocytes in your skin reduces andoestrogenlevels decline. As a result, less protective melanin is produced, making the skin appear lighter.

"As melanin helps protect the skin from the environmental damage and sun exposure, a decline in the production of melanin results in skin that is more prone to damage from sun exposure.

"As a consequence, it is very important to protect the skin regularly and correctly the second these hormonal changes appear."

When choosing skincare products thatll protect and repair skin during the perimenopause and menopause, Dr Meder recommends looking out for the following ingredients:

Moisturisers- hyaluronic acid, glycerine, carrageenan, chondrus crispus extract, gluconolactone and others.

Fatty acids and lipids- primrose, apricot, olive, macadamia, sweet almond, argan, borago, canola, meadowfoam, sunflowers, and sesame oil, as well as shea butter, squalane, cacao and, in some cases, coconut butter.

Prebiotics and probiotics- alpha-glucan oligosaccharide, inulin, and others, including some bacterial ferments and lysates (alteromonas filtrate, lactobacillus lysate, and saccharomyces).

Antioxidants- resveratrol, green tea, aloe barbadensis, rosemary and wild carrot extracts, vitamin E and C, and beta-carotene.

Remodelers- EGF (Epidermal Growth Factor) and others growth factors, plant stem cells, and peptides (Matrixyl-3000, Rigin, Syn-Tack and others).

Anti-inflammatories- centella asiatica, aloe barbadensis, green tea, calendula officinalis and chamomilla recutita extracts, panthenol, peptide skinasensyl, and albatrellus ovinus.

Microcirculation and capillary strengtheners- niacinamide (vitamin B3), caffeine, horse chestnut extract, and escin.

"Some ingredients - such as retinol or hydroxyl acids - can potentially increase the sensitivity of the skin, cause dryness, or increase ultraviolet sensitivity during the perimenopause and menopause," she went on.

"Sadly, many of these ingredients can actually help perimenopausal andmenopausal skin in many ways by improving the renewal process, lightening pigmentation, decreasing the appearance of wrinkles, and helping restore skin elasticity.

"Luckily, there are some great alternatives to these more aggressive ingredients. For example, retinol and retinol derivatives can be replaced with bakuchiol a natural ingredient that acts in a similar way to retinol - promoting the same benefits but with no side effects."

"Studies have found that HRT can provide several benefits to the skin. The reduction of oestrogen levels during the menopause has a detrimental effect on the skin, so it can be corrected, at least in part, through the early use of HRT in perimenopause.

"When HRT is introduced in the perimenopause period, skin dryness and sensitivity have been shown to be prevented. In addition, long-term use of HRT has been shown to restore the skins water-holding capacity and barrier function of the epidermis.

"Some studies have also found that HRT can control, in part, the dermal thickness and laxity, collagen content and density, as well as the skins mechanical properties and stress reaction."

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Human heart cells change during spaceflight, say scientists in study that could have far-reaching effects on c – MEAWW

By daniellenierenberg

Human heart cells are changed by spaceflight but return to mostly normal on Earth, according to a study that examined how the human heart functions in spaceflight. The scientists were surprised as to how quickly human heart muscle cells could adapt to the environment in which they are placed.

The research team examined the cell-level cardiac function and gene expression in human heart cells that were cultured aboard the International Space Station (ISS) for 5.5 weeks. They found that heart muscle cells -- derived from stem cells -- adapted well to their environment during and after spaceflight.

The analysis, says the team, shows that exposure to microgravity altered the expression of thousands of genes, but largely normal patterns of gene expression reappeared within 10 days after returning to Earth.

These findings provide insight into how the human heart functions at the cellular level in spaceflight. This study suggests that the human heart muscle cells are very adaptable to the environment in which they are placed, including microgravity. Microgravity is an environment that is not very well understood in terms of its overall effect on the human body, and studies like this will be able to help shed light on how the cells of the body behave in space," Dr. Joseph C. Wu, Director, Stanford Cardiovascular Institute at Stanford University School of Medicine, told MEA WorldWide (MEAWW).

The researchers explain that human heart muscle cells, like the whole heart, change their functional properties in spaceflight and compensate for the apparent loss of gravity by changing their gene expression patterns at the cellular level.

"This study does not tell us how the heart as a whole changes in microgravity. There are several other types of cells in the heart that were not included in this study. We also do not know how the cells might react if they were exposed to microgravity for a longer period of time. However, these are both things we can test in the future. The results we observed in this study will allow us to focus those future studies on characteristics of the heart muscle cells we know are strongly affected by microgravity," Dr. Wu told MEAWW.

With extended stays aboard the ISS becoming commonplace, there is a need to better understand the effects of microgravity on cardiac function, say experts. Past studies have shown that spaceflight induces physiological changes in cardiac function. Astronauts on space shuttle missions have experienced reduced heart rate, lowered arterial pressure, and increased cardiac output. But to date, most cardiovascular microgravity physiology studies have been conducted either in non-human models or at tissue, organ, or systemic levels, says the team.

"The National Aeronautics and Space Administration [NASA] Twin Study demonstrated that long-term exposure to microgravity reduces mean arterial pressure and increases cardiac output. However, little is known about the role of microgravity in influencing human cardiac function at the cellular level," says the study published in 'Stem Cell Reports'.

Accordingly, the research team used human induced pluripotent stem cells to study the effects of spaceflight on human heart function.

"We studied human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). We generated hiPSC lines from three individuals by reprogramming blood cells and then differentiated them into hiPSC-CMs," says the study.

Dr. Wu explains that human induced pluripotent stem cells (hiPSCs) are stem cells that can be produced from a small sample of blood or skin through a process called "reprogamming".

"These hiPSCs can be then turned into almost any cell type of interest, including beating human heart muscle cells, or cardiomyocytes. Since these hiPSC-derived cardiomyocytes mimic the function of true adult human heart cells, we can use them as a model for how the cells of the human heart respond to microgravity," Dr. Wu told MEAWW.

Beating hiPSC-CMs were launched to the International Space Station aboard a SpaceX spacecraft, as part of a commercial resupply service mission. Simultaneously, ground control hiPSC-CMs were cultured on Earth for comparison.

"Upon return to Earth, space-flown hiPSC-CMs showed normal structure and morphology. However, they did adapt by modifying their beating patterns and calcium recycling patterns," the findings state.

The researchers performed RNA sequencing. "These results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples. A comparison of the samples revealed that hiPSC-CMs adopt a unique gene expression pattern during spaceflight, which reverts to one that is similar to groundside controls upon return to normal gravity," says the study.

The findings, according to the researchers, could provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth.

"We know that humans can spend months and years in space. Through decades of analyses, we know that the human heart as a whole organ changes its shape, size, and function in spaceflight. These changes are one reason why astronauts must exercise in space for hours every day to keep their heart muscles strong. While our cell-based experiments were able to confirm that changes also occur on the cellular level, we cannot directly translate this to the organ-level without further studies. The changes in our hiPSC-cardiomyocytes are not adverse effects, but rather adaptations to microgravity. The changes reflect how the cells of the human body can quickly adapt to a low gravity environment," Dr. Wu told MEAWW.

The research team now plans to test different treatments on the human heart cells to determine if they can prevent some of the changes the heart cells undergo during spaceflight.

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The Third Generation of PRP Is Here – Jewish Link of New Jersey

By daniellenierenberg

PRP, or platelet-rich plasma, is part of a revolution in medicine. PRP contains an abundance of growth factors that play a valuable role in healing many ailments. The PRP technology has been developing for the benefit of patients, resulting in improved outcome and great results.

Platelet-rich plasma has evolved over the past 15 years from an experimental treatment and an idea that concentrated platelets can heal injuries to an everyday treatment that benefits so many. Platelets are concentrated by taking your blood in a tube or syringe and spinning the blood in a high-speed centrifuge that causes the components of blood to separate, including the red blood cells, white blood cells and platelets. The first generation of platelets involved one or two spins to separate the platelets, often including an anticoagulant to prevent clotting and solidifying of the platelets so it can be spread as a liquid around the target. This PRP has been effective for a range of musculoskeletal conditions. The second generation of PRP involves formation of a platelet-rich fibrin matrix (PRFM) that is valuable as a gel that can be applied to wounds, surgical sites and for dental conditions.

The third generation of PRP, also called CGF or concentrated growth factors,

was first developed and described in 2006 by an Italian physician (Dr. Sacco) and has recently become widely available in the United States with the Medifuge centrifuge. With a single spin, the blood is spun at multiple speeds, which concentrates the platelets while also isolating cells that express CD34+. This is a type of stem cell that greatly enhances the effectiveness of the platelets. The other advantage of this third-generation PRP is that without anticoagulants the platelets can be applied quickly as a liquid to apply to injured tendons and ligaments or for cosmetic benefit. By waiting a few minutes the platelets solidify, which is great for applying to wounds. Even when applied as a liquid, the third generation platelets solidify soon after injected, which helps attach the platelets to the area injected. This allows the platelets to provide growth factors for a longer duration to increase effectiveness.

There are many applications for this advanced PRP. Ligament and tendon injuries respond very well to PRP. These injuries often do not heal spontaneously because the ligaments and tendons do not get good blood flow. With PRP and its accompanying growth factors, the tendon and ligament is able to finally heal, providing long-term relief. In contrast to a steroid injection, which provides short-term relief and may contribute to tissue degeneration, PRP helps build and strengthen tissue and provides long-term relief.

To clarify, tennis elbow, golfers elbow, rotator cuff tendonitis, wrist tendonitis, iliotibial band syndrome, Osgood-Schlatters and Achilles tendonitis are all examples of tendon injuries characterized by weakening of the tendon fibers or even partial tears. PRP strengthen the tendon and heals all of these conditions.

Ligament injuries include all joint sprains and strains such as ankle sprains, shoulder strains, etc. The hallmark of joint arthritis is weakening of the ligaments that leads to wear and tear of the joint, with a cascade of cartilage erosion that leads to bone spurs, then joint space narrowing and eventually bone on bone. Any time you see a bone spur, chances are that there is a loose ligament that created the conditions that led to that spur. Platelets heal the ligaments so that the joint is more stable and the arthritic pain is relieved and recurrent ankle sprains stop recurring.

Thus, PRP is very effective for arthritic joints, including knee arthritis, hip arthritis and shoulder arthritis among others. The PRP is effective at strengthening the joint capsule that is comprised of ligaments and can provide support for the joint cartilage. Even with severe bone-on-bone arthritis, PRP can help strengthen the ligaments around the joint, which helps reduce pain.

PRP can also help you improve your appearance. With the vampire facial you get the benefit of the healing growth factors, which lead to increased collagen and blood flow for skin rejuvenation. The great aspect of this treatment is that this is a very natural way to naturally enhance your skin. Without undergoing surgery you can achieve a youthful appearance. So while stars such as Bar Rafaeli and Kim Kardashian have used platelets to enhance their appearance, the vampire facial is accessible to you and will give your skin a healthy, revitalized feeling. Everyone has an inner beauty. PRP helps your outer beauty so it is in sync with your inner beauty.

There are other cosmetic benefits to platelets. The growth factors that the platelets release can heal scars. This includes unsightly scars after a surgery or a laceration. Growing collagen within the scar will usually improve its appearance. Acne scars, which are tiny holes along the skin surface, are filled in with platelets. Burn scars may not be totally eliminated with PRP, but the growth factors can have dramatic effects on the appearance of these scars.

Another cosmetic benefit of PRP is hair growth. PRP leads to increased hair follicle formation increasing the hair density. While not practical for total hair loss, PRP is excellent for treating thinning hair in men and women. The best part is that you are stimulating the follicle growth with your own platelets without the use of medications or other invasive procedures. So if you run your hand through your hair and you feel it is thinner than you would like, PRP may be for you.

PRP is abundant, safe and the worlds most sophisticated repair system. Nothing else comes close to its amazing properties. PRP is a powerful source of growth factors. Whats best is that it comes from your own body so you are healing your own body with your own platelets. Whether you have an injury that needs the healing benefit of platelets, or if you want to enhance your appearance, promote hair growth or improve a scar, or for other challenges that can be enhanced with platelets, you should consider PRP to improve your quality of life. The success of PRP has been enhanced with the new technology of third-generation PRP. The concentrated growth factors (CGF) optimize platelets that are enhanced by stem cells for maximal benefit.

Dr. Slaten is a pain wellness physician in Ridgewood. For more than 20 years he has been practicing regenerative techniques with great skill and an open mind. Check out his website at http://www.njprp.com for more information.

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Medical Skin Care Products Market to Witness a Pronounce Growth During 2017 2025 – Zebvo

By daniellenierenberg

Medical skin care products are used for beautifying or to address some other skin care problems. The cosmetic industry is booming and skin care forms a very huge part of this industry. The aesthetic appearance is so important that people spend a lot on skin care products and treatment. People being more technologically aware of the various new skin care products trending in the market. In addition to the aesthetic application, the medical skin care products are also used to address issues such as acne, pimples or scars.

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Medical Skin Care Products Market: Drivers and Restraints

The medical skin care products is primarily driven by the need of natural based active ingredients products which are now trending in the market. Consumers demand medical skin care products which favor health and environment. Moreover, the consumers are updated with the trends so that various companies end up providing such products to satisfy the customers. For instance, a single product face mask has thousands of different variants. This offers consumers different options to select the product depending on the skin type. Moreover, the market players catering to the medical skin care products are offering products with advanced technologies. For instance, Santinov launched the CICABEL mask using stem cell material based on advanced technologies. The stem cells used in the skin care product helps to to protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis.

Medical Skin Care Products Market: Segmentation

On the basis of product type the medical skin care products market can be segmented as:

On the basis of application, the medical skin care products market can be segment as:

On the basis of distribution channel, the medical skin care products market can be segment as:

Medical Skin Care Products Market: Overview

Medical skin care products are used to address basic skin problems ranging from acne to scars. There are various advancements in the ingredients used to offer skin care products to the consumers. For instance, the use of hyaluronic acid and retinoids is the latest development in the industry. The anti-aging creams are at the forefront as the help treating issues such as wrinkles, scars, acne, and sun damage. Another, product in demand is the probiotic skincare which include lactobacillus and bifidobacterium.

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Medical Skin Care Products Market: Region-wise Outlook

In terms of geography, medical skin care products market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America dominated the global medical skin care products market as international players are acquiring domestic companies to make their hold strong in the U.S. LOral is accelerating its U.S. market by signing a definitive agreement with Valeant Pharmaceuticals International Inc. to acquire CeraVe, AcneFree and Ambi skin-care brands for US$ 1.3 billion. The acquisition is expected LOreal to get hold of the brands in the price-accessible segment. Asia Pacific is expected to be the fastest growing region owing to the increasing disposable income and rising awareness towards the skin care products.

Medical Skin Care Products Market: Key Market Participants

Some of the medical skin care products market participants are Avon Products Inc., Beiersdorf AG, Colgate-Palmolive Company, Kao Corporation, LOral S.A., Procter & Gamble, Shiseido Company, The Estee Lauder Companies Inc., Unilever PLC, Revlon, Clinique Laboratories, llc., Murad, LLC., SkinCeuticals, RMS Beauty, J.R. Watkins and 100% PURE.

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AVROBIO, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update – Business Wire

By daniellenierenberg

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc. (NASDAQ: AVRO) (the Company), a Phase 2 clinical-stage gene therapy company, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.

We are thrilled with the progress across our pipeline, including the dosing of the first patient in our cystinosis program and receipt of orphan drug designation for our investigational gene therapy for Gaucher disease, commented Geoff MacKay, President and Chief Executive Officer of AVROBIO. In our Fabry program, we have now dosed eight patients across two clinical trials and we are on track to use our optimized lentiviral vector and a conditioning regimen utilizing therapeutic drug monitoring for the first time to dose a patient in our Phase 2 clinical trial for Fabry disease by the end of 2019. While our rapid expansion and early data have been exciting, we are humbled by the needs of the rare disease communities with whom we engage. They impress a sense of urgency on our work to deliver a new paradigm that we believe can supersede current treatment options and potentially provide patients freedom from a lifetime of disease.

Program Updates and Milestones

Third Quarter 2019 Financial Results

AVROBIO reported a net loss of $17.1 million for the third quarter of 2019 as compared to a net loss of $11.6 million for the comparable period in 2018. This increase was due to increased research and development expenses, as well as increased general and administrative expenses.

Research and development expenses were $13.0 million for the third quarter of 2019 as compared to $9.2 million for the comparable period in 2018. This increase was driven by increased program development activities related to the advancement of the Companys pipeline, as well as increased personnel-related costs resulting from an increase in employee headcount.

General and administrative expenses were $5.0 million for the third quarter of 2019 as compared to $3.0 million for the comparable period in 2018. This increase was primarily due to an increase in employee headcount, expenses associated with being a publicly traded company, including consulting expenses, and the impact of non-cash stock-based compensation.

As of September 30, 2019, AVROBIO had $206.4 million in cash and cash equivalents, as compared to $126.3 million in cash and cash equivalents as of December 31, 2018. The cash balance as of September 30, 2019 reflects the receipt of net proceeds of $129.5 million from the Companys July 2019 follow-on equity offering. Based on the Companys current operating plan, AVROBIO expects its cash and cash equivalents as of September 30, 2019 will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2021.

About AVROBIO, Inc.

AVROBIO, Inc. is a leading, Phase 2 gene therapy company focused on the development of its investigational gene therapy, AVR-RD-01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, cystinosis and Pompe disease. The Companys plato platform includes a proprietary vector system, automated cell manufacturing solution and refined conditioning regimen deploying therapeutic drug monitoring. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON. For additional information, visit http://www.avrobio.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy, prospective products and goals, the therapeutic potential of our product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, the intended incentives conferred by orphan-drug designation, potential regulatory approvals and the timing thereof, expected benefits from the appointment of Ms. Verdin to the position of Chief Human Resources Officer and Ms. May to the position of Chief Commercial Officer, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products, and the market opportunity for and anticipated commercial activities relating to our product candidates, and statements regarding the Companys financial and cash position and expected cash runway. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

September 30,

December 31,

2019

2018

Cash and cash equivalents

$

206,362

$

126,302

Prepaid expenses and other current assets

7,345

3,718

Property and equipment, net

2,673

2,634

Other assets

825

825

Total assets

$

217,205

$

133,479

Accounts payable

$

1,408

$

2,784

Accrued expenses and other current liabilities

8,502

7,822

Deferred rent, net of current portion

535

689

Total liabilities

10,445

11,295

Total stockholders equity

206,760

122,184

Total liabilities and stockholders equity

$

217,205

$

133,479

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

(Unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

2019

2018

2019

2018

Operating expenses:

Research and development

$

13,042

$

9,232

$

37,755

$

22,286

General and administrative

5,022

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Natural anti-ageing alternatives that actually work – IOL

By daniellenierenberg

Beauty/6 November 2019, 2:00pm/LIZ HOGGARD

London - On the run up to her 50th birthday, Charlotte Vhtz noticed her skin was changing.

"When youre a child, skin renewal takes place every three to five days," she says. "But when you get into your 50s, it takes two to three months. Even if you apply the most amazing expensive cream, its going on top of dead skin cells. It cant penetrate, so it wont work."

An organic beauty pioneer, Charlotte didnt want to use chemical "tweakments", so she started researching cutting-edge, scientifically proven botanicals that could delay ageing.

"I knew I needed to find a way to exfoliate the skin without being too harsh. I love wrinkles, but I dont like dry, sagging skin."

A former nurse, Charlotte has a background in pharmaceuticals and is fascinated by science. But she also believes passionately in the power of nature.

After six years of research, Charlotte, now 60, has just launched her signature range, Age Defy+ by Cha Vhtz, a natural skincare regime that uses a blend of innovative plant-based alternatives aimed at skin aged 30, 40, 50 and beyond.

Here, she explains how anti-ageing plant extracts, among them pomegranate, hibiscus, neroli and sea holly, can be just as effective.

Skin-plumper

SWAP: Botox for hibiscus. With its magical reputation for increasing skin elasticity, its no wonder hibiscus is called the Botox plant.

It has an incredible ability to inhibit the activity of the enzyme elastase, which is responsible for breaking down our skins precious elastin.

Hibiscus actively combats the ageing process by firming and lifting your skin, allowing it to snap back.

Because of the slightly exfoliating effect of the organic acids found in the plant, hibiscus also helps speed up cell turnover, resulting in a more even-looking skin tone.

It can even help to control acne breakouts, bringing your skin back in balance for a gorgeous, glowing complexion.

Hibiscus also enhances the skins ability to retain moisture, a key factor in keeping a youthful complexion.

Wrinkler-buster

SWAP: Hyaluronic acid (a much-used additive in anti-ageing creams) for beech bud extract.

Beech bud extract is an exceptional ingredient, rich in a range of substances that boost the metabolism, smooth the skins surface and restore hydration.

Perhaps its no surprise that the beech is known as the Everlasting Youth Tree.

Exfoliator

SWAP: Alpha Hydroxy Acids, or AHA (chemical compounds used in abrasive cosmetic exfoliators) for pineapple extract.

Exfoliate dead skin cells by rubbing a thin slice of pineapple or papaya over your face. Leave for five minutes, then rinse off with tepid water.

Pineapple extract is rich in skin-boosting vitamins C and E and bromelain, a protein-digesting enzyme.

Rejuvenator

SWAP: Butylene Glycol (a type of alcohol used as a solvent in anti-ageing serums) for sea holly.

A beautiful, purple, thistle-like plant, sea holly is amazing because it has evolved to survive in the harshest conditions.

An extract is obtained from cultured plant stem cells, which contain all the attributes of the whole plant and, as a result, have powerful regenerative and rejuvenating properties.

Sea holly stimulates and protects the skins natural elastin and collagen, both of which decrease as you age, resulting in greater skin radiance and luminosity.

Anti-ager

SWAP: Dermal fillers for extract of the herb baikal skullcap.

Much-used in Chinese medicine, the extract baicalin comes from the roots of baikal skullcap, a herb in the mint and sage family native to East Asia.

Its an ingredient with remarkable anti-ageing properties in adults aged 30 or over.

Hydrator

SWAP: Retinol (a popular chemical skincare ingredient) for squalane.

Squalane is the saturated, or stable, form of the compound squalene, originally obtained for commercial purposes from shark liver oil, but today extracted from olive oil.

Adult skin is lubricated and protected against external aggressors by the sebum our skin produces. In healthy skin, sebum contains 10 percent to 13 percent squalene. This level drops as we get older.

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Transient Wave of Hematopoietic Stem Cell Production in Late Fetuses and Young Adults – Technology Networks

By daniellenierenberg

Hematopoietic stem cells (HSCs) are responsible for the constant replenishment of all blood cells throughout life. One of the major challenges in regenerative medicine is to produce tailor-made HSCs to replace the defective ones in patients suffering from blood related diseases. This would circumvent the shortage of donor HSCs available for the clinic. To achieve the controlled production of bona fide HSCs in vitro, in a dish, a better understanding is required of where, when and how HSCs are physiologically produced in vivo, in the living body. Researchers from the groups of Catherine Robin(Hubrecht Institute) and Thierry Jaffredo (UPMC, LBD IBPS, Paris) have found a previously unappreciated hematopoietic wave taking place in the bone marrow of late fetuses and young adults and producing HSCs from resident hemogenic endothelial cells of somite origin. This transient hematopoietic wave fills the gap between the completion of embryonic blood production and the beginning of adult bone marrow hematopoietic production in both chicken and mice.

Endothelial origin of hematopoietic stem cells

The constant production of short-lived blood cells, needed for proper oxygenation of tissues and protection against pathogens throughout life, relies on a small cohort of HSCs. The first HSCs derive from specialized endothelial cells, named hemogenic endothelial (HE) cells, via an endothelial to hematopoietic transition (EHT). EHT transiently occurs in the main arteries, such as the aorta, during the embryonic development of vertebrates. The pool of HSCs is then amplified before migrating to the bone marrow where HSCs will reside during adult life. Whether EHT occurs past the embryonic stage and in other organs, such as the bone marrow, was unknown until now.

Hemogenic endothelial cells in the bone marrow

To find out whether EHT occurs past the embryonic stage and in the bone marrow, the researchers used a combination of experimental embryology, genetic, transcriptomic and functional approaches on chicken and mouse models. By tracing bone marrow-forming endothelial cells through fluorescent genetic labelling and live imaging analyses, they found that the entire vascular network of the bone marrow derives from the somites. The somites are segments of the body that will progressively form important tissues of the organism as the embryo develops, including bones, muscles and skin. Unexpectedly, the researchers found that some somite-derived endothelial cells produce HSCs and multipotent progenitors in the late fetus and young adult bone marrow, through the same EHT process that was thus far only seen in the embryo. These cells are molecularly very similar to the cells undergoing EHT or recently emerged HSCs in the embryonic aorta, with a prominent Notch pathway, endothelial-specific genes and transcription factors involved in EHT. The results therefore demonstrate that HSCs are newly generated past embryonic stages, from hemogenic endothelial cells from somitic origin and via EHT, the same mechanism that occurs in the embryo.

A new wave of blood cell production

The yolk sac of the embryo produces two partially overlapping waves of hematopoiesis. The first (primitive) wave gives rise to hematopoietic cells that last only during embryonic development. The second (definitive) wave produces various progenitors that migrate to the fetal liver to produce the immediately needed blood cells. These progenitors are sufficient for the embryo to survive until birth, when the aorta-derived HSC-dependent wave will take over. The transient hematopoietic production discovered in the present study fills the gap between the end of the yolk sac hematopoiesis and the bone marrow HSC-dependent production of blood cells. Indeed, the pool of HSCs that expanded in the fetal liver starts to colonize the bone marrow only just before birth. HSCs are present in very low numbers and time is most likely required before they find their final adult-type niches and start to differentiate and proliferate into more committed progenitors and mature blood cells. The transient hematopoietic wave that the researchers describe in late fetal and young adult stages might also prepare the bone marrow niches for the HSCs coming from the fetal liver.

Stem cell therapies

Defects in HSCs lead to various blood-related disorders and cancers that are partly treated by HSC transplantations. The controlled production of bona fide HSCs from pluripotent precursors remains very difficult to achieve in vitro, in a petri dish, and therefore requires a better understanding of the HSC production as it occurs physiologically in vivo, in the living body. Identifying all steps of hematopoietic production and the molecular events controlling this process is of fundamental interest and should help to devise innovative stem cell therapies for hematopoietic disorders in the future.

Reference:Yvernogeau, L., Gautier, R., Petit, L., Khoury, H., Relaix, F., Ribes, V., Jaffredo, T. (2019). In vivo generation of haematopoietic stem/progenitor cells from bone marrow-derived haemogenic endothelium. Nature Cell Biology. https://doi.org/10.1038/s41556-019-0410-6

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Stem cell therapy giving disabled, elderly pets a second chance at life – CW39

By daniellenierenberg

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A breakthrough medical procedure using stem cell therapy is transforming the lives of disabled pets, and their owners are documenting these transformations in astounding before and after videos some featuring dogs barely able to walk that are suddenly able to run.

Dr. Carmen Petti of the Avon Lake Animal Clinic said while stem cells are proven to help things like arthritis and skin allergies, it is still in the early stages for many diseases and ailments. It's also expensive, costing anywhere between $1,000 to $2,500.

The procedure requires sedation and a minimally invasive surgery where doctors remove two to three tablespoons of fat loaded with stem cells. In one study, 99% of patients saw improvements that lasted up to two years.

Doctors and patients say they are amazed at the improvement they've seen in their patients and pets. They also say that as the procedure becomes more common, it could also become cheaper and more affordable.

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What pears to pick for your fall recipes starting with a pear tart and pear butter – The Detroit News

By daniellenierenberg

For pear butter, you'll want a variety that breaks down in cooking. Bartlett pears will do well.(Photo: Abel Uribe, TNS)

Apples may get all of autumns accolades, but its time for pears to muscle in on the action.

Understanding which pear varieties are best for which uses will help you choose wisely from the fruit youll see at farmers markets, farm stands and grocery stores.

You can eat any pear raw, from juicy Bartletts to crisp Asian pears. But in cooking, you may want the pear to retain its shape, or you may want it to melt into a concentrated sauce. I remember pear varieties that hold their shape for poached pears, and for the pear tart we offer here with a simple mnemonic of ABC: Anjou, Bosc and Comice.

Some varieties are more grainy or gritty than others but peeling any pear will help reduce that graininess. As pears ripen on the tree, they develop stone cells, and most of these lie just under the skin. Most pears are harvested before theyre fully ripe for this reason. While the skin is full of nutrients, sometimes you just want that grittiness to go away.

Like apples, cut pears will brown when exposed to air. For salads and other raw uses where appearance is important, place the pears in water acidulated with lemon juice for a quick bath to prevent browning.

These are the varieties youre likely to see this season, with a bit of information about them and their best uses.

A ripe Bartlett, the juiciest of all the pears, will leave your chin dripping when you eat it out of hand. (Terrence Antonio James/Chicago Tribune/TNS)(Photo: Terrence Antonio James, TNS)

Anjou: Firm and mild flavored, Anjous are good for cooking where you want the pear to pick up the flavors of its cooking companions. Red and green Anjous have the same flavor.

Asian: As crisp as a ripe apple, Asian pears are very mild in flavor. Theyre the outlier in the pear family, more apple than pear.

Bartlett: The juiciest of all the pears, a ripe Bartlett will leave your chin dripping when you eat it out of hand. Choose red or green Bartletts when you want the fruit to cook into a sauce, as we do in the vanilla-cardamom pear butter recipe here.

Bosc: Crisp and mildly sweet, Boscs are the classic choice for poached pears. Theyre easy to recognize because of their cinnamon-colored russeted skin. They tend to be a nice size as well.

Comice: Brightly flavored with the quintessential pear taste, Comice pears are less grainy than many other varieties.

Concorde: A favorite in Europe, the Concorde has a long neck that makes it immediately identifiable. Its distinctively vanilla flavor makes it a favorite for roasting and grilling, but its also great out of hand.

Forelle: A pretty speckled pear thats popular in Europe, this small pear is best for snacking. Its name comes from the German word for trout, because its colors echo the flashing brilliance of the fish. Grown in small quantities in the Pacific Northwest, Forelle tells you its ripe when the skin under its red speckles turns from green to yellow.

French butter: Small with concentrated flavors, make sure French butter pears are fully ripe before use. Underripe fruit has a sharp, tannic flavor. Good for snacking, or in salads.

Seckel: Just as with French butter pears, make sure the little Seckel pears are fully ripe before eating to avoid a tannic hit. Best out of hand, or in salads.

Robin Mather is a longtime food journalist and the author of The Feast Nearby, a collection of essays and recipes from a year of eating locally on a budget. Follow her as she writes her third book at thefeastofthedove.com.

A pastry shell of ground almond meal, butter and sugar holds a pastry cream and poached pears. Sliced almonds finish off the dessert. (Terrence Antonio James/Chicago Tribune/TNS)(Photo: Terrence Antonio James, TNS)

PEAR-ALMOND TART

This simple tart will look and taste more impressive than its simple ingredients might suggest. Remember that you want pears that will hold their shape for this tart. If you cant find creme fraiche, substitute lightly sweetened sour cream as a garnish at serving time.

Prep: 30 minutes

Cook: 40 minutes

Makes: about 12 servings

Crust:

2 1/4 cups ground almond meal

4 1/2 tablespoons sugar

8 tablespoons melted salted butter

Filling:

2 cups sugar, divided use (plus more for browning)

3 Anjou, Bosc or Comice pears, peeled, sliced in half

1 1/2 cups milk

2 teaspoons vanilla

3 eggs, lightly beaten

1/4 cup flour

1/4 cup sliced toasted almonds

Creme fraiche, sweetened sour cream or whipped cream

1. For the crust: Heat the oven to 350 degrees. Combine almond meal, sugar and melted butter in a medium bowl. Stir to combine. Pat the crust mixture into the bottom and up the sides of a 12-inch tart pan and press into place with the bottom of a drinking glass. Bake the crust until just colored, 10 to 15 minutes. Remove and allow to cool completely before filling.

2. For the filling: Heat 4 cups water and 1 1/2 cups sugar to a boil in a large saucepan over medium-high heat. Reduce heat to low. Add the pears; poach until tender, 20-25 minutes. Remove pears from the syrup. Allow to cool, then cut out cores. Cut the pears into fans by slicing into 1/4-inch slices that remain attached by about 1/2 inch at the stem end. Set aside.

3. Combine milk and vanilla in a small saucepan and bring it to just a simmer over medium heat. (Dont let it boil over.) Combine eggs, remaining 1/2 cup sugar and the flour in a large saucepan. Temper the mixture by slowly whisking in a little of the hot milk. Then gradually whisk in the rest. Cook, whisking continuously, over medium heat. At the first sign of a boil, 3 to 6 minutes, remove pan from the heat while continuing to whisk until mixture begins to thicken. Allow the custard to cool.

4. Spoon cooled custard into the tart shell. Lay the fanned-out pears, stem end inward, in the custard. Scatter the sliced almonds over top. Sprinkle with 1 to 2 tablespoons sugar. Heat the broiler in the oven. Place the tart on the middle rack, 4 to 5 inches from the broil. Allow to broil until pears and custard are golden, about 5 minutes, watching carefully.

5. Serve warm with creme fraiche, sweetened sour cream or whipped cream.

Nutrition information per serving: 428 calories, 22 g fat, 7 g saturated fat, 69 mg cholesterol, 54 g carbohydrates, 45 g sugar, 8 g protein, 101 mg sodium, 4 g fiber

VANILLA-CARDAMOM PEAR BUTTER

Prep: 35 minutes

Cook: 8-10 hours

Makes: about 7 half-pints

Youll definitely want to use ripe Bartlett pears for this fruit butter because they cook into a silky puree. Making this pear butter in the slow cooker means you dont have to stand over it while it cooks. Weve given directions to both can and freeze this sumptuous delight.

6 1/2 pounds Bartlett pears, peeled, cored and cut into 1/2-inch cubes

Juice of 1 large lemon

1/2 cup sugar

1/4 teaspoon coarse salt

2 teaspoons vanilla

1 teaspoon ground cardamom

4 tablespoons unsalted butter

1. Tumble all ingredients except butter into a slow cooker. Stir to blend, then cover and cook on low until the pear butter is very thick and mounds on a spoon, 8 to 10 hours. Test its readiness by placing a spoonful on a plate; if no liquid escapes around the edges, the pear butter is ready. If it weeps, continue to cook with the lid crosswise to allow excess liquid to evaporate.

2. Stir in the butter until it is fully melted. Ladle the hot pear butter into sterile half-pint jars, leaving 1/4-inch headspace. To can, apply lids and rings just until finger tight; process in a boiling water bath for 10 minutes. To freeze, allow the pear butter to cool to room temperature, then freeze without lids. Once pear butter is frozen, add lids and freeze for up to six months.

Nutrition information per tablespoon: 21 calories, 0 g fat, 0 g saturated fat, 0 mg cholesterol, 5 g carbohydrates, 3 g sugar, 0 g protein, 5 mg sodium, 1 g fiber

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What pears to pick for your fall recipes starting with a pear tart and pear butter - The Detroit News

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Celgene to Present New and Updated Data on Key Hematology Pipeline Therapies at American Society of Hematology (ASH) 2019 Annual Meeting – Business…

By daniellenierenberg

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ: CELG) today announced data from nearly 70 Company-sponsored, global alliance and investigator-initiated clinical studies evaluating Celgenes investigational and approved therapies will be presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, Fla.

Celgene has a deep and ongoing commitment to innovative research and development in treatments for serious blood disorders, with the potential to transform patient outcomes, said Alise Reicin, M.D., President, Global Clinical Development for Celgene. We look forward to ASH as an opportunity to highlight our commitment and leadership in the research and development of novel therapies for the treatment of blood cancers through new insights in both CD19 and BCMA targeted cell therapies and important progress in our myeloid pipeline.

In leukemia and lymphoma, highlighted studies this year include safety and efficacy results from the pivotal TRANSCEND NHL-001 study of an investigational CD-19 targeted chimeric antigen receptor (CAR) T cell therapy lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell non-Hodgkin lymphoma. Additional liso-cel data from three ongoing studies will evaluate the use of the therapy in an outpatient setting, as well as in transplant noneligible patients with relapsed/refractory large B-cell non-Hodgkin lymphoma (PILOT) and in patients with relapsed/refractory chronic lymphocytic leukemia (TRANSCEND CLL-004).

In multiple myeloma, other notable investigational cell therapy abstracts include the first phase 1 clinical data from the bi-specific T-Cell Engager (TCE) CC-93269 and updated phase 1 clinical data from CAR T program, bb21217, both targeting the B-cell maturation antigen (BCMA) in relapsed/refractory disease.

Several abstracts focusing on data in myeloid diseases including longer-term response data from the phase 3 MEDALIST study of luspatercept to treat anemia in patients with IPSS-R very low-, low-, or intermediate-risk myelodysplastic syndromes with ring sideroblasts who require red-blood-cell (RBC) transfusions will be presented. Additionally, the first data from a phase 2 study of luspatercept in myelofibrosis-associated anemia, results from a study of fedratinib in myelofibrosis patients with low platelet counts, and the first data from CELMoD agent CC-90009, a GSPT1 degrader in relapsed or refractory acute myeloid leukemia (AML) will be presented.

Selected abstracts include*:

Lymphoma & Chronic Lymphocytic Leukemia

Multiple Myeloma

Myeloid Diseases

Beta thalassemia

A complete listing of abstracts can be found at https://www.hematology.org/Annual-Meeting/abstracts/

The safety and efficacy of investigational agents and/or investigational uses of approved marketed products have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.

*All times Eastern Time

About REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM)

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)

REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low-or intermediate-1risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities

REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL)

REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL)

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials

REVLIMID is only available through a restricted distribution program, REVLIMID REMS.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS

REVLIMID REMS Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. Patients may require dose interruption and/or dose reduction. MM: Monitor complete blood counts (CBC) in patients taking REVLIMID + dexamethasone or REVLIMID as maintenance therapy, every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Monitor CBC in patients on therapy for del 5q MDS, weekly for the first 8 weeks of therapy and at least monthly thereafter. See Boxed WARNINGS for further information. MCL: Monitor CBC in patients taking REVLIMID for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. FL/MZL: Monitor CBC in patients taking REVLIMID for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 2-4, and then monthly thereafter

Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on the patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision

Increased Mortality in Patients With CLL: In a clinical trial in the first-line treatment of patients with CLL, single-agent REVLIMID therapy increased the risk of death as compared to single-agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID and in patients with FL or MZL receiving REVLIMID + rituximab therapy, an increase of hematologic plus solid tumor SPM, notably AML, have been observed. In MM patients, MDS was also observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment

Increased Mortality with Pembrolizumab: In clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with MM with a PD-1-or PD-L1- blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID + dexamethasone. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered

Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN, or DRESS is suspected and should not be resumed following discontinuation for these reactions

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with REVLIMID. The patients at risk of TLS are those with high tumor burden prior to treatment. Closely monitor patients at risk and take appropriate preventive approaches

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before starting REVLIMID treatment and during therapy

Early Mortality in Patients With MCL: In another MCL study, there was an increase in early deaths (within 20 weeks); 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L)

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

Follicular Lymphoma/Marginal Zone Lymphoma

DRUG INTERACTIONS

Periodically monitor digoxin plasma levels due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

About INREBIC

INREBIC (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

IMPORTANT SAFETY INFORMATION

WARNING: ENCEPHALOPATHY INCLUDING WERNICKES

Serious and fatal encephalopathy, including Wernickes, has occurred in patients treated with INREBIC. Wernickes encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

WARNINGS AND PRECAUTIONS

Encephalopathy, including Wernickes: Serious and fatal encephalopathy, including Wernickes encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal.

Wernickes encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernickes encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernickes, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

Anemia: New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC occurred due to anemia in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent

Thrombocytopenia: New or worsening Grade 3 thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month; with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to less than or equal to Grade 2 or baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated.

Gastrointestinal Toxicity: Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patient and vomiting in 39% of patients. Grade 3 diarrhea 5% and vomiting 3.1% occurred. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic anti-emetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with anti-diarrheal medications promptly at the first onset of symptoms. Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or less or baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed.

Hepatic Toxicity: Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If re-occurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC.

Amylase and Lipase Elevation: Grade 3 or higher amylase 2% and/or lipase 10% elevations developed in INREBIC-treated patients. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n=608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose.

ADVERSE REACTIONS: The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%).

DRUG INTERACTIONS: Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Avoid INREBIC with dual CYP3A4 and CYP2C19 inhibitor. Coadministration of INREBIC with drugs that are CYP3A4 substrates, CYP2C19 substrates, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC.

PREGNANCY/LACTATION: Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose.

RENAL IMPAIRMENT: Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions.

HEPATIC IMPAIRMENT: Avoid use of INREBIC in patients with severe hepatic impairment.

Please see full Prescribing Information, including Boxed WARNING.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com. Follow Celgene on Social Media: Twitter, Pinterest, LinkedIn, Facebook and YouTube.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: management's time and attention is diverted on transaction related issues, including the planned divestiture of OTEZLA; disruption from the proposed transaction makes it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.

Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.

All trademarks are the property of their respective owners.

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Celgene to Present New and Updated Data on Key Hematology Pipeline Therapies at American Society of Hematology (ASH) 2019 Annual Meeting - Business...

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Industry Research On Stem Cell Therapy Market : Report With Pluristem Therapeutics, Cytori Therapeutics Inc, Geron Corporation, Vericel Corporation,…

By daniellenierenberg

This Stem Cell Therapy report has several aspects of marketing research and analysis which includes market size estimations, market dynamics, company & market best practices, entry level marketing strategies, positioning and segmentations, competitive landscaping, opportunity analysis, economic forecasting, industry-specific technology solutions, roadmap analysis, targeting key buying criteria, and in-depth benchmarking of vendor offerings. This Stem Cell Therapy market report offers all-inclusive study about production capacity, consumption, import and export for all the major regions across the world.

Stem Cell Therapy Market is expected to reach USD 15.63 billion by 2025, from USD 7.72 billion in 2017 growing at a CAGR of 9.2% during the forecast period of 2018 to 2025. The Stem Cell Therapy market report contains data for historic year 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025 (Updated values listed in sample report).

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Stem cell therapy is the therapy which uses stem cells for the treatment or prevention of a disease. Bone marrow transplant is the widely applicable therapy which is followed by umbilical cord blood. Research is going on to develop various sources (such as cord blood cells, bone marrow and skin) to use these cells for treatment of various disorders like neurodegenerative diseases and conditions such as heart disease, diabetes and other conditions. Some of the major players operating in the global stem cell therapy market are

Others: ViaCyte, Inc, AbbVie, Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc,, International Stem Cell Corporation, Aastrom Biosciences, Inc., Advanced Cell Technology, Cryo Cell International, Cytori Therapeutics, Inc., Geron Corporation, and Invitrogen and others. The global stem cell therapy market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of the global stem cell therapy market for global, Europe, North America, Asia Pacific and South America.

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Major Market Drivers and Restraints:

Drivers:

Restraints:

Segmentation:

The global stem cell therapy market is segmented based on

Potential held by the report

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Global Cryopreservation Equipments in Stem Cells Market to Witness Significant Revenue Growth During the Forecast Period, 20192023 – Health News…

By daniellenierenberg

The Global Cryopreservation Equipments in Stem Cells Market Report 2019 offers a profound analysis of the Cryopreservation Equipments in Stem Cells trade. It demonstrates a quick overview of trade knowledge and terminology of the market. The report highlights well-known performers from the global And Cryopreservation Equipments in Stem Cells along with their contribution to the marketplace to see their progress at intervals the calculable time. The global Cryopreservation Equipments in Stem Cells investigation report covers recent improvements whereas forecasting the expansion of most players along with their market shares.

Cryopreservation Equipments in Stem Cells report provides featured analysis that will drive your business to the next level. It overviews including growth factors, market demand, current trends, and forecast research by expert studies. This report estimate upcoming challenges and offers a real solution to the Cryopreservation Equipments in Stem Cells.

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Following are some of the various segmentation of the market available in the Cryopreservation Equipments in Stem Cells Market report:

Leading players in the market: Thermo Fisher Scientific, Charter Medicals, Linde Gas Cryoservices, praxair

Differentiation of the market based on types of product: Liquid Phase, Vapor Phase

Differentiation of the market based on types of its application: Totipotent Stem Cell, Pluripotent Stem Cell

Geographical Classification of the market: North America (U.S., Canada, Mexico), Europe (Germany, U.K., France, Italy, Russia, Spain, etc.), Asia-Pacific (China, India, Japan, Southeast Asia, etc.), South America (Brazil, Argentina, etc.), Middle East & Africa (Saudi Arabia, South Africa, etc.)

Cryopreservation Equipments in Stem Cells Market

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Our report will address client queries: 1. What is the market share of each region and top countries present in these regions?2. Which countries will depict the highest growth potential in the coming years?3. At which rate the Cryopreservation Equipments in Stem Cells market is growing globally and what are the future trends of this industry?4. Which are top product types and applications holding good potential and growth opportunities?5. Which are top Cryopreservation Equipments in Stem Cells industry players and who is their market competitors?6. Which are market drivers and constraints at present and during the forecast period?7. Which are the traders, dealers, and distributors operating in Cryopreservation Equipments in Stem Cells Industry?

The report on the keyword market is based on a detailed evaluation of the market, with the inclusion of comprehensive primary and secondary research. A Detailed assessment of the keyword market in terms of competitive scenario is supported by individual-level analysis of various aspects related to the market.

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Lymphatic System Discovered To Play Key Role in Hair Regeneration – Technology Networks

By daniellenierenberg

Given the amount of wear and tear its subjected to on a daily basis, the skin has a phenomenal ability to replenish itself. Spread throughout it are small reservoirs of stem cells, nested within supportive microenvironments called niches, which keep a tight rein on this repair process. Too much tissue might cause problems like cancer, while too little might accelerate aging.

Until now, scientists were uncertain whether the stem cells themselves could instruct other stem cells to form new skin by reshaping their niche. But new research in Science, led by Elaine Fuchs, the Rebecca C. Lancefield Professor, indicates that stem cells can indeed influence tissue regeneration. The study identifies a molecular coordination tool used by stem cells to signal across niches.

The researchers also discovered a new component of the niche: a specialized type of vessel called lymphatic capillaries, which transport immune cells and drain excess fluids and toxins from tissues. These capillaries form an intimate network around the stem cell niche within each hair follicle, the study showed, thereby interconnecting all its niches.

By turning the skin completely transparent, says postdoctoral fellow Shiri Gur-Cohen, we were able to reveal the complex architecture of this network of tubes.

Hair-follicle stem cells control the behavior of lymphatic capillaries by secreting molecules that act as an on-off switch for drainage, the scientists found, enabling them to control the composition of fluids and cells in the surrounding locale and ultimately synchronize regeneration across the tissue.

The involvement of the lymphatic system in this process is a new concept, says Fuchs, and might potentially provide new therapeutic targets for lymph-related conditions such as wound-healing defects and hair loss.

Reference

Gur-Cohen et al. (2019) Stem celldriven lymphatic remodeling coordinates tissue regeneration. Science. DOI: https://doi.org/10.1126/science.aay4509

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Some of the deadliest skin cancers may start in your hair – Siliconrepublic.com

By daniellenierenberg

Cells responsible for our hair colour could also be the starting point for some of the deadliest skin cancers.

Scientists in the US have discovered an unexpected origin of deadly skin cancers. In a paper published to Nature Communications, a team from NYU showed that some of these cancers may originate in stem cells in the hair follicles that give it colour, rather than in skin layers.

Hair follicles exist within skin layers as complex organs, but the study has shown that immature pigment-making cells may develop cancer-causing genetic changes, exacerbated by exposure to normal hair growth signals.

Previous models of this disease had put forward the idea that ultraviolet radiation through sunlight was a major risk factor in melanoma. However, this latest study argued that triggers may always be there in hair follicles. Unlike normal follicles, newly cancerous pigment stem cells migrate up and out of the follicles to establish melanomas in nearby surface skin before spreading deeper, it said.

The teams focus was on stem cells that mature into melanocytes, cells that make the protein pigment melanin, which typically protect skin by absorbing the suns damaging rays. By absorbing some wavelengths of visible light but reflecting others, pigments create hair colour.

In testing, specially bred mice were used with an ability to edit genes in follicular melanocyte stem cells only, which could be easily tracked. This confirmed melanoma cells can arise from melanocyte stem cells, which abnormally migrate up and out of hair follicles to enter the outermost layer of the skin.

They continued to move deeper into the skin layer where they not only shed their follicular origins, but also acquired signatures similar to neurons and skin cells almost exactly like those seen in human melanoma tissue.

By knowing where to look for the original, cancer-causing event, the researchers temporarily eliminated signals one by one in the follicular environment to see if cancer still formed in their absence.

Our mouse model is the first to demonstrate that follicular oncogenic melanocyte stem cells can establish melanomas, which promises to make it useful in identifying new diagnostics and treatments for melanoma, said the studys first author Qi Sun.

While our findings will require confirmation in further human testing, they argue that melanoma can arise in pigment stem cells originating both in follicles and in skin layers, such that some melanomas have multiple stem cells of origin.

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UM Today | UM Today the Magazine | Fall 2019 | After the Fire – UM Today

By daniellenierenberg

Twenty seconds. Give or take.

Spencer Beach cant say for sure just how long he was on fire.

Long enough to stumble to two exitstwiceand yank on door handles that wouldnt budge.

The flash fire that engulfed him in an Edmonton home was sucking in all the oxygen, creating a vacuum that sealed him inside. A flooring installer by trade, he had been removing linoleum in the laundry rooma rush job since the manufacturer mislabelled the boxes and the contractor didnt want to incur penalties for a delay. Beach and the rest of the crew were often told to use their boss homemade shortcut: douse the flooring in a contact thinner to reactivate the glue. That way, you could just peel it off.

He was on his hands and knees when he first heard a whistle as loud as a thousand kettles, followed by a boom as the furnace set the fumes alight.

Now the skin on his face felt like it was shrinking. His lips, like theyd been swarmed by bees.

The heat was inside of me. It wasnt like any burn youve ever felt, Beach says. It was everywhere.

With no way out, he curled up on the floor, interlocking his fingers behind his head. His mind flashed to his wife, Tina, blonde and four months pregnant with their first child. He had just left her a voice message: the job was nearly done, he was the only one left, hed be home soon. Tonight, hed plan his buddys stag party.

Beach got to his feet and tried the door one more time.

In his right hand, Dr. Sarvesh Logsetty holds a pair of scissors. In his left, a piece of paper grabbed from the many stacks in his office at Winnipegs Health Sciences Centre (HSC), where he is head of the burn unit.

The surgeon is stumped.

Hes trying to remember the strategic cuts to make for a trick he would do as a kid. Its a paper craft that turns a 4-by-5-inch sheet into an open shape large enough to walk through.

What am I doing wrong?

Logsetty wants to use the analogy to explain the skin graft meshing techniques he routinely does for patients whove suffered severe burns to large swaths of their body. The techniques also use strategic cutsto expand pieces of skin up to nine times their original size.

Every centimetre counts in these life-saving reconstructive surgeries where patches of unharmed skin are removed from one site to cover another, explains the University of Manitoba professor of surgery and psychiatry.

Ta da, he says, holding up the large paper circle. Damn, that was driving me insane.

Dr. Sarvesh Logsetty's curiosity about suturing goes back to age four, to Hyderabad, India, where he would hang around the medical clinic run by his great-aunt // PHOTO BY DAVID LIPNOWSKI [BA(HONS)/08]

Finding solutions is what the 51-year-old has spent decades doing, to alleviate pain and hardship for burn patients. Each one of my research projects, he says, reflects a patients journey.

Logsetty knows Beachs well, having operated on him more than a dozen times. He was working the day Beach was rushed to University of Alberta Hospital. The surgeon remembers how this 29-year-oldwith burns to more than 90 per cent of his bodywas more worried about how others would handle the news than he was his own chances for survival (about five per cent).

Even afterwards, hes always thought about how he can help other people and how he can use his experience to help them get through, says Logsetty, who brought his expertise to UM in 2007.

One persons recovery involves a slew of professionals.

Beyond nurses to do dressing changes, there are dietitians, physiotherapists, occupational therapists, psychologists, psychiatrists and social workers. On the burn ward at HSC, the team includes UM students across disciplines. The unit admits 100 to 200 patients a year, and treats another 250 to 400 (including cases of frostbite and flesh-eating disease). About 40 per cent of patients are children. Among the adults, the majority are men, who tend to engage in riskier behaviour than women, Logsetty notes.

When compared to other health conditions, theres an added layer. With any burn, theres a sense of guilt. Did I do something that caused this? Especially as a parent. That adds to the burden, says Logsetty. Its different than something spontaneous like cancer, where it isnt that they left the oil on the stove for too long or didnt check the temperature when they put their child in the bathtub.

With any burn, theres a sense of guilt. Did I do something that caused this? Especially as a parent. That adds to the burden. SARVESH LOGSETTY

Among 20- to 60-year-olds, burns are most often flame-related mishaps involving cooking oils catching fire, accelerants flashing back while burning grass, or house fires erupting in the night, Logsetty says. Burns from scalding are most common in kids and the elderly.

His research probes what social determinants increase your chances. A study released with UM psychiatrist Dr. Jitender Sareen [MD/95, BSc(Med)/95] last year showed people with a low income were as much as five times more likely to suffer burns. And the researchers mapped high-incidence areas in Winnipeg for policymakers to target prevention strategies.

Logsetty offers a window into the daily challenges on the burn unit. Within its dual-chamber isolation rooms, theres an ongoing battle against infection, down to the microscopic fibres of hospital curtains that may harbour antibiotic-resistant bacteria.

Burn patients face a far greater risk because their injuries arent straightforward open wounds. Theres dead skin sitting there, providing a perfect food source for bacteria. And because the skin is dead, theres no link to the bodys blood. No trigger to get infection-fighting white blood cells to activate and defend. So the bacteria can happily grow, getting stronger, says Logsetty. The risk of infection is really high.

The seeping wounds are kept covered and clean. Peeling off the dressings can be excruciatingly painful and take hours. No matter what we use, the dressings tend to stick, says Logsetty. This agony is what drives him and UM collaborator Song Liu, a medical microbiology and infectious diseases researcher, also in the Rady Faculty of Health Sciences, in their efforts to reinvent the burn bandage.

Together, theyre developing not only a less sticky coating but a dressing they hope will transform burn care. Theyre designing a fabric to detect infection, alert medical staff by changing colour, and then release antibiotics from withinall without having to remove it, Logsetty says.

Different colours would indicate different bugs. If the spot of colour were to grow bigger, it would tell nurses the infection wasnt getting any better. The bandage will be made of nanofibres, or straw-like chemical structures that break down when they come into contact with bacterial enzymes. The centres will be filled with either a liquid to release dye or a liquid containing the antibiotic. A bandage that both diagnoses and treats infection would be a first in the field. Logsetty says they could have a tangible product in as little as five years.

Liu also holds a patent for an antibiotic-resistant fabric, which could one day mean self-cleaning hospital curtains. He bonded a chlorine-like chemical to the curtain that kills bacteria on contact, one that not only wont wash out in the laundry but is reactivated by water. One of Logsettys recent studies showed that, within two weeks of being washed, five out of eight untreated hospital curtains tested positive for antibiotic-resistant MRSA.

PHOTOS BY AMBER BRACKEN

Leather hiking boots. Leather knee pads. A leather work belt. Beach didnt think twice about the gear he put on the morning of Aug. 24, 2003. (But he did contemplate calling in sickjust a feeling that he should, but one he ignored.)

The leather is what saved the less than 10 per cent of Beachs body surface that wasnt burned. His feet below the ankles. A patch in the middle of each knee. His waistline.

Theres a line around my waist where you could see where my belt was, he says.

Only once the vapours and air pressure subsided in the home was he able to open the door to the garage and escape. A neighbour then came running with a hose.

Since that day, Beach has undergone 38 surgeries.

His burns reveal the most severe form: third- and fourth-degree, which tear through the epidermis and dermis and extend into the muscle, fat and bones. At first, these sites (that appear white or charred-black) are the least painful for patients, since the flames have destroyed the nerve endings.

While lesser burns can heal on their ownas cells lining our sweat ducts and hair follicles automatically spread out to rebuildsevere burns require grafting.

Skin from Beachs feet is now on his face. As is skin from his knees and hip. Pieces of his foreskin form his delicate, upper eyelids while skin from his scrotum shapes his lower.

Logsetty can use meshing instruments that stretch and expand what small percentage of skin survivesthe graphs look like criss-crossed grids, almost translucentbut each time he does, the skin gets thinner, leaving more room for scar tissue to fill in the gaps. Its the scarring that leads to chronic pain.

[With Beach] I had to take three per cent and expand it into more than 90 per cent, somehow or another, says Logsetty. The key to advancing burn care, he says, is to develop ways to grow better skin.

[With Beach] I had to take three per cent and expand it into more than 90 per cent, somehow or another. SARVESH LOGSETTY

Beach received synthetic skin, as well as skin from cadavers, before new skin was cultured from his own cells. With Logsetty at the helm, Beach became the firstand is still the onlyCanadian to receive a unique, double-layer skin thats more resilient than anything thats come before. A sample of his skin, the size of a business card, was cultured in a lab in Cincinnati, OH, and then multiplied time and time again to eventually cover nearly half his body.

Experimental in the early 2000s, the technique is still innovative today, says Logsetty, but not yet widely available because the company has faced hurdles bringing it to market. From an overall standards of burn care, its a gamechanger, he says.

Even though there are still improvements to makethe skin doesnt contain pigment, hair follicles or sweat ducts (so on a hot summer day, Beach has to watch for heat stroke)it means less scarring and greater quality of life, says Logsetty.

Hes also in the process of developing a research project at UM that will explore new ways to use stem cells to create skin, and is collaborating with a Quebec company, Loex, on a similarly robust skin alternative.

Skin-grafting surgeries can be marathons of endurance and difficulty. An intensive operation can take 12 hours, but shorter is best since patients are already so unstable going in. The temperature of the room is kept at 29.9C to prevent patients from becoming hypothermic. Their whole body is exposed on the tablein order to graft different areasand without skin, theyre without a key organ that helps regulate body temperature. When our temperature drops, we bleed more, so theres also a greater risk of bleeding out on the table. Disposable warming blankets, inflated with warm air, help retain heat.

In the stifling environment, Logsetty and the team wear surgical gowns made of Gortex or other waterproof fabrics. (One of his research projects studies the effects on the medical team, including how much weight they lose from sweat during a procedure.)

On this ward, named after Manitoba firefighters, the mortality rate is less than three per cent, on par with the top burn centres across North America, notes Logsetty. Not many of their patients are firefighters nowadays, given how safety training and gear have evolved. But unfortunately, when they do become injured, he says, its usually devastating.

Nine months after the fire, Beach rolled over for the first time. He had lost 63 pounds and at six-foot-two was down to 112. The scar tissue had built up on his ligaments and tendons, and his muscles were wasting away with atrophy. The movement was small but it felt like a big win that came just in time. After the fire, he was angry, depressed, suicidal; now he wanted to see what else he could do for himself.

With progress comes greater survival rates, which mean more people living with the long-term consequences of burn injuries like disability, financial problems and chronic pain. Trauma survivors are at least four times more likely to take their own life, Logsetty and Sareen revealed in a 2014 study. Theyve since discovered theyre also twice as likely to have depression, anxiety or substance-abuse issues.

The standard of care I try to hold myself toand teach my studentsis What would you expect for you or your loved one? SARVESH LOGSETTY

Logsetty says patients often tell him they dont want to go on. He helps them reintegrate with the life they once had, as much as possible. Its not, I fixed your hernia, your sutures are out, you can call me if you have a problem. There is a continuity of care we dont see in most other surgery.

Thats why hes made this his lifes work. One patient describes Logsetty as the most caring and considerate doctor I have ever met; another says he created a place of love in the burn unit.

The only burn expert between Edmonton and Toronto, he makes himself available 24-7 to residents and nurses, even when not officially on call. The standard of care I try to hold myself toand teach my studentsis What would you expect for you or your loved one? says the father of two kids (under age seven), and husband to epidemiologist Rae Spiwak [BA(Adv)/00, MSc/04, PhD/17], who also studies mental-health issues in trauma patients. The biggest thing Ive learned is that life can change in an instant.

This summer, Logsetty spoke at Winnipegs inaugural Face Equality Awareness event for people living with facial differences. Its important, he adds, to help people understand that, although the outside of somebody might have changed, the inside is still the samepart of what our team does really well is help burn survivors come to that understanding themselves.

It was Beachs wife who held up the mirror for him the first time, only once hed consulted with a psychologist. He couldnt bring himself to look beyond his nose, with its missing lobes and exposed bridge. Gone was the dimpled grin of a guy who was always the life of the party.

Now, if kids stare at the grocery store, hell engage with a smile and a wave. Often, they think hes just really olda grandpa, not a father, to his kids, he says. When adults approach, which hes totally fine with, its always the same question: Can I ask what happened?

Beach doesnt have photos of what he used to look like up in his house, only because theyre not picture people. And no longer does he appear as his former self in his dreams.

Im extremely proud of who I am, Beach says.

Hes a motivational speaker who finds fulfillment in trying to create positive change in the workplacewhos spoken to Winnipeg workers about putting safety before money and supervisors demands. But his life isnt without ongoing challenges.

He has nerve damage and reduced mobility in his joints.

(He says he has the equivalent of seven-and-a-half fingers, since doctors had to amputate portions, up until they found blood flow.) And with some stubborn wounds that wont heal, he regularly gets blood infections20 in the last 10 years. Nonetheless, he renovated his basement and next, hell build a fence.

Im extremely proud of who I am. SPENCER BEACH

With burn survivors like Beach, Logsetty notes, The scar doesnt define them. They define themselves.

In a recent Facebook post, he signed off one tough son-of-a Beach.

You want to be the person you used to be, Beach says, but now you have a different body to do it with.

He returnedjust onceto the site where it happened. Where a new house now stands.

I had to see it.

Early in his career Dr. Sarvesh Logsetty saw how each burn unit across the country was labouring in its own bubble. We have some very good burn centres across Canadapeople are doing great work and researchbut we didnt really work together as a burn program in Canada as a community.

When he joined UM in 2007 he established the Advancement of Burn Care Network and made Winnipeg its base. And last year he launched the Canadian Burn Association and annual symposium further connecting the multidisciplinary players in burn care including firefighters and survivors to learn whats working whats not and what to try next.

He says research in burn treatments is grossly underfunded since there are fewer champions for the cause. Were still at the infancy of really understanding wound healing says Logsetty how to improve it how to avoid scars where we can and how we can make them better.

While the frequency of burns has dropped dramatically since the 1960swith greater safety awareness smoke detectors and legislation to safeguard water heaterstrauma as a whole is still the leading cause of death in Canadians 40 and under. It costs the system more money than just about any other health-care problem thats out there, yet we barely hear about traumatic injury says Logsetty who as a general surgeon is also tasked with removing knives from abdomens after weekend violence, or bowels burst in car collisions. In the last week alone hes removed two spleens ruptured in crashes.

What frustrates me from an academic perspective is that trauma doesnt have a home. There is no institute for traumait gets lumped in under muscoskeletal health and arthritis. That means, in terms of resources, were struggling with identification of the importance of trauma and struggling with helping people understand why we do the research we do and how it affects the people that it affects.

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Meet the biohackers seeking to turbocharge their bodies and minds – Euronews

By daniellenierenberg

Biohackers believe that we should be using all the technology available to make our bodies and minds work the best they can in everyday life. And they held a summit about it in Helsinki over the weekend

Most people who've heard of Biohacking think of electronic chips inserted under the skin - Cyborg stuff. But here they're promoting a wearable ring to measure the body.

People like Ramsey who's testing out a machine which steadily takes the body to air conditions you'd expect at high altitude...believe in using all the information and modern technology available to optimse human performance.

"I feel amazing - mentally and cognitively - like a stoic. I wake up every morning feeling like the Hulk," says Ramsey Morgan - Biohacker from Seattle, USA.

The movement is trying to make itself more mainstream and accessible.

"That can be like nutrition and diet, that can be taking a sauna, that can be just meditating, that can be injecting yourself with stem cells or something like that. All of these things are exapmles of Biohacking. You're changing your physiological state in order to achieve a certain goal," explains Siim Land - Estonian Biohacker.

And while most of us probably don't get enough sleep, the Biohackers say there's vibration technology to help.

"It affects to the nervous system by calming down the sypathetic side, the fight and fleet [flight] side. So basically, when you calm that down, the sleep comes naturally. You don't have to take any pills or anything," says Katja Nyman - Neurosonic.

One of the products here at the Biohackers summit is the Vielight Neuron, and our reporter, Jack Parrock tested it out.

"This a photobiomodulation device , so this applicator goes inside your nostril like that. And then the headpiece goes on top of your head," Gennady Lemud, VieLight Communications and Marketing Director tells our reporter.

The light rays being pumped onto my head and up my nose are intended to increase oxygenation in the blood and boost performance and happiness. But at well over 15 hundred euros, these devices aren't cheap.

Some Biohackers use blood tests to regularly check their liver function. One of the most controversial aspects of Biohacking is DNA testing. The medical community is still cautious and there are concerns about the data that's harvested by companies. They say there's nothing to worry about.

"We're looking at a few snips, a few genes...100...nothing. So we can't use that information for anything more than delivering information back to you as the consumer or the customer," says Chris Moore - Nordic Laboratories

It's not all so technical - getting in a sauna and a 4 degree celsius bath is enough for some Biohackers. But with the ever evolving technological world we live in - these guys think they're the future.

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