Skin is our largest organ and something we may take for granted when its healthy.

As an academic dermatologist I frequently hear misleading facts that seem to be stubbornly enduring.

Here are some of the most commonly shared myths that can be cleared up immediately, and some truths you can rely on.

TRUE Skin constantly renews itself

The skin provides a dynamic barrier between your bodys internal environment and the outside world.

Cells called keratinocytes in the epidermis (the outer layer of skin) are constantly dividing to produce a supply of cells that move up through this layer and are shed from its surface.

Skin is a rich source of stem cells with the capacity to divide and renew themselves.

FALSEDrink two litres of water a day for healthy skin

The amount of water you drink does not directly affect your skin.

Water is supplied to the skin by blood flowing through the dermis, the inner layer of skin; water is lost from the epidermis, especially in a dry environment.

Water is needed to maintain skin hydration and when you become seriously dehydrated your skin appears dull and is less elastic.

In a healthy person the internal organs kidneys, heart and blood vessels control the amount of water reaching the skin.

There is no fixed volume of water that you need to drink, it simply depends on the amounts you are using and losing.

TRUE Stress can make skin unhealthy

There are many health issues in modern life that we blame on stress, but several skin conditions have been shown in scientific studies, to be worsened by life events, possibly via stress hormones including cortisol (a steroid hormone made in the adrenal glands).

Notable examples are alopecia areata, an auto-immune condition where the bodys immunity begins to attack the hair follicles, causing hair to fall out; psoriasis, another auto-immune condition that causes skin thickening, scaling and inflammation; and eczema, itchy red skin inflammation often occurring alongside asthma, hay fever and other allergies.

Unfortunately a flare up of these skin conditions is exactly what you dont need when you are feeling stressed or under pressure.

FALSE Eating chocolate causes acne

Acne vulgaris, the common teenage acne which can actually persist into your 30s and 40s, occurs as a result of the interaction between hormonal effects on grease glands in the skin, plus the skins immune response to blocked pores and microbes living on the skin.

Eating a high fat diet is unhealthy for many reasons, but it doesnt cause acne.

In fact some tablets prescribed for severe acne such as oral isotretinoin are better absorbed when pills are swallowed with a fatty meal and that could include chocolate.

FALSE Washing powder causes eczema

Eczema is a condition where the skin is dry, itchy and red. It is caused by a combination of genetic factors (how your skin is made) and environmental effects, leading to inflammation.

Soap, detergents and washing powders can irritate the skin and contribute to dryness because they remove oil from the skin (just as washing-up liquid removes grease from your dishes).

Biological washing powders contain enzymes proteins that break down fats and other proteins to remove stains and these can irritate sensitive skin, so they may worsen eczema.

It is important that any washing power is thoroughly rinsed out of clothing before it is worn, to avoid skin irritation.

FALSE White marks on nails = calcium deficiency

Itchiness usually occurs due to dry skin, an infection or an allergic reaction.

However, it can also be a sign of cancer.

Although it is unclear how some forms of the disease cause itchiness, medics believe it may be due to substances released by the tumour or how the body reacts to the growth.

This itching tends to be all over the body but worse on the legs and chest.

It usually goes away once cancer treatment starts.

But cancer drugs themselves can also cause itchiness, which can be a sign they are working.

Certain anti-depressants, steroid creams and complementary therapies like foot massages can help ease the irritation.

To cope people should limit the numbers of baths they have, apply unscented moisturisers, wear natural fabrics and keep rooms cool.

Keeping nails short also reduces the damage scratching the skin can cause.

Source:

Nails are manufactured in the nail matrix, an area under the skin at the top edge of your nail.

If the matrix is traumatised, bumped or bitten, an irregularity in the developing nail occurs and air can become trapped.

This appears as a white mark as the nail grows out. Calcium is important for healthy nails (as well as bones and teeth) but these white marks are not a sign of deficiency.

TRUE AND FALSE Sunshine is good for you

Many people have experienced the feel-good factor of a sunny day, but there are good and bad effects of sunlight.

Light from the sun includes a mixture of different wavelengths of light: some are visible to the human eye, some are shorter than the colours we can see these are called ultraviolet (UV) and some are longer, the infrared. Different wavelengths have different effects on skin.

UVB is used by skin to manufacture vitamin D which is essential for bone health. Without sun exposure this vitamin must be obtained from the diet.

Dermatologists use specific wavelengths of UVA and UVB in carefully controlled doses to reduce skin inflammation, a valuable treatment for some skin conditions.

But when the skin is exposed to too much UV it can damage the skin cells DNA, leading to uncontrolled growth the basis of cancer.

As a simple rule, unless you have a disease or treatment that suppresses your immune system, sunshine is good for you in moderation, but always avoid getting sunburned.

KEEP IT SIMPLE

The basic principles of keeping skin healthy are mainly common sense. You should wash your skin regularly to remove dirt, but not so much that you remove the essential moisture and water-proofing substances.

Use a moisturiser if your skin feels tight or dry a greasy ointment works best unless you have acne-prone skin, in which case you should use a non-greasy water-based cream.

Avoid stress if possible, eat a healthy diet and drink water when you feel thirsty. And finally, protect your skin from too much sun with a hat and clothing or sunscreen.

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The SEVEN myths and truths about healthy skin - Stock Daily Dish

Skin Stem Cells Comments Off on The SEVEN myths and truths about healthy skin – Stock Daily Dish | November 26th, 2019

The era of environmentally conscious users has hit the market; and theres a sharp increase of customers who prefer sustainable life choices. They tend to seek out and promote cruelty-free products and brands. Consumers today are becoming more and more vigilant about the ingredients used in their favourite merchandise, the technology, and science behind it all, especially when it comes to cosmetics.

This change in mindset has created a completely new sector of skincare: vegan products. Completely warding off any animal products or by-products, veganism is becoming the popular choice of the modern world. Having a vegan outlook helps in the detoxing of your body and gives great health benefits to your skin. Plabita Sharma, a skincare expert at The Body Shop, India, underlines some benefits of vegan skincare products:

Skin-friendly: Vegan products are a rich source of nourishment and natural goodness as they are made from plants, minerals, and some safe synthetic ingredients.

Animal-friendly/not tested on animals: While not everyone is an animal rights activist, but knowing the essentials used on your skin are not tested on animals is guilt-free in itself.

Safe from harmful chemicals: Choosing vegan products will save you from harmful chemicals and cruel cosmetics and give you glowing skin.

Prevents various skin problems: Vegan products decreases the chances of skin problems such as rashes, allergies, eczemas, acne, skin inflammation and skin diseases due to lack of chemicals used. These are perfect for sensitive skin.

Remedy for all skin concerns: Ingredients such as Vitamin E, Vitamin A, Red Algae, Coconut Oil, Plant stem cells and alike products benefit the skin addressing all kinds of concerns. Like Vitamin C for radiance, Tea tree oil for grumpy acne, aloe vera to soothe the skin, wheat germ oil to nourish the skin and many more.

(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)

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This is why you should switch to vegan skin care products - Hindustan Times

Skin Stem Cells Comments Off on This is why you should switch to vegan skin care products – Hindustan Times | November 25th, 2019

Discovery of New Method Speeds Up Precision 3D BioprintingAndrew Wheeler posted on November 19, 2019 |

In the world of additive manufacturing (AM), the promises of bioprinting would be truly groundbreaking if they were to be kept and fully realized. The unscalable mountain is the ability to 3D print patient-specific organs. There would be no more organ rejection from transplants in post-operative care. In 2017, Gartner predicted that this medical innovation would occur within a decade.

Currently, simple tissues are 3D printed by various companies. For example, Poietis established and commercialized a laser methodology for 3D printing biological matter like skin cells and liver tissue. They released a commercial skin product in 2018 and established a partnership with LOral and BASF. Another example comes from the company CELLINK. It makes bioprinters used by pharmaceutical researchers in order to test the effects of drugs on living human tissue.

The technology and techniques of 3D bioprinting still have a long way to go before patient-specific organ transplants transform from fantasy to reality. Recent developments from TU Wien in Austria highlight one of the main factors in achieving what is now impossible: speed.

These are living cells photographed in a 3D scaffold. Weeks 1, 3 and 5 are pictured from left to right. The top images show the 3D setup and the bottom shows just one layer. The indications for increased precision and speed are significant for bioprinting and the ultimate goal of 3D printing patient-specific organs for transplants. (Image courtesy of TU Wien.)

The 3D scaffold and bioink developed at TU Wien will allow researchers to achieve new levels of accuracy in ongoing studies about the behavior of cells. The cell behavior as diseases spread is an important aspect of discovering new treatment methods. The introduction of stem cells to the new process makes it possible to create fully customized tissue.

3D bioprinting techniques differ in many ways. Some are less precise while others produce cells that do not last very long. Some cells produced through 3D bioprinting have material properties that limit their efficacy.

Cell behavior can differ greatly depending the chemical properties, shape and mechanical nature of the environment. For example, it is important for the environment to be permeable in order to ensure the survival and multiplication of cells embedded within. Countering that, the environment must strike the right type of balance in respect to stiffness and flexibility so that the structures do not degrade.

The key is to have new environments for embedding the cells, either liquids or gels, that solidify exactly where they are shot with a focused laser beam. The catch-22 is that the laser beam and the materials must not in any way harm the embedded living cells, and it has to happen as rapidly as possible.

TU Wien researchers solved this complex issue by using two-photon polymerization methods. These methods use a chemical reaction that has specific prerequisites for activation. When a molecule of the material that makes up the environment where the living cells are embedded absorbs two photons, an extremely intense laser beam activates a chemical reaction. At the precise point where the two photons are absorbed, the environmental substance stiffens but the surroundings remain liquid. The level of precision and intricacy at which structures can be constructed increases.

This process alone is slow, but using scaffolds has helped researchers develop a method that enables them to print structures in a few hours. Additionally, these new structures have an increased likelihood of surviving and living longer.

Researchers can now define exactly how an environmental structure should behave to foster specific types of cell migration and growth. They also can predict with greater accuracy how long a structure will last and when it will degrade.

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Discovery of New Method Speeds Up Precision 3D Bioprinting - ENGINEERING.com

Skin Stem Cells Comments Off on Discovery of New Method Speeds Up Precision 3D Bioprinting – ENGINEERING.com | November 25th, 2019

Tonight, the ABC will air a three-part documentary series tackling sexual harassment in the workplace.

Among many other brave and formidable women, one of the people featured in the documentary is me.

Except, ironically, you cant actually know what happened to me. What precisely was done to me, which led me to being on your TV screens. You also cant know how my employers handled the situation. You cant know what happened to that perpetrator.

Despite the name of the documentary, Silent No More, I, for a large part, am legally silenced.

This is absolutely through no fault of the incredible documentary makers, who fought so hard for the inclusion of my story. Rather, the non-disclosure agreement (NDA) I signed when I resigned from the workplace after experiencing ongoing sexual harassment from this one employee.

I suppose one of the questions on your mind must be what compelled me to sign an NDA. I had just turned 18 when the perpetrator walked into my life. I was also 18 when I resigned and the settlement, including the NDA, was processed.

Now 21, I dont think Im far enough away from the experience to truly understand how my age impacted the situation. However, I am certain that when youre 18 and your employers, colleagues and perpetrator arent, the imbalance of power between all parties is only tipped further.

At no age is it easy to stare down the barrel of a sexual harassment case, but when youre 18 years old and receiving letters from lawyers, my mind said to get out. Fast.

When I first told my mum what this man was doing to me at work, I just wanted to resign. I didnt want to report. I just so desperately wanted to get out. I had become terrified and physically sick with fear at work, that I wanted the fastest one-way route out of that place: resignation.

With some convincing from my mum and a lawyer, we started some very simple proceedings. Opening up conversations with the employer about my options. To be transparent, I could have escalated my claim to the states Workplace Health and Safety regulator or taken it to court. It was explained that both of those could be quite long and rigorous processes to endure.

And, like many people who dont report allegations of violence, they were simply processes I could not endure. Few people warned me the process of reporting, which I cant talk about, would incur a different type of trauma to the harassment itself. I still had uni to go to the next day, work in my other jobs, and also be an 18-year-old who didnt run home fuelled by bottled panic from the train station.

So, thats how we came to me resigning and settling. Settlement involves a whole bunch of things and agreements, which you cant know about, but the biggest part of the settlement is the NDA inclusion.

I balanced what the settlement gave me; my safety, against what it took away from me; my ability to explain what had been done to me, and I chose my safety.

Despite the way it tears at my heart that people cant know about my experiences, I would choose my safety again. Because, unfortunately, we still do live in a cruel structure that makes many of us choose.

Safety.

Or, your voice.

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"I was 18 when I came home and told my mum I was being sexually harassed at work." - Mamamia

Skin Stem Cells Comments Off on "I was 18 when I came home and told my mum I was being sexually harassed at work." – Mamamia | November 25th, 2019

In Switzerland we know how to make watches. We also know how to stop time, reads the giant poster in the lobby.

Im at Victoria-Jungfrau Grand Hotel and Spa in Interlaken to sample their Better Aging program and find out if you really can stop the clock and stay looking young or if such ideas are just cuckoo.

The area certainly has a feel of youthful exuberance about it when I arrive Im greeted by paragliders, their colourful canopies drifting down onto the green across from the hotel. During my stay, not a day goes by without seeing the red and yellow wings in death-defying loops.

I can watch them from my room a smart black, brown and gold chamber housing a hard double bed with two single duvets, the traditional Swiss arrangement presumably designed to prevent greedy partners from hogging the covers. Every evening theres a Swiss truffle on my pillow.

The balcony looks out towards the Bernese Alps and the snowy peaks of Jungfrau, which means young woman or maiden. The setting of my anti-ageing quest really couldnt be better.

My journey begins at Nescens Spa, a bright space with lots of natural light, candles and trailing plants.

Spa director Hans-Peter notes down my vitals and bids me stand on a body analysis machine before Im whisked off to a room with personal trainer Brigitte, an intimidatingly fit-looking 49-year-old with a blonde crop.

Its not all bad news I have more muscle than her but I have a lot of body fat (not exactly news to me). She tells me my visceral fat is of particular concern and, among other things, advises me to avoid fruit with a high sugar content such as pineapple and grapes.

The next step is easier to take a de-stressing massage using anti-ageing Nescens oil. This should smoothe the skin and boost cell recapitalisation. The massage is gentler than others Ive had, and quite relaxing, but I cant say my skin looked different afterwards.

The spa does boast outstanding relaxation areas, however. Comfortable couches with mountain views, a smart sauna and the apex of steam rooms with twinkly lights in its starry ceiling, a fountain in middle and a gentle mint scent wafting through the air.

The next morning we come at the ageing issue via exercise with a morning of gentle Pilates. Its run by another uber-fit blonde, Iris.

Then its time for a Better Aging lunch beetroot, goats cheese and orange salad followed by a delicious sea bream with basillicum and vegetables.

Usually guests on the programme stay for at least four days, during which time meals are matched to help them achieve their fitness goals but this cant be easy with a pizzeria, Sapori, as part of the hotel.

The afternoon is dedicated to more exercise a brisk 5km walk with Iris again, through woodland and along the river, emerald with glacier water.

I have the highest hopes for todays anti-ageing treatment a classic silk bliss facial using Sensai products.

My beautician, Nicole, explains how the silk in the range was previously reserved for the Emperor of Japan. Apparently the products can activate your stem cells to help remove wrinkles.

The facial begins with Sensai Silky Purifying Creamy Soap followed by a steamer to open the pores, and some seriously thorough extraction work.

Next came the Silky Purifying Silk Peeling Mask and a mud soap wash and mask, left for six minutes. Finally came four more serums and creams.

My skin looked blotchy but felt very soft afterwards like a velvety cushion. The blotchiness was gone within half an hour, replaced with a glow. The next morning I could feel a spot coming on my neck but my face was plump, smooth and even.

The next day, after a Better Aging breakfast of light bites including tomatos, olives and smoothies, Im back with Brigitte for Nescens Full Body Training. Im cheered by the sight of some pensioners in the class. How hard can it be?

Quite hard, is the answer a full-on but not unbearable 45 minutes of planks, sit ups, star jumps and stretching giant blue elastic bands.

Afterwards I reward myself with a swim in the stunning pool. The main spa has a white, black and gold theme and incredible views.

It also has a lovely outdoor jacuzzi which you swim out to, with bubble beds, jets to massage your feet and back, and a clearer look at the mountains.

At the end of my trip I was more relaxed, my skin felt smoother and I felt fitter. While I may not look younger, as someone approaching 40 Im certainly less stressed about ageing.

Victoria-Jungfrau Grand Hotel and Spa (Picture: Yvette Caster/Metro.co.uk)

Where to stay in Switzerland

Rooms at Victoria-Jungfrau Grand Hotel and Spa cost from 296 per night, with breakfast. Better Aging guests get a 50 per cent discount in high season and 25 per cent discount in low season.

The Better Aging program lasts from four days and costs from 2,499 per person, which includes treatments, personal training and meals.

I flew with Swiss Air from Heathrow to Zrich. Flights cost from 177 return.

To get to the spa I took the train from Zrich airport to Interlaken OST via Bern. Return tickets cost from 116 via Switzerland Tourism. The hotel was about five minutes from the station by taxi.

A Swiss Travel Pass offers unlimited travel throughout the rail, bus and boat network. It includes entrance to 500 museums and costs from 185.

For more on Switzerland visit http://www.MySwitzerland.com.

Where to stay in Heathrow

I stayed at the Radisson Blu Edwardian Heathrow a decadent way to extend the spa experience.

The lobby features an impressive chandelier and theres dark wood and bronzes throughout.

The hotels spa has just had a revamp, and has a relaxation area, cosy sauna, powerful jacuzzi and beautiful blue and gold steam room.

The revamped Radisson spa at the hotel (Picture: Yvette Caster/Metro.co.uk)

I loved the showers you use between each part of the spa. Im sure they would delight fellow Pratchett fans, bringing to mind the Archchancellors bathroom as they do. There were buttons for cold mist, Caribbean storm and waterfall (but thankfully no Old Faithful).

I also tried their chocolate orange massage a thorough, full body treatment. I wasnt overpowered by scent and only really noticed the mild smell of cocoa when it was applied to my chest. It left me feeling refreshed and smelling sweet.

The hotel has two places to dine, Indian restaurant Anayu and Steak and Lobster. My T-bone steak was pleasant, although the blue cheese sauce was a bit bland, while the skinny fries were deliciously seasoned.

I enjoyed chatting to Radissons virtual host, Edward. You can text him anything 24/7 order room service, ask for late checkout and enquire about hotel services. It was like having my own PA.

Rooms at Radisson Blu Edwardian cost from 76.50 per night. They are offering Stay, Park and Fly packages from 102.50 per night, including parking for trips for eight to 15 days.

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The fountain of youth? I tested a better anti-ageing program in Switzerland - Metro.co.uk

Skin Stem Cells Comments Off on The fountain of youth? I tested a better anti-ageing program in Switzerland – Metro.co.uk | November 24th, 2019

Acne is a bummer, whether it shows up on your big day . . . or just a Monday. Chances are you've had to deal with it at some point in your life. (That's why you're reading this, right?) Whether the problem is hormonal, cystic, or something else entirely, it's pretty safe to say no one is excited when they see a new pimple in the mirror.

Now's the time to break up with breakouts for good. Here are top-rated products to add to your clear skin arsenal, straight from Sephora.

You'll find solutions to brighten and treatments to lighten (old scars), not to mention products that exfoliate skin and zap zits. There's even makeup for pimple-prone skin, too.

If you're ready to stage an acne attack (that's an attack on acne, not of acne), find the blemish-blasting products from Sephora that other shoppers are loving ahead.

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Solve Your Problem (Skin) With These Top-Rated Acne Products From Sephora - POPSUGAR

Skin Stem Cells Comments Off on Solve Your Problem (Skin) With These Top-Rated Acne Products From Sephora – POPSUGAR | November 24th, 2019

Aristotle already observed in the fourth century B.C. that some animals can regrow their tails after losing them, but the mechanisms that support this kind of regeneration remain difficult to understand.

Using single-cell genomics, scientists at the Wellcome Trust / Cancer Research UK Gurdon Institute at the University of Cambridge developed an innovative strategy to show what happens in different tadpole cells when they regenerate their tails.

Recent advances at Cambridge in next-generation single-cell sequencing mean that scientists can now track which genes are turned on throughout a whole organism or tissue, at the resolution of individual cells. This technique, known as single-cell genomics, makes it possible to distinguish between cell types in more detail based on their characteristic selection of active genes.

These groundbreaking discoveries are beginning to reveal a map of cellular identities and lineages, as well as the factors involved in controlling how cells choose between alternative pathways during embryo development to produce the range of cell types in adults.

Using this technology, Can Aztekin and Dr Tom Hiscock under the direction of Dr Jerome Jullien made a detailed analysis of cell types involved in regeneration after damage in African clawed frog tadpoles (Xenopus laevis). Details were published in the journal Science.

Dr Tom Hiscock said: Tadpoles can regenerate their tails throughout their life; but there is a two-day period at a precise stage in development where they lose this ability. We exploited this natural phenomenon to compare the cell types present in tadpoles capable of regeneration and those no longer capable.

The researchers found that the regenerative response of stem cells is orchestrated by a single sub-population of skin cells, which they named Regeneration-Organizing Cells, or ROCs.

Can Aztekin said: Its an astonishing process to watch unfold. After tail amputation, ROCs migrate from the body to the wound and secrete a cocktail of growth factors that coordinate the response of tissue precursor cells. These cells then work together to regenerate a tail of the right size, pattern and cell composition.

In mammals, many tissues such as the skin epidermis, the intestinal epithelium and the blood system, undergo constant turnover through life. Cells lost through exhaustion or damage are replenished by stem cells. However, these specialised cells are usually dedicated to tissue sub-lineages, while the ability to regenerate whole organs and tissues has been lost in all but a minority of tissues such as liver and skin.

Professor Benjamin Simons, a co-author of the study said: Understanding the mechanisms that enable some animals to regenerate whole organs represents a first step in understanding whether a similar phenomenon could be reawakened and harnessed in mammalian tissues, with implications for clinical applications.

This research was funded by the University of Cambridge, the Cambridge Trust andthe Wellcome Trust;and supported by theEuropean Molecular Biology Organization, the Royal Society,theEuropean Molecular Biology Laboratory, and Cancer Research UK.

Source: University of Cambridge Research

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Scientists find a cell that helps tadpoles tails regrow - Fourways Review

Skin Stem Cells Comments Off on Scientists find a cell that helps tadpoles tails regrow – Fourways Review | November 23rd, 2019

DetailsCategory: Small MoleculesPublished on Friday, 22 November 2019 14:04Hits: 311

Two Phase III Calquence trials demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability

Calquence combined with obinutuzumab and as monotherapy reducedthe risk of disease progression or death by 90% and 80%, respectively in ELEVATE-TN

LONDON, UK I November 21, 2019 I AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDAs Real-Time Oncology Review and newly established Project Orbis programmes.

The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.1

Dave Fredrickson, Executive Vice President, Oncology Business Unit said: With over 20,000 new cases anticipated this year in the US alone, todays approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favourable tolerability profile. The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.

Dr Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE-TN trial, said: Tolerability remains an issue in the current treatment landscape of chronic lymphocytic leukaemia, which may require ongoing therapy for many years. In the ELEVATE-TN and ASCEND trials comparing Calquence to commonly used treatment regimens, Calquence demonstrated a clinically meaningful improvement in progression-free survival in patients across multiple settings, while maintaining its favourable tolerability and safety profile.

The results of the interim analysis of the ELEVATE-TN trial will be presented at the upcoming American Society of Hematology congress.2

The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with either Calquence in combination with obinutuzumab or Calquence monotherapy versus chlorambucil chemotherapy plus obinutuzumab, a current standard-of-care combination used in the control arm.1

In the Calquence combination arm, risk of disease progression or death was reduced by 90% (HR 0.10; 95% CI, 0.06-0.17, p<0.0001) and in the monotherapy arm it was reduced by 80% (HR 0.20; 95% CI, 0.13-0.30, p<0.0001).1

The median time to disease progression for patients treated with Calquence in combination with obinutuzumab or as a monotherapy has not yet been reached versus 22.6 months (95% CI, 20-28) for chlorambucil plus obinutuzumab.1

ELEVATE-TN safety overview (most common ARs, 15%):1

Includes multiple ADR terms.

In patients treated with the combination of Calquence plus obinutuzumab, adverse reactions (ARs) led to treatment discontinuation in 11% of patients and a dose reduction of Calquence in 7% of patients. In the monotherapy arm, ARs led to discontinuation in 10% and dose reduction in 4% of patients.1 In the control arm, ARs led to regimen discontinuation in 14% of patients with a dose reduction of chlorambucil in 28% of patients.3 There were no dose reductions for obinutuzumab.1,3

In 1,029 patients with haematologic malignancies who were treated with Calquence 100mg approximately every 12 hours across multiple clinical trials, where 88% received treatment for at least six months and 79% received treatment for at least one year, serious or Grade 3 infections occurred in 19%, and Grade 3 atrial fibrillation and flutter occurred in 1.1% of patients.In the same patient population, major haemorrhage occurred in 3.0% (serious or Grade 3 bleeding or any central nervous system bleeding), with fatal haemorrhage occurring in 0.1% of patients. Second primary malignancies (all grades) including skin cancers occurred in 12% of patients.1

The US approval is among the first to be granted under Project Orbis, an initiative of the US FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicines among international partners. The FDA, the Australian Therapeutic Goods Administration, and Health Canada collaborated on this review. 4

About Calquence

In the US, Calquence (acalabrutinib) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). In the US, Canada, Australia, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina, Singapore, Chile, and recently India, Calquence is indicated for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Approved under accelerated review in the US, continued approval for previously treated MCL is contingent upon verification and confirmation of clinical benefit in confirmatory trials.

Calquence is a next-generation selective inhibitor of Brutons tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.1,5,6,7 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.1

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 23 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrm macroglobulinaemia and follicular lymphoma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating Calquence versus ibrutinib in patients with previously treated high-risk CLL, and ACE-CL-311 evaluating Calquence in combination with venetoclax and with/without obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without 17p deletion or TP53 mutation.

About ELEVATE-TN

ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy ofCalquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity).1,8

The primary endpoint is PFS in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints include objective response rate, time to next treatment and overall survival.1,8

About ASCEND

ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.1,9

The primary endpoint is PFS assessed by an IRC, and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.1,9

About CLL

Chronic lymphocytic leukaemia (CLL) is one of the most common types of leukaemia in adults, with an estimated 105,000 new cases globally each year and 20,720 new cases in the US in 2019, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.10,11,12,13 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.10 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.10 This could result in anaemia, infection and bleeding.10 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

About AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients lives and the Companys future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZenecas main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. CALQUENCE (acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.

2. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Abstract 31 at: American Society of Hematology 2019 Annual Meeting and Exposition. Available online. Accessed November 2019.

3. Data on File. REF-64711. AstraZeneca Pharmaceuticals LP, Wilmington, DE.

4. US Food and Drug Administration. Project Orbis. Available online. Accessed November 2019.

5. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).

6. Khan Y & OBrien S. Acalabrutinib and its use in treatment of chronic lymphocytic leukemia. Future Oncol. 2018;15(6).

7. Byrd JC, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016; 374:323-332.

8. ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL. NCT02475681. Available online. Accessed November 2019.

9. ClinicalTrials.gov. A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL. NCT02970318. Available online. Accessed November 2019.

10. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available online. Accessed November 2019.

11. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.

12. American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Available online. Accessed November 2019.

13. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.

SOURCE: AstraZeneca

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Calquence approved in the US for adult patients with chronic lymphocytic leukaemia | Small Molecules | News Channels - PipelineReview.com

Skin Stem Cells Comments Off on Calquence approved in the US for adult patients with chronic lymphocytic leukaemia | Small Molecules | News Channels – PipelineReview.com | November 23rd, 2019

Aristotle already observed in the fourth century B.C. that some animals can regrow their tails after losing them, but the mechanisms that support this kind of regeneration remain difficult to understand.

Using single-cell genomics, scientists at the Wellcome Trust / Cancer Research UK Gurdon Institute at the University of Cambridge developed an innovative strategy to show what happens in different tadpole cells when they regenerate their tails.

Recent advances at Cambridge in next-generation single-cell sequencing mean that scientists can now track which genes are turned on throughout a whole organism or tissue, at the resolution of individual cells. This technique, known as single-cell genomics, makes it possible to distinguish between cell types in more detail based on their characteristic selection of active genes.

These groundbreaking discoveries are beginning to reveal a map of cellular identities and lineages, as well as the factors involved in controlling how cells choose between alternative pathways during embryo development to produce the range of cell types in adults.

Using this technology, Can Aztekin and Dr Tom Hiscock under the direction of Dr Jerome Jullien made a detailed analysis of cell types involved in regeneration after damage in African clawed frog tadpoles (Xenopus laevis). Details were published in the journal Science.

Dr Tom Hiscock said: Tadpoles can regenerate their tails throughout their life; but there is a two-day period at a precise stage in development where they lose this ability. We exploited this natural phenomenon to compare the cell types present in tadpoles capable of regeneration and those no longer capable.

The researchers found that the regenerative response of stem cells is orchestrated by a single sub-population of skin cells, which they named Regeneration-Organizing Cells, or ROCs.

Can Aztekin said: Its an astonishing process to watch unfold. After tail amputation, ROCs migrate from the body to the wound and secrete a cocktail of growth factors that coordinate the response of tissue precursor cells. These cells then work together to regenerate a tail of the right size, pattern and cell composition.

In mammals, many tissues such as the skin epidermis, the intestinal epithelium and the blood system, undergo constant turnover through life. Cells lost through exhaustion or damage are replenished by stem cells. However, these specialised cells are usually dedicated to tissue sub-lineages, while the ability to regenerate whole organs and tissues has been lost in all but a minority of tissues such as liver and skin.

Professor Benjamin Simons, a co-author of the study said: Understanding the mechanisms that enable some animals to regenerate whole organs represents a first step in understanding whether a similar phenomenon could be reawakened and harnessed in mammalian tissues, with implications for clinical applications.

This research was funded by the University of Cambridge, the Cambridge Trust andthe Wellcome Trust;and supported by theEuropean Molecular Biology Organization, the Royal Society,theEuropean Molecular Biology Laboratory, and Cancer Research UK.

Source: University of Cambridge Research

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Scientists find a cell that helps tadpoles tails regrow - North Coast Courier

Skin Stem Cells Comments Off on Scientists find a cell that helps tadpoles tails regrow – North Coast Courier | November 22nd, 2019

By Paul Biegler

US scientists have overcome a major stumbling block in the creation of mini-organs, programming cells to take on the desired shape rather than relying on 3D printing or external scaffolds.

This inside out approach, described in a paper in the journal Cell Systems, could signal a paradigm shift in how mini-hearts, kidneys and brains are grown on the lab bench a technique used to study disease that may one day lead to personalised organ transplants.

The team, led by bioengineer Todd McDevitt at Gladstone Institutes in the US, was driven by an enduring issue with state-of-the-art ways of producing mini-organs such as 3D printing. The cells just wont stay put.

Making a mini-organ or organoid starts when scientists take a persons skin cell and, using the right mix of agents, turn it into an induced pluripotent stem cell. This IPS cell is the blank cheque of biology, capable of becoming almost any cell type.

Grow it into a mini-kidney, say, and you can reproduce kidney diseases and test treatments in a dish sitting on your lab bench. But how faithful that model is depends on the physical organisation of the cells; to mimic a real deal kidney, 3D printing is often used.

But cells, much like unruly teenagers, have a mind of their own and will often wander away from their printed position.

McDevitts team wanted to own those cellular minds and so took control of two genes that together make up something of a joystick that directs how the cells organise.

CDH1 and ROCK1 figure heavily in the complex moves that lead to the final configuration of a group of cells. The pair influences stickiness and repulsion between cells, the surface tension that makes them spherical and their overall speed of migration.

The researchers used the editing tool CRISPR to knock out the two genes at various stages in the evolution of a clump of cells. Their aim was to make a bulls eye pattern, a shape thats common in human development, including in early embryo formation.

To detect that aspirational pattern, they engineered another tweak making the cells fluoresce when CDH1 and ROCK1 were neutralised.

But there was a problem.

Factor in all the potential time points where the genes could be knocked out, the proportion of cells to be targeted, and a host of other variables, and the researchers calculated theyd need to do nearly 9000 trial-and-error experiments.

So they called on AI. They trained a machine learning model to compute the precise pattern of gene knockouts needed to realise their dream shape.

Machine learning can predict what movie you might like based on your viewing history, but it can also generate new insights into biological systems by mimicking them, says co-author Demarcus Briers, from the Boston University Bioinformatics Program.

Our machine-learning model allows us to predict new ways that stem cells can organise themselves, and produces instructions for how to recreate these predictions in the lab.

That model hit a bulls eye, quite literally, allowing the team to produce the concentric pattern of cells they were aiming at.

"We've shown how we can leverage the intrinsic ability of stem cells to organise," says McDevitt. "This gives us a new way of engineering tissues, rather than a printing approach where you try to physically force cells into a specific configuration."

Ultimately, that concrete target shape will give way to a target in the abstract, one with potential to shift the life course.

"We're now on the path to truly engineering multicellular organization, which is the precursor to engineering organs," McDevitt says. "When we can create human organs in the lab, we can use them to study aspects of biology and disease that we wouldn't otherwise be able to."

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AI helps cells pull themselves together - Cosmos

Skin Stem Cells Comments Off on AI helps cells pull themselves together – Cosmos | November 20th, 2019

They always say time changes things, but you actually have to change them yourself. Andy Warhol

As the early adopter mindset filters out into mainstream thinking and behaviors, brands need no longer target their innovations towards a small group of consumers the floor is open and the consumer demand growing across all demographics for brand innovation.

The boundaries of what we might have traditionally considered as personal care are shifting with brands exploring new territories and opportunities to take care of the body and mind from a more holistic perspective.

Here we take a look at a selection of ten current and emerging trends from brands leading notable movements of change.

New occasions

Brands developing targeted personal care solutions for the more active amongst us are on the rise. Natural luxury spa brand Espa have launched a new body care collection designed for use post workout, and include a Muscle Rescue Balm and Fitness Shower Oil specially formulated to sooth tired muscles.

Mantastic expressions

Practical and affordable male grooming brand Harrys questions conventional definitions of what it means to be a man, celebrating the messiness of masculinity and championing social causes that challenge outdated stereotypes. The subtle and playful illustration of a Mammoth on the pack calls attention to the brand's message that extinct perceptions of masculinity need to be abolished.

Sustainable living

Born from a belief that small changes can have a big impact, Eco + Amour has collaborated with some of the trendiest eco-conscious brands to offer a refillable, more sustainable, beauty, personal care and home care shopping experience. No doubt Im not the only one with at least three different moisturizers and deodorants in the bathroom at any one time - refreshingly, Eco + Amour encourages consumers to only buy what they need.

Eco-friendly packaging

Netherlands based designer Don Yaw Kwaning is exploring sustainable innovation using the soft rush plant. Through a process of separating the pith from the fibers, you are left with a foam which has lightweight, shock-resistant and insulating properties all without the need for bonding agents. The fibers can be developed into materials such as paper and corrugated cardboard, a fantastic new eco-packaging solution.

Clean living, clean design

The broader trend towards clean living (both in terms of health and sustainability) and clean beauty has been broadly adopted across the personal care category particularly by more agile brands. For the most part, the fragrance category has been slow to respond, continuing to follow traditional premium colours, codes and cues. Minimalism is the new luxury and Le Labo is a great benchmark - a sight for sore eyes and indeed has clear stand out on shelf against the swathe of rose gold and metallic designs of other fragrance super brands. Taking cues from the premium spirits category with the bottles heavy foot, the label design also mimics tasting notes as though from a distillery. A fantastic example of the value in looking cross-category for design inspiration.

Leveraging health and wellness

In support of the ever-popular self-care movement, personal care brands have an opportunity to incorporate health and wellness solutions into their product functionality and design. Japanese haircare brand Feather Aqua explores holistic health and wellness for the scalp founded on the premise that taking care of your head takes care of your hair. The brand uses amino acids and natural plant extracts coupled with aromatherapy fragrances to also elevate the state of mind and mood of the consumer.

New wave supplements

Wellness start-up Hello.me has recently launched a special natural supplement designed to combat the negative effects of using contraceptive pills. The Top Up Tonic reportedly relives symptoms such as bloating, mood swings and breast tenderness.

Harnessing advances in technology

World leader in regenerative medicine, Professor Augustinus Bader has utilized the restorative power of stem-cell technology to provide consumers with the ultimate solution in high-end anti-ageing skincare. The TFC8 patented technology activates the bodys stem cells to biologically repair damage to the skin caused by lifestyle and environmental factors mobilizing our bodys natural abilities to renew.

Delicious derrires

Never has Sir Mix-A-Lot been more relevant. Products aimed at targeting elasticity, firmness, dry skin and sagging of the bottom have flooded the market over the last year. Masks in particular are on the rise. Niche Los Angeles brand Anese brings us Down with the thickness, a collagen mask that detoxes, plumps and softens your bottom.

A sculpting revolution

The onslaught of easily accessible fitness solutions across social media and personalized app technologies has begun to filter out into the personal care market. Be for Beauty brings us a BOD range (Body on Demand), a ritual of products designed to tighten and sculpt the body through the reduction of water retention. The range includes bath salts which are designed to tone the body, clear out excess toxins and can supposedly eliminate up to 3lbs of excess water retention weight all within a 20-minute soak.

Kirsty Cole, head of growth at Anthem Amsterdam & Brussels.

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Ten brands blurring boundaries in personal care and beyond - The Drum

Skin Stem Cells Comments Off on Ten brands blurring boundaries in personal care and beyond – The Drum | November 20th, 2019

Regenerative medicine is one of modern sciences most exciting developments. Defined by the Medical Research Council, regenerative medicine is an interdisciplinary field that seeks to develop the science and tools that can help repair or replace damaged or diseased human cells or tissues to restore normal function.

In the human body, the liver is the only organ capable of regenerating itself spontaneouslyeven after serious injurybut in the future, any part of the human body may be capable of doing so. Our own cells will also be able to treat and cure diseases and conditions of the blood and immune system, as well as restore the blood system after treatments for specific cancers.

Once only imaginable in science fiction, the latest applications include engineered skin tissue to treat burn victims, custom-grown bones for implants and joint replacements, personalized dietary treatments using gut bacteria and just recently, the worlds first 3D vascularized engineered heart was created using a patients own cells and biological materials.

As scientists understanding and the tools at their disposal become more advanced, the closer to the widespread commercialization of regenerative medicine the pharmaceutical industry finds itself.However, offering regenerative medicine therapies at scale requires one of the biggest shake-ups to the global pharmaceutical supply chain ever seen. Without it, the world risks missing out on the curative promises of this next-generation medical technology.

Regenerative medicine is one of, if not the most, exciting advancements in modern science which has far-reaching benefits for big pharma, healthcare systems and patient outcomes.

Regenerative medicine is a growth industry in more than one sense of the word; as a sector, its growing from strength to strength. In fact, last year the global regenerative medicine market was worth $28 billion and its expected to grow to $81 billion by 2023.

As a more efficient and less invasive alternative to transplanting cells or organs to replace damaged or lost tissue, established pharma companies alongside small biotech start-ups are racing to discover and bring to market medicine-based approaches that stimulate the bodys natural ability to repair itself.The cutting-edge innovations of regenerative medicine generally fall into three distinct categories:

Replenish Replace Rejuvenate

Stem cells can generate vital growth factors to naturally reduce inflammation, increase muscle mass, repair joints, grow hair and boost the immune system, replenishing the body. Organ regeneration and 3D printing are replacing the reliance on the failing donor system and overcoming the issue of organ rejection. The root causes of aging are being better understood and delayed by using stem cells to rejuvenate the body.

Marking a new era in healthcare and one which has the promise of addressing the needs of an aging population challenged by escalating chronic diseases, regenerative medicine is certainly a game-changer. Beyond more effective medical treatments that can be applied routinely despite age, comorbidities, or disease severity, it also has the potential to cure many of todays incurable diseases and support healthcare systems to move towards a preventative model.

Today, regenerative medicine is largely confined to a research environment. In fact, according to a recent report, there were 1,028 clinical trials for regenerative therapies taking place globally at the end of 2018.

Regenerative medicine is poised to transform healthcare as we know it, offering potential cures for deadly diseases which before would require long-term treatment to manage. However, while billions are being spent on regenerative medicine research and clinical studies, little resource has, so far, been allocated to the management and delivery of innovative medical therapies at scale.

Currently, the race appears to be on between smaller Medtech companies and large multi-national pharmaceutical companies to see who wins first-mover advantage in the regenerative medicine market. Today, many established pharmaceutical companies prefer to partner with Medtech startups to in-license products in early clinical development stages as opposed to conducting early development on their own which comes at a huge cost. This is a risk-reduction tactic, but it could mean big pharma misses the boat.

The question remains unanswered as to whether a peer-to-peer collaborative model will prosper where Medtech companieswho are in some instances one step ahead of big pharma in terms of drug developmentare happy to be a third-party provider to big pharma who have the budgets and networks to truly deliver the regenerative medicine revolution.

Regulation is, and will continue to, play a hugely important role in delivering regenerative medicines from a lab setting to a clinical setting. Only recently, the FDA announced a new policy framework for the development of regenerative medicine products, taking into account the dynamic and fast-moving nature of the field.

Ultimately, the governments aim is to protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies according to Former FDA Commissioner Dr. Scott Gottlieb. The FDA plans to achieve this over the coming years by driving stakeholder engagement with the developing regulatory framework in order to efficiently advance access to safe and effective regenerative medicine advanced therapies.

However, so far, progress by the pharma industry in coming into compliance with FDAs regulations for regenerative medicines has been slow, despite the grace period set by the FDA before it fully exercises enforcement fast approaching (ending in November 2020).

In order to speed up the process of bringing novel medicines to market, the FDA is toying with the idea of fast-tracking products that are deemed low risk to patients if sponsors have engaged with the regulatory process and demonstrated responsibility by filing Investigational New Drug Applications (INDs).

The FDA has also promised to strengthen its enforcement action against drug developers who are marketing unapproved products, prioritizing cases where the threat to patient health and safety is largest.For example, last November the FDA stepped in where a Californian business was selling stem cell products using umbilical cord blood for the treatment of arthritis and other conditions, despite this form of treatment not having FDA approval for that particular use. Several patients (at least 12) undergoing this treatment were hospitalized after developing infections of the bloodstream and joints, as well as abscesses along the spine and skull.

In summary, one of the FDAs central aims over the coming years is to drive stakeholder engagement with the developing regulatory framework for regenerative medicine advanced therapies in order to efficiently advance access to safe and effective new products.

The promise of regenerative medicine requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network.

Once these novel drugs become mainstream, the entire healthcare ecosystem will have to adapt. Regulatory approval for any drug relies on it safely and successfully fulfilling its medical intent. As such, information about supply chain management needs to be submitted to the regulator after the completion of phase three clinical trials, including packaging, labeling, storage and distribution.

The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far, even more so than for biologic medicine. Thats because, unlike many mass-market drugs, regenerative medicine is either personalized or matched to a unique donor-recipient.

The distribution of regenerative medicine therapies is further complicated by the fact they are also extremely sensitive to exogenous factors like time and temperature. Therefore, there are strict conditions under which these therapies must be transported and received.

Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability across the pharma supply chain. These are giving clinicians access to view the progress of therapies and their distribution in real-time and allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible and avoid costly wastage.

The live tissues and cells which form the basis of regenerative medicine products are highly sensitive and some have a shelf life of no more than a few hours, making distribution a complex task. Therefore, materials need to be transported from the site of harvest to manufacturing facilities, and from manufacturing facilities to medical institutions under strictly controlled conditions, within certain time periods and temperatures, according to different cell and tissue requirements which can vary from product to product.

Temperature-controlled logistics solutions are vital to ensure a safe, effective and financially viable supply chain network for these high-value shipments. Cryopreservation is one technique increasingly being used to deliver medicines at optimum temperature using vapor phase nitrogen, however, many clinical settings remain ill-equipped to handle such equipment.

Onsite production is an alternative manufacturing arrangement, particularly for autologous products which are derived from a patients own cells. However, this throws up a number of compliance and infrastructure challenges, as the hospital would need to comply with a host of regulations including installing a licensed clean room which may not be possible given budget restrictions and limited space onsite.As a first-generation technology, stakeholders will have a greater tolerance for higher pricing, but only for a limited time period. By streamlining the currently very expensive manufacturing process and improving supply chain management, yields will automatically get larger and costs will slowly come down.

While there are many challenges in the road ahead, 2019 certainly appears to be the start of regenerative medicines move to the big time. Just like big data and artificial intelligence is transforming the practice of medicine, regenerative medicine holds the promise of extending the bodys natural ability to replenish, replace and rejuvenate itself.

If the global health industry can work collaboratively on overcoming the challenges presented by delivering safe and effective advanced therapies, a dramatic extension of the human healthspan is possible. We may even reach the point where no disease is considered incurable, transforming healthcare as we know it.

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Regenerative Medicine: Overcoming The Supply Chain Challenges - Contract Pharma

Skin Stem Cells Comments Off on Regenerative Medicine: Overcoming The Supply Chain Challenges – Contract Pharma | November 20th, 2019

I have a four-foot-tall robot in my house that plays with my kids. Its name is Jethro.

Both my daughters, aged 5 and 9, are so enamored with Jethro that they have each asked to marry it. For fun, my wife and I put on mock weddings. Despite the robot being mainly for entertainment, its very basic artificial intelligence can perform thousands of functions, including dance and teach karate, which my kids love.

The most important thing Jethro has taught my kids is that its totally normal to have a walking, talking machine around the house that you can hang out with whenever you want to.

Given my daughters semi-regular use of smartphones and tablets, I have to wonder how this will affect them in the future. Will they have any fear of technologies like driverless cars? Will they take it for granted that machine intelligences and avatars on computers can be their best friends, or even their bosses?

Will marrying a super-intelligent robot in 20 years be a natural decision? Even though I love technology, Im not sure how I would feel about having a robot-in-law. But my kids might think nothing of it.

This is my story of transhumanism.

Courtesy of Zoltan Istvan

My transhumanism journey began in 2003 when I was reporting a story for National Geographic in Vietnams demilitarized zone and I almost stepped on a landmine.

I remember my guide roughly shoving me aside and pointing to the metal object half sticking out of the ground in front of me.

I stared at the device that would have completely blown my legs off had my boot tripped the mine. I had just turned 30. The experience left me shaken. And it kept haunting me.

That night as I lay tense and awake in my hotel room, I had the epiphany that has helped define the rest of my life: I decided that the most important thing in my existence was to fight for survival. To put it another way: My goal was to never die.

Because I was not religious, I immediately turned to the thing that gave meaning to my world: science and technology. I took a leap of faith and made a wager that day. I later called this (and even later, dedicated a book to it) the transhumanist wager.

The life extension business of transhumanism will be a $600 billion industry by 2025.

My idea for an immortality wager came from Pascals Wager, the famous bet that caught on in the 17th century that loosely argued it was better to believe in God than not to, because you would be granted an afterlife if there was indeed a God. My transhumanist wager was based in my belief that its better to dedicate our resources to science and technology to overcome death while were still aliveso we dont ever have to find out whether there is an afterlife or not. It turns out I wasnt alone in my passion to live indefinitely through science. A small social movement, mostly of academics and researchers, were tackling similar issues, starting organizations, and funding research.

Some of them called themselves transhumanists.

Fast-forward 16 years from my landmine incident, and transhumanism has grown way beyond its main mission of just overcoming death with science.

Now the movement is the de facto philosophy (maybe even the religion) of Silicon Valley. It encapsulates numerous futurist fields: singularitarianism, cyborgism, cryonics, genetic editing, robotics, AI, biohacking, and others.

Biohacking in particular has taken offthe practice of physically hacking ones body with science, changing and augmenting our physiology the same way computer hackers would infiltrate a mainframe.

Its pretty obvious why it has emerged as such a big trend: It attracts the youth.

Not surprisingly, worrying about death is something that older people usually do (and, apparently, those younger people who almost step on landmines). Most young people feel invincible. But tell young people they can take brain drugs called nootropics that make them super smart, or give them special eye drops that let them see in the dark, or give them a chip implant that enhances human ability (like the one I have), and a lot of young people will go for it.

In 2016, I ran for the US presidency as the Transhumanist Party nominee. To get support from younger biohackers, my team and I journeyed on the Immortality Busmy 38-foot coffin-shaped campaign busto Grindfest, the major annual biohacking meet-up in Tehachapi, California. In an old dentists chair in a garage, biohackers injected me with a horse syringe containing a small radio-frequency-identification implant that uses near-field communication technologythe same wireless frequency used in most smartphones. The tiny deviceits about the size of a grain of ricewas placed just under the skin in my hand. With my chip, I could start a car, pay with bitcoin, and open my front door with a lock reader.

Four years later, I still have the implant and use it almost every day. For surfers or joggers like myself, for example, its great because I dont have to carry keys around.

One thing I do have to navigate is how some religious people view me once they understand I have one. Evangelical Christians have told me that an implant is the mark of the beast, as in from the Bibles Book of Revelations.

Even though Im tagged by conspiracy theorists as a potential contender for the Antichrist, I cant think of any negatives in my own experiences to having a chip implant. But as my work in transhumanism has reached from the US Military to the World Bank to many of the worlds most well-known universities, my chip implant only exasperates this conspiracy.

While people often want to know what other things Ive done to my body, in reality becoming a cyborg is a lot less futuristic and drastic than people think.

For me and for the thousands of people around the world who have implants, its all about functionality. An implant simply makes our lives easier and more efficient. Mine also sends out pre-written text messages when peoples phones come within a few feet of me, which is a fun party trick.

But frankly, a lot of the most transformative technology is still being developed, and if youre healthy like me, theres really not much benefit in doing a lot of biohacking today.

I take nootropics for better brain memory, but theres no conclusive research I know of that it actually works yet. Ive done some brainwave therapy, sometimes called direct neurofeedback, or biofeedback, but I didnt see any lasting changes. I fly drones for fun, and of course I also have Jethro, our family robot.

For the most part, members of the disabled community are the ones who are truly benefiting from transhumanist technologies today. If you have an arm shot off in a war, its cyborg science that gives you a robot arm controlled by your neural system that allows you to grab a beer, play the piano, or shake someones hand again.

But much more dramatic technology is soon to come. And the hope is that it will be availableand accessibleto everyone.

I asked to be added to a volunteer list for an experiment that will place implants in peoples brains that would allow us to communicate telepathically, using AI. (Biohacking trials like this are secretive because they are coming under more intense legal scrutiny.)Im also looking into getting a facial recognition security system for my home. I might even get a pet dog robot; these have become incredibly sophisticated, have fur softer than the real thing (that doesnt shed all over your couch or trigger allergies) and can even act as security systems.

Beyond that, people are using stem cells to grow new teeth, genetic editing to create designer babies, and exoskeleton technology that will likely allow a human to run on water in the near future.

Most people generally focus on one aspect of transhumanism, like just biohacking, or just AI, or just brainwave-tech devices. But I like to try it all, embrace it all, and support it all. Whatever new transhumanist direction technology takes, I try to take it all in and embrace the innovation.

This multi-faceted approach has worked well in helping me build a bridge connecting the various industries and factions of the transhumanist movement. Its what inspired me to launch presidential and California gubernatorial campaigns on a transhumanist platform. Now Im embarking on a new campaign in 2020 for US president as a Republican, hoping to get conservatives to become more open-minded about the future.

The amount of money flowing into transhumanist projects is growing into many billions of dollars. The life extension business of transhumanism will be a $600 billion industry by 2025, according to Bank of America. This is no time for transhumanism to break apart into many different divisions, and its no time to butt heads. We need to unite in our aim to truly change the human being forever.

Transhumanistsit doesnt matter what kind you arebelieve they can be more than just human. The word natural is not in our vocabulary. Theres only what transhumanists can do with the tools of science and technology they create. That is our great calling: to evolve the human being into something better than it is.

Because transhumanism has grown so broadly by now, not all transhumanists agree with me on substantially changing the human being. Some believe we should only use technology to eliminate suffering in our lives. Religious transhumanists believe we should use brain implants and virtual reality to improves our morality and religious behavior. Others tell me politics and transhumanism should never mix, and we must always keep science out of the hands of the government.

We need unity of some significant sort because as we grow at such a fast rate there are a lot of challenges ahead. For example, the conservative Christian Right wants to enact moratoriums against transhumanism. The anarcho-primativists, led by people like the primitivist philosopher and author John Zerzan (who I debated once at Stanford University), want to eliminate much technology and go back to a hunting-gathering lifestyle which they believe is more in tune with Earths original ecology. And finally, we must be careful that the so-called one percent doesnt take transhumanist technology and leave us all in the dust, by becoming gods themselves with radical tech and not sharing the benefits with humanity.

I personally believe the largest danger of the transhumanist era is the fact that within a few decades, we will have created super-intelligent AI. What if this new entity simply decides it doesnt like humans? If something is more sophisticated, powerful, intelligent, and resilient than humans, we will have a hard time stopping it if it wants to harm or eliminate us.

Whatever happens in the future, we must take greater care than we ever have before as our species enters the transhumanist age. For the first time, we are on the verge of transforming the physical structure of our bodies and our brains. And we are inventing machines that could end up being more intelligent and powerful than we are. This type of change requires that not only governments act together, but also cultures, religions, and humanity as a whole.

In the end, I believe that a lot more people will be on board with transhumanism than admit it. Nearly all of us want to eliminate disease, protect our families from death, and create a better path and purpose for science and technology.

But I also realize that this must be done ever so delicately, so as not to prematurely push our species into crisis with our unbridled arrogance. One day, we humans may look back and revel in how far our species has evolvedinto undying mammals, cyborgs, robots, and even pure living data. And the most important part will be to be able to look back and know we didnt destroy ourselves to get there.

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What it means to be a cyborg in 2019 - Quartz

Skin Stem Cells Comments Off on What it means to be a cyborg in 2019 – Quartz | November 20th, 2019

Were still waiting for CBD-infused skincare products to hit shelves in Canada, but products have been at retail for years containing hemp seed oil and cannabis sativa seed oil that are full of omega fatty acids and can be quite hydrating. They may not have the anti-inflammatory benefits of CBD, but consumers have been relying on their skin-boosting affects for ages.

So, just in time for an early blast of winter, here are some online options available at Well.ca for keeping your skin and complexion in check this season including one for the boys:

Chapped lips are sadly on their way now that temperatures have dipped below zero. Arm yourself with an all-natural, hemp-infused lip balm that is so affordable you may want to buy two one to stash in your purse and the other at your desk. Bonus: It also contains antioxidant-packed matcha green tea. Hurraw! Green Tea Lip Balm, $5

If youre like me, your fingers and hands have already started to show signs of winters wear. My cuticles are tattered and my summer-soft hands are rough and dry. Last winter, I relied on North American Hemp Co.s hand cream, and I am reaching back into my wallet for this one. Aside from cannabis sativa seed oil, it also contains vitamins A and E for a powerful solution to dry digits. North American Hemp Co. Hemp Hang Nail Help Hand & Nail Cream, $21

One of the tricks of the beauty trade is switching up your cleanser in the colder months for one that wont leave your face feeling dry and tight. Enter Andalou Naturals CannaCell Cleansing Foam that contains 100 per cent pure hemp seed oil, as well as hemp stem cells, vitamins C, E, as well as B vitamins for good measure. Already added to cart. Andalou Natural CannaCell Cleansing Foam, $19

This cult favourite serum from clean beauty brand Herbivore contains glow-inducing ingredients like olive-derived squalane and cannabis sativa seed oil to hydrate, soften and tone the complexion. And it will look pretty in your shelfie pics on Instagram. Herbivore Emerald Deep Moisture Glow Oil, $60

Bar soap is back baby! Brands and consumers are focusing once again on bar soap as a way to help reduce plastics. Buck Nakeds Dead Sea Mud and Argan Oil soap is a powerful detoxifier, while also adding hydrating ingredients back into the skin with the help of Argan oil backed up by hemp oil. On top of all of that, the bar is biodegradable, so no icky ingredients are washing down your water drain. Buck Naked Soap Company Dead Sea Mud + Argan Soap, $9

This may be for men, but whos stopping you from slathering on this cedar and Bourbon-scented natural deodorant that also contains skin-soothing cannabis sativa seed oil. A holiday gift perhaps? Olivina Men Bourbon Cedar Deodorant, $11

The sole ingredient in these blotting papers from mass beauty line NYX is cannabis sativa seed oil. While the papers will help take away unwanted shine on your T-zone and forehead, the cannabis oil will add a slight bit of hydration back into your complexion, yet keeping it matte. These blotters, there are 50 in a pack, are perfect for your purse while youre trekking to all those holiday parties. NYX Bare With Me Hemp Seed Oil Blotting Papers, $8

Michelle Bilodeau is a writer and editor about fashion, beauty and cannabis. She is also a co-host on theOn A High podcast

Want to keep up to date on whats happening in the world of cannabis?Subscribeto the Cannabis Post newsletter for weekly insights into the industry, what insiders will be talking about and content from across the Postmedia Network.

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Seven beauty basics to buy right now that will help you forget winter's early blast - The GrowthOp

Skin Stem Cells Comments Off on Seven beauty basics to buy right now that will help you forget winter’s early blast – The GrowthOp | November 20th, 2019

3D bioprinting has come a long way in recent years, with scientists using living tissue to print organs as complex as human skin. Researchers in Austria have unveiled an advancement with a process that can integrate living cells into structures at unprecedented speeds and resolution.

TU Wien developed the new technique using a novel bioink that allows cells to be embedded in a 3D matrix and printed with micrometer precision. The technique performs at a speed of one meter per second, much faster than past methods.

Images show living cells spreading in a 3D scaffold -- from left to right: week 1, week 3 week 5. Top: 3D setup, bottom: one layer only. The process was developed by researchers at TU Wien to create precision bioprinting. (Source: TU Wien)

"Using these 3D scaffolds, it is possible to investigate the behavior of cells with previously unattainable accuracy, said Aleksandr Ovsianikov, head of the 3D Printing and Biofabrication research group at the Institute of Materials Science and Technology at TU Wien. It is possible to study the spread of diseases, and if stem cells are used, it is even possible to produce tailor-made tissue in this way.

Exact Science

To successfully bioprint cells that can turn into living tissue with various characteristics, its key to process the cells in a certain way. While there are many techniques for 3D bioprinting, not all are created equal, said Ovsianikov. Some methods are imprecise or only allow a very short time window in which the cells can be processed without being damaged, while others have material challenges.

He noted that the behavior of a cell behaves depends crucially on the mechanical, chemical and geometric properties of its environment. "The structures in which the cells are embedded must be permeable to nutrients so that the cells can survive and multiply, said Ovsianikov. But it is also important whether the structures are stiff or flexible, whether they are stable or degrade over time.

The team can print 3D objects at microscopically fine resolutions, but using living cells at this size has been challenging. "You need liquids or gels that solidify precisely where you illuminate them with a focused laser beam, Ovsianikov noted. However, these materials must not be harmful to the cells, and the whole process has to happen extremely quickly.

Speeding the Process

To solve this issue, TU Wien researchers have been using what are called two-photon polymerization methods, which use a chemical reaction that is only initiated when a molecule of the material simultaneously absorbs two photons of a laser beam with particularly high intensity. At the point of photon absorption, the substance hardens, while it remains liquid everywhere else, which makes this method best suited to produce extremely fine structures with high precision.

While this allows for high resolution, its a rather slow processtypically in the range of micrometers or a few millimeters per second. This means the cells could die before printing is complete.

Now using the scaffolds, researchers have developed a method that fabricates cell-friendly materials at greater speeds. This means they can print a structure in just a few hours, giving cells a good chance of surviving and developing further. "Our method provides many possibilities to adapt the environment of the cells," said Ovsianikov.. Depending on how the structure is built, it can be made stiffer or softer.

He added that even fine, continuous gradients are possible. In this way, it is possible to define exactly how the structure should look in order to allow the desired kind of cell growth and cell migration. The process can also alter the laser intensity to determine how easily the structure will be degraded over time.

Based on the research, the team has created a company, UPNano, to further develop this technique and create bioprinting innovations. They also published a paper on their work in the journal Advanced Healthcare Materials.

Elizabeth Montalbano is a freelance writer who has written about technology and culture for more than 20 years. She has lived and worked as a professional journalist in Phoenix, San Francisco and New York City. In her free time she enjoys surfing, traveling, music, yoga and cooking. She currently resides in a village on the southwest coast of Portugal.

January 28-30:North America's largest chip, board, and systems event,DesignCon, returns to Silicon Valleyfor its 25th year!The premier educational conference and technology exhibition, this three-day event brings together the brightest minds across the high-speed communications and semiconductor industries, who are looking to engineer the technology of tomorrow. DesignCon is your rocket to the future. Ready to come aboard?Register to attend!

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New Process can 3D Print Living Cells with Precision and Speed - DesignNews

Skin Stem Cells Comments Off on New Process can 3D Print Living Cells with Precision and Speed – DesignNews | November 20th, 2019

A young Hull man whose life was saved by the generous people of Hull after being diagnosed with terminal cancer says he is looking forward to the future.

In 2014, Kye Eastwood, now 28, faced an unimaginable battle after being told there was nothing more UK doctors could do for him in his battle against Hodgkins Lymphoma - but there was hope.

The people of Hull heroically clubbed together and raised 46,000 within a month, paying for ground breaking - and life-saving - stem cell - treatment in Maryland, US.

Now, five years on, Kye and his fianc Chanelle Urquhart, 24, of Kingswood, are looking forward to their lives together - after what Kye has described as one of the most difficult years of his life.

Although the pioneering treatment cleared Kye of cancer, Kye has ongoing health issues. He is still undergoing chemotherapy and he is unable to work.

Despite this, he was told he was not allowed his PIP (Personal Independence Payment) benefits from the Department for Work and Pensions (DWP) after he underwent an eligibility assessment.

He said the report was "all wrong", stating he could do a number of things he could not do, which meant he was deemed fit for work.

He said: The report said I had a healthy complexion - that is completely wrong in the first place because of the vitiligo (pigmentation of the skin) I have.

Chanelle said he also split open a sore on his back trying to lift his arms further above his head during the assessment and it still needs treatment months later.

Although he has since had his benefits reinstated after the report was proved to be wrong, the trauma of living without any income and the strain it put on him for months has taken its toll.

He said: Someone came around in March theyd decided I was poorly enough for them to come to me rather than me go to them. I was on my cycle of chemo at the time and having massive allergic reactions.

Everything in the report was wrong and the woman who came didnt even look at any of the medical evidence and made out that I could move more.

"What the report said was not reflective of what happened in the meeting. We got a letter saying I wasnt entitled and why, and the report shed sent off.

Kye appealed and received another assessment and a complaint was put into the DWP by Chanelle, who sent pictures of Kyes skin and statements from every one of his doctors and specialists who see him in Rotherham.

Three months later, Kyes benefits were reinstated.

Chanelle said: He was three months without them, which help with his mobility. He was struggling to get to Rotherham, the treatment which ultimately keeps him alive.

She added the complaint has been escalated and is being looked at by an independent case examiner.

A DWP spokesman said: "We have apologised to Mr Eastwood for the confusion over his reapplication for PIP. It was resolved promptly and he is in receipt of all the benefits he is entitled to."

Chanelle said Kye would love nothing more than to go back to work but he needs something flexible that could work around treatment and hospital appointments.

She said: He was always working before the cancer and would love to go back to work and do things but its trying to find something he would be able to do safely, and something that would work around his health problems.

Kye added: I dont know an employer that would want me to be off at least a week every month while I go to my appointments.

During Kye's treatment the couple flew back and forth to Washington for a period of seven months and were able to stay at the amazing centre along with other families of people having treatment there.

During the time between treatments, they were able to explore the country and while staying in San Antonio in 2015 when they had been together for just six months, Kye proposed.

Chanelle said: At the time it happened, we hadnt been together for very long but we didnt know if he was going to survive. We instantly clicked and it was obvious it was going to work out.

Kye said: I knew I was going to do it. Wed known each other for years.

Five years later and they are still going strong - Chanelle even got to be the one to tell Kye he was cancer-free.

She said: He was in America and Id had to stay at home because I couldnt get the time off work.

"Theyd done a scan and the doctor had emailed me and told me he was completely clear. I was in Morrisons and was crying. I was trying to call him but he didnt have any signal.

I got through to him and just said, your cancer has completely gone'. Then he went to the car and told his mum.

Despite the relief at being given the all clear, Kye has faced difficulty during his recovery and still suffers side effects from all of his treatments.

Not long after he was told he was in remission, he started to suffer with a condition called Graft Versus Host Disease (GvHD).

The disease is classed as a medical complication of receiving of transplanted tissue from a different person such as Kyes stem cell treatment.

The white blood cells left in the donated tissue only recognise the receiver as foreign and begin to attack the receivers cells.

This has left Key with patches of dry skin on his body. His skin is thinner and he has vitiligo, which changes the pigment and colour.

Kye said: It started with a bit of itchy skin and I had a dry patch that wouldnt go away and we went for blood tests and they kept coming back really abnormal, my liver levels were through the roof.

Chanelle said: That was quite worrying as its quite dangerous and they were trying all sorts of things.

He now goes to Rotherham every week for treatment for the GvHD, and is on daily chemotherapy tablets.

He says he has tried a lot of different treatments but at the moment, this combination is working - although doctors are looking at other methods.

The GvHD in itself keeps the cancer at bay so doctors want to try and find a healthy balance.

Chanelle said: Hes hooked up to a machine that removes a certain volume of blood cells, which they separate. They give him his red blood cells back and treat the white blood cells with a UV light before putting them back in his body."

As well as GvHD Kye suffers with fatigue, breathlessness, bad sinuses and says he is now going deaf.

He has tried to get back to his fitness level before the cancer, even trying out BMXing, but he tires easily and becomes weak.

Despite all of the stress and heartache throughout this year, the pair are now looking forward to the future.

Kye said: Chanelle wants to finish her degree and get a job and a nice house. Were quite different to a lot of people who get engaged and start planning a wedding straight away. Weve got all the time in the world.

Ill have to be five years in remission before no more check ups, but the scares are always there.

They always will be, Chanelle added.

Kye and Chanelle say a few years down the line, they are still hugely grateful to the people of Hull for helping them to save his life.

Chanelle said: We would like to say thank you to everyone who contributed any money, or shared the story, or got involved in any of the fundraisers.

"They are what made this possible and have given Kye this second chance at life and they are why he is still here.

He was on palliative care and was going to die he probably wouldnt have made it to Christmas.

Kye said: It feels like such a long time ago. Im definitely looking forward to 2020."

Sophie Corcoran is a reporter for Hull Live and the Hull Daily Mail. Her interests include positive news, news about homelessness, court news and breaking news.

You can follow all the latest stories on her Facebook page here , her Twitter page here or on the Hull Live website here.

You can also call her on 01482 315174 or email sophie.corcoran@reachplc.com

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Chemotherapy and constant pills but DWP tells Hull man Kye Eastwood 'you're fit for work' - Hull Daily Mail

Skin Stem Cells Comments Off on Chemotherapy and constant pills but DWP tells Hull man Kye Eastwood ‘you’re fit for work’ – Hull Daily Mail | November 20th, 2019

November is Alzheimers Awareness Month. Its a fitting time to look at the latest Israeli advances in preventing, diagnosing and treating the progressive and incurable brain disorder.

Alzheimers disease (AD) is the most common cause of the 9.9 million new cases of dementia diagnosed each year worldwide. The disease primarily strikes the elderly population, affecting 30 percent of those over age of 85.

AD impacts memory, thinking and language skills, and even the ability to carry out simple tasks.

The disease occurs when a protein called amyloid beta aggregates in brain tissues. These protein clumps kill nerve cells, leading to damage in the brain-function mechanisms.

Here are 10 examples of promising Israeli approaches reported within the past two years alone.

PREVENTION

Various genetic, lifestyle and environmental factors can put a person at risk for AD. Among them are diabetes, high blood pressure, obesity, smoking, depression, cognitive inactivity or low education, and physical inactivity.

Preventing the onset of AD is the focus of these approaches:

Eitan Okun, Alzheimers disease researcher at Bar-Ilan University. Photo: courtesy

Most vaccines work by mounting an immune response toward a weakened pathogen to boost the immune systems ability to fight the real pathogen.

Okuns approach primes the body to attack amyloid beta protein clumps in the brain, the signature sign of AD.

Following experiments on mice, Okun is preparing for human trials on people at known risk of developing the disease in their 50s or younger: those genetically inclined toward Alzheimers and people with Down syndrome.

These critical trials will determine whether the vaccine actually works in humans, said Okun. Depending on the success rate and side effects from [human] testing, we will be able to know how much more time is needed to make the vaccine available on a global scale.

Okun also is investigating new ways to diagnose AD earlier and more accurately using advanced MRI (magnetic resonance imaging) technologies to detect initial signs of amyloid protein aggregation in the brain.

BGU Prof. Alon Friedman has invented a new treatment to prevent neurological diseases. Photo courtesy of Dr. Merav Shamir

Introduced by BGN Technologies of Ben-Gurion University of the Negev, the novel therapy hinges on the fact that a malfunctioning BBB allows neurotoxic blood products to enter the brain and cause damage leading to neurological diseases.

The lab of Prof. Alon Friedman discovered that treating the BBB at early stages can protect the brain and prevent disease development.

Their proposed treatment would combine Memantine and Losartan, which have been shown in preclinical studies to protect the integrity of the BBB when administered together. Partners are being sought to continue development.

Prof. Ester Segal of the Technion. Photo: courtesy

They reported on this advance in a recent cover story of the journal Small.

Nanoscale silicon chips invented in Prof. Ester Segals lab allow for the direct insertion of neural growth factor protein into the brain and its gradual release into the target tissue, bypassing the BBB (see above). Afterward delivering all the therapeutic protein loaded onto them, the chips safely dissolve.

In a series of experiments, we showed in mice that the two ways of delivering the platform into the brain led to the desired result, said Technion doctoral student Michal Rosenberg.

Our technology has also been tested in a cellular model of Alzheimers disease and indeed, the protein release has led to rescuing the nerve cells.

DIAGNOSIS

PET scans and spinal taps are now the gold standard for diagnosing AD. Theyre both expensive and carry risks.

Cheaper, noninvasive tests being developed in Israel also could be critical in providing a much earlier diagnosis, when treatment would be most effective.

Thats because the same beta-amyloid proteins that clump in the brain of AD patients appear in the retina of the eyes up to 15 years before the onset of AD symptoms.

RetiSpec developed the retinal scanner at the Ontario Brain Institute in Canada. Clinical studies are ongoing in Israel and Canada.

In October, RetiSpec received the Alzheimers Drug Discovery Foundations Diagnostics Accelerator Award to fund continued development of its hyperspectral imaging technology.

This could allow doctors to compare brain scans taken over time from the same patient, and to differentiate between healthy and diseased brain tissue, without resorting to invasive or dangerous procedures such as brain tissue biopsies, explained lead researcher Dr. Aviv Mezer.

Clara is based on a relatively recent understanding that AD affects the brains orientation system before it affects memory.

The overlap between how the self is oriented to the world and the brain mechanisms that are disturbed by Alzheimers disease is astonishing, Arzy told ISRAEL21c.

Clara asks patients questions about themselves and their relationships to people, places and events. It then compares that information to a baseline and generates a computer-based test tailored for the individual that can diagnose very early Alzheimers.

The team from Dr. Shahar Arzys computational neuropsychiatry lab at Hadassah Hebrew University Medical Center in Jerusalem. Photo: courtesy

According to a study Arzys team published in the Proceedings of the National Academy of Sciences and in the American Psychological Associations journal Neuropsychology, Clara is 95 percent accurate.

Clara is now in the midst of a five-year test at Harvard to compare data generated by the system with data from AD markers taken via amyloid PET scan, quantitative and functional MRI and other neuropsychological tests.

Jaul and Oded Meiron (a cognitive neuroscientist who heads the Electrophysiology and Neuro-cognition Lab in Herzogs Clinical Research Center for Brain Sciences) published an articlein the Journal of Alzheimers Disease outlining their discovery of the link between the two conditions.

The reason is that the abnormal changes in the brain that lead to dementia are happening in other parts of the body, including the skin. Skin tissue and brain tissue derive from the same embryonic stem cells.

Jaul and Meiron are working with an American company to develop a test to identify a biomarker for abnormal cell density in the skin of dementia patients. They hope that this skin test could pinpoint an individuals type and stage of dementia. The biomarkers show the most promise in identifying AD, they say.

TREATMENT

A variety of approved medications for AD including Exelon, developed in Israel cannot cure or stop the progression of the disease. They only relieve or delay AD symptoms, such as memory loss and confusion.

A few Israeli pharmaceuticals under development aim to improve Alzheimer treatment options.

Breathing in pure oxygen in a pressurized room or chamber stimulates the release of growth factors and stem cells, which promote healing.

This revolutionary treatment for Alzheimers disease uses a hyperbaric oxygen chamber, which has been shown in the past to be extremely effective in treating wounds that were slow to heal, said lead researcher Prof. Uri Ashery.

Asherys group tested the therapy on a mouse model of Alzheimers disease. The treatment was found to reduce behavioral deficiencies compared to control mice.

Remarkably, the treatment also reduced plaque pathology and neuroinflammation in the test mice by about 40 percent.

Further research will investigate the underlying mechanisms of the therapy and evaluate its beneficial effects in Alzheimer patients.

Yotam Nisemblat, CEO of ProteKt Therapeutics. Photo: courtesy

Incubated at FutuRx in Ness Ziona, ProteKt was spun out of PKR kinase inhibitor research by University of Haifa Prof. Kobi Rosenblum. Inhibition of the enzyme PKR is a unique idea for improving memory consolidation.

Protein aggregation tends to increase with age and can lead to neurodegeneration because proteins can adopt an erroneous configuration, where theyre misfolded, explains Prof. Martin Kupiec.

The paper he and his colleagues published in Molecular Cell describes how removing glucose from a particular aggregated protein made the blob dissolve.

If the results can be replicated in more complex proteins, scientists will have a new research avenue toward treatments that could reverse the neurodegenerative effect of protein aggregates, Kupiec says.

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10 promising ways to prevent, diagnose and treat Alzheimer's - ISRAEL21c

Skin Stem Cells Comments Off on 10 promising ways to prevent, diagnose and treat Alzheimer’s – ISRAEL21c | November 20th, 2019

The latest lifestyle, fashion and travel trends

He is one of the most googled names in beauty, and she, one of the most prominent figures in fashion.

It was therefore a fitting match for Victoria Beckham to join forces with Augustinus Bader the notoriously publicity-shy director of stem cell biology and cell technology at the University of Leipzig for her first foray in to skincare.

Bader became a household beauty name in February 2018, after the launch of his cult-product The Cream caused convulsions of desire to ripple throughout the beauty industry thanks to its ultra-hydrating and restorative qualities.

And so when looking for a scientific collaborator to join her on her endeavour in to skincare, it seemed a natural fit for the two to merge theircomplementingareas of expertise.

The Cell Rejuvenating Priming Moisturizer (Victoria Beckham Beauty)

Cue the result of the pairing: Victoria Beckham Beautys Cell Rejuvenating Priming Moisturizer.

The moisturiser is the new-and-improved iteration of the Morning Aura Primer Beckham launched as part of her collaboration with Este Lauder in 2016.

The product, which Beckham has re-developed with the help of 59-year-old Bader, is a multifunctional cream thatclaims to prime, impart a glow and also to repair.

Commenting on the collaborative beauty effort, Beckham took to her Instagram page to note: It has been a dream to develop, with Augustinus, a priming moisturizer that works to improve the health of my skin and gives that fresh, natural glow that I love.

Meanwhile Bader said: "It was an honour to collaborate with Victoria for her first Skin launch. I'm excited to share some of our skincare benefits in this product. It's the first product of its kind to care for your skin cells while also preparing your skin for makeup application."

A celebrity facialist has revealed VB's 9-step daily skincare routine

This marks the first skincare product 45-year-old Beckham has launched under her beauty line, which she debuted to critical-acclaim in September, alongside the brands co-founder, Sarah Creal.

Victoria Beckham Beauty has the tagline Luxury Performance, Clean Beauty, and is refusing to pigeonhole itself as just a beauty brand, instead referring to itself as clean beauty movement.

Cell Rejuvenating Priming Moisturizer costs 92 for 30ml and launches tomorrow exclusively at victoriabeckhambeauty.com and augustinusbader.com.

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Everything you need to know about Victoria Beckhams first skincare product launching tomorrow - Evening Standard

Skin Stem Cells Comments Off on Everything you need to know about Victoria Beckhams first skincare product launching tomorrow – Evening Standard | November 18th, 2019

Gallant Stem Cell Therapy For Dogs is one of the product companies to be featured on Shark Tank Season 11 Episode 8. The story behind the birth of Gallant Stem Cell Therapy For Dogs is pretty interesting. Here are some of the unknown facts about Gallant and its founders, Aaron Hirschhorn.

Aaron Hirschhorn is the founder and former-CEO of the popular dog-sitting marketplace DogVacay. Aaron is a noted entrepreneur with more than 20 years of experience in building companies and investing in them. DogVacay app was launched in 2013 and Aaron managed to raise $47 million from his erstwhile investors.

Aaron was the finalist in the Ernst & Young Entrepreneur of the Year Award 2016. In April 2017, Aarons DogVacay app merged with Rover.com and eventually went on to become a $1 billion pet services marketplace.

Trouble struck Aarons life when he suffered a massive back injury and was forced to undergo stem cell treatment which yielded amazing results to his surprise. Aaron, being an ardent dog lover wondered why this cutting-edge medical technology of stem cell transplants cannot be applied to dogs.

As a result, Gallant was born in the middle of 2018. According to Gallant, Your pups stem cells haveincredible healing power. Extract and store these powerful cells during your pets spay/neuter, so that you can unleash their potential when your best friend needs it most.

Ever since its inception, the mission of Gallant stem cell therapy is to help pets live a healthier life and make use of the epic technology of stem cell therapy in saving the lives of tons of dogs.

Dogs enter their senior years around 7 and begin feeling the effects of aging as early as 4! Traditional methods of treatment for injury and age-related conditions are expensive and can have harmful side effects. Stem cells are incredible natural healers. However, up to 99% of stem cells are lost over time due to aging. This forms the bottomline of Gallants business problem.

Gallant raised $7 million investment in August 2019.

https://gallant.com/

From the moment you entrust Gallant with your dogs stem cells, were actively invested in their long-term health and well-being. Working in tandem with you and your veterinarian, we will collect and store these powerful cells now, so down the road we can help to treat the most common health problems your dog may face. We will also update you on new and potentially life-changing treatments as they become available.

Pick your pups stem cell storage plan you dont have to have a spay/neuter procedure scheduled yet! You can always add that in later. Our proprietary process requires no additional training, so any veterinarian you trust to alter your dog is qualified. Ahead of your dogs spay/neuter, we will connect with your vet and send our collection kit directly to their office.

2. Collect

On the big day, we align with your vet before the procedure and arrange for a courier. During your dogs spay/neuter procedure, your veterinarian will take out the stem cell-rich reproductive tissue they would normally discard into the collection kit.

3. Preserve

Once the tissue is received by our scientists, we send confirmation to both you and your veterinarian. Your dogs tissue is first inspected for quality before isolating the stem cells. The stem cells are then counted and frozen in liquid nitrogen to preserve their potency in our secure, state-of-the-art laboratory. Once this process is complete, you and your veterinarian will be notified that your pets stem cells are safely stored. The cells are then monitored by our team to ensure they stay perfectly preserved.

4. Treat

Your pets stem cells are at the ready to be sent to your veterinarian if/when treatment is needed. Treatments are out-patient procedures and cost about $300. A stem cell procedure is not painful to your pet and does not require anesthesia to administer.

Gallants stem cell therapy is receiving a lot of exciting reviews online. The therapy has been successful in saving scores of dogs with conditions like osteoarthritis, skin conditions, chronic dry eye.

Gallant is offering a $395 off discount for using the code SHARKTANK

How did Gallant fare in Shark Tank Season 11? What did the Sharks have to tell about it? Did Gallant Get a Deal on Shark Tank? More information to be updated soon in this post.

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Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts - TheNewsCrunch

Skin Stem Cells Comments Off on Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts – TheNewsCrunch | November 18th, 2019

Global oncology drugs market was estimated to be US$ 119 billion in 2018 is expected to reach US$ 350.01 billion by 2027, growing at an estimated CAGR of 12.7% over the forecast period.

Cancer is a disease, which involves the abnormal growth of cells that results in the formation of a tumor. However benign tumors are not cancers. The abnormal tumor cells have the tendency to spread to other local tissues and may also spread to different parts of body through blood and lymphatic system. Different types of cancers such as lung cancer, colorectal, breast cancer, and others are predominant among the populace. Treatment of cancer depends upon the stages of the disease progression. Chemotherapy is majorly used in the earlier stages whereas other therapy options such as targeted therapy drugs, immunological therapy drugs are used in late stage.

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The detailed research study provides qualitative and quantitative analysis of the global oncology drugs market. The market has been analyzed from demand as well as supply side. The geographical analysis done emphasizes on each of the major countries across North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

Key Findings of the Report:

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Key Market Segments of Oncology drugs market are:

By Indication

Oncology drugs Market By Treatment

Oncology drugs Market By Geography

For more information ask our experts@https://www.absolutemarketsinsights.com/reports/Oncology-Drugs-Market-2019-2027-273

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Oncology drugs market is expected to grow at a CAGR of 12.7% over the forecast period owing to rising number of pipeline cell-therapy products, says...

Skin Stem Cells Comments Off on Oncology drugs market is expected to grow at a CAGR of 12.7% over the forecast period owing to rising number of pipeline cell-therapy products, says… | November 18th, 2019