Real beauty is reflected in your skin. If you want a clearer, younger looking skin, non-surgical cosmetic treatments and some maintenance after that can let you achieve immediately visible and long-lasting results. You dont have to always undergo cosmetic surgery to improve appearance and reduce the signs of ageing. In fact, you can choose non-surgical cosmetic treatments to reduce wrinkles, plump up your lips, smoothen the surface of your skin. We spoke with Dr. Anup Dhir Senior Consultant, Cosmetic Surgeon, Apollo Hospital, Delhi to know more about non-cosmetic procedures that can bring a drastic change in your appearance and here's what the doctor had to say.Non-surgical cosmetic treatments: Broadly, these treatments are of three types. We can use laser and other energy based devices like radiofrequency and ultrasound, we can do injectables like botox, fillers microfat and PRP, or we can do time tested older procedures like chemical peels, dermabrasion and microneedling to rejuvenate the skin.Laser skin resurfacing for wrinkles is very commonly done with carbon dioxide or erbium fractional laser and helps by removing the top layer of the skin and making it look younger. Laser hair reduction is done with lasers for facial and body hair and normally six sittings are needed at monthly intervals.Radiofrequency energy devices like thermage, exilis, e matrix etc. and ultrasound devices like HIFU help in formation of new collagen under the skin by directing energy at a particular level under the skin.

Botox injection for wrinkles -This injection is very commonly used for treatment of facial wrinkles and weakens the muscles which cause wrinkles. It has to be repeated after 4-6 months.

Anti-wrinkle treatment by fillers is again a very popular procedure in which hyaluronic acid fillers are injected into scars and wrinkles. The resulting improvement lasts for 9-15 months.

Fat injection for scars and wrinkles are the gold standard for rejuvenation and in this, your own body fat is sucked, processed and injected in the facial wrinkles. Microfat and nanofat are the types of fat which can be used. The fat has its own stem cells and they help to rejuvenate the skin and improve texture and; help in face lift and rejuvenation of hands also.

PRP skin rejuvenation is done by taking your blood and making platelet rich plasma from it and this is injected in the facial skin and it can also be used in the scalp to reduce the hair fall and help in regrowth.

Dermabrasion involves taking the outer layer of skin with a diamond roller under a local anesthetic and the new skin on healing has less scars. The purpose of surgical dermabrasion is to help diminish the appearance of deeper scars and skin imperfections and smoothen the skin.

Chemical peels use a chemical solution to smoothen the texture of your skin by removing the damaged outer layers. It is one of the least invasive ways to improve the appearance of your skin. Superficial peels with fruit acids like glycolic acid etc. are also called lunchtime peels as they have hardly any down time and can give quick results. As sun exposure, acne, or just getting older can leave your skin tone uneven, wrinkled, spotted or scarred, these peels can help these conditions. They also helps to whiten the skin.

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How to get a beautiful skin without surgery - Times of India

Skin Stem Cells Comments Off on How to get a beautiful skin without surgery – Times of India | October 24th, 2020

Augustinus Bader on his revolutionary approach to skincare

The mind behind the most coveted products in beauty discusses thescience behind the brand

When Augustinus Bader first launched The Cream in 2018, it was hailed as a miracle. In a matter of weeks, it could transform any skin type within any age range, dispelling wrinkles, redness, dryness, scaring, visible pores, sagginess, and practically every other skin concern it would usually take a shelf load of serums to combat. While miraculous, magical, and other mystical attributions caneasily, and quite fairly, be applied to Augustinus Bader products, the real genius of the brand comes down to pure science.

The Augustinus Bader skincarebrand was the by-product of its namesakes development of medical-grade cream, which could heal severe burn injuries to an extent that was previously only possible through skin grafts. Professor Bader, a stem cell and biomedical scientist at Leipzig University, was hoping to get the cream backed by a pharmaceutical company but, in the words of his business partner Charles Rosier, clinical trials cost tens of tens of millions of dollarsand the majority of accidents around burns happen to children, often in third-world countries. For a pharmaceutical company, when the outcome is not necessarily the most profitable outcome, theres less interest.

Inspired to make Baders cream widely available, Rosier encouraged the Professor to translate the principles of his burn cream into skincare. In my mind, I thought, if we create a cream thats superior to whats on the market and its a big success, then he can focus on is research and we can finance the clinical trial.

Baders cream centred around one, revolutionary hypothesisthat the body already possesses all of the stem cells it needs to regenerate itself. The problem, when it comes to the skins inability to heal from severe injuries or just the everyday effects of ageing, is that the bodys ability to trigger those regenerative cells has been impeded.

Bader developed this hypothesis based on two observations. First, that the size of the wound affects the bodys ability to heal. Asmall paper cut heals quickly, while a large scale burn takes time to heal and often leaves scar tissue. Secondly, the body automatically knows where the site of an injury is. When you cut your left hand, your body immediately starts sending cells to the area of the cut so that the skin can rebuild. Yet,the same tissue would never rebuild on your right hand because it rebuilt on your left. Only where there is a wound is the body rebuilding.

In Baders words, If the cut is super small, you would have a small distance between the edges of the cut skin and the cells can still communicate over this small distances through the hand, and would close the wound. But if you burn your hand, the cells would be dying and the signal response cannot arrive at this injury. The response is totally different, the small cut heals perfectly, while on the other side the big injury kills this confirmation.

So the basis of [my] hypothesis is that this is probably just the absence of specific molecules that cannot arrive to the site of the injury because cells are dying or are blocked. So many, many years ago I started trying to find solutions to this problem because genetically speaking were the same human being, why would we have these limitations, why would we have these problems? It doesnt make any sense.

I thought, why not try to replace what the cells would be doing if they were present? That triggering complex, which singles the cells to respond to the injury, or, when it comes to skincarewrinkles, is the secret, miracle likeelement of Baders cream.

Unlike most skincare, which just changes the outside surface of the skin, Baders skincare works from the inside out, transforming the bodys internal, cellular communication for exterior changes. I think ageing is just a lack of repair, a lack of regeneration. Skin is a living organism, which has to be remodelled, meaning repaired a little bit everyday. But you can accelerate this repair lead.

Theres something super, super sensitive inside of you, which are these cells that sense the microenvironment and respond to the need. So the cream, in a way, is only a toolbox, which helps your stem cells when they sense this need to interact more appropriately.

This new approach to the effects of ageing is a revolution in skincare that, no doubt, heralds the beginning of a new science-driven, cellular-focused trend in the industry.

This year, Bader has launched a number of additional products to his line beyond The Cream and its companion The Rich Cream. The new additions include a Cleansing Gel, Face Oil, Body Cream and, as of today, Cleansing Balm with more releases set for the next year.

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Augustinus Bader on his revolutionary approach to skincare - Wallpaper*

Skin Stem Cells Comments Off on Augustinus Bader on his revolutionary approach to skincare – Wallpaper* | October 23rd, 2020

Getting up there in years comes with its drawbacks and benefits, and the onset of facial lines and volume loss that comes tends to be at the top of the list as one of its main disadvantages. You can count facial aging right up there with the onslaught of back pain and the occasional grey hair turning into a full head of silver. To soften those where did they come from facial lines and give skin a more youthful glow, these anti-agers target the main offenders: wrinkles and uneven skin tone and texture.

2/8

Glycolipids in Dr. Loretta Intense Replenishing Serum ($70) trash moisture on the skin surface to help hydrate skin while the antioxidant lipochroman combats free radicals and protects from harmful UV light, leaving skin looking plump, smooth and rejuvenated.

3/8

Apply a layer of Augustinus Bader The Face Oil ($230) morning and night. Utilizing Professor Baders TFC8 technology, the oil promotes cellular renewal, which helps smooth skin texture and reduce the look of fine lines and wrinkles.

4/8

The name says it all with Zo Skin Healths Firming Serum ($235). Lightweight and tolerable for even sensitive skin types, this anti-ager includes the brands ZCORE complex which consists of a synthetic tetrapeptideand sweet yellow clover to help strengthen skin laxity. Plant stem cells provide plant stem cell complex provides powerful antioxidant protection while sodium DNA helps stimulate cell repair and reduce inflammation.

5/8

Harnessing the brands signature ingredient, La Prairies Skin Caviar Liquid Lift ($690) blends two types of caviar, Premiere and Absolute, into a milky emulsion to deliver the perfect dose of serum that promises firmer skin and enhanced elasticity.

6/8

Bioeffect Limited Edition EGF Serum ($495) is said to have twice the original EGF formulas anti-aging benefits due to its inclusion of a rare black barley that is grown at the brands state-of-the-art greenhouse in Iceland. The EGF stands for Epidermal Growth Factor, which in this serum is totally plant derived and signals skin cells to prompt collagen and elastin production. The unique bottle was designed by Icelandic artist Shoplifter and is made from black obsidian.

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8 Skin-Boosting, Anti-Aging Treatments for Generation Xers and Beyond - NewBeauty Magazine

Skin Stem Cells Comments Off on 8 Skin-Boosting, Anti-Aging Treatments for Generation Xers and Beyond – NewBeauty Magazine | October 23rd, 2020

Top notch ingredients are vital when it comes to creams. We chatted with skin care pros to see which ingredients are the best . This helped us pick out the products with the most oomph.

We also factored in:

Pricing guide

Night creams def have a rep for being expensive and some totally are. You should expect to pay more for extra bells and whistles (e.g. designer brands, fancy packaging, etc.). But thats definitely not the case percent of the time. You can find awesome, dermatologist-recommended products for around $10.

This guide will help you pick the best cream for your skin and budget:

$ = $10$20$$ = $25$50$$$ = $51$75$$$$ = over $76

Whether youre looking for a simple cream that gives your skin a glowy boost or a powerful cream for more mature skin to help reduce fine lines, theres a cream for you. Here are the top 22 night creams for every need.

Price: $$$$

Designed for all skin types, this lightweight cream uses retinol to reduce the appearance of lines. Hyaluronic acid delivers hydration and improves skins tone and texture. It also has niacinamides and picolinamides that support your skins natural barrier and lock in moisture.

Cons: Some peeps with sensitive skin said it caused irritation.

Buy Murad Retinol Youth Renewal Night Cream online.

Price: $

Unlike some heavy duty hydrators, this cream is oil-free and wont clog pores. You can use it day and night without worrying about pesky pimples.

It has the benefits of anti-aging while being lightweight enough to not trigger acne, says dermatologist Erum Ilyas, MD, MBE, FAAD. If youre looking for a cream but dont want to risk breakouts, this is a nice one to try.

Cons: It might not be hydrating enough for dry skin.

Buy OLAY Total Effects 7-in-1 Anti-Aging Moisturizer online.

Price: $$

Found: An overnighter that fights the signs of aging and keeps breakouts at bay. Retinol helps plump skin to reduce the appearance of lines and wrinkles. Salicylic and lactic acids keep bacteria from clogging pores and causing breakouts.

Cons: Salicylic acid can be drying.

Buy Arcona PM Blemish Lotion online.

Price: $$

This concentrated balm harnesses the power of colloidal oatmeal and sweet almond oil to soothe itchy, inflamed skin. It promotes a smoother and more even skin texture and can help reduce redness. Its even safe to use around your eyes and on your lids.

Cons: Some users found the rich texture to be a bit greasy.

Buy Skinfix Eczema Dermatitis Face Balm online.

Price: $$

This cream delivers heavy duty hydration to fight ashiness (thanks, avocado and shea butter). The vitamin C can help combat hyperpigmentation from exposure to UV rays (which is more likely in darker skin).

Cons: It might trigger breakouts in oily or acne-prone skin.

Buy Eve Hansen Vitamin C Night Cream online.

Price: $$

This super hydrating treatment straddles the line between cream and mask. Ingredients like squalene, glycerin, and fountain plant quench parched skin. It also helps protect the skins natural barrier to keep moisture in.

Cons: Some users complain that the texture is too thick to the point of being straight up sticky.

Buy Kiehls Ultra Facial Overnight Hydrating Masque online.

Price: $$$$

Dermatologist Deborah Longwill, DO, FAOCD, counts this potent potion as a current fave.

It combines the anti-aging ingredient resveratrol with antioxidant-rich ingredients like glycoin and ectoin, she explains.

These ingredients help shield your skin from environmental stresses. They also work to enhance elasticity, improve texture, and hydrate cells.

Cons: Its on the spendy side.

Buy Doctors Daughter Extremolyte Stem Cell Serum online.

Price: $$$

This hydrating-but-not-overly-heavy cream nourishes and plumps skin with ingredients like ceramides and hyaluronic acid. Oh, and its been clinically tested to reduce fine lines, dryness, and loss of firmness in just 7 nights.

Cons: Steer clear if youre not a lavender fan.

Buy IT Cosmetics Confidence in Your Beauty Sleep Night Cream online.

Price: $$

Does added fragrance irritate your skin? Same. Thankfully, this non-irritating cream that gets the job done. Its also loaded with vitamin E which fights redness and inflammation.

Cons: This cream is definitely on the thick side. It might feel heavy on oily skin.

Buy Olay Regenerist Night Recovery Anti-Aging Face Moisturizer online.

Price: $

Retinols a go-to ingredient for minimizing the appearance of fine lines thanks to its ability to protect the skin-plumping protein collagen.

It also has hyaluronic acid, a moisturizer to help prevent irritation and dryness that may be a better option for those with dry or sensitive skin, says dermatologist Susan A. Bard, MD.

Cons: Some users report experiencing redness or rashes.

Buy Neutrogena Rapid Wrinkle Repair Night Moisturizer online.

Price: $$$

This cream uses bakuchiol, a natural retinol alternative. Thats good news if you have sensitive skin.

Its a functional analog of retinol meaning it has the same effect, with one huge advantage: Its less irritating because its also an anti-inflammatory agent, Ilyas says.

Cons: Its got a strong peachy scent that you might love or hate.

Buy OLEHENRIKSEN Goodnight Glow Retin-Alt Sleeping Crme online.

Price: $

Ahhh. Heres a cooling gel cream made with licochalcone, a licorice-based skin soother. It fights redness and irritation in folks with sensitive, rosacea-prone skin. The creams noncomedogenic so it wont clog your pores either.

Cons: This stuffs very gentle. But it still might be too strong on super sensitive skin. Def do a patch test before slathering it all over your face.

Buy Eucerin Redness Relief Night Cream online.

Price: $

Bard loves recommending this simple, no-frills wrinkle fighter to patients. Its inexpensive, easy to find at most drugstores, and it works.

It contains retinol which helps improve fine lines and wrinkles, stimulate collagen production and decrease pigmented spots, she says.

Cons: The retinol in this formula is designed for daily use. But its still worth starting off gradually and work your way up. This gives your skin time to adjust.

Buy RoC Retinol Correxion Deep Wrinkle Night Cream online.

Price: $$

Lotus and peach extract fight oxidative stress and keep your skin looking glowy. But what really sets this lightweight cream apart is the floral peach aroma that comes wafting out the second you open the jar. Another perk: Its good for all skin types.

Cons: Its not formulated to fight fine lines or wrinkles.

Buy Lotus Youth Preserve Dream Face Cream online.

Price: $$$

Grease is not the word here. The gel formula delivers hydration but its still light and cooling. Its got niacinamide, viniferine, and natural pearlizers to fight the appearance of dark spots even out skin tone.

Cons: Some peeps said it didnt brighten their skin.

Buy Caudalie Vinoperfect Instant Brightening Moisturizer online.

Price: $$$

TBH the whole women vs. men products thing is silly. Right? But this cream feels a bit more manly thanks to the neutral packaging and woodsy scent. It fights fine lines and wrinkles with retinol and uses the antioxidant ferulic acid to combat dark spots and sun damage.

Cons: The heavy-duty retinol can be a little harsh especially if your skins not used to it.

Buy Dr. Dennis Gross Ferulic + Retinol Moisturizer online.

Price: $$

Glycolic acid is great at reducing the appearance of dark spots because it can suppress the production of melanin. The acid improves skins elasticity and boosts firmness too. So its an all-around awesome fountain of youth-kinda option.

Cons: Its a serum. If youre looking for hydration, youll still want to layer a moisturizer over top.

Buy Bolden Nighttime Repair Serum with 10% Glycolic Acid online.

Price: $$

Vitamin C and collagen are your eyes BFF. They brighten and plump the delicate skin around your peepers. This ones got both and a little goes a long way.

Cons: Its thick and rich. So it might clog your pores if it ends up on your T-zone.

Buy OLEHENRIKSEN Banana Bright Eye Cream online.

Price: $$$

This certified-organic cream boasts vitamin C, fruit stem cells, grape-seed oil, and squalene. It will brighten and hydrate without the use of parabens, petroleum, sulfates, pesticides, or phthalates.

Cons: The grape-seed oil might be too much for oily or acne-prone skin.

Buy Juice Beauty Stem Cellular Anti-Wrinkle Overnight Cream online.

Price: $

You can legit get amazing results from a night cream without spending megabucks. This dermatologist-developed moisturizer plumps and renews skis with a peptide complex. It also restores the skins natural barrier with essential ceramides. Plus its not greasy!

Cons: This is definitely a utilitarian option. If you love extras like scents or pretty packaging, skip it.

Buy CeraVe Skin Renewing Night Cream online.

Price: $

The suns UV rays can seriously stress your skin. This can cause dark spots, discoloration, and fine lines. But ingredients like green tea and vitamin C help fight sun-induced stress. This hydrating cream delivers both.

Cons: The packaging looks like it came from 1995, which, depending on what youre going for might ruin your #shelfie. (Or maybe not.)

Buy LILY SADO TEA+C Green Tea + Vitamin C Moisturizer online.

Price: $

Snow mushroom and sodium hyaluronate deliver mega moisture, while soothing lavender oil and chamomile extract help you chill and unwind. After anointing yourself with this vegan lotion, you might just wanna close your eyes and doze off.

Cons: You wont get as much anti-aging action here.

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22 Best Night Creams 2020 for All Skin Types and Concerns - Greatist

Skin Stem Cells Comments Off on 22 Best Night Creams 2020 for All Skin Types and Concerns – Greatist | October 23rd, 2020

Global cosmetic skin care market is set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Increasing self-consciousness among population and rising demand for anti- aging skin care products are the factor for the market growth.

Global Cosmetic Skin Care Market By Product (Anti-Aging Cosmetic Products, Skin Whitening Cosmetic Products, Sensitive Skin Care Products, Anti-Acne Products, Dry Skin Care Products, Warts Removal Products, Infant Skin Care Products, Anti-Scars Solution Products, Mole Removal Products, Multi Utility Products), Application (Flakiness Reduction, Stem Cells Protection against UV, Rehydrate the skins surface, Minimize wrinkles, Increase the viscosity of Aqueous, Others), Gender (Men, Women), Distribution Channel (Online, Departmental Stores and Convenience Stores, Pharmacies, Supermarket, Others), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026

Interpret a Competitive Outlook Analysis with Sample Report: https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cosmetic-skin-care-market&dw

Market Definition: Global Cosmetic Skin Care Market

Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.

Market Drivers:

Market Restraints:

Key Benefits:

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Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of industry in these regions, from 2020 to 2027, covering

Global cosmetic skin care market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of cosmetic skin care market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Few of the major competitors currently working in the global cosmetic skin care market are LOral, Unilever, New Avon Company, Este Lauder Companies, Espa, Kao Corporation, Johnson & Johnson Services, Inc., Procter & Gamble, Beiersdorf, THE BODY SHOP INTERNATIONAL LIMITED, Shiseido Co.,Ltd., Coty Inc., Bo International, A One Cosmetics Products, Lancme, Clinique Laboratories, llc., Galderma Laboratories, L.P., AVON Beauty Products India Pvt Ltd, Nutriglow Cosmetics Pvt. Ltd, Shree Cosmetics Ltd among others.

Cosmetic Skin Care Market: Key Questions Answered in Report

The research study on the Cosmetic Skin Care market offers inclusive insights about the growth of the market in the most comprehensible manner for a better understanding of users. Insights offered in the Cosmetic Skin Care market report answer some of the most prominent questions that assist the stakeholders in measuring all the emerging possibilities.

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Cosmetic Skin Care Market (Covid 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 -...

Skin Stem Cells Comments Off on Cosmetic Skin Care Market (Covid 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 -… | October 21st, 2020

Stem Cells Market report would come handy to understand the competitors in the market and give an insight into sales, volumes, revenues in the Stem Cells Industry & will also assists in making strategic decisions. The report also helps to decide corporate product & marketing strategies. It reduces the risks involved in making decisions as well as strategies for companies and individuals interested in the Stem Cells industry. Both established and new players in Stem Cells industries can use the report to understand the Stem Cells market.

In Global Market, the Following Companies Are Covered:

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Analysis of the Market:

Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources: Embryos formed during the blastocyst phase of embryological development (embryonic stem cells) and Adult tissue (adult stem cells).

Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).

Market Analysis and Insights: Global Stem Cells Market

In 2019, the global Stem Cells market size was expected to grow by the end of 2026, with a steady rate of CAGR during 2021-2026.

Global Stem Cells Scope and Market Size

Stem Cells market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Stem Cells market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.

Segment by Type, the Stem Cells market is segmented into Umbilical Cord Blood Stem Cell, Embryonic Stem Cell, Adult Stem Cell, Other, etc.

Segment by Application, the Stem Cells market is segmented into Diseases Therapy, Healthcare, etc.

Regional and Country-level Analysis

The Stem Cells market is analysed and market size information is provided by regions (countries).

The key regions covered in the Stem Cells market report are North America, Europe, China, Japan, Southeast Asia, India and Central & South America, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of revenue for the period 2015-2026.

Competitive Landscape and Stem Cells Market Share Analysis

Stem Cells market competitive landscape provides details and data information by vendors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by player for the period 2015-2020. Details included are company description, major business, company total revenue and the revenue generated in Stem Cells business, the date to enter into the Stem Cells market, Stem Cells product introduction, recent developments, etc.

The major vendors include CCBC, Vcanbio, Boyalife, Beikebiotech, etc.

This report focuses on the global Stem Cells status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Stem Cells development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

Stem Cells Market Breakdown by Types:

Stem Cells Market Breakdown by Application:

Critical highlights covered in the Global Stem Cells market include:

The information available in the Stem Cells Market report is segmented for proper understanding. The Table of contents contains Market outline, Market characteristics, Market segmentation analysis, Market sizing, customer landscape & Regional landscape. For further improving the understand ability various exhibits (Tabular Data & Pie Charts) has also been used in the Stem Cells Market report.

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In the end, Stem Cells Industry report provides the main region, market conditions with the product price,profit, capacity, production, supply, demand and market growth rateand forecast etc. This report also Present newproject SWOT analysis,investment feasibility analysis, andinvestment return analysis.

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Stem Cells Market 2020 is predicted to rise with a CAGR of XX% by 2026 | Including Growth Prospect, Market Size & Growth, Key Vendors, Top most...

Skin Stem Cells Comments Off on Stem Cells Market 2020 is predicted to rise with a CAGR of XX% by 2026 | Including Growth Prospect, Market Size & Growth, Key Vendors, Top most… | October 19th, 2020

Transparency Market Research (TMR) has published a new report titled, Autologous cell therapy Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the global autologous cell therapy market was valued at US$ 7.5 Bn in 2018 and is projected to expand at a CAGR of 18.1% from 2019 to 2027.

Overview

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Rise in Prevalence of Neurological Disorders & Cancer and Others to Drive Market

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Bone Marrow Segment to Dominate Market

Neurology Segment to be Highly Lucrative Segment

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Hospitals Segment to be Highly Lucrative Segment

North America to Dominate Global Market

Competitive Landscape

The global autologous cell therapy market is fragmented in terms of number of players. Key players in the global market include Pharmicell Co., Inc., Castle Creek Biosciences, Inc., Vericel Corporation, Lineage Cell Therapeutics, Inc., BrainStorm Cell Therapeutics, Caladrius Biosciences, Inc., Opexa Therapeutics, Inc., Regeneus Ltd., Takeda Pharmaceutical Company Limited., Sangamo Therapeutics, U.S. Stem Cell, Inc. and other prominent players.

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Autologous Cell Therapy Market is Anticipated to Expand at a CAGR of 18.1% from 2019 to 2027 - Eurowire

Skin Stem Cells Comments Off on Autologous Cell Therapy Market is Anticipated to Expand at a CAGR of 18.1% from 2019 to 2027 – Eurowire | October 19th, 2020

Skin is a complex, living organ made up of several structural components that (quite literally) touches a lot of different parts of us. When you look at the makeup, there's collagen, elastin, hyaluronic acid, ceramides, lipids, and so forth; from there, it's also affected by the muscle composition and bone underneath. This is all to say, when wrinkles formit's hardly ever due to a singular reason.

So to start, there is the fact that many components of our skin structure decline with age. "As we age, we lose collagen, fat, and start to resorb bone. These changeslead to volume loss, thin, saggy skin. As a result, our nasolabial folds become more pronounced," says Lolis.

It's also important to note that these lines are exacerbated with movement, the same way crow's feet can come from squinting and the "11's" can come from scrunching yourbrow. "Laugh lines are formed by constant use of the orbicularis orbis muscle which allows us the ability to speak," says Masur. "Over time as we age the skin protecting this muscle becomes stretched creating laxity increasing the appearance of these folds. The region around the mouth known as the peri-oral area is one of the thinnest-skinned on the face, making us more susceptible to fine lines or wrinkles forming the 'laugh lines.'"

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Laugh Lines Are Totally Normal How To Ease Them Sans Injections - mindbodygreen.com

Skin Stem Cells Comments Off on Laugh Lines Are Totally Normal How To Ease Them Sans Injections – mindbodygreen.com | October 17th, 2020

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The healthcare industry has been focusing on excessive research and development in the last couple of decades to ensure that the need to address issues related to the availability of drugs and treatments for certain chronic diseases is effectively met. Healthcare researchers and scientists at the Li Ka Shing Faculty of Medicine of the Hong Kong University have successfully demonstrated the utilization of human induced pluripotent stem cells or hiPSCs from the skin cells of the patient for testing therapeutic drugs.

The success of this research suggests that scientists have crossed one more hurdle towards using stem cells in precision medicine for the treatment of patients suffering from sporadic hereditary diseases. iPSCs are the new generation approach towards the prevention and treatment of diseases that takes into account patients on an individual basis considering their genetic makeup, lifestyle, and environment. Along with the capacity to transform into different body cell types and same genetic composition of the donors, hiPSCs have surfaced as a promising cell source to screen and test drugs.

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In the present research, hiPSC was synthesized from patients suffering from a rare form of hereditary cardiomyopathy owing to the mutations in Lamin A/C related cardiomyopathy in their distinct families. The affected individuals suffer from sudden death, stroke, and heart failure at a very young age. As on date, there is no exact treatment available for this condition.

This team in Hong Kong tested a drug named PTC124 to suppress specific genetic mutations in other genetic diseases into the iPSC transformed heart muscle cells. While this technology is being considered as a breakthrough in clinical stem cell research, the team at Hong Kong University is collaborating with drug companies regarding its clinical application.

The unique properties of iPS cells provides extensive potential to several biopharmaceutical applications. iPSCs are also used in toxicology testing, high throughput, disease modeling, and target identification. This type of stem cell has the potential to transform drug discovery by offering physiologically relevant cells for tool discovery, compound identification, and target validation.

A new report by Persistence Market Research (PMR) states that the globalinduced pluripotent stem or iPS cell marketis expected to witness a strong CAGR of 7.0% from 2018 to 2026. In 2017, the market was worth US$ 1,254.0 Mn and is expected to reach US$ 2,299.5 Mn by the end of the forecast period in 2026.

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Customization to be the Key Focus of Market Players

Due to the evolving needs of the research community, the demand for specialized cell lines have increased to a certain point where most vendors offering these products cannot depend solely on sales from catalog products. The quality of the products and lead time can determine the choices while requesting custom solutions at the same time. Companies usually focus on establishing a strong distribution network for enabling products to reach customers from the manufacturing units in a short time period.

Entry of Multiple Small Players to be Witnessed in the Coming Years

Several leading players have their presence in the global market; however, many specialized products and services are provided by small and regional vendors. By targeting their marketing strategies towards research institutes and small biotechnology companies, these new players have swiftly established their presence in the market.

Explore Extensive Coverage of PMR`sLife Sciences & Transformational HealthLandscape

Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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Induced Pluripotent Stem Cells Market To Grow At 7% YOY In Forecast Years 2026 - The Think Curiouser

Skin Stem Cells Comments Off on Induced Pluripotent Stem Cells Market To Grow At 7% YOY In Forecast Years 2026 – The Think Curiouser | October 17th, 2020

Switch up your regular makeup routine for a more naturally radiant look by switching to CC cream. Its perfect for days when you want lighter coverage, or you can use it as a primer. The benefit of CC cream is that it works both harder and smarter for you. Often, they contain extra nourishing ingredients to boost your hydration and sun protection to prevent damage from harmful UV rays. Plus, they use color-correcting technology and pigments to even out skin tone, cover blemishes, and diminish the look of fine lines and wrinkles. Its a great alternative or addition to your foundation for an easy, glowy, radiant look.

Put your best face forward with the Super CC Cream from Physicians Formula. It contains micro color-correcting pigments and anti-aging ingredients to even out skin tone and to reduce the appearance of fine lines, age spots, and dullness. Plus, youll get a good dose of moisturizing elements, as well as SPF 30 that protects your skin from additional sun damage. The formula is lightweight and blends easily, making application quick and straightforward, leaving your skin feeling smooth and youthful.

BUY

Chanels CC Cream packs a punch in correcting signs of aging and proving beautifully light coverage. It is infused with extracts from the murunga plum, a native Australian superfruit. This plant is rich in vitamin C and antioxidants for improving texture and glow while protecting the skin from free radicals. The broad-spectrum sunscreen component covers you for both UVA and UVB damage. Meanwhile, the addition of hyaluronic acid draws moisture to the skin for a plump, youthful look. With continual use, your skin will look younger, healthier, and more radiant.

BUY

Enjoy 24-hour hydration with this CC cream formula from Lancome. It contains SPF50 physical sunscreen, as well as mineral filters for full-coverage color correction. Improve your skin texture, minimize pores, balance uneven skin tone, and reduce the appearance of fine lines and wrinkles, all in one easy step. It also has an antioxidant complex, vitamin E, and mint-extract to add additional environmental protection, hydration, and an energizing feel.

BUY

Giorgio Armani brings cutting-edge technology and the expertise of makeup artist Linda Cantello together in this Prima Color Control Glow Moisturizer. Enjoy long-lasting hydration from vitamin E, moringa oleifera extract, and adenosine. When it comes to coverage, the five shades adapt to the skins color to enhance the natural luminosity while hiding blemishes and fine lines. Plus, added menthol-based ingredients leave you feeling refreshed and awake, ready to tackle the day ahead.

BUY

If youre looking for a CC cream that does more for you, the Bare Minerals Complexion Rescue is an excellent option. Youll not only get radiant coverage but sun protection and long-lasting skincare benefits. The oil-free, water-infused formula keeps the skin hydrated for up to 12 hours after application, and with continual use, can boost the skins overall hydration. Made with 97% naturally derived ingredients, the gel-cream texture feels light and smooth on the skin. Lastly, there are 20 flexible shades to choose from, which naturally adapts to your skin tone.

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Get glowing skin by using Cliniques Moisture Surge CC Cream. The oil-free formula provides a shot of hydration, so your skin looks good from the inside out. Next, it instantly color corrects to diminish any redness, dullness, or imperfections, giving you a healthy vibrance. A sun protection factor of 35 prevents additional damage from harmful UV rays, yet the formula is lightweight and feels beautiful on the skin. Use it on its own for an easy, glowy vibe, or add additional foundation for a full-coverage look.

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Youll be feeling and looking fresh as a daisy with Supergoops Daily Correcting CC Cream. It contains brightening ingredients such as apple extract and mica, which reflects the light to give you a youthful, glowy look. Vitamin C and alpha-hydroxy acids keep the skin smooth, while sodium hyaluronate is a humectant that draws moisture into the skin, keeping you hydrated. Wear this CC cream daily to minimize skin discoloration, dryness, fine lines, and blotchiness. Plus, the SPF 35 UV protection is mineral-based, rather than chemical, making it suitable for sensitive skin types.

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Nourish, hydrate, and protect your skin all in one step by using Olays lightweight Total Effects Tone Correcting CC Cream. It feels light on your skin while still providing a heavy dose of beneficial ingredients. There are seven vitamins and antioxidants for extra protection, including vitamin B3 and VitaNiacin Complex II, both of which improve the skins appearance and repairs the barrier. It also corrects your skin tone, diminishes fine lines, and minimizes the pores. You can use this product in place of both your moisturizer and foundation, as well as sunscreen, thanks to the SPF 15.

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Choose from eleven different shades in IT Cosmetics inclusive CC+ Cream range. This foundation replacement corrects any color imbalances and pigmentation issues, as well as hydrates and protects your face from the sun and environmental aggressors. It was developed in collaboration with plastic surgeons to ensure you get the most benefit. Its chock full of active ingredients, including niacin, peptides, hydrolyzed collagen, and hyaluronic acid, as well as antioxidants and minerals. Combined, these ingredients hydrate, reduce the appearance of acne scarring and wrinkles, evening out skin tone, tackling dark under-eye circles, and minimizing large pores. The result is a flawless, radiant complexion that wont crack or crease, leaving you feeling beautiful and confident.

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Fruit stem cells and vitamin C come together in this lightweight CC cream. Youll enjoy beautiful tinted coverage that easily replaces your foundation when you feel like a more natural look. It also reduces the appearance of fine lines and wrinkles while evening out skin tone and texture. Plus, you need not worry about sun damage, with broad-spectrum SPF 30 protection from UVA and UVB rays. There are seven shades to choose from, ranging from Natural Glow to Deep Glow.

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Enjoy medium coverage with the Ultra CC Cream from Pacific Store. This illuminating formula contains coconut water, kelp, and ginseng for a light, smooth finish that rehydrates your skin. The color correcting minerals even out your skin tone and hide any blemishes, while the SPF 17 physical sunscreen protects your skin from UV damage. Plus, its vegan, cruelty-free, and comes in a 100% recyclable container.

BUY

Cle Cosmetics adds an extra element to their CCC cream a color control and change cream. This product can replace both your primer and foundation, as well as sunscreen, thanks to the powerful SPF50. It offers more substantial coverage than regular CC creams and matches flawlessly to your skin using unique Micro Capsule Technology. Plus, it comes in ten different, inclusive colors, so no matter your skin tone, you can rock a dewy, moisturized complexion all day long.

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Protect and hydrate your skin while looking fabulous. The Honest Beauty Clean Corrective cream is a six-in-one formula that primes, perfects, protects, blurs, brightens, and moisturizes. It boasts vitamin C to improve skin tone, as well as an antioxidant blend to protect from environmental damage. Physical sunscreens also shield your skin from sun damage, with a sun protection factor of 30. Plus, it provides blue light defense and is vegan and cruelty-free.

BUY

Embrace smoother, beautiful skin with Alamys Smart Shade CC cream. It features color correction technology that reduces imperfections, discoloration, and dullness while providing a boost of hydration. It also adjusts to your natural skin tone. Meanwhile, the SPF35 protects your face from the suns damaging rays. Lastly, the hypoallergenic, fragrance-free formula also makes it great for anyone with more sensitive skin.

BUY

This mattifying tinted moisturizer from black Up is designed specifically for black women and people of color with darker skin tones a segment of the beauty market often left out of CC cream shades. You can use it on its own as a lightweight foundation or put it to work as a primer. In one simple step, it evens out skin tone, targets dark spots and excess sebum, and improves the natural radiance of the skin. Plus, it adds a boost of hydration to keep your skin feeling smooth and supple.

BUY

The best CC cream will combine high levels of hydration and protection, as well as match your skin tone. You want both sun protection in the form of sunscreen and protection from environmental aggressors by including vitamins and antioxidants. Look for brands like Physicians Formula, Supergoop!, and IT Cosmetics. If you have darker skin, look for inclusive brands such as IT Cosmetics, black Up, and Cle Cosmetics.

The BB stands for beauty balm or blemish balm. It's very similar to CC cream in that it combines the benefits of skincare with makeup to give you light coverage for a simple, natural look, or as a primer. You'll enjoy hydrated, illuminated skin with regular use. This most significant difference is that it doesn't provide comprehensive coverage, so if you need more, then a CC cream or foundation will be the better option.

CC cream stands for color corrector or complexion corrector cream. It's a lightweight alternative to foundation or can be used in conjunction with it, as a primer. It often contains nourishing ingredients to boost hydration, sun protection elements, and color-correcting technology. It's the best of both worlds, combing skincare and makeup into one fantastic product.

You can use a primer in addition to CC cream, but it's not always necessary. Primer acts to fill in and smooth out imperfections but doesn't necessarily provide additional benefits such as moisturizing or sun protection. Meanwhile, CC cream corrects discoloration and smooths out the skin, while giving that extra protection. If you have heavy acne scarring or deeper wrinkles, a primer will still be beneficial. However, if you're looking to even out your complexion and increase hydration, the CC cream will be sufficient by itself.

CC cream stands for color corrector or complexion corrector cream. It's lighter weight than foundation but provides more coverage than BB cream. All you need to do is substitute it for your foundation in your makeup routine, or use it as a primer. Start with a cleansed, toned, and moisturized face. Then using a beauty blender or your fingertips, apply the liquid all over your face, ensuring you're fully smoothed out around the edges, building up the coverage as you desire.

You can use CC cream on the days where you're not vibing a full face of makeup but still want some coverage. It's great when you're running behind schedule or just a bit time-poor. You can also use it as a primer under your regular foundation. CC Cream eliminates steps in your makeup routine, such as using a separate sunscreen, color corrector, and foundation, which can save you time in the morning.

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15 Best CC Creams for a Flawless Complexion - The Trend Spotter

Skin Stem Cells Comments Off on 15 Best CC Creams for a Flawless Complexion – The Trend Spotter | October 17th, 2020

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An international team of researchers has published a study showing how the control of stem cell metabolism is critical to maintaining hair follicles. The study appeared in the high-impact journal Cell Metabolism.

University of Arkansas researchers included Kyle Quinn, associate professor of biomedical engineering, and Olivia Kolenc, a graduate student in Quinn's lab. The project was led by Sara Wickstrm, associate professor at the University of Helsinki, and included researchers from the research groups of Professor Sabine Eming at the University of Cologne and Martin Denzel at the Max Planck Institute for Biology of Ageing in Germany.

The team studied how the metabolism of stem cells in hair follicles is critical to the growth and long-term maintenance of hair. The follicles are unique in mammals because unlike most organs or tissues, they naturally regenerate and cycle through phases of rest, growth and degeneration. Those cycles are maintained by stem cells. Kolenc used advanced non-invasive skin imaging to monitor hair follicle metabolism in live mice.

Kolenc's work showed how the metabolism of stem cells changes as the follicle transitions to a growth phase, which provided a critical foundation to the study's larger goal of discovering the cell signaling pathways associated with the metabolic control of stem cell fate and hair follicle cycles.

The study provides insight into how our organs are maintained by stem cells and how aging can result in conditions such as hair loss. Kolenc said hair follicle stem cells aren't like some stem cells, which can transform into a wide variety of different cell types. Instead, she said, they can transform to match the surrounding area in the skin tissue.

"Hair follicle stem cells are able to differentiate into a subset of what's in their surrounding area," she said. "They can't just create any other cell, but they can contribute to regeneration and increasing the number of cells within the skin tissue."

Kolenc said hair follicle stem cells are unique among the cells in our skin because they can contribute to repair and regeneration of the skin.

"There are few populations of stem cells known to exist within the skin, so this is really a big target to help skin wound healing," she said.

Kolenc said the opportunity to contribute to such a large-scale project was special.

"It's a bit humbling," she said. "I contributed a small part to a large project that was conducted over many years. It's a cool feeling to see something like that with my name on it."

"Olivia played an important role in this study by monitoring hair follicle stem cells within their natural environment in live skin," Quinn said. "The insights she gained during this work will be very helpful as she continues studying how our metabolic imaging techniques can be applied to aging and wound healing research."

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Biomedical Engineering Team Contributes to High-impact Study on Metabolism - University of Arkansas Newswire

Skin Stem Cells Comments Off on Biomedical Engineering Team Contributes to High-impact Study on Metabolism – University of Arkansas Newswire | October 16th, 2020

Vanderbilt University researchers have reported the counterintuitive discovery that certain chemotherapeutic agents used to treat tumors can have the opposite effect of tissue overgrowth in normal, intact mammary glands, epidermis and hair follicles. The researchers also are the first to report the discovery of an innate immune signaling pathway in fibroblaststhe spindle-shaped cells responsible for wound healing and collagen productionthat causes cells to proliferate. Such signaling pathways previously were attributed only to immune cells.

The article describing the research, DNA Damage Promotes Epithelial Hyperplasia and Fate Mis-specification via Fibroblast Inflammasome Activation, was published in the journal Developmental Cell on Oct. 13.

The findings of this work, led by postdoctoral fellow Lindsey Seldin and Professor and Chair of the Department of Cell and Developmental Biology Ian Macara, have broad implications for diseases associated with the immune system like psoriasis, as well as cancer and stem cell research.

Understanding the functionality of stem cells and the way that their behavior is regulated has been a longstanding research interest for Seldin. Normal stem cells have an amazing ability to continuously divide to maintain tissue function without forming tumors, she explained. We wanted to understand what happens to these cells in their native environment when subjected to damage, and if the response was connected to a specific tissue.

By testing perturbations to the epidermis, mammary gland and hair follicles vis--vis mechanical damage or DNA damage through chemotherapeutic agents, the researchers saw a paradoxical response: Stem cells, which otherwise would divide slowly, instead divided rapidly, promoting tissue overgrowth.

When the tissues were subjected to DNA damage, their stem cells overly proliferated, giving rise to different cells than they normally would. This was a very perplexing result, said Seldin, the papers lead author. We were determined to figure out if this was a direct response by the stem cells themselves or by inductive signals within their environment. The key clue was that stem cells isolated from the body did not behave the same way as in intact tissuean indication that the response must be provoked from signals being sent to the stem cells from other surrounding cell types.

The investigators turned their attention to fibroblasts, the predominant component of the tissue microenvironment. When fibroblasts in the epidermis were removed, the stem cell responsiveness to DNA damage was diminished, indicating that they played an important role. RNA sequencing revealed that fibroblasts can signal by way of inflammasomescomplexes within cells that help tissues respond to stress by clearing damaged cells or pathogens, which also in this case caused stem cells to divide. This is an astounding discovery, said Macara. Inflammasome signaling has previously been attributed only to immune cells, but now it seems that fibroblasts can assume an immune-like nature.

Seldin intends to replicate this work in the mammary gland to determine whether fibroblasts initiate the same innate immune response as in the epidermis, and more broadly how fibroblasts contribute to the development of cancer and other diseases associated with the immune system.

This work was supported by NCI/NIH grants R35CA132898, F32CA213794 and T32CA119925, as well as American Cancer Society grant PF-18-007-01-CCG.

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Vanderbilt researchers make counterintuitive discoveries about immune-like characteristics of cells, chemotherapys impact on tissue growth -...

Skin Stem Cells Comments Off on Vanderbilt researchers make counterintuitive discoveries about immune-like characteristics of cells, chemotherapys impact on tissue growth -… | October 16th, 2020

HAIFA, Israel, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center.

GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient's body as foreign and attack it. The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.

Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3-month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported. Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells.

Prof. Ram of Ichilov Hospital commented, From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and tapering of steroid doses."

Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants. The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication, stated Pluristem CEO and President, Yaky Yanay.

About cGvHDChronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT). The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is 30% to 40% by National Institutes of Health criteria1. The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer. The donated cells identify the recipients body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints. Long term immunosuppression is given to try to prevent or treat cGvHD. Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor StatementThis press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the patient enrollment for cohort II for its Phase I/II study of its PLX-PAD cells, the implication from the results of the first patient cohort in the study, the belief that GvHD is an indication that has a significant need for enhanced treatments among patients undergoing bone marrow transplants and that the preliminary results from cohort I of the study, and the prior preclinical data, indicate that PLX-PAD cells may potentially treat chronic GvHD patients and mitigate symptoms. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana RubinDirector of Investor Relations972-74-7107194danar@pluristem.com

_________________________________

1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105., https://pubmed.ncbi.nlm.nih.gov/25398933/

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Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease...

Skin Stem Cells Comments Off on Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease… | October 16th, 2020

Oct. 15, 2020 10:45 UTC

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The approval is based on results from the Phase 3 KEYNOTE-204 trial in which KEYTRUDA significantly reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p<0.0027]) compared to brentuximab vedotin (BV). Additionally, median progression-free survival (PFS) was 13.2 months (95% CI, 10.9-19.4) for patients treated with KEYTRUDA and 8.3 months (95% CI, 5.7-8.8) for patients treated with BV. The FDA also approved an updated pediatric indication for KEYTRUDA for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy.

An estimated 8,500 patients in the U.S., many of them 40 years of age or younger, will be diagnosed with cHL this year. Now patients with cHL who progress after frontline therapy have a new option in KEYTRUDA, which has demonstrated a clinically meaningful improvement in progression-free survival compared to brentuximab vedotin, said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. At Merck, we are committed to improving outcomes for patients with cancer. Todays FDA approval builds upon our growing range of options for people with blood cancers.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

The patients with cHL who do not achieve remission following initial treatment or who relapse after transplantation face a poor prognosis, reflecting the unmet need for improved therapies in the relapsed/refractory setting, said Dr. John Kuruvilla, hematologist and associate professor of medicine, Princess Margaret Cancer Centre and University of Toronto. With this approval, KEYTRUDA has the potential to change the current standard of care and help these patients achieve better outcomes.

KEYTRUDA was previously approved under the FDAs accelerated approval process for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after three or more prior lines of therapy based on data from the KEYNOTE-087 trial. In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from KEYNOTE-204.

This approval was reviewed under the FDAs Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. For this application, a modified Project Orbis was undertaken, and the FDA is collaborating with the Australian Therapeutic Goods Administration and Health Canada on their ongoing review of the application.

Data Supporting the Approval The approval was based on data from KEYNOTE-204 (NCT02684292), a randomized, open-label, active-controlled trial conducted in 304 patients with relapsed or refractory cHL. The trial enrolled adults with relapsed or refractory disease after at least one multi-agent chemotherapy regimen. Patients were randomized 1:1 to receive either KEYTRUDA 200 mg intravenously every three weeks or BV 1.8 mg/kg intravenously every three weeks.

Treatment was continued until unacceptable toxicity, documented disease progression or a maximum of 35 cycles (up to approximately two years). Disease assessment was performed every 12 weeks. Randomization was stratified by prior autologous HSCT (yes vs. no) and disease status after frontline therapy (primary refractory vs. relapse less than 12 months after completion vs. relapse 12 months or more after completion). The main efficacy measure was PFS as assessed by blinded independent central review (BICR) using 2007 revised International Working Group (IWG) criteria.

Patients were enrolled and randomized to KEYTRUDA (n=151) or BV (n=153). The study population characteristics were median age of 35 years (range, 18 to 84); 57% male; 77% white, 9% Asian and 3.9% Black. The median number of prior therapies was two (range, 1 to 10) in the KEYTRUDA arm and three (range, 1 to 11) in the BV arm, with 18% in both arms having one prior line. Forty-two percent of patients were refractory to the last prior therapy, 29% had primary refractory disease, 37% had prior autologous HSCT, 5% had received prior BV, and 39% had prior radiation therapy.

In KEYNOTE-204, KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p=0.0027]) and showed a median PFS of 13.2 months (95% CI, 10.9-19.4). Median PFS was 8.3 months (95% CI, 5.7-8.8) for patients treated with BV. For PFS, in the KEYTRUDA arm, there were 81 patients (54%) with an event versus 88 patients (58%) in the BV arm. For patients treated with KEYTRUDA, the objective response rate (ORR) was 66% (95% CI, 57-73), with a complete response rate of 25% and a partial response rate of 41%. For patients treated with BV, the ORR was 54% (95% CI, 46-62), with a complete response rate of 24% and a partial response rate of 30%. The difference in ORRs is not statistically significant. Among the responding patients, median duration of response (DOR) was 20.7 months (range, 0.0+ to 33.2+) with KEYTRUDA and 13.8 months (range, 0.0+ to 33.9+) with BV.

In KEYNOTE-204, the median duration of exposure to KEYTRUDA was 10 months (range, 1 day to 2.2 years), with 68% receiving at least six months of treatment and 48% receiving at least one year of treatment. Serious adverse reactions occurred in 30% of patients who received KEYTRUDA. Serious adverse reactions in those greater than or equal to 1% of patients included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia and sepsis. Three patients (2%) died from causes other than disease progression: two from complications after allogeneic HSCT and one from an unknown cause.

Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 14% of patients; 7% of patients discontinued treatment due to pneumonitis. Dosage interruption of KEYTRUDA due to an adverse reaction occurred in 30% of patients. Adverse reactions that required dosage interruption in greater than or equal to 3% of patients were upper respiratory tract infection, pneumonitis, transaminase increase and pneumonia. Thirty-eight percent of patients had an adverse reaction requiring systemic corticosteroid therapy. The most common adverse reactions (greater than or equal to 20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, rash and cough (20% each).

About Hodgkin Lymphoma Hodgkin lymphoma is a type of lymphoma that develops in the white blood cells called lymphocytes, which are part of the immune system. Hodgkin lymphoma can start almost anywhere most often in lymph nodes in the upper part of the body, with the most common sites being in the chest, neck or under the arms. Worldwide, there were approximately 80,000 new cases of Hodgkin lymphoma, and more than 26,000 people died from the disease in 2018. In 2020, it is estimated nearly 8,500 people will be diagnosed with Hodgkin lymphoma in the United States. Classical Hodgkin lymphoma accounts for more than nine in 10 cases of Hodgkin lymphoma in developed countries.

About KEYTRUDA (pembrolizumab) Injection, 100 mg KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients. Pneumonitis occurred in 8% (31/389) of patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib) Immune-Mediated Hepatitis KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and post-marketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risk of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients; those 1% included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression. The most common adverse reactions (20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, and cough (20% each).

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with MSI-H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Lactation Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the final dose.

Pediatric Use In KEYNOTE-051, 161 pediatric patients (62 pediatric patients aged 6 months to younger than 12 years and 99 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 24 months).

Adverse reactions that occurred at a 10% higher rate in pediatric patients when compared to adults were pyrexia (33%), vomiting (30%), leukopenia (30%), upper respiratory tract infection (29%), neutropenia (26%), headache (25%), and Grade 3 anemia (17%).

Mercks Focus on Cancer Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit http://www.merck.com/clinicaltrials.

About the Merck Access Program for KEYTRUDA At Merck, we are committed to supporting accessibility to our cancer medicines. Merck provides multiple programs to help appropriate patients who are prescribed KEYTRUDA have access to our anti-PD-1 therapy. The Merck Access Program provides reimbursement support for patients receiving KEYTRUDA, including information to help with out-of-pocket costs and co-pay assistance for eligible patients. More information is available by calling 855-257-3932 or visiting http://www.merckaccessprogram-keytruda.com.

About Mercks Patient Support Program for KEYTRUDA Merck is committed to helping provide patients and their caregivers support throughout their treatment with KEYTRUDA. The KEY+YOU Patient Support Program provides a range of resources and support. For further information and to sign up, eligible patients may call 85-KEYTRUDA (855-398-7832) or visit http://www.keytruda.com.

About Merck For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the worlds most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the companys ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the companys patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2019 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov).

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201015005355/en/

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FDA Approves Expanded Indication for Merck's KEYTRUDA (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) -...

Skin Stem Cells Comments Off on FDA Approves Expanded Indication for Merck’s KEYTRUDA (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) -… | October 16th, 2020

Using a brush or comb, in the shower, passing your hand through your hair In a 2015 IFOP survey, three out of four French people (76%) without baldness declared that they lost their hair. In addition, after 65 years, three in ten men suffer from androgenetic alopecia (or baldness). In general, therefore, we often see a loss of density with age, both in men and in women. However, science has long looked into the phenomenon of age-related hair loss, both to understand its origin and to treat it. Focusing on stem cells seems to offer the best hope for a cure, based on numerous studies.

The hair transplant procedure is indeed a sometimes expensive and invasive procedure. As for drugs, finasteride used for androgenetic alopecia in men can induce side effects such as loss of libido and erectile dysfunction while minoxidil can cause hypertrichosis. Today, researchers therefore seem to be looking more at alternative solutions, and in particular by focusing on stem cells.

Stem cells, directly linked to hair lossFor decades, researchers have always focused on keratinocytes, cells that make up the epidermis and integuments (body hair, hair, etc.). However, as part of a study conducted by the University of Calgary (Canada), the team of researchers focused on a small cell group present in hair follicles and in skin stem cells. : fibroblasts. And according to them, these fibroblasts are the main cause of age-related hair loss.

By studying the sparse coat of elderly mice, they noticed that fibroblast stem cells had lost their regenerative function or were malfunctioning. There werent enough of them to regenerate fibroblasts. As a result, the fibroblasts and hair follicles began to miniaturize and were no longer able to produce hair, explains Biernaskie, head of the research team.

Remember that fibroblasts are important because they send messages to keratinocytes to force them to divide, and in so doing, orchestrate the growth cycles of hair follicles allowing the production of new hairs. When the fibroblasts become scarce, the signal then becomes too weak to reach the keratinocytes and maintain the process of capillary growth. For Jeff Biernaskie: if we want to one day succeed in preventing hair loss or re-grow those that are already falling, we must work to preserve the function of these stem cells which are found in the hair follicles.

Against hair loss, but not only!This finding may help guide future research on hair loss more precisely. Scientists at the University of Calgary are particularly hoping to find a way to prevent this degeneration by blocking certain genetic mutations that occur directly in stem cells in fibroblasts.

They also believe that this will have wider implications. Indeed, Wisoo Shin, lead author of the study, points out that similar fibroblasts are found in most of our organs, maintaining their integrity and promoting tissue regeneration. Finding a way to promote self-renewal to produce new functional fibroblasts into old age therefore also offers the hope of being able to treat certain injuries and help the skin to regenerate.

Lamia spent a couple of years interning at an organization that offered medical consultation before joining the editorial team at FLWL News. An enthusiastic fitness freak in the room, she offers the best amounts of insights and craft-based writing style to keep us up to date about the medicine industry, health and science.

Email:lamia@flwl.orgPhone: +1 512-845-8162

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Stem cells are believed to play a key role in hair loss - FLWL News

Skin Stem Cells Comments Off on Stem cells are believed to play a key role in hair loss – FLWL News | October 14th, 2020

Electric organoid: Neurons derived from people with 22q11.2 syndrome are hyperexcitable and show calcium-signaling deficits.

Courtesy of Pasca lab

Neurons derived from people with 22q11.2 deletion syndrome, a genetic condition linked to autism, show deficits in electrical activity and calcium signaling, according to a new study1. A single gene appears to be largely responsible for these defects, the study shows.

Up to 20 percent of people who lack part or all of the chromosomal region 22q11.2 have autism. Individuals with the deletion may also have schizophrenia, seizures, heart defects, immune dysfunction or learning problems.

The new findings uncover factors that may contribute to the development of psychiatric conditions associated with 22q11.2 deletion syndrome. They could also help researchers identify new therapeutic targets, says lead author Sergiu Pasca, associate professor of psychiatry and behavioral sciences at Stanford University in California.

The syndrome is relatively common, occurring in up to 1 in 4,000 newborns, Pasca says. But researchers do not fully understand how genes in the 22q11.2 region contribute to autism or other conditions, he adds.

To solve this molecular puzzle, Pasca and his team reprogrammed skin cells from 15 people with the deletion and 15 controls into induced pluripotent stem cells. Using a technique they developed in 2015, they coaxed these cells to turn into neurons, which self-organize in a dish into spherical clusters called organoids. The organoids show some key features of the developing cerebral cortex, a brain region implicated in autism.

The neurons derived from people with 22q11.2 syndrome spontaneously fire four times as frequently as neurons derived from controls, the researchers found. And the electrical activity of the 22q cells does not set off the usual spike in calcium levels, which is crucial for neurons to exchange messages.

In some other syndromes tied to schizophrenia and autism, calcium-channel genes are mutated. But the number of channels and the speed at which they work in 22q neurons is the same as in control neurons. Instead, the 22q cells show an unusually low voltage difference across the cell membrane when they arent firing, causing the signaling defects and hyperexcitability, the researchers found.

The researchers suspected that a gene called DGCR8 might be responsible for the neuronal deficits in the organoids because it lies within 22q11.2 and is linked to abnormal electrical activity in the neurons of mice2. DGCR8 is essential for the synthesis of short RNA fragments, called microRNAs, that regulate gene expression.

Lowering DGCR8s expression levels in control neurons reproduced the abnormalities seen in 22q neurons. In contrast, boosting the genes activity in 22q neurons or treating them with antipsychotic drugs prevented them from being overly excitable and reversed their calcium-signaling defects. The study was published 28 September in Nature Medicine.

Previous studies have analyzed lab-grown neurons derived from people with schizophrenia or autism-related disorders such as Rett and fragile X syndromes. But most used only a few human-derived cell lines, says Guo-li Ming, professor of neuroscience at the University of Pennsylvania in Philadelphia. The new study, Ming says, has a total of 30 human lines thats a huge effort.

By studying brain organoids derived from so many people, the researchers were able to identify the gene that might be involved in the psychiatric conditions associated with 22q11.2 syndrome, says Sally Temple, scientific director of the Neural Stem Cell Institute in Rensselaer, New York. Whenever we have a light shining ahead, saying, This is what you should really be looking at, it means that were making progress, she says.

The study participants with 22q11.2 syndrome vary in their psychiatric diagnoses, and yet all the brain organoids derived from their cells show the same neuronal abnormalities. Thats somewhat surprising, because we know there are a lot of differences in the genetic background of different people, Ming says.

The deletion might conspire with other factors to ultimately determine which psychiatric conditions a person has, Pasca says. It could be that the deletion causes cellular defects, and once there is a stressor such as social stress, disease develops. Its also unclear whether these cellular defects are related to the high prevalence of seizures in people with 22q11.2 syndrome, he says.

The hallmarks of most neuropsychiatric conditions can change over time, says Giuseppe Testa, director of the stem cell epigenetics unit at the European Institute of Oncology in Milan, Italy. Studies that look at a larger number of people with 22q11.2 deletion syndrome or other neurodevelopmental conditions could help to elucidate the relationship between the neuronal defects observed in the lab and the psychiatric manifestations of the conditions, Testa says. The new study, however, is a great resource for understanding how the 22q11.2 deletion contributes to schizophrenia and autism, he says.

Pascas team is trying to pinpoint molecules that could open new therapeutic avenues for 22q11.2 deletion syndrome. The antipsychotics they tested restore the unusual voltage differences in the 22q neurons, but they dont address the core mechanisms responsible for psychiatric conditions linked to the syndrome, Pasca says.

Whats more, antipsychotics have many side effects, and not all individuals respond to them, he says. We need better therapies we need to identify what the key molecular players are and target those.

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Brain organoids reveal neuronal flaws in syndrome tied to autism - Spectrum

Skin Stem Cells Comments Off on Brain organoids reveal neuronal flaws in syndrome tied to autism – Spectrum | October 14th, 2020

IRVINE, Calif., Oct. 9, 2020 /PRNewswire/ --AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and COVID-19, announced today the publication of the peer-reviewed manuscript, "Retina organoid transplants develop photoreceptors and improve visual function in RCS rats with RPE dysfunction,"in the journal Investigative Ophthalmology & Visual Science. The study, led by researchers at AIVITA Biomedical and the Sue & Bill Gross Stem Cell Research Center of the University of California, Irvine, used 3D-retina organoids generated from human stem cells developed by AIVITA to provide insight into the potential use of transplanted retina organoids as a therapeutic option for blinding diseases.

In the study, transplanted retina organoid sheets were examined to determine if human stem cell-derived photoreceptors coulddevelop, survive and function in vivo without the support of healthy retina pigment epithelium (RPE). Visual function was examined through a variety of tests, including optokinetic testing (OKT), electroretinogram (ERG), and superior colliculus (SC) brain recording. These tests concluded that retina organoid transplantations demonstrated significant improvement in visual function compared to non-surgery and sham surgery controls, supporting the application of AIVITA's stem cell technologies in visual disease therapeutics.

"Leveraging our expertise in stem cell growth and differentiation, I'm excited to see the promise of our technology platform in potential therapeutics for vision loss," said Hans Keirstead, Ph.D., chief executive officer of AIVITA and a contributing author to the paper. "To our knowledge, this study is the first to show that it's possible for photoreceptors derived from stem cells to survive and function after transplantation when a host has a dysfunctional RPE."

This work is supported by funding from the California Institute for Regenerative Medicine (CIRM) and National Institutes of Health (NIH).

About AIVITA Biomedical AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of people with cancer.

SOURCE AIVITA Biomedical, Inc.

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AIVITA Biomedical's Stem Cell Therapeutic in Vision Loss Published in Investigative Ophthalmology & Vision Science - PRNewswire

Skin Stem Cells Comments Off on AIVITA Biomedical’s Stem Cell Therapeutic in Vision Loss Published in Investigative Ophthalmology & Vision Science – PRNewswire | October 10th, 2020

Patients with cystic fibrosis experience recurrent lung infections that eventually destroy their airways, shortening their average life expectancy to 50 years in Canada. Current drug treatments, which target a malfunctioning pathway in cells that causes the infections, are costly and have varying effectiveness.

Now, with funding from Medicine by Design, a researcher at the Hospital for Sick Children (SickKids) is combining stem cells, gene editing and computational modelling to try to hijack an alternative cell pathway in the hopes of restoring lung function in these patients.

If successful, our study will be the first to provide proof-of-concept that this alternative approach to treating cystic fibrosis is effective, saysAmy Wong, a scientist working in developmental and stem cell biology at SickKids who is also an assistant professor in the department of laboratory medicine and pathobiology in the University of Torontos Temerty Faculty of Medicine.

Wongs project is one of seven across U of T and its affiliated hospitals that have been awarded 2020New Ideas AwardsandSeed Fundawards from Medicine by Design. Through a $1 million investment, Medicine by Design is supporting research aimed at advancing new concepts expected to be important to regenerative medicine in the coming years. The funded projects will have potential impacts in diseases and conditions such as vision loss, amyotrophic lateral sclerosis (ALS), intestinal disease in premature babies and more.

Supporting novel strategies and approaches is crucial to moving regenerative medicine into the future, saysMichael Sefton, executive director of Medicine by Designand a University Professor at U of Ts Institute of Biomedical Engineeringand thedepartment of chemical engineering & applied chemistry in the Faculty of Applied Science & Engineering.

Our 2020 New Ideas project portfolio integrates mathematical modelling, physics and computational biology with stem cell biology and biomedical engineering, and strengthens engagement with clinicians who are key to translating our research into patient impact. We are particularly delighted this year to support so many outstanding early-career researchers, who will ensure Toronto remains a global leader in regenerative medicine for years to come.

Wong is one of three investigators to receive a 2020 New Ideas Award, which is valued at $100,000 per year for up to two years. Four additional projects were selected for Seed Fund Awards of $100,000 each for one year to further develop their potential.

Medicine by Design selected the funded projects from among 36 short-listed proposals, which were evaluated and ranked through an external peer review process. Applications were submitted by clinicians and researchers at U of T and its affiliated hospitals from a wide range of disciplines including biochemistry, biomedical engineering, developmental and stem cell biology, immunology, neuroscience and surgery.

Medicine by Design builds on decades of made-in-Canada excellence in regenerative medicine dating back to the discovery of stem cells in the early 1960s by Toronto researchers James Till and Ernest McCulloch. Regenerative medicine uses stem cells to replace diseased tissues and organs, creating therapies in which cells are the biological product. It can also mean triggering stem cells that are already present in the human body to repair damaged tissues or to modulate immune responses. Increasingly, regenerative medicine researchers are using a stem cell lens to identify critical interactions or defects that prepare the ground for disease, paving the way for new approaches to preventing disease before it starts. Medicine by Design is made possible thanks in part to a $114-million grant from theCanada First Research Excellence Fund.

Current cystic fibrosis drug treatments target a genetic mutation that causes epithelial cells, which line the airway and act as a barrier against viruses, to function improperly. The mutation affects the function of an important ion channel in cells, called CFTR, which helps to maintain the right balance of fluid in the airways. Poor function causes mucosal obstructions in the airways and prevents clearance of foreign pathogens, which leads to chronic infections and ultimately destroys airway tissue.

In her project, Wong will explore an alternative ion channel in the epithelial cells to determine if it can be hijacked and used to compensate for the lack of function caused by the mutant CFTR. The research will be conducted using a combination of stem cell-derived lung models, gene editing and computational modelling.

Wongs project builds on decades of cystic fibrosis research at SickKids, where the cystic fibrosis gene was first identified 30 years ago.

To date, more than 2,000 mutations in the cystic fibrosis gene have been identified, says Wong. SickKids scientists and U of T researchers have become the epicentre of incredible cystic fibrosis research to understand how this disease works at the genetic and molecular level.

Wong says that, while the idea of targeting an alternative pathway is not necessarily ground-breaking on its own, its the array of tools now available that makes the idea a potential game changer.

We have access to an incredible resource of primary cells and stem cells from more than 100 individuals with cystic fibrosis harbouring various mutations. Wong says.Our lab has developed human lung models from stem cells that can be used to model lung disease such as cystic fibrosis. And with new advanced tools in single-cell genomics and gene-editing, coupled with key collaborations for computational modelling, we are poised to find new therapeutic targets for cystic fibrosis.

Leo Chou, an assistant professor at the Institute of Biomedical Engineering, andHyun Kate Lee, an assistant professor in the department of biochemistry in the Temerty Faculty of Medicineboth Medicine by Design New Investigators are also leading 2020 New Ideas projects.

Chou, along with co-investigatorsJulie Lefebvre, a scientist at SickKids and U of T assistant professor of molecular genetics, andValerie Wallace, a senior scientist at the Krembil Research Institute, University Health Network and a U of T professor of laboratory medicine and pathobiology and ophthalmology, will focus on cell transplantation in the retina, a process that has demonstrated encouraging pre-clinical results such as partial vision restoration in several animal disease models.

Recent research had demonstrated that this restoration is a result of the transfer of proteins complex molecules required for the structure, function and regulation of the bodys tissues between host tissue and donor cells. But the scope of that transfer process is not well understood. Chous project will develop an imaging approach to detect the transfer of mRNA molecules between host and donor cells. The outcomes from this project will inform the future design of cell transplantation therapies and lead to novel methods to deliver therapeutics. This project could improve therapies for retinal diseases and visual impairments, and inform strategies for other degenerative disorders.

Lee and co-investigatorPenney Gilbert,an associate professor at the Institute of Biomedical Engineering, will look at a common but not well-understood structure called the neuromuscular junction (NMJ), which mediates communication between neurons and muscles throughout the body. Defects in NMJ integrity and function underlie fatal diseases such as ALS. NMJ diseases, which affect more than 500,000 people globally, lack effective treatments. This project will use stem cells derived from reprogrammed skin cells of healthy people to develop NMJs in culture. Through high-resolution imaging, the healthy human NMJs will be studied both on their own and along with NMJs built from ALS patient cells. Through this work, the research team aims to identify genes to target to improve the health of NMJs, which could eventually help prevent or delay NMJ degeneration and even promote regeneration.

Michael Garton, an assistant professor at the Institute of Biomedical Engineering, has received a Seed Fund award to tackle the challenge of translating the genetic tools of synthetic biology an area of research that aims to create or redesign biological components using engineering methods into effective medical therapies against a number of diseases.

But they are difficult to translate into human therapies, Garton says, because the bodys T-cells immune cells that detect and destroy cells containing foreign material will identify these tools as foreign and destroy them.

Instead of switching off the T-cells, Gartons goal is to use computational modelling and high-throughput screening to selectively turn off the bodys foreign antigen display system so the immune system will still respond to foreign invaders when necessary, but allow cells containing synthetic tools to survive. If successful, this approach could enable a new generation of synthetic biology-enhanced cell therapies for a range of diseases.

Medicine by Design funding will help to facilitate the integration of synthetic biology and regenerative medicine and aid the development of cell-based therapies that perform better than nature, says Garton.

Other Seed Fund projects will encompass research in repairing the heart after paediatric cardiac surgery, treating an intestinal emergency in premature babies and creating a database for cell lineage paths.

John Parkinson, a senior scientist at SickKids and a U of T professor of biochemistry and molecular genetics, along with co-investigatorsJason Maynes, Wasser Chair in Anesthesia and Pain Medicine at SickKids and a U of Tassociate professor of anesthesiology and biochemistry, andWilliam Navarre, an associate professor in the department of molecular genetics, will investigate manipulating the microbiome, or community of microorganisms in the gut, to improve cardiac repair in post-operative treatment of a congenital heart disorder. Through a process that will identify prebiotics in breast milk that help enhance the production of molecules that research has shown can aid cardiac repair, the team will organize both observational (how disease alters the microbiome) and interventional (how the microbiome alters the disease) multi-site trials, which will provide the opportunity to immediately translate findings into changes in patient care regimens and improve outcomes.

CliniciansAgostino Pierro, a surgeon at the Division of General and Thoracic Surgery at SickKids and a U of T professor of surgery and physiology, and Philip Sherman, a senior scientist and gastroenterologist at the Division of Gastroenterology, Hepatology and Nutrition at SickKids and U of T professor of dentistry, pediatrics and laboratory medicine and pathobiology, have proposed a novel way of enhancing gut repair for a common intestinal emergency in premature babies, called necrotizing enterocolitis (NEC). A leading cause of death for these infants, NEC causes complications such as blindness, intellectual disability, repeat hospitalizations and gut damage even in those that survive. This project will look at whether intestinal organoids organ-like structures grown in the laboratory from stem cells that mimic some of the functions of native intestines can potentially stimulate repair of the gut and recovery from NEC. The project will define how to best transplant organoids, identify how the organoids protect the intestine from injury and assess if organoid transplantation is a valid new treatment for NEC.

Lincoln Stein, who is head of adaptive oncology at the Ontario Institute for Cancer Research and a professor in the department of molecular genetics at U of T, has received seed funding to build a database called Cytomics Reactome, which will be freely available to Canadian and international researchers. The database will build on recent technologies that open the door to the possibility of deciphering cell lineage paths the series of steps that lead a young, undifferentiated cell into a specialized one at single-cell resolution. To accelerate the path from basic research to clinical application, the database will systematically organize pre-existing knowledge of cell lineage paths into a comprehensive, interactive and easily accessible map that can serve as a framework for interpretation and integration of the latest experimental findings.

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U of T's Medicine by Design invests $1 million to advance new ideas in regenerative medicine - News@UofT

Skin Stem Cells Comments Off on U of T’s Medicine by Design invests $1 million to advance new ideas in regenerative medicine – News@UofT | October 10th, 2020

Two years ago I received an Augustinus Bader cream in a goody bag. I hadnt heard of it at the time, so paid little attention, although it looked nice enough a sleek, big blue bottle with rose gold accents. Shortly after, having just run out of my current moisturiser, I dug it out to give it a go. A few days later, forensically inspecting my skin in the mirror as I am wont to do in my more idle moments, I thought this stuff is actually really great. This was swiftly followed by another thought oh dear when I discovered it costs a whopping 205 a pop (for 50ml, you can get 15ml for 65). But it was too late, I was hooked. And that is how I became a woman who drops 205 on a moisturiser.

I am probably the least glamorous and definitely least well-known member of the Augustinus Bader fan club, which has swiftly reached legendary status in the beauty world and beyond. Kim Kardashian West, Naomi Campbell, Kate Bosworth, Priyanka Chopra and Diane Kruger all love the cult brand. Victoria Beckham invited Professor Bader to sit front row at her AW20 show; she also tapped his talents to collaborate with her on her debut skincare line (from seeing VB up close I can testify that this is a woman who knows good skincare, and the Cell Rejuvenating Power Serum is indeed excellent).

Professor Augustinus Bader and Victoria Beckham Getty

The latest addition to the Bader fan club is Emma Corrin. Prepping the new Diana for The Crowns Zoom press junket this week, her makeup artist Florrie White revealed she used The Cream and The Face Oil on the young actress. I use The Cream on everyone; me and my clients, White tells me. It instantly plumps and smooths the skin with three perfect pumps and creates a calm and luxurious base for every make-up look. Everyone always comments on how lovely it feels on their skin.

Today Augustinus Bader is a cult phenomenon but the founder is a man who seems to be more at home in a laboratory than on a red carpet. A leader in stem cell biology, and head of stem cell research at the University of Leipzig, Professor Bader has spent over 30 years focusing on how reawakening these cells can aid the healing process in particular embarking on a mission to help burns victims. In 2008, Bader formulated a groundbreaking wound gel that could help heal third-degree burns without the aid of surgery or skin grafts.

It was this breakthrough that led to the founding of the skincare line. After all, if it could have this effect on serious injuries, imagine what the technology could do for those of us lucky enough to have run-of-the-mill skin niggles? The brand launched with two hero products: The Cream and The Rich Cream which, according to the brand literature, contain patented TFC8 (Trigger Factor Complex) technology, which supports the skins natural processes, leaving all skin types mature, dry, oily, or sensitive looking restored, renewed and regenerated.

I was useless at science at school and all this technical talk is pure gobbledygook to me. What I can tell you is what its done for me. My skin is super sensitive, I have eczema, and have found that Augustinus Bader creams genuinely help to soothe it when it is aggravated. I have found that since using it, my complexion appears clearer, more even and the Holy Grail of beauty dewy (despite drinking gallons of water a day, I have never achieved that before). My mum, who observes me with the scrutiny that only mothers do, confirms that my skin looks great (I am privvy only to this information because she thought it was a result of finally listening to her by stopping smoking and making the hours before midnight count). Is it expensive? Well, yes, theres no way around that. However, in much the same way that I think that an impeccably cut designer jacket earns its value back in cost per wear, I have found that since using The Cream and The Rich Cream my skincare regime has simplified.

Sure, theres an element of hype involved. I still find it thrilling to be In The Know about something. But, for me and my skin, Augustinus Bader lives up to it. Believe me, I wish it wasnt true (I am not snobby with beauty products, and would happily wax lyrical about a 5 wonder find if Id discovered one), but thats the 205 price I have to pay and Id say its worth it.

READ MORE: 'I Just Love The Way A Polished Lipstick Completes A Look': Victoria Beckham's New Posh Lipsticks Explained In Her Own Words

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Discover The Augustinus Bader Wonder Cream Loved By The A List - Grazia

Skin Stem Cells Comments Off on Discover The Augustinus Bader Wonder Cream Loved By The A List – Grazia | October 10th, 2020

The biotech industry has been soaring this year, with the SPDR S&P Biotech ETF (XBI) up 26.6% year to date so far. The race for a COVID vaccine has primarily driven this performance, but what if there was another segment of the biotech industry that top hedge fund managers are all going after right now? While many managers are known to take risks, its certainly worth looking into if there is a consensus between them.

The AlphaClone Alternative Alpha ETF (ALFA) tracks an index of equity securities that hedge funds have significant exposure to. The ETFs top three holdings are all biotech firms working on cancer drugs. While many investors have their attention on biotech and pharmaceutical companies working on a COVID vaccine, big money has been focused on the next big thing in biotech, the future oncology drug boom.

Cancer is the second leading cause of death in the U.S. behind heart disease. Almost everyone knows someone that has been affected by one of the many vicious types of cancer. There are now numerous companies focused on ways to treat and cure the various forms. While COVID is at the forefront, cancer is a long-term play. There is even an ETF that covers the cancer industry, the Loncar Cancer Immunotherapy ETF (CNCR), which is up over 39% over the last six months.

As the oncology drug market is expected to reach $394 billion by 2027, here are the three top cancer stocks based on a consensus of hedge fund managers: Seattle Genetics (SGEN), Fate Therapeutics (FATE), and Blueprint Medicines (BPMC).

Seattle Genetics (SGEN)

SGEN is a biotech firm focused on developing antibody-drug conjugates. Its lead lymphoma drug, Adcetris, has been performing quite well since it launched, and it is the primary growth driver for the company. The drugs label was also expanded, providing more revenue for the company. SGEN has been collaborating with Takeda (OTCMKTS:TKPHF), a Japanese pharmaceutical company, for the global development and commercialization of Adcetris.

In addition to Adcetris, the company has a promising pipeline of drug candidates for its antibody-drug conjugate (ADC) technology. In December, the FDA granted accelerated approval to Padcev to treat patients with metastatic bladder cancer, who were previously treated with a checkpoint inhibitor and platinum-based chemotherapy. This drug was created in collaboration with Astellas Pharma (OTCMKTS:ALPMF), another pharmaceutical company.

In April, the FDA approved Tukysa for the treatment of metastatic HER2-positive breast cancer. Investors should also be happy with the news Merck (MRK) plans to buy a 2.9% stake in SGEN. The companies are co-developing and selling SGENs breast cancer therapy, ladiratuzumab vedotin.

The company is rated a Strong Buy in our POWR Ratings system, with a grade of A in Trade Grade, Buy & Hold Grade, and Peer Grade. Those are three out of the four components that make up the POWR Ratings. The stock is also ranked #2 out of 377 Biotech stocks.

Fate Therapeutics (FATE)

FATE is a clinical-stage biopharmaceutical company engaged in the development of programmed cellular immunotherapies for cancer and immune disorders. The company has been building up its pipeline of immuno-oncology product candidates. These treatments are designed to elicit an immune response in patients with cancer.

The companys progress with FT596 is encouraging. FT596 is cell cancer immunotherapy derived from its iPSC line. The induced pluripotent stem cell (iPSC) platform provides a competitive advantage for the company as iPSC cells are stem cells that can become almost any cell type. They are grown from the same cell instead of a patients donated cells. This means that one engineered cell line can be manufactured for many patients, creating what is known as off the shelf immunotherapy.

If the development of this type of therapy is successful, this would reduce the cost of manufacturing and provide a potential cash cow for the company. FATE has entered into collaborations with other companies for fund and research expertise. It is currently working with Ono Pharmaceutical (OTCMKTS:OPHLY) for two off-the-shelf iPSC-derived CAR T-cell product candidates, and Janssen Biotech develop iPSC-derived CAR NK and CAR T-cell product candidates.

FATE is rated a Strong Buy in our POWR Ratings system. It holds a grade of A in Trade Grade, Buy & Hold Grade, and Peer Grade. It is also ranked #24 out of 377 stocks in the Biotech industry. The stock is up a whopping 145.3% after finishing the day up 6.7%.

Blueprint Medicines (BPMC)

BPMC is a biopharmaceutical company focused on improving patients lives with diseases driven by abnormal kinase activation. The company has developed a small molecule drug pipeline in cancer. The firms lead product, Ayvakit, was approved by the FDA in January to treat metastatic gastrointestinal stromal tumor. The drug generated $5.7 million in the second quarter, so its off to a good start.

The company is also looking to expand its label as it is being studied for advanced and smoldering forms of systemic mastocytosis, a condition where certain immune cells, called mast cells, build up under the skin and, or in the bones, intestines, and other organs. If approved for other labels, that should help drive further growth.

Last month, the FDA approved the companys second drug, Gavreto, for the treatment of RET fusion-positive NSCLC or non-small lung cancer. BPMC worked on the drug with Roche (OTCMKTS:RHHBY). Lung cancer is responsible for more cancer deaths than any other in men and women. If Gavreto can become a standard treatment, it could become a goldmine for the company. The drug can also treat medullary thyroid cancers.

BPMC is rated a Strong Buy in our POWR Ratings system. It has grades of A in Trade Grade, Buy & Hold Grade, and Peer Grade. It is also the #9 ranked stock in the Biotech industry. The stock is up over 27% for the past three months and 8.5% over the past week.

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SGEN shares were unchanged in after-hours trading Friday. Year-to-date, SGEN has gained 75.72%, versus a 9.31% rise in the benchmark S&P 500 index during the same period.

David Cohne has 20 years of experience as an investment analyst and writer. Prior to StockNews, David spent eleven years as a Consultant providing outsourced investment research and content to financial services companies, hedge funds, and online publications. David enjoys researching and writing about stocks and the markets. He takes a fundamental quantitative approach in evaluating stocks for readers. More...

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