New research could be a breakthough in collagen and stem cell research – Truth In Aging
By daniellenierenberg
New research has identified two actives that can prevent stem cell decline as we age and increase collagen 17 levels in cells. It was published in Nature last year and has just been covered in Scientific American. The study was described as elegant by a prominent dermatologist, not involved in the project. As I am always on the look out for next big thing in antiaging skincare, I pounced.
Ill cut straight to the car chase. The two actives are Y27632 and apocynin and I was curious to see if they could be tracked down outside of a lab and, perhaps, in our potions and lotions. The first is a chemical that I havent been able to track down. Happily, I had better luck with apocynin.
Apocynin has been identified in a specific strain of cannabis, but also in cloudberry. And rubus chamaemorus (AKA cloudberry) seed oil is in a facial oil by Keracell. Ill post a link at the end of this article.
So, how do Y27632 and apocynin work? Emi Nishimura, a professor of stem cell biology at Tokyo Medical and Dental University in Japan, revealed that aging and UV exposure deplete stem cells of a crucial collagen protein. Heres what happens.
As part of normal skin health, the top layer of the epidermis is constantly being sloughed off and replaced from a self-replenishing pool of stem cells in the basal layer. These stem cells have roots that anchor them to a thin piece of tissue called the basement membrane that connects the epidermis and the dermis. Only when tethered can they replicate and mature into another type of cell.
This is where collagen 17 comes in. This collagen protein does the tethering (see the "adhesive molecule" in the illustration above), rooting the stem cell to the basement membrane. As stem cells become damaged, they lose precious amounts of collagen 17. The more protein they lose, the weaker their bond to the basement membrane, until eventually they are forced out by neighboring healthy cells.
Thats why this study is potentially a breakthrough. It has identified the process, the key protein that needs to be replenished and the chemicals that might just be able to do that.
You can find rubus chamaemorus (AKA cloudberry) seed oil and a potential source of apocynin in KERACELL Liquid Gold Enriching Elixir ($160 in the shop).
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New research could be a breakthough in collagen and stem cell research - Truth In Aging
Restoring vision to the blind – Science Magazine
By daniellenierenberg
Surveys consistently report that people fear total blindness more than any other disability, and currently the major cause of untreatable blindness is retinal disease. The retina, a part of the brain that extends into the eye during development, initiates vision by first detecting light with the rod and cone photoreceptors. Four classes of retinal neurons then begin the analysis of visual images. Defects in the optical media that transmit and focus light rays onto the retina (lens and cornea) can usually be dealt with surgically, although such treatments are not available in some parts of the world, resulting in as many as 20 to 30 million legally blind individuals worldwide. Untreatable retinal disease potentially causes legal or total blindness in more than 11 million people in the United States alone, but progress in treatments raises the possibility of restoring vision in several types of retinal blindness (1).
Retinal neurons comprise bipolar and horizontal cells, which are second-order neurons that receive signals from the photoreceptors in the outer retina. Third-order amacrine and retinal ganglion cells are activated in the inner retina by bipolar cells. Axons from the ganglion cells form the optic nerve and carry the visual message to the rest of the brain (see the figure). The cells most susceptible to blinding retinal disease are the photoreceptors and ganglion cells. Whereas progress has been made in combating blindness caused by photoreceptor degeneration, little can be done currently to address ganglion cell loss, such as occurs in glaucoma.
The approach that has been most successful in restoring photoreceptor loss that results in complete blindness is the use of retinal prosthetic devices, with two now approved for clinical use (2). These devices electrically stimulate either bipolar or ganglion cells. They require goggles that have a camera that converts visual stimuli into electrical stimuli that activate the device, which in turn stimulates the retinal cells. Several hundred of these devices have been implanted in blind or virtually blind individuals, 70 to 80% of whom report improvement in quality of life. For those who are completely blind, the ability to experience again at least some visual function is viewed as a miracle.
There are substantial limitations to the devices, however. The best visual acuity attained so far is poor (20/500) and visual field size is limited, but many improvements, mainly technical, are being developed and tested, including the potential use of electronic low-vision devices to increase visual field size and acuity (3). Retinal prostheses are not useful for patients who are blind because of loss of ganglion cells and/or the optic nerve, but prostheses that bypass the retina and stimulate more central visual structures, including the lateral geniculate nucleus (the intermediary between retina and cortex) and visual cortex, are being developed and tested in humans (4). There remain considerable technical issues, but preliminary data indicate that such devices are feasible.
A second approach to treat photoreceptor degeneration and potential blindness, now in the clinic, is gene therapy (5). This involves injecting a viral construct into the eye that contains a normal gene to replace an abnormal one. Success so far has been limited to the treatment of Leber congenital amaurosis (LCA) type 2, a rare form of retinitis pigmentosa in which the gene whose product is required to form the correct isomer of vitamin A aldehyde, the chromophore of the visual pigments, is mutated. Little of the correct isomer is made in LCA patients, resulting in substantial loss of photoreceptor light sensitivity. This is reversed when viral constructs encoding the normal gene are injected deep into the eye between the photoreceptors and pigment epithelium.
Two factors make this approach feasible in LCA: The genetic defect is monogenic, and many of the photoreceptors in the patients remain alive, although compromised. Thus, how broadly feasible gene therapy will be for treating the enormous range of inherited retinal diseases now known to exist (300) remains to be seen. But at least a dozen other gene therapy trials on monogenic inherited eye diseases similar to LCA are under way (6). Other methods to manipulate genes are now available, including CRISPR-mediated editing of retinal genes. So far, the experiments have been mainly on isolated cells or retinas, but these powerful techniques are likely to have eventual clinical applications.
A variation on the use of gene therapy techniques is optogenetics, in which light-sensitive molecules are introduced into non-photosensitive retinal cells. This approach holds much promise for restoring vision to totally blind individuals whose photoreceptors have been lost. Using viruses to insert genes encoding light-sensitive molecules into bipolar and ganglion cells, as well as surviving photoreceptor cells that are no longer photosensitive, has been accomplished in animals and shown to restore some vision (7). Again, technical issues remain: The cells made light-sensitive require bright light stimuli, and the light-sensitive cells do not adapt. That is, whereas photoreceptors normally allow vision over as much as 10 log units of light intensity, the cells made light-sensitive respond only to a range of 2 to 3 log units. Various methods to overcome these limitations are now being developed, and at least one clinical trial is under way. Experiments to make cortical neurons sensitive to light or other stimuli that better penetrate the skullmagnetic fields or ultrasound, for exampleare also being developed and tested in animals.
Other promising approaches to restore vision are being explored. In cold-blooded vertebrates, retinal cells (in fish) and even the entire retina (in amphibians) can regenerate endogenously after damage. Regeneration of retinal cells in zebrafish is now quite well understood (8). The regenerated neurons come from the major glial cell in the retina, the Mller cell. After retinal damage, Mller cells reenter the cell cycle and divide asymmetrically to self-renew and produce a progenitor cell that proliferates to produce a pool of cells capable of differentiating into new retinal cells that repair the retina.
A number of transcription factors and other factors identified as being involved in retinal regeneration in zebrafish have been shown to stimulate some Mller cell proliferation and neuronal regeneration in mice. Regenerated bipolar and amacrine cells, as well as rod photoreceptors, have so far been identified in mouse retinas, and these cells are responsive to light stimuli (9, 10). Further, cells postsynaptic to the regenerated neurons are activated by light stimuli, indicating that the regenerated neurons have been incorporated into the retinal neural circuitry. So far, the regenerative capacity of mammalian Mller cells is limited, but directed differentiation of specific types of neurons with a mix of factors appears to be a possibility. Regrowth of ganglion cell axons after the optic nerve is disrupted is also under active investigation, and although the number of axons regrowing is low (10%), those that do regrow establish synaptic connections with their correct targets (11). Therefore, endogenous regeneration is still far from clinical testing, but substantial progress has occurred.
The retina lines the back of the eye and consists of rod and cone photoreceptors, as well as four types of neuron: second-order bipolar and horizontal cells and third-order retinal ganglion cells (RGCs) and amacrine cells. Mller glial cells fill the spaces between the neurons. The pigment epithelium, critical for photoreceptor function, underlies the retina. Photoreceptors and RGCs are most susceptible to blinding retinal disease. Progress in combating photoreceptor degeneration has been made, but there are few strategies to address RGC loss.
A long-studied area of research is transplantation of retinal cells, particularly photoreceptors, into diseased retinas. In experiments with mice, transplanted postmitotic rod photoreceptor precursor cells derived from embryonic retinas or from stem cells appeared to integrate into diseased retinas in reasonable numbers and to be functional. A surprising and unexpected complication in the interpretation of these experiments was recently discovered. Rather than integrating into diseased retinas, the donor cells appear to pass material (RNA or protein) into remaining host photoreceptor cells, rejuvenating them, and these appear to be most of the functional cells (12). The current evidence suggests that only a small proportion of the donor cells integrate, but progress in overcoming this setback is being made.
More success has been reported with stem cells induced to become pigment epithelial (PE) cells, which provide essential support for photoreceptors. A number of blinding retinal diseases relate to the degeneration of the PE cells, and replacement using such cellsin a suspension or on a scaffoldis being actively pursued. PE cells do not need to integrate synaptically with retinal cells; they simply need to contact the photoreceptor cells. This is achieved when PE cells are placed between the retina and the back of the eye. Early clinical trials suggest that the transplants are safe, but retinal detachment, a serious complication, can occur and efficacy has yet to be shown (13).
The finding that donor photoreceptor cells can help diseased host retinal cells to recover function suggests that certain substances can provide neuroprotection. Indeed, a substantial number of such neuroprotective molecules have been shown to affect retinal disease progression, especially degeneration of photoreceptor cells. No one factor has been shown to be effective generally, but two have received much attention. One, ciliary neurotrophic factor (CNTF), promotes photoreceptor survival in light-induced photoreceptor degeneration and in several other models of retinal degeneration (14). Some evidence suggests that CNTF acts primarily on Mller cells, but how it works, and on what cells, is still unclear. The other factor, rod-derived cone viability (RDCV) factor, has received less research attention, but with recent industrial support, it is now being advanced to the clinic. Current evidence indicates that RCDV factor protects cones after rod degeneration.
Two of the most common retinal diseases in developed countriesage-related macular degeneration (AMD), the leading cause of legal blindness (visual acuity of less than 20/200), and glaucoma, the leading cause of total blindnessare not monogenic diseases, and so genetic treatments for them are not obvious. Attempts to understand the etiology of these diseases are under way, but currently their underlying causes are still unclear. A difficulty presented by AMD is that no animal model is readily available, because it is a disease of the fovea, which mediates high-acuity vision. Except for primates, other mammals do not possess this small critical retinal area. Whereas large primates are not feasible for extensive cellular or molecular studies, small primates such as marmosets that have a fovea are potential models but have not been used much to date.
Other approaches for restoring vision have been suggested and have even yielded some progress. From both normal humans and those with an inherited retinal disease, skin biopsy cells can be induced to form tiny retinal eyecups called organoids (15). Containing all retinal cell types, these structures could be a source of retinal cells for studying retinal disease development and possible therapies, as well as for cell transplantation. A fovea has not been observed in any organoid so far, but this is not beyond the realm of possibility. Another suggested approach is to surgically transplant whole eyes into blind individuals. This appears feasible, but whether there is sufficient optic nerve regrowth remains an open question.
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Restoring vision to the blind - Science Magazine
What’s the Next ‘"nstagram Face"? – Papermag
By daniellenierenberg
Are you hallucinating or are you seeing the same face everywhere? You know the one. Highly sculpted. Quasi-"exotic." Suggestively cyborgian with equidistant almond eyes, '90s-supermodel high cheekbones and a poufy cupid pout. Dubbed "Instagram Face" in a New Yorker article by writer Jia Tolentino, it's an exactingly symmetrical look facilitated over the last decade by high-tech advancements in digital facial-tuning filters and injectable facial fillers, aka tweakments, aka the minimally invasive cosmetic procedures that have made Botox and Juvderm household names. Filters and fillers.
Though this chiseled face devoid of smiles, frowns, furrowed brows of worry or concentration and wrinkles is primarily found on women, it was, in many ways, a face forged by men. As of 2018, 85% percent of board-certified plastic surgeons in the US were male, while 92% of their patients were female. Meanwhile, Facebook, which owns Instagram, home to some of the most popular filters behind these trends, has a tech workforce that was, as of 2019, 77% male.
Historically, this "Oz behind the curtain" dynamic when it comes to "ideal femininity" is not new. From 1950s advertising executives brainstorming buxom, button-nosed visions of domesticity to 1980s filmmakers placing a prepubescent Brooke Shields in The Blue Lagoon's thinly veiled mainstream erotica, men in positions of power have consistently manufactured the American beauty construct.
And, like any functioning ideology, that construct has mutated to mirror its moment. The face of the 2010s indeed, the supposedly ideal face at the core of the beauty paradigm for eons has often relied on an essential recipe that Dr. Andrew Jacono, a prominent New York plastic surgeon and author of 2019's bestseller The Park Avenue Face, likens to the perfectly balanced proportions reflected in the wings of a butterfly or the gothic cathedrals of France. But remember in the early '90s when we sea-changed seemingly overnight from the flawless buoyancy of Cindy Crawford to the fucked-up teeth and waifish "heroin chic" of Kate Moss? Apart from the golden ratio, there is another beauty truth we could probably all agree upon: The trend pendulum eventually swings. Does that mean that we're in for a face envisioned by women? And, if so, what would that face look like? Could we imagine it might appear not less but more emotive?
In sharp contrast to the tacit perfectionism of filter/ filler plasticity, Doniella Davy, the makeup artist for HBO's aesthetic bombshell Euphoria, said in an interview with Allure that she, herself, leaves the house every day in a different color of glitter or eyeliner because she's presenting herself to the world in a way that feels authentic. "I don't need anyone's approval," she put it. Similarly, rather than using makeup to convey a character's stereotypical core identity in keeping with traditional Hollywood sets, Davy applies a Technicolor palette to the show's stars as a way to signal their changing and changeable emotional states. It's a vibe makeup artists like Pat McGrath, who rhinestoned eyebrows and gilded undereyes for Marc Jacobs' Spring 2020 New York Fashion Week show not to mention drag queens and the LGBTQIA communities have been experimenting with since the dawn of time. Lady Gaga and Lizzo clearly got the memo. But the crayon box sensibility does seem to hold a new grip on our collective cultural imagination. According to Google Trends, the search term "glitter eye" spiked in September in the wake of NYFW Spring 2020, then again in February on the night of the Oscars, when Janelle Monae showed up in a hooded dress dripping with thousands of crystals part Little Red Riding Hood, part disco ball matched by glittery silver eyeliner and cherry red lips.
One potentially telling facet of these new trends' appeal is the fact that they leave much more room for experimentation and customization. Because if beauty is based not just on symmetry but also on value and rarity, and if a glut of influencers have all bought the same injectable features and nearly anyone can go out and mimic them by following one of thousands of rote YouTube tutorials with a highlighter stick and some concealer, does that face even look special anymore? What, then, will we all be fixating on in the decade ahead? Look a little closer at Euphoria. There is a common denominator: Across moods and characters, the skin beneath operates like a clean canvas. It looks raw, fresh, tween. And its desirability isn't limited to the show, to 20-somethings or to Hollywood. It's already attracted a cultish, worldwide following.
The Korean beauty world calls it "glass skin." The basic properties are pristine porelessness and crystalline clarity. We can supposedly achieve glass skin by slathering ourselves daily with several kinds of moisturizers, toners, hydrophilics and exfoliants following a bajillion-step K-beauty routine. Or, in certain states where it is legal, we could have semi-permanent BB Glow pigment microneedled into our skin. But one downside to tattooing fake skin into actual skin is that BB Glow needling is not FDA approved and runs the risk of severe allergic reaction, among other untested, uncharted waters. Artificial intelligence could help. As though to underscore our oncoming skin-tone mania, at CES, the tech expo in Las Vegas this January, the two main beauty attractions were Procter & Gamble's Opt wand and L'Oral's Perso, both AI gadgets that purport to scan and analyze skin in order to optimize the camouflaging of spots, sunspots and hyperpigmentation over time.
Plastic surgeons, whose procedures, injections and treatments have proffered permanent (or semi-permanent) versions of the contouring and highlighting that ruled the 2010s, are also thinking about how this pendulum shift could affect their practices. "When times are harder and people have to work harder, more chiseled, masculine features become more desirable. Because of this, in the last decade, you saw a lot of chiseled features come into play," Dr. Simon Ourian, a cosmetic dermatologist, tells me, in the glitzy waiting room of his Rodeo Drive enclave, Epione, an aesthetic surgery center in Beverly Hills. Referring to the economic challenges of the Great Recession and its recovery over the last decade, he goes on to say, "Women who were trying to show their strength and independence came to fruition by showing very strong features." But, he adds, for centuries, when the economy is strong, as it seems to be now, society has appreciated a softer, "more feminine look."
Ourian invented the Coolaser, a cosmetic dermatology office mainstay that evens skin tone. He is also the A-list's go-to expert in Hollywood, counting among his openly vocal celebrity clients Miley Cyrus, Iggy Azalea, Lady Gaga and the entire Jenner-Kardashian clan, including Kylie and Kim.
We talk about what, specifically, that new softer look might be led by, now that the chiseled cheekbones, chins and jawlines Ourian pioneered have become a worldwide phenomenon. Given his inside line, I'm hoping he'll share what the starlet subset is starting to request that they weren't requesting a year ago. He defers, not wanting to dictate trends from his "little office in Beverly Hills," but he admits he derives all of his trend intel from Facebook and Instagram, casually mentioning, on the subject of the platforms' instantaneity, the summer boob job. "Temporary breast augmentation started a few years ago because now we can inject fillers into the breasts and they go away after a few months," he explains. "So if you don't want to commit the rest of your life to being one or two sizes bigger, you can try it for a summer and fit better into your bathing suit." (And, judging by the rash of articles about the surge of temporary, non-invasive "Botox brow lifts" among the same cohort of stars and influencers who personify "Instagram Face," it's not just lips and breasts that are getting these temporary enhancements.)
And does this mean a person could theoretically "try on" Ourian's signature cheekbones too? Will party prep soon include the prosthetic cheekbones that paraded down Balenciaga's controversial Spring 2020 runway? According to Ourian, yes. "You can do the same thing with your face," he says. "You can get a filler in your face that lasts a month or two and if you don't like it, it goes away ... It's like trying something on in a dressing room. That appeals to the concept of the Instagram generation who want to change a filter and see how they look."
Whatever strange, weird extremes the fashion world might pursue, however, Ourian maintains that neither of those two adjectives should be confused with beauty. "One definition of beauty has been average," he notes. "You take a thousand people in a society and you superimpose that face. The average of those faces is what's considered to be beautiful by the people of that society, because they are not very strange." But one thing, he admits, has changed: "Now that instead of seeing a thousand people, our eyes are used to seeing millions of people because of the internet, our average has expanded."
In keeping with our ocular intake's exponential widening, Ourian concedes that the spectrum for what could be considered beautiful has expanded. Noses, he says, are no longer really a thing. "Ten years ago if you showed someone with a larger behind or a larger nose or a different skin color, few people would jump at it and say that's beautiful," he says, citing the model Winnie Harlow, who's rendered the skin condition vitiligo no less a beauty disqualifier than blue eyes or blond hair. But symmetry, he emphasizes sternly, will never go away. Rather than a cathedral, he points to the sleek sofa I'm sitting on and says pointedly, "Even furniture looks better when it's symmetrical."
After a decade of the Ourian-Kardashian beauty dynasty, however, LA's young, rising beauty vanguard seem to be ready for a look that's less kittenish, more renegade. When I meet up with 26-year-old photographer Kelia Anne MacCluskey, who's shot for PAPER, Playboy and The New York Times, and her boyfriend Lucky Pettersen, 27, a casting director who's cast campaigns for Gucci, Levi's and Calvin Klein, for drinks at a tapas spot in Highland Park, both suggest in their own way that they're constantly searching for models and talent with gap teeth or a unibrow, the sort of authentic, identifying mark that makes an instant, unforgettable impact. Pettersen, for example, philosophizes on Gen Z's desire for honesty as exemplified by 22-year-old model Salem Mitchell. After trolls compared her freckled skin to overripe fruit, Mitchell launched herself on Instagram by posting a photo in response, hashtag #bananaface.
Yet as empowering as a swing toward this aesthetic individualism might sound, it would be nave to assume that any new trend would outright eschew the inherent pressures of the beauty paradigm. New standards will be set, new expensive treatments spawned. At the moment, unibrows and sequin brows aside, all overarching signs point to a standard centered on pristine skin.
In Perfect Me, a book about the perils of our current global beauty ethic, British academic Heather Widdows attributes this growing preoccupation to a "forensic gaze" fueled by visual culture and the omnipresence of hi-def screens and cameras that require us to look smooth and luminous "not just when our picture is likely to be taken (on holidays or at weddings), but increasingly all the time ... given that we can imagine ourselves (or our failings) being photographed in almost any context." In an interview with PAPER, she cautions that the "forensic gaze of HD TV and selfie culture is something we need to take much more seriously as shaping who we think we are and putting pressure on us to perfect our faces in ways that really aren't possible for living, breathing, sweating, aging human beings." She also argues that the widening of the beauty spectrum under the auspices of the internet might actually be just the opposite: a contraction. Whereas, pre-internet, beauty norms were decided by the more localized scopes of one's cultural community into micro-ranges, these ranges are converging into a more singular worldwide beauty window with less room for divergence: "thin and slim, with breasts and butt curves, smooth, luminous, glowing skin, and large eyes and lips ... White women are just as unable to attain the beauty ideal without intervention as Asian and Black women are," she says.
But what if we could regrow our own genuine genetic skin the way it looked before sun damage, cigarettes, sleeplessness, acne and other little scars set in?
What if we rolled out of bed in the morning and didn't have to waste a single second thinking about makeup, let alone fueling the industrial beauty complex and its ecological fallout with our hard-earned third-wave feminist salaries because we'd woken up in our own living, breathing, sweating childhood skin? "That is truly the holy grail of cosmetic dermatology," according to Ourian. "What makes a kid's skin perfect aside from the fact that they haven't been exposed to the environment their skin repairs itself much faster," he explains. Up until now, there was no way to unlock the skin's reparative memory. Ourian gets enthused again. Declaratively, he pronounces: "Stem cells are going to be the biggest thing." And he's not talking about the Vampire Facial craze. He does not think having one's skin needle-scratched raw and bloody before pouring stem cell serum derived from placentas onto it is of any use. No, if you ask Ourian, the holy grail, the next Botox, is injectable skin.
In his office, he already performs a version of it with stem cells derived from the patient, but it's expensive and not as efficient or effective as Ourian believes it will soon become. "First I have to get rid of all the old junk, Coolaser to get rid of the sun damage," he explains. "To get this baby skin we have to retrain it to keep itself healthy, and that's where the stem cells come in ... but in the next five or ten years we will achieve a level of age reversal that will mimic the way your skin was in your 20s or pre-teens." He's hoping it becomes as mainstream as Botox: "For a few hundred dollars, you can get it done."
Then and now, there will always be the non-conformists who consciously push back against the ever-tightening beauty construct, whether it's dictated by Kim-face, Glass-face or any face in between. The artists, activists, intellectuals and outsiders: Alicia Keys, Salem Mitchell, Frances McDormand, Heather Widdows, maybe your daughter or son or nonbinary child, maybe mine. For her part, Widdows has this advice for anyone who wants to help broaden beauty norms: "Call out 'lookism.' We need to name it (as we once named sexism) and make body shaming not and never okay." In the meantime, Simon Ourian will be chasing his white whale. As we age, the extraorbital fat pads that cushion our eyeballs in our ocular sockets erode, and the eyes sink into the face. "We can put a fat pad in the back of the eyes surgically, but not in a quick procedure," he explains. "So that keeps me up at night. How do I put fat pads back behind the eyes without cutting faces?"
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What's the Next '"nstagram Face"? - Papermag
Cosmetic Skin Care Market is Thriving with Rising Latest Trends by 2026 | Top Players- L’Oreal, Unilever, New Avon, Estee Lauder Companies, Espa, Kao,…
By daniellenierenberg
Cosmetic Skin CareMarketBusiness Insights and Updates:
The latest Marketreport by a Data Bridge Market Researchwith the title[Global Cosmetic Skin CareMarket Industry Trends and Forecast to 2026].The new report on the worldwide Cosmetic Skin CareMarketis committed to fulfilling the necessities of the clients by giving them thorough insights into the Market. The various providers involved in the value chain of the product include manufacturers, suppliers, distributors, intermediaries, and customers.The reports provide Insightful information to the clients enhancing their basic leadership capacity identified.Exclusive information offered in this report is collected by analysis and trade consultants.
Global cosmetic skin care market is set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026.
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.Get PDF Samplecopy(including TOC, Tables, and Figures) @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cosmetic-skin-care-market
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Cosmetic Skin Care Market is Thriving with Rising Latest Trends by 2026 | Top Players- L'Oreal, Unilever, New Avon, Estee Lauder Companies, Espa, Kao,...
Research frozen by COVID-19 begins to thaw – The Age
By daniellenierenberg
Last week, she was given the all-clear to start re-entering the lab after it closed in March due to COVID-19 restrictions.
"We fired up the lab and turned everything back on. It felt fantastic to be back working towards research goals," she said.
Professor Sharon Ricardo's lab was closed under COVID-19 restrictions.Credit:Jason South
Over the last few months, she has been churning through grant writing and Zoom meetings.
She said her days spent video-conferencing and doing administrative work were "tiring but productive".
Professor Ricardo said a healthy balance between laboratory work and paperwork was important to her and her team as they "became researchers because we get excited about what we do".
They produce three-dimensional miniature kidneys from skin cells useful for disease modelling, called organoids.
The organoids are made by collecting patients' skin cells, developing them into stem cells, and "adding factors to the cell cultures to form mini kidneys," she said.
According to Professor Ricardo, the closure of the laboratories has seriously impeded some of her students' research.
One of her PhD students had one organoid experiment left to go when the restrictions came in to play and labs were closed.
"We had to freeze the lines and turn off all the incubators," she said.
The Universitys labs are reopening gradually. Hygiene and social distancing measures were being taken to ensure the safety of staff and students, she said.
"You go to the lab, perform what you need to do, and go home," said Professor Ricardo. Shes received strict instructions not to hang around the office.
Even with the new social distancing measures, she is very excited to be back with her colleagues.
"Every time I see somebody at work, I feel like I am seeing my best friend," she said.
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Universities Australia Chief Executive Catriona Jackson said COVID-19 has "upended almost every area of endeavour" across the university research sector.
"Australias researchers have pivoted their work to join the community in fighting the virus, from world-leading vaccine and treatment research to work on all aspects of the deep social and economic impact of the crisis," she said.
The pandemic has been devastating for the university research community. "The loss to university R&D [research and development] is estimated at $2.5 billion in 2020, placing at risk at least 38 per cent of research salaries," said Ms Jackson.
While specific regulations around reopening physical research facilities differ for each state and university, Ms Jackson said they are closely following guidance from medical authorities and government.
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Research frozen by COVID-19 begins to thaw - The Age
Weekly Update: Global Coronavirus Impact and Implications on Cosmetic Skin Care Market Forecast Report Offers Key Insights, Key Drivers, Technology -…
By daniellenierenberg
The recently published market study by MRRSE highlights the current trends that are expected to influence the dynamics of the Cosmetic Skin Care market in the upcoming years. The report introspects the supply chain, cost structure, and recent developments pertaining to the Cosmetic Skin Care market in the report and the impact of the COVID-19 on these facets of the market. Further, the micro and macro-economic factors that are likely to impact the growth of the Cosmetic Skin Care market are thoroughly studied in the presented market study.
According to the report, the Cosmetic Skin Care market is expected to grow at a CAGR of ~XX% during the forecast period, 20XX-20XX and attain a value of ~US$ XX by the end of 20XX. The report is a valuable source of information for investors, stakeholders, established and current market players who are vying to improve their footprint in the current Cosmetic Skin Care market landscape amidst the global pandemic.
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Reasons to Trust Our Business Insights
Critical Data in the Cosmetic Skin Care Market Report
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Regional Assessment
The regional assessment chapter in the report offers an out and out understanding of the potential growth of the Cosmetic Skin Care market across various geographies such as:
Application Assessment
The presented study ponders over the numerous applications of the Cosmetic Skin Care and offers a fair assessment of the supply-demand ratio of each application including:
below:
Global Cosmetic Skin Care Market, Product Analysis
Global Cosmetic Skin Care Market, Application Analysis
In addition the report provides cross-sectional analysis of all the above segments with respect to the following geographical markets:
Global Cosmetic Skin Care Market, by Geography
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The report resolves the following doubts related to the Cosmetic Skin Care market:
‘I found out on Facebook.’ 5 teachers share how they feel about returning to school full-time. – Mamamia
By daniellenierenberg
On Monday, it was announced thatNSW public schools will return to the classroom full time from next Monday, two months after COVID-19 restrictions forced around 800,000 children to study remotely.
Its a normal school week from next week and they need to be attending. Rolls will be marked as normal and unexplained absences will be followed up, NSW Education Minister Sarah Mitchell said on Tuesday.
However, many teachers are not pleased with how they discovered the return to full-time schooling, withNSW Teachers Federation president Angelo Gavrielatos saying the union had not been consulted before the governments decision.
He said teachers had already planned for the previously announced staggered return to school, with face-to-face learning gradually scaled up throughout term two.
This caused a lot of concern, frustration and anger among teachers and principals across the state. They turned themselves inside out not once, not twice, but repeatedly, trying to come to terms with this crisis, Gavrielatos told ABC television.
This is a pandemic that we find ourselves in thats what makes what happened last night even more important and more disrespectful.
Listen: The risk And reality of a COVID19 second wave in Australia. Post continues below audio.
Mamamiaspoke to five teachers about how they discovered the news of the return to full-time schooling, and how they feel about it. Heres what they had to say.
I went on Facebook last night and saw an article and was shocked! I checked my staff emails and there was no information. I messaged every other teacher I knew and no one had any idea except for seeing it on Facebook.
We all found this out through Facebook, except for those who dont seem to have social media, who found out when Gladys Berejeklian announced it this morning. The principals were not informed so they were unable to inform us!
There has still been no official communication from the department or our union. It was infuriating to find out on Facebook! But I dont blame any principals or teachers or the Department of Education, as they all found out at the same time as I did, in the same way. Which is disgusting!
I think its been a really hard time to navigate. I have been frustrated by the way weve been treated, but I dont blame anyone.
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'I found out on Facebook.' 5 teachers share how they feel about returning to school full-time. - Mamamia
TICEBA >< Advantages of Skin Stem Cells
By daniellenierenberg
Coronavirus and Mesenchymal Stem Cells
Therapy for Pneumonia Patients infected by 2019 Novel Coronavirus
Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)
Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus
On the website of the Harvard Stem Cell Institute you will find the following news release about the ongoing clinical trial conducted by our daughter company RHEACELLin patients suffering from limbal stem cell deficiency: Restoring vision: A stem cell therapy for cornea regeneration reaches the clinical-trial stage.
The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and several European competent national regulatory authorities. The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) for the treatment of EB.
The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and the German regulatory authority (Paul Ehrlich Institute). The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of LSCD.
In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).
In South Korea the problem of hair loss solved with the help of stem cells of adipose tissue – The Times Hub
By daniellenierenberg
New treatment for baldness has shown its effectiveness: for its realization has been applied proteins derived from stem cells of adipose tissue means. The experiment was carried out by scientists from South Korea.
The scientific staff of the Busan University as part of the experience tested the ability to cure the most familiar type of baldness androgenic alopecia, utilizing extract of stem cells of adipose tissue. This disease can not be attributed to the most hazardous to health, but it negatively affects the psychological status and life of the people. Highest quality drugs against the disease have side effects, including erectile dysfunction, therefore physicians continue to look for safe assets.
For the experiment, scientists from South Korea has invited nine women and 29 men of middle age who had suffered from androgenic alopecia. They were divided into two groups, representatives of one of them they rubbed my skin with the extract of stem cells, and the second placebo. Four months later, the experience of those volunteers, to whom was applied the protein to stem cells, the researchers found a significant increase in hair volume and diameter of follicles. Next, the researchers intend to perform a similar experiment with a larger number of respondents from different population groups.
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In South Korea the problem of hair loss solved with the help of stem cells of adipose tissue - The Times Hub
Stanford Researchers Investigate New Drug that Can Treat Mild COVID-19 Cases and Stem Viral Shedding – HospiMedica
By daniellenierenberg
Image: A scanning electron microscope image of SARS-CoV-2 (Photo courtesy of NIAID-RML)
The drug, interferon-lambda, is a manufactured form of a naturally occurring protein that has been given in previous clinical trials to more than 3,000 people infected with hepatitis viruses. Results in laboratory settings and in animals also suggest that lambda-interferon may be helpful in controlling viruses that cause respiratory illnesses such as influenza and SARS, an often fatal disease, as well as help snuff out other common viral infections. Interferon-lambda orchestrates the bodys natural defenses against infection by issuing a call in the troops order to constituent cells of the immune system. Receptors for interferon-lambda are restricted to the linings of the lungs, intestine and liver, thus producing fewer side effects.
The clinical trial is underway at Stanford Medicine will determine whether the drug can keep people who have just tested positive for the coronavirus out of the hospital, help them recover faster and make them safer to be around in the meantime. The researchers will also investigate whether the drug stems viral shedding, which would reduce transmission to family members and the community. The investigators are recruiting 120 participants who have just been diagnosed with cases of mild COVID-19 at Stanford Health Care and other local hospitals, emergency rooms, clinics and drive-through testing sites. Trial participants, randomly sorted into two groups, will be given single injections under the skin of either a placebo or interferon-lambda. Then they will be monitored for 28 days for symptoms, disease severity, rates of hospitalization, and duration and quantity of viral shedding.
Even though these individuals may not need hospitalization, infection with COVID-19 results in respiratory symptoms and lost productivity, said Upinder Singh, MD, professor of infectious diseases and of microbiology and immunology at the school, who is co-leading the study. Plus and this is important patients with mild disease contribute to community disease transmission. Limiting viral shedding from this group would reduce transmission to family members and others, which is crucial to controlling epidemic disease spread.
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Stanford Researchers Investigate New Drug that Can Treat Mild COVID-19 Cases and Stem Viral Shedding - HospiMedica
‘I need to talk about the ‘third birth’ no one prepares you for: The post-baby poo.’ – Mamamia
By daniellenierenberg
I didnt have any mum friends to give me the heads up on this a few years ago, and I vowed to never let someone else walk into that battlefield unprepared.
I know poo talk isnt very graceful, but knowledge is power, and absolutely no one had given me the much-needed secret poo power prep talk.
So, heres yours, with all the learnings that made my second time around much more bearable.
LISTEN: We take a look at the final month of pregnancy, including what to pack in your hospital bag. Post continues after audio.
Soften those bad boys up with stool softeners. If you ignore them, theyll go away only works for door-knockers. The longer you leave these guys, the harder theyll knock. With each passing day, your poo will join forces and create a solid army. A rock-solid army of pain.
Pushing can be a scary feeling. Everything down there is vulnerable, and I was worried I might give birth to my entire uterus mid poo. I didnt (phew). I found the stool softeners helped with this and I didnt need to use so much scary force the second time round.
So to sum it up? Prunes and prune juice are your friends, drink loads of water, and dont be afraid to ask for laxatives if you need them.
Hold your fragile stitched (or unstitched) front if that makes you feel more comfortable and secure. It may still be an uncomfortable experience, but it doesnt have to feel like the ass apocalypse I experienced. NO ONE PREPARED ME FOR IT.
Dont be scared though, Id still do it all again for my kids. Just be prepared so you can crap like a queen on the porcelain throne.
If you didnt struggle with a post-birth poo, I have only one question How does it feel to be one of Gods favourites?
This post originially appeared on Living My Family Life and has been edited and republished with full permission.
Katie Bowman is a mum to a 4-year-old girl and two-year-old twin girls. A part-time hairdresser, she spends her time blogging about her days of chaos on her Facebook page,Living My Family Life.
Feature Image: Supplied.
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'I need to talk about the 'third birth' no one prepares you for: The post-baby poo.' - Mamamia
What It’s Like to Grow a ‘Mini-Brain’ From Your Own Cells – Discover Magazine
By daniellenierenberg
This story appeared in the June 2020 issue as "Out of His Mind."Subscribeto Discover magazine for more stories like this.
It isnt every day that writer Philip Ball is asked to contribute to scientific experiments typically, hes reporting on them instead. But in 2015, scientists from a London-based project called Created Out of Mind asked Ball and a few other creatives if theyd participate in their work and then reflect on the experience. He agreed.
Ball first gave a sample, made up of cells from his skin, which was reprogrammed into stem cells that were subsequently grown into a brain organoid or, as the research team called it, a miniature brain in a dish. These futuristic-sounding specimens arent literal brains, and they dont look it, either. The round, cream-colored clusters of neurons simply resemble little blobs. Theyre not conscious. But they can be studied to better understand brain development such as where and when certain proteins misfold, which can signal whether a person will develop dementia.
This stained microscope image shows cells growing in a cross-section of a brain organoid, with neurons visible in red. (Credit: Chris Lovejoy and Selina Wray)
The researchers then asked Ball to reflect on his experience through writing. What started as a few blogs for Created Out of Mind eventually bloomed into a book, How to Grow a Human. Here, Ball recounts his time spent with his mini brain, and how the process gave him new insight into the future of lab-grown life.
Id pop into the lab from time to time and see how things were going. At one point, I stopped by and one of the researchers told me that the organoids werent looking great for some reason, they werent growing as they thought they might. We werent sure quite how they were going to turn out, and in the end many of them died before they could fully form.
Philip Ball (Credit: Richard Houghton)
But one day, out of the blue, one of the project leaders dropped me an email with photos and said, Look, heres your mini brain. And there it was ... I wish there was some drama to it, but the researchers were pretty casual about it because they grow these things all the time. And I wish I could say that I remember thinking, Oh my God, this is my second brain, but I think I was more relieved than anything that it actually grew into an organoid. The fact that they actually got one that had these really clear, discernible structures in it was pretty remarkable. If anything, I felt a little bit proud of myself that we actually created something in the end.
For me, one of the really interesting things I gleaned from the project was that the stuff we are made from is incredibly versatile. The technology of transforming cells from virtually any other tissue in the body is relatively new, and its leading to all sorts of directions in medicine and research. I was fascinated to see firsthand what extraordinary things cells even mature, adult cells are capable of.
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What It's Like to Grow a 'Mini-Brain' From Your Own Cells - Discover Magazine
The Cell Therapy Industry to 2028: Global Market & Technology Analysis, Company Profiles of 309 Players (170 Involved in Stem Cells) -…
By daniellenierenberg
DUBLIN--(BUSINESS WIRE)--The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.
The cell-based markets was analyzed for 2018, and projected to 2028. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.
The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 309 of these are profiled in part II of the report along with tabulation of 302 alliances. Of these companies, 170 are involved in stem cells.
Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 25 Figures. The bibliography contains 1,200 selected references, which are cited in the text.
This report contains information on the following:
The report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.
Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.
Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.
Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.
Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.
Key Topics Covered
Part I: Technologies, Ethics & Regulations
Executive Summary
1. Introduction to Cell Therapy
2. Cell Therapy Technologies
3. Stem Cells
4. Clinical Applications of Cell Therapy
5. Cell Therapy for Cardiovascular Disorders
6. Cell Therapy for Cancer
7. Cell Therapy for Neurological Disorders
8. Ethical, Legal and Political Aspects of Cell therapy
9. Safety and Regulatory Aspects of Cell Therapy
Part II: Markets, Companies & Academic Institutions
10. Markets and Future Prospects for Cell Therapy
11. Companies Involved in Cell Therapy
12. Academic Institutions
13. References
For more information about this report visit https://www.researchandmarkets.com/r/7h12ne
Stem cells therapy A prospective treatment against coronavirus? – Daily Excelsior
By daniellenierenberg
Dr Shikha Sharma
Coronavirus disease (COVID-19) is an unforgettable word in 2020. World health organization has declared COVID-19 as pandemic and according to the Worldometer site, it has affected 212 countries and territories and has caused approximately 2.8 lakhs deaths so far. According to the various published scientific evidences COVID-19 is an infectious disease caused by new coronavirus that can lead to lung dysfunction. There are 7 coronaviruses that are known to cause disease in humans and among these 3 can cause the severe respiratory infection. These are severe acute respiratory syndrome coronavirus (SARS-CoV) identified in 2002 in China, Middle East respiratory syndrome coronavirus (MERS-CoV) identified in 2012 in Saudi Arabia and severe acute respiratory syndrome coronavirus2 (SARS-CoV2) commonly called COVID-19 identified in late 2019 in Wuhan, China. SARS-CoV, MERS-CoV and COVID-19 are closely related but COVID-19 spread more quickly than the other two. Over 8000 people from 29 different countries were affected with SARS-CoV epidemic during 2002-2004 while 40.78 lakhs people are affected with COVID-19 so far. In most cases, immune response (bodys defence system) triggered by the COVID-19 infection is sufficient to combat its pathogenesis leads to the recovery of patient. However, in some cases, COVID-19 infection causes highly inflammatory form of lung cells death and injury as the most dangerous phase of its pathogenesis which leads to the overproduction of inflammatory cytokines by bodys own immune cells creating cytokine storm that results in damage to the lung tissues causing pneumonia, acute respiratory distress syndrome (ARDS) and sepsis. In Pneumonia and ARDS air sac of lungs fill with fluid or pus. These complications lead to severe condition such as shortness of breath that require treatment with oxygen and ventilator. Therefore controlling inflammatory response is utmost important to prevent coronavirus lethality rate and for the longer life of a patient. Currently no specific treatment is available for COVID-19 infection but several vaccines, drugs and stem cells testing in various countries has generated hope to combat its pathogenesis. Recent breakthrough has demonstrated mesenchymal stem cells (MSCs) as cell medicine therapy to reduce COVID-19 infection.What are MSCsMSCs are multipotent adult stem cells that are capable of differentiating into various cell types such as fat cells, bone cells, liver cells, pancreatic cells, brain cells, heart cells and skin cells thus can participate in the repair and regeneration of various tissues and organs of the body. Inside the body, upon injury, MSCs migrate to the injured site and participate in the regeneration and repair of the organ either by differentiation or by paracrine secretion or both. In addition MSCs possess immunomodulatory and anti-inflammatory properties that contributes to its cell medicinal properties. MSCs can be isolated from various tissues such as bone marrow, peripheral blood, body fat, muscle, placenta, umbilical cord, umbilical cord blood, teeth and hair follicles and can be expanded ex vivo and used for transplantation for treating disease and disorders after genetic stability test.How MSCs reduce COVID-19pathogenesisAs reported by various research groups that upon intravenous injection or through mist inhalation the significant population of MSCs migrate to the lung and secrete various immunomodulatory and anti-inflammatory factors to cure lung dysfunction by normalizing immune response altered by COVID-19 and stimulate lung repair. Moreover MSCs are resistant to COVID-19 infection and can be used for autologous and allogenic transplantation.Clinical trial with MSCs for COVID-19There are several clinical trials registered with MSCs for the treatment of COVID-19 from various countries such as China, USA, UK, Germany, UAE, Jordan and Iran and some reports have been published. Approximately 100 patients have been treated with MSCs therapy from moderate to critical conditions within 10-15 days of transplantation. A first case treated with MSCs showed the recovery of 65 year old critical ill patient in Baoshan Peoples Hospital, Longling County, China. Initially the patient was treated with antiviral therapy and immunomodulator thymosin alpha1 but hasnt shown any recovery. Later after 10 days patient was diagnosed with severe pneumonia, acute respiratory distress syndrome, multiorgan injury, type2 diabetes, moderate anaemia, electrolyte disturbance, immunosuppression, acute gastrointestinal bleeding and other symptom was shifted to ICU and on ventilator. They showed that after three MSCs injections along with thymosin alpha1 lead to the recovery of patient from COVID-19 infection. FDA has approved 24 patient clinical trial in USA to test safety and efficacy of MSCs from umbilical cord to prevent COVID-19 infection. Recently, in USA three critically ill patients in ICU and on ventilator recovered from COVID-19 infection with MSCs treatment. An Israeli pharmaceutical company Pluristem therapeutics have tested MSCs therapy on 7 critically ill patient and found positive results. More recently, UAE also reported the treatment of 73 COVID-19 infected patients with stem cells. They have developed the technology to isolate the stem cells from patient blood, activate them and reintroduce them by mist inhalation. These reports are indicative that MSCs hold the potential to treat the COVID-19 infection by preventing bodys own defense system from overreacting and normalise its response to fight against COVID-19 infection. Many companies from different countries are seeking approval to begin clinical trial with stem cells against COVID-19 infection.Why are we lagging behind when we have stem cell companies/labs/facility in our country? We also produce GMP grade stem cells for transplantation. China tested the stem cell therapy on first patient when all other therapies failed and stem cells was one of option left to save the life of the patient. In India also so many deaths are happening due to COVID-19 we can also check if stem cells can reduce the mortality rate. Moreover as per some reports MSCs dont stay inside the body for more than 1-3 months and they eventually die and dont result in teratoma formation. Our government along with doctors and scientist can also formulate committee on stem cells and begin such initiative to test MSCs for the treatment of COVID-19 infection. Nevertheless, MSCs has joined the army along with the other possible interventions to prevent the COVID-19 illness.(The author is (PhD and Postdoc in Stem Cells)feedbackexcelsior@gmail.com
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Stem cells therapy A prospective treatment against coronavirus? - Daily Excelsior
Augustinus Bader Launches The Hand Treatment in Response to COVID-19 Pandemic Exclusive Details – Allure
By daniellenierenberg
As a skin-care brand, Augustinus Bader prides itself on releasing products not out of frivolity or trying to up its bottom line, but out of necessity. As Charles Rosier, cofounder and CEO of Augustinus Bader, puts it: "We want to only add product when we feel we are relevant," he tells Allure via phone from Paris, France, where he is currently self-isolating. "Our latest initiative was a reaction to something that we felt was needed by the consumer by everyone."
The brand's newest offering, The Hand Treatment, is meant to be just that. As it stands, given the current COVID-19 situation, we are all washing our hands (or should be) much more than we might otherwise normally do so. However, as you've also likely experienced dry skin and flaking cuticles, just as is the case with everywhere else on the body, overwashing the skin on our hands can bring on a host of issues all their own. Even if you forgo washing for an alcohol-based hand sanitizer, the effects can be just as profound if not more so.
"We are seeing more and more hand dermatitis," explains New York City-based board-certified dermatologist Dhaval Bhanusali, who is not affiliated with Augustinus Bader. "By overwashing, we strip the good oils from our skin and leave it dry and susceptible to breakdown."
Our skin's moisture barrier is responsible for keeping the good things in (like hydration and natural oils) and the bad things out (like allergens and bacteria). When the lipid barrier on the hands (or anywhere on the body) becomes too dried out, it can literally start to break down and lose functionality. Simply put, in order for our skin to function and remain healthy, its barrier must be intact. However, we're not saying that you should stop washing your hands just that it's equally important to replenish hydration after doing so.
That's where Augustinus Bader's new Hand Treatment comes into play. It's formulated with a blend of ultra-nourishing ingredients, including vitamin E, glycerin, and shea butter, as well as honey and white peony extract both of which also have natural antibacterial properties. However, as with all Bader products, the key ingredient is something called TFC8, which stands for its proprietary Trigger Factor Complex-8.
For those unfamiliar with the brand, TFC8 is not one singular ingredient but rather, a proprietary blend of "natural amino acids, high-grade vitamins, and synthesized molecules naturally found in skin," cosmetic chemist Ginger King (who is not affiliated with the brand) previously told Allure. In a nutshell, TFC8 provides an ideal environment in which our skin's stem cells can naturally regenerate it acts as a sort of guide, helping to set the skin's inherent repair system back on track.
"The TCF8 technology focuses on intrinsic repair processes based in intrinsic repair cells, which we call stem cells," Bader explains. "We wanted to develop a hand cream with our technology, which helps to protect and care for the skin."
The results of using TFC8 topically, according to Augustinus Bader himself, a German stem-cell scientist, and his many devotees (our own editor in chief among them), read like a laundry list of skin-care goals: Increased hydration, a strengthened skin barrier, faded fine lines, and dark spots. The proprietary ingredient is, of course, also formulated into the brand's other offerings: two creams for the face, one for the body, and most recently, a makeup primer collaboration with Victoria Beckham Beauty.
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Augustinus Bader Launches The Hand Treatment in Response to COVID-19 Pandemic Exclusive Details - Allure
Citius Announces Data on NoveCite Mesenchymal Stem Cells (NC-MSCs) to be Presented at the American Society of Gene and Cell Therapy (ASGCT) Annual…
By daniellenierenberg
CRANFORD, N.J., May 13, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that data on NoveCite MSCs will be presented this week at the American Society of Gene and Cell therapy (ASGCT) annual meeting. NC-MSCs are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. Earlier this year, Citius signed an exclusive option agreement to in-license NC-MSCs for acute respiratory distress syndrome (ARDS), including in COVID-19 patients, from Novellus.
The data to be presented show that NC-MSCs secrete higher levels of anti-inflammatory proteins compared to MSCs derived from bone marrow. From the abstract: "Comparative secretome analysis showed overexpression of multiple neuroprotective and anti-inflammatory factors, including CXCL1, VEGF-A, and CXCL5." In addition, NC-MSCs showed therapeutic benefit in an experimental autoimmune encephalomyelitis (EAE) mouse model, delaying disease progression and improving the clinical score compared to the control group, while bone marrow-derived MSCs showed no difference from the control.
"We are pleased to present these data at the annual meeting of the ASGCT," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus. "While conventional MSCs have shown promise in the treatment of inflammatory lung disease, protein secretion and manufacturability remain challenges for these approaches. The data that will be presented this week show that iPSC-derived MSCs secrete higher levels of anti-inflammatory proteins, and exhibit greater expansion potential than bone marrow-derived MSCs. We believe that these properties make iPSC-derived MSCs especially well-suited for an allogeneic cell therapy for ARDS."
"Last month Citius signed an exclusive option agreement with Novellus for worldwide development and commercial rights related to the use of these uniquely derived MSCs for the treatment of ARDS. The pre-clinical data that is being presented at the ASGCT annual meeting adds to our confidence in the higher potency of these MSCs, which we expect will result in better outcomes for patients with COVID-19 and ARDS," stated Myron Holubiak, CEO of Citius Pharmaceuticals. "We intend to study these cells in the clinic later this year to determine safety, efficacy, and the optimal dose of these cells in moderate to severe ARDS patients with COVID-19."
Citius has submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) for use of these MSCs for patients with Acute Respiratory Distress Syndrome (ARDS) due to SARS-CoV-2 disease.
Presentation Information:Title:Mesenchymal Stem Cells (MSCs) Generated Using mRNA Reprogramming Show Enhanced Growth Potential, Secretome, and Therapeutic Efficacy in a Demyelinating Disease ModelPresenter:Harris, Jasmine, Novellus, Inc.Date and Time: Wednesday, May 13 | 5:30 PM - 6:30 PM
About Acute Respiratory Distress Syndrome (ARDS)ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.
About Coronavirus Treatment Acceleration Program (CTAP)In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 will benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.
About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.
About Novellus, Inc.Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.
Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the ability to access the FDA's CTAP program for the MARCO trial; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and our Phase III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing our product candidates, including any licensed from Novellus, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.
Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677 x105 [emailprotected]
SOURCE Citius Pharmaceuticals, Inc.
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Citius Announces Data on NoveCite Mesenchymal Stem Cells (NC-MSCs) to be Presented at the American Society of Gene and Cell Therapy (ASGCT) Annual...
QurAlis Hauls In $42M to Move New ALS Therapies Into Human Testing – Xconomy
By daniellenierenberg
XconomyBoston
Few drugs exist that treat amyotrophic lateral sclerosis, a progressive disease that kills the nerve cells that allow patients to initiate and control muscle movement.
QurAlis, a Cambridge, MA-based startup, has an ambitious plan to develop a number of precision therapies for the disease based on forms of the condition identified by genetic mutation or a biomarker that CEO Kasper Roet (pictured) hopes to could one day, in combination, help most ALS patients.
Now the company has raised $42 million from investors in the US, Europe, and Japanmoney that will fund a move from the LabCentral incubator in Kendall Square to its own office, more than double the companys headcount by years end, and get at least one of its programs into human testing sometime next year.
The company is leveraging stem cell research from company co-founders Kevin Eggan and Clifford Woolf, Harvard University professors whoby harvesting normal skin cells from ALS patients and turning them into cells such as the motor neurons that damages as the disease progresseshave created models with the same DNA and gene mutations as those patients in an effort to identify new therapeutics for known ALS genes.
Mutations in more than 25 human genes have been implicated in ALS, the company says, and its strategy is to systematically investigate treatments targeting specific disease-causing mechanisms in patient subgroups. Some of those genes are also believed to cause frontotemporal dementia, a common cause of dementia that QurAlis also plans to treat.
One program QurAlis is advancing is intended for patients whose neurons are damaged and killed by the overactivation of certain receptors for glutamate, a key neurotransmitter, in a process known as excitotoxicity.
The company is also working on a treatment intended to return the autophagy process, through which cells recycle unwanted or damage components, to normal functioning. To do so, QurAlis is looking to target the enzyme TBK1, which plays a key role.
Roet, in an interview, said the company views its strategy as analogous to that pursued by Bostons Vertex Pharmaceuticals (NASDAQ: VRTX), which has developed multiple drugs for forms of cystic fibrosis (CF) caused by certain mutations, and late last year received approval for a combination of those drugs for about 90 percent of all CF patients.
We have identified ALS as a disease that we think we understand now, at least for specific subgroups of patients, he said. We understand what is driving the disease and we are able to develop very specific therapies for those patients.
Eggan, Woolf, Roet, and Jonathan Fleming launched QurAlis just over two years ago with seed funding from investors including MP Healthcare Venture Management, the investment arm of Mitsubishi Tanabe Pharma; the investment arm of Amgen (NASDAQ: AMGN); and Alexandria Venture Investments. Mitsubishi Tanabe markets edaravone (Radicava), one of four FDA-approved treatments for ALS. The FDAs 2017 nod for the drug made it the only ALS therapy OKd in the past 20 years.
The Cambridge, MA-based company said the new capital, a Series A financing round, brings the total it has raised to $50.5 million. The investment was led by LS Polaris Innovation Fund, Mission BioCapital, Dutch firm Inkef Capital, and the Dementia Discovery Fund. New investors including Droia Ventures, which operates from Luxembourg and Belgium, Mitsui Global Investment, and Dolby Family Ventures also participated, as did earlier investors including Amgen, MP Healthcare, and Sanford Biosciences.
As part of the deal, LS Polariss Amy Schulman, Inkef Capitals Roel Bulthuis, Dementia Discovery Funds Jonathan Behr, and Droia Ventures Luc Dochez join Mission BioCapitals Johannes Fruehauf on the QurAlis board.
Earlier this year some of the same investors, including Amgen and Dolby Family Ventures, backed a Series A financing for EnClear Therapies, a spinout of QurAlis. That company raised $10 million to advance the development of a dialysis-like medical device designed to filter out harmful proteins in the cerebral spinal fluid of patients with neurodegenerative diseases.
Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.
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QurAlis Hauls In $42M to Move New ALS Therapies Into Human Testing - Xconomy
Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003 – Yahoo Finance UK
By daniellenierenberg
Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003
Mont-Saint Guibert, Belgium, 13 May, 2020: Novadip Biosciences (Novadip or the Company), a clinical-stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform, today announces positive data from the interim analysis of its Phase I/IIa clinical trial for autologous NVD-003 in adults with non-healing fracture of the lower limb.
NVD-003 is a novel autologous cell-based osteogenic (bone healing/[bone forming]) product that has been generated from Novadips proprietary 3M tissue regeneration platform. This platform is aimed at healing damaged tissues by restoring their natural physiology and consists of a 3-dimensional, scaffold-free extracellular matrix (ECM), utilizing differentiated adipose-derived stem cells (ASCs) to restore the physiology of natural healing. NVD003 presents as a scaffold-free 3D implant to fill critical-size bone defects where healing is compromised.
This phase I/II study is investigating in five European centers the potential of NVD-003 to promote bone union in nine adults with a non-healing fracture of the lower limb. There was 100% manufacturing success for NVD-003 and grafting surgery was completed successfully in all patients without deviating from standard medical practice. To date, with a median of 12 months post-treatment, no NVD003 related safety signal has been reported. Further exploratory analysis performed on data from the first five patients to complete a six month follow up showed a strong positive trend in radiological healing with confirmed bone formation for all patients and radiologically confirmed union for three of the patients.
Prof. Gunnar Anderson (MD, PhD), Professor and Chairman Emeritus of the Department of Orthopedic Surgery at Rush University Medical Center, Chicago, Illinois and Chairman of the Scientific Advisory Board commented: The early results of this study are remarkable both clinically and for the patients and we look forward to replicating these in a larger group in the future. It is hugely encouraging that we may potentially have a future solution for these patients with unmet needs.
Dr. Denis Dufrane (MD, PhD), Chief Executive Officer, Chief Scientific Officer commented: We are encouraged by the data from this interim analysis, which demonstrates the potential of our tissue regeneration 3M3 platform to restore natural healing processes in patients with reputedly difficult to treat bone defects. We look forward to further progressing NVD-003s clinical program in bone non-union and in patients with other similar conditions with no effective treatment option and hope to provide full study results in 2025.
NVD-003 is also in clinical stage for congenital pseudarthrosis of the tibia (CPT), a rare and disabling pediatric condition with very limited treatment options and has demonstrated clinical proof-of-concept in case studies.
Novadips tissue regeneration platform drives several new classes of product candidates with an initial focus on autologous cell therapies for critical size tissue reconstruction. Allogeneic therapeutics are in development for prevalent and complex tissue defects for bone and skin tissue and exosomes/miRNA-based therapeutics are being developed for immediate (off-the-shelf) clinical use.
- End -
Notes to editors
Novadip Biosciences
Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its unique 3D tissue regeneration technology platform to generate multiple product candidates to address hard and soft tissue reconstruction for patients who have limited or no treatment options. The companys proprietary 3M3 platform is a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly-specific growth factors and miRNAs to mimic the physiology of natural healing and creates a range of products that address specific challenges in tissue regeneration. Novadips initial focus is on critical size bone reconstruction. The company is also applying its 3M3 platform to develop truly novel off-the-shelf/allogeneic therapies to address more prevalent tissue defects and miRNA/exosome products for broader indications. For more information, visit http://www.novadip.com .
For further information, please contact:
Novadip Biosciences
Denis Dufrane
Chief Executive Officer, Chief Scientific Officer
+32 (10) 779 220
For media enquiries:
Consilium Strategic Communications
Chris Gardner, Matthew Neal, Angela Gray
+44 (0) 20 3709 5700
Protocol Management, Off-the-Shelf Therapies Help Bring CAR T Into More Settings – Targeted Oncology
By daniellenierenberg
Carlos R. Bachier, MD
Chimeric antigen receptor (CAR) T-cell therapies quickly burst into the spotlight of hematology-oncology disease management because of their potential to illicit deep and durable responses from patients whose disease is relapsed or refractory to multiple previous lines of therapy. Relevant professional meetings and oncology publications exploded with research and news about CAR T cells, and this cellular therapy strategy is now being explored across hematologic and solid malignancies.
CAR T cells are a scientific revolution, Tania Jain, MBBS, assistant professor of oncology at Johns Hopkins University in Baltimore, Maryland, said in an interview with Targeted Therapies in Oncology (TTO). They have brought about a paradigm shift in terms of how were treating patients.
The 2 currently FDA-approved CAR T-cell therapies, axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), are both indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma; additionally, tisagenlecleucel is approved for patients up to 25 years with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1-3 With a second wave of approvals likely on the horizon for therapies such as lisocabtagene maraleucel (liso-cel) and idecabtagene vicleucel (bb2121), CAR T is gaining traction and will likely play an increasingly prominent role in the future treatment paradigm in oncology.
CAR T-cell therapy administration is largely limited to the inpatient setting at both academic institutions and large accredited cancer centers, making such treatments unavailable to most patients. Other challenges with this type of therapy include its potential to cause serious toxicities resulting in organ damage and death.4
David G. Maloney, MD, PhD
Due to the promising efficacy of these agents, investigators have been working toward viable solutions to bring CAR T-cell therapies to more patients by alleviating difficulties associated with therapy delivery and patient care.
CAR T-cell therapies, both those currently approved and the many being explored in late-phase clinical trials, are produced from autologous T cells obtained from the patient receiving therapy. This personalization has led to tremendous success, yet it is a large part of why CAR T-cell therapy use remains limited to a select group of patients.
Time is an important consideration for patients who have experienced multiple relapses and may be too weakened by numerous lines of prior therapy to wait several weeks for the CAR T-cell manufacturing process. The effects of previous treatments or the disease itself can also present challenges, as manypatients are rendered lymphopenic and may be unable to produce enough T cells for harvesting. Roadblocks may remain for patients who are not limited by these factors; manufacturing success and effectiveness of the CAR T-cell product can be negatively influenced by disease-related dysfunctions of patients T cells.4
A new option, off-the-shelf CAR T-cell products, may help solve these problems. These premade products are manufactured using allogeneic donor cells (instead of autologous cells from the patient), and they present immediate advantages to clinicians, such as immediate availability, opportunity for product standardization, and decreased cost.5
The advantages [include] being able to access the cellular therapy in real time, as opposed to autologous products that havetobe manufactured,Craig S. Sauter, MD, clinical director of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center in New York, New York, explained in an interview withTTO. This is particularly important for patients who are not responding to therapy, which is a current requirement for treatment with CAR T cells, he added.
Findings from a phase I trial (NCT01430390) in patients with relapsed or refractory B-cell malignancies showed that patients with non-Hodgkin lymphoma (NHL) experienced durable responses with an Epstein-Barr virusspecific cytotoxic lymphocyte CAR product derived from cells harvested from third-party donors (rather than from their more precisely matched stem cell donors). All 4 patients with NHL and a single patient with chronic lymphocytic leukemia, who were treated with third-party cells, remained disease free and alive at the time of analysis, with a median follow-up of over 2 years.6
The advantages [of this type of therapy are] that it eliminates the need for apheresis [and] shipping cellular products back and forth. [Instead, clinicians] have a pharmaceutical product on the shelf for access, Sauter, who was an author on the trial, said. Another notable product being investigated in clinical trials is UCART19, an allogeneic engineered anti CD19CAR T-cell product, which is being evaluated in the phase I CALM trial in adult patients with relapsed or refractory B-cell ALL (NCT02746952) and in the phase I PALL trial of pediatric patients with relapsed or refractory CD19-positive B-cell ALL (NCT02808442). Other off-the-shelf agents are described in theTABLE.5
Issues with inpatient CAR T-cell therapy administrationinclude high demands on health care resources and strain on patients and their families. Moving treatment to the outpatient setting has the potential to reduce this strain; however,clinicians taking over care of patients receiving CAR T-cell therapy must be prepared with the proper resources to identify and manage adverse events associated with therapy.
One of the most notable risks to patients receiving CAR T-cell therapy is cytokine release syndrome (CRS), a systemic inflammatory response that is characterized by increased serum levels of inflammatory cytokines, fever, hypotension, hypoxia, and organ dysfunction.4 [CAR T] can also lead to neurological events and can cause confusion and, in some patients, seizures,Carlos R. Bachier, MD, Director of Cellular Research at Sarah Cannon Cancer Center in Nashville, Tennessee, explained in an interview with TTO.
Regardless of the infusion setting, patients require close monitoring in the hours and days following therapy administration. A review byLucrecia Yez, PhD, MS, and colleagues stated that key criteria for treating patients in the outpatient setting include an educated caregiver and necessary infrastructure allowing for outpatient visits plus adequate emergency and intensive care unit (ICU) access. Patients followed as outpatients must be given twice-daily temperature checks for a minimum of 14 days following treatment and preferably extending up to 3 to 4 weeks following infusion. Anysigns of back pain, skin rash, dizziness, chills, shortness of breath, chest pain, tachycardia, or neurological events that may indicate neurotoxicity or signs of CRS must be reported immediately so treatment can begin as quickly as possible.7
Because of the risk of CRS and neurotoxicity, both FDA-approved agents are restricted under the Risk Evaluation and Mitigation Strategy, an FDA-mandated program that builds in caution for use of agents with serious safety concerns.8,9 Therefore, 2 doses of tocilizumab (Actemra), an interleukin (IL)-6 receptor antagonistthat was approved in 2017 for management of CRS associated with CAR T-cell therapy,1,4 should be on hand for each patient before the infusion of CAR T cells. Steroids have also demonstrated efficacy against CRS, but concernssurrounding CAR T-cell suppression with these agents have established them as a second-line choice after tociluzumab.9
Immune effector cellassociated neurotoxicity syndrome (ICANS) is a group of neurologic symptoms associated with treatments such as CAR T-cell therapy. Predisposing factors include younger age, higher tumor burden, high levels of pretreatment inflammation, and history of early or high-grade CRS. Treatments for complications of ICANS vary. Some centers may prescribe prophylactic antiepileptic medications, such as levetiracetam, to prevent seizures in patients with grade 2 or higher neurologic events. AntiIL-6 therapy can be considered in patients with concurrent CRS, but corticosteroids are the preferred regimen in those with neurotoxicity alone.9
In February of this year, the investigational CAR T-cell product liso-cel was granted priority review by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who had undergone at least 2 prior therapies.10 Investigators believe that liso-cel therapy may have a place in a broad range of patients and in the outpatient setting.11
It turns out liso-cel has a low incidence of [CRS and ICANS], and they occurred relatively late compared with other products, said Bachier. Because of this low incidence, the strategy was to deliver liso-cel in an outpatient setting.
The feasibility of liso-cel administration on an outpatient basiswas evaluatedby Bachier and colleagues, and the results were presented at the 2020 Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood & Marrow Transplant Research, held February 19 to 23, 2020, in Orlando, Florida.12
The authors analyzed data from 3 clinical trials of liso-cel, with a focus on the subset of participants who were treated as outpatients. The included trials were the phase I TRANSCEND-NHL-001 (NCT02631044) and phase II OUTREACH (NCT03744676) trials in patientswhohadundergone at least 2 lines of prior treatment, as well as the PILOT study (NCT03483103), which examined liso-cel as second-line therapy in patients who were ineligible for autologous hematopoietic stem cell transplant because of age, organ function, or ECOG performance score. All 3 studies allowed outpatienttreatment, with some patients receiving their therapy in the nonuniversity setting.
This clinical trial included sites that were not a part of a university but had experience treating patients for stem cell transplant, Bachier said. Some of these sites that participated were notyour traditional university centers that had traditionally been involved in the development of these therapies.
Much caution was required in order to maximize patient safety and treatment efficacy. The approach of doing CAR T-cell therapy, in general, in the outpatient setting requires a robust clinical ability of the centers, said coauthor David G. Maloney, MD, PhD, medical director of Cellular Immunotherapy at the Immunotherapy Integrated Research Center of Fred Hutchinson Cancer Research Center in Seattle, Washington, in an interview. We were able to get people safely to the hospital, and it was rare that you would have to do escalation of care when people were admitted. Most of the time, patients could bemanagedand wereout of the ICU, withrare exceptions. But again, you still have to have the wherewithal to get patients to the ICU pot entially for aggressive care if needed.
Results of the analysis of outpatient data from the 3 trials showed that rates of toxicity and response were similar to those previously reported for the entire patient cohort (both inpatients and outpatients) of the TRANSCEND-NHL-001 trial.
Based on these results, the indication is that you can deliver [liso-cel] in the outpatient setting and the outcomes are good compared with those treated in the inpatient setting, said Bachier. Aside from that, it also showed that liso-cel could be safely administered outside of university programs and in more community-based programs, most of them being aligned [with] or part of stem cell and bone marrow transplant programs.
When planning or setting up a CAR T-cell therapy outpatient program, investigators anticipate possible barriers to successfultreatment. The greatest barrier, according to Bachier, is access to physicians and staff who are knowledgeable and trained to manage toxicities related to CART-cell therapy. These therapies still should not, in my opinion, be delivered [by clinicians in] community centers that do not have the expertise to deliver the therapies safely, he said.
Maloney added that centers should be required to have the ability to triage patients 24/7 and allow for patients to be directly admitted to the hospital if needed. In the case of the analysis of outpatient data from the 3 liso-cel trials however, he said, We found that around 30% to 40% of patients did not actually ever require hospitalization, whichis quite interesting. Most of the 60% to 70% of patients who were hospitalized were admitted for fever, he added.
In addition, sites must gain accreditation and approval, Jain pointed out.
Every center that intends to do CAR T-cell therapy is first approved by each of the companies [that manufacturethese agents], Jain said. The centers also have to be approved by FACT [Foundation for the Accreditation of Cellular Therapy], which is the same organization that approves centers for allogeneic stem cell transplant. These are some of the largest things that a center needs to go through, which takes care of things like developing standard practices and other guidelines to make sure that these [therapies] are used safely and appropriately.
As investigators and oncologists explore the feasibility of moving CAR T-cell therapy into more settings, 2 questions arise: What settings have on this therapy?
What type of training and skills do clinicians need? Like other clinicians, Sauter has concerns about new allogeneic cellular therapies,andhe hopes future research will focus on mitigating these challenges. The concern would be that these are not autologous products and there is the risk of rejection from the host immune system, he said. Strategies to circumnavigate that risk are at the forefront of investigationin off-the-shelf CAR T cells.
The research is not stopping with CAR T-cell therapy,though. Were seeing a lot of new molecules coming in that will be challenging the roles of CAR T cells, [such as] specific antibodies, which may even work in cases of CAR T-cell failure, Maloney said. We are still learning how to make those more effective and safer.
References:
1. FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine releasesyndrome.FDAwebsite.PublishedAugust30,2017.AccessedApril14, 2020. bit.ly/2RC4eQ8
2. FDA approves axicabtagene ciloleucel for large B-cell lymphoma. FDA website. Published October 18, 2017. Accessed April 14, 2020. bit.ly/2yYIQOp
3. FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma. FDA website. Published May 1, 2018. Accessed April 14, 2020. bit.ly/34zPoi8
4. Rafiq S, Hackett CS, Brentjens RJ. Engineering strategies to overcome the current roadblocks in CAR T cell therapy. Nat Rev Clin Oncol. 2020;17(3):147167. doi: 10.1038/s41571-019-0297-y
5. DepilS,DuchateauP,GruppSA,MuftiG,PoirotL.Off-the-shelfallogeneic CAR T cells: development and challenges. Nat Rev Drug Discov. 2020;19(3):185199. doi: 10.1038/s41573-019-0051-2
6. Curran KJ, Sauter CS, Kernan CS, et al. Durable remission following off-theshelf chimeric antigen receptor (CAR) T-cells in patients with relapse/refractory (R/R) B-cell malignancies. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, 2020; Orlando, FL. Abstract 120. bit.ly/2ufDYCu
7. Yez L, Snchez-Escamilla M, Perales MA. CAR T cell toxicity: current managementandfuturedirections. Hemasphere.2019;3(2):e186.doi:10.1097/ HS9.0000000000000186
8. Risk evaluation and mitigation strategies | REMS. FDA website. Updated August 8, 2019. Accessed April 14, 2020. bit.ly/2ykhLVt
9. JainT,BarM,KansagraAJ,etal.UseofchimericantigenreceptorTcell therapy in clinical practice for relapsed/refractory aggressive B cell non-Hodgkin lymphoma: an expert panel opinion from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant. 2019;25(12):2305-2321. doi: 10.1016/j.bbmt.2019.08.015
10. U.S. Food and Drug Administration (FDA) accepts for Priority Review Bristol-Myers Squibbs Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B-cell lymphoma. News release. Bristol-Myers Squibb; February 12, 2020. Accessed April 15, 2020. bit.ly/37ruQbs
11. Helwick C. Strong activity shown for lisocabtagene maraleucel CAR T-cell therapy in aggressive large B-cell lymphoma. ASCO Post website. Published February 25, 2020. Accessed April 15, 2020. bit.ly/3eoD0pT
12. Bachier CR, Palomba ML, Abramson JA, et al. Outpatient treatment with lisocabtagene maraleucel (liso-cel) in 3 ongoing clinical studies in relapsed/refractory (R/R) large B cell non-Hodgkin lymphoma (NHL), including second-line transplant noneligible (TNE) patients: TRANSCEND NHL 001, OUTREACH, and PILOT. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, Orlando, FL. Abstract 29. bit.ly/37I7DC9
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Protocol Management, Off-the-Shelf Therapies Help Bring CAR T Into More Settings - Targeted Oncology
Warning over common garden weed that causes horrific burns – Cambridgeshire Live
By daniellenierenberg
Families stuck at home during lockdown are being warned about a common but dangerous garden weed which can leave children - and adults - with burns and blisters.
Giant Hogweed has been dubbed Britain's most dangerous plant because of the horrific burns it inflicts on anyone who touches it - especially children - its set to thrive in the weeks ahead thanks to recent weather conditions.
The plant grows wild as well as in gardens and is becoming common the in the UK, but when it comes into contact with skin it causes a painful blistering rash.
The recent warm weather and plenty of rain after a mild winter has created the perfect conditions for this hazardous plant to thrive.
The hogweed looks relatively attractive and is part of the carrot family, but contains toxic chemicals.
Giant hogweed, or Heracleum mantegazzianum, is a weed which has dangerous effects on human health.
Growing up to five metres tall, its sap contains toxic chemicals which react with light when in contact with human skin, causing blistering within 48 hours.
Effectively it prevents the skin from protecting itself from sunlight, which can lead to very bad sunburn and scarring.
It's actually pretty and looks a bit like cow parsley. It's got green stem spotted with dark red which varies from 38 cm in diameter. Each dark red spot on the stem surrounds a hair, and large, coarse white hairs occur at the base of the leaf stalk.
It produces white flowers clustered in an umbrella-shaped head that is up to 80 cm in diameter across its flat top.
Colette Jones, Chairwoman of Friends of Close Park where Giant Hogweed was spotted, told The Bolton News : "Children are drawn to them because they grow so tall. They break them off to use them as sticks not realising how dangerous they are."
Exposure can result in blisters, long-lasting scars, and - if it comes in contact with eyes - blindness.
The blisters will form within 48 hours - scars can last for years.
It can also cause cause long-term sunlight sensitivity in people who touch it.
Black or purplish scars may be left on your skin for years after.
Medical professionals say you should cover the affected area, and wash it with soap and water.
The blisters heal very slowly and can develop into phytophotodermatitis, a type of skin rash which flares up in sunlight.
If you feel unwell or have a severe reaction you are advised to see a doctor.
Giant hogweed was among the foreign plants introduced to Britain in the 19th century as an ornamental plant, but it's now widespread throughout the British Isles.
It's invasive, which means that it chokes off other plants and can reduce wildlife in an area.
The plant is native to the Caucasus region and Central Asia.
The Wildlife and Countryside Act 1981 made it illegal to plant or cause giant hogweed to grow in the wild.
It is found in most of the UK, along footpaths and riverbanks though it also grows in places like parks, cemeteries and wasteland.
The sap of giant hogweed has chemicals which are toxic to humans and cause photosensitivity. The sap is phototoxic and can cause phytophotodermatitis.
When they touch skin, they effectively remove any protection against the sunlight causing severe skin inflammations.
Children have been hospitalised and suffered third-degree burns to their skin before.
The severe reaction to the plant is caused by the presence of linear derivates of furanocomarin in the plant's leaves, seeds, flowers, stems and roots.
The chemicals enter the cells' nucleus forming bonds with DNA and cause cells to die.
The RHS advises caution when removing the plant - cover arms and legs, and ideally wear a face mask when working on it.
Cut plant debris, contaminated clothing and tools are potentially hazardous too.
Wash any skin that comes in contact with the plant immediately.
The Wildlife and Countryside Act 1981 made it illegal to plant or cause giant hogweed to grow in the wild. Giant hogweed clearances are carried out to remove the plant.
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Warning over common garden weed that causes horrific burns - Cambridgeshire Live