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Career prospects to choose from after class 12th – thenortheasttoday.com

Posted: July 8, 2020 at 3:58 am

CAREER OPTIONS | JULY 08, 2020:

Choosing the right subject and career can put you in a dilemma as it requires research along with a lot of thought process. Deciding what subject to opt for after class 12 is a critical decision every student has to make. Sadly, many students rush and begin career planning at the last minute and end up choosing popular careers, but not suited to their talent.

It must be realised that there is one profession that does not fit all and therefore it is high time for you to start brainstorming to know what options lay ahead of you after school so that you can make a smart and right decision.

It is always advisable to try to choose your career based on your interests or one which is closest to it; try not to grab whatever is left out or blindly follow what your best friends are pursuing and do not take up the course just because you are being forced by the family.

We often make these mistakes for so many reasons, but it is hoped that this article will provide you with some clarity and guidance in finding your desired career option.

MedicalOne of the most popular professions in the Medical sector that every parent desires their children to pursue is Doctor. Medical is a vast field, apart from MBBS and BDS, there also exist numerous medical courses.

Some of them are Nursing, Ayurveda, Allopathy, Homoeopathy, Unani, Veterinary, science courses (B.Sc.), teacher training courses, paramedical courses and other diploma courses.

Apart from top medical colleges in India, you can also apply for medical courses in NEIGRIHMS, Guwahati Medical College, Regional Institute of Medical Science- Lamphelpat, Manipur, Assam Medical College, Regional Institute of Paramedical & Nursing Sciences- Zemabawk, Mizoram, Sikkim Manipal Institute of Medical Sciences, Gangtok Sikkim, Agartala Government Medical College Tripura, Lokapriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Tezpur Assam.

ManagementThe most sought after career in the management courses is Bachelor of Business Management (BBA). Under (BBA) you can opt for your specialization in Finance, Marketing, and Hotel Management. It is one of the top-paying careers indeed.

BBA Courses can be pursued in Guwahati College, Institute of Hotel Management Assam, Dispur college, Assam downtown, Royal Global University, Dibrugarh University, Kaziranga University, North East Institute of Management Science (NEIMS), Jorhat, Sikkim Manipal University -Sikkim, and other private institutions, followed by an internship to enhance your skills and knowledge.

Journalism and Mass CommunicationMass Communication is quickly gaining popularity with young job seekers all over the country. Some of the specialisations you can opt are television, newspaper, radio, advertising, Public Relation etc.

Mass Communication Courses are being offered in various institutions across the Northeast and in various parts of India. Some of the institutes in Northeast are Tezpur University, Assam Don Bosco University, Royal Global University, St. Antonys College, Meghalaya, and Assam School of Journalism.

LawLaw as a profession is in high demand nowadays. If you are interested in pursuing law then you can get yourself enrolled in any genuine and recognised institutes in your city, which offers a course in Law.

Some of the best colleges in Northeast are NEF Law College Assam, Tezpur law college, J.B Law College, NEHU Meghalaya, Shillong Law College, and BRM Government Law College.

AviationThis sector has witnessed enormous growth over the last few decades. This sector is becoming more popular among women nowadays. Students can pursue their flying dreams soon after completing their class 12 by joining short term or long training courses in any genuine and recognised institutes in your city or outside.

Some of the Institutes in Northeast are North East Institute of Management Science Assam and Jettwings Institute of Aviation & Hospitality Management in Guwahati and Shillong.

BankingThe banking sector is a booming industry. If you have passed out your class 12 but dont want to study further and immediately want to start earning then this is the right option for you.

You can sell an insurance policy by joining with SBI, HDFC, LIC and many others. But if you are heading to be an officer or a branch manager then soon after your graduation enrol with exams like SBI, RBI, IBPS, and NABARD. If you find it difficult to prepare for the exams, coaching centres are everywhere.

DanceCareers in this field can be that of a choreographer, performer, and teacher. If you aspire for a career in dance, you can sharpen your skills with training and guidance. There is no specific age to learn dancing. All you need is the will power to master the art.

Fashion DesigningIf you can style a simple dress in such a way that it can instantly grab eyeballs, go for fashion designing. Learn how to blend creativity and styling and bring out the best pieces of clothes that can flaunt any silhouette.

Fashion designing courses can be pursued in Global Institute of Fashion Technology Assam, Guwahati institute of fashion Technology, North East Institute of Fashion Technology (NEIFT) Guwahati, NIFT Shillong, and Guwahati College of Design.

ChefToday, cooking is more than an activity cramped to traditional kitchens. The ability of a chef today has become very modern which is a blend of passion, creativity and hard work for the art of cooking.

If you have a passion for cooking then courses in food processing, catering technology and other relevant areas are being offered by different institutions. The best institutions in Northeast are Assam Institute of Hotel Management, IHM Meghalaya, North East Institute of Management Science etc.

Performing ArtsIf you are a creative and expressive individual passionate about your craft then this is the right option for you. To become a successful performing artist, you can enhance and master your skills by enrolling short term courses in Acting, Dance, and Music.

PilotThe pilot is the one who operates the aeroplane, so without a pilot, the aeroplane will not fly. If you want to become a pilot then this career is for you.

Courses for this profession are available across India and abroad.

SportsOther than actually being an active sportsperson, sports has a highly paid career, such as sports management, sports medicine, sports journalism, adventure sports, fitness and health clinics, sports goods manufacture/marketing or as a commentator.

If you are aspiring to become a trainer or a manager, a graduate degree in physical education can be pursued after Class 12.

EngineeringEngineering is a multi-disciplined field. Engineering as a career has drawn the attention of students in India in a big way and a large number of aspirants taking the engineering exams are testimony to this fact.

Though a large number of students are appearing for different engineering exams like JEE, BITSAT, VITEEE, SRMJEE, not many are aware of the various career options. The most popular types of engineering courses include Mechanical, Chemical, Civil, Electrical and Aerospace engineering.

With the advancement and upliftment of technology, new engineering disciplines like biotechnology, computer, automobile engineering and genetic engineering have gained massive popularity among students.

Top Engineering Colleges in North East is National Institute of Technology, Agartala, National Institute of Technology, Mizoram, National Institute of Technology, Nagaland, National Institute of Technology, Sikkim, National Institute of Technology, Meghalaya, Assam University, NEHU, Tezpur University, Silchar.

Armed ForceDo you love your country and are patriotic enough to devote your entire life in the Service of the nation? Then this is the right option for you.

The above-mentioned careers are just a few of them, there are numerous other careers to explore. The innovative careers right now are jewellery designing, Interior designing, website designing, architecture, writer, blogger, digital marketing, and a lot more.

Besides these, if your dream job is not mentioned here, do not hesitate just follow your dreams. With determination, conviction and hardwork, anything is possible for you.

Good luck!

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Career prospects to choose from after class 12th - thenortheasttoday.com

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Feliciano receives $667K DOD grant to explore developmental disorder that causes tumors in the body and brain – Clemson Newsstand

Posted: July 8, 2020 at 3:55 am

The research team includes (from left) Victoria Neckles, David Feliciano, Tori Riley, Aidan Sokolov and Jennie Holmberg.Image Credit: College of Science

CLEMSON, South Carolina College of Science associate professor and researcher David Feliciano has received a $667,000 grant from the Department of Defense to explore the cellular underpinnings of Tuberous Sclerosis Complex (TSC), a developmental disorder characterized by the growth of benign tumors throughout the body, most notably in the brain.

Young children with TSCoften have seizures, learning disabilities, behavioral issues, and a high rate of autism. A hallmark of the disorder is the presence of growths in the brain called subependymal giant cell astrocytomas (SEGAs). SEGAs can block cerebrospinal fluid flow resulting in hydrocephalus, behavioral changes, nausea, headaches, seizures, and are a cause of mortality. SEGAs can be surgically removed, however, their presence in infancy usually precludes immediate removal. Early intervention improves prognosis.

About a third of the TSC cases are inherited from a parent, while about two thirds of cases arise during in utero development, said Feliciano, of biological sciences. There are clues leading to a TSC diagnosis. For example, an infant may have seizures characterized by a head bobbing motion that almost looks like he or she is nodding off, skin lesions, and red bumps comprised of blood vessels on the face, especially on the nose and cheeks.

According to Feliciano, scientists know that TSC occurs because of a mutation on either the TSC1 or TSC2 gene. These genes normally produce proteins that stop cell growth via the mammalian target of rapamycin (mTOR) pathway. However, TSC1 or TSC2 mutations result in excessive mTOR activity and cell growth.

Coronal section of a mouse brain olfactory bulb genetically modified by in vivo neural stem cell electroporation (blue, old neurons; cyan, young neurons; magenta, nuclei of all cells).Image Credit: Courtesy of Victoria Riley

In the course of the three-year project, Feliciano will generate a novel mouse model of TSC, characterize the molecular pathways in this model, and test two potential drug therapies to evaluate their effectiveness on treating these harmful SEGAs.

The model will have mutations engineered in the neural stem cells of newborn mice. When these stem cells divide, the cellular progeny will be deficient in the Tsc2 gene, mimicking the human disease. These mice will also express an inducible fluorescent protein allowing the altered cells to be tracked by microscopy.

Well be able to closely examine how the SEGAs form in this model, Feliciano said. We can examine the cell types and cellular processes that are altered, and we can study how the biochemical pathways are altered within the SEGA cells.

While we have developed other models of TSC, none to date fully recapitulate SEGAs, Feliciano added. Having a SEGA model is important because it allows one to interrogate the molecular pathways and identify mechanisms of pathogenesis. In the final step of the project, Feliciano will test the effectiveness of two potential therapies which may stop the formation of SEGAs.

TSC is a relatively rare disorder, occurring in one out of every 6,000 births. TSC provides a framework to understand the pathways that orchestrate normal brain development. Many other diseases are also characterized by changes to the same pathways, although the causative genes are unknown. Therefore, the results of this research will be applicable to additional diseases, said Feliciano, citing cancer and epilepsy as two examples.

This research is supported by the Department of Defense Award Number W81XWH-19-TSCRP-IDA. The content is solely the responsibility of the authors and does not necessarily represent the official views of the DoD.

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Feliciano receives $667K DOD grant to explore developmental disorder that causes tumors in the body and brain - Clemson Newsstand

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Notre Dame Adjusts to the COVID-19 Pandemic | Notre Dame Magazine | University of Notre Dame – ND Newswire

Posted: July 7, 2020 at 2:47 pm

Theology professor John Cavadini records one of his classes in a vacant DeBartolo Hall. Photo by Matt Cashore 94

Michael Chamberlain 20 carried all his belongings out of ONeill Hall on March 16 and packed them into his car. A California resident, the Notre Dame senior planned to drive to Houston and stay with his brother for the near future.

I was ready to leave, but I wasnt ready to leave this soon, Chamberlain said, noting that the final months of senior year are a memorable time, but the Class of 2020 would be forced to forego many traditional senior rituals.

Spring 2020 was a semester unlike any other in Notre Dames history. Students left for spring break expecting to return in a week for the second half of the semester and the promise of spring weather and campus activities. Suddenly, before they knew it, daily life was upended.

In February, as the coronavirus spread through Italy, the University halted its study programs in Rome and flew students home to the United States. In early March, the University recalled all students studying abroad and suspended its international programs until further notice. The change impacted 483 students who had been overseas.

Notre Dame announced March 11 that all in-person classes were suspended, joining colleges across the country that did the same. The University extended spring break an additional week, then resumed classes entirely via online instruction for the rest of the semester.

A modern pandemic is uncharted territory for Notre Dame and other universities. Administrators have no playbook for how to proceed.

Traditional lecture and laboratory courses transformed into online courses using Zoom video conferencing. Many undergraduates returned to their childhood bedrooms, taking classes online, sharing time and space with their parents and siblings, and keeping in virtual touch with Notre Dame friends.

Faculty members accustomed to teaching in lecture halls got quick training on how to transition to online instruction. In a concession to the unusual circumstances, undergraduates were given the option after seeing their grade for each course for the spring semester of choosing either to receive the letter grade or take a pass/no credit for that course.

One would have to go back to World War II, when most of the campus was transformed into a U.S. Navy training facility, to find such a major disturbance to University routine. Between 1942 and 1946, when the undergraduate population was reduced to a few hundred students, some 11,925 men completed their officer training at Notre Dame before entering military service.

To prevent spread of the virus, faculty and nonessential staff members were told to work from their homes starting in mid-March. Some students returned briefly to campus after spring break to collect some of their belongings from their residence halls. For those who requested it, the University gathered and shipped laptops, textbooks and other academic materials to students homes. And a total of 127 students, including international students who could not return home, were provided housing on campus.

After in-person classes halted, second-year law student Kaitlyn Wallace moved back to Kansas City, Missouri. She lived at home with her parents and younger brother and sister, participating in classes online from her bedroom.

I think I was really fortunate. My parents have good Wi-Fi, Wallace says. Everyone in the family knew my class schedule. They wouldnt bother me during class time. The family sheltered at home and stayed well, venturing out only for walks and trips to the grocery store.

Wallace says online classes went more smoothly than she expected, with professors and students adapting quickly. It was really pretty seamless, she says. She kept in touch with law school friends via daily phone calls and continued to pay rent on her South Bend apartment.

Wallace was looking forward to a job as a summer associate at a Chicago law firm. Although many students found their summer positions canceled because of the pandemic, hers was not. However, because of the coronavirus, the job became virtual, with Wallace working for the firm online from a Chicago apartment rather than in the office.

She is hoping Notre Dame can adhere to plans to resume in-person classes in August that the Universitys president, Rev. John I. Jenkins, CSC, 76, 78M.A., announced in May. I would much prefer the classes be in-person, but I dont want there to be a COVID-19 outbreak in South Bend, she says. She feels University leaders have done a good job through the coronavirus crisis, and she trusts them to make the right decision about fall classes. Theyve been really transparent about all the decisions theyve had to make.

As winter turned into spring, Notre Dame looked and felt different.

No celebrations marked St. Patricks Day. The Blue-Gold football game and all other spring sports events were canceled. DeBartolo Performing Arts Center cut short the remainder of its spring season. Corridor walls in campus classroom buildings were covered with flyers about lectures and arts events that would never happen. Fewer candles burned in the Grotto.

In accordance with a decision by Indianas Catholic bishops, all public Masses in the Basilica of the Sacred Heart and elsewhere on campus were suspended from mid-March until late May. For probably the first time in Notre Dame history, there was no public Mass on Easter Sunday. Masses continued to be celebrated in the basilica and were livestreamed online.

By late March, in an unprecedented move, the University suspended laboratory research operations across campus, the only exception being for coronavirus-related research. The hibernation included more than 300 laboratories, most in science and engineering.

Donny Hanjaya-Putra 07, an assistant professor of aerospace and mechanical engineering, studies stem cells and molecular therapies. His lab, which includes one graduate student and two postdoctoral researchers, was among those closed.

He says he understood the need for the hibernation, but worried about how it would impact the careers of those in his lab. The most precious resource we have is time. For grad students and postdocs, time is critical for them, Hanjaya-Putra says. For some students, the shutdown might mean a delay in their coursework and postponement of graduation.

While hibernation will cause delays for some research, the COVID-19 crisis likely will point to expanded research paths for academics, says Robert Bernhard, Notre Dames vice president for research. There will be infectious disease research opportunities, he says.

As spring progressed, thousands of tulips and other spring flowers were in full bloom, but few people were around to see them. Wearing face masks and practicing social distancing, construction workers continued their labors on the new Corby Hall, a new residence hall and the McKen-na Hall replacement. Based on the international economic downturn and financial uncertainty, future construction projects were placed on hold.

Notre Dame instituted a staff hiring and wage freeze, but continued to pay and provide benefits to all full-time and benefits-eligible part-time regular employees. The University refunded undergraduates $20 million in room and board for the portion of the spring semester they were not on campus. Administrators further barred nonessential expenses, including business travel, for the foreseeable future.

The University established a Student Emergency Relief Fund with donations from senior campus administrators and other private gifts. The fund will assist students whose families face unemployment and other hardships caused by the pandemic.

Meanwhile, some members of the Notre Dame community tested positive for COVID-19, the University announced on its coronavirus response web page. To protect privacy, no numbers or details were released.

By June 11, Indiana recorded more than 38,700 confirmed COVID-19 cases and 2,198 deaths. St. Joseph County had reached 1,475 confirmed cases and 56 virus-related deaths.

The commencement ceremony set for May 17 in Notre Dame Stadium was canceled. Instead, the University held a virtual online degree ceremony on that day, and plans a full, in-person Class of 2020 commencement on Memorial Day weekend 2021.

During the virtual ceremony, Father Jenkins formally conferred degrees on the graduates. In his charge to the class, Jenkins made reference to the Greatest Generation, as Americans who grew up during the Great Depression and helped win World War II have come to be known. What set them up for greatness was the adversity in which they were reared and the challenges that shaped them, he said.

Hardship has a way of bringing out what is highest and best in all, Jenkins told the graduates. The story of the Class of 2020 will include the massive social, economic and public health challenges that are now facing the world.

Im sorry for these hardships, but they are your opportunity, he said. You see, you cannot be the Fighting Irish if you never had to fight through anything. You have your fight. Seize it.

In advance of the ceremony, all graduates received commemorative boxes from the University containing a letter from Jenkins, a graduation stole, a candle and a copy of the 2020 Dome, the campus yearbook.

A virtual commissioning ceremony for Notre Dames 2020 ROTC graduates was livestreamed the same weekend. One by one, the graduates took their commissioning oath online. Many participated from their homes, often joined by close family.

Summer classes, at least through July 6, were online-only. Reunion weekend, traditionally the first weekend in June, was canceled, with plans to reschedule it in the future. And the various conferences, programs and camps that usually make campus a busy place even in summer were shuttered.

Jenkins plan to begin the fall semester on August 10 brings students to campus two weeks earlier than originally scheduled. The plan eliminates fall break and sets final exams before Thanksgiving.

Notre Dames leaders have been consulting with experts from Johns Hopkins and the Cleveland Clinic, as well as the St. Joseph County Health Department, to prepare for comprehensive COVID-19 testing, contact tracing, quarantining and isolation space for those infected when in-person classes resume.

The plan for students, faculty and staff will include social distancing, mask requirements and extensive cleaning of campus spaces. Faculty have been asked to prepare courses for both in- person and remote instruction, which would allow any student in isolation or quarantine to continue to participate.

Patrick Paulsen 20 spent the spring living in a house in South Bend with nine other seniors, staying mostly to themselves and focusing on their online classes. As the weather warmed, they invited other friends to visit them outdoors, where they could keep their distance.

While Senior Week activities were canceled, the group organized its own informal Champagne on the Steps, a tradition of toasts on the front steps of the Main Building. There were no caps and gowns this year, but the housemates were going to watch their virtual commencement together at their house. Paulsen says they made a day of it.

The week after the virtual commencement, Paulsen and his girlfriend planned to drive home to the Pacific Northwest. Hes from Seattle, and shes from Portland. The idea was to fill the car Grapes of Wrath style, and head west, he says.

Prior to the pandemic, Paulsens postcollege plan was to work for a couple years and then apply to law school. With the world economy battered and the U.S. unemployment rate at 14.7 percent by May, he realized full-time job openings would be rare. Paulsen plans to live with his parents at home in Seattle, seek a part-time job and study for the LSAT.

Paulsen and his friends already are looking forward to reuniting next May to celebrate their commencement. The housemates took time this spring to talk about the impact of the pandemic and the abrupt shift in their world. They know it will have a lasting impact on their lives, he says. This is a once-in-a-hundred-years kind of thing.

Margaret Fosmoe is an associate editor of this magazine

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Frontrunner for the VA GOP’s 2021 Gubernatorial Nomination Rallies in Honor of Far-Right Paramilitary Group Member; As Del. Jay Jones Points Out, the…

Posted: July 7, 2020 at 2:45 pm

How did you spend *your* fourth of July holiday? Probably not like the frontrunner for the Virginia GOPs 2021 gubernatorial nomination, Amanda Chase, who was hanging out in Richmond yesterday with her buddies including right-wing extremist groups, a gun club and white supremacists. Chase was also busy opining that Confederate monuments despite all historical evidence to the contrary are NOT symbols of hate. By the way, since the media didnt report this key information, for whatever reason(s), Chases rally yesterday was as she herself posted on Facebook in honor of Duncan Lemp. Who was Duncan Lemp, you ask? Heres the Wikipedia entry on his fatal shooting by police:

On March 12, 2020, Duncan Socrates Lempwas fatally shot at his home inPotomac, Maryland, during ano-knockpolice raidby the Montgomery County Police DepartmentsSWATteam.Lemp was astudentand asoftware developerwho associated himself with the3 Percenters, a far-right paramilitary militia group

Lemp associated himself with the3 Percenters, a far-right paramilitary militia group, and set up websites for other such organizations.He also frequented the4chanandRedditmessage boards, sites popular withinternet trolls.He was a member of theUnited States Transhumanist Party, having joined on September 6, 2019.A week before the raid, Lemp posted a picture of two people armed with rifles onInstagram, with text referring to boogaloo, a term used by theboogaloo movementas coded language for an anticipated war against the government or liberals.

Thats a pretty important piece of information youd think the media would have reported, by the way, butnope, that might take a minute or two of using Google or whatever. And god forbid they actually give their readers the full context of whats going on. Ugh.

Anyway, so what was the reaction from the Virginia GOP to State Senator Chases rally with white supremacists in honor of a former member of a far-right paramilitary militia group? So far, as Del. Jay Jones (D) pointed out a few minutes ago the silence is deafening here. And its not like Virginia Republicans werent tweeting yesterday; see the Virginia GOP Twitter feed, which has tweets on their U.S. Senate candidate, handing out Trump yard signs, etc. But anything on Chase and her white supremacists rally in Richmond yesterday. Nope, nada. Theres also nothing from the VA Senate GOP Twitter feed either on Chases Fourth of July festivities. Cat got the Virginia GOPs tongue? Do these folks actually *approve* of Chases behavior, are they just terrified of her, or both? Or, ultimately, do they realize that if they condemn Chase, theyd have to also condemn Trump and others in their own party, and thats something they cant bring themselves to do?

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Stem Cells Sales Market Growth By Manufacturers, Type And Application, Forecast To 2026 – 3rd Watch News

Posted: July 7, 2020 at 2:44 pm

New Jersey, United States,- Market Research Intellect sheds light on the market scope, potential, and performance perspective of the Global Stem Cells Sales Market by carrying out an extensive market analysis. Pivotal market aspects like market trends, the shift in customer preferences, fluctuating consumption, cost volatility, the product range available in the market, growth rate, drivers and constraints, financial standing, and challenges existing in the market are comprehensively evaluated to deduce their impact on the growth of the market in the coming years. The report also gives an industry-wide competitive analysis, highlighting the different market segments, individual market share of leading players, and the contemporary market scenario and the most vital elements to study while assessing the global Stem Cells Sales market.

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Stem Cells Sales Market Growth By Manufacturers, Type And Application, Forecast To 2026 - 3rd Watch News

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Mesenchymal Stem Cells Market Growth By Manufacturers, Type And Application, Forecast To 2026 – 3rd Watch News

Posted: July 7, 2020 at 2:44 pm

New Jersey, United States,- Market Research Intellect sheds light on the market scope, potential, and performance perspective of the Global Mesenchymal Stem Cells Market by carrying out an extensive market analysis. Pivotal market aspects like market trends, the shift in customer preferences, fluctuating consumption, cost volatility, the product range available in the market, growth rate, drivers and constraints, financial standing, and challenges existing in the market are comprehensively evaluated to deduce their impact on the growth of the market in the coming years. The report also gives an industry-wide competitive analysis, highlighting the different market segments, individual market share of leading players, and the contemporary market scenario and the most vital elements to study while assessing the global Mesenchymal Stem Cells market.

The research study includes the latest updates about the COVID-19 impact on the Mesenchymal Stem Cells sector. The outbreak has broadly influenced the global economic landscape. The report contains a complete breakdown of the current situation in the ever-evolving business sector and estimates the aftereffects of the outbreak on the overall economy.

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This study analyzes the growth of Mesenchymal Stem Cells based on the present, past and futuristic data and will render complete information about the Mesenchymal Stem Cells industry to the market-leading industry players that will guide the direction of the Mesenchymal Stem Cells market through the forecast period. All of these players are analyzed in detail so as to get details concerning their recent announcements and partnerships, product/services, and investment strategies, among others.

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The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Mesenchymal Stem Cells market. Additionally, it includes a share of each segment of the Mesenchymal Stem Cells market, giving methodical information about types and applications of the market.

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This report gives a forward-looking prospect of various factors driving or restraining market growth.

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Mesenchymal Stem Cells Market Growth By Manufacturers, Type And Application, Forecast To 2026 - 3rd Watch News

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Dr Borehams Crucible: Mesoblast within months of 3 major trial results, key regulatory decision – Stockhead

Posted: July 6, 2020 at 9:46 am

The worlds biggest listed pure-play stem cell developer has a busy slate of clinical work, notably in therapies for advanced heart failure, chronic back pain and graft-versus-host disease (GvHD).

Now these programs are approaching a thrilling denouement and, as the Demtel man enthused, theres more: Mesoblast (ASX:MSB) is also undertaking an expanded coronavirus trial after a 12-patient effort showed promising results in treating acute respiratory distress syndrome (Ards), the usual cause of death with COVID-19.

The patients received infusions of Mesoblasts allogeneic (off the shelf) mesenchymal stem cell candidate, remestemcel-L, acquired from Osiris for $106m in 2013.

Meanwhile, results from two phase III trials are expected this (September) quarter: a 566-patient effort for chronic heart failure and a 404-patient trial for chronic lower back pain caused by disc degeneration.

And in September, the US Food and Drug Administration will rule on whether or not the company can market its GvHD therapy on American shores.

Mesoblast founder and CEO Prof Silviu Itescu notes that across all its therapies the company is targeting the most severe cases where alternative therapies dont exist.

Mesoblasts proprietary process selects precursor and stem cells from the bone marrow of healthy adults, creating a master cell bank. This cell kitty is then expanded into thousands of doses for off-the-shelf use, without the need for tissue matching.

Mesoblast is targeting a common market across all its disease indications: inflammation. In the case of heart disease, tissue macrophages (cells) churn out inflammatory factors that damage heart muscle and cause fibrosis and vascular dysfunction.

The stem cells respond to severe inflammation by switching the culprit macrophages off and converting them to nice cells that actually protect the heart muscle.

This is the central mechanism in each of our disease states: heart failure, back pain, GvHD and rheumatoid arthritis, Professor Itescu says. We have the potential to make a big difference in some very big disease states where inflammation is central.

Backed by the Pratt familys listed investment vehicle Thorney Investments, Mesoblast debuted on the ASX in 2004 and reached a peak valuation of $2.5bn in 2011 before suffering a reality check.

Culprits included a phase II heart trial that failed to meet primary endpoints, a badly executed Nasdaq listing and Israel pharma house Teva Pharmaceuticals decision to walk away from a heart program partnership in 2016.

Mesoblast dual listed on the Nasdaq in November 2015, accompanied by a $US63m capital raising.

The companys Ards and GvHD programs are based on mesenchymal stem cell assets acquired from US pharma group Osiris Therapeutics in October 2013.

Mesoblasts own-developed cells are called mesenchymal precursor cells and they are being developed for rheumatoid arthritis and diabetic nephropathy, as well as the aforementioned heart failure and lower back pain programs.

Ards is bought on by an excessive immune response to the virus in the lungs. The immune cells produce inflammatory cytokines, which destroy lung tissue and can also damage the liver, kidney and heart.

Remestemcell-L has the potential to tame the cytokine storm in Ards and may offer a life-saving treatment for those unfortunate individual sufferers of COVID-19 Ards, Professor Itescu says.

Mesoblasts COVID-19 proclamations have been coming so thick and fast that its been Ard(s) just to keep up. But the core excitement cluster was around Mesoblasts April 23 disclosure of the results of the trial at New Yorks Mt Sinai Hospital, covering moderate to acute Ards cases.

Under the compassionate use protocol, the patients were treated with two infusions of remestemcel-L over the first five days.

The results? Nine of the 12 patients came off a ventilator within a median 10 days, with 83 per cent survival (the Grim Reapers spin on this is that two of them died).

In comparison, only 9 per cent of patients at one reference hospital (38 out of 445 patients) were able to come off the ventilator with standard-of-care treatment.

Another US hospital reported that only 38 patients of 320 or 12 per cent survived.

Of course, 12 people good and true are adequate numbers for a jury, but sub-optimal to comprise a statistically significant trial.

Thus, the company is enrolling 300 patients in a phase III, randomised, controlled trial of severe Ards patients at 30 sites.

The first patients were dosed in early May, with about 15 sites established as the company chases the disease from the northeast to the southern states.

Mesoblast chief medical officer Professor Fred Grossman says the company is carefully choosing hot spots such as Alabama which, as of late May had the no vacancy signs outside its intensive care wards.

The sites are recruiting quite quickly, he says. There is a tremendous interest in this study.

The trial leaders will undertake an interim analysis at 30 days, and when 30 per cent of patients have reached their primary endpoint. At that point the trial can be dumped on futility grounds, or expanded to the control group because it appears to be working.

Remestemcell-L has investigational new drug (IND) status with the US Food and Drug Administration, meaning the company swiftly can initiate trials on patients with very dismal prospects.

Long-suffering Mesoblast investors will recall that the companys shares tumbled 28 per cent in November 2018 after a 159-patient trial of Rexlemestrocel-L (Revascor) for end-stage heart failure did not meet its primary endpoint of weaning patients from left ventricle assist devices (LVADs or heart pumps).

The company claimed the endpoint was set by the independent !!! investigators and was of little real clinical interest. What really mattered was that the trial showed reduced gastrointestinal bleeding by 76 per cent and hospitalisations by 65 per cent.

Investors are now nervously awaiting the first readout of the broader 566-patient chronic heart failure trial across 59 US sites.

Mesoblast targeted patients with class three or four disease, the sickest 15 to 20 per cent of patients who have failed standard-of-care drugs.

Class three patients have a 20 per cent chance of dying within two years while with class four its a case of flip a coin that you will be around in 12 months.

At this stage, Mesoblast retains its heart treatment rights except in China, where it is partnered with Tasly Pharmaceutical.

Mesoblasts phase III back pain trial aimed to enroll 404 patients with lower back pain caused by degenerative disc disease.

The endpoint of the trial, dubbed MPC-06-ID, is an improvement in pain and function over 24 months.

As with the heart trial, results are imminent and its a toss-up as to what release will hit the ASX announcements feed first.

The company is liaising with its global back pain partner Grunenthal GmbH about the clinical protocol for a European phase III confirmatory trial.

In Japan, Mesoblast is partnered with JCR Pharmaceutical for its approved GvHD treatment called Temcell and its off and racing in that smallish but enthusiastic market.

Meanwhile, the company is angling to enter the US market for a similar GvHD treatment, branded Ryoncil.

GvHD afflicts about half of the 30,000 patients annually undergoing allogeneic bone marrow transplant, typically for blood cancers, with their bodies rejecting the alien transplant.

In March, the FDA granted priority review with a September 30 action date, but we might have a good idea of the outcome in August.

Why? Because thats when the FDAs relevant advisory committee meets to vote on the matter and the (virtual) gathering is open to the public.

A date is yet to be set. While advisory committee views are not binding on the FDA, they usually presage the final decision.

If approved, Mesoblast could be selling Ryoncil in the US by the time were carving the Christmas turkey (badly, in the case of your columnist).

Buoyed by the COVID-19 results, Mesoblast in May wasted no time tapping institutional investors for an idle $US90m ($129.6m) in a placement.

Mesoblast already had a healthy cash balance of $US60m.

The raising was struck at $3.20 a share, a modest 7 per cent discount to the prevailing price.

The funds, in the main, will be used to scale-up manufacturing of remestemcell-L and to support the phase III trial, as well as for working capital and general corporate purposes.

The company also has $US67m available through existing financing facilities and partnerships.

Mesoblast reported revenue of $US31.45m for the nine months to March 2020, up 113 per cent. The reported loss narrowed 34 per cent to $US45.3m, reflecting curtailed research and development spend by $US7.5m, or 15 per cent.

The revenue included $US5.9m of JCR royalties from Temcell sales in Japan and milestone revenue of $US25m.

The company stands to pocket up to $US150m of royalties and milestones from Grunenthal prior to any European launch of Revascor.

Successful sales could result in up to $US1bn in milestone payments.

Over the last decade, Mesoblasts ASX shares have traded as high as $9 (October 2011) and as low as $1.03 (December last year).

To the Meso-sceptics the company has promised far too much with limited commercial success, while raising $1bn since listing 16 years ago.

Dare we say that Mesoblast now looks more focused and to be getting somewhere?

When we last covered Mesoblast in March 2019, Professor Itescu said he was 95 per cent certain the company would do what no other Aussie biotech in phase III had done: win FDA drug approval.

Well, Clinuvel has stolen that Aussie first honour, but Mesoblast is well placed to get over the line with a GvHD treatment in the US, which presents a market eight times the size of Japans.

Its certainly rare for a biotech to expect results for three major trials and a key regulatory decision in the space of months.

If the heart and back pain results are definitively positive and the FDA green lights GvHD, the company hits the jackpot. If two or more of them bomb lets not go there.

Your ultra conservative columnist regards the COVID-19 stuff as the icing on the cake with an outside chance of success, especially given the hundreds of other programs in the coronavirus-busting sector.

Disclosure: Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort. But he hopes to become proficient in turkey carving by December 25.

This column first appeared in Biotech Daily.

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GMOs: Pros and Cons, Backed by Evidence – Healthline

Posted: July 5, 2020 at 6:48 am

GMOs, short for genetically modified organisms, are subject to a lot of controversy.

According to the U.S. Department of Agriculture (USDA), GMO seeds are used to plant over 90% of all maize (corn), cotton, and soy grown in the United States, which means that many of the foods you eat likely contain GMOs (1).

Although most notable organizations and research suggest that GMO foods are safe and sustainable, some people claim they may harm your health and the environment.

This article helps explain what GMOs are, provides a balanced explanation of their pros and cons, and gives guidance on how to identify GMO foods.

GMO, which stands for genetically modified organism, refers to any organism whose DNA has been modified using genetic engineering technology.

In the food industry, GMO crops have had genes added to them for various reasons, such as improving their growth, nutritional content, sustainability, pest resistance, and ease of farming (2).

While its possible to naturally give foods desirable traits through selective breeding, this process takes many generations. Also, breeders may struggle to determine which genetic change has led to a new trait.

Genetic modification significantly accelerates this process by using scientific techniques that give the plant the specific desired trait.

For example, one of the most common GMO crops is Bt corn, which is genetically modified to produce the insecticide Bt toxin. By making this toxin, the corn is able to resist pests, reducing the need for pesticides (3).

GMO crops are incredibly common in the United States, with at least 90% of soy, cotton, and corn being grown through genetic techniques (4).

In fact, its estimated that up to 80% of foods in supermarkets contain ingredients that come from genetically modified crops.

While GMO crops make farming much easier, there is some concern around their potential effect on the environment and their safety for human consumption specifically surrounding illnesses and allergies (5).

However, the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and USDA maintain that GMOs are safe for human and animal consumption (6).

GMOs are food items that have been made using genetic engineering techniques. They comprise 90% of soy, cotton, and corn grown in the United States and are deemed safe for human consumption.

GMO foods may offer several advantages to the grower and consumer.

For starters, many GMO crops have been genetically modified to express a gene that protects them against pests and insects.

For example, the Bt gene is commonly genetically engineered into crops like corn, cotton, and soybeans. It comes from a naturally occurring bacteria known as Bacillus thuringiensis.

This gene produces a protein that is toxic to several pests and insects, which gives the GMO plants a natural resistance. As such, the GMO crops dont need to be exposed to harmful pesticides as often (7).

In fact, an analysis of 147 studies from 2014 found that GMO technology has reduced chemical pesticide use by 37% and increased crop yields by 22% (8).

Other GMO crops have been modified with genes that help them survive stressful conditions, such as droughts, and resist diseases like blights, resulting in a higher yield for farmers (9, 10, 11).

Together, these factors help lower the costs for the farmers and consumers because it allows a greater crop yield and growth through harsher conditions.

Additionally, genetic modification can increase the nutritional value of foods. For example, rice high in beta carotene, also called golden rice, was developed to help prevent blindness in regions where local diets are chronically deficient in vitamin A (12).

Moreover, genetic modification may be used simply to enhance the flavor and appearance of foods, such as the non-browning apple (13).

In addition, current research suggests that GMO foods are safe for consumption (14).

GMO foods are easier and less costly for farmers to grow, which makes them cheaper for the consumer. GMO techniques may also enhance foods nutrients, flavor, and appearance.

Although current research suggests that GMO foods are safe, there is some concern around their long-term safety and environmental impact (14).

Here are some of the key concerns around GMO consumption.

There is some concern that GMO foods may trigger an allergic reaction.

This is because GMO foods contain foreign genes, so some people worry that they harbor genes from foods that may prompt an allergic reaction.

A study from the mid-1990s found that adding a protein from Brazil nuts to GMO soybeans could trigger an allergic reaction in people sensitive to Brazil nuts. However, after scientists discovered this, they quickly abandoned this GMO food (15).

Although allergy concerns are valid, there have been no reports of allergic reactions to GMO foods currently on the market.

According to the FDA, researchers who develop GMO foods run tests to ensure that allergens arent transferred from one food to another (16).

In addition, research has shown that GMO foods are no likelier to trigger allergies than their non-GMO counterparts (17).

Yet, if you have a soy allergy, both GMO and non-GMO soy products will prompt an allergic reaction.

Similarly, theres a common concern that GMO foods may aid the progression of cancers.

Because cancers are caused by DNA mutations, some people fear that eating foods with added genes may affect your DNA.

This worry may stem partly from an early mice study, which linked GMO intake to a higher risk of tumors and early death. However, this study was later retracted because it was poorly designed (18, 19, 20).

Currently, no human research ties GMO intake to cancers.

The American Cancer Society (ACS) has stated that theres no evidence to link GMO food intake to an increased or decreased risk of cancer (21).

All the same, no long-term human studies exist. Thus, more long-term human research is needed.

Although GMO crops are convenient for farmers, there are environmental concerns.

Most GMO crops are resistant to herbicides, such as Roundup. This means that farmers can use Roundup without fear of it harming their own crops.

However, a growing number of weeds have developed resistance to this herbicide over time. This has led to even more Roundup being sprayed on crops to kill the resistant weeds because they can affect the crop harvest (22, 23, 24).

Roundup and its active ingredient glyphosate are subject to controversy because animal and test-tube studies have linked them to various diseases (25, 26, 27).

Still, a review of multiple studies concluded that the low amounts of glyphosate present on GMO foods are safe for human consumption (28).

GMO crops also allow for fewer pesticide applications, which is a positive for the environment.

That said, more long-term human research is necessary.

The main concerns around GMOs involve allergies, cancer, and environmental issues all of which may affect the consumer. While current research suggests few risks, more long-term research is needed.

Although GMO foods appear safe for consumption, some people wish to avoid them. Still, this is difficult since most foods in your supermarket are made with ingredients from GMO crops.

GMO crops grown and sold in the United States include corn, soybean, canola, sugar beet, alfalfa, cotton, potatoes, papaya, summer squash, and a few apple varieties (29).

In the United States, no regulations currently mandate the labeling of GMO foods.

Yet, as of January 2022, the USDA will require food manufacturers to label all foods containing GMO ingredients (6).

That said, the labels wont say GMO but instead the term bioengineered food. It will display either as the USDA bioengineered food symbol, listed on or near the ingredients, or as a scannable code on the package with directions, such as Scan here for more information (6).

Presently, some foods may have a third-party Non-GMO project verified label, which indicates that the product contains no GMOs. However, this label is voluntary.

Its also worth noting that any food labeled 100% organic does not contain any GMO ingredients, because U.S. law prohibits this. However, if a product is simply labeled organic, it may contain some GMOs (30).

In the European Union (EU), foods with more than 0.9% GMO ingredients must list genetically modified or produced from genetically modified [name of food]. For foods without packaging, these words must be listed near the item, such as on the supermarket shelf (31).

Until the new regulations come into place in the United States, there is no clear way to tell if a food contains GMO ingredients.

However, you can try to avoid GMO foods by eating locally, as many small farms are unlikely to use GMO seeds. Alternatively, you can avoid foods that contain ingredients from the GMO crops listed above.

Until the 2022 USDA rule takes effect, its hard to determine which foods contain GMOs in the United States. You can avoid GMOs by limiting GMO ingredients, eating locally, looking for third-party non-GMO labels, or buying 100% organic.

GMOs are foods that have been modified using genetic techniques.

Most foods in your local supermarket contain GMO ingredients because theyre easier and more cost-effective for farmers, which makes them cheaper for the consumer.

In the United States, foods grown using GMO techniques include corn, soybean, canola, sugar beet, alfalfa, cotton, potatoes, papaya, summer squash, and a few varieties of apples.

Although current research suggests that GMO foods are safe for consumption, some people are concerned about their potential health effects. Due to a lack of long-term human studies, more research is needed.

In the United States, its currently not mandatory to label foods that contain GMOs. However, as of 2022, all foods that contain GMO ingredients must have the term bioengineered food somewhere on the packaging or a scannable code to show that it has GMO ingredients.

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Genetically modified mosquitoes could be released in Florida this summer – WFLA

Posted: July 5, 2020 at 6:48 am

(THE CONVERSATION) This summer, for the first time, genetically modified mosquitoes could be released in the U.S.

On May 1, 2020, the company Oxitec received anexperimental use permitfrom the U.S. Environmental Protection Agency to releasemillions of GM mosquitoes(labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population.

However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.

Genetic engineering for disease control

Coral reefs that can withstand rising sea temperatures,American chestnut treesthat can survive blight andmosquitoes that cant spread diseaseare examples of how genetic engineering may transform the natural world.

Genetic engineering offers an unprecedented opportunity for humans to reshape the fundamental structure of the biological world. Yet, as new advances ingenetic decodingandgene editingemerge with speed and enthusiasm, the ecological systems they could alter remain enormously complex and understudied.

Recently, no group of organisms has received more attention for genetic modification than mosquitoes toyield inviable offspringor make themunsuitable for disease transmission. These strategies hold considerable potential benefits for the hundreds of millions of people impacted bymosquito-borne diseaseseach year.

Although the EPA approved the permit for Oxitec, state approval is still required. A previously planned release in the Florida Keys of an earlier version of Oxitecs GM mosquito (OX513) waswithdrawn in 2018aftera referendum in 2016indicated significant opposition from local residents. Oxitec has field-trialed their GM mosquitoes inBrazil, the Cayman Islands, Malaysia and Panama.

Thepublic forumon Oxitecs recent permit application garnered 31,174 comments opposing release and 56 in support. The EPA considered these during their review process.

Time to reassess risk assessment?

However, it is difficult toassess how EPA regulatorsweighed and considered public comments and how much of theevidence used in final risk determinationswas provided solely by the technology developers.

The closed nature of this risk assessment process is concerning to us.

There is a potential bias and conflict of interest when experimental trials and assessments of ecological risk lackpolitical accountabilityand are performed by, or in close collaboration with, the technology developers.

This scenario becomes more troubling with afor-profit technology companywhen cost- and risk-benefit analyses comparing GM mosquitoes to other approachesarent being conducted.

Another concern is thatrisk assessmentstend to focus on only a narrow set of biological parameters such as the potential for the GM mosquito to transmit disease or the potential of the mosquitoes new proteins to trigger an allergic response in people and neglect other importantbiological,ethicalandsocialconsiderations.

To address these shortcomings, the Institute for Sustainability, Energy and Environment at University of Illinois Urbana-Champaign convened a Critical Conversation on GM mosquitoes. The discussion involved 35 participants from academic, government and nonprofit organizations from around the world with expertise in mosquito biology, community engagement and risk assessment.

A primary takeaway from this conversation was an urgent need to make regulatory procedures more transparent, comprehensive and protected from biases and conflicts of interest. In short, we believe it is time to reassess risk assessment for GM mosquitoes. Here are some of the key elements we recommend.

Steps to make risk assessment more open and comprehensive

First, an official, government-funded registry for GM organisms specifically designed to reproduce in the wild and intended for release in the U.S. would make risk assessments more transparent and accountable. Similar to the U.S.database that lists all human clinical trials, this field trial registry would require all technology developers to disclose intentions to release, information on their GM strategy, scale and location of release and intentions for data collection.

This registry could be presented in a way that protects intellectual property rights, just as therapies entering clinical trials are patent-protected in their registry. The GM organism registry would be updated in real time and made fully available to the public.

Second, a broader set of risks needs to be assessed and an evidence base needs to be generated by third-party researchers. Because each GM mosquito is released into a unique environment, risk assessments and experiments prior to and during trial releases should address local effects on the ecosystem and food webs. They should also probe the disease transmission potential of the mosquitos wild counterparts andecological competitors, examine evolutionary pressures on disease agents in the mosquito community andtrack the gene flowbetween GM and wild mosquitoes.

To identify and assess risks, a commitment of funding is necessary. The U.S.EPAs recent announcementthat it would improve general risk assessment analysis for biotechnology products is a good start. But regulatory and funding support for an external advisory committee to review assessments for GM organisms released in the wild is also needed;diverse expertise and local community representationwould secure a more fair and comprehensive assessment.

Furthermore, independent researchers and advisers could help guide what data are collected during trials to reduce uncertainty and inform future large-scale releases and risk assessments.

The objective to reduce or even eliminate mosquito-borne disease is laudable. GM mosquitoes could prove to be an important tool in alleviating global health burdens. However, to ensure their success, we believe that regulatory frameworks for open, comprehensive and participatory decision-making are urgently needed.

This article was updated to correct the date that Oxitec withdrew its OX513 trial application to 2018.

[Deep knowledge, daily.Sign up for The Conversations newsletter.]

This article is republished from The Conversation under a Creative Commons license. Read the original article here:https://theconversation.com/genetically-modified-mosquitoes-could-be-released-in-florida-and-texas-beginning-this-summer-silver-bullet-or-jumping-the-gun-139710.

The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.)

Brian Allan,University of Illinois at Urbana-Champaign;Chris Stone,University of Illinois at Urbana-Champaign;Holly Tuten,University of Illinois at Urbana-Champaign;Jennifer Kuzma,North Carolina State University, andNatalie Kofler,University of Illinois at Urbana-Champaign

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Connection Between Psoriasis and Joint Disease Indicates Early Treatment Can Be Key – AJMC.com Managed Markets Network

Posted: July 5, 2020 at 6:48 am

Researchers identified a protein that can not only worsen skin inflammation but also plays a key role in damaging joints and bones of patients with psoriasis.

Patients with psoriasis show higher rates of diverse comorbid conditions, such as psoriatic arthritis (PsA), which occurs in one-third of patients with psoriasis and can cause severe, disabling joint disease. However, the reason why so many people with psoriasis develop PsA hasnt been clear.

Since the damage that occurs as a result of PsA is irreversible, identifying patients with PsA early, before too much damage is done to bones, tendons, and joints, is an important consideration, researchers noted.

A team led by Case Western Reserve University School of Medicine researchers discovered that normalizing KLK6 can eliminate skin inflammation and reduce the arthritis-like damage.

"To discover that turning down KLK6 eliminated the skin inflammation and even improved the arthritis-like changesthat was unbelievable," Nicole Ward, PhD, the study's principal investigator and a professor of nutrition and dermatology at the medical school, said in a statement. "This suggests that clinicians need to aggressively treat patients with psoriasis to prevent the arthritis changes, which generally occur after the skin disease presents itself. Since the joint and bone damage are largely irreversible in patients, prevention becomes critical."

In previous research, Ward found that the skin of patients with psoriasis had 6 times more KLK6 than normal. In addition, the PAR1 receptor protein, which causes cellular/tissue responses like inflammation when activated, is overproduced in these patients skin and immune cells. The theory that came from these findings was that KLK6 drove inflammation through signaling of PAR1.

In this new study, the researchers overproduced KLK6 through genetic engineering to develop psoriasis-like skin disease. When PAR1 was deleted, there was a reduction in skin inflammation, as well as an improvement in bone and joint problems.

"These findings suggest that chronic inflammation originating in the skin has the capacity to cause distant joint and bone destruction seen in arthritis, according to Ward.

Reference

Billi AC, Ludwig JE, Fritz Y, et al. KLK6 expression in skin induces PAR1-mediated psoriasiform dermatitis and inflammatory joint disease. J Clin Invest. 2020;130(6):3151-3157. doi:10.1172/JCI133159

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