StemCell Therapy

HealthCoronavirusHalf a million people were on the waiting list for treatment in Yorkshire and the North East in August, official figures show.

Sunday, 18th October 2020, 11:45 am

The regions, which are often combined for statistical purposes, had an average waiting time of 12 weeks.

Though this is below the Governments pledge of 18 weeks from diagnosis to treatment, 43 per cent of people waited longer, many people significantly so.

The figures show there were some people who waited as long as two years for treatment, with plastic surgery having the longest waiting times.

Cardiothoracic surgery had the shortest waiting times but considerably fewer patients than other areas of medicine.

Ear, nose and throat and opthalmology had the largest number of patients and some of the longest waiting times.

Consulant opthalmic surgeon at Optegra, Shafiq Rehman, told The Yorkshire Post there had been a dramatic increase in cataract referrals in recent months, as people struggled to cope in lockdown with increasingly poor vision, and said he expected waiting times to get worse.

It is highly likely that the additional pressure caused by the fallout from Covid-19 will dwarf the usual seasonal pressures for the NHS and sadly the result is likely to be that elective NHS activity - routine out-patient appointments, cataract surgery, elective hip/knee surgeries - will be most heavily affected and I foresee many areas of the UK experiencing long delays to access routine elective medical care in the coming six to twelve months ahead.

He urged people with medical concerns not to risk making problems worse by delaying seeing a doctor.

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Half a million people in Yorkshire waiting for hospital treatment - this surgery has the longest waiting times - Yorkshire Post

As health systems are set to start reporting their third quarter earnings results this week, new research highlights hospitals' ongoing fears about financial viability, patient volumes and supply stocks.

That's as new hotspots in the Midwest report rising COVID-19 case loads and hospitals prepare for the pandemic to collide with flu season, potentially causing stress on capacity once again.

The takeaway is that most hospitals aren't expecting a return to normal anytime soon, although it depends on the trajectory on ongoing efforts to develop vaccines and treatments. Most executives see 2022 as the timeline for seeing some regularity, according to Kaufman Hall.

About 20% of hospital executives surveyed by the group recently said they were "extremely concerned" about their financial viability until an effective vaccine or treatment is available. Another 50% said they were "moderately concerned."

Some major hospital systems, however, have not fit this pattern. Earlier this month, HCA Healthcare previewed better-than-expected third quarter financial results and said it was returning all $6 billion it received from CMS in federal COVID-19 relief funding.

How health systems are doing now depends larger on their status at the beginning of this year, as well as market position and size, Lance Robinson, managing director at Kaufman Hall and one of the report's authors, said.

"If you were strong going into the COVID crisis, you're probably able to weather it much better than if you were teetering on low margins and low volumes to begin with," he said. "So I think it really just exposed those health systems and providers that were already not doing well."

Meanwhile, patient volumes are falling again after a rebound in early fall. And older people at a higher risk for severe symptoms from COVID-19 are less likely to return for care, according to a Kaiser Family Foundation analysis of Epic EHR data.

That research showed that total admissions for this year will come in about 10% lower than had been forecast, possibly more if restrictions on elective procedures are reinstituted later this year.

"[I]f the coronavirus begins to spread more rapidly later in the fall and non-emergency procedures are once again delayed, it could have serious consequences both for hospitals' financial stability and the health of patients," according to the report.

Outpatient volumes are also rebounding at a varying rate, according to a Commonwealth Fund report published last week. While some areas like dermatology and opthalmology are seeing rates actually exceed pre-pandemic levels, most are still falling short. Pulmonology, for example, is 20% below pre-pandemic levels still.

Multiple reports have shown crashes in pediatric visits, putting a strain on children's hospitals across the country.

Hospital executives are also dealing with changes in workforce and expenses. Three-quarters told Kaufman Hall they are ramping up monitoring and resources going toward mental health and burnout concerns among staff.

They noted that costs for personal protective equipment and labor expenses for nursing staff have increased significantly.

The Kaufman Hall survey conducted in August found 40% saying case numbers are rising and 36% saying they're staying level. Nearly half said the length of stay among COVID-19 patients had led to them canceling elective procedures.

That isn't likely to have improved in the past two months. Eight states set new records last week for novel coronavirus infections recorded in a single day, according to the COVID Tracking Project, and fears about another surge in the coming weeks abound.

Volumes are also varying by service area. About 60% of respondents said oncology levels had returned to 90% of what they were before the pandemic. Not quite half said the same about cardiology surveys while orthopaedics, neurology and radiology trailed at 37% reporting nearly normal volumes. Pediatrics was in the last at 22%

Executives said they are worried about the expected changes in payer mix. The biggest concern is an increase is uncompensated care, followed by higher percentage of self-pay and Medicaid patients.

Those concerns are far from unfounded. At the beginning of this month, more than 4 million people had enrolled in Medicaid because of the pandemic and resulting recession. And more than 14 million may have lost health coverage because of job losses.

To help offset those adjustments, executives are turning to supply reprocessing most, according to Kaufman Hall.After that, nearly 60% said they implemented furloughs and 56%instituted salary freezes or reductions. That was followed by permanent workforce reduction (31%), suspending matching contributions to retirement plans (25%) and restructuring physician contracts (19%).

Permission granted by Kaufman Hall

Supply chain concerns have not entirely waned. In recent months, hospitals have been focused on building up stockpiles of personal protective equipment to prepare for potential case surges. Some states, like California and New York,have mandated they have a 90-day supply on hand.

That presents a new challenge of logistics and warehouse management, said Jeff Ashkenase, group vice president at group purchasing organization Premier.

Providers are generally feeling much better about their access to PPE than they did in March and April, but they may never feel secure that they have enough of everything that could be needed, he said.

"So, we're sort of operating in peril," he said. "We're operating in normal cases and volumes and the types of work that we did and simultaneously building up the stockpile."

Only 3% of hospital staff responding to a recent survey from Premier said accessing the Strategic National Stockpile through their state was an "easy process." About 30% said it was difficult, while 44% said they "managed" and 22% did not access the national stockpile.

Ashkenase called for more coordination to improve the efficiency of shared stockpiles. "With all the stockpiles, the need for more transparency on what's in the stockpile and how to access it, when you will get it, will be beneficial," he said.

Respondents to Premier said regulatory flexibility had been most helpful to them in preparing for another wave. Expanded telehealth coverage and payment was cited the most, followed by reimbursement for alternative care settings and workforce changes like allowing clinicians to practice at the top of their license.

As major public hospital operators begin their Q3 earnings reports with Tenet leading the pack Tuesday, Robinson said he'll be watching for what areas are seeing patients returning and how quickly.

"And then on the expense side, it's obviously the PPE and the staffing requirements that are going to need to be out there, especially if we have a third wave of COVID," he said.

And looking even farther out, the traditional method of looking to the past year's metrics won't work when looking toward 2021 and 2022, Robinson said.

"I think clients are struggling with, 'How do I even begin to build a budget for 2021? What does that look like?'" he said.

Originally posted here:
Providers' rocky road to recovery could last into 2022 - Healthcare Dive

Connective Tissue Growth Factor Market Overview 2020 2025

This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

The risingtechnology in Connective Tissue Growth Factor Marketis also depicted in thisresearchreport. Factors that are boosting the growth of the market, and giving a positive push to thrive in the global market is explained in detail.

Get a Sample PDF copy of the report @ https://reportsinsights.com/sample/167828

Key Competitors of the Global Connective Tissue Growth Factor Market are:BLR Bio LLCFibroGen IncProMetic Life Sciences IncRXi Pharmaceuticals Corp

Historical data available in the report elaborates on the development of the Connective Tissue Growth Factor on national, regional and international levels. Connective Tissue Growth Factor Market Research Report presents a detailed analysis based on the thorough research of the overall market, particularly on questions that border on the market size, growth scenario, potential opportunities, operation landscape, trend analysis, and competitive analysis.

Major Product Types covered are:BLR-200IB-DMDOLX-201PBI-4050Others

Major Applications of Connective Tissue Growth Factor covered are:Hypertrophic ScarsOpthalmologyGenetic DisordersLiver FibrosisOthers

This study report on global Connective Tissue Growth Factor market throws light on the crucial trends and dynamics impacting the development of the market, including the restraints, drivers, and opportunities.

The fundamental purpose of Connective Tissue Growth Factor Market report is to provide a correct and strategic analysis of the Connective Tissue Growth Factor industry. The report scrutinizes each segment and sub-segments presents before you a 360-degree view of the said market.

Market Scenario:

The report further highlights the development trends in the global Connective Tissue Growth Factor market. Factors that are driving the market growth and fueling its segments are also analyzed in the report. The report also highlights on its applications, types, deployments, components, developments of this market.

Highlights following key factors:

:-Business descriptionA detailed description of the companys operations and business divisions.:-Corporate strategyAnalysts summarization of the companys business strategy.:-SWOT AnalysisA detailed analysis of the companys strengths, weakness, opportunities and threats.:-Company historyProgression of key events associated with the company.:-Major products and servicesA list of major products, services and brands of the company.:-Key competitorsA list of key competitors to the company.:-Important locations and subsidiariesA list and contact details of key locations and subsidiaries of the company.:-Detailed financial ratios for the past five yearsThe latest financial ratios derived from the annual financial statements published by the company with 5 years history.

Our report offers:

Market share assessments for the regional and country level segments. Market share analysis of the top industry players. Strategic recommendations for the new entrants. Market forecasts for a minimum of 9 years of all the mentioned segments, sub segments and the regional markets. Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations). Strategic recommendations in key business segments based on the market estimations. Competitive landscaping mapping the key common trends. Company profiling with detailed strategies, financials, and recent developments. Supply chain trends mapping the latest technological advancements.

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Connective Tissue Growth Factor Market, Share, Application Analysis, Regional Outlook, Competitive Strategies & Forecast up to 2025 - The Think...

Culture Books

The e-book debut also delivers all new Pinoy monstersmeaning none of your usual aswangs and tikbalangs.

Halloween is just around the corner, and since youll most likely be spending the spooky celebration at home, you might as well curl up with a good horror book. Writer, musician, filmmaker and podcaster Wincy Aquino Ong has released his first collection of short fiction entitledTales For A Rainy Season. If youre looking for fresh new scares, this might be the reading material for you.

Ive always been a fan of Rod SerlingsThe Twilight Zone,says the 38-year-old. So I thought to myself: I want to write a book thats sort of a Pinoy version ofThe Twilight Zonemix in the supernatural with mundane details all Filipinos can relate to, and end the story with a note the reader wasnt expecting.

In writing the book, Ong challenged himself to steer clear of whats been done before in Filipino horror fictionthe aswangs, the white ladies, the tikbalangs that are common fixtures in the genre.

Apparently, theres still a lot to be mined in Pinoy horror culture after youve gone past the aswangs from Siquijor, the White Lady from Balete Drive, and the Snake Man in Robinsons Galleria, says Ong. I looked deeper into the annals of our local folklore and urban legends, these rabbit holes on the Internet, and I found so many obscure gems that a horror writer can easily turn into a short story.

Tales for a Rainy Seasonclaims it has everythingfrom Nardong Putik (the gangster who could turn himself invisible by using consecrated mud) to Baguio hippies who practice ritual suicides. One of the stories explores that urban legend of Jose Rizal being the man behind the Whitechapel Murders.

Entitled The Opthalmologists Case, Ongs alternate take on the Sherlock-Holmes-meets-Rizal story comes from all the Rizaliana he imbibed from prep to college in Ateneo de Manila. Marilou Diaz-Abaya, one of Ongs teachers and the director of the 1998 epic on the National Hero, also shared with Ongs class the wealth of information she discovered while working on the biopicstuff not usually included in a Rizal class.

One of the pieces of trivia from those classes thats stayed with Ong is Rizals stint as a horror writer. He wrote one calledJunto al Pasig, which is like aStranger Thingsadventure tale where a group of kids fight Satan during a Holy Week procession. Truly cool stuff, says theTales for A Rainy Seasonauthor.

Which brings us back to The Opthalmologists Case. I wanted to explore that urban legend that connected Rizal to the Jack the Ripper murders in 1888. Historically speaking, he was there in London when it all happened! And since Im a big Sherlock Holmes fan, I couldnt think of any other detective who could dig up the case...I pictured more as a fugitive movie, where Rizal is on the run from the law, and Sherlock and Watson are on his tail.

Ong describes the story as an exciting chase through the many corners of 19th century London, and via the story, readers will get a glimpse of the life of an Ilustrado in those timesthe boarding houses, their habits and vices, the nightlife in the seedier parts of the city. More than that, I wrote the story because I wanted to see how the smartest Filipino there ever was can match up to the terrifying mind that is Sherlock Holmes.

Ong is not exactly a stranger to the horror genre. He is the writer and director behind the 2011 Cinemalaya horror filmSan Lazaroand 2014sOvertimeunder GMA Films.For him, a good horror story should have other things going for it than the scares. A good horror story must also have humor and drama.Also, it all boils down to the hero of your story and how much you care for him or her, says the author. Before you expose your hero to the ghost or the monster, he should be someone you root for and care about.

Tales for a Rainy Season,now available for download at the Amazon Kindle Store and Kindle Unlimited.

Read more here:
Sherlock Holmes meets Jose Rizal in this debut horror story collection - ABS-CBN News

In a recent clinical trial for an immune cell therapy for lymphoma, 62% of patients experienced complete cancer clearance in spite of the fact that some of them were on their 5th line of treatment. Stem cell therapies have the potential to enact more of these paradigm-shifting treatments. Proposition 14 will continue to advance these therapies and bring them to full development as available cures.

The vision of stem cell therapy is that a physician can just as easily grab an IV bag full of therapeutic cells as they might draw a drug into a syringe. Conceived through Proposition 71 in 2004, the California Institute for Regenerative Medicine (CIRM) serves as a vehicle to support all aspects of stem cell research. Medical progress requires not just well-designed clinical studies but also a well-trained workforce, educated at the intersection of stem cell biology, engineering, and chemistry.

Since 2008, CIRM has supported the training of nearly 1300 Community College and California State University students for the emerging field of Regenerative Medicine through the Bridges to Stem Cell Research and Therapy Program. The Bridges Training Program has functioned as a pathway for first-generation and underrepresented students from Humboldt to San Diego, to all of the biomedical sectors startup and cell therapy companies, academic research institutes, graduate and medical school, and more. Exposure to hands-on labs, advanced seminar discussions, and a required paid internship fully prepares these students for entering the stem cell workforce. Over 80% of Bridges alumni have either advanced to graduate school or joined the biomedical workforce in industry or academic institutions. These Programs bring a greater return than the initial cost of training.

SPONSORED

Consider Vahid Hamzeinejad, a bright high school student, headed to UC Berkeley to begin his college career. Enter the Great Recession; Vahid found himself back at home, working non-stop to help keep his parents restaurant afloat. Not giving up on his commitment to an education, he enrolled at the College of the Canyons. After completing an Associates degree, Vahid transferred to Cal Poly, hoping to join the Bridges Program. After receiving the Bridges core training, Vahid started his internship at ViaCyte, where he continues to work today, as a critical member of the team supporting ViaCytes clinical development of a functional cure for diabetes. The nearly $30 billion that California currently spends on diabetes treatments could be significantly reduced, in no small part due to the efforts of a student that cost taxpayers $36,000 to educate. That is before considering the benefit to patients quality of life that would occur by replacing insulin pumps, glucose monitors, and constant vigilance with a stem-cell-derived tissue that regulates blood sugar levels biologically making and secreting its own insulin.

Passing Proposition 14 will enable this and other unparalleled treatments for diabetes, heart disease, cancer, and neurological disorders.

Signed,

Robert Kam and the CIRM Bridges Program

SPONSORED

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CIRM Bridges to Stem Cell Research & Therapy The Bridge to Everywhere (in biomedicine) OP-ED - The Silicon Valley Voice

InvestorPlace

In late September, a U.S. House vote to remove marijuana from the federal Controlled Substances Act was delayed until after the presidential election. If the House remains controlled by Democrats, industry analysts expect the Marijuana Opportunity Reinvestment and Expungement (MORE) Act to potentially pass before the end of 2020. Then, it would be up to the Senate to possibly take a similar action. Today, we will look at three marijuana stocks to buy with decriminalization in the agenda.Canada is the first and only G7 nation to have legalized cannabis nationwide. In the U.S., at the federal level, marijuana is illegal and remains a Schedule I drug. Legal status varies at the state level. However, Democratic vice president nominee Kamala Harris has recently said marijuana would be decriminalized at the federal level under a Biden administration.2018 saw excessive speculation in marijuana stocks. Yet since 2019, a wide range of issues have affected the cannabis industry. Recreational cannabis sales in Canada hit significant headwinds and never reached the levels investors hoped. Although revenue improved for some companies, they have yet to become profitable. And cash burn remains concerning. As a result, most marijuana stocks have been on a roller coaster ride and hit new lows. Put another way, the bubble has burst.InvestorPlace - Stock Market News, Stock Advice & Trading TipsAccording to recent research led by Douglas Berman of Ohio State University, the COVID-19 pandemic has both introduced tremendous new challenges for the cannabis industry and exacerbated long-standing difficulties for businesses in this arena.7 Value Stocks to Buy in an Overvalued MarketNonetheless, with difficulties usually come new opportunities while industry leaders and innovations may appear. With that information, here are three marijuana stocks that could benefit from U.S. developments at the federal level:Constellation Brands(NYSE:STZ)ETFMG Alternative Harvest ETF(NYSEARCA:MJ)GW Pharma(NASDAQ:GWPH)Marijuana Stocks: Constellation Brands(STZ)Source: ShinoStock / Shutterstock.comConstellation Brands is best known as a leading producer and marketer of alcoholic beverages. It holds a large portfolio of beer, wine and distilled spirits brands. Several of those well-recognized brands include Corona, Modelo, Robert Mondavi, Svedka vodka, Casa Noble tequila and High West whiskey. It is one the fastest-growing large consumer packaged goods companies stateside. Outside the U.S., it has operations in Italy, Mexico and New Zealand.The Victor, New York-based group is on our list of marijuana stocks because in 2018, it took a large stake in Ontario, Canada-based Canopy Growth(NYSE:CGC), one of the leading Canadian marijuana producers. STZs 38%-stake in CGC means the latter now has considerable managerial and financial backing.So far, this equity stake in Canopy Growth has been an earnings drag for Constellation Brands, and it will likely remain so in the near future. However, any potential improvement in the outlook of the pot sector in Canada and the U.S. could easily benefit STZ stock. Therefore, this indirect play on CGC could be a less risky approach for many investors.Year-to-date, STZ stock is down about 1.5%. However, that metric tells only half the story. Since the lows hit in early spring, the stock is up about 80%. The current forward price-earnings and price-sales ratios stand at at 20.88 and 4.78 respectively. Wed look to buy the the dips in price, especially if there is a decline toward the $175 level.ETFMG Alternative Harvest ETF (MJ)Source: ShutterstockThe ETFMG Alternative Harvest ETF offers exposure to Canadian cannabis producers as well as a number of firms with exposure to the industry, albeit indirectly. Thus the fund could be appropriate for long-term investors who are interested in the pot sector, but would like to have access to a diverse range of companies.MJ, which has 37 holdings, tracks the Prime Alternative Harvest index. Canopy Growth, Cronos (NASDAQ:CRON), and Tilray (NASDAQ:TLRY) top the list of holdings. Top-10 names make up around half of net assets, which stand around $550 million. The ETF was launched in 2015.7 Value Stocks to Buy in an Overvalued MarketSo far this year, the fund is down more than 30% and hit an all-time low in March. Since 2019, MJ has lost considerable value, driven by the industrys weakness and poor earnings by most pot companies. These stocks tend to be very choppy when their quarterly earnings are due. Given the volatility in the sector, long-term investors should be ready for large short-term price fluctuations in the fund. The sector is risky, but MJs diversification makes it safer than many alternatives.GW Pharma (GWPH)Source: ShutterstockOur final marijuana stock is the cannabis-focused biotech GW Pharma. According to a recent report by the United Nations, Britain is the biggest producer and exporter of legal cannabis in the world. And almost all of the exports are in a single drug, i.e., Sativex, produced by the UK-based GW Pharma. It is used to treat spasms in multiple sclerosis patients.Earlier in the year, the U.S. Drug Enforcement Administration also descheduled Epidiolex, another one of the companys products. As a result, it is no longer listed as a controlled substance stateside. In August, the U.S. Food and Drug Administration approved it to treat seizures in tuberous sclerosis complex.GW is also one of MJs largest holding, accounting for 6.41% of its assets. GWPH stock could be an alternative way to get exposure to the cannabis industry. Year-to-date, the shares are down around 8%. A potential decline toward $90 or below would improve the safety margin for long-term investors.On the date of publication, Tezcan Gecgil did not have (either directly or indirectly) any positions in the securities mentioned in this article.TezcanGecgil has worked in investment management for over two decades in the U.S. and U.K. In addition to formal higher education in the field, she has also completed all 3 levels of the Chartered Market Technician (CMT) examination. Her passion is for options trading based on technical analysis of fundamentally strong companies. She especially enjoys setting up weekly covered calls for income generation. She also publisheseducationalarticles on long-term investing.More From InvestorPlaceForget The Election Pick These Stocks for the Win in 2021Why Everyone Is Investing in 5G All WRONGAmericas #1 Stock Picker Reveals His Next 1,000% WinnerRevolutionary Tech Behind 5G Rollout Is Being Pioneered By This 1 CompanyThe post 3 Marijuana Stocks to Buy With Decriminalization on the Table appeared first on InvestorPlace.

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Former NFL Players Show Interest in Regenerative Medicine and Cell Therapies - Yahoo Finance

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Regenerative Medicine Market.

Trusted Business Insights presents an updated and Latest Study on Regenerative Medicine Market. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Regenerative Medicine Market during the forecast period.It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2020 2029 (Includes COVID-19 Business Impact)

We have updated Regenerative Medicine Market with respect to COVID-19 Business Impact.Inquire before buying

This report focuses on the Regenerative Medicine market and value at the global level, regional level, and company level. From a global perspective, this report represents the overall Regenerative Medicine market size by analyzing historical data and future prospects. Regionally, this report focuses on several key regions: North America, Europe, Japan, China, Southeast Asia, India, Latin America, and South America.

Global Regenerative Medicine Market: Segment Analysis

The research report includes specific segments by region (country), by Company, by Type, and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2019 to 2029. An in-depth analysis of the segments assists in identifying the different factors that will aid market growth.

Global Regenerative Medicine Market: Regional Analysis

The research report includes a detailed study of regions of North America, Europe, Japan, China, Southeast Asia, India, Latin America, and South America. The report has been curated after observing and studying various factors that determine regional growth such as the economic, environmental, social, technological, and political status of the particular region. Researchers have studied the data of revenue, sales, and manufacturers of each mentioned region. This section analyses region-wise revenue and volume for the forecast period of 2019 to 2029.

Global Regenerative Medicine Market: Competitive Landscape

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2019 to 2029.List of Companies Profiled

Report Coverage

The potential to directly alter human genes was first recognized nearly more than 50 years ago. Cell and gene therapy, represent overlapping fields of biomedical research with similar therapeutic goals. Regenerative medicine also comprises of therapeutic tissue engineering and biomaterials -engineered substances used in medical applications to supplement or replace a natural body function. The increased number of the clinical trials and the use of the regenerative medicine for the development of the medicine to treat chronic diseases are some of the factors propelling the regenerative medicine market trends.

The report provides qualitative and quantitative insights on the regenerative medicine industry trends and detailed analysis of market size and growth rate for all possible segments in the market. The market is segments include type, application, distribution channel, and geography. On the basis of the type, the market is segmented into cell therapy, gene therapy, tissue engineering and platelet rich plasma. On the basis of the application, the market is segmented into orthopedics, wound care, oncology and others. On the basis of distribution channel, the regenerative medicine market is segmented into hospitals, clinics and others. Geographically, the market is segmented into five major regions, which are North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The regions are further categorized into countries.

Along with this, the regenerative medicine market report comprises analysis of the industry dynamics and competitive landscape. Various key insights provided in the report are prevalence and incidence of diabetes by key countries, advancements in insulin delivery devices, recent industry developments such as mergers & acquisitions, pricing analysis, technological advancements, and key industry trends.

SEGMENTATION

By Product

By Application

By Distribution Channel

By Geography

Key Industry Developments

In September 2020, Takeda Pharmaceutical Company Limited announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. The facility provides end-to-end research and development capabilities and will accelerate Takedas efforts to develop next-generation cell therapies, initially focused on oncology with the potential to expand into other therapeutic areas.

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U., and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world.

Takedas Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development, and commercialization. It provides bioengineering, chemistry, manufacturing, and control (CMC), data management, analytical, and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

In 2018, Novartis received EU approval for one-time gene therapy Luxturna, which has been developed to restore vision in people with rare and genetically-associated retinal disease.

In 2018, Novartis received EU approval for its CAR-T cell therapy, Kymriah.In 2017, Integra LifeSciences launched its product, Integra Dermal Regeneration Template Single Layer Thin for dermal repair defects reconstruction in a one-step procedure.

Looking for more? Check out our repository for all available reports on Regenerative Medicine Market in related sectors.

Quick Read Table of Contents of this Report @ Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2020 2029 (Includes COVID-19 Business Impact)

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Original post:
Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By...

Gosselies, Belgium, 12 October 2020, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announce that CEO, Miguel Forte, MD, PhD will present at the annual Cell & Gene Meeting on the Mesa to be held virtually October 12-16. Miguel Forte will also chair the session The European Regulatory Environment for ATMPs Should we expect more or less regulation? with the participation of panelists from the European Organization for Rare Diseases (EURORDIS), the European Medicines Agency (EMA) and the European Commission.

Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a five-day virtual conference featuring more than 120 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies. The meeting also includes over 100 panelists and featured speakers taking part in 20 in-depth sessions covering all aspects of cell and gene therapy commercialization. Companies presentations will be available to view on-demand throughout the entirety of the conference

Please visit http://www.meetingonthemesa.com for full information including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Stringham at lstringham@alliancerm.org and interested media should contact Kaitlyn Dupont at kdupont@alliancerm.org.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

For US Media and Investor Enquiries:LHA Investor RelationsYvonne BriggsTel: +1 310 691 7100ybriggs@lhai.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics to present at 2020 Virtual Cell & Gene Meeting on the Mesa - GlobeNewswire

Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed. Specifically, that entails improving manufacturing to control variables and thus ensure product consistency, and maturing the regulatory environment to improve predictability.

Manufacturing cells is not like manufacturing small molecules, Brian Culley, CEO of Lineage Cell Therapeutics, told BioSpace. For cell therapy products to mature into real products that deliver on the promises of 10 years ago, they must be scalable which drives affordability and they must solve their purity issues.

On the clinical side, cell and gene therapies must find places where small molecules, antibodies or other traditional approaches may not be the best option.

For example, The era of transplant medicine is unfolding before us, Culley said. Because of the transplant component, cell therapy may enable changes the body never could do alone.

Lineage is addressing dry AMD and spinal cord injuries with two of its therapeutics.

Our approach is fundamentally different from traditional approaches. We replace the entire cell rather than modulate a pathway. There is a rational hypothesis where cell therapy can win, but first we need to fix the operational hurdles, Culley said.

To address the manufacturing challenges, Culley said, We work only with allogeneic approaches. For us, not being patient-specific is a huge advantage.

Not long ago, the industry was focused on 3D manufacturing in bioreactors.

Were beyond that, Culley said. For our dry AMD product, we can manufacture 5 billion retinal cells in a three liter bioreactor. The advantage is that the cells exist in a very homogenous space and are 99% pure.

As a result, they are more affordable and can be harvested with little manipulation.

Manual manipulation affects gene expression, he pointed out, so minimizing that, as well as the vast quantities of plastics typically required, results in a more controlled process and a more consistent product.

Additionally, Lineage introduced a thaw and inject formulation, so the cell therapy can be thawed in a water bath, loaded into a chamber and injected, all within a few minutes. Traditional dose administration requires washing, plating and reconstituting the cells the before they are administered to a patient.

Getting rid of the prior day dose prep is one example of the maturation of the field, which we are deploying today to help usher in a new branch of medicine, Culley said.

At Lineage, were tackling problems that largely were intractable. For dry AMD, theres nothing approved by the FDA. No one know why the retinal cells die off, so we manufacture brand new retinal cells (OpRegen) and implant them, Culley said. Were seeing very encouraging clinical signs, including the first-ever case of retinal restoration.

Retinal cells compose a thin layer in the back of the eye, Culley explained.

They start to die off in one spot, and that area grows outward. When we inject our manufactured cells where the old ones died, weve seen the damaged area shrink and the architecture in previously damage areas completely restored, Culley said. Weve treated 20 patients for dry AMD in, ostensibly, safety trials, but you cant help but notice efficacy when a patient reads five more lines on an eye chart. Its hard to imagine our intervention wasnt responsible for that, especially when humans cant regenerate retinal tissue.

The spinal injury program (OPC1) may represent an even greater breakthrough. As with dry AMD, there is no FDA-approved therapy.

We manufacture oligodendrocytes and transport them into the spinal cord, to help produce the myelin coating for axons, he told BioSpace. Because of the oligodendrocytes, the axons grow, become myelinated, and begin to function. Small molecule and antibody therapies havent been able to do that.

So far, 25 people have been treated in a Phase I/II trial. Culley reported cases in which a quadriplegic man, after OPC1 therapy, is now typing 30 to 40 words per minute, and another who now can throw a baseball. Its not unusual for patients who initially were completely paralyzed to now schedule their treatments around college classes, Culley said.

Humans can have varying degrees of recovery from spinal cord injury, but these are higher than we would expect, Culley said.

Other cell and gene companies are advancing solutions, too.

Many companies with induced pluripotent stem cells (iPSCs) are trying to figure out how to get scalability, purity, and reproducibility to work for them. Its not a quick fix, he said.

One of the challenges is balancing the clinical and manufacturing aspects of development.

If you have a technology thats not yet commercially viable, but you have clinical evidence, its tempting to focus on the clinical side, Culley said.

Too many companies do that, and then find their candidate must be reworked for scale up. Therefore, consider scale up and manufacturing early.

Theres a need for balance at a more granular level, too. For example, he asked, How many release criteria do you need? Just because you know a cell expresses a certain surface marker, does that add to your process? Ive seen companies ruined by trying to be perfect, and others by rushing headlong, seeing evidence where evidence doesnt exist.

As Lineage matures its processes to support larger clinical trials, the greatest challenges have been time It takes 30 to 40 days to grow cells, Culley said and regulatory uncertainty. Often, there is no regulatory precedence so there are holes to be addressed. For example, cell and gene therapies sometimes have a delivery component such as a scaffold or delivery encapsulation technology that also must be considered. Real-time regulatory feedback isnt available, so you proceed, presuming that what youre doing will be acceptable to regulators.

The FDA recognizes that new, disruptive technologies and approaches are being used, and must be used, for cell and gene therapy to reach patients.

The FDA is responsive and is trying to push guidance out, Culley said, but it takes time.

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Disruptive Technologies and Mature Regulatory Environment Vital for Cell Therapy Maturation - BioSpace

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Woolly worm race champion to predict winter weather this upcoming season - WJHL-TV News Channel 11

As health sciences researchers conduct clinical trials to develop safe and effective therapies and vaccines for COVID-19, two nontrial pre-approval access pathways expanded access and right-to-try are becoming more widely-known to the general public.

A study published in Regenerative Medicine written by University of Minnesota Associate Professor Leigh Turner, Simon Fraser University Professor Jeremy Snyder, and New York University Assistant Professor Alison Bateman-House suggests thatmost patients engaged in online crowdfunding and seeking nontrial preapproval access to investigational medical products obtain them using the expanded access regulatory pathway rather than through what is known as the right-to-try.

The federal Right To Try (RTT) Act became law in 2018. It allows for individuals with life-threatening diseases to access investigational medical products if they:

Supporters, including President Trump, promote the right-to-try option as an important pathway for obtaining access to investigational medical products, said Turner, who is with the U of Ms Center for Bioethics. To date, however, few individuals appear to be obtaining access to such products on a right-to-try basis. Right-to-try has been promoted as a faster and less bureaucratic alternative to expanded access.

However, our research findings suggest that when it comes to crowdfunding campaigns on GoFundMe, references to right-to-try often reflect a poor understanding of nontrial preapproval access. In reality, at least according to the crowdfunding campaigns we examined, expanded access is the route by which individuals more commonly access investigational products outside clinical trials.

Expanded access, while also providing access to investigational medical products provided outside clinical trial context, differs significantly from the right-to-try pathway in that it requires FDA and institutional review board (IRB)oversight. The FDA and the IRB review submitted requests and decide if an investigational medical product should be provided on an expanded access basis. President Trump, for example, recently obtained access to an investigational product for COVID-19 a monoclonal antibody cocktail on an expanded access basis.

The experimental interventions allowed under the RTT Act and through an expanded access basis are not commonly covered by insurers. As a result, many individuals engage in online crowdfunding activity to cover the often substantial costs associated with accessing investigational interventions provided outside clinical trials.

Turner and his co-authors identified 79 GoFundMe campaigns referencing right-to-try and 115 campaigns referencing expanded access between April 2019 and April 2020. These campaigns also discussed seeking experimental medical interventions in the U.S.

When restricting analysis to campaigns initiated in 2018 and later, which is around the time the RTT Act was made into law, the researchers identified:

Through this study, researchers found that:

It is important to note that the campaigns on GoFundMe list donation goals and funds received but they may not accurately reflect costs associated with seeking access to investigational medical products pursued via expanded access pathway or a right-to-try option. Furthermore, data collected on crowdfunding sites does not necessarily reflect experiences of individuals who seek access to investigational medical products administered outside clinical trials but do not engage in crowdfunding activities.

Acknowledging these limitations, the study does suggest that, in practice, expanded access provides meaningful access to investigational medical products whereas right-to-try is more rhetorical slogan than practical option.

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Crowdfunding campaigns seeking donations supporting the use of investigational medical products provided via expanded access or 'right-to-try'...

This report also researches and evaluates the impact of Covid-19 outbreak on the Japan Regenerative Medicine Products industry, involving potential opportunity and challenges, drivers and risks. We present the impact assessment of Covid-19 effects on Japan Regenerative Medicine Products and market growth forecast based on different scenario (optimistic, pessimistic, very optimistic, most likely etc.).

Global Japan Regenerative Medicine Products Market Overview:

The research report, titled [Global Japan Regenerative Medicine Products Market 2020 by Company, Regions, Type and Application, Forecast to 2025], presents a detailed analysis of the drivers and restraints impacting the overall market. Analysts have studied the key trends defining the trajectory of the market. The research report also includes an assessment of the achievements made by the players in the global Japan Regenerative Medicine Products market so far. It also notes the key trends in the market that are likely to be lucrative. The research report aims to provide an unbiased and a comprehensive outlook of the global Japan Regenerative Medicine Products market to the readers.

Get PDF Sample Copy of this Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) @ https://www.marketresearchhub.com/enquiry.php?type=S&repid=2785605&source=atm

Global Japan Regenerative Medicine Products Market: Segmentation

For clearer understanding of the global Japan Regenerative Medicine Products market, analysts have segmented the market. The segmentation has been done on the basis of application, technology, and users. Each segment has been further explained with the help of graphs figures. This breakdown of the market gives the readers an objective view of the global Japan Regenerative Medicine Products market, which is essential to make sound investments.

Segment by Type, the Regenerative Medicine Products market is segmented intoCell TherapyTissue EngineeringBiomaterialOthers

Segment by Application, the Regenerative Medicine Products market is segmented intoDermatologyCardiovascularCNSOrthopedicOthers

Regional and Country-level AnalysisThe Regenerative Medicine Products market is analysed and market size information is provided by regions (countries).The key regions covered in the Regenerative Medicine Products market report are North America, Europe, Asia Pacific, Latin America, Middle East and Africa. It also covers key regions (countries), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, U.A.E, etc.The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of sales and revenue for the period 2015-2026.

To understand the changing political scenario, analysts have regionally segmented the market. This gives an overview of the political and socio-economic status of the regions that is expected to impact the market dynamic.

Global Japan Regenerative Medicine Products Market: Research Methodology

To begin with, the analysis has been put together using primary and secondary research methodologies. The information has been authenticated by market expert through valuable commentary. Research analysts have also conducted exhaustive interviews with market-relevant questions to collate this research report.

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Global Japan Regenerative Medicine Products Market: Competitive Rivalry

The research report also studied the key players operating in the global Japan Regenerative Medicine Products market. It has evaluated and elucidated the research and development statuses of these companies, their financial outlooks, and their expansion plans for the forecast period. In addition, the research report also includes the list of strategic initiatives that clearly explain the achievements of the companies in the recent past.

Competitive Landscape and Regenerative Medicine Products Market Share AnalysisRegenerative Medicine Products market competitive landscape provides details and data information by players. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by players for the period 2015-2020. Details included are company description, major business, company total revenue and the sales, revenue generated in Regenerative Medicine Products business, the date to enter into the Regenerative Medicine Products market, Regenerative Medicine Products product introduction, recent developments, etc.The major vendors covered:AcelityDePuy SynthesMedtronicZimmerBiometStrykerMiMedx GroupOrganogenesisUniQureCellular Dynamics InternationalOsiris TherapeuticsVcanbioGamida CellGolden MeditechCytori TherapeuticsCelgeneVericel CorporationGuanhao BiotechMesoblastStemcell TechnologesBellicum Pharmaceuticals

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Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Japan Regenerative Medicine Products market

Chapter 2: Evaluating the leading manufacturers of the global Japan Regenerative Medicine Products market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Japan Regenerative Medicine Products market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

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Research report covers the Japan Regenerative Medicine Products Market Forecasts and Growth, 2019-2025 - Eurowire

Oct. 16, 2020 13:00 UTC

PRINCETON, N.J.--(BUSINESS WIRE)-- The Geistlich Medical business unit of Geistlich Pharma AG, a family owned, Swiss based global leader in regenerative solutions is proud to announce that the General Services Administration (GSA) has added Geistlich Derma-Gide Advanced Wound Matrix to the Federal Supply Schedule (FSS). Geistlich Pharma focuses on a wide variety of clinical indications.

The GSA award will pave the way for physicians and staff of Veterans Administration facilities to utilize Geistlich Derma-Gide for the management of hard to heal wounds. The product is FDA cleared for a wide variety of indications, including diabetic foot ulcers, venous leg ulcers, surgical wounds, and first/second degree burns (among others).

Advanced wound care for those in need

Geistlich Medical has partnered with Recon-Supply, a Service-Disabled Veteran-Owned Small Business owned by Marine Corps veteran Stephen Clark and his wife Katy Clark. It was important to Geistlich Medical to partner with a SDVOSB in order to support and honor those that have served in the US Military, says Geistlich CEO Paul Note. We found a great organization in Recon-Supply and look forward to serving the Veterans Administration facilities as they treat those in need of advanced wound care. All nine of the Geistlich Derma-Gide sizes are a part of the FSS so that physicians and their staff have full access to the portfolio of products available to the broader healthcare market.

Novel second-generation xenograft

Geistlich Derma-Gide Advanced Wound Matrix is a novel second generation xenograft product that features an advanced 4D design: Dual-sourced, highly refined, bi-layered, and structurally optimized. It has demonstrated a 90% closure rate in its first 10 patient observational study recently published in International Wound Journal1. A larger prospective, randomized clinical trial is currently underway, with interim results to be published in late 2020.

1 Armstrong, DG, Orgill, DP, Galiano, RD, et al. An observational pilot study using a purified reconstituted bilayer matrix to treat nonhealing diabetic foot ulcers. Int Wound J. 2020; 17: 966 973.

About Geistlich Pharma

Geistlich Pharma has existed since 1851 and is family-owned. It specializes in the regeneration of bone, cartilage and tissue. More than 700 employees worldwide work for Geistlich in the area of regenerative medicine. With its twelve affiliates and 60 distribution partners, Geistlichs medical devices and medicinal products reach around 90 markets worldwide.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201016005406/en/

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Geistlich Derma-Gide Added to the General Services Administration's Federal Supply Schedule - BioSpace

Market Study Report, LLC recently added a report on Regenerative Medicine market that delivers a holistic view on industry valuations, market size, profit estimations, SWOT analysis and regional landscape of the market. In addition, the report points out key challenges and growth opportunities, while examining the current competitive standings of key players in during the forecasted timeline.

The research report on Regenerative Medicine market report provides a detailed analysis of this business landscape. The document analyses various market dynamics such as the opportunities and factors which drive the market growth. The market is poised to generate notable revenue and display a remunerative growth rate during the analysis timeframe, cites the report.

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Additionally, the report assesses the existing market competition trends and elaborates on various risk factors which may hamper the growth of the Regenerative Medicine market during the analysis timeframe.

The document also highlights the impact of COVID-19 pandemic on the growth of Regenerative Medicine market.

Additional takeaways of the Regenerative Medicine market report:

Details of the regional analysis of the Regenerative Medicine market:

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Table of Contents:

The key questions answered in the report:

For More Details On this Report: https://www.marketstudyreport.com/reports/global-regenerative-medicine-market-2020-by-company-regions-type-and-application-forecast-to-2025

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Regenerative Medicine Market to Witness a Pronounce Growth During 2020 to 2025 - TechnoWeekly

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

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

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

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

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

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

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

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

Contact:

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

_________________________________

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

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

While the US Food and Drug Administration (FDA) is still receiving investigational new drug applications (INDs) for cell and gene therapies, officials are concerned about the impact of the COVID-19 pandemic on clinical trials.Its clear that COVID-19 has adversely affected all aspects of development of cell and gene therapies, said Peter Marks, director of FDAs Center for Biologics Evaluation and Research (CBER), said at the Alliance for Regenerative Medicines Meeting on the Mesa. For some of the studies that are ongoing there are some real challenges to overcome in terms of endpoints that may have been missed.The pandemic also has disrupted global harmonization efforts around gene therapies, Marks said.We were on the cusp, in fact, working with global regulators trying to get towards more harmonization of gene therapy programs in different countries, he said. Were trying to keep it moving but its a challenge to do.Marks noted that before COVID-19 he spent about 75% of his time on cell and gene therapies, but the pandemic has forced him to shift priorities. Some things have less policy demands at this point in time. At this point in time its very much reversed and its probably 80% of my time on COVID-related activities.Marks also noted that CBERs Office of Tissues and Advanced Therapies (OTAT) has been struggling to keep up with its workload even before the pandemic. With the influx of applications for cell and gene therapies over the last five years, Marks said the office, Should have doubled in size and its only modestly larger, 15-20% larger in size.Marks said he is not satisfied with the level of dialogue the agency has been able to have with gene therapy developers. Especially early on, we should be able to have this dialogue that really facilitates setting things up well so that our knowledge of the entire fieldwe help leverage that for every sponsor.Weve been so strapped in terms of personnel that its hard to do that, Marks said, noting that COVID-19 has exacerbated things even further. Because the number of gene therapy applications hasnt fallen off dramatically, some of the trials may not be moving as quickly, but the applications keep coming in. Marks said that OTAT has also had to shift priorities during the pandemic and that he hopes the next user fee cycle will bring in the resources necessary to staff up further.Speaking on a separate panel with members of industry, OTAT Director Wilson Bryan echoed Marks sentiment.We were stretched thin before the pandemic, and with the flood of work that came in, it really had an impact, he said. Sometimes folks dont like to admit this, but we all know weve had delayed meetings, weve had to delay review of some applications because of giving priority to the pandemic.However, Bryan said the office is getting its balance and is working to catch up on some of its delayed activities.Bryan expressed some worry about the financial well-being of some of the smaller companies his office works with. Were hearing a lot about their struggles to stay afloat and continue and finish off their development programs and whether or not those development programs are going to be sufficient to meet regulatory standards, he said.One of the challenges, said Timothy Schroeder, CEO of CTI Clinical Trial & Consulting, will be dealing with gaps in data from clinical trials. The question is going to be how do sponsors, how do regulatory authorities and how do companies such as ourselves fill those gaps?On the regulator side, Bryan said his office is working with companies on an individual basis to sort out those issues, which differ from one indication to the next.Bryan added that one positive to come of the pandemic is greater interest in remote outcome assessments in clinical trials. If we have an energy now to develop outcome measures and validate outcome measures that allow us to reliably capture information from patients in remote locations, that will ultimately facilitate development, he said.The pandemic also has significantly disrupted FDAs ability to conduct surveillance and preapproval inspections. While the agency has resumed some domestic inspections and mission-critical foreign inspections, it also is leveraging other sources of information, including inspection reports from other regulators, and requesting documents from applicants and facilities in lieu of on-site inspections where possible. (RELATED: FDA issues pandemic inspections FAQ guidance, Regulatory Focus 19 August 2020).Were considering virtual inspections, particularly for companies where the site has a track record, but if its a site that is brand new with no track record or if its a site with that has a bad track record, were hesitant to do that, Bryan said.Bryan also raised the prospect of FDA inspectors tagging along remotely for an inspection being conducted by other regulators. Is it possible that we could have an inspection by European inspectors and have US regulators going along for a virtual inspection at the same time? We think about those things, I dont know that weve done them yet, Bryan said, adding that he is not sure whether FDA inspectors would be comfortable with the information they would get.Curran Simpson, chief operations and technology officer at REGENXBIO, said he sees promise in virtual audits and believes the level of documentation a site provides can be indicative of its compliance.How often have I walked into a manufacturing facility thats well-run but has terrible documentation? Almost never. I think virtual audits, if you do a risk-based approach and the audit partner has the ability to send documentation in an efficient way and you have experienced people doing this, I think youre going to get the same flavor of an audit very quickly from the level of the documentation, he said.Of course, youll want to accompany that to the extent possible with imaging of the facility, Curran said, To see if those practices are being followed, the overall cleanliness of the facility and the management of material movement If you dont get a good impression from the documentation that youre working through, its probably a bigger issue that you want to escalate.Amy DuRoss, co-founder and CEO of Vineti, an enterprise software company specializing in advanced therapies, expressed some doubts about the current potential for fully remote audits.Certainly our piece of the chain because were enterprise software is readily auditable remotely, but I would say that the overall system and in manufacturing, Im not sure weve evolved as a species yet to adapt our remote techniques to get a full picture I dont think were there yet, she said.

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FDA officials, experts discuss impact of COVID-19 on cell and gene therapies - Regulatory Focus

The immune response to infections is a delicate balance. We need just enough action to clear away the offending bacteria or viruses, but not so much that our own bodies suffer collateral damage.

Macrophages are immune cells at the front line, detecting pathogens and kicking off an inflammatory response when needed. Understanding how macrophages determine when to go all-out and when to keep calm is key to finding new ways to strike the right balance particularly in cases where inflammation goes too far, such as in sepsis, colitis and other autoimmune disorders.

Two macrophages (blue) fighting to engulf the same pathogen (green). GIV/Girdin is shown in red.

In a study published October 14, 2020 in the Proceedings of the National Academy of Sciences, researchers at University of California San Diego School of Medicine discovered that a molecule called Girdin, or GIV, acts as a brake on macrophages.

When the team deleted the GIV gene from mouse macrophages, the immune cells rapidly overacted to even small amounts of live bacteria or a bacterial toxin. Mice with colitis and sepsis fared worse when lacking the GIV gene in their macrophages.

The researchers also created peptides that mimic GIV, allowing them to shut down mouse macrophages on command. When treated with the GIV-mimic peptide, the mices inflammatory response was tempered.

When a patient dies of sepsis, he or she does not die due to the invading bacteria themselves, but from an overreaction of their immune system to the bacteria, said senior author Pradipta Ghosh, MD, professor at UC San Diego School of Medicine and Moores Cancer Center. Its similar to what were seeing now with dangerous cytokine storms that can result from infection with the novel coronavirus SARS-CoV-2. Macrophages, and the cytokines they produce, are the bodys own immune-stimulating agents and when produced in excessive amounts, they do more harm than good.

Digging deeper into the mechanism at play, Ghosh and team discovered that the GIV protein normally cozies up to a molecule called Toll-like receptor 4 (TLR4). TLR4 is stuck right through the cell membrane, with bits poking inside and outside the cell. Outside of the cell, TLR4 is like an antenna, searching for signs of invading pathogens. Inside the cell, GIV is nestled between the receptors two feet. When in place, GIV keeps the feet apart, and nothing happens. When GIV is removed, the TLR4 feet touch and kick off a cascade of immune-stimulating signals.

Ghoshs GIV-mimicking peptides can take the place of the protein when its missing, keeping the feet apart and calming macrophages down.

We were surprised at just how fluid the immune system is when it encounters a pathogen, said Ghosh, who is also director of the Institute for Network Medicine and executive director of the HUMANOID Center of Research Excellence at UC San Diego School of Medicine. Macrophages dont need to waste time and energy producing more or less GIV protein, they can rapidly dial their response up or down simply by moving it around, and it appears that such regulation happens at the level of gene transcription.

Ghosh and team plan to investigate the factors that determine how the GIV brake remains in place when macrophages are resting or is removed to mount a response to a credible threat. To enable these studies, the Institute for Network Medicine at UC San Diego School of Medicine recently received a new $5 million grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Ghosh shares this award with her colleagues Debashis Sahoo, PhD, assistant professor at UC San Diego School of Medicine and Jacobs School of Engineering, and Soumita Das, PhD, associate professor of pathology at UC San Diego School of Medicine.

Co-authors of the study include: Lee Swanson, Gajanan D. Katkar, Julian Tam, Rama F. Pranadinata, Yogitha Chareddy, Jane Coates, Mahitha Shree Anandachar, Vanessa Castillo, Joshua Olson, Victor Nizet, Irina Kufareva, Soumita Das, all at UC San Diego.

Funding for this research came, in part, from the National Institutes for Health (grants AI141630, AI155696, CA100768, CA160911, DK107585, UL1TR001442, DK 0070202), DiaComp and Helmsley Charitable Trust.

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Protein that Keeps Immune System from Freaking Out Could Form Basis for New Therapeutics - UC San Diego Health

As President Trump claims that he is immune to COVID-19 and isolated reports emerge of reinfection, what is the truth about immunity to COVID-19?

To date, there have been six published cases of COVID-19 reinfection, with various other unverified accounts from around the world. Although this is a comparably small fraction of the millions of people known to have been infected, should we be concerned? To unpick this puzzle, we must first consider what we mean by immunity.

When we are infected with any pathogen, our immune system quickly responds to try to contain the threat and minimise any damage. Our first line of defence is from immune cells, known as innate cells. These cells are not usually enough to eliminate a threat, which is where having a more flexible "adaptive" immune response comes into play our lymphocytes.

Lymphocytes come in two main varieties: B lymphocytes, which make antibodies, and T lymphocytes, which include cells that directly kill the germy invaders.

As antibodies are readily measured in blood, they are often used to indicate a good adaptive immune response. However, over time, antibodies levels in our blood wane, but this doesn't necessarily mean protection is lost. We retain some lymphocytes that know how to deal with the threat our memory cells. Memory cells are remarkably long-lived, patrolling our body, ready to spring into action when needed.

Vaccines work by creating memory cells without the risk of a potentially fatal infection. In an ideal world, it would be relatively easy to create immunity, but it's not always that straightforward.

Although our immune system has evolved to deal with a huge variety of pathogens, these germs have also evolved to hide from the immune system. This arms race means that some pathogens such as malaria or HIV are very tricky to deal with.

Infections that have spilled over from animals - zoonotic diseases - are also challenging for our immune system because they can be completely novel. The virus that causes COVID-19 is such a zoonotic disease, originating in bats.

COVID-19 is caused by a betacoronavirus. Several betacoronaviruses are already common in the human population most familiar as a cause of the common cold. Immunity to these cold-causing viruses isn't that robust but immunity to the more serious conditions, Mers and Sars, is more durable.

Data to date on COVID-19 shows that antibodies can be detected three months after infection, although, as with Sars and Mers, antibodies gradually decrease over time.

Of course, antibody levels are not the only indication of immunity and don't tell us about T lymphocytes or our memory cells. The virus causing COVID-19 is structurally similar to Sars, so perhaps we can be more optimistic about a more durable protective response time will tell. So how worried then should we be about reports of reinfection with COVID-19?

The handful of case reports on reinfection with COVID-19 don't necessarily mean that immunity is not occurring. Issues with testing could account for some reports because "virus" can be detected after infection and recovery. The tests look for viral RNA (the virus's genetic material), and viral RNA that cannot cause infection can be shed from the body even after the person has recovered.

Conversely, false-negative results happen when the sample used in testing contains insufficient viral material to be detected for example, because the virus is at a very low level in the body. Such apparent negative results may account for cases in which the interval between the first and second infection is short. It is hugely important, therefore, to use additional measures, such as viral sequencing and immune indicators.

Reinfection, even in immunity, can happen, but usually this would be mild or asymptomatic because the immune response protects against the worst effects. Consistent with this is that most verified cases of reinfection reported either no or mild symptoms. However, one of the latest verified cases of reinfection which happened just 48 days after the initial infection actually had a more severe response to reinfection.

What might account for the worse symptoms the second time round? One possibility is the patient did not mount a robust adaptive immune response first time round and that their initial infection was largely contained by the innate immune response (the first line of defence). One way to monitor this would be to assess the antibody response as the type of antibody detected can tell us something about the timing of infection. But unfortunately, antibody results were not analysed in the recent patient's first infection.

Another explanation is that different viral strains caused the infections with a subsequent impact on immunity. Genetic sequencing did show differences in viral strains, but it isn't known if this equated to altered immune recognition. Many viruses share structural features, enabling immune responses to one virus to protect against a similar virus. This has been suggested to account for the lack of symptoms in young children who frequently get colds caused by betacoronaviruses.

However, a recent study, yet to be peer-reviewed, found that protection against cold-causing coronaviruses did not protect against COVID-19. In fact, antibodies recognising similar viruses can be dangerous accounting for the rare phenomenon of antibody-dependent enhancement of disease (ADE). ADE occurs when antibodies enhance viral infection of cells with potentially life-threatening consequences.

It should be emphasised, though, that antibodies are only one indicator of immunity and we have no data on either T lymphocytes or memory cells in these cases. What these cases emphasise is a need to standardised approaches in order to capture the critical information for robust evaluation of the threat of reinfection.

We are still learning about the immune response to COVID-19, and every piece of new data is helping us unpick the puzzle of this challenging virus. Our immune system is a powerful ally in the fight against infection, and only by unlocking it can we ultimately hope to defeat COVID-19.

Sheena Cruickshank, Professor in Biomedical Sciences, University of Manchester.

This article was originally published byThe Conversation. Read the original article.

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What We Know And Don't Know About COVID-19 Reinfection Cases - ScienceAlert

Having healthy juices is an easy and effective way to enhance your immunity to combat all diseases and infections. Here are 5 juice recipes from Arooshi Agarwal, Nutritionist and founder of Arooshis Nutrylife to amp up your immune system.

Our immune system works constantly without a pause and so it requires the best fuel for its performance in figuring out which cells belong to our body and which doesnt. These internal little wonderful warriors (antibodies) that protect us from diseases, infections, and what not needs ultimate care so that we are kept healthy and strong from inside. The immune system doesnt only need the right conditions to perform but also requires the right nutrition.

The current global crisis has made us realize the importance of immunity in our daily lives. Good immunity wont come easy without taking care of the gut (small intestine) and liver health. More than 70% of our immune system is in our gut which forms a foundation of our overall health. These two are one of the most important organs in our body that ensures the immunity that we need in our daily life to combat all sorts of illnesses. Having different types of juice is one of the most effective ways to boost our immune system. Hence, Arooshi Aggarwal, nutritionist and founder of Arooshis Nutrylife, shares some easy juice recipes.

5 juice recipes shared by nutritionist Arooshi Agarwal.

Green Juice

Green juice is a powerhouse of supplements for a solid immune system. It works best for detoxifying the liver.You need Wheat Grass, bottle gourd, a handful of mint leaves, and lime. Do not add salt or any condiments, try taking it raw. Blend these green veggies. You can adjust the consistency either with water or coconut water. The ideal time to consume this juice is in the morning.This juice is packed with antioxidants, iron, potassium magnesium which have a nerve and muscle relaxing effect. This juice helps in reducing the inflammation, cools down the body heat and antioxidants help in building up the antibodies.

White Juice

For this juice, you will need bottle gourd, green apple, celery and ginger. Ginger has always been the go-to food for colds. This is because it kills rhinovirus, the infectious agent responsible for the common cold. Celery is filled with sodium, a natural electrolyte that helps to treat dehydration. Green apples are also rich in vitamin C that boosts our immunity. Blend these together with water and drink.

Orange juice

For orange juice, you will be needing carrots, pumpkin, and apricots. This juice is rich in Vitamin A which is also fat-soluble vitamin and helps us fight against eye infections and provides a better vision.

Red juice

For this refreshing juice, you will need beetroot, tomato, ginger, garlic, and turmeric. These are wonder veggies to improve immunity. These veggies keep gut flora (good bacteria) healthy and improve gut health. Not only this juice refreshes the mood but also helps to treat influenza, runny nose, and body aches. This juice is so healthy that it calms down the symptoms of Rheumatoid Arthritis as turmeric, garlic, and ginger have strong inflammatory effects.

Yellow juice

For this, you will need pineapple, carrot mint leaves and lemon. This juice is loaded with immunity builders. It helps in treating cold, cough, and sore throat. Pineapple can reduce the bronchial inflammation which provides better respiration and relieves from the excess mucus formation. This juice is high on Vitamin C, vitamin A, iron, potassium, and antioxidants which also benefit the skin and hair health.

Remember

These five juices will be a blessing to your immune system and vital organs. Also remember, hydration, exercise, and a healthy diet play a very important role to keep your immune system up. While juicing may benefit your physical health, it is equally important to take care of your mental health. A healthy mind resides in a healthy body and vice versa!

Also Read:Significance of self screening in early detection of Breast Cancer explained by Dr Chandrani Mallik

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Boost your immune system with THESE 5 healthy juice recipes shared by Nutritionist Arooshi Agarwal - PINKVILLA

At the front line of our immune system macrophages are standing by, detecting pathogens and kicking off an inflammatory response when needed. Understanding how these immune cells know when to go all-out and when to keep calm is critical to finding new ways to strike the right chord in cases where the immune system overreacts, such as in sepsis and other autoimmune disorders.

Researchers at the University of California (UC) San Diego School of Medicine report they have discovered a protein that acts as a brake on macrophages. Their findings, TLR4 signaling and macrophage inflammatory responses are dampened by GIV/Girdin, were published in the Proceedings of the National Academy of Sciences.

Sensing of pathogens by Toll-like receptor 4 (TLR4) induces an inflammatory response; controlled responses confer immunity but uncontrolled responses cause harm. Here we define how a multimodular scaffold, GIV, or Girdin, titrates such inflammatory response in macrophages, noted the researchers.

When the team deleted the GIV gene from mouse macrophages, the immune cells overreacted to small amounts of live bacteria. Mice with colitis and sepsis fared worse when lacking the GIV gene in their macrophages. They also created peptides that mimic GIV, which allowed them to put the brakes on mouse macrophages on command. When treated with the GIV-mimic peptide, the mices inflammatory response was tempered.

When a patient dies of sepsis, he or she does not die due to the invading bacteria themselves, but from an overreaction of their immune system to the bacteria, explained Pradipta Ghosh, MD, professor at UC San Diego School of Medicine and Moores Cancer Center. Its similar to what were seeing now with dangerous cytokine storms that can result from infection with the novel coronavirus SARS-CoV-2. Macrophages, and the cytokines they produce, are the bodys own immune-stimulating agents and when produced in excessive amounts, they do more harm than good.

Further observation revealed that the GIV protein works together with TLR4. Outside of the cell, TLR4 is like an antenna, searching for signs of invading pathogens. Inside the cell, GIV waits between the receptors two feet. When in place, GIV keeps the feet apart, and nothing happens. When GIV is removed, the TLR4 feet touch and sends off immune-stimulating signals.

We were surprised at just how fluid the immune system is when it encounters a pathogen, said Ghosh, who is also director of the Institute for Network Medicine and executive director of the HUMANOID Center of Research Excellence at UC San Diego School of Medicine. Macrophages dont need to waste time and energy producing more or less GIV protein, they can rapidly dial their response up or down simply by moving it around, and it appears that such regulation happens at the level of gene transcription.

The researchers are looking forward to investigating the factors that determine how the GIV brake remains in place when macrophages are resting or is removed to mount a response to a credible threat. The Institute for Network Medicine at UC San Diego School of Medicine recently received a $5 million grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Ghosh shares this award with her colleagues Debashis Sahoo, PhD, assistant professor at UC San Diego School of Medicine and Jacobs School of Engineering, and Soumita Das, PhD, associate professor of pathology at UC San Diego School of Medicine.

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Protein That Pumps the Brakes on Macrophages in Immune Overreaction - Genetic Engineering & Biotechnology News