StemCell Therapy

Blindness is the inability to see anything, including light.

If youre partially blind, you have limited vision. For example, you may have blurry vision or the inability to distinguish the shapes of objects. Complete blindness means you cant see at all.

Legal blindness refers to vision thats highly compromised. What a person with regular vision can see from 200 feet away, a legally blind person can see from only 20 feet away.

Seek medical attention right away if you suddenly lose the ability to see. Have someone bring you to the emergency room for treatment. Dont wait for your vision to return.

Depending on the cause of your blindness, immediate treatment may increase your chances for restoring your vision. Treatment may involve surgery or medication.

If youre completely blind, you see nothing. If youre partially blind, you might experience the following symptoms:

Your childs visual system begins to develop in the womb. It doesnt fully form until about 2 years of age.

By 6 to 8 weeks of age, your baby should be able to fix their gaze on an object and follow its movement. By 4 months of age, their eyes should be properly aligned and not turned inward or outward.

The symptoms of visual impairment in young children can include:

The following eye diseases and conditions can cause blindness:

Blindness is a potential complication if you have diabetes or have a stroke. Other common causes of blindness include:

The following conditions can impair vision or cause blindness in infants:

The following categories of people are at risk for blindness:

A thorough eye exam by an optometrist will help determine the cause of your blindness or partial loss of vision.

Your eye doctor will administer a series of tests that measure:

Theyll examine the general health of your eyes using a slit lamp. Its a low-power microscope paired with a high-intensity light.

A pediatrician will screen your baby for eye problems shortly after birth. At 6 months of age, have an eye doctor or pediatrician check your child again for visual acuity, focus, and eye alignment.

The doctor will look at your babys eye structures and see whether they can follow a light or colorful object with their eyes.

Your child should be able to pay attention to visual stimuli by 6 to 8 weeks of age. If your child doesnt react to light shining in their eyes or focus on colorful objects by 2 to 3 months of age, have their eyes examined right away.

Have your childs eyes examined if you notice crossed eyes or any other symptoms of impaired vision.

In some cases of vision impairment, one or more of the following may help restore vision:

If you experience partial blindness that cant be corrected, your doctor will provide guidance on how to function with limited vision. For example, you can use a magnifying glass to read, increase the text size on your computer, and use audio clocks and audiobooks.

Complete blindness requires approaching life in a new way and learning new skills. For example, you may need to learn how to:

You can also consider getting some adaptive products, like a specialized smartphone, color identifier, and accessible cookware. Theres even adaptive sporting equipment, like sensory soccer balls.

A persons long-term outlook for restoring vision and slowing vision loss is better when treatment is preventive and sought immediately.

Surgery can effectively treat cataracts. They dont necessarily result in blindness. Early diagnosis and treatment are also important in cases of glaucoma and macular degeneration to help slow down or stop vision loss.

To detect eye diseases and help prevent vision loss, get regular eye examinations. If you receive a diagnosis of certain eye conditions, such as glaucoma, treatment with medication can help prevent blindness.

To help prevent vision loss, the American Optometric Association recommends you have your childs eyes examined:

If you notice symptoms of vision loss between routine visits, make an appointment with their eye doctor immediately.

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Blindness: Symptoms, Causes, Risk Factors & More

After being shortlisted for the LVMH Prize in 2017, South Korean label BLINDNESS headed by designers Jisun Park and Kyu-yong Shin has continued to sculpt out a head-turning repertoire of innovative menswear. Late last year, the brand continued to showcase its experimental take on the sartorial by being shortlisted as finalists for the coveted Woolmark Prize, and have now returned with a lush new arrangement of loosely-tailored goods for the FW20 season.

Spotlighted in a high-contrast lookbook, BLINDNESSs latest thematic underlay incorporates ideas of pollution and environmental consciousness, expressing these motifs in the form of marine-styled fishnets that are spotlighted throughout the lookbook. The looks remain anchored by various leather boots and Chelseas, whereby tight trousers are balanced by oversized jackets, further accented by pops of color. Notable pieces include a large black overcoat with louche tailoring, whereby white stripes have been knit into the woolen textile, various lapel blazers featuring similar detailing, and cable-knit sweats with pronouncing distressing. Throughout the lookbook, hints of military and navy dress take hold, reemphasizing the collections ties to protecting the seas.

Take a detailed look at BLINDNESS FW20 above. For those interested in scoring a piece, the range is likely to hit BLINDNESS webstore in the coming weeks.

For more fashion news, the 2020 LVMH Prize has been canceled.

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BLINDNESS Looks to the Seas for FW20 - HYPEBEAST

Richard P. Holm, M.D,, Prairie Doc Published 10:48 p.m. CT April 16, 2020

Rick Holm

In a recent national survey, 26.9 million American adults age 18 and older reported experiencing vision loss. Of course, vision loss means blindness or the inability to see at all, but the definition also includes those having trouble seeing, even when wearing glasses or contact lenses. While not everything is preventable or reversable, early detection and intervention are among our most effective tools to prevent vision loss.

Mrs. E who lived well into her 90s, would come into my office, never complaining about her eyesight. However, the diagnosis of age-related macular degeneration (AMD) was obvious to me because, when she and I had a face to face conversation, she would look a foot to the left of my nose. The AMD had destroyed her central vision and she used her peripheral vision to see. AMD is the most common cause of blindness in the elderly. Risk factors include a family history of AMD, aging, smoking, obesity and hypertension. We can reduce our risk if we stop smoking, eat less, exercise and visit our eye doctor on a regular basis.

Almost the opposite of AMD is glaucoma, where the peripheral vision is lost, and the central vision is spared. This gradual and painless loss of vision is due to injury of the optic nerve and is commonly the result of increased pressure of the fluid within the eyeball. When glaucoma progresses, even the central vision can be lost but, if diagnosed early, treatment can help.

Diabetic retinopathy and cataracts are more common than AMD or glaucoma. Diabetes causes new tiny, and unfortunately very fragile, blood vessels to develop on the retina, and, when these delicate blood vessels bleed, they cause swelling, scarring, and progressive spotty vision loss. Cataracts, the leading cause of blindness in the world, cause the clouding of the lens of the eye.

For most of these eye conditions, there are methods to diagnose, treat and prevent the blinding consequences, yet many people skip regular eye exams. The message is staring you in the face, or perhaps a foot to the left of your noseget your eyes checked every year. Due to the coronavirus pandemic, most non-urgent eye appointments are being deferred to the latter half of the year. Contact your eye doctor to discuss the best option for you.

Richard P. Holm, MD passed away in March 2020 after a battle with pancreatic cancer. He was founder of The Prairie Doc and author of Lifes Final Season, A Guide for Aging and Dying with Grace available on Amazon. Dr. Holms legacy lives on through his Prairie Doc organization. For free and easy access to the entire Prairie Doc library, visit http://www.prairiedoc.org and follow Prairie Doc on Facebook, featuring On Call with the Prairie Doc a medical Q&A show streaming on Facebook and broadcast on SDPB most Thursdays at 7 p.m. central.

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The message that is staring you in the face - Argus Leader

According to a case study, a teenage boy in UK suffered blindness due to his poor eating habits. It is said that the boy was a fussy eater, and use to eat a lot of junk food like white bread, chips and processed meat. He had a very poor diet due to which he had a vitamin B12 deficiency. He also suffered from anemia. After complaining about the same, the doctors prescribed him vitamin b12 shots and a proper nutritional food diet.

The boy at the age of 14, did visit his regular doctor, where he complained about fatigue. But otherwise he was healthy and was not taking any medicines, but he had also called himself as fussy eater where his 80% diet was on junk food. After a year, his hearing weakened, and then he again visited another doctor. He was also prescribed some test where it did not show any signs of blindness or hearing. By the next two years, his condition got more worst and his vision started getting more worst. The time he saw an ophthalmologist he was diagnosed with damage in his eyes nerves. Again after taking some tests it was showing that deficiency of vitamin B12. Further after revelation it was seen that the boy could not avoid certain food items like bread, meat, etc. and he had also stopped taking his injections. Further the diagnosis revealed that had deficiency of copper, vitamin D, and selenium too and his bones did get weak because of low mineral efficiency.

These all deficiencies caused the boy for his impartial blindness and hearing loss. Many people call themselves picky eaters, but such eating habits can lead to such disorders. The boys habits were quite extreme and harmful that even the vitamin B12 shots did not work for him. With his nutritional supplements, he was referred to treat with mental counseling for his eating habits. Though his vision did not get worse, surely his eyesight did not improve either.

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Study Shows Excessive Junk Food Leads To Blindness - TheLoop21

Adhering closely to the Mediterranean-style diet particularly one rich in vegetables and fish is associated with higher cognitive function among older adults, according to a National Institutes of Health-funded study published this week in the journal Alzheimers & Dementia.

The study found no link, however, between the Mediterranean diet and slower cognitive decline.

These findings suggest that eating healthful foods may help keep our brains functioning at higher levels during the aging process, even if those levels arent quite as high as they were when we were younger.

For the study, researchers at the National Eye Institute (NEI) analyzed data from two major randomized clinical trials the Age-Related Eye Disease Study (AREDS) and AREDS2 that had previously investigated the effects of diet on age-related macular degeneration (AMD), an eye disease that gradually damages the retina, the light-sensitive tissue at the back of the eye. AMD is a leading cause of permanent vision loss and blindness in people aged 60 and older.

Both studies had reported that certain nutrients, particularly the antioxidants found in fruits and vegetables and the omega-3 fatty acids found in fish, were associated with a lower risk of developing AMD later in life. The authors of the current study wanted to see if the diets of the participants in the AREDS studies also had an effect on their cognitive function. Other research has shown an association between AMD and dementia, and the two conditions are known to share some environmental risk factors, such as smoking and high blood pressure.

We do not always pay attention to our diets. We need to explore how nutrition affects the brain and the eye, says Dr. Emily Chew, the studys lead author and director of the NEI Division of Epidemiology and Clinical Applications, in a released statement.

For the study, Chew and her colleagues used data from 7,756 ARED participants who had completed cognitive tests while in those clinical trials. The participants were aged 55 to 80 when they entered the trials, and were followed for 10 years.

At the start of the trials, the participants filled out a detailed questionnaire designed to assess their diet over the previous year. Based on those questionnaires, the NEI researchers scored each participant on how closely they adhered to the Mediterranean diet, which emphasizes whole fruits, vegetables, whole grains, nuts, legumes, fish and olive oil, as well as reduced amounts of red meat and alcohol.

Then the researchers looked for associations between the participants diets and their cognitive functioning. They found that, in general, the people who most closely adhered to the Mediterranean diet had the highest cognitive function throughout the decade of the study. The differences were small, but still statistically significant.

The individual components of the diet that appeared to have the greatest protective effect on the brain were fish and vegetables. Fish was also the only food associated with slowing down the process of cognitive decline. At the 10-year mark, the people with the highest fish intake exhibited not only higher rates of cognitive functioning, but also the lowest rate of decline.

These findings held even after the researchers adjusted the data to account for education levels.

The benefits from the Mediterranean diet were similar for people with and without a gene ApoE known to raise the risk of late-onset Alzheimers disease. That finding suggests, say the researchers, that the diets influence on cognitive functioning is independent of genetic risk. The people with ApoE did, however, tend to have lower average scores for cognitive function than those without the gene. They also tended to show more cognitive decline.

This is an observational study, and therefore cant prove a connection between diet and higher cognitive abilities. In addition, it relies on people self-reporting the foods they ate. Such reporting can be inaccurate.

In addition, most of the people in the study had some degree of AMD. Whether or not the findings can be generalized to other populations is unclear.

Still, the findings are provocative, for they support other observational studies that have found a link between the Mediterranean diet (or one thats similar) and better cognitive function and slower cognitive decline.

Scientists arent sure why the Mediterranean diet might help the brain, explains the National Institute of Aging (NIA) on its website. This primarily plant-based diet has been shown to improve cardiovascular health, which may, in turn, reduce dementia risk. In contrast, the typical Western diet increases cardiovascular disease risk, possibly contributing to faster brain aging.

In addition, this diet might increase specific nutrients that may protect the brain through anti-inflammatory and antioxidant properties, the agency says.

FMI: Youll find an abstract of the NEI study on the website for Alzheimers & Dementia, although the full paper despite being funded by the government is behind a paywall. For more information on diet and the risk of dementia, go to the NIAs website.

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Mediterranean diet linked to higher cognitive functioning during aging - MinnPost

Retinal diseases contributing heavily to the demand growth of intravitreal (IVT) injectables

Hereditary retinal diseases is the major cause of visual loss. Macular degeneration, Diabetic Retinopathy is the important and prominent cause of blindness.

According to Genentech Retinal disease report, around 11 million US population are affected with age-related macular degeneration, 7.7 million people are affected with diabetic retinopathy and around 1.1 million population are affected with retinal vein occlusions.

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Company Profiles

Anti-VEGF intravitreal (IVT) injectables medication is most likely use to treat retinal disorders. Increasing prescription of anti-VEGF anticipate the growth of the intravitreal (IVT) injectables market. Many manufacturers aims to develop drugs with anti-VEGF inhibitor, as a result leading to an increase in the demand for intravitreal (IVT) injectables.

North America to have substantial revenue growth in intravitreal (IVT) injectables Market

North America region shown to have high growth inintravitreal (IVT) injectables market. Low vision and blindness are prevailing in the region and high prescription of anti-VEGF intravitreal (IVT) injectables medication has increases the growth of intravitreal (IVT) injectables market. It is estimated that intravitreal (IVT) injectables create an incremental $ opportunity worth US$ 4,350 Mn between 2018 and 2028.

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Lucentis marketed by Roche and Eylea marketed by Regeneron in the United States, are the commonly prescribed biologics use in intravitreal (IVT) injectables. Apart from this, Avastin and Macugen are also widely used in intravitreal (IVT) injectables market.

The North America region holds a significant share in intravitreal (IVT) injectables among all other regions, due to the increase in prescription of retinal biologics, high healthcare facilities and availability and usage of expensive drugs.

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Intravitreal (IVT) Injectables Market: Segmental Analysis

The global intravitreal (IVT) injectables market has been segmented on the basis of drug class, indication and distributional channel. On the basis of drug class, the intravitreal (IVT) injectables market has been segmented into anti-VEGF, corticosteroids, antibiotics, antivirals and antifungals. Based on indication, the intravitreal (IVT) injectables market has been segmented into diabetic retinopathy, macular degeneration, endophthalmitis, retinal vein occlusions and others.

In terms of revenue, the anti-VEGF segment is expected to have a major share in intravitreal (IVT) injectables during the forecast period as it prevents angiogenesis and also minimize the leakage of fluid that occurs due to retinal diseases.

On the basis of distributional channel, the intravitreal (IVT) injectables market has been categorized into hospital pharmacies, retail pharmacies, drug stores, mail order pharmacies and others. The hospital pharmacies is expected to have high revenue growth in intravitreal (IVT) injectables, owing to the availability of biologics and increase in prescription of anti-VEGF drugs.

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Demand for Intravitreal IVT Injectable Market to be Fueled by Changes in Consumer Perception in the Light of COVID-19 - Lake Shore Gazette

An Albertville City Schools custodian was announced as a finalist in the 2020 Cintas Custodian of the Year contest.

According to Albertville Kindergarten & Pre-K Principal Beth Rigsby, Howell Beasley, Albertville Kindergarten and Pre-K (AKPK) custodian is a finalist in the nationwide 2020 Custodian of the Year contest. She said the school was planning to make the announcement during a surprise school-wide assembly, Monday, March 16, but since the schools closed due to the coronavirus (COVID-19) pandemic they werent able to hold an assembly. Currently, Beasley is in the running to win a $10,000 cash prize, $5,000 in products and services from Cintas Corporation and Rubbermaid Commercial Products and a comprehensive training and development package from ISSA, The Worldwide Cleaning Industry Association, valued at $20,000.

Since Beasley nor the students or faculty knew he had been chosen as a finalist, Rigsby and a few staff members surprised the custodian at AKPK.

What? I cant believe it; I may need to sit down, my knees feel wobbly, Beasley said, after the announcement was made. This was a big surprise. Im very thankful.

Beasleys job title may be custodian, but Rigsby said to the 600 students at AKPK, hes a superhero. She said Beasley has worked 36 years at AKPK, formerly known as Big Spring Lake.

Mr. Howell greets each class with a sincere and warm good morning and goes above and beyond to make students feel supported, Rigsby said. When some children are having a tough day, Mr. Howell makes them his buddy and enlists their help with picking up trash around the school to distract them from their troubles.

If someone is in need in our school or community, Mr. Howell saves the day by helping to ensure they feel special and have everything they need, she continued. He even takes time out of his day to escort a student with blindness up and down the busy hallways to assure she makes it to class safely. His unwavering dedication and pride in his work constantly touches the lives of every person at Albertville Kindergarten & Pre-K.

Beasley said he appreciates his job and looks forward to helping others. He said the students at AKPK are what makes his job rewarding.

I dont mind working, Beasley said, when asked about his career with AKPK. I dont know any different, Ive always worked, but this is home to me and the people are part of my family. I was poor growing up, and I have what I have because of hard work.

I enjoy helping others and I love to help make others happy if I can, he added.

Hosted by Cintas Corporation, the Custodian of the Year contest shines a spotlight on the extraordinary yet often invisible heroes who contribute more than cleanliness to their schools. Now through Friday, April 17, everyone is encouraged to vote for Beasley at custodianoftheyear.com.

This contest shows just how important custodians are to their schools and communities, Christiny Betsch, Cintas marketing manager, said. The number of heartfelt stories we received made it almost impossible to narrow down the top 10 finalists. These 10 finalists have hearts of gold, and were honored to share their stories with the public.

The greatest number of public votes determines the winner of the 2020 Custodian of the Year contest.

It was difficult narrowing down thousands of stories to 10 finalists, John Barrett, ISSA executive director, said. Each custodian has their own unique story, showcasing their astonishing commitment and dedication, which is why these finalists are so worthy of recognition.

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AKPK employee named 2020 Cintas Custodian of the Year finalist - Sand Mountain Reporter

MIAMI, April 16, 2020 /PRNewswire/ -- TissueTech, Inc., the pioneer in the development and clinical application of regenerative human birth tissue products, announced today that the U.S. Food and Drug Administration (FDA) has granted their cryopreserved human umbilical cord investigational biologic product TTAX02 RMAT designation for the treatment of spina bifida in-utero.

This designation aims to streamline development of regenerative medical products used in the FDA's Investigational New Drug (IND) program for the treatment of serious or life-threatening diseases such as spina bifida. In spina bifida, the spinal canal opens along vertebrae in the lower or middle back of the fetus. It is the most common neural tube defect in the U.S. and is characterized by incomplete development of the brain, spinal cord, and/or protective covering around the brain and spinal cord.1

"Although rare, patients who suffer from open spina bifida have a ten times greater death rate than the national average from ages five to 40 years,"2 said Amy Tseng, TissueTech Co-Founder, President and Chief Executive Officer. "This RMAT designation highlights the need for an effective treatment for this life-threatening condition and the great potential TTAX02 holds."

The benefits of in-utero fetal surgery are promising and include less exposure of the vulnerable spinal nerve tissue and bone to the intrauterine environment. Additionally, doctors have discovered that in-utero fetal surgical repair of spina bifida may positively affect fetal hindbrain development in-utero, decreasing the severity of certain complicationssuch as Chiari II and hydrocephalusor reduce the need for surgery to implant a shunt.1

In addition to the RMAT designation, TissueTech is also planning to conduct a Phase 3 clinical trial to demonstrate the safety and efficacy of TTAX02 when used as a single patch to cover the neural placode, or a dual patch to close both the skin and meningeal defects during in-utero fetal surgical repair of spina bifida, to determine if it may improve clinically meaningful neurological outcomes after birth.

About TissueTech, Inc.TissueTech, Inc.,the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., pioneered the development and clinical application of human birth tissue-based products. Founded in 1997, Bio-Tissue markets products for the ophthalmology and optometry markets; and Amniox markets products for use in the musculoskeletal and wound care markets. Clinicians have performed more than 500,000 human implants with the company's products and published more than 360 peer-reviewed studies supporting its technology platform. The Company's first product, AmnioGraft, is the only tissue graft designated by the FDA as homologous use for promoting ophthalmic wound healing as acting as an anti-scarring, anti-inflammatory and anti-angiogenic agent and supporting epithelial adhesion and differentiation. Learn more at https://tissuetech.com/.

Physicians are encouraged to visit the TissueTech Physician Portalto learn more about TissueTech's platform technology, review product application guides, and view educational webinars.

1 https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Spina-Bifida-Fact-Sheet

2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2786149/

SOURCE TissueTech

tissuetech.com

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TissueTech Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from US Food and Drug Administration - PRNewswire

What to know

The CDC is recommending that everyone wear a cloth mask when going out in public. The Manufacturing Development Center at the Wake Forest Institute for Regenerative Medicine, part of Wake Forest Baptist, recently conducted tests of about 400 cloth masks made by community volunteers. The tests looked at how well various types of material filtered out particles the size of many viruses and bacteria (0.3-1.0 microns in diameter). The effectiveness of the masks varied widely, with the best reaching 79% filtration compared to surgical masks at 62% to 65% filtration and N95 masks at 97%. However, according to Dr. Scott Segal, the chair of anesthesiology at Wake Forest Baptist and the originator of the tests, the worst-performing masks filtered out only 1% of particles. Here are some of the findings and other recommendations from Segal.

Tight weave fabric that doesnt show much light passing through is a good performing design.

Best materials and designs

Two layers of high-quality, heavyweight quilters cotton with a thread count of 180 or more

Fabrics with an especially tight weave and thicker thread, such as batiks or heavy T-shirt fabric

Double-layer mask with a simple cotton outer layer and an inner layer of flannel

A lower grade cotton (more open weave) with light passing through is a poorer performing design.

Inferior materials and designs

Single-layer masks

Double-layer designs using lower quality, lightweight cotton

Fabric used in breathable T-shirts designed to be porous

How can you tell suitable fabric?

Use the light test: If you hold the fabric up to a bright light, it shouldnt be easy to see light coming through it, and you shouldnt see a lot of light outlining the weave.

Other things to know

Masks are mostly to protect other people by reducing the chance an infected wearer can spread virus droplets by sneezing or coughing, even before they show other symptoms. However, masks can provide some protection for an uninfected wearer, depending on effectiveness.

Segal recommends using a design with ties over elastic loops, because ties can provide a tighter and more customizable fit. It can also be difficult to find elastic, and elastic can break down with repeated washings.

A well-fitting mask is likely to feel a bit uncomfortable and stuffy when wearing it. Wearing a mask takes some getting used to even for medical professionals, Segal said. You could try wearing a mask in your house first to get adjusted to it.

Dont touch your face after positioning the mask, and dont adjust the mask while youre out. This could spread any virus particles that get on the mask.

Its important to be able to breathe through the mask, and very thick fabric or HEPA vacuum bags could make that difficult. If a person cant breathe through the mask, theyre likely either to ditch the mask or to breathe around the sides of it, Segal said, defeating the purpose of wearing a mask.

Some vacuum bags and filter materials contain fiberglass threads, which could be dangerous to inhale.

Some mask designs utilize a pocket for a replaceable filter. The Baptist study didnt find that a filter added much more effectiveness to already good designs, but Segal said that some places have had success with them, so they are an option.

Even if a masks material isnt the best, something is generally better than nothing when it comes to covering your face.

NOTE

Homemade masks are no substitute for staying home, social distancing and proper handwashing technique (at least 20 seconds with soap and water). Those are still the best ways to fight the COVID-19 virus. Dont let wearing a mask give you a false sense of security or entice you to relax your social distancing.

What youll need

Removing and caring for masks

Wash hands after removing the mask and after changing the interior filter, if your mask has one. Change the filter after every time you go out.

Moisture from your breath makes the mask less effective, so dont reuse a wet mask.

Untie by the straps. Dont touch the front of the mask as you remove it.

Wash masks in the washing machine with detergent in hot water after use.

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Face Masks: What to know, and how to sew your own - Greensboro News & Record

NEW YORK, April 15, 2020 /PRNewswire/ -- The stem cell therapy market was valued at US$ 1,534.55 million in 2019 and is estimated to reach US$ 5,129.66 million by 2027; it is expected to grow at a CAGR of 16.7% from 2020 to 2027.

Read the full report: https://www.reportlinker.com/p05882135/?utm_source=PRN

The increasing awareness related to the stem cells therapy in effective disease management and growing demand for regenerative medicines are the key factor driving the stem cell therapy market. However, high cost related of the stem cell therapy limits the growth of the market.Stem cell research has been widely investigated globally for various medical applications, especially for the treatment of humans.This raises the importance of creating public awareness about stem cell research and its clinical potential.

The main role of stem cells is in the replacement of dying cells and reconstruction of damaged tissues. Based on the extensive stem cell research, many scientists have claimed that these cells could probably be used in the treatment of various diseases, including cancer and cardiovascular disease.There is a large number of potential treatment procedures that are undergoing clinical trials, and a notably few stem cell therapies have won FDA (i.e., US Food and Drug Administration) approval for clinical usage. For instance, in 2019, the FDA approved Fedratinib for the first-line treatment for myelofibrosis. Moreover, stem cell therapies are widely used in bone marrow transplantation, and these therapies have benefited thousands of people suffering from leukemia. Hematopoietic stem cells are used for treating more than 80 medical diseases, including immune system disorders, blood disorders, neurological disorders, metabolic disorders, genetic disorders, and several types of cancers, such as leukemia and lymphoma; this is also likely to boost the demand for this treatment procedure during the forecast period. Researchers are further investigating the use of stem cell therapies in the treatment of autoimmune disorders.

The global stem cell therapy market has been segmented on the basis of type, treatment, application type, and end user.Based on type, the market has been segmented into adult stem cell therapy, induced pluripotent stem cell therapy, embryonic stem cell therapy, and others.

The adult stem cell therapy held the largest share of the market in 2019; however, induced pluripotent stem cell therapy is estimated to register the highest CAGR in the market during the forecast period.Based on treatment, the stem cell therapy market has been segmented into allogeneic and autologous.

The allogeneic segment held a larger share of the market in 2019; however, the market for the autologous segment is expected to grow at a higher CAGR during the forecast period.Based on application type, the stem cell therapy market has been segmented into musculoskeletal, dermatology, cardiology, drug discovery and development, and other applications.

The musculoskeletal segment held the largest share of the stem cell therapy market in 2019, whereas the drug discovery and development segment is expected to report the highest CAGR during 20202027. Based on end user, the market has been segmented into academic and research institutes, and hospitals and specialty clinics. The academic & research institutes held the largest share of the market in 2019, and it is also expected to report the highest CAGR during the forecast period.Several essential secondary sources referred to for preparing this report are the FDA, World Health Organization (WHO), Organisation for Economic Co-operation and Development, National Institutes of Health, Spanish Agency for Medicines (AEMPS), Japanese Society for Regenerative Medicine, and Indian Council of Medical Research, among others.

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Stem Cell Therapy Market to 2027 - Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography - P&T Community

MELBOURNE, Australia, April 17, 2020 (GLOBE NEWSWIRE) --Cynata Therapeutics Limited (ASX: CYP), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that a scientific paper describing the use of Cymerus mesenchymal stem cells (MSCs) in a model of Acute Respiratory Distress Syndrome (ARDS) has been accepted for publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).1The AJRCCM, commonly known as The Blue Journal, is widely regarded as the foremost peer-reviewed journal in the field of respiratory and critical care medicine.

Background

The study was conducted in 14 sheep with severe ARDS supported by extracorporeal membrane oxygenation (ECMO), which were given an endobronchial infusion of either Cymerus MSCs (n=7) or placebo (n=7). Animals were monitored and supported for 24 hours, at which time the study concluded.

ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to a range of insults, including infection, trauma and inhalation of noxious substances. It has received significant global attention in recent times, as it is one of the most serious complications experienced by patients suffering from COVID-19. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation, and results in hospital mortality ofup to 46%.2 In addition, survivors of ARDS are often left with severe long-term illness and disability.3

ECMO is a last-line intervention used in patients whose lungs are unable to provide an adequate amount of oxygen to the blood, despite the use of ventilators and other interventions. ECMO circulates blood through an artificial lung, oxygenating the blood before returning it to the patients circulation. ECMO can help support the vital organs in patients with severe ARDS, but it is not in itself a treatment for ARDS and the mortality among patients supported by it remains high.

This study was conducted independently of Cynata by a group of leading academics known as the Combining Extracorporeal Life Support and Cell Therapy in Critical Illness (CELTIC)Investigators, led by Professor John Fraser of the Critical Care Research Group, The Prince Charles Hospital, Brisbane. The study was funded by the Queensland Government, the National Health and Medical Research Council (NHMRC), the Intensive Care Society UK, and the Prince Charles Hospital Foundation.

Key Results

Cymerus MSC treatment was shown to exert a number of important beneficial effects in this study:

There were no statistically significant differences in oxygenation index between groups. The authors of the paper suggested that this may have been due to the severity of the lung injury induced; the fact that the observation period may have been too short to observe all beneficial effects of the treatment; and practical challenges performing these assessments during ECMO.

The authors also observed that a different dose regimen and/or route of administration could lead to further improved outcomes.

The study also found that MSCs adhere to the membranes in the ECMO device, resulting in a significant increase in pressure, and there was a higher incidence of thrombosis in the lungs observed post-mortem. While this did not lead to failure of the ECMO device or other observed adverse events, the study team considered that it could potentially do so, and therefore concluded that they cannot currently recommend the use of MSCs in combination with ECMO. It is important to note that this finding is relevant to MSCs in general (regardless of source), as it is related to the propensity of MSCs to adhere to plastic, but it does not have implications for the treatment of patients with ARDS who are NOT receiving ECMO.

Dr Kilian Kelly, Cynatas Chief Operating Officer, commented:

We are very encouraged by the beneficial effects of Cymerus MSCs on a number of important, clinically-relevant endpoints in this model of ARDS. These results provide valuable guidance on the potential clinical utility of Cymerus MSCs in the treatment of ARDS. It is also very useful to learn more about the practical mechanical challenges associated with administering MSCs at the same time as ECMO, but it is important to note that most patients with ARDS do not receive ECMO. Furthermore, in humans with ARDS who are not receiving ECMO, we expect to be able to administer repeated intravenous infusions of MSCs, which may have advantages compared to the approach that was taken in this preclinical study. We are currently in discussions with leading key opinion leaders about a possible clinical trial in human patients with ARDS, including those who have developed ARDS as a result of the devastating COVID19 pandemic.

Authorised for release by Dr Ross Macdonald, Managing Director & CEO

About Cynata Therapeutics (ASX: CYP)

Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus, a proprietary therapeutic stem cell platform technology. Cymerus overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.

Cynatas lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Cynata plans to advance its Cymerus MSCs into Phase 2 trials for GvHD, critical limb ischemia and osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of asthma, diabetic wounds, sepsis, heart attack and cytokine release syndrome, a life-threatening condition stemming from cancer immunotherapy.

______________________

1 Millar JE, Bartnikowski N, Passmore MR, et al. Combined Mesenchymal Stromal Cell Therapy and ECMO in ARDS: A Controlled Experimental Study in Sheep. Am J Crit Care Med, 2020.2 Bellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. Jama. 2016;315(8):788.3 Herridge MS, Tansey CM, Matte A, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364(14):1293-304.

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Preclinical Study Showing Beneficial Effects of Cymerus MSCs in Acute Respiratory Distress Syndrome Accepted for Publication in Leading Peer-Reviewed...

Gene Therapy R&D and Revenue Forecasts 2020-2030

Retroviruses, Lentiviruses, Adenoviruses, Adeno Associated Virus, Herpes Simplex Virus, Poxvirus, Vaccinia Virus, Naked/Plasmid Vectors, Gene Gun, Electroporation, Lipofection, Cancer, Rare Diseases, Cardiovascular Disorders, Ophthalmologic Conditions, Infectious Disease, Neurological Disorders, Diabetes Mellitus

LONDON, April 17, 2020 /PRNewswire/ -- The gene therapy market is projected to grow at a CAGR of 32% in the first half of the forecast period. In 2019, the cancer treatment submarket accounted for 55.8% of the gene therapy drug market. Visiongain estimated that gene therapy for rare diseases will be the driver for market growth in the first half of the forecast period.

How this report will benefit youRead on to discover how you can exploit the future business opportunities emerging in this sector.

In this brand-new 215-page report you will receive 157 charts all unavailable elsewhere.

The 215-page Visiongain report provides clear detailed insight into the gene therapy market. Discover the key drivers and challenges affecting the market.

By ordering and reading our brand-new report today you stay better informed and ready to act.

To request sample pages from this report please contact Sara Peerun at sara.peerun@visiongain.com or refer to our website: https://www.visiongain.com/report/gene-therapy-rd-and-revenue-forecasts-2020-2030/#download_sampe_div

Report Scope

Gene Therapy market forecasts from2020-2030

This report assesses the approved gene therapy products in the market and gives revenue to 2030

Provides qualitative analysis and forecast of the submarket by indication for the period 2020-2030: Cancer Cardiovascular disorders Rare diseases Ophthalmological diseases Infectious Diseases Neurological Disorders Diabetes Mellitus Other therapeutic uses

Profiles leading companies that will be important in the development of the gene therapy market. For each company, developments and outlooks are discussed and companies covered in this chapter include: UniQure Biogen Bluebird Bio Spark Therapeutics Applied Genetics Technologies Corporation Oxford Biomedica GenSight Biologics & Other Companies

Assesses the outlook for the leading gene treatment R&D pipeline for 2019 and discusses technological progress and potential. Profiles appear for gene therapy drug candidates, with revenue forecasts for four leading agents: Collategene (AMG0001, AnGes MG/Vical) BC-819 (BioCancell) BC-821 BioCancell SPK-CHM Spark Therapeutics SPK-FIX Spark Therapeutics/Pfizer SPK-TPP1- Spark Therapeutics Lenti-D (Bluebird Bio) LentiGlobin (Bluebird Bio) VM202-DPN ViroMed

Provides qualitative analysis of trends that will affect the gene therapies market, from the perspective of pharmaceutical companies, during the period 2020 to 2030. SWOT analysis is provided and an overview of regulation of the gene therapy market by leading region given.

Our study discusses factors that influence the market including these: Translation of research into marketable products modifying human DNA gene transfer for therapeutic use, altering the nuclear genome Genomic editing technology and other supporting components Collaborations to develop and launch gene-based products acquisitions and licensing deals Supporting technologies for human genetic modification, gene replacement and targeted drug delivery Gene therapies for ophthalmologic diseases next-generation medicines Regulations in the United States, the European Union and Japan overcoming technological and medical challenges to pass clinical trials.

To request a report overview of this report please contact Sara Peerun at sara.peerun@visiongain.com or refer to our website: https://www.visiongain.com/report/gene-therapy-rd-and-revenue-forecasts-2020-2030/

Did you know that we also offer a report add-on service? Email sara.peerun@visiongain.comto discuss any customized research needs you may have.

Companies covered in the report include:

4DMT (4D Molecular Therapeutics)AbeonaAGTC (Applied Genetics Technologies Corporation)AMT (Amsterdam Molecular Therapeutics) AnGes MGAsklepios BioPharmaAstraZenecaAudentes TherapeuticsAvalanche BiotechBayer HealthcareBeijing Northland Biotech CoBenda PharmaceuticalBenitec BiopharmaBioCancellBiogenBiogen IdecBluebird BioBMS (Bristol-Myers Squibb)Broad Institute/Whitehead InstituteCelgeneCell Therapy CatapultCellectisChiesi Farmaceutici Clearside BiomedicalConvergence PharmaceuticalsDaiichi Sankyo Dimension TherapeuticsEditas MedicineFondazione TelethonFrancis Crick Institute Genable Technologies LtdGenethonGenSight BiologicsGenVecGoogleGSK (GlaxoSmithKline)Henry Ford Health SystemHSCI (Human Stem Cells Institute)HSR-TIGET (San Raffaele Telethon Institute for Gene Therapy), ImaginAbImmune Design Corp InoCardInovioIntellia TherapeuticsInvetechKite PharmaKolon GroupKolon Life ScienceLysogeneMitsubishi Tanabe Pharma Corporation NeuralgeneNightstaRxNorthwestern Memorial HospitalNovartisOXB (Oxford Biomedica)PfizerPNP TherapeuticsPrecision Genome Engineering Inc aka PregenenProNaiProtek GroupRaffaele HospitalREGENX BiosciencesRenova TherapeuticsRocheRoszdravnadzorSangamo BiosciencesSanofiSarepta TherapeuticsShanghai Sunway BiotechShenzhen SiBiono GeneTechSotex Pharm Firm Spark TherapeuticsSynerGene TherapeuticsTakara BioTAP BiosystemsThermo Fisher ScientificTissueGeneToolGenUC BerkeleyUC San Francisco uniQureUS Business Innovation Network Vertex PharmaceuticalsVical IncorporatedViroMedVM BiopharmaVoyage Therapeutics

List of Organisation Mentioned ASCO (American Society of Clinical Oncology)ASI (Agency for Strategic Initiatives) CAT (Committee for Advanced Therapies) CBER (Center for Biologics Evaluation and Research)CHMP (Committee for Medicinal Products for Human Use)CHOP (The Children's Hospital of Philadelphia)DCGI (Drugs Controller General of India)DHHS (Department of Health and Human Services)EMA (European Medicines Agency)FDA (US Food and Drug Administration)INSERM (Institut National de la Sant et de la Recherche Mdicale) IRB (Institutional Review Boards) MFDS (Korean Ministry of Food and Drug Safety) MHLW (Ministry of Health, Labour, and Welfare)MHRA (Medicines and Healthcare Products Regulatory Agency)Ministry of Health Commission NHS (National Health Service)NICE (the National Institute for Health and Care Excellence)NIH (National Institutes of Health) OHRP (Office for Human Research Protections)PMDA (Pharmaceuticals and Medical Devices Agency) RCGM (Review Committee of Genetic Manipulation) Russian Ministry of Healthcare and Social DevelopmentSFDA (State Food and Drug Administration of China) SMC (Scottish Medicines Consortium) The Fund for Promotion of Small Innovative Enterprises in Science and TechnologyThe IGI (Innovative Genomics Initiative)The Innovative Genomics Initiative The Walter and Eliza Hall Institute The Wellcome Trust Sanger Institute WFH (World Federation of Hemophilia)WHO (World Health Organization)

To see a report overview please e-mail Sara Peerun on sara.peerun@visiongain.com

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Visiongain Report: The Gene Therapy Market is Projected to Grow at a CAGR of 32% in the First Half of the Forecast Period - P&T Community

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that results of a four-week pivotal study (SEP361-201) evaluating the safety and efficacy of SEP-363856 in patients with schizophrenia were published online in the New England Journal of Medicine (NEJM).

In this study, once-daily, flexible-dose (50-75 mg) treatment with SEP-363856 demonstrated a statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo after four weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001). Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale - Severity (CGI-S) (p<0.001). In addition, improvement was observed in all major PANSS (positive, negative and general psychopathology) subscales (p<0.02). SEP-363856 was well tolerated throughout the study and the overall discontinuation rate was comparable for SEP-363856 and placebo.1

These data represent an exciting step forward in schizophrenia research. The steps that led to identifying this new mechanism of action, targeting TAAR1, were very novel and they reflected a courageous and innovative approach by Sunovion to identifying new ways to treat schizophrenia, said John Krystal, M.D., Chair of Psychiatry and Co-Director, Yale Center for Clinical Investigation at Yale School of Medicine and co-author of the NEJM publication. For the last 60 years, antipsychotics that bind to dopamine receptors have been the standard of care, despite their side effect profile. It is my hope that these results for SEP-363856 support a new schizophrenia treatment for people who have been diagnosed with this serious mental health condition. SEP-363856 could have a big impact on people with schizophrenia, their families, and on the public health burden posed by schizophrenia.

SEP-363856 is a novel trace amine-associated receptor 1 (TAAR1) agonist with serotonin 1A (5-HT1A) agonist activity that is being evaluated in patients with schizophrenia. SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors, which are thought to mediate the effects of currently available atypical antipsychotic medicines. SEP-363856 is being studied in the DIAMOND (Developing Innovative Approaches for Mental Disorders) Phase 3 global development program for schizophrenia with additional indications under consideration. The U.S. FDA granted Breakthrough Therapy Designation for SEP-363856 for the treatment of schizophrenia in May 2019.

Publication of these findings in the New England Journal of Medicine demonstrates the potential of SEP-363856 to be the first TAAR1 agonist for the treatment of schizophrenia, said Kenneth Koblan, PhD, Chief Scientific Officer of Sunovion. This innovative approach to the treatment of schizophrenia may provide a completely new option for the 23 million people worldwide who live with this serious mental health condition. Sunovion is committed to developing new treatment options for these patients and continuing to study SEP-363856 to further evaluate its clinical benefit in schizophrenia and other neuropsychiatric conditions.

As noted in the NEJM publication, in the six-month, open-label extension study, SEP-363856 demonstrated continued improvement across efficacy measures, including the PANSS total score, the CGI-S score, and the Brief Negative Symptom Scale (BNSS) total score and appeared to be safe and well-tolerated.

About SEP-363856SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia and other psychiatric conditions. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. SEP-363856 is being studied in a global Phase 3 development program for schizophrenia (DIAMOND) with additional indications under consideration. The U.S. FDA granted Breakthrough Therapy Designation for SEP-363856 for schizophrenia in May 2019.

About SchizophreniaSchizophrenia is a chronic, serious and often severely disabling brain disorder that affects more than 23 million people worldwide2 and approximately one in 100 adults (about 2.4 million people) in the United States.3 It is characterized by positive symptoms, such as hallucinations, delusions and disorganized thinking as well as negative symptoms, such as lack of emotion, social withdrawal, lack of spontaneity and cognitive impairment that includes problems with memory, attention and the ability to plan, organize and make decisions.2

About Sunovion Pharmaceuticals Inc. (Sunovion)Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovions vision is to lead the way to a healthier world. The companys spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the companys websites: http://www.sunovion.com, http://www.sunovion.eu and http://www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. 2020 Sunovion Pharmaceuticals Inc. All rights reserved.

For a copy of this release, visit Sunovions website at http://www.sunovion.com

References

1 Koblan, K., Kent, J., Hopkins, S., Krystal, J., Cheng, H., Goldman, R., Loebel, A., A non-D2 Binding Drug for the Treatment of Schizophrenia. New England Journal of Medicine. April 16, 2020, Vol. 382, Issue 16, p. 1497-1506. Available online: https://www.nejm.org/doi/full/10.1056/NEJMoa1911772. Accessed April 2020.2 World Health Organization. Mental Disorders. [Internet]. Available from: https://www.who.int/news-room/fact-sheets/detail/mental-disorders. Accessed September 2018.3 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed September 2018.

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New England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion's SEP-363856 for the Treatment of Schizophrenia - Business Wire

SALT LAKE CITY, April 13, 2020 (GLOBE NEWSWIRE) -- Predictive Biology, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (Predictive or The Company), announced that on April 9th it submitted an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the immediate use of mesenchymal stem cells (MSCs) derived from umbilical cord tissue for the treatment of Acute Respiratory Distress Syndrome (ARDS), secondary to SARS-CoV-2, coronavirus disease 2019 (COVID-19).

The pandemic caused by COVID-19 has shown to develop into severe ARDS in 30% of hospitalized patients with a 22%-62% mortality rate (Murthy et al., 2020) for those requiring hospitalization in an intensive care unit. Currently, there is no confirmed treatment that can demonstrate safety or efficacy for the treatment of COVID-19.

Coronavirus can be deadly, in large part because the virus can cause cytokine storms in which the patients own immune system triggers a runaway response causing more damage to the patient, than to the virus it's trying to eliminate, said John Sorrentino, Chairman of Predictive Technology Group. Respiratory distress kills hundreds of thousands of people each year worldwide. There is clinical data from early clinical trials that seem to indicate that the avoidance of the cytokine storm utilizing MSCs may be a critical component for the treatment of COVID-19 infected patients.

A recent review article published in Pain Physician, concluded that, The limited but emerging evidence regarding UC MSC [umbilical cord mesenchymal stem cells] in managing COVID-19 suggests that it might be considered for compassionate use in critically ill patients to reduce morbidity and mortality in the United States.

The proposed IND clinical trial will utilize Predictives proprietary core technology of naturally occurring MSCs derived from umbilical cord tissue (UC-MSCs) to assess the efficacy as an add-on therapy to standard treatment of patients with severe Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19.

Predictives UC MSC product, CoreCyte, [currently regulated by the FDA as a tissue-based product under 21 CFR 1271.3(d)(1) and Section 361 of the Public Health Service Act] has already beenused as an allograft in over50,000 patients. Physicians have reported to Predictive that over 1,100 patients have been treated with CoreCyte via intravenous administration. No serious adverse events have been reported with CoreCyte regardless of the route of administration. If Predictives EUA request is approved, CoreCyte would be available immediately to critically ill patients with ARDS due to COVID-19 infections.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize and personalize precision patient care. The Companys entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests and companion therapeutics in order to support a patient from diagnosis through treatment.

Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictives tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit http://www.predtechgroup.com

About Predictive Biotech, Inc.

Predictive Biotech is a leader in regenerative medicine, its products are derived from tissue sources rich in properties that support the bodys natural ability to heal itself. All products are safely, ethically and minimally processed to deliver allografts that preserve the naturally occurring characteristics and factors of the donor tissue. Predictives signature products are uniquely born from the Whartons jelly layer of the umbilical cord and amniotic fluid and tissue.

With over 100,000 units delivered, product safety and consistency has been realized by thousands of practices throughout the United States. A national network of clinics, health systems, researchers and physicians leverage Predictives four proprietary products: AmnioCyte, AmnioCyte Plus, PolyCyte, and CoreCyte.

Forward-Looking Statements:

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks The Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect The Company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect The Company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by The Company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive BiotechInfo@predictivebiotech.com888-407-9761

Investor ContactJeremy FefferLifeSci Advisorsjeremy@lifesciadvisors.com212-915-2568

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Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical...

When Mika Matera-Vatnick 21 received President Martha E. Pollacks email in March announcing the closing of campus, her first thought was, What am I gonna do with my flies?

Matera-Vatnick, like many other undergraduate student researchers on campus, had to abandon her honors thesis research project as classes transitioned online for the remainder of the semester.

Last spring, Matera-Vatnick joined the Wolfner lab, led by Prof. Mariana Wolfner, molecular biology and genetics.

Research is the main thing Im involved with on campus. When Im not in class, Im in the lab, she said.

Currently, her research is on pause, since as of March 28, faculty and students are no longer allowed to work in laboratories, barring Matera-Vatnick access to laboratory equipment that is essential to the continuation of her research.

Matera-Vatnick is exploring the genetic basis of sperm competition in fruit flies the competitive process between sperm of two or more different males to fertilize the same egg during sexual reproduction.

Her passion for genetics started during a summer research experience at the bioethics department at the National Institutes of Health after her freshman year, where she learned about personalized medicine.

We are all unique with our own unique genomes and we need to treat patients based on their individual needs and their own genome. This is what led me to take the genetics and genetics lab courses at Cornell, she said.

Specifically, Matera-Vatnick is researching whether there are certain genes linked to mating plug ejection times.

Mating plugs are gelatinous secretions used in the mating in fruit flies and other species, including various primates such as kangaroos and reptiles. These secretions are deposited by a male into a female genital tract and later harden into a plug that glues the tract together. The plugs prevent females from re-mating, making it possible for females to store sperm.

In my experiments, Im comparing how long different strains of flies take to go through the process of mating plug ejection and seeing if there is a genetic basis and where in the gene this might come from, Matera-Vatnik said.

In fruit flies, the female expels the mating plug within five hours of mating in a process called mating plug ejection. The timing of ejection influences the paternity share of the fruit flys mates, playing an important role in mate competition.

Paris Ghazi / Sun Senior Editor

Matera-Vatnick experimenting in the Wolfner lab.

Matera-Vatnik randomly selected genetically diverse types of fruit flies to assess the time it takes for female fruit flies to undergo mating plug ejection. Mating plug ejection times can be compared to genetic variations across these specific fruit fly lines.

This comparison can reveal key genes associated with mating plug ejection, evolutionary histories of neural circuits and the role of these neuronal pathways in female sexual selection when a female chooses a male to mate with.

Understanding the process of sexual selection in insect reproduction may contribute to developing strategies for controlling pests and disease vectors in agriculture and public health.

Matera-Vatnick spent last summer at Weill Cornell Medicine in New York City learning about computational biology, which is the analysis of biological data through computer simulated models. In contrast to the work she did at WCM, Matera-Vatnick typically conducts her research on fruit flies in a wet lab. A wet lab is a lab where experiments are conducted and chemicals are handled, whereas in a dry lab, data is analyzed with computers and other technology.

Not much is known about the genetic basis that underlies the variations in mating plug ejection timing, but Matera-Vatnik is determined to find out.

I learned so much about how computational tools can be used to answer biological questions that are impossible to answer in a wet lab. I think that combining wet lab and computational power together will bring a unique angle to the questions Im interested in answering, she said.

Though research on campus has been put on hold, Matera-Vatnick is hopeful she can finish this project as her honors thesis.

This is the project that will be my senior thesis project. With all the uncertainty of being here, and hopefully the plan is to stay here over the summer, I want to take this project as far as I can before I graduate, Matera-Vatnick said.

Matera-Vatnick is currently in her hometown Washington, D.C. While she is unable to continue her research at the Wolfner Lab, she still attends weekly lab meetings and will be drafting sections of her honors thesis for the rest of the semester. She plans on taking the MCAT at the end of summer, if permitted.

In the meantime, Matera-Vatnick hopes to make the most of her Cornell research experience, upon her return to campus.

Im trying to take as much as I can from campus, Matera-Vatnick said. Thanks to amazing mentorship from my [Principal Investigator], graduate students and other students in the lab, I can say Im very lucky with who Ive surrounded myself with on campus.

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Student Spotlight on Mika Matera-Vatnick '21: Researching Insect Reproduction Genetics - Cornell University The Cornell Daily Sun

Great lab race to find cure for COVID-19

Researchers are trying to create and kill some of the most powerful viruses in the world in an ongoing competition.

Orlando, FL(FOX 35 Orlando) - Researchers are trying to create and kill some of the most powerful viruses in the world in an ongoing competition.

Youve heard of the space race, but did you know theres a race to find a cure for COVID-19? Dr. Paul Gulig, Department of Molecular Genetics and Microbiology at the University of Florida's College of Medicine says it's happening in several counties.

"Theres been discussion which tests were better," he says. "There can be an element of competition, almost sportslike and that is were in this altruistically. We generally want to help human health and mankind. At UF and around the world people are working on that."

He adds that when you have a limited resource like grant funding and the demand exceeds the supply, by definition, there is competition.

"We have to have a better grant proposal than the next person or theyre going to get the money and were not."

However, he says its not just about the money.

"Whoever comes up with the best things first is going to be able to come up with bragging rights."

But even with a race in research, he believes something positive has come out of this.

"Research scientists are banning together, I think theyre coming up with ways to collaborate that they havent before."

Dr. Michael Pape, professor of practice at the University of Central Floridas College of Business agrees, saying you can see the difference just by looking at ClinicalTrials.gov.

"There are 45 vaccine related clinical trials going on for COVID-19 and that is within two months. So youve got this type of contrast because of the pace of innovation, the ability to share information."

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Worldwide competition to find cure for COVID-19, other deadly viruses - WOGX

APRIL 17, 2020 -- Hydroxychloroquine (HCQ) does not help clear the SARS-CoV-2 virus or relieve symptoms for COVID-19 patients more than standard care alone and has more side effects, a randomized controlled trial of 150 hospitalized adults in China suggests.

However, two experts caution that because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients.

Wei Tang, with the Departments of Pulmonology and Critical Care Medicine at Ruijin Hospital, in Shanghai, China, and colleagues enrolled patients with COVID-19 from 16 treatment centers in China in February. They posted their findings on the medRxiv preprint server, but their paper has not been peer reviewed. A coauthor told Medscape Medical News the work has been submitted to a journal.

The overall 28-day negative conversion rate of SARS-CoV-2, which was the primary endpoint, was similar in the two 75-patient treatment groups. The Kaplan-Meier estimate for negative conversion rate was 85.4% in the HCQ plus standard of care (SOC) arm, vs 81.3% in the SOC-only group (P = .341). Negative conversion rates for the two groups were similar at days 4, 7, 10, 14, and 21.

Adverse events were reported in 8.8% of patients in the control group compared with 30% in the HCQ group. Diarrhea was the most common side effect, occurring in 10% of patients in the HCQ group vs none in the control group. Two patients in the HCQ arm had serious adverse events; one experienced disease progression, and the other experienced upper respiratory tract infection.

Patients in the HCQ group received a high loading dose of 1200 mg daily for 3 days followed by a maintenance dose of 800 mg daily for the remaining days. Total duration was 2 weeks for patients with mild or moderate disease and 3 weeks for those with severe disease.

No Difference in Relief of Symptoms

The two arms were similar in alleviation of symptoms by day 28: 59.9% with HCQ plus SOC vs 66.6% with SOC alone.

However, the researchers said that in a post hoc analysis, they found a significant reduction of symptoms after adjusting for the confounding effects of antiviral agents (hazard ratio, 8.83; 95% confidence interval, 1.09 71.3).

In addition, Tang and colleagues report a significantly greater reduction of C-reactive protein (CRP), a biomarker for inflammation, from baseline to day 28 in the HCQ group in comparison with the control group (6.986 vs 2.723 mg/L).

The authors suggest the alleviation of symptoms may come from HCQ's anti-inflammatory effects.

The mean age of the patients was 46 years, and 55% were male. Almost all patients had mild or moderate disease; two had severe disease.

Experts Say Study Arms May Not Have Been Comparable

J. Michelle Kahlenberg, MD, PhD, research professor of rheumatology at the University of Michigan in Ann Arbor, told Medscape Medical News that it's important to note that in the post hoc analysis, 89% of the patients in this trial were receiving other therapy in addition to HCQ.

"When [the researchers] say they saw improvement in symptoms when they removed the confounders, what they actually did was remove the patients from the analysis that got antivirals, and that left 14 patients in each arm," Kahlenberg said.

Moreover, Kahlenberg noted, 20% of patients who received HCQ had mild symptoms, whereas only 9% of those in the SOC group did.

"We don't know how those patients played out in the post hoc analysis whether it was the patients who were really mild that didn't get the antivirals that were left in the hydroxychloroquine group and that's why they had a slightly faster resolution of symptoms," she said.

She said that in this study, the researchers calculated CRP in milligrams per liter, whereas in the United States, it is measured in milligrams per deciliter. The conversion highlights the fact that the reduction in CRP was not terribly noteworthy, she said.

"The patients with COVID who tend to tank and have cytokine storms ? their CRP is much higher," she said. "So the small improvement in CRP wasn't that exciting.

"I don't think this gets us anywhere closer to an answer. It's another muddy study," she said.

Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.

Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.

For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.

"It makes me wonder whether the randomization was truly random," Plowe said.

Plowe also questioned the authors' statement that they didn't see cardiac arrhythmia events, such as prolonged QT intervals. "I can't see any evidence that they did an EKG on anybody," he said.

"This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug's anti-inflammatory properties. If that's the case, I'm not sure this particular drug, as opposed to others, would be the way to go," Plowe said.

Mixed Results in Other Studies

"Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients," the authors write.

However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.

Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.

By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.

References

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Original post:
COVID-19: Hydroxychloroquine Does Not Work Better Than Standard Treatments in Trial - MedicineNet

The current time is unprecedented. We havent seen anything like this in the last ~100 years and (hopefully) wont see in the next 100 years. But, as a Ph.D. student in Molecular Genetics, it is moving to answer curious questions that people from non-scientific backgrounds might have regarding how coronavirus works and what can be done to slow it down.

In addition, I was fortunate enough to participate in the COVID-19 testing facility at the Weizmann Institute of Science, Israel. As the number of infections in Israel is going up, the facility at the Israel National Center for Personalized Medicine was commissioned to ramp the testing numbers. The center is one of the most sophisticated, top-of-the-line facilities, which can run ~4000 tests a day at its fullest capacity, while presently only 2500 tests are performed a day in Israel for a population of ~9 million. The idea of this article is to show how a COVID-19 testing facility looks like and take a step-by-step look at the operational pipeline.

A scheme of the operational pipeline for COVID-19 testing

Step 1 at Station A: The nasopharyngeal swab samples are received from hospitals/paramedical service in plastic tubes along with a document containing the patient information. Upon reception, each sample is cleaned and disinfected thoroughly with 70% ethanol and packed in a cooler box for internal transportation.

Team of volunteers at Station A (Image: Weizmann Institute of Science)

Step 2 at Station B: Here, hundreds of tubes are prepared, each containing a special kind of solution, called lysis/shield buffer. The genetic information of the SARS-Cov-2 virus (nCoV-2) is encoded by a molecule called RNA, which is a rather unstable molecule. The solution can stabilize the RNA molecule. It also contains a detergent that can inactivate the viral particles. Each of the tubes carries a unique barcode.

Step 3 at Station C: The swab samples from Station A and the buffer solutions from Station B are brought here. Station C is a biosafe room with biological hoods. These hoods are extremely sterile chambers, free from any biological contamination so that the technicians have minimal chance to come in contact with the virus. Each swab sample is manually inspected and added to the lysis buffer solution inside the hood. The barcode and the sample document are uploaded to an internal tracking software. The viral particles are inactivated from now on and can be handled with less stringency. The test tubes with the samples are then arranged in racks. The remaining swab sample from patients is returned to a fridge in order to be stored for at least 48 hours, in case a repetition of the test becomes necessary.

Step 4 at Station D: The racks (containing the sample in lysis buffer) from Station C are brought to Station D where an automated system can take a small volume containing the patient swab and put into a 96-well plate format. Such 96-well plates are routinely used in molecular biology approaches to detect nucleic acids (DNA/RNA).

Step 5 at Station E: In this station, a robotic liquid handler can assemble all the ingredients required for the subsequent chemical reactions. In the first reaction, the RNA from the virus is converted to its complementary DNA (cDNA) by an enzyme called reverse-transcriptase (co-incidentally, also first discovered in a virus). In the next reaction, the cDNA is acted upon by an enzyme (called DNA-polymerase that can work at high temperature) to produce multiple copies of a part of the cDNA by a process called polymerase chain reaction (PCR). The choice of the part of the cDNA is critical as it gives specificity to the detection of SARS-CoV-2, vis-a-vis other coronaviruses. The output of the test is typically in the form of a number (called, Ct) between 5-40, which is inversely related to the viral load in the patient. Thus, the lower the Ct, the more likely the patient is positive.

To increase the confidence in the test, two such regions of the nCoV-2 cDNA (N1 and N2) are chosen. For a test to be called positive, both N1 and N2 have to return a number below 40. More typically, the number hovers between 30 and 40 for positive cases. For negative cases, the numbers are above 40.

Step 6: In the last step, the data and corresponding patient ID are uploaded to the internal software and the final results are sent to the Ministry of Health.

All the stations are staffed with teams of 3-4 technicians while the entire operation is managed by a control center overlooking all stations and ensuring a smooth relay of materials and information between teams.

The team at the command center ensuring a streamlined operation (Image: Weizmann Institute of Science

Accuracy: RT-PCR based testing for the nCoV-2 virus is an extremely accurate test, with about a 3% chance of being falsely negative. Other than the operational steps, the false-negatives can arise from the presence of an extremely low amount of viral particles in the tested swab, below the detection limit of PCR. According to the US CDC, nasopharyngeal swabs are likely to yield the best results compared to swabs from other parts (nasal, oral, etc,)

What about scaling up?

In the present framework, all actions from Station D onwards (involving inactivated virus) are handled by automation, so it is relatively easy to scale up. However, all activities from receiving the samples to inactivating them are done manually under extreme care by trained professionals so as to minimize contamination of samples or spillage. Thus, it becomes one of the most time- and effort- consuming parts of the operation. Additionally, the collection of swabs is also done by trained front-line workers one-by-one, adding to the effective testing time. Thus, the rate-limiting step of the entire process becomes the collection and pre-processing of the samples, instead of the actual tests. The current end-to-end time (from the reception of the sample to delivery of results) is ~24 hours.

Further reading/watching:

Sandipan Dasgupta is a Ph.D. candidate at Weizmann Institute of Science, Israel and a co-founder of Weizmann Biotech Club. Previously, he was an Israel-Asia Leaders fellow at Israel-Asia Center, Jerusalem. He regularly blogs on India-Israel relations and is passionate about connecting global innovation ecosystems to India.Note: All opinions expressed are personal and are not endorsed by any affiliated institution or organization.

Read the original here:
How does a COVID-19 testing center look like? - The Times of Israel

Many species of fish and shellfish have been domesticated relatively recently compared with most livestock species, and so have diverse gene pools with major potential for selective breeding, according to a new review paper in Nature Reviews Genetics.

The development of tools to gain insight into the genetics of these species, and apply such tools for breeding and management, provides opportunities to release that potential, researchers say.

Most aquaculture species can produce many offspring, and large populations with improved genetics can be bred quickly for improved production performance.

The benefits may include improved growth, resistance to disease or robustness in diverse farming environments.

Farmed fish is on course to overtake wild fish as the main source of seafood, and consequently genetic tools and expertise are in high demand to increase the efficiency and sustainability of aquaculture systems, which currently rely mostly on unselected stocks.

Insight into the genomes of species can enable careful selection of a farming population with desirable traits, and monitoring genomic variation will help maintain genetic diversity as farm populations develop.

In the future, technologies such as genome editing could be used to introduce desirable traits, such as disease resistance, into farmed species, and surrogate breeding could be employed to support production of preferred species.

The review paper a collaboration between experts from Universities of Edinburgh, Exeter, Stirling, and Aberdeen is an output of the AquaLeap consortium project.

AquaLeap is funded by the Biotechnology and Biological Sciences Research Council, the Natural Environment Research Council and the Scottish Aquaculture Innovation Centre, in partnership with the Centre for Environment, Fisheries and Aquaculture Science, Hendrix Genetics, Xelect, The National Lobster Hatchery, Tethys oysters, and Otter Ferry SeaFish.

Environmental biologist Dr Eduarda Santos, from the University of Exeter, who is the co-author of the study, said: "The rapid expansion of aquaculture has contributed to increased food security across the globe, however, issues related to domestication of desired species and emergence of diseases, limit its further development.

"Genomics has the potential to offer solutions to many of these limitations by improving our knowledge of the genomes of cultured organisms, genetic selection, and better understanding of the dynamic interactions between genes and the environment, to maximise food production."

Dr Jamie Stevens, also from the University of Exeter and co-author added: "We only have to look at the example of Atlantic salmon to see the immense value of a sequenced genome to the relatively recent optimisation of a wild species for the aquaculture market.

"Similarly, we anticipate the delivery of a genome for other species, including the European lobster, will offer similar opportunities to develop molecular tools with which to rapidly increase the potential of lobster as an aquaculture species and improve the sustainability of its wild populations."

Professor Ross Houston, from the Roslin Institute, agreed, saying: "There is a timely opportunity to harness the potential of farmed aquatic species, to ensure food security for a growing population. Genomic selection and biotechnology can speed up this process, and recent developments in these fields will soon be translated to benefit aquaculture production for many of these species across the world."

Originally posted here:
Why genetics is key to the evolution of aquaculture - The Fish Site

The novel coronavirus likely originated in bats, but the pathogen may have then hopped into dogs before infecting humans, a new study suggests.

But not everyone agrees with that hypothesis. One expert told Live Science that "there are a lot of weaknesses" in the study and that the data don't support the study's conclusions.

Before the new coronavirus SARS-CoV-2 made the jump to humans, two other coronaviruses, SARS-CoV and MERS-CoV, evolved in bats and passed through other animals on their way to people. SARS-CoV passed through civets and MERS-CoV through camels, and the molecular structure of SARS-CoV-2 suggests that the virus also passed through an intermediate animal, but scientists don't yet know which one.

In February, authors of a preliminary study published to the preprint database bioRxiv suggested that pangolins may bridge the gap between bats and humans, since SARS-CoV-2 and related coronaviruses that infect pangolins sport similar spike proteins a structure on the surface of the virus that allows it to infect cells. But other scientists argued that, despite their spike proteins, pangolin coronaviruses bear many differences to SARS-CoV-2 that make pangolins unlikely to be the source of infection, The New York Times reported.

With the mystery unresolved, biology professor Xuhua Xia of the University of Ottawa in Canada launched his own investigation into how the coronavirus passed from bats to people. His analysis, published April 14 in the journal Molecular Biology and Evolution, offered a new solution: dogs.

Xia reached his conclusion by scanning the genetic code of SARS-CoV-2 and other coronaviruses for a specific feature known as a CpG site, a sequence of genetic code in which the compound cytosine (C) is followed by the compound guanine (G). The human immune system sees CpG sites as a red flag, signaling that an invasive virus is present. A human protein called zinc finger antiviral protein (ZAP) latches onto the CpG sites on the viral genetic code and recruits help to break down the pathogen, according to UniProt, an online protein database. The theory follows that, the fewer CpG sites, the less vulnerable a virus will be to ZAP.

Related: 10 deadly diseases that hopped across species

Xia found that SARS-CoV-2 carries fewer CpG sites than the other known coronaviruses that first evolved in animals, including SARS-CoV and MERS-CoV. In addition, the closest known relative of SARS-CoV-2, the bat coronavirus RaTG13, contains fewer CpG sites than related bat coronaviruses, according to the analysis. "This suggests that SARS-CoV-2 may have evolved in a new host (or new host tissue) with high ZAP expression," which would place evolutionary pressure on the virus to shed CpG sites, Xia wrote.

Essentially, in order to survive and reproduce, a pathogen like SARS-CoV-2 needs to be able to evade the hosts immune fighters, and in this case it would mean getting rid of CpG sites that could alert ZAP proteins to the virus.

Unfortunately, little data exists on exactly how much ZAP appears in different animal tissues, Xia told Live Science. So he worked backwards, looking for animal coronaviruses with low CpG levels. He found a coronavirus that primarily infects the canine intestine, and thus inferred that the dog gut might contain adequate ZAP levels to drive viral evolution in this way.

"Only canids seem to have the tissue generating low-CpG CoVs during my study," Xia said. If a precursor to SARS-CoV-2 breached the canine intestine, then this would have "resulted in rapid evolution of the virus" to lose CpG sites and become better equipped to infect humans, he wrote in the paper. Beyond the low CpG levels, the paper did not note other genetic similarities between SARS-CoV-2 and the dog coronavirus, but suggested that the canine gut might provide the right environment for such viruses to evolve.

But why the dog intestine? Some research suggests that ZAP mRNA, which contains instructions to build the protein, appears in both the dog lung and colon but that higher concentrations accumulate in the lungs, Xia said. It may be that a glut of ZAP in the lungs guards the organ from coronaviruses, while the lower concentrations of ZAP in the colon leave the gut open to severe infection, though there are reasons to be cautious in coming to this conclusion, Xia said.

But does this hypothesis make sense?

"I think the data do not support these conclusions," Pleuni Pennings, an assistant professor of ecology and evolution at San Francisco State University, who was not involved in the study, told Live Science in an email. Pennings, whose research group has examined the CpG levels of many viruses, pointed out several weaknesses in the study's logic.

In a 2018 study published in the journal PLOS Genetics, Pennings surveyed CpG levels in the HIV virus and investigated how the pathogen evolves within individual people. She then led a similar study of several other viruses including Dengue fever virus, influenza, and hepatitis B and C to learn how often these bugs lose or gain CpG sites through mutations. Her group found that, in general, mutations that add CpG sites tend to be found in viral samples taken from people less often than mutations that remove CpG sites from the genome.

CpG-creating mutations may be costly to viruses in that they alert the body to infection, so over time, evolutionary forces minimize their appearance, Pennings said. That said, many viruses still carry CpG sites, so the mutations may carry some benefit "even if it comes with a slight cost," she added. So SARS-CoV-2 is not unusual in that way.

"There are many viruses with lower [CpG] values than SARS-CoV-2," Pennings said. "When you look at all viruses, the [CpG] value is not strange at all," she said.

Xia did find that SARS-CoV-2 contains fewer CpG sites than other animal-borne coronaviruses, and assuming that finding is correct, then it raises the question of why that came to be, she added.

But even if there is an evolutionary reason to explain why SARS-CoV-2 lost CpG sites, that evolutionary reason may not give the virus a special advantage for infecting humans, Pennings said.

In his paper, Xia noted that studies have "shown an association between decreased CpG in viral RNA genomes and increased virulence," meaning low-CpG viruses appear associated with more severe infection. However, although evolution favors mutations that delete CpG sites, and there's a general trend tying fewer CpG sites to more severe infection, "it doesnt mean that viruses with low numbers of CpG sites are necessarily more virulent," Pennings said. For example, the BK virus contains very few CpG sites and resides in the kidneys of an estimated 60% to 80% of adults, but typically only triggers symptoms in immunosuppressed people, she noted. (The virus was named the initials of the first person it was isolated from.)

If the CpG levels present in SARS-CoV-2 are somehow related to disease severity, "then this would provide an efficient way for vaccine development," Xia said. In this hypothetical scenario, scientists could eliminate CpG sites from the coronavirus genome in a lab dish, thereby weakening the bug to the point that it could safely be incorporated into a vaccine. But as of yet, no correlation has been drawn between CpG and the relative severity of SARS-CoV-2 infections.

Several pangolin coronaviruses included in Xia's study also contained few CpG sites, on par with SARS-CoV-2 and the bat virus RaTG13. Given other genetic differences between human and pangolin coronaviruses, however, the ancestor shared between this low-CpG pangolin coronavirus and SARS-CoV-2 would likely have existed over 130 years ago, Xia said. "We expect a SARS-CoV-2 progenitor to be much more recent," he said.

But did dogs serve as an intermittent host for the coronavirus? At this point, there's little evidence to suggest so.

Originally published on Live Science.

More here:
New study suggests COVID-19 hopped from dogs to humans. Here's why you should be skeptical. - Live Science