Vir Biotechnology Announces New Research Describing the Structural Basis of SARS-CoV-2 Omicron Immune Evasion and Receptor Engagement
– Growing body of evidence validates Vir’s approach of targeting a highly conserved region of the spike protein –
Lui Franciosi Tracking Published Fall Numbers of Seniors During this COVID-19 Pandemic
VANCOUVER, British Columbia, Dec. 31, 2021 (GLOBE NEWSWIRE) -- Franciosi Consulting Ltd. is currently tracking the number of falls involving seniors and that have been reported in the public domain during this COVID-19 pandemic. In particular, government sites such as the Canadian Institute for Health Information, online media reports and survey portals from various countries are being searched to determine these numbers as well as the nature and location of the falls in designated senior housing such as long term care, assisted living and independent living. Lui Franciosi states, “During this pandemic, seniors have likely not had the same level of exercise and therefore their body core strength is not as optimal to prevent injury. It is known that falls are the leading cause of injuries among seniors, accounting for 61 per cent of injury-related deaths and 81 per cent of injury-related hospitalizations in Canada. There are close to 5,000 deaths each year linked to seniors’ falls and nearly 100,000 hospitalizations.” The aim of this work is to better understand how many of these falls are actually predictable and whether an algorithm could be developed to help healthcare staff and families prevent falls, especially in frequent fallers.
View post:
Lui Franciosi Tracking Published Fall Numbers of Seniors During this COVID-19 Pandemic
Baudax Bio Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
MALVERN, Pa., Dec. 31, 2021 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) (the “Company”), a pharmaceutical company focused on commercializing and developing innovative products for acute care settings, today announced that the Compensation Committee of Baudax Bio’s Board of Directors approved inducement grants of stock options to purchase an aggregate of 109,250 shares of Baudax Bio’s common stock and restricted stock units covering 31,900 shares of Baudax Bio’s common stock to 14 newly-hired employees, with a grant date of December 29, 2021. The equity awards were granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of each individual’s employment compensation and were granted as an inducement material to his or her acceptance of employment with Baudax Bio.
Link:
Baudax Bio Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
Cronos Group Provides Bi-Weekly MCTO Status Update
TORONTO, Dec. 31, 2021 (GLOBE NEWSWIRE) -- Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos Group” or the “Company”) is providing a default status report in accordance with the alternative information guidelines set out in National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”).
Originally posted here:
Cronos Group Provides Bi-Weekly MCTO Status Update
Unproved Stem Cell Clinics Proliferate in the U.S …
Patients seeking stem cell therapies for achy joints or shoulder injuries no longer need to hop a plane to Mexico or China. More than 550 clinics around the U.S. offer unproved interventions for sports injuries and conditions including autism, multiple sclerosis and Alzheimers disease. In cities like Beverly Hills or New York a prospective patient may only need to drive some 20 or 30 minutes from the center of town to find such a treatment.
This vast stem cell market has boomed in recent years, particularly for orthopedic applications such as easing joint pain or for facelifts and other cosmetic procedures. In one frequently advertised regimen a patient might have adult stem cells harvested from his own fat tissue and injected at an injury site, purportedly to speed recovery. Professional athletes including football stars Peyton Manning and Chris Johnson have reportedly used stem cell injections to help them get back onto the field.
Yet there is a darker side to the promise of these treatments. There is little systematic data about patients long-term outcomespositive or negativeand in most cases there is no scientific evidence that these costly procedures work. Many of these cellular therapies may not do much of anything but there is also the serious risk that recipients of cell injections could develop serious complications including blood clots or dangerous immune reactions, says Paul Knoepfler, a stem cell researcher at the University of California, Davis, School of Medicine and co-author of a new analysis, published Thursday in Cell Stem Cell.*
One U.S. patient traveled to China, Mexico and Argentina for stem cell therapies following a stroke and went on to develop a huge mass in his lower spinereplete with someone elses cells, according to a recent account in The New England Journal of Medicine. Without clear evidence that these procedures are safe, effective and actually tap the type of cells they claim to use, they should be avoided, Knoepfler says. (Bone marrow stem cell therapies used for cancer and blood disorder treatments, however, are widely accepted medical procedures.)
Armed with new data about the proliferation of stem cell clinics, Knoepfler and co-author, University of Minnesota bioethicist Leigh Turner, are seeking to correct the widespread belief that such procedures only happen overseas: Patients wishing to engage in stem cell tourism need only drive minutes from metropolitan areas across the U.S., not to a foreign country, they note.
Such clinics have often sidestepped heavy regulatory scrutiny, claiming they are eligible for a U.S. Food and Drug Administration exemption that applies to minimally manipulated cells. Some claim to extract a patients cells found in fat, bones or other tissues and inject them back into the same patient at a different sitesuch as a joint or a saggy chinwithin the same operation, all without substantially altering the cells. But many of these clinics also offer myriad types of stem cell treatment that would suggest they are not compliant with federal regulations, the authors wrote.
Amid this stem cell therapy explosion, the FDA recently issued draft guidance that would clarify and tighten its regulation of this area. The FDA is concerned that the hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful, FDA spokesperson Andrea Fischer said in a statement. If the proposed guidelines are enacted, the FDA would likely bring more of these clinics under its purview and regulate offerings in the same way as biological drugs. Public interest in this contentious area is undeniable: The FDA is holding a delayed public hearing on stem cell regulation this fall, after it was overwhelmed by audience sign-ups for its scheduled hearing in April.
This all should still be in the research phase without question, says Peter Rubin, a stem cell researcher who chairs the Department of Plastic Surgery at the University of Pittsburgh Medical Center and runs a clinical trial to test the use of stem cells to repair severe facial wounds and limb injuries in soldiers. We need to establish credible data around these therapies before bringing them to patients, he adds. Rubin, who was not involved in Knoepfler and Turners latest research, plans to testify at the hearing this fall.
Currently, hundreds of U.S. clinics61 percent of the businesses in the new analysismarket therapies that use fat stem cells. Although details vary between clinics, that often means the clinic gives a patient liposuction then chemically separates stem cells from the fat and centrifuges them before injecting them into an injury site to purportedly help a patient heal faster or to alleviate pain. Fat is a structural tissue, and if you break down its biological properties so it can no longer provide padding or cushioning, then it has been manipulated, Rubin says. Such procedures, he says, would likely require FDA regulation under the new proposed guidelines.
To get a new count showing exactly how widespread stem cell clinics have become, Knoepfler and Turner scoured the internet for Web sites marketing stem cell interventions. They found 351 U.S. businesses engaged in direct-to-consumer marketing of such services offered at 570 clinics. Most of the clinics were concentrated in California, Florida, Texas, Colorado, Arizona and New York, but most states had at least one. There were also certain hot spot cities with a dozen or more clinics such as Beverly Hills, New York, San Antonio and Los Angeles. The authors could not verify that the clinics truly offer what is advertised on their Web sites, the sources of their stem cells or their interactions with the FDA.
Yet what they did find, Knoepfler says, was very concerningparticularly because some of the ads targeted conditions that affect particularly vulnerable populations, including children. Nine clinics promoted stem cell treatments for autism and cerebral palsy and another 33 advertised therapies for muscular dystrophy, a disease that primarily afflicts kids. Alzheimers disease treatments were offered by 27 clinics. These are the conditions that most concern me because there is the most striking gap between the marketing claims being made and the actual evidence that is available, Turner says. In effect [the patients] are participants in unapproved human-subjects research without even realizing it.
*Editor's Note (7/11/16): This sentence was edited after posting to clarify information about the authorship of the study.
Read the rest here:
Unproved Stem Cell Clinics Proliferate in the U.S ...
Exploring the potential of stem cell-based therapy for aesthetic and plastic surgery – Newswise
Abstract:
Over the last decade, stem cell-associated therapies are widely used because of their potential in self-renewable and multipotent differentiation ability. Stem cells have become more attractive for aesthetic uses and plastic surgery, including scar reduction, breast augmentation, facial contouring, hand rejuvenation, and anti-aging. The current preclinical and clinical studies of stem cells on aesthetic uses also showed promising outcomes. Adipose-derived stem cells are commonly used for fat grafting that demonstrated scar improvement, anti-aging, skin rejuvenation properties, etc. While stem cell-based products have yet to receive approval from the FDA for aesthetic medicine and plastic surgery. Moving forward, the review on the efficacy and potential of stem cell-based therapy for aesthetic and plastic surgery is limited. In the present review, we discuss the current status and recent advances of using stem cells for aesthetic and plastic surgery. The potential of cell-free therapy and tissue engineering in this field is also highlighted. The clinical applications, advantages, and limitations are also discussed. This review also provides further works that need to be investigated to widely apply stem cells in the clinic, especially in aesthetic and plastic contexts.
Read the rest here:
Exploring the potential of stem cell-based therapy for aesthetic and plastic surgery - Newswise
Avra, Inc. Completes its Merger with Springs Rejuvenation, LLC, a Stem Cell and Anti-Aging Treatment Company – Yahoo Finance
ATLANTA, GA, Dec. 20, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Avra, Inc. (OTC PINK: AVRN), is pleased to announce that it has closed the merger with Springs Rejuvenation, LLC (https://springsrejuvenation.com). The surviving entity will be Springs Rejuvenation, Inc. (SPRINGS), a Chamblee, Georgia anti-aging and stem cell center focusing on stem cell therapy, facial rejuvenation, hair rejuvenation, non-surgical hair restoration, protein rich plasma (PRP) injections, and anti-aging treatments.
The merger documents have been filed with the State of Nevada. They have also been posted on OTC Markets along with the Consolidated financials in the last quarterly filing. On December 20, 2021, Avra, Inc. filed a Corporate Action with FINRA for a name and ticker change.
SPRINGS was founded and incorporated in the State of Georgia in May of 2019 by Dr. Charles Pereyra. The company currently has one facility located in Chamblee, Georgia. Dr. Pereyra, has assembled a very skilled team of doctors and support staff to expand the business. They include Dr. Juan P. Nieto M.D., Dr. Andrew Bernstein M.D., and Alyssa Stilwell, as executive director.
Dr. Pereyra is a practicing physician with multiple peer-reviewed publications. He earned an undergraduate degree from Cornell University, where his work with stem cells began, a Doctorate of Medicine (M.D.) from St. Georges University, and completed his residency training at New York Presbyterian Hospital Brooklyn.
Stem cell therapy is a form of regenerative medicine, designed to repair damaged cells within the body by reducing inflammation and modulating the immune system. This makes stem cell therapy a viable treatment option for a variety of medical conditions. Stem cell therapies are currently being researched throughout the country with many positive results. Showing profound outcomes in autoimmune, inflammatory, neurological, and orthopedic conditions; including Multiple Sclerosis, Lupus, Crohns disease, COPD, Parkinson's, ALS, Stroke, Congestive Heart Failure and more. Recently the FDA has begun to grant INDs for use of products containing stem cells for several conditions.
Story continues
A primary goal of the merger is to allow SPRINGS to duplicate its model of high-quality stem cell treatments throughout the United States. SPRINGS is in the process of opening a facility in Austin, Texas, in conjunction with an existing clinic, and a third location in southeast Florida. The Company plans to open a total of ten new facilities in the next twelve months.
I am excited for SPRINGS Rejuvenation to take the next step with the Avra merger. Ive always been passionate about delivering the highest quality care to my patients and making sure they have the most cutting-edge medical treatments available. For over a decade a community of only a select few has benefited from use of stem cells. With this merger we will not only expand our reach to many communities, but also drive down the cost of stem cells for everyone, making access to these remarkable treatments much easier. Im incredibly excited for the future, said Dr. Charles Pereyra.
Contact:
See more here:
Avra, Inc. Completes its Merger with Springs Rejuvenation, LLC, a Stem Cell and Anti-Aging Treatment Company - Yahoo Finance
Stem Cell Treatment Improves Type 1 Diabetes in 1 Patient – Everyday Health
Type 1 diabetes management is a lifelong job that cant be eliminated by lifestyle changes or any currently available drugs or medical devices. Because theres no cure and no simple way to treat this chronic disease, its easy to understand why people might get excited about an experimental stem cell therapy that appears to reverse the condition even if it has worked for only a few months in a single patient.
The experimental treatment that has all the buzz right now is so early in development it doesnt even have an official name its just called VX-880. The company developing the drug, Vertex Pharmaceuticals, announced the initiation of the first human trials for this stem cell therapy in March. Then, in October, the company shared preliminary results from the first of 17 patients to be included in these trials.
All the patients in these trials have type 1 diabetes, an autoimmune disease that develops when the body attacks and destroys insulin-making islet cells in the pancreas. Insulin is a hormone that helps convert sugars in our bloodstream into energy that fuels our body. Without functional islet cells to make insulin, sugars rise to dangerously high levels in the bloodstream. To prevent this, people with type 1 diabetes have to regularly inject insulin to manage their blood sugar.
For the first patient in these VX-880 trials, 90 days of stem cell therapy dramatically reduced both blood sugar levels and the need for daily insulin shots, according to the preliminary results released by Vertex. Before starting treatment, this patient used 34 units of insulin daily and had an A1C level, which reflects average blood sugar levels over about three months, of 8.6 percent, indicating dangerously high blood sugar. After three months of stem cell therapy, the patient used 2.9 units of insulin daily and their A1C levels dropped to 7.2 percent, a level that still signifies diabetes but is improved.
VX-880 is potentially game-changing therapy, says John Buse, MD, PhD, the chief of endocrinology and the director of the Diabetes Center at the University of North Carolina School of Medicine in Chapel Hill.
But Dr. Buse, who has no connection to Vertex or these trials, also cautions that much longer trials with far more patients will be needed before we can really tell how safe or effective this therapy might be or whether it would be appropriate to use for every patient who has type 1 diabetes.
Simon Heller, MD, a diabetes researcher and a clinical professor at the University of Sheffield in the U.K. with no connection to Vertex or the trials, agrees. It has promise, but it should not be regarded as a likely treatment option, probably for some years, Dr. Heller says.
This means its far too soon to ask your doctor about whether stem cell therapy might work for you or a loved one living with type 1 diabetes.
And even if this drug does one day reach the market, its unclear how easy it would be for you to access or afford it. Insurance might not cover the treatment, and copays might be steep if it is covered. Vertex has been criticized for selling medicines that cost several hundred thousand dollars annually, a practice the company defendsas necessary to support research and development of new drugs.
It will be very expensive to start with Id guess, says Heller, who has received research funding and consulting fees from companies that sell drugs and devices to treat diabetes.
RELATED: Type 1 Diabetes May Be 2 Different Diseases, Early Study Suggests
Early work on VX-880 began more than a decade ago with a basic question: Could scientists find a way to replace dysfunctional islet cells in the pancreas with cells capable of making insulin?
Scientists thought embryonic stem cells might be the answer because they can in theory be transformed into any type of human cell in a lab. Researchers working to eradicate type 1 diabetes spent years fine-tuning a process to convert embryonic stem cells into functional islet cells. This work is complex because investigators needed to figure out how islet cells were created naturally inside the pancreas, then sort out how to program embryonic stem cells to grow into islet cells in the lab, a process thats unique for every type of cell in the body.
Stem cell therapies involve replacing diseased or dysfunctional cells with healthy ones. All these lab experiments eventually led to VX-880, an infusion of replacement islet cells derived from embryonic stem cells. This is not only a potential breakthrough in the treatment of type 1 diabetes, its also one of the first practical demonstrations that embryonic stem cells might indeed be used to make treatments that replace dysfunctional cells in this case islet cells in the pancreas, says one of the scientists who developed the drug, Doug Melton, PhD, the codirector of the Harvard Stem Cell Institute in Cambridge, Massachusetts, and an investigator at the Howard Hughes Medical Institute in Chevy Chase, Maryland.
Unlike other treatments for type 1 diabetes, VX-880 gives patients functional islet cells so they can make their own insulin, giving them enough of this hormone to regulate their blood sugar. In theory, this could mean people with type 1 diabetes no longer need to check their blood sugar levels and inject insulin several times a day to stay in a healthy range.
RELATED: How to Develop a Type 1 Diabetes Plan With Your Childs School
If this experimental drug lives up to its early promise, the infused replacement islet cells would provide the patient with the natural factory to make their own insulin, Dr. Melton said in a statement released by the Harvard Stem Cell Institute in October after preliminary results from tests in one patient came out.
One wrinkle to this approach is that patients would also need to take immunosuppressants the same medicines given to people who receive organ donations to stop the body from rejecting the new islet cells. Patients would potentially require lifelong therapy with both VX-880 and immunosuppressants. Long-term risks of immunosuppressants include susceptibility to serious infections, according to the Cleveland Clinic.
Scientists are also studying how to use whats known as encapsulated islet cells (a different form of cells than those used in VX-880) that are surrounded by a membrane that helps prevent the body from mounting an immune system attack to reject them. These encapsulated islet cells have the potential to be used without immunosuppressants, saidBastiano Sanna, PhD, the executive vice president and chief of cell and genetic therapies at Vertex, in the statement released by the company with its preliminary trial results.
For now, however, any optimism about the potential to eradicate type 1 diabetes needs to be tempered by the reality that we know how well VX-880 works only in a single patient for a handful of months, says Heller.
One big unanswered question at this point is whether this experimental stem cell therapy can safely and reliably provide the body with working islet cells that can ramp up and scale back insulin production so that levels of the hormone rise and fall in concert with the amount of sugars circulating in the bloodstream, Heller notes. This process of detecting how much insulin is needed is crucial for helping to maintain healthy blood sugar levels over time.
With just one person it is much too early to say whether this will turn out to be a realistic treatment, but it might, Heller says. We really need to see the results of a trial involving a largish number of patients for a time longer than 90 days.
RELATED: 11 Celebrities Living With Type 1 Diabetes
More here:
Stem Cell Treatment Improves Type 1 Diabetes in 1 Patient - Everyday Health
Avra, Inc. Completes its Merger with Springs Rejuvenation, LLC, a Stem Cell and Anti-Aging Treatment Company – GlobeNewswire
ATLANTA, GA, Dec. 20, 2021 (GLOBE NEWSWIRE) -- viaNewMediaWire --Avra, Inc. (OTC PINK: AVRN), is pleased to announce that it has closed the merger with Springs Rejuvenation, LLC (https://springsrejuvenation.com). The surviving entity will be Springs Rejuvenation, Inc. (SPRINGS), a Chamblee, Georgia anti-aging and stem cell center focusing on stem cell therapy, facial rejuvenation, hair rejuvenation, non-surgical hair restoration, protein rich plasma (PRP) injections, and anti-aging treatments.
The merger documents have been filed with the State of Nevada. They have also been posted on OTC Markets along with the Consolidated financials in the last quarterly filing. On December 20, 2021, Avra, Inc. filed a Corporate Action with FINRA for a name and ticker change.
SPRINGS was founded and incorporated in the State of Georgia in May of 2019 by Dr. Charles Pereyra. The company currently has one facility located in Chamblee, Georgia. Dr. Pereyra, has assembled a very skilled team of doctors and support staff to expand the business. They include Dr. Juan P. Nieto M.D., Dr. Andrew Bernstein M.D., and Alyssa Stilwell, as executive director.
Dr. Pereyra is a practicing physician with multiple peer-reviewed publications. He earned an undergraduate degree from Cornell University, where his work with stem cells began, a Doctorate of Medicine (M.D.) from St. Georges University, and completed his residency training at New York Presbyterian Hospital Brooklyn.
Stem cell therapy is a form of regenerative medicine, designed to repair damaged cells within the body by reducing inflammation and modulating the immune system. This makes stem cell therapy a viable treatment option for a variety of medical conditions. Stem cell therapies are currently being researched throughout the country with many positive results. Showing profound outcomes in autoimmune, inflammatory, neurological, and orthopedic conditions; including Multiple Sclerosis, Lupus, Crohns disease, COPD, Parkinson's, ALS, Stroke, Congestive Heart Failure and more. Recently the FDA has begun to grant INDs for use of products containing stem cells for several conditions.
A primary goal of the merger is to allow SPRINGS to duplicate its model of high-quality stem cell treatments throughout the United States. SPRINGS is in the process of opening a facility in Austin, Texas, in conjunction with an existing clinic, and a third location in southeast Florida. The Company plans to open a total of ten new facilities in the next twelve months.
I am excited for SPRINGS Rejuvenation to take the next step with the Avra merger. Ive always been passionate about delivering the highest quality care to my patients and making sure they have the most cutting-edge medical treatments available. For over a decade a community of only a select few has benefited from use of stem cells. With this merger we will not only expand our reach to many communities, but also drive down the cost of stem cells for everyone, making access to these remarkable treatments much easier. Im incredibly excited for the future, said Dr. Charles Pereyra.
See the original post:
Avra, Inc. Completes its Merger with Springs Rejuvenation, LLC, a Stem Cell and Anti-Aging Treatment Company - GlobeNewswire
Global Regenerative Medicine Market is Expected to Reach USD 57.08 Billion by 2027, Growing at a CAGR of 11.27% Over the Forecast Period. -…
DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Market Size, Share & Trends Analysis Report by Product (Cell-based Immunotherapies, Gene Therapies), by Therapeutic Category (Cardiovascular, Oncology), and Segment Forecasts, 2021-2027" report has been added to ResearchAndMarkets.com's offering.
The global regenerative medicine market size is expected to reach USD 57.08 billion by 2027, growing at a CAGR of 11.27% over the forecast period.
Recent advancements in biological therapies have resulted in a gradual shift in preference toward personalized medicinal strategies over the conventional treatment approach. This has resulted in rising R&D activities in the regenerative medicine arena for the development of novel regenerative therapies.
Furthermore, advancements in cell biology, genomics research, and gene-editing technology are anticipated to fuel the growth of the industry. Stem cell-based regenerative therapies are in clinical trials, which may help restore damaged specialized cells in many serious and fatal diseases, such as cancer, Alzheimer's, neurodegenerative diseases, and spinal cord injuries.
For instance, various research institutes have adopted Human Embryonic Stem Cells (hESCs) to develop a treatment for Age-related Macular Degeneration (AMD).
Constant advancements in molecular medicines have led to the development of gene-based therapy, which utilizes targeted delivery of DNA as a medicine to fight against various disorders.
Gene therapy developments are high in oncology due to the rising prevalence and genetically driven pathophysiology of cancer. The steady commercial success of gene therapies is expected to accelerate the growth of the global market over the forecast period.
Regenerative Medicine Market Report Highlights
Key Topics Covered:
Market Variables, Trends, & Scope
Competitive Analysis
Covid-19 Impact Analysis
Regenerative Medicine Market: Product Business Analysis
Regenerative Medicine Market: Therapeutic Category Business Analysis
Regenerative Medicine Market: Regional Business Analysis
Companies Mentioned
For more information about this report visit https://www.researchandmarkets.com/r/kovhgl
Go here to read the rest:
Global Regenerative Medicine Market is Expected to Reach USD 57.08 Billion by 2027, Growing at a CAGR of 11.27% Over the Forecast Period. -...