Stem Cell Clinic

Probiotics Market to Experience Significant Growth during the Forecast Period 2021-2028 Bolivar Commercial – Bolivar Commercial

By Adult Stem Cells

Probiotics Market is anticipated to observe growth during the forecast period due to growing demand at the end user level. The business report gives a clue about the uncertainties that may come up due to changes in business activities or introduction of a fresh product in the market. The facts and figures included to produce this report are based on the data collection modules with large sample sizes. It is a meticulous analysis of current scenario of the market, which takes into consideration several market dynamics. Probiotics Market Research study assists customers in understanding a range of drivers and restraints in theProbiotics Marketwhich impacts the market during forecast period.

In addition, the whole Probiotics Market report provides with the information about company profile, product specifications, capacity, production value, and market shares for each company for the year 2021 to 2028 with the help of competitive analysis study. A strong research methodology used in the report consists of data models that include market overview and guide, vendor positioning grid, market time line analysis, company positioning grid, company market share analysis, standards of measurement, top to bottom analysis and vendor share analysis. The world class Probiotics Market research report certainly helps to diminish business risk and failure.

DOWNLOAD FREE SAMPLE REPORT:https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-probiotics-market&Shiv

CAGR

Probiotics market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 91.25 billion by 2027 growing at a CAGR of 7.12% in the above-mentioned forecast period. The growing popularity of probiotic dietary supplements among customers is driving the growth of the probiotics market.

The top most players with the entire requirement cover in this report:

The major players covered in the probiotics market report are Chr. Hansen Holding A/S, Yakult Honsha Co., Ltd, Nestl, DuPont, MORINAGA & CO., LTD., BioGaia AB, Protexin, Daflorn Probiotics UK. , DANONE, Yakult USA, Deerland Enzymes, Inc., UAS Laboratories, among other domestic and global players

Segmentation

Global Stem Cell Therapy Market By Type (Allogeneic Stem Cell Therapy, Autologous Stem Cell Therapy), Technology (Cell Acquisition, Cell Production, Cryopreservation, Expansion and Sub-Culture), Product (Adult Stem Cells, Human Embryonic Stem Cells, Induced Pluripotent Stem Cells), Applications (Musculoskeletal Disorders, Wounds, Injuries, Cardiovascular Diseases, Surgeries, Gastrointestinal Diseases, Other Applications), End Users (Therapeutic Companies, Cell And Tissues Banks, Tools And Reagent Companies, Service Companies), Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa) Industry Trends and Forecast to 2027

Access Full TOC, Table & Figures:https://www.databridgemarketresearch.com/toc/?dbmr=global-probiotics-market&Shiv

The Report Consolidates All The Fundamental Factors:

The cutthroat scene gives intensive portion of the overall industry for driving business sector players as indicated by deals and volume produced. The report conveys a presence, contenders, and gross edge for each driving player. Besides, the report likewise cooks the natty gritty data about the essential angles, for example, drivers and limiting elements which will characterize the future development of the market. The report gives a serious scene to the main market players. The report shares restrictive experiences into the market to assist with keying players and new contestants comprehend the capability of interests in the Probiotics Market.

The report is an unobtrusive exertion of informed authorities and experts to convey market gauge and investigation. It highpoints the exceptional discernments conveyed by industry specialists. The report gives a natty gritty appraisal of key market elements and extensive data about the construction of the Probiotics Market industry. The report considers contending factors which is significant to take your business to the creative level. This archive is a splendid source that gives present just as future investigation of the business exhaustively.

The report gives imperative bits of knowledge into the overall market, especially the predominant development openings, patterns, and serious situations. The Probiotics Market report gives a natty gritty examination of item advancements, item types, import-trade, esteem chain streamlining, piece of the pie, development sway on homegrown and limited market players.

ACCESS FULL REPORT: https://www.databridgemarketresearch.com/reports/global-probiotics-market?utm_source=Shiv&utm_medium=Shiv&utm_id=Shiv

It isolates the market size, by volume and worth, contingent on the sort of usage and region. The report involves past and figures grandstand information, domains of utilization, esteem procedures, and fundamental associations by the geographical region.

Further, the statistical surveying report gives local market examination creation, deals, exchange, and territorial estimate. it additionally gives Probiotics Market money growth strategies like item includes, value pattern examination, channel highlights, territorial and industry speculation opportunity, cost and income estimation, financial execution assessment.

Key Benefits of The Report:

Link:
Probiotics Market to Experience Significant Growth during the Forecast Period 2021-2028 Bolivar Commercial - Bolivar Commercial

Hiltzik: The battle against unlicensed stem cell clinics – Los Angeles Times

By Stem Cell Clinic

In 2017, the Food and Drug Administration closed a loophole exploited by clinics pitching unproven, ineffective and potentially hazardous stem cell therapies directly to consumers.

Those treatments were illegal, the FDA ruled. That was the good news. The agency, however, suspended its enforcement for three years to give these operators time to get right with its regulations. During the pandemic, the FDA added six months to the deadline, so its period of regulatory forbearance expired on May 31.

What happened in the meantime? Instead of stem cell purveyors reaching out to the FDA to work out how to meet federal regulations, a torrent of shady operations poured into the field so many that the task of protecting the public from them may now exceed the FDAs capabilities.

Dont believe the hype.

The FDAs warnings against unlicensed stem cell clinics

Thats the concern of Leigh Turner, a public health expert at UC Irvine, longtime critic of stem cell treatment claims and author of a new study that tracked the explosion of businesses offering purported stem cell treatments and cures during the FDAs hands-off period.

The paper is essentially a follow-up to a seminal study Turner conducted with Paul Knoepfler of UC Davis in 2016, which identified 351 businesses hawking stem cell treatments directly to consumers through 540 clinics.

Newsletter

Get the latest from Michael Hiltzik

Commentary on economics and more from a Pulitzer Prize winner.

Enter email address

Sign Me Up

You may occasionally receive promotional content from the Los Angeles Times.

Turners new study, which was published Thursday in the peer-reviewed journal Cell Stem Cell, identified 1,480 businesses operating 2,754 clinics nationwide.

That hardly seems like progress, Turner told me. Now the problem the FDA faces is four times larger than what existed in 2016. The FDA only has so many employees and so many inspectors. They dont really have enough inspectors to send them to 1,480 businesses.

The FDA hasnt been entirely inactive. Over the last 3 years it issued more than 400 warning letters to stem cell marketers, clinics and healthcare providers, notifying them that they may be operating outside the law. But it hasnt done much more than that.

The proliferation of stem cell claims points to a major breakdown in Americas healthcare regulatory system generally.

Given the size of this clinic industry the risk to the public is huge, Knoepfler says. The industry threatens the authority of the FDA itself. It might be one of the largest and most serious noncompliance challenges that the FDA has ever faced in its history. What would the FDA do if pharmaceutical firms were selling unapproved drugs at 2,700 clinics all over the country? It would be considered a national emergency.

State medical boards, which have at least nominal authority to ride herd on the practices of licensed physicians in this field, have done little of note. The Medical Board of California, a state that with 347 clinics is the largest center of facilities in Turners database, created a two-member Stem Cell and Regenerative Therapy Task Force in 2018.

The task force hasnt met since 2019, according to a board spokesman, and hasnt issued any reports. Board records indicate that it received 33 complaints about stem cell treatments from 2018 through this year, and has taken no disciplinary or administrative actions in response.

California hasnt done much to rise to the challenge, Turner says.

A few words may be useful about the regulatory environment. The chief targets of the FDAs enforcement program, such as it is, have been clinics that extract fat cells from customers through liposuction and then supposedly extract stem cells from the fat and inject them back into the customers bodies as treatments. Some purportedly extract stem cells from customers bone marrow.

The conditions for which these treatments are commonly offered include pain, sports injuries, heart and lung disease, multiple sclerosis, Parkinsons, Alzheimers, autism, diabetes, vision loss and erectile dysfunction.

No scientifically validated evidence exists for any of these claims, the FDA notes. The only stem cell products approved by the FDA are a few derived from umbilical cord blood, and then only for a very limited category of blood system diseases.

Beyond that, the agency advises consumers, Dont believe the hype.

The purveyors of unproven and unlicensed treatments identified by Turner charge as much as $28,000 for their services, with an average of more than $5,000 often ponied up by unwary customers seduced by advertising and irresponsibly credulous reports in the press.

The treatments typically are not covered by insurance, so customers are paying out of pocket.

Under FDA regulations, most stem cell treatments being sold to customers are illegal. Thats because the products are deemed to be unlicensed drugs. Exceptions exist for some surgical procedures and in cases in which almost identical cells are reinjected into patients, but the FDA says few of the targeted clinics qualify.

The FDAs position was endorsed by a federal judge in Miami in 2019, when she shut down a clinic that the FDA had sued for offering unapproved stem cell procedures. The clinic lost an appeal of her ruling in June. A separate lawsuit the FDA filed against California Stem Cell Treatment Center and associated businesses is awaiting a verdict from U.S. Judge Jesus G. Bernal in Riverside following a trial he conducted in May.

The offered treatments are not only unproven, but potentially hazardous. Reports of adverse outcomes from unlicensed treatments have proliferated, some of them gruesome. In a report issued in June, researchers at the Pew Charitable Trusts documented reports of adverse outcomes from 360 patients between 2004 and mid-2020.

These figures are almost certainly conservative, as clinics operating outside the law are highly unlikely to follow rules mandating that they report adverse reactions among their customers. Indeed, the FDA in its lawsuit against the California defendants asserted that numerous adverse outcomes experienced by their patients were not reported to the agency.

A note cited by the FDA from the file of one patient who was unable to walk for six months after receiving a stem cell injection in her knee from a clinic associated with the defendants, read, Not all treatments are successful. Not really adverse event due to the treatment. At trial, defendant Mark Berman said the clinics product has had very rare adverse events.

FDA officials have said that their expectations that stem cell treatment purveyors would engage with the agency during the forbearance period to work out how to come into compliance with its regulations proved wildly optimistic. We have been very disappointed in the number of clinics that have come in, Wilson Bryan, a top FDA official, told a law conference in June.

The FDA may not have recognized that the clinics they were targeting never had any intention of meeting its regulations.

Were talking about a huge number of businesses that are failing to comply with federal law, but have no reasonable prospects of coming into compliance, Turner says. They dont have clinical research programs. They dont have qualified stem cell researchers. Theyre just peddlers putting out a shingle on the internet.

Instead of using that three-year period to change their practices and comply with the law, lots of businesses stayed in the marketplace and did nothing to change what they were doing, and a huge number of other operators poured into the marketplace.

Over the last five years or so, or since Turner and Knoepfler published their original report, stem cell treatment claims have become just one more offering by practitioners advertising other services of dubious effectiveness.

Stem cell treatment has become just a routine claim, Turner says, from all kinds of orthopedic clinics, sports medicine clinics, podiatrists, chiropractors, naturopaths, wellness clinics. They market an array of services and stem cells are just something else they can sell, like cryotherapy or acupuncture.

Its unclear whether some of these operations really even use stem cells some may be offering just costly placebos, Turner conjectures.

The threat to public health from unlicensed and unproven stem cell claims will only get worse if the FDA fails to act forcefully.

People make the mistake of thinking that these are businesses that will go under if they get a bit of a push from the FDA or FTC [Federal Trade Commission] Turner says. The truth is that some of them are quite well capitalized and have the resources to go out and join these battles.

The FDA may be waiting for Judge Bernals ruling before taking the next step but thats dependent on his finding in the FDAs favor. It could seek mass injunctions, admittedly a big practical challenge, Knoepfler says. He adds, Looking ahead, the agency should take quick, large-scale, and even creative actions if it has any hope to make a dent in this clinic industry.

Read this article:
Hiltzik: The battle against unlicensed stem cell clinics - Los Angeles Times

Cell therapy biotech PlateletBio reels in $75M as it looks ahead to first clinical test – MedCity News

By Stem Cell Clinic

PlateletBio, a company developing a new class of cell therapies based on the biology of platelets, has raised $75.5 million to advance its drug pipeline, including a lead candidate for a rare bleeding disorder on track to reach the clinic next year.

Platelets are components of blood best known for their role forming clots that stop bleeding. But Watertown, Massachusetts-based PlateletBio notes that platelets have other properties, including a role delivering growth factors and proteins throughout the body. PlateletBio is developing therapies that take advantage of these properties, but rather than using platelets from a patient or healthy donors, the startup makes them.

In the body, platelets are formed in bone marrow. PlateletBio produces its platelet-like cells, or PLCs, inside a bioreactor that mimics bone marrow conditions. The source material for its PLCs are stem cells, which have the ability to become almost any cell or tissue in the body.

Platelets are technically not cells. They dont have a nucleus, but thats an advantage for therapeutic applications. Since a PlateletBio therapy wont introduce DNA into a patients body, the potential risks that come from introducing foreign genetic material are avoided. PlateletBio says it can produce PLCs with new features and therapeutic payloads that include antibodies, signaling proteins, therapeutic proteins, and nucleic acids.

PlateletBios lead cell therapy candidate is being developed to treat immune thrombocytopenia, a blood disorder in which the immune system mistakenly sees a patients platelets as foreign and destroys them. Immune thrombocytopenia patients have dangerously low platelet counts that make them susceptible to bleeding.

There is no FDA-approved treatment for the underlying cause of immune thrombocytopenia, but corticosteroids are used to try to dampen the immune systems attack on platelets. Platelet transfusions are another option, but the National Organization for Rare Disorders notes that these treatments are usually reserved for emergencies because the platelets are likely to be destroyed by antibodies produced by the patient.

Patients who have not responded to earlier treatments have two FDA-approved small molecule options: Tavalisse, from Rigel Pharmaceuticals, and the Swedish Orphan Biovitrum drug Doptelet. Sanofi aims to treat the disease with a small molecule called rilzabrutinib. That drug is designed to block Brutons tyrosine kinase, a protein that plays a role in the development of a B cells, a type of immune cell. Sanofi acquired the molecule last year via its $3.7 billion acquisition of Principia Biopharma.

The lead disease target for the Principia drug was multiple sclerosis. In September, Sanofi reported that rilzabrutinib failed that Phase 3 study. A separate Phase 3 test in immune thrombocytopenia is ongoing, as is a mid-stage clinical trial in another autoimmune condition called IgG4-related disease.

PlateletBio isnt the only company trying to turn a component of the blood into a new type of cell therapy. Cambridge, Massachusetts-based Rubius Therapeutics is developing cell therapies based on red blood cells. After disappointing early clinical trial results in the rare disease phenylketonuria last year, Rubius shifted its focus to cancer and immune system disorders. PlateletBios PLCs would represent an entirely new approach to treating immune thrombocytopenia. According to PlateletBios website, the company plans to file an investigational new drug application for its therapeutic candidate in the first half of next year.

PlateletBio is based on the research of Harvard University scientist Joseph Italiano, who co-founded the company under the name Platelet BioGenesis. When the startup emerged in 2017, it was developing platelets that could address the platelet shortage problem facing blood donation centers. Two years ago, the startup expanded its Series A round with $26 million in additional financing and plans to make its platelets into cell therapies. Besides immune thrombocytopenia, other diseases the biotech aims to treat include osteoarthritis and liver fibrosis.

PlateletBios latest financing, a Series B round, adds new investors SymBiosis, K2 HealthVentures, and Oxford Finance. Earlier investors Ziff Capital Partners and Qiming Venture Partners also participated in the new round.

This is a major milestone for PlateletBio, adding capital and resources needed to advance our innovative platelet-like cell therapy science and manufacturing platform and support key corporate initiatives over the next 18 to 24 months, Sam Rasty, the startups president and CEO, said in a prepared statement.

Photo by Flickr user Marco Verch via a Creative Commons license

See more here:
Cell therapy biotech PlateletBio reels in $75M as it looks ahead to first clinical test - MedCity News

VDH: Cases surge again to third-worst on record – Vermont Biz

By Stem Cell Clinic

Vermont Business MagazineThe Vermont Department of Healthis reporting today that COVID-19 cases surged again to 376 cases, the third highest on record. This was an increase of 114 from Saturday.Cases Friday were377 and there were 487 cases on Thursday, which was the all-time record. The 12worst days have all come since mid-September, following fromthe Delta variant surge that began in July. There were no additional COVID-related death, which stand at384 statewide.

Based on record high cases this past week, Governor Phil Scott issued a statement Thursday afternoon urging Vermonters to get vaccinated. He said in part, "The simple fact is, this pandemic is being driven by the unvaccinated, including 53,000 eligible adults. The three lowest vaccinated counties account for 25% of todays cases, yet they only make up 10% of our state population. Unvaccinated Vermonters are up to 5 times as likely to contract COVID in Vermont and they account for 70-85% of our hospitalizations and ICU stays. Unvaccinated adults are directly contributing to the strain on our hospital capacity. Enough is enough, its time to step up and get vaccinated something over 90% of your fellow Vermont adults have done."

Cases have been especially high in the Northeast Kingdom, which has had elevated case rates in recent weeks. Chittenden County had the most cases with 83 and Washington County had51.

Meanwhile, the CDC gave final approval late Tuesday for Pfizer vaccines for children 5-11 and parents could start signing up their kids starting Wednesday morning (for vaccine information or to registerCLICK HERE). Shots for 5-11 are available starting Friday at some state clinics and as early as Sunday at some pharmacies.

There are about 44,000 kids in the 5-11 age band in Vermont. Human Services Secretary Mike Smith said there will be plenty of first and second doses available for all who sign up. The doses are a third of the strength of the adult dose and like the adult Pfizer regimen will require a followup shot for full immunity.

See locations of vaccine clinics and case dashboards below.

There are 45 people hospitalized (up thrtee) with 12in the ICU (downtwo).Hospitalizations are high but have been stable.

Recent fatalities have all been amongVermonters 50 and older, with most in the oldest age band, which has been the case since the beginning of the pandemic.

There were 39 COVID-related deaths in Vermont in October, which is the third-worst month on record. There are nine so far in November.

The 11 worst days for cases have all come since mid-September,as the Delta variant has taken oversince early July.

Financial Regulation Commissioner Michael Pieciak said both the case counts and fatalities have not shown dramatic reductions, as they have in other parts of the nation, particularly the South, or even in southern New England.

While the health experts do not understand exactly why this is, given Vermont's high vaccination rate, Pieciak said the three Northern New England states are all showing a similar pattern.

In addition, Health Commissioner Mark Levine, MD, continues to urge Vermontersto get their booster dose, especially if they're over 65. The immunity appears to wane over time and older Vermonters and those immunocompromised were among the first vaccinated last winter.

The elderly have been especially vulnerable to COVID, with the vast majority of fatalities coming among those 80 and over (206total deaths, while having by far the fewest number of infections for any age band.). One death Saturday for 80+.

Thestate announced last Thursday nightthat boosters for Moderna (like already approved Pfizer, six months after second dose) and Johnson & Johnson (two months after first dose)would begin immediately. The CDC is also allowing people to change/ mix and match vaccines.

TheFDA Tuesdayapproved the low-dose Pfizer vaccine for children5-11. Human Services Secretary Mike Smith said if the CDC approves it tonight then the state will allow parents to sign up their kids as early as 8 am tomorrow morning with doses being available as early as Thursday.

He said that in addition to the usual vaccination clinics, the state will also be bringing the vaccine directly to 112 schools around the state, especially to those in outlying areas where transportation or fewer pharmacies could make it more difficult for kids to get their shots.

Dr Rebecca Bell, President, Vermont Chapter of the American Academy of Pediatrics, at the governor's press conference Tuesday, sought to alleviate parents' fears.

She said the efficacy of this lower dose children's vaccine is still 91 percent. And unlike with adults, children in the control group did not show any of the flu-like symptoms that some adults have experienced.

Parents should also take comfort that a vaccinated child would no longer have to quarantine if they were a close contact to someone that tested positive. This issue has kept many kids out of school even though they never contracted COVID.

The Northeast Kingdom has the highest case rate of any region of the state, with Orleans County having the highest county rate, with over 1,000 cases per 10,000 residents. Bennington has the second highest rate with over 900 per 10,000.

Smith said the state will reinstitutepop up vaccination sitesin the NEK to increase vaccination rates, which are the lowest in the state. See list of upcoming NEK clinicsHEREand see below for statewide list of clinics.

COVID cases reported today were high in southern Vermont, with Bennington County alone reporting 34 and Rutland County 24.

But with all three boosters now available, vaccines for kids available and cases apparently declining, Governor Scott said Tuesday,"I'm more hopeful today than I have been in weeks."

Education Secretary Dan French announced Tuesday that the state was once again delaying the roll out of the 80 percent rule for ending school mask mandates. It will not happen go into effect until January 18, 2022, when students return to school after the Martin Luther King Holiday break.

The governor and his staff reiterated that these are recommendations only, because there is no State of Emergency, not mandates. The local school districts, like local businesses and individuals, must make their own rules.

As the Delta variantcontinues to be active in Vermont, Governor Scottiscalling on all Vermonters to act responsibly.

The new school guidance reads:

"To allow school districts time to calculate the percentage of currently eligible students who have received two doses of a two-dose vaccine, schools should require universal masking for all students and staff when indoors until January 18, 2022.

"Currently, all Vermonters ages 12 and older are eligible to be vaccinated.

"After January 18, 2022, masks should no longer be required for all those eligible for vaccination when the vaccination rate (two doses of a two-dose vaccine) among students is equal to or greater than 80% of the schools currently eligible population.

"Masks should be required indoors for students younger than 12, who are not eligible to be vaccinated at this time.

"Masks, when required, may be removed when needed for instructional or operational purposes.

"Masks are currently required for all passengers on buses per federal regulation, regardless of age or vaccination status.

"Masks should not be required outdoors. Guidance will be updated when vaccine eligibility expands."

The state also released school sports guidance Tuesday.

See Vaccination & COVID-19 Dashboards & Vaccination Sites TableBelow

Addison County

New Cases:5

Recent Cases 14 days:91

Bennington County

New Cases:20

Recent Cases 14 days:352

Caledonia County

New Cases:30

Recent Cases 14 days:204

Chittenden County

New Cases:83

Recent Cases 14 days:651

Essex County

New Cases:8

Recent Cases 14 days:90

Franklin County

New Cases:48

Recent Cases 14 days:301

Grand Isle County

New Cases:2

Recent Cases 14 days:26

Lamoille County

New Cases:15

Recent Cases 14 days:134

Orange County

New Cases:14

Recent Cases 14 days:169

Orleans County

New Cases:42

Recent Cases 14 days:334

Pending Validation

New Cases:4

Recent Cases 14 days:6

Rutland County

New Cases:15

Recent Cases 14 days:412

Washington County

New Cases:51

Recent Cases 14 days:283

Windham County

New Cases:6

Recent Cases 14 days:176

Windsor County

New Cases:33

Recent Cases 14 days:261

Most cases in Vermont are in the younger age groups with the 20-29 reporting the most, with nearly 7,300 total cases out of 37,100+, but only one death. The over 79 demographic has the fewest cases (just over 1,200) but by far the most fatalities with 188, or more than half the state total.

Financial Commissioner Michael Pieciak said Tuesday (SEE HIS FULL SLIDE DECK HERE) cases across the nation are falling fast and that the seven-day and 14-day averages in Vermont and the Northeast also are falling but at a slower rate. Vermont's seven-day infection rate is down15 percent. For the 14-day average, while overall it is down 2 percent for those who are fully vaccinated, it's up 9percent for those who are not fully vaccinated (which includes the unvaccinated).

Cases in high vaccination regions of the country are not displaying the typical Delta variant pattern, as in India, of a spike followed by a steep drop off after a couple months.

In Vermont, Delta has shown slow growth and a long plateau. Health Commission Mark Levine suggested that the drop off here could be another couple of weeks off, but he frankly was not sure.

He and Governor Scott and Human Services Secretary Mike Smith all urged that everyone who is eligible to get a vaccine to get one now, to get a booster now and to wear a mask while at an indoor gathering.

Governor Scott said the data shows that virus transmission with Delta is occurring at things like weddings and baby showers and birthday parties, sort of small and medium events where people are gathered for a period of time. It is not happening while visiting a convenience store or other type place where you are in an out, he said. Nor is it happening at outdoor gathering events.

Pieciak,in his COVID-19 Modeling presentation, said deaths seem to have slowed down a little as Delta has taken its toll. There have been 23 in October so far (as of the 21st)

Still, September was the second worst month for COVID-related deaths in Vermont since the beginning of the pandemic, with 45.

December 2020 was the worst with 71 and April 2020 was third worst with 35.

Meanwhile, the state is ramping up antigen testing in schools to keep kids in school who otherwise would be sent home if there were a close contact of someone who tests positive. Children now have a higher rate of infection than adults.

Governor Scott and state officials are urging all those who are eligible now to get vaccinated or get a booster shot, to do so, in order to reduce community transmission of the novel coronavirus (see clinic sites below).

As of October 1, many more Vermonters can now schedule and receive their Pfizer vaccine booster shots. He said there is plenty of vaccine supply.

We know vaccines are safe and effective, and these additional doses add even more protection. So, I encourage anyone who is eligible to register for your booster today, said Governor Scott. At the same time, we continue to urge those who have not yet gotten their first dose to get vaccinated. The data shows we are now in a pandemic of the unvaccinated, and vaccines are the best way to protect yourself, friends and family, and to make sure we continue moving forward from the pandemic.

Governor Scott said that the state will take a very broad interpretation of eligibility.

"We've reflected on this," Scott said. "We'regoing to be quitelenientin terms of whoshould beincluded and if they'd like tohave a booster we'd like to find a wayfor them to have it. So Iexpect that number is substantiallyhigherat this point. So our interpretation ofthis will be,again, quite broad."

Addition of Rapid Testing Tools Will Help Keep More Kids in School

When a student or staff member with COVID-19 is present in school during their infectious period, the school may implement Test to Stay for unvaccinated close contacts.

Unvaccinated, asymptomatic students (ages 5 and up) and staffwho areclosecontacts of a positiveCOVID-19case.

View post:
VDH: Cases surge again to third-worst on record - Vermont Biz

ElevateBio Supercharges Gene Editing and Therapeutic Product Development Capabilities Through Acquisition of Life Edit Therapeutics – Yahoo Finance

By Induced Pluripotent Stem Cells

- Life Edit's genome editing capabilities to be fully integrated with ElevateBio's other cell and gene enabling technologies, including induced pluripotent stem cells (iPSCs), viral vector, and cellular engineering

- Brings a broad array of editing modalities, including deletion, insertion, base editing, and CRISPRa/CRISPRi

CAMBRIDGE, Mass., October 27, 2021--(BUSINESS WIRE)--ElevateBio, LLC (ElevateBio), a cell and gene therapy technology company focused on powering transformative cell and gene therapies, today announced that it has acquired all of AgBiome Delta, LLCs (AgBiome) shares of Life Edit Therapeutics, Inc. (Life Edit). Life Edit offers a powerful suite of gene editing technologies that have the potential for any genomic sequence of interest to be removed, added, or altered. Life Edit holds one of the world's largest and most diverse arrays of novel RNA-guided nucleases and base editors that offer greater specificity and broad genome access. These nucleases were derived from AgBiome's proprietary non-pathogenic microbe collection, which could potentially reduce immunogenicity risks.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211027005153/en/

"ElevateBios powerful suite of enabling technologies, which now includes Life Edits genome editing capabilities as well as our existing iPSC, viral vector, and cell engineering platforms, is designed to disrupt the rapidly advancing fields of cell and gene therapy," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "Our vision is to build a world-class center of excellence in genome engineering to push the boundaries of therapeutic development and drive innovation for our own therapeutic pipeline as well as provide access to these critical technologies to our growing number of industry partners."

"Genome editing is a central component of all cell and gene therapy development, and access to novel RNA-guided nucleases and base editors that offer specificity and broad genome coverage will be critical. We believe Life Edit's technology is one of the most versatile in the field, opening up enormous potential," Mitchell Finer, Chief Executive Officer of Life Edit and President, R&D of ElevateBio. "This integration will also enable Life Edit to have greater access to ElevateBios drug development and manufacturing capabilities as we build and advance the pipeline, which will initially focus on developing in vivo gene therapies to address neurologic conditions with high unmet need. In addition, by combining Life Edit's gene engineering capabilities with ElevateBios iPSC technology, our goal is to expand the number of therapeutic uses, including potentially making universal or hypoimmune cells that go undetected by the immune system."

Story continues

Life Edit was spun out of AgBiome in October 2020 and AgBiome continues to retain rights for gene editing outside of human therapeutics.

About Life Edit Therapeutics:Life Edit has one of the world's largest and most diverse arrays of novel RNA-guided nucleases and base editors active in mammalian cells. They were developed from a proprietary collection of non-pathogenic organisms and offer gene editing tools with higher fidelity, novel functionality, reduced immune response risk, and easier delivery. Life Edit has a large and diverse library of RNA-guided nucleases, including Type II and Type V systems that encompass knock-out and knock-in capabilities, transcriptional regulation, and base editing when coupled with one of our proprietary deaminases. The company's nuclease collection has a broad range of Protospacer Adjacent Motifs (PAMs). These short sequences must accompany the DNA sequence for the enzyme to edit a gene, which offers unprecedented access to genomes. Life Edit has identified several classes of DNA modifying enzymes, including novel deaminases that can edit cytidine (C) or adenine (A). Many of the company's RGNs are smaller than widely used CRISPR-Cas systems, offering ease and flexibility for in vivo delivery and manufacturing.

Life Edit is headquartered in Morrisville, NC. Visit us at http://www.lifeeditinc.com, or follow Life Edit on LinkedIn and Twitter.

About ElevateBio:ElevateBio is a cell and gene therapy technology company built to power the development and manufacturing of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering, that can be leveraged across the entire portfolio and by strategic partners. At the center of the business model is ElevateBio BaseCamp, a centralized research and development (R&D) and manufacturing company that offers R&D, process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also developing its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.

ElevateBio is located in Waltham, MA. Visit us at http://www.elevate.bio, or follow ElevateBio on LinkedIn, Twitter, or Instagram.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211027005153/en/

Contacts

Investor: Catherine Hu chu@elevate.bio 646-535-8276

Media: Courtney Heath ScientPR Courtney@scientpr.com 617-872-2462

See the original post here:
ElevateBio Supercharges Gene Editing and Therapeutic Product Development Capabilities Through Acquisition of Life Edit Therapeutics - Yahoo Finance

ReNeuron enters cancer therapy collaboration with UCL – ShareCast

By Induced Pluripotent Stem Cells

Cell-based therapeutic specialist ReNeuron has entered a collaboration agreement with University College London (UCL), it announced on Tuesday, to conduct research into the generation of immune cells from induced pluripotent stem cells (iPSCs), for anti-cancer cell therapies.

The AIM-traded firm said it would be working alongside Dr Claire Roddie, associate professor at the UCL Cancer Institute, and the team at the UCL CAR-T cell cancer therapy programme.

It said it would provide UCL with iPSCs from its CTX immortalised neural progenitor cell line to be assessed for their ability to differentiate into functional T cells and natural killer (NK) cells.

If this first objective was met, the CTX-iPSC cell line would be further used to generate chimeric antigen receptors (CAR) T cells, or CAR-NK cells.

ReNeuron explained that CARs allow T and NK cells to target receptors present on the surface of cancer cells, allowing them to recognise and specifically kill tumour cells.

Dr Roddie and her team had extensive expertise in generating CAR cells, the company said, adding that both groups would work collaboratively to generate haematopoietic stem cells, lymphoid progenitors and cytotoxic T cells from the CTX-iPSCs.

We are very much looking forward to working with Dr Roddie and her team at UCL in this exciting and rapidly growing research space, said chief scientific officer Dr Stefano Pluchino.

This collaboration is another strong development for ReNeuron which demonstrates the uniqueness and strong translational potential of our proprietary iPSC technology platform and will allow us to further expand into the oncology space.

If this initial research is successful, significantly large numbers of cancer patients can be treated with next generation alternate cancer therapies.

At 1243 BST, shares in ReNeuron Group were up 4.91% at 119.6p.

Continued here:
ReNeuron enters cancer therapy collaboration with UCL - ShareCast

Shah on the Potential Utility of NK Cells in Multiple Myeloma – OncLive

By Induced Pluripotent Stem Cells

Nina Shah, MD, discusses the potential utility of natural killer cells in multiple myeloma.

Nina Shah, MD, hematologist and oncologist, associate professor of medicine, Department of Medicine, University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, discussesthepotential utility of natural killer (NK) cells in multiple myeloma.

NK cells are a potential type of allogeneic cellular therapy for patients with multiple myeloma, explains Shah. However, a challenge with NK cells is that there are not as many NK cells as other cells; therefore, NK cells need to be expanded and often engineered, Shah explains. One example of engineeringinducibleNK cells is being evaluated by Fate Therapeutics. The NK cells are engineered from a human induced pluripotent stem cellbank to then be cultured, Shah adds.

Moreover, the NK cells strongly express CD16 and Fc receptor on the cell surface. Additionally, CD38 is engineered so utilizing daratumumab (Darzalex) is an option with both engineering tactics, Shah continues. Additionally, the cells are engineered in the context of CAR so targeting BCMA is an option to kill cells. An IL-15 receptor fusion protein was also engineered to allow the NK cells to persist. Preclinical data have shown that the cells are active and persistent, Shah explains.

Overall, more data are anticipated, which will include patients with relapsed/refractory multiple myeloma who received NK cells with a monoclonal antibody, such as daratumumab, Shah explains. Moreover, this approach would be given off-the-shelf, which could open an accessible option to patients, Shah concludes.

See original here:
Shah on the Potential Utility of NK Cells in Multiple Myeloma - OncLive

Exacis Biotherapeutics Announces Strategic Partnership With CCRM For Specialty Manufacturing Of Services And Investment For Development Of…

By Induced Pluripotent Stem Cells

Cambridge, MA, - Exacis Biotherapeutics, Inc., a development-stage immuno-oncology company working to harness the immune system to cure cancer, today announced initiation of a strategic partnership with Toronto-based Centre for Commercialization of Regenerative Medicine (CCRM) for specialty manufacturing services related to the development of Exacis innovative, iPSC-derived mRNA-engineered NK cell products to treat cancer. The partnership also includes a cash investment into Exacis by CCRM Enterprises Holdings Ltd., the for-profit venture investment arm of CCRM, which will be used to fund operations.

Exacis CEO Gregory Fiore, MD, commented, We welcome CCRM as a key partner to allow us to rapidly advance our virus-free manufacturing processes to make novel NK cell products that are engineered for performance and to avoid rejection. CCRM is a recognized leader in iPSC-derived cell therapy development and manufacturing and we are thrilled to have them as a partner. Their confidence in Exacis is evidenced by the accompanying investment, by CCRM Enterprises Holdings Ltd., underscoring the unique value proposition offered by Exacis differentiated platform and approach to cell therapies. We look forward to partnering with CCRMs CDMO experts to apply our mRNA based technologies to develop best-in-class products to treat challenging hematologic and solid tumors.

Cynthia Lavoie, PhD, President and CIO of CCRM Enterprises Inc. added, We are pleased to support Exacis by way of an investment, and with our sector expertise and specialized infrastructure. This is a successful model that we have employed in the past to support promising technologies and together we will develop leading cell therapy products that utilize the substantial potential of the Exacis platform as it advances its iPSC-derived cell programs.

About Exacis Biotherapeutics

Exacis is a development stage immuno-oncology company focused on harnessing the human immune system to cure cancer by engineering next generation off-the-shelf NK and T cell therapies aimed at hematologic malignancies and solid tumors. Exacis was founded in 2020 with an exclusive global license to a broad suite of patents covering the use of mRNA based cell reprogramming and gene editing technologies for use in generating engineered NK and T cells for oncology applications. These patents were developed and are owned by Factor Bioscience.

Exacis differentiated cell therapy platform avoids the use of DNA and viruses and uses instead a proprietary mRNA based technology. Exacis uses the technology to generate iPSCs and to edit their genomes to create stealthed, potent allogeneic cell products, termed ExaNK, ExaCAR-T or ExaCAR-NK cells.

About CCRM

CCRM is a global, public-private partnership headquartered in Toronto, Canada. It receives funding from the Government of Canada, the Province of Ontario, and leading academic and industry partners. CCRM supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, strategic investors and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients, with specialized teams, funding and infrastructure. CCRM is the commercialization partner of the University of Toronto's Medicine by Design. CCRM is hosted by the University of Toronto. Visit us at ccrm.ca.

About CCRMEnterprises Inc.

CCRMEnterprises Inc. is the for-profit venture investment arm of the Centre for Commercialization of Regenerative Medicine (CCRM).CCRM Enterprises invests in early stage ventures and projects developing therapeutics and enabling technologies. Through an extensive network of investors, it can bring together risk capital to support these early-stage ventures as they scale up along the development pathway.By tapping into CCRMs manufacturing infrastructure and expertise, CCRM Enterprises provides capital-efficient support to accelerate and de-risk these high potential, early-stage ventures, further enabling the development of an advanced therapies ecosystem. CCRM Enterprises Holdings Ltd. is the associated entity that holds shares in CCRM portfolio companies. Learn more about our investing strategy here.

About T and Natural Killer (NK) Cell Therapies

T and NK cells are types of human immune cells that are able to recognize and destroy cancer cells and can be modified through genetic engineering to target specific tumors.

Contact Exacis Biotherapeutics for further information and media:

Exacis Biotherapeutics info@exacis.com

View original post here:
Exacis Biotherapeutics Announces Strategic Partnership With CCRM For Specialty Manufacturing Of Services And Investment For Development Of...

Team finds way to enhance stem cell therapy for CNS injuries – BioPharma-Reporter.com

By Stem Cell Treatment

The scientists, Christopher Rathnam and colleagues, say they have designed a way of controlling the formation of 3D spheroids made from stem cells, while enhancing the spheroids ability to differentiate into functional neurons.

The technology led to an increase in stem cell survival and differentiation two challenges with existing stem cell therapy systems in a mouse model of spinal cord injury, noted the team in a paper published inScience Advances

We believe that our technology platform is an ideal candidate for improving many other types of cell therapies that require high cell survival and effective control of cell fate, making it useful not only for treating [spinal cord injuries] but also for various other diseases and disorders, said the authors.

Although stem cell therapy holds enormous potential for treating debilitating injuries and diseases of the CNS, the team outlined how low survival and inefficient differentiation have restricted its clinical applications.

Recently, 3D cell culture methods, such as stem cellbased spheroids and organoids, have demonstrated advantages by incorporating tissue-mimetic 3D cell-cell interactions, said the experts.

However, a lack of drug and nutrient diffusion, insufficient cell-matrix interactions, and tedious fabrication procedures have compromised their therapeutic effects in vivo, they added.

To address these issues, the Rathnam led team developed a method in which biodegradable manganese dioxide nanosheets guide the rapid assembly of neural stem cells, derived from human induced pluripotent stem cells (iPSCs), into 3D spheroids.

The technique also enables controlled drug release inside the core of the spheroids, which could help to improve cell survival and differentiation, they said.

To evaluate the efficacy of the structures, which they termed synthetic matrix-assisted and rapidly templated (SMART) spheroids, the researchers implanted them at injury sites in a mouse model of spinal cord injury.

As controls, they injected cell suspensions and conventional neurospheres, formed without the use of their novel nanosheets, at the spinal cord injury sites, with the same total number of cells per animal and at the same concentrations.

They found significantly higher cell survival and improved neuronal differentiation efficiency for the SMART neurospheres compared with the controls both 7 days and 1 month after injection.

Read more:
Team finds way to enhance stem cell therapy for CNS injuries - BioPharma-Reporter.com

Bacterial Infections Linked with Unapproved Stem Cell Treatments – Contagionlive.com

By Stem Cell Treatment

Unproven products marketed as stem cell therapies could be risky, according to a new study from the Centers for Disease Control and Prevention, which analyzed bacterial infections from unapproved products derived from umbilical cord blood.

The case series study, published in JAMA Network Open, examined 20 bacterial infections in eight states. It involved reviewing medical records, sterility testing of products and whole-genome sequences of patient and product isolates for participants who developed bacterial infections after receiving stem cell treatments between August 2017 and September 2018.

The findings of this investigation show that stem cell therapies that are not FDA-approved or that are not used for the approved medical conditions can pose serious health risks to patients with no benefit, Kiran Mayi Perkins, MD, lead investigator with the CDCs Outbreak and Response Team, told Contagion. Currently, the only stem cell products derived from umbilical cord blood that are FDA-approved for use in the United States are approved for use in patients with disorders that affect the production of blood, but they are not approved for other uses. However, these products are often illegally marketed by clinics as being safe and effective for treating a wide range of diseases or conditions. Therefore, patients should be aware of the unproven benefits and the potential risks to their health when using unapproved and unproven stem cell products for conditions that they have not been shown to effectively treat.

All but one of the patients in the study required hospitalization after receiving stem cell treatment for conditions including osteoarthritis, rheumatoid arthritis and injury. The CDC performed sterility testing on vials of product and compared bacterial isolates with those from the patients.

We were surprised by the magnitude of bacterial contamination found in the vials that we tested; over half of the vials of the stem cell product that we tested were contaminated with bacteria, and many of these vials had very high bacterial counts, Perkins said.

Unapproved stem cell products have been marketed for conditions such as joint diseases, sports injuries and chronic pain and have become more prevalent as people seek products to prevent and treat COVID-19, the study noted. However, these uses are not approved by the US Food and Drug Administration (FDA).

ReGen Series products processed by Genetech and distributed by Liveyon were recalled after bacterial infections were reported in Texas and Florida in 2018, and a national investigation was launched. Information was gathered about patients, product administration, infection control practices and product manufacturing and distribution.

The bottom line is that many stem cell clinics are offering unproven products that have the potential to be dangerous, Perkins said. There is good research that is being done on stem cell therapies, but there are also a lot of clinics that are selling stem cells for unproven uses. To date, the only stem cell treatments approved by the FDA are products made from a donors umbilical cord blood that are used to treat certain cancers and disorders of the blood and immune system. If the cells are being used to treat other conditions such as pain, orthopedic conditions, autism, anti-aging, or COVID-19, they are not approved and may not be safe. We urge all patients and health care practitioners considering stem cell therapies to ensure that the stem cell product is being used for the approved indication or under an Investigational New Drug Application (IND) and is on FDAs list of approved products.

The states in which confirmed bacterial infections were identified as of March 2021 are Texas, Florida, California, Arizona, Kansas, Maine, Colorado and Massachusetts.

The treatments were injected into the patients knees, shoulders, spine or digits or administered through intravenous infusion or as a nasal spray. Infections included 10 at the injection site, five bloodstream infections and five with both injection site and bloodstream infections. Most common bacteria were Escherichia coli and Enterobacter cloacae.

CDC will continue to investigate any reports that it receives that are concerning for infectious risks to patients associated with the receipt of stem cell products and will report these to FDA, the agency that has regulatory oversight for these types of therapies, Perkins said.

Excerpt from:
Bacterial Infections Linked with Unapproved Stem Cell Treatments - Contagionlive.com

→←