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Broadening access to cancer fighting therapy led by UH researcher | University of Hawaii System News – University of Hawaii

By Adult Stem Cells

Stephanie Si Lim

A therapy that helps modify a patients T cells (a type of immune cell) to make them more capable of fighting cancer was recently brought to Hawaii by Stephanie Si Lim, assistant professor at the University of Hawaii Cancer Center and pediatric hematologist oncologist at Kapiolani Medical Center for Women & Children. Chimeric Antigen Receptor T-cell therapy (CAR T-cell therapy) can result in the development of life-saving treatments for cancers that are difficult to treat.

Si Lim is leading the initiative at Kapiolani Medical Center for Women & Childrenpart of Hawaii Pacific Healthto build a broader cellular immunotherapy program. A key goal of the program is to introduce CAR T-cell therapy to the medical community in Hawaii in the form of clinical trials and U.S. FDA (Food and Drug Administration) approved products. This will ensure that patients have access to the best available treatments for cancer.

CAR T-cell therapy is now available to children and young adults with non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia, and will soon be available to adult patients.

The first CAR T-cell clinical trial opened on May 14, 2022, at Kapiolani Medical Center for Women & Children, leveraging the infrastructure and expertise of the hospitals stem cell transplant and clinical research programs. Moving forward, all patients living in Hawaii, including the neighbor islands who qualify for this clinical trial, will be able to receive treatment on Oahu without having to travel to the continental U.S.

Si Lim said, We are so excited to be able to offer CAR T-cell therapy to our patients here in Hawaii. This is a momentous step for our medical community as we continue to strive to offer the best and most cutting-edge therapies to patients in need.

Currently, CAR T-cell therapy is proven to be particularly effective against B-cell malignancies and multiple myelomaboth common forms of cancer in adults and pediatric populations in Hawaii. Over the next few years, it is expected that new FDA-approved CAR T-cell treatments will also be available for other cancers in the state, including breast and prostate.

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Broadening access to cancer fighting therapy led by UH researcher | University of Hawaii System News - University of Hawaii

The amniotic products market is expected to grow from US$ – GlobeNewswire

By Stell Cell Research

New York, July 21, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Amniotic Products Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type, Application, End User, and Geography" - https://www.reportlinker.com/p06295644/?utm_source=GNW The amniotic membrane and suspension are two products that can be used for treatment.

The amniotic membrane is the innermost layer of the placenta that nourishes and maintains an unborn child. Amniotic fluid is the liquid that surrounds the baby until delivery. Due to the high prevalence of burn wounds, demand for wound care biologics, such as amniotic membranes, has increased significantly.According to the WHO, many burn cases occur in low- and middle-income countries, with over 2-3rd occurring in the WHO African and Southeast Asian areas.

Every year, one million people in India suffer from mild to severe burns (Source: WHO).Other Southeast Asian countries, such as Bangladesh and Nepal, have a high rate of burn cases.

An estimated 173,000 children in Bangladesh yearly suffer from moderate to severe burns. Burn is Nepals second most prevalent injury, accounting for 5% of disability cases. Based on type, the amniotic products market has been bifurcated into amniotic membranes and amniotic suspensions.The amniotic membranes segment is likely to hold the largest share of the market in 2022.

The amniotic membrane segment growth is growing due to increasing research in stem cell and regenerative medicine, high R&D investments, and an increase in the number of surgeries conducted globally.Further, they are commonly employed in the treatment of bacterial keratitis, corneal ulcers, cataract, glaucoma, bullous keratopathy, corneal degeneration, ocular dystrophy, eyelid reconstruction, and other eye surface problems.

The expansion in the worlds senior population increases the number of ophthalmology surgeries, , resulting in a growing need for tissue-based products.Further, PalinGen, Fl?Graft, AmbioDisk, and AmnioFix are examples of commercially available dehydrated amniotic membranes.

In addition, these membranes are widely used in the treatment and management of surgical wounds and incisions, owing to properties such as their ability to maintain a watertight seal, inhibit inflammatory responses, and prevent disease transmissions. Hence, these factors are driving the segment growth. In December 2016, the US passed the 21st Century Cures Act.This new law was passed with the goal of advancing regenerative medicine research and medical innovation.

The Act contains a number of provisions that could impact the development and approval of many products in the coming years.A new "Regenerative Medicine Advanced Therapy" classification and a fast-track approval procedure for innovative regenerative medicine products and therapies have been developed due to this Act.

The passage of this Act could lead to the approval of new regenerative medicine products and therapies in the US and a boost in regenerative medicine research and development.It was designed to promote patient access to electronic health information, advance innovation, and address information blocking practices.

The 21st Century Cures Act was created to help speed up medication development and approval processes, allowing for faster and more efficient delivery of new medical advancements to patients. These requirements are expected to improve interoperability and facilitate electronic health information access, exchange, and use. A few key primary and secondary sources referred to while preparing the report on the prostate cancer nuclear medicine diagnostics market are the World Health Organization (WHO), the Centers for Disease Control and Prevention, and the National Programme for Prevention, Management and Rehabilitation of Burn Injuries. Read the full report: https://www.reportlinker.com/p06295644/?utm_source=GNW

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The amniotic products market is expected to grow from US$ - GlobeNewswire

Vegan Oysters in Shells? This Startup Just Developed a Prototype to Save the Oceans – VegNews

By Stell Cell Research

Cell-cultured seafood startup Pearlita Foods has successfully created the worlds first plant-based oyster prototype that looks and tastes just like a traditional oyster. The prototype is made using plant-based and cell-based technologies with a proprietary mushroom and seaweed base as well as Pearlitas novel flavor mixture that gives the oyster a pure, delicate, and authentic ocean taste and texture. The startup also plans to create biodegradable oyster shells that will impart the same experience as traditional oysters but remove the need for shucking, making it easier for consumers to serve and eat.

Earlier this year, Pearlita embarked on producing an alternative to oysters in an effort to meet the demand for ocean-derived delicacies using plant-based and cell-based technologies without harming the oceans. The startup will begin by rolling out its hybrid product while it continues to develop its cell lines for a line of fully cultured oysters. To cultivate oysters, Pearlita isolates cells from an oyster tissue sample, and with it, the startup is able to produce thousands of cultivated oysters.

While the startup continues its research and development on cultured oysters and biodegradable shells, Pearlita will debut its hybrid plant-based oyster using recycled oyster shells for its showcasing and tastings. In North Carolina, where Pearlita is headquartered, many coastal communities offer shell recycling drop-off locations to build new oyster reefs instead of disposing of the shells in landfills.

Pearlita Foods

According to Pearlita, over 85 percent of wild oyster reefs have been lost globally due to overfishing. Pearlita wants to change the seafood industry and it is striving to make cultivated oysters and other cell-based seafood commonplace so that traditional oysters can remain in the oceans and contribute to healthy ecosystems. Additionally, according to government advisories from the Centers for Disease Control and Prevention, ocean-derived bivalve shellfish such as clams, geoducks, mussels, scallops, and oysters can transmit norovirus to the people who eat them. These illness outbreaks are most often linked to oysters and can be deadly.

The startup aims to produce oysters with no reliance on the ocean or live animals, by using stem cells and bioreactors to produce cell-based oysters that are rich in flavor and nutrition. And because they are produced in a sterile environment, cultivated seafood is devoid of bacteria and virus contamination. Going forward, Pearlita plans to develop squid and scallop prototypes as well and work on scaling up production.

The cellular aquaculture startup recently secured investment from investment firm CULT Food Science to help scale its prototype. We are impressed by and proud of Pearlitas successful production of its first cultivated oyster prototype. Pearlitas commitment to making the world a better place and doing its part to increasing the worlds food security is encouraging as we possess the same goals, Lejjy Gafour, Chief Executive Officer of CULT, said in a statement. Pearlita is taking great steps to advance the production of cultured seafood on a mass scale. We are energized by the positive contributions that their team is making to the cellular agriculture industry.

Finless Foods

While Pearlita is focusing on developing ethical and sustainable seafood alternatives to ocean delicacies such as oysters, other food technology companies are tackling fish species such as tunawhich is the most consumed fish in the United States. Finless Foods is taking a similar approach to Pearlita by using plants and cultivated cells to make sustainable seafood, starting with tuna which will be available to restaurants and foodservice channels this year.

Earlier this year, Finless Foods showcased its plant-based tuna as part of a poke bowl and tacos served to guests at the Food Network & Cooking Channel South Beach Wine & Food Festival in Miami. The product is made from a blend of nine proprietary, plant-based ingredients that together mimic the texture and taste of sushi-grade tuna while also being able to withstand the addition of citrus and marinades.

Tuna plays an important role in ocean health and has historically been a difficult species for aquaculture, Finless Foods co-founder Brian Wyrwas said in a statement. We felt that developing viable alternatives would yield the greatest net impact for our ocean.

Other competitors in the cellular aquaculture space include San Diego-based BlueNalu, which is working to develop cell-based alternatives to fish, including yellowtail amberjack which it sampled in a private-tasting in 2019. In San Francisco, cellular aquaculture startup Wild Type is also working on growing sushi-grade meat made from a small amount of fish cells. Its pilot facility became operational in 2021 and Wild Type hopes to open an adjacent tasting restaurant where its cultivated fish can be showcased in traditional (but more sustainable) sushi preparations.

Over in Singapore, the countrys first cell-based seafood startup, Shiok Meats, is creating cultivated crab and lobster. Currently, Singapore is the only country in the world that allows the sale of cultivated meat. There, cultivated chicken made by GOOD Meat (a subsidiary of Eat Just) was approved for sale in December 2020.

For the latest vegan news, read: Chipotle Invested a $150 Million Funding Round For Vegan Steak StartupNavy Will Test Vegan Meat on at Least 2 US BasesCountry Crocks First Whipping Cream Is Made From Lentil Milk

Nicole Axworthy is the News Editor at VegNews and author of the cookbook DIY Vegan.

Happy birthday, VegNews! To celebrate, we're having a mega subscription salecomplete with incredible vegan prizes.

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Happy birthday, VegNews! To celebrate, we're having a mega subscription salecomplete with incredible vegan prizes.

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Vegan Oysters in Shells? This Startup Just Developed a Prototype to Save the Oceans - VegNews

University of Minnesota scientist responds to fraud allegations in Alzheimer’s research – Star Tribune

By Stell Cell Research

A senior University of Minnesota scientist said it is "devastating" that a colleague might have doctored images to prop up research, but she defended the authenticity of her groundbreaking work on the origins of Alzheimer's disease.

Dr. Karen Ashe declined to comment about a U investigation into the veracity of studies led by Sylvain Lesn, a neuroscientist she hired and a rising star in the field of Alzheimer's research. However, she criticized an article in Science magazine that raised concerns this week about Lesn, because she said it confused and exaggerated the effect the U's work had on downstream drug development to treat Alzheimer's-related dementia.

"Having worked for decades to understand the cause of Alzheimer disease, so that better treatments can be found for patients, it is devastating to discover that a co-worker may have misled me and the scientific community through the doctoring of images," Ashe said in an e-mail Friday morning. "It is, however, additionally distressing to find that a major scientific journal has flagrantly misrepresented the implications of my work."

Questions have surfaced about as many as 10 papers written by Lesn, and often coauthored by Ashe and other U scientists, and whether they used manipulated or duplicated images to inflate the role of a protein in the onset of Alzheimer's.

The Science article detailed efforts by Dr. Matthew Schrag, an Alzheimer's researcher in Tennessee, who colorized and magnified images from Lesn's studies in ways that revealed questions about whether they were doctored or copied. Expert consultants agreed in the article that some of the images in the U studies appeared manipulated in ways that elevated the importance of a protein called A*56.

Many of the images were of Western blot tests showing that A*56, also called amyloid beta star 56, was more prevalent in mice that were older and showed signs of memory loss.

The U studies have been so influential on the course of Alzheimer's research over the past two decades that any evidence of manipulation or false study results could fundamentally shift thinking on the causes of the disease and dementia. The investigation also implicates two successful researchers on a key measure by which they are judged: their ability to pull in federal grants.

Lesn was a named recipient of $774,000 in National Institutes of Health grants specifically involving A*56 from 2008 through 2012. He subsequently received more than $7 million in additional NIH grants related to the origins of Alzheimer's.

Lesn, who did not reply to an e-mail asking for comment, came to the U in 2002 as a postdoctoral research associate after earning his doctorate at the University of Caen Normandy. He took charge of his own U lab by 2009 and became associate director of graduate studies in the neuroscience program in 2020. He was the first- or last-named author on all of the disputed studies, meaning he either instigated the research or was the senior scientist overseeing the work.

Ashe said there are two classes of A proteins, which she refers to as Abeta, and that her efforts have focused on one while drugmakers have unsuccessfully targeted the other with potential Alzheimer's treatments. As a result, she said it was unfair of the Science article even as it raised concerns about research improprieties to pin an entire industry's lack of progress on the scrutinized U research.

"It is this latter form that drug developers have repeatedly but unsuccessfully targeted," she said. "There have been no clinical trials targeting the type 1 form of Abeta, the form which my research has suggested is more relevant to dementia. [The article] has erroneously conflated the two forms of Abeta."

The scientific journal Nature is reviewing a 2006 study led by Lesn regarding the existence and role of A*56 and urging people to use it cautiously for now. Concerns emerged in part because researchers at other institutions struggled to replicate the results.

Two other 2012 and 2013 papers were corrected earlier this year, with U researchers acknowledging errant images but stating that they didn't affect the overall conclusions. However, Schrag said he has concerns the corrected images also were manipulated.

"I think those corrected images are quite problematic," he said.

Beneath the research controversy is a fundamental search and debate over the causes of Alzheimer's and related dementia. One theory is that certain Abeta proteins result in the development of amyloid plaques, which clog up space between nerve cells in the brain and inhibit memory and cognition. Another is that tau proteins clump inside the brain's thinking cells and disrupt them.

Ashe's research has explored both possibilities. Since 1986, she has been a named recipient of more than $28 million in NIH grants, making her one of the most productive researchers in U history.

Complicated legacy

Despite a remarkable history of life-saving inventions and surgical accomplishments, the U also has a legacy of research stars being implicated in scandals.

The late Dr. S. Charles Schulz stepped down as U psychiatry chair in 2015 amid claims by a grieving family that their son, who died by suicide, was coercively recruited into a schizophrenia drug trial.

Duplicated images and errors forced the correction of a 2002 Nature study, led by Dr. Catherine Verfaillie, claiming that certain adult stem cells possessed flexible abilities to grow and develop other cell types.

The late Dr. John Najarian was a pioneer in organ transplantation who elevated the U's global profile, but he faced federal sanctions in the 1990s related to illicit sales of an experimental anti-rejection medication that improved transplant outcomes.

A U investigation of Lesn's work will follow its standard policy of research misconduct allegations, according to a statement from the medical school.

Originally posted here:
University of Minnesota scientist responds to fraud allegations in Alzheimer's research - Star Tribune

Global Virus Filtration Market To Be Driven By The Increasing Incidence Of Chronic Diseases In The Forecast Period Of 2021-2026 This Is Ardee – This…

By Stell Cell Research

The new report by Expert Market Research titled, GlobalVirus Filtration MarketReport and Forecast 2021-2026, gives an in-depth analysis of the global virus filtration market, assessing the market based on its segments like product, applications, end-use, and major regions. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report summary@https://bityl.co/CQEk

The key highlights of the report include:

Market Overview (2016-2026)

One of the major factors driving to the virus filtration is the rising prevalence of chronic diseases. The increasing number ofchronicdiseases such ascancer,diabetes, and autoimmune disorders is expected to drivebiologicsdemand. The major driver, which is anticipated to increase the market growth during the forecast period, is the compliance of the product with drug development and manufacturing regulatory frameworks such as the Current Good Manufacturing Practice (cGMP) legislation. The increased focus on vaccines,proteintreatments, blood products, cellular therapy products, gene therapy products, tissue products, and stem cell products is likely to stimulate demand for consumables such as reagents, kits, and membranes. Increased demand for outsourcing services that cater to the specialised demands of vaccine and therapeutic protein manufacturing companies has come from a surge in the number of vaccine and therapeutic protein manufacturing companies, providing lucrative growth potential for the industry.

Industry Definition and Major Segments

Viruses are characterised as unwanted tiny contagious agents or particles that must be eradicated in order to prevent drug infertility, especially in the pharmaceutical sector. Virus filtration membranes are used to remove viruses from biopharmaceutical products during purification. It is a critical practice in the pharmaceutical sector because it ensures the purity and consistent consumption of vital products while also optimising the economic process and reducing waste. Virus filtering is usually done at the end of any process purification stage.

Explore the full report with the table of contents@https://bityl.co/CQEl

By product, the market includes:

The end use of the industry is divided into:

The leading application of the industry includes:

On the basis of region, the industry is divided into:

Market Trends

The demand for medicinal biologics is increasing, which drives up the demand for virus filtration products in research and development and manufacturing. CROs are cooperating with biotechnology and biopharmaceutical businesses to create new medications and therapies, which is projected to drive the market expansion. The increased usage of these products for virus filtration provides lucrative growth opportunities to the market. Product advancements and new product launches support vendors in maintaining their dominance in the market, which is anticipated to boost the market growth. The presence of big biopharmaceutical and biotechnology companies, well-developed healthcare infrastructure, and access to advanced products are some of the major factors contributing to growth of the marker. The increasing adoption of single-use technologies, coupled with rapid technological advancement, is anticipated to propel the market growth during the forecast period.

Key Market Players

The major players in the market are Merck Group, Asahi Kasei Corporation, Sartorius Group, General Electric, Danaher Corporation, Pendotech, Lonza Group, and Charles River Laboratories, Inc, among others. The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

About Us:

Expert Market Research (EMR) is leading market research company with clients across the globe. Through comprehensive data collection and skilful analysis and interpretation of data, the company offers its clients extensive, latest and actionable market intelligence which enables them to make informed and intelligent decisions and strengthen their position in the market. The clientele ranges from Fortune 1000 companies to small and medium scale enterprises.

EMR customises syndicated reports according to clients requirements and expectations. The company is active across over 15 prominent industry domains, including food and beverages, chemicals and materials, technology and media, consumer goods, packaging, agriculture, and pharmaceuticals, among others.

Over 3000 EMR consultants and more than 100 analysts work very hard to ensure that clients get only the most updated, relevant, accurate and actionable industry intelligence so that they may formulate informed, effective and intelligent business strategies and ensure their leadership in the market.

Media Contact

Company Name: Claight Corporation Contact Person: Steven Luke, Corporate Sales Specialist U.S.A. Email:sales@expertmarketresearch.com Toll Free Number: +1-415-325-5166 | +44-702-402-5790 Address: 30 North Gould Street, Sheridan, WY 82801, USA Website:https://www.expertmarketresearch.com

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*We at Expert Market Research always thrive to give you the latest information. The numbers in the article are only indicative and may be different from the actual report.

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Global Virus Filtration Market To Be Driven By The Increasing Incidence Of Chronic Diseases In The Forecast Period Of 2021-2026 This Is Ardee - This...

Global Stem Cell Banking Market To Be Driven At A CAGR Of 13.5% In The Forecast Period Of 2021-2026 This Is Ardee – This Is Ardee

By Stem Cell Medicine

The new report by Expert Market Research titled, Global Stem Cell Banking Market Report and Forecast 2021-2026, gives an in-depth analysis of the globalstem cell banking market, assessing the market based on its segments like Service type, product type, utilisation, bank type, application, and major regions like Asia Pacific, Europe, North America, Middle East and Africa and Latin America. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report summary@https://bityl.co/CPix

The key highlights of the report include:

Market Overview (2021-2026)

The global stem cell bank market is primarily driven by the advancements in the field of medicine and the rising prevalence of genetic and degenerativediseases. Further, the increasing research and development of more effective technologies for better preservation, processing, and storage of stem cells are aiding the growth. Additionally, rising prevalence of chronic diseases globally is increasing the for advances inmedicaltechnologies, thus pushing the growth further. Moreover, factors such as rising health awareness, developinghealthcare infrastructure, growing geriatric population, and the inflatingdisposableincomes are expected to propel the market in the forecast period.

Industry Definition and Major Segments

Stem cells are undifferentiated cells present in bone marrow,umbilical cordadipose tissue and blood. They have the ability to of differentiate and regenerate. The process of storing and preserving these cells for various application such as gene therapy, regenerative medicine and tissue engineering is known as stem cell banking.

Explore the full report with the table of contents@https://bityl.co/CPiy

By service type, the market is divided into:

Based on product type, the industry can be segmented into:

The market is bifurcated based on utilization into:

By bank type, the industry can be broadly categorized into:

Based on application, the industry can be segmented into:

On the basis of regional markets, the industry is divided into:

1 North America 1.1 United States of America 1.2 Canada 2 Europe 2.1 Germany 2.2 United Kingdom 2.3 France 2.4 Italy 2.5 Others 3 Asia Pacific 3.1 China 3.2 Japan 3.3 India 3.4 ASEAN 3.5 Others 4 Latin America 4.1 Brazil 4.2 Argentina 4.3 Mexico 4.4 Others 5 Middle East & Africa 5.1 Saudi Arabia 5.2 United Arab Emirates 5.3 Nigeria 5.4 South Africa 5.5 Others

Market Trends

Regionally, North America is projected to dominate the global stem cell bank market and expand at a significant rate. This can be attributed to increasing research and development for stem cell application in various medical fields. Further, growing investments of pharmaceutical players and development infrastructure are other factors that are expected to stem cell bank market in the region. Meanwhile, Asia Pacific market is also expected to witness fast growth owing to the rapid development in healthcare facilities and increasing awareness of stem cell banking in countries such as China, India, and Indonesia.

Key Market Players

The major players in the market are Cryo-Cell International, Inc., Smart Cells International Ltd., CSG-BIO Company, Inc., CBR Systems Inc., ViaCord, LLC, LifeCell International Pvt. Ltd., and a few others. The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

About Us:

Expert Market Research (EMR) is leading market research company with clients across the globe. Through comprehensive data collection and skilful analysis and interpretation of data, the company offers its clients extensive, latest and actionable market intelligence which enables them to make informed and intelligent decisions and strengthen their position in the market. The clientele ranges from Fortune 1000 companies to small and medium scale enterprises.

EMR customises syndicated reports according to clients requirements and expectations. The company is active across over 15 prominent industry domains, including food and beverages, chemicals and materials, technology and media, consumer goods, packaging, agriculture, and pharmaceuticals, among others.

Over 3000 EMR consultants and more than 100 analysts work very hard to ensure that clients get only the most updated, relevant, accurate and actionable industry intelligence so that they may formulate informed, effective and intelligent business strategies and ensure their leadership in the market.

Media Contact

Company Name: Claight Corporation Contact Person: Steven Luke, Corporate Sales Specialist U.S.A. Email:sales@expertmarketresearch.com Toll Free Number: +1-415-325-5166 | +44-702-402-5790 Address: 30 North Gould Street, Sheridan, WY 82801, USA Website:https://www.expertmarketresearch.com

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*We at Expert Market Research always thrive to give you the latest information. The numbers in the article are only indicative and may be different from the actual report.

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Global Stem Cell Banking Market To Be Driven At A CAGR Of 13.5% In The Forecast Period Of 2021-2026 This Is Ardee - This Is Ardee

How effective is stem cell therapy for liver cirrhosis? – Times of India

By Stem Cell Treatment

Lifestyle diseases are gradually moving up the ranks causing deaths globally. Liver diseases appear to be one such condition, with a significantly increased number of patients being diagnosed each year. According to the WHO data published in 2017, liver disease was responsible for around 2.95% of the total deaths in India, accounting for one-fifth of all cirrhosis-associated deaths globally. Earlier, infections such as hepatitis B and C were the main causes; however, alcohol consumption and obesity are now becoming bigger contributors to liver disease. We know that the liver is responsible for detoxifying alcohol and drugs, but also performs multiple other functions, including glucose supply to the brain, food digestion, producing blood during foetal development, storing nutrients, etc. We also know that the liver can regenerate, but that does not mean a fully damaged liver can grow back on its own. Therefore, it is important to pay attention to signs of liver disease and initiate treatments promptly. Liver cirrhosis Cirrhosis is a condition where scars form in the liver causing the normal liver tissue to harden, thereby preventing the effective functioning of the organ. Cirrhosis and liver cancer are the prime causes of death due to liver disease globally. Regenerative medicine researcher Dr Pradeep Mahajan shares that alcohol consumption, viral hepatitis, autoimmune diseases, non-alcoholic fatty liver disease, and several inherited metabolic disorders can cause cirrhosis. The disease process begins as inflammation (swelling) in the liver tissue followed by scar formation and ultimately liver failure. Considering that there is no cure for cirrhosis per se, symptom and lifestyle management remain the mainstay of conventional treatment. Liver transplantation is the only curative option for severe cases; however, the issue of organ shortage is a chief and ever-growing concern. How can one get treated? Dr Mahajan says: Since we know that the liver can regenerate itself, the way ahead is to diagnose the liver disease as early as possible and find ways to enhance its regenerative potential. This is where cell and growth factor-based therapy can be beneficial. Stem cells in our body are capable of differentiating into liver (and various other) cells. In addition, they are also capable of regulating the immune system, reducing inflammation, enhancing blood supply, and stimulating other cells to perform their functions more efficiently. Similarly, growth factors can be isolated from blood/platelets, which serve as nutrition for cells of the body. These can help in cirrhosis by stabilising the internal environment of the liver making it more conducive to healing and regeneration. We are simply trying to find ways to capitalise on the healing potential of the liver before issues like scarring happen. Of course, lifestyle modification will be required to enhance the outcomes, but the end goal is to prevent the need for (or at least delay) liver transplantation, which can significantly affect a patients quality of life, adds Dr Mahajan.

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How effective is stem cell therapy for liver cirrhosis? - Times of India

Kite’s CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) – Gilead Sciences

By Stem Cell Treatment

Tecartus (Brexucabtagene Autoleucel) First and Only CAR T in Europe to Receive Positive CHMP Opinion to Treat Adults 26+ with r/r ALL

If Approved, it will Address a Significant Unmet Need for a Patient Population with Limited Treatment Options

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). If approved, Tecartus will be the first and only Chimeric Antigen Receptor (CAR) T-cell therapy for this population of patients who have limited treatment options. Half of adults with ALL will relapse, and median overall survival (OS) for this group is only approximately eight months with current standard-of-care treatments.

Kites goal is clear: to bring the hope of survival to more patients with cancer around the world through cell therapy, said Christi Shaw, CEO, Kite. Todays CHMP positive opinion in adult ALL brings us a step closer to delivering on the promise that cell therapies have to transform the way cancer is treated.

Following this positive opinion, the European Commission will now review the CHMP opinion; the final decision on the Marketing Authorization is expected in the coming months.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant, creating a significant burden on a patients quality of life, said Max S. Topp, MD, professor and head of Hematology, University Hospital of Wuerzburg, Germany. If approved, patients in Europe will have a meaningful advancement in treatment. Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

Results from the ZUMA-3 international multicenter, single-arm, open-label, registrational Phase 1/2 study of adult patients (18 years old) with relapsed or refractory ALL, demonstrated that 71% of the evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) with a median follow-up of 26.8 months. In an extended data set of all patients dosed with the pivotal dose (n=78) the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for responders (patients who achieved CR or CRi). Among efficacy-evaluable patients, median duration of remission (DOR) was 18.6 months. Among the patients treated with Tecartus at the target dose (n=100), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 25% and 32% of patients, respectively, and were generally well-managed.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter (US, Canada, EU), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and allo-SCT rate were assessed as secondary endpoints.

About Acute Lymphoblastic Leukemia

ALL is an aggressive type of blood cancer that develops when abnormal white blood cells accumulate in the bone marrow until there isnt any room left for blood cells to form. In some cases, these abnormal cells invade healthy organs and can also involve the lymph nodes, spleen, liver, central nervous system and other organs. The most common form is B cell precursor ALL. Globally, approximately 64,000 people are diagnosed with ALL each year, including around 3,300 people in Europe.

About Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. In ZUMA-2, CRS occurred in 91% (75/82) of patients receiving Tecartus, including Grade 3 CRS in 18% of patients. Among the patients who died after receiving Tecartus, one had a fatal CRS event. The median time to onset of CRS was three days (range: 1 to 13 days) and the median duration of CRS was ten days (range: 1 to 50 days). Among patients with CRS, the key manifestations (>10%) were similar in MCL and ALL and included fever (93%), hypotension (62%), tachycardia (59%), chills (32%), hypoxia (31%), headache (21%), fatigue (20%), and nausea (13%). Serious events associated with CRS included hypotension, fever, hypoxia, tachycardia, and dyspnea.

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 81% (66/82) of patients with MCL, including Grade 3 in 37% of patients. The median time to onset for neurologic events was six days (range: 1 to 32 days) with a median duration of 21 days (range: 2 to 454 days) in patients with MCL. Neurologic events occurred in 87% (68/78) of patients with ALL, including Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS.

The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus.

Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of febrile neutropenia (11 (14%)) plus the concurrent events of fever and neutropenia (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion.

Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus.

Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.

Adverse Reactions: The most common non-laboratory adverse reactions ( 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions ( 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Tecartus; the risk that physicians may not see the benefits of prescribing Tecartus for the treatment of blood cancers; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Tecartus including BOXED WARNING, is available at http://www.kitepharma.com and http://www.gilead.com .

Kite, the Kite logo, Tecartus and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies .

View source version on businesswire.com: https://www.businesswire.com/news/home/20220722005258/en/

Jacquie Ross, Investors investor_relations@gilead.com

Anna Padula, Media apadula@kitepharma.com

Source: Gilead Sciences, Inc.

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Kite's CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) - Gilead Sciences

Stem cells: Could we gain the power to induce cell regeneration? Dr Catherine Berry – The Scotsman

By Stem Cell Treatment

In short, stem cells initiate the production of new tissue cells, which can then replace their diseased counterparts.

Mesenchymal stem cells (MSCs) are adult stem cells found in many areas of the body such as bone marrow. The unique thing about these cells is their compatibility with a range of tissues such as bone, cartilage, muscle, or fat. MSCs respond to injury or disease by migrating to these damaged areas, where they restore tissue function by replacing the damaged cells.

It has recently been shown that the success of MSCs relies on their ability to release cell signals their mechanism to initiate tissue regeneration. These signals are packaged into extracellular vehicles (EVs) which are essentially bubbles of information. These are released by MSCs and taken up by the injured or diseased tissue cells to kickstart their inbuilt process of regeneration.

Through funding from the Royal Society of Edinburgh, research has started into the development of artificial EVs as a viable alternative to cell therapy. These EVs will contain the key molecules released by stem cells when they are responding to injury cues in the body.

The power to induce tissue regeneration would provide a significant new tool in biomedical treatment, such as incorporating EVs into synthetic hydrogels within a wound dressing to encourage and accelerate healing.

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Within the lab setting, we have been able to manipulate stem cell cultures to produce EVs with different signal make-ups, and accurately identify their properties.

Controlling and identifying the different make-ups contained in EV signals which in turn induce different cell responses is crucial if we want to operationalise their use in medicine.

We now aim to synthesise artificial vesicles, or bubbles, for different clinical problems, such as, for example, bubbles with potent wound-healing properties that would help our ability to use new artificial stem cell therapy.

The research is underway and it is showing promise that we may be able to harness the regenerative power of stem cells in the near future.

An artificial EV-based approach also has several advantages over stem cell-based therapies, such as having increased potency and greater consistency in treatment, and at a lower cost to carry out.

Both inside and on the surface of the body, we would have the ability to induce a process vital to medical treatment we work with every day and, in turn, open a whole new avenue of possibilities in biomedical science.

Dr Catherine Berry is a reader in the Centre for the Cellular Microenvironment at the University of Glasgow, and a recipient of the Royal Society of Edinburghs personal research fellowship in 2021. This article expresses her own views. The RSE is Scotland's national academy, bringing great minds together to contribute to the social, cultural and economic well-being of Scotland. Find out more at rse.org.uk and @RoyalSocEd.

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Stem cells: Could we gain the power to induce cell regeneration? Dr Catherine Berry - The Scotsman

S’porean doctor, a sought-after top expert in cell therapy, appointed to WHO expert panel – The Straits Times

By Stem Cell Treatment

SINGAPORE - A Singaporean doctorwho is one of the top cell therapy experts in the worldhas been appointed to a World Health Organisation (WHO) expert panel.

Dr Mickey Koh is so sought-after in his field that for the past 15 years, he has been holding two jobs in two different countries.

The 56-year-old shuttles between England and Singapore, spending six weeks at a time in London, where he oversees the haematology department and looks after bone marrow transplant patients at St George's University Hospital, before returning to Singapore for a week and a half to head the cell therapy programme at the Health Sciences Authority.

Cell therapy is a growing field of medicine that uses living cells as treatment for a variety of diseases and conditions. This is an increasingly important therapeutic area and both his employers have agreed to his unusual schedule.

Over in London, Dr Koh is head of the Haematology Department at St George's Hospital and Medical School. In Singapore, he is the programme and medical director of the cell and gene therapy facility at the Health Sciences Authority.

In May, Dr Koh was selected to be on the WHO Expert Advisory Panel on Biological Standardisation.

Individuals on the panel have to be invited by WHO to apply, and are well recognised in their respective scientific fields. Eminent names on the panel include the current president of the Paul-Ehrlich-Institut in Germany, which is the country's federal agency, medical regulatory body and research institution for vaccines and biomedicine.

The WHO panel, which is made up of about 25 members, provides detailed recommendations and guidelines for the manufacturing, licensing and standardisation of biological products, which include blood, monoclonal antibodies, vaccines and, increasingly, cell-based therapeutics.

The recommendations and advice are passed on to the executive board of the World Health Assembly, which is the decision-making body of WHO.

Dr Koh's role had to be endorsed by the British government and was a direct appointment by the director-general of WHO.

His appointment as a panel expert will last for a term of four years.

Speaking to The Straits Times, Dr Koh shared his thoughts about the importance of regulation: "We are well aware that there is a very lucrative worldwide market peddling unproven stem cell treatments, where side effects are often unknown, and such unregulated practice can result in serious harm.

"This is already happening. People are claiming that you can use stem cells to treat things like ageing, and even very serious conditions like strokes, without any evidence."

With many medications now taking the form of biologics - a drug product derived from biological sources such as cells - the next wave of treatment would be the utilisation of these cells for the treatment of a wide range of diseases, Dr Koh said.

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S'porean doctor, a sought-after top expert in cell therapy, appointed to WHO expert panel - The Straits Times

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