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From asthma to cancer to infertility, the new treatments, jabs and meds making us healthier… – The Sun

By daniellenierenberg

WHEN it comes to health, the news in recent times has been sombre.

It has been another rollercoaster year battling Covid, with the UK emerging from a third lockdown in spring.

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Millions of people have since had their jabs, and boosters are being rolled out as winter looms large.

But Covid is not the only big health story to come out of the past two years.

Behind the scenes, scientists around the world have been working on medical trials in the hope of finding cures for major illnesses.

And there have been dozens of major breakthroughs that could save billions of lives and change the way diseases are treated forever.

Just this month it emerged the vaccine for the human papillomavirus virus (HPV) could eradicate cervical cancer within the next few years.

From asthma to Alzheimers and cancer to infertility, CLARE OREILLY looks at the new treatments, vaccines and medicines that could put an end to some of the most common and deadly conditions.

CERVICAL cancer kills more than two women every day in the UK, claiming around 850 lives every year.

Yet a new study has found the disease could soon be a thing of the past.

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Kings College London scientists found the human papillomavirus (HPV) vaccine cut cases by 90 per cent.

The jab, which was first rolled out to teenage girls in the UK in 2008 then to boys in 2019, prevents HPV, which is responsible for nearly all cases of cervical cancer.

The study, in the Lancet, tracked women who received some of the first doses and found it prevented an estimated 17,200 pre-cancers and 450 cases in women in their twenties.

Cancer Research UKs chief executive Michelle Mitchell said: Its a historic moment to see the first study showing that the HPV vaccine has and will continue to protect women from cervical cancer.

A NEW antibody-based treatment developed by scientists in the UK and Germany could soon yield a vaccine to prevent Alzheimers.

The degenerative condition is thought to be caused by a type of protein that sticks to brain cells.

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The scientists were able to trigger the immune system to make antibodies, which targeted the protein before it was deposited.

Professor Mark Carr, who led a team at the University of Leicester, said: It has the real potential to provide an effective treatment for Alzheimers using a therapeutic antibody and highlights the potential of a simple vaccine.

Meanwhile, a year-long study has started in Norway where Alzheimers patients will receive a transfusion of blood taken from runners.

It is hoped the chemicals released in the blood after running have a rejuvenating effect to slow disease progression.

THREE new drugs are being put through trials in the hope they could end the misery of hot flushes for menopausal women.

Hot flushes are thought to be caused by changes in hormone levels affecting the bodys temperature control.

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But the medicines fezolinetant, elinzanetant and pavinetant can block the receptors which are responsible for the common symptom.

London GP Dr Zoe Watson says it could be years before the treatment is available on the NHS, though.

She says: It looks interesting in theory, but there are question marks over its efficacy, its side-effect profile and its cost.

Certainly if it does this well then it could be extremely useful for women whose most troubling menopausal symptom is hot flushes.

However, menopause is much more than just hot flushes and halting periods."

A BRAND new injection could reverse spinal cord injuries and allow patients to walk again just four weeks after treatment.

Developed by a team at Northwestern University in the US, the jab encourages nerves to regrow.

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It gave paralysed mice the ability to walk and human trials are expected to begin next year.

For decades, this has remained a major challenge for scientists because our bodys central nervous system, which includes the brain and spinal cord, doesnt have any significant capacity to repair itself after injury.

Professor Samuel Stupp said: Our research aims to find a therapy that can prevent individuals from becoming paralysed after major trauma or disease.

We are going straight to the FDA [the US Food and Drug Administration] to get this approved for use in patients.

DEMENTIA affects around 850,000 people in the UK and costs 26.3billion a year, but scientists at Durham University have made a breakthrough.

They are working on a treatment that could boost memory and muscle control in patients with the killer disease.

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Using infrared light to zap the brain improved the memory and thought processing in trials of healthy people.

And the next step is to enlist dementia patients to test the therapy.

Its delivered by a specially equipped helmet, which beams invisible light waves into the brain and forces cells to boost levels, improving blood flow too.

Dr Paul Chazot, who led the study, said: While more research is needed, there are promising signs that therapy involving infrared light might also be beneficial for people living with dementia and this is worth exploring.

ANYONE with asthma knows how debilitating it can be to receive a diagnosis.

Yet more than five million people in the UK are asthmatic. But a brand new drug, already approved for use on the NHS, is set to transform the lives of many with the condition, making attacks less frequent and less severe.

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Dupilumab is prescribed to treat eczema and rhinosinusitis a type of sinusitis where the nasal cavity as well as sinuses become inflamed.

Its from a family of drugs used to treat Covid.

Currently only patients with very serious asthma who have had at least four severe asthma attacks in the last year and are ineligible for other biological treatments will be considered for a prescription.

But the drug is set to change the lives of many asthma sufferers across the country.

HALF of us will get cancer at some point in our lives. But new jab Survivin could change the landscape dramatically, scientists say.

The first clinical trials are already under way, and the injection works to boost the bodys immune system. It supercharges the immune cells, helping them seek out and destroy cancerous cells while leaving healthy cells alone.

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Currently there are 36 terminally ill patients taking part in the trials, which are focused on ovarian, prostate and lung cancers.

Michelle Mitchell, chief executive of Cancer Research UK, said: Just this month we heard the HPV vaccine has likely prevented hundreds of women from developing cervical cancer.

This is a new and exciting frontier in cancer medicine and if this trial and others are successful, we could see thousands more lives saved.

AROUND seven per cent of all men are affected by infertility.

And while treatments currently focus on solutions rather than cures, scientists at the University of Georgia, in the US, are looking to reverse male infertility altogether.

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The researchers have used primate embryonic stem cells the building blocks of all cells in the body to grow sperm cells in the earlier stages of development in a petri dish.

These spermatids, which lack a head and tail for swimming, were capable of fertilising a rhesus macaque egg in vitro.

Lead researcher and associate professor Dr Charles Easley says: This is a major breakthrough towards producing stem cell-based therapies to treat male infertility in cases where the men do not produce any viable sperm cells.

It is the first step that shows this technology is potentially translatable.

GETTING through the blood/brain barrier to target treatments for brain cancer is complex.

But now a team of scientists in Toronto, Canada, have found a way to use ultrasound beams.

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They help open the barrier and can help facilitate drug delivery, which could change the way the disease is treated.

A trial this year saw four women with breast cancer that had spread to their brains treated with magnetic resonance-guided focused ultrasound (MRgFUS).

It allowed the antibody therapy herceptin to pass into their brain tissue, and caused the tumours to shrink without damaging any healthy tissue.

Dr Nir Lipsman, who led the study, said: It has long been theorised that focused ultrasound can be used to enhance drug delivery, but this is the first time we have shown we can get drugs into the brain.

A DRUG taken in pill form is to be trialled to combat the deadliest form of cancer.Auceliciclib is already used to treat brain tumours.

But now scientists hope it can help fight pancreatic cancer, which is often first diagnosed when it is at a late stage.

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Professor Shudong Wang and her team at the University of South Australia are also working on new ways to detect the disease.

She said: Pancreatic cancer is extremely difficult to diagnose at an early stage because there are very few symptoms.

If it is caught early the malignant tumour can be surgically removed, but once it spreads into other organs it is lethal.

Chemotherapy and radiotherapy only buy patients a little extra time.

The team hopes the drug will be more effective and with fewer side-effects than current treatment options.

THE heroic scientists who developed the Covid vaccine did not stop there.

The team at the University of Oxford has also developed a malaria jab that will save billions of lives.

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A trial showed 77 per cent of volunteers who were vaccinated stayed malaria-free over the following 12 months.

More than 100 malaria vaccines have been developed in recent decades, but the Oxford jab is the first to have such a high success rate.

Halidou Tinto, professor of parasitology and the principal investigator on the trial, said: These are very exciting results showing unprecedented efficacy levels from a vaccine that has been well-tolerated in our trial programme.

We look forward to the upcoming phase III trial to demonstrate large-scale safety and efficacy data for a vaccine that is greatly needed.

A DRUG that repairs cancerous cells could revolutionise the way breast cancer is treated.

Patients given olaparib as part of a two-and-a-half year trial were 42 per cent less likely to see their cancer return.

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There was also a 43 per cent dEcrease in the risk of the disease spreading.

Until the breakthrough earlier this year, the drug was mainly used for late-stage cancers, but the new findings suggest it is effective as an early treatment.

Professor Andrew Tutt, professor of oncology at the Institute of Cancer Research who led the study, said: Women with early-stage breast cancer who have inherited BRCA1 or BRCA2 mutations are typically diagnosed at a younger age.

Up to now, there has been no treatment that specifically targets the unique biology of these cancers to reduce the rate of recurrence, beyond initial treatment such as surgery.

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Cell and Gene Therapy Market to reach US$ 47,095.2 Mn by end of 2028, Says Coherent Market Insights – PRNewswire

By daniellenierenberg

SEATTLE, Nov. 18, 2021 /PRNewswire/ -- According to Latest Report, The global cell and gene therapy marketis estimated to account for 47,095.2 Mn in terms of value by the end of 2028.

Genetic mutations can lead to a wide range of serious malfunctions at the cellular level, including diseases such as cancer. These treatments use "living drugs" to repair damaged tissues and replace diseased organs, and they have the potential to cure a wide variety of ailments. In addition to regenerating damaged organs, cell and gene therapy can cure cancer, and the treatment process is fast-paced, with significant progress made in recent years. For the cell and gene therapy industry to reach its full potential, early interaction with payers and regulators is crucial. This will facilitate a fast-tracked clinical trial. While embracing new platform technologies is challenging, early collaboration with other industries will ensure a faster path to market for the new therapies. In addition to this, a play-to-win attitude is critical to success in this field. The success of gene and cell therapies will depend on achieving clinical and research goals.

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Market Drivers

1. Increasing incidence of cancer and other target diseases is expected to drive growth of the global cell and gene therapy market during the forecast period

With growing incidence of cancer and target diseases such as measles and tuberculosis, the adoption of gene and cell therapy has increased. According to the World Health Organization (WHO), in 2019, around 1.4 million people died from tuberculosis worldwide with around 10 million people being diagnosed with the same. According to the same source, in 2018, around 9.6 million died due to cancer with over 300,000 new cases of cancer being diagnosed each year among children aged 0-19 years across the globe. Gene therapy uses genes to treat or prevent disease, where it allows doctors to insert a gene into a patient's cells instead of using drugs or surgery. Therefore, it has the potential to completely treat genetic disorders.

2. Growing investments in pharmaceutical R&D activities are expected to propel the global cell andgene therapy market growth over the forecast period

Key pharmaceutical companies in the market are focused on research and development activities pertaining to gene therapy. Currently, gene therapy is being widely researched for various diseases including cancer, cystic fibrosis, hemophilia, AIDS, and diabetes. For instance, in November 2021, Sio Gene Therapies reported positive interim data for gene therapy trial of Phase I/II of AXO-AAV-GM1 for the treatment of GM1 gangliosidosis, a genetic disorder that progressively destroys nerve cells in the brain and spinal cord.

Market Opportunity

1. Increasing demand for cell and gene therapies can present lucrative growth opportunities

The demand for cell and gene therapies is increasing with growing cases of genetic disorders, chronic diseases, etc. According to the Cystic Fibrosis Foundation (CFF), in the U.S., over 1,000 new cases of cystic fibrosis are diagnosed each year. Moreover, According to the WHO, the number of people with diabetes has increased from 108 million in 1980 to 422 million in 2014. According to the same source, in 2016, around 1.6 million deaths were directly caused due to diabetes. Cell and gene therapies have the potential to treat the aforementioned diseases.

2. Growing regulatory approval can provide major business opportunities

Key companies are focused on research and development activities, in order to gain regulatory approval and enhance market presence. For instance, in March 2021, Celgene Corporation, a subsidiary of Bristol Myers Squibb, received the U.S. Food and Drug Administration (FDA) approval for the first cell-based gene therapy Abecma indicated for the treatment of multiple myeloma.

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Market Trends

1. Stem cell therapy

In the recent past, stem cell therapies have gained significant importance across the healthcare sector. Stem cell therapy has the potential to treat tissue damage and have low immunogenicity. Furthermore, it can enhance the growth of new healthy skin tissues, improve collagen production, stimulate hair development after loss, and can be used in the treatment of various diseases including Parkinson's disease, Alzheimer's disease, cancer, spinal cord injury, etc.

2. North America Trends

Among regions, North America is expected to witness significant growth in the global cell and gene therapy market during the forecast period. This is owing to ongoing clinical trials combined with key companies focusing on R&D activities pertaining to cell and gene therapy. Moreover, the presence of key market players such as Thermo Fisher Scientific, Takara Bio Inc., Catalent Inc., and more are expected to boost the regional market growth in the near future.

Competitive Section

Major companies operating in the global cell and gene therapy market are Thermo Fisher Scientific, Merck KGaA, Lonza, Takara Bio Inc., Catalent Inc., F. Hoffmann-La Roche Ltd, Samsung Biologics, Wuxi Advanced Therapies, Boehringer Ingelheim, Novartis AG, and Miltenyi Biotec.

For instance, in July 2021, Minova Therapeutics Inc. entered into a collaboration and license agreement with Astellas Pharma Inc. for the research, development, and commercialization of novel cell therapy programs for diseases caused by mitochondrial dysfunction.

Global cell and gene therapy Market, By Region:

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About Us:

Coherent Market Insightsis a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having sales office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 57 countries worldwide.

Contact Us:Mr. ShahSenior Client Partner Business DevelopmentCoherent Market InsightsPhone: US: +1-206-701-6702UK: +44-020-8133-4027Japan: +81-050-5539-1737India: +91-848-285-0837Email: [emailprotected] Website: https://www.coherentmarketinsights.comFollow Us:LinkedIn |Twitter

SOURCE Coherent Market Insights

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Cell and Gene Therapy Market to reach US$ 47,095.2 Mn by end of 2028, Says Coherent Market Insights - PRNewswire

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BioRestorative Therapies Enters into Letter of Intent with PRC Clinical – GlobeNewswire

By daniellenierenberg

PRC Clinical to Provide Start-up CRO Services for BRTX-100 Phase 2 Clinical Trial

MELVILLE, N.Y., Nov. 19, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company" or BioRestorative) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced that it has entered into a letter of intent with PRC Clinical, a CRO specializing in clinical trial management, with regard to PRC Clinical providing startup clinical project management activities for the Companys BRTX-100 Phase 2 clinical trial to treat chronic lumbar disc disease.

We are pleasedto announce that we have entered into a letter of intent for PRC Clinical to provide startup activities for our Phase 2 study. PRC has extensive experience and expertise in managing clinical studies in the stem cell and regenerative medicine space. They also have theexperienced and professionalnetwork of clinicians and study sites streamlining patient enrollment, site monitoring and management. Additionally, we have been working with and familiarizing ourselves with PRCs team and capabilities since 2019. We are thrilled to finally be in a position to begin the process of validating our technology through the FDA process, while keeping shareholders updated along the regulatory pathway, said Lance Alstodt, CEO of BioRestorative.

PRC Clinical has provided specialty CRO services for nearly 20 years. Their innovative approach to executing studies for biotech and pharmaceutical companies combines high-touch human elements and cutting-edge technology with extensive experience and deep therapeutic knowledge. PRC Clinical is an all inclusive CRO and has specialized expertise across regenerative medicine, CNS, ophthalmology, pulmonary and COVID-19, rare and orphan disease and more complex indications.

PRC Clinical is pleased to begin start-up CRO activities for BRTX-100. We look forward to being able to bring our stem cell experience to this trial. We are committed to supporting BioRestoratives development of BRTX-100 and its clinical application, said Curtis Head, CEO of PRC Clinical.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Email: ir@biorestorative.com

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Former England and Everton footballer Gary Stevens’ son tragically dies aged four – Mirror.co.uk

By daniellenierenberg

Jack Stevens was diagnosed with juvenile myelomonocytic leukaemia and underwent stem cell treatment but has sadly lost his battle as his father's former clubs pay tribute

The young son of former England footballer Gary Stevens has died tragically aged four.

Stevens son Jack was diagnosed with a rare form of blood cancer.

Just a year ago his family were hopeful of a recovery after Jack underwent a stem cell transplant following his diagnosis with juvenile myelomonocytic leukaemia.

The stem cells Jack received from older brother Oliver had engrafted, meaning they had entered Jacks bone marrow, enabling him to produce his own white blood cells.

The transplant procedure was brought forward after Jack responded to two rounds of preparatory chemotherapy, negating an original plan for five cycles of treatment.

He was discharged to a nearby apartment and during the week lived with mum Louise.

Stevens a brilliant right-back in Howard Kendalls magical mid-1980s Everton team and the couples other sons, Oliver and Josh, would join Jack and Louise at weekends.

This morning Everton said: "Everyone at Everton is deeply saddened to learn that Gary Stevens four-year-old son, Jack, has passed away following his courageous battle with leukaemia.

"Our thoughts are with Gary and his family at this incredibly sad time."

Image:

Stevens, 59, began his football career with Everton, representing the Toffees for six seasons and making over 200 appearances between 1982-1988.

He then transferred to Glasgow Rangers where he played a part in their treble-winning season in 1993.

After another six-year stint, he returned to Merseyside to finish his career plying his trade for Tranmere Rovers.

Stevens earned 46 caps for England during his playing days before moving into physiotherapy after his retirement.

Tranmere shared Everton's post and issued their own touching message, which read: "The thoughts of everyone at Tranmere Rovers are with Gary Stevens and his family at this sad time."

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Stem Cell Therapy for Heart Failure Reduced Major Cardiac Events and Death – Diagnostic and Interventional Cardiology

By daniellenierenberg

November 19, 2021 Stem cell therapy helped to reduce the number of heart attacks, strokes and death among people with chronic, high-risk, NYHA class II or III heart failure with reduced ejection fraction (HFrEF), especially among those who have higher levels of inflammation, yet hospitalization was not reduced, according to late-breaking research presented at the American Heart Associations Scientific Sessions 2021.

Heart failure is a condition when the heart is unable to adequately pump blood to meet the bodys need for oxygen and nutrients. In heart failure with reduced ejection fraction (HFrEF), the heart muscle enlarges and weakens, resulting in a decrease in pumping ability and fluid buildup in the bodys tissues. Inflammation plays a significant role in the progression of heart failure over time.

This study set out to examine the effects of using stem cells (mesenchymal precursor cells) injected into the heart to target inflammation and treat chronic heart failure. Researchers hypothesized that a single injection of stem cells from healthy adult donors in addition to guideline-directed medical therapy (GDMT) for heart failure would affect the number of times participants were hospitalized for heart failure events and reduce heart attacks, strokes, and/or death.

Cell therapy has the potential to change how we treat heart failure, said Emerson C. Perin, M.D., Ph.D., the studys lead author, the director of the Center for Clinical Research and medical director of the Texas Heart Institute in Houston. This study addresses the inflammatory aspects of heart failure, which go mostly untreated, despite significant pharmaceutical and device therapy development. Our findings indicate stem cell therapy may be considered for use in addition to standard guideline therapies.

The Randomized Trial of Targeted Transendocardial Delivery of Mesenchymal Precursor Cells in High-Risk Chronic Heart Failure Patients with Reduced Ejection Fraction study also called the DREAM-HF trial, is the largest stem cell therapy study to date among people with heart failure. In this multi-center, randomized, sham-controlled, double-blind trial, researchers enrolled 537 participants (average age 63, 20% female) with heart failure and reduced ejection fraction, which is when the left side of the heart, its main pumping chamber, is significantly weakened.

Heart failure was defined using the New York Heart Association (NYHA) functional classification system. This classification system places patients in one of four categories based on how much they are limited during physical activity. Class I heart failure means no limitation of physical activity, with class IV heart failure meaning an inability to have any physical activity without discomfort.

Participants were randomly divided into two groups: 261 adults received an injection of 150 million mesenchymal precursor cells, commonly known as stem cells, directly into the heart using a catheter. The remaining 276 adults received a scripted, or sham, procedure. Healthy adult donors provided the mesenchymal precursor cells.

The study participants were discharged from the hospital the day after the procedure, and researchers followed these participants for an average of 30 months. The studys focus was to examine if the stem cell treatment affected the likelihood of participants returning to the hospital for treatment of worsening heart failure. They also tracked whether participants had a heart attack or stroke, or died, and measured levels of high-sensitivity C-reactive protein (CRP), a measure in the blood indicating inflammation.

While researchers did not see a decrease in hospitalizations due to the stem cell treatment, they did notice several other significant results. The findings include:

We were impressed to learn that stem cell treatment effects were additive to current standard heart failure treatments, Perin said. For the first time, the known anti-inflammatory mechanism of action of these cells may be linked to a cause-and-effect benefit in heart failure. The stem cells acted locally in the heart, and they also helped in blood vessels throughout the body.

Perin and colleagues believe further research is needed to better understand how these stem cells may affect the course of progression of heart failure and how these therapies may be directed to the patient groups that could see the most benefits.

Limitations to the research include the selection of endpoints commonly used in heart failure studies. The studys results suggest that traditional endpoints associated with recurrent heart failure hospitalization do not fully reveal the benefits or mechanisms of these stem cells on heart attack, stroke and death in patients with chronic heart failure.

Co-authors are Barry H. Greenberg, M.D.; Kenneth M. Borow, M.D.; Timothy D. Henry II, M.D.; Farrell O. Mendelsohn, M.D.; Les R. Miller, M.D.; Elizabeth Swiggum, M.D.; Eric D. Adler, M.D.; Christopher A. James, P.A.; and Silviu Itescu, M.D. Authors disclosures are listed in the abstract.

The study was funded by Mesoblast Inc.

https://www.dicardiology.com/article/late-breaking-science-presentations-aha-2021-meeting

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Global Induced Pluripotent Stem Cell (iPSC) Market Report 2021-2028 – Increasing Demand for Body Reconstruction Procedures and Tissue Engineering -…

By daniellenierenberg

DUBLIN--(BUSINESS WIRE)--The "Induced Pluripotent Stem Cell (iPSC) Market Share, Size, Trends, Industry Analysis Report By Application (Manufacturing, Academic Research, Drug Development & Discovery, Toxicity Screening, Regenerative Medicine); By Derived Cell; By Region, Segment & Forecast, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.

The global Induced Pluripotent Stem Cell (iPSC) market size is expected to reach $2,893.3 million by 2028

The ability to model human diseases in vitro as well as high-throughput screening has greatly propelled market growth. Companies have effectively overcome market hurdles faced in the recent past such as proper culturing and differentiation of derived cells at a commercial scale and have developed state-of-the-art manufacturing processes that can achieve scalability and can achieve stringent quality parameters. Such trends are propelling the overall industry growth.

Companies have also developed advanced platforms for Induced pluripotent stem cells that guarantee close connection with a host of in-house technologies that are useful in the proper definition of disease signatures as well as relationships between genetic mutations as well as that properly describe perturbation of specific molecular pathways. This has resulted in the creation of human translational models that are aiding better target identification of diseases that have high unmet medical needs.

Many companies have developed transfection kits, reprogramming vectors, differentiation media, live staining kits, immunocytochemistry, among others to aid the smooth workflow of iPSC production.

However, it has been observed in the recent past that the demand for cells for screening and other purposes is significant and that there are significant challenges that pose a significant hurdle in large-scale iPSC production and differentiation.

Heavy investment in R&D activities pertaining to the development and optimization of iPSC reprogramming process in order to achieve sufficient production is a key industry trend. In the recent past, companies focused more on hepatic, cardiac, pancreatic cells, among others.

However, with the advent of a number of new participants as well as advancements and breakthroughs achieved, it is anticipated that the application portfolio will further increase in the near future.

Industry participants operating in the industry are:

Key Topics Covered:

1. Introduction

2. Executive Summary

3. Research Methodology

4. iPSC Market Insights

4.1. iPSC - Industry Snapshot

4.2. iPSC Market Dynamics

4.2.1. Drivers and Opportunities

4.2.1.1. Increasing demand for body reconstruction procedures and tissue engineering

4.2.1.2. Rising Investments across the globe

4.2.2. Restraints and Challenges

4.2.2.1. Scalability Issues

4.3. Porter's Five Forces Analysis

4.4. PESTLE Analysis

4.5. iPSC Market Industry trends

4.6. COVID-19 Impact Analysis

5. Global iPSC Market, by Derived Cell

5.1. Key Findings

5.2. Introduction

5.3. Hepatocytes

5.4. Fibroblasts

5.5. Amniotic Cells

5.6. Cardiomyocytes

6. Global iPSC Market, by Application

6.1. Key Findings

6.2. Introduction

6.2.1. Global iPSC Market, by Application, 2017 - 2028 (USD Million)

6.3. Manufacturing

6.4. Academic Research

6.5. Drug Development & Discovery

6.6. Toxicity Screening

6.7. Regenerative Medicine

7. Global iPSC Market, by Geography

7.1. Key findings

7.2. Introduction

7.2.1. iPSC Market Assessment, By Geography, 2017 - 2028 (USD Million)

8. Competitive Landscape

8.1. Expansion and Acquisition Analysis

8.1.1. Expansion

8.1.2. Acquisitions

8.2. Partnerships/Collaborations/Agreements/Exhibitions

9. Company Profiles

9.1. Company Overview

9.2. Financial Performance

9.3. Product Benchmarking

9.4. Recent Development

For more information about this report visit https://www.researchandmarkets.com/r/ykewbe

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FDA Approves Merck’s KEYTRUDA (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery – Business…

By daniellenierenberg

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo. Median DFS has not been reached for either group.

Despite decades of research, limited adjuvant treatment options have been available for earlier-stage renal cell carcinoma patients who are often at risk for recurrence. In KEYNOTE-564, pembrolizumab reduced the risk of disease recurrence or death by 32%, providing a promising new treatment option for certain patients at intermediate-high or high risk of recurrence, said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School. With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

KEYTRUDA is foundational for the treatment of patients with certain advanced cancers, and this approval marks the fourth indication for KEYTRUDA in earlier stages of cancer, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. KEYTRUDA is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma. This milestone is a testament to our commitment to help more people living with cancer.

In RCC, Merck has a broad clinical development program exploring KEYTRUDA, as monotherapy or in combination, as well as other investigational products across multiple settings and stages of RCC, including adjuvant and advanced or metastatic disease.

Data Supporting the Approval

KEYTRUDA demonstrated a statistically significant improvement in DFS in patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared with placebo (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010). The trial will continue to assess overall survival (OS) as a secondary outcome measure.

In KEYNOTE-564, the median duration of exposure to KEYTRUDA was 11.1 months (range, 1 day to 14.3 months). Serious adverse reactions occurred in 20% of these patients receiving KEYTRUDA. Serious adverse reactions (1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% of those treated with KEYTRUDA, including one case of pneumonia. Adverse reactions leading to discontinuation occurred in 21% of patients receiving KEYTRUDA; the most common (1%) were increased alanine aminotransferase (1.6%), colitis and adrenal insufficiency (1% each). The most common adverse reactions (all grades 20%) in the KEYTRUDA arm were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%) and hypothyroidism (21%).

About KEYNOTE-564

KEYNOTE-564 (ClinicalTrials.gov, NCT03142334) is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating KEYTRUDA as adjuvant therapy for RCC in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of disease (NED). Patients must have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion[s] in M1 NED participants) with negative surgical margins for at least four weeks prior to the time of screening. Patients were excluded from the trial if they had received prior systemic therapy for advanced RCC. Patients with active autoimmune disease or a medical condition that required immunosuppression were also ineligible. The major efficacy outcome measure was investigator-assessed DFS, defined as time to recurrence, metastasis or death. An additional outcome measure was OS. Patients were randomized (1:1) to receive KEYTRUDA 200 mg administered intravenously every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity.

About Renal Cell Carcinoma (RCC)

Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCCs. Renal cell carcinoma is about twice as common in men than in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In the U.S., it is estimated there will be more than 76,000 new cases of kidney cancer diagnosed and almost 14,000 deaths from the disease in 2021.

About Mercks Early-Stage Cancer Clinical Program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS 1)] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

Non-muscle Invasive Bladder Cancer

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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FDA Approves Merck's KEYTRUDA (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery - Business...

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Stem cell therapy for diabetes – PubMed Central (PMC)

By daniellenierenberg

Stem cell therapy holds immense promise for the treatment of patients with diabetes mellitus. Research on the ability of human embryonic stem cells to differentiate into islet cells has defined the developmental stages and transcription factors involved in this process. However, the clinical applications of human embryonic stem cells are limited by ethical concerns, as well as the potential for teratoma formation. As a consequence, alternative forms of stem cell therapies, such as induced pluripotent stem cells, umbilical cord stem cells and bone marrow-derived mesenchymal stem cells, have become an area of intense study. Recent advances in stem cell therapy may turn this into a realistic treatment for diabetes in the near future.

Keywords: Embryonic stem cell, induced pluripotent stem cell, mesenchymal stem cell, diabetes

This lecture is based on a recent review.[1]

The increasing burden of diabetes worldwide is well-known, and the effects on health care costs and in human suffering, morbidity, and mortality will be primarily felt in the developing nations including India, China, and countries in Africa. New drugs are being developed at a rapid pace, and the last few years have seen several new classes of compounds for the treatment of diabetes e.g. glucagon-like peptide (GLP-1) mimetics, dipeptidyl-peptidase-4 (DPP-4) inhibitors, sodium glucose transporter-2 (SGLT2) inhibitors. New surgical treatments have also become increasingly available and advocated as effective therapies for diabetes. Gastric restriction surgery, gastric bypass surgery, simultaneous pancreas-kidney transplantation, pancreatic and islet transplantation have all been introduced in recent years. To avoid the trauma of a major operation, there have been many studies on the transplantation of isolated islets removed from a cadaveric pancreas. There was encouragement from the Edmonton protocol described by Shapiro and colleagues in the New England Journal in 2000. The islets were injected into the portal vein and patients, especially those suffering from dangerous, hypoglycemic unawareness, were treated before they had developed severe complications of diabetes, especially renal complications. While the early results were promising, with some 70% of the patients requiring no insulin injections after two years, at five years, most of these patients had deteriorated and required insulin supplements, despite some having received more than one transplant of islets. In the more recent series of patients, the Edmonton group has reported better long-term results with the use of the monoclonal anti-lymphocyte antibody, Campath 1H given as an induction agent, 45% of patients being insulin-independent at five years, and 75% had detectable C-peptide.

However, cadavaric pancreata and islets compete for the same source and are limited in number, and so, neither treatment could readily be offered to the vast majority of diabetic patients. Some have attempted to use an alternative source, for example, encapsulated islets from neonatal or adult pigs. This is still very experimental and will be a far away alternative with many technical and possibly ethical obstacles to overcome.

More recently, with the successes in the development of pluripotent adult stem cells (from Yamanaka, awarded the 2012 Nobel prize for medicine for developing induced pluripotent stem cells iPSCs), new approaches to seek a methods that may be more accessible and available have been attempted. Much hope was derived initially from embryonic stem cell (ESC) research, since these cells can be persuaded to multiply and develop into any tissue, but the process was expensive, and the problem of teratoma formation from these stem cells proved extremely difficult to overcome. Many of the important factors related to fetal development are not understood and cannot be reproduced. However, some progress has been made, and (occasionally) cells been persuaded to secrete insulin, but so far, there have been very minimal therapeutic application.

Scientists are now aware that to persuade a cell to produce insulin is only one step in what may be a long and difficult journey. Islets cells are highly specialized to have not only a basal release of insulin but also to respond rapidly to changes in blood glucose concentration. With insulin, the process and regulation of switching off secretion is as important as the switching on secretion.

A variety of approaches has been made with different starting points. The stem cell reproduces itself and can then also divide asymmetrically and form another cell type: This is known as differentiation. Although initially they were thought to be available only from embryos, non-embryonic stem cells can now be obtained without too much difficulty from neonatal tissue, umbilical cord, and also from a variety of adult tissues including bone marrow, skin, and fat. These stem cells can be expanded and made to differentiate, but their repertoire is restricted compared with embryonic stem cells: oligo- or pluri- as opposed to toti-potent embryonic stem cells. Even more, recently, there has been much interest in the process of direct cell trans-differentiation, in which a committed and fully differentiated cell, for example a liver cell, is changed directly to another cell type, for example an islet beta-cell, without induction of de-differentiation back to a stem cell stage.

Yamanaka, in 2006, was able to produce pluripotent stem cells from mouse neonatal and adult fibroblast cultures by adding a cocktail of four defined factors.[2] This led to a series of other studies developing the process, which was shown to be repeatable with human tissue as well as laboratory mice. The use of iPS cells avoided the ethical constraints of using human embryos, but there have been other problems and obstacles still. There have been emerging reports of iPS cells becoming antigenic to an autologous or isologous host, and the cells can accumulate DNA abnormalities and even retain epigenetic memory of the cell type of origin and thus have a tendency to revert back. Like embryonic stem cells, iPS cells can form teratoma, especially if differentiation is not complete.

Despite this, there has been very little success in directing differentiation of iPSCs to form islet beta-cells in sufficient quantity that will secrete and stop secretion in response to changes in blood glucose levels.

Another approach that has been tried is to combine gene therapy with stem cells. Some progress has been made in trying to express the desired insulin gene in more primitive undifferentiated cells by coaxing stem cells with differentiation factors in vitro and then by direct gene transfection using plasmids or a viral vector. We, and others, have used a human insulin gene construct and introduced ex vivo or in vivo into cells by direct electroporation (in ex vivo cells obviously) or by viral vectors. The adenovirus, adeno-associated virus, and various retro viruses have been most studied, especially the Lentivirus. However, any type of genetic engineering raises fears not only of infection from the virus but also of the unmasking of onco-genes, leading to malignancy, and there are strict regulations how to proceed to avoid these risks.

We have been interested in umbilical cord stem cells and in mesenchymal stem cells as targets for combined stem cell and gene therapy. These cells can be obtained in a reasonably easy and reproducible manner from otherwise discarded umbilical cord, or readily accessible bone marrow, selecting out the cells using various standard techniques. Fat, amnion, and umbilical cord blood are also sources, from which mesnechymal stem cells can be derived. After a proliferative phase, the cells take up an appearance similar to a carpet of fibroblasts, which can differentiate into bone, cartilage, or fat cells. Although mesenchymal stem cells from the various sources mentioned may look similar, their differentiation potentials are idiosyncratic and differ, which makes it inappropriate and difficult to think of them as a uniform source of target cells. Neonatal amnion cells and umbilical cord cells have low immunogenicity and do not express HLA class II antigens. They also secrete factors that inhibit immune reactions, for example, soluble HLA-G. Although immunogenicity is reduced significantly, they are still not autologous and, therefore, there remains a risk for allograft rejection. They have the advantage that they could be multiplied, frozen, and banked in large numbers and could be used in patients already needing immunosuppressive agents, for examples those having renal transplants.

In Singapore, our studies of umbilical cord-derived amnion cells have shown some success in having expression of insulin and glucagon genes, but little or no secretion of insulin in vitro. Together with insulin gene transfection in vitro, after peritoneal transplantation into sterptozotocin-induced diabetic mice, there was some improvement in glucose levels.[3] Our colleagues in Singapore[4,5] have used another model of autologous hepatocytes from streptozotocin-induced diabetic pigs. These separated hepatocytes were successfully transfected ex-vivo with a human insulin gene construct by electrophoration, and then the cells were injected directly back into the liver parenchyma using multiple separate injections. The pigs were cured of their diabetes for up to nine months - which is a remarkable achievement. As these were autotransplantations, no immunosuppressive drugs were necessary, but the liver cells were obtained from large open surgical biopsies. This necessity of surgical removal of liver tissue would limit its applicability, but nevertheless has been a good proof of concept study. In the context of autoimmune diabetes, the risk of recurrent disease may well persist unless the target of autoimmune attack could be defined and eliminated. In these porcine experiments, the human insulin gene with a glucose sensing promoter EGR-1 was used. There was no virus involved, and the plasmid does not integrate. Division of the transfected cell would dilute gene activity, but large numbers of plasmid can be produced cheaply. The same group of workers successfully transfected bone marrow mesenchymal stem cells with the human insulin gene plasmid using the same EGR-1 promoter and electrophoration. This cured diabetic mice after direct intra-hepatic and intra-peritoneal injection.

Finally, there should be caution in interpreting the results of these and other reports of cell and gene therapy for diabetes. In gene transfection and/or transplantation of insulin-producing cells or clusters in the diabetic rodent, there have been many reports in the literature, but only a few of these claims have been reproduced in independent laboratories. We have suggested the need to satisfy The Seven Pillars of Credibility as essential criteria in the evaluation of claims of success in the use of stem cell and/or gene therapy for diabetes.[1]

Cure of hyperglycemia

Response to glucose tolerance test

Evidence of appropriate C-peptide secretion

Weight gain

Prompt return of diabetes when the transfecting gene and/or insulin producing cells are removed

No islet regeneration of stereptozotocin-treated animals and no re-generation of pancreas in pancreatectomized animals

Presence of insulin storage granules in the treated cells

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How The Overlap Between Artificial Intelligence And Stem Cell Research Is Producing Exciting Results – Forbes

By daniellenierenberg

Passage Of California Stem Cell Proposition Boosts Research

For the last decade and more, Stem Cell research and regenerative medicine have been the rave of the healthcare industry, a delicate area that has seen steady advancements over the last few years.

The promise of regenerative medicine is simple but profound that one day medical experts will be able to diagnose a problem, remove some of our body cells called stem cells and use them to grow a cure for our ailment. Using our body cells will create a highly personalized therapy attuned to our genes and systems.

The terminologies often used in this field of medicine can get a bit fuzzy for the uninitiated, so in this article, I have relied heavily on the insights of Christian Drapeau, a neurophysiologist and stem cell expert.

Drapeau was one of the first voices who discovered and began to speak about stem cells being the bodys repair system in the early 2000s. Since then, he has gone on to discover the first stem cell mobilizer, and his studies and research delivered the proof of concept that the AFA (Aphanizomenon flos-aquae) extract was capable of enhancing repair from muscle injury.

Christian Drapeau is also the founder of Kalyagen, astem cell research-based company, and the manufacturers of Stemregen. This stem cell mobilizer combines some of the most effective stem cell mobilizers Drapeau has discovered to create an effective treatment for varying diseases.

How exactly do stem cell-based treatments work? And how is it delivering on its promise of boosting our abilities to regenerate or self-heal?

Drapeau explains the concept for us;

Stem cells are mother cells or blank cells produced by the bone marrow. As they are released from the bone marrow stem cells can travel to any organ and tissue of the body, where they can transform into cells of that tissue.Stem cells constitute the repair system of the body.

The discovery of this function has led scientists on a long journey to discover how to use stem cells to cure diseases, which are essentially caused by cellular loss. Diseases like Diabetes and age-related degenerative diseases are all associated with the loss of a type of cell or cellular function.

However, what Drapeaus research has unearthed over the last few decades is that there are naturally occurring substances that show a demonstrated ability to induce the release of stem cells from the bone marrow. These stem cells then enter the bloodstream, from where they can travel to sites of cell deficiency or injury in the body to aid healing and regeneration. This process is referred to as Endogenous Stem Cell Mobilization (ESCM).

Stemregen is our most potent creation so far, explains Drapeau, and it has shown excellent results with the treatment of problems in the endocrine system, muscles, kidneys, respiratory systems, and even with issues of erectile dysfunction.

Despite the stunning advancements that have been made so far, a concern that both Drapeau and I share is how this innovation can be merged with another exciting innovation; AI.

Is it even a possibility? Drapeau, an AI enthusiast, explains that AI has already been a life-saver in stem cell research and has even more potential.

On closer observation, there are a few areas in which AI has greatly benefited stem cell research and regenerative medicine.

One obstacle that scientists have consistently faced with delivering the full promise of regenerative medicine is the complexity of the available data.Cells are so different from each other that scientists can struggle with predicting what the cells will do in any given therapeutic scenario. Scientists are faced with millions of ways that medical therapy could go wrong.

Most AI experts believe that in almost any field, AI can provide a solution whenever there is a problem with data analysis and predictive analysis.

Carl Simon, a biologist at the National Institute of Standards and Technology (NIST) and Nicholas Schaub recentlytested this hypothesiswhen they applied Deep Neural Networks (DNN), an AI program to the data they had collected in their experiments on eye cells. Their research revolved around causes and solutions for age-related eye degeneration. The results were stunning; the AI made only one incorrect prediction about cell changes out of 36 predictions it was asked to make.

Their program learned how to predict cell function in different scenarios and settings from annotated images of cells. It soon could rapidly analyze images of the lab-grown eye tissues to classify the tissues as good or bad. This discovery has raised optimism in the stem cell research space.

Drapeau explains why this is so exciting;

When we talk about stem cells in general, we say stem cells as if they were all one thing, but there are many different types of stem cells.For example, hair follicle and dental pulp stem cells contain neuronal markers and can easily transform into neurons to repair the brain. Furthermore, the tissue undergoing repair must signal to attract stem cells and must secrete compounds to stimulate stem cell function. A complex analysis of the tissue that needs repair and the conditions of that tissue using AI, in any specific individual, will help select the right type of stem cells and the best cells in that stem cell population, along with the accompanying treatment to optimize stem cell-based tissue repair.

Christian Drapeau

Ina study published in Februaryof this year inStem Cells, researchers from Tokyo Medical and Dental University (TMDU) reported that their AI system, called DeepACT, had successfully identified healthy, productive skin stem cells with the same accuracy that a human could. This discovery further strengthens Drapeaus argument on the potentials of AI in this field.

This experiment owes its success to AIs machine learning capabilities, but it is expected that Deep Learning can be beneficially introduced into regenerative medicine.There are many futuristic projections for these possibilities, but many of them are not as far-fetched as they may first seem.

Researchers believe that AI can help fast-track the translation of regenerative medicine into clinical practice; the technology can be used to predict cell behavior in different environments. Therefore, hypothetically, it can be used to simulate the human environment. This means that researchers can gain in-depth information more rapidly.

Perhaps the most daring expectation is the possibility of using AI to pioneer the 3D printing of organs. In a world where organ shortage is a harsh reality, this would certainly come in handy. AI algorithms can be utilized to identify the best materials for artificial organs, understand the anatomic challenges during treatment, and design the organ.

Can stem cells actually be used along with other biological materials to grow functional 3D-printed organs? If this is possible, then pacemakers will soon give way to 3D-printed hearts. A 3D-printedheart valvehas already become a reality in India, making this even more of an imminent possibility.

While all of these possibilities excite Drapeau, he is confident that AIs capabilities with data analysis and prediction, which is already largely in use, would go down as its most beneficial contribution to stem cell research;

It was already shown that stem cells laid on the connective tissue of the heart, the soft skeleton of the heart, can lead the entire formation of a new heart. Stem cells have this enormous regenerative potential. AI can take this to another level by helping establish the conditions in which this type of regeneration can be orchestrated inside the body.But we have to be grateful for what we already have, over the last 20 years, I have studied endogenous stem cell mobilization and today the fact that we have such amazing results with Stemregen is testament that regenerative medicine is already a success.

As AI continues to scale over industry boundaries, we can only sit back and hope it delivers on its full potential promise. Who knows? Perhaps AI really can change the world.

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Dr Pengyi Yang wins National Stem Cell Foundation Metcalf Prize – News – The University of Sydney

By daniellenierenberg

Dr Pengyi Yang uses computational expertise to build virtual cells.

DrPengyiYanghasreceived one of two annual $55,000 Metcalf Prizes from the National Stem Cell Foundation of Australia inrecognition of his leadership in the field.

DrYangholds a joint position with the University of SydneySchool of Mathematics & Statistics, theCharles Perkins Centreand theChildren's MedicalResearch Institute. His work aims toremove much of the guesswork from stemcell science and eventually stemcell medicine.

Todays stem cell treatmentshave beenthe product of trial anderror, DrYang said.

My virtual stem cell will allow us to understand whats happening inside a single stem cell that makes it decide what type of cell it will becomesuch as, but not limited to,hair, skin, muscle, nerveorbloodcells.

He is mapping the many, complex influencescontrollingstem cells andthe waythey specialise into different cell types.

Stem cells are amazing because they can produce any kind of cell in the body. Theyre fundamental toregenerative medicine,DrYang said.

But, when theircontrols fail,rogue stem cells can lead to cancer.

Allhumanlifestartsas a single stem cell. It goes on to produce cells that eventually become every type of tissue and organ of the human body. Even in adulthood, stem cellsrepairandreplacetissue all the time.

People are excited about the potential of stem cell medicine, but thereality is extremely complicated. Thousands of genes, complex gene networks, environmental factors, and an individuals own health are all involved in pushing stem cells to become specific cell types,DrYang said.

DrYang, a computerscientist turned stem cell researcher, uses computational science and statistics to understand how stem cells function at a fundamental level work that will be useful forthe entire stem cell field ofresearch.

We need a computermodel to bring all of these influences togetherso we can identify the specific gene networks that drive the stem cells towards each cell type,he said.

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SC21- 21st century cellular medicines specialists – The Thaiger

By daniellenierenberg

Sponsored Article

Although stem cells are known to work wonders, there is still a lot of misunderstanding about what they are, what they do, and how they work.

The good news is that StemCells21 can clear everything up for you. SC21 produces all of its cellular medications in-house, and all of its treatments are performed at its cutting-edge medical centre in Bangkok. Its a one-stop shop that adheres to high-quality standards.

This company will be on display at the Thailand International Boat Show, which will be hosted at Royal Phuket Marina from January 6 to 9 next year. Staff from StemCells21 will be on hand to walk you through the producers, pricing, and techniques.

StemCells21s laboratory is a full-scale culture & analysis laboratory specialising in the production & treatment of Mesenchymal Stem Cells (StemCells21), and Natural Killer Cells (ImmuneCells21). It has also launched a new generation of regenerative medicine called Pluripotent Stem Cells (iPSC21), which hold great potential for impacting chronic diseases in the quest for anti-ageing.

The lab has seven scientists & stem cell researchers, a couple of who have worked with Professor Shinya Yamanaka, who was awarded the Nobel Prize in Physiology or Medicine in 2012 for the discovery that mature cells can be reprogrammed to become pluripotent (iPS cells).

Photo Via: Stemcells 21

Before StemCells21 was created, Managing Director Paul Collier and co-founder Sergei Dmitrievs experienced the power of stem cells either first hand or through the treatment of someone close to them. They knew that stem cells could deliver positive health results, and also knew stem cell treatmentsand the clinics that administered themhad room for improvement.

After deep laboratory investigation, they came to see that most clinics utilised relatively low-quality stem cells and incomplete treatments. While these clinics could deliver a certain level of positive results, they were only scratching the surface of the promise that stem cell treatments could deliver.

Furthermore, the clinics themselves frequently provided a less-than-ideal patient experience. Clinics were generally hectic, unprofessional, and unwelcoming. Patients were often administered a single treatment and sent on their way, unsure if they had experienced an efficacious treatment or if they had travelled and paid for nothing.

StemCells21 was created to offer superior results and give you a welcoming experience. It was set up to provide the global community with access to treatments that few people are aware of, and to offer health benefits that are superior to what most people ever imagined were possible.

The SC21 complex in Bangkok houses the StemCells21, ImmuneCells21, and IPS21 laboratories, as well as the premium 5* IntelliHealth+ (IH+) Clinic.

IntelliHealth+ is a state-of-the-art medical centre licensed by the Thai medical authorities. The luxurious design, efficient workflow layouts, and modern treatments make it the ideal choice for customers seeking a premium level of healthcare in 5* settings.

The centre treats patients from all over the world and has staff who speak fluent English, Arabic, Chinese, Russian, Thai and Spanish.

Furthermore, SC21s come from all corners of the globe for these cutting edge treatments. Many VIPs travel to the clinic including presidents, prime ministers, sports stars, football managers, bank owners and heads of major corporations, many of whom return every six to twelve months and have been doing so for years.

Recently, SC21 treated a ten-year-old British boy who had Ewing sarcoma develop in his arm, which then spread to other areas. He had tried every treatment option in the UK. His trip and treatment were sponsored by UK football teams and the public. Since he started treatment hes put on weight, hes vibrant, and his demeanour has totally changed. Various tests and scans have shown he is responding very well to the immunotherapy course and will perform another round in a few months time.

SC21 focuses on three main areas: anti-ageing and longevity; orthopaedic and muscular-skeletal issues (knee, hip, back & shoulder); and chronic diseases (diabetes, liver cirrhosis, lung, respiratory, hearing & vision disorders). Aside from that, the clinic can also help with chronic fatigue and burn-out syndrome.

Outpatient services for anti-ageing, immunotherapy and regenerative medicine are available at the centre. The anti-ageing clinic has a cutting-edge approach to skin rejuvenation, dermatology, detoxification, and wellbeing. A youthful appearance, more energy, improved mental capacity and mobility, reduced aches and pains, and a stronger immune system are among the benefits.

Photo Via: Stemcells 21

The high level of traditional medicine and the unique protocols designed by the IH+ teams give patients real therapeutic benefits and longevity.

According to Paul Collier, a client typically receives two sessions of stem cell injections during a treatment intravenous for systemic and local to the target and is required to stay in Bangkok for two days following their procedure to monitor any complications that may arise. Then theyre given a two-month take-home kit that comprises self-administered injections (similar to insulin) that target specific growth factors in organs or tissues that need to be repaired. These can also be taken orally, but they are less effective.

He goes on to say that stem cells are the foundation of the human body. They split over and over to produce humans from an embryo at the start of our lives. They restore cells in your blood, bone, skin, and organs throughout your life to keep you alive and functioning. Stem cells have two distinct properties that distinguish them from other types of cells in our bodies.

First, they can self-renew (mitosis), which is a stage of the cell cycle in which replicated chromosomes are divided into two new nuclei. As a result, identical duplicated cells are produced.

Secondly, they have the ability to differentiate into specialized cells such as cartilage, heart cells, liver cells, and neurons. No other cell in the body has the natural ability to generate new cell types.

Mesenchymal Stem Cells (MSCs) are at the core of StemCells21s regenerative programs. They are multipotent stem cells derived from various adult and fetal tissues. A large number of studies have shown the beneficial effects of MSC-based therapies to treat different pathologies, including neurological disorders, cardiac ischemia, diabetes, and bone and cartilage diseases.

StemCells21 also has arthritis treatment, which reduces inflammation & joint pain, increases cartilage growth, improves mobility & joint stability and lessens dependence on medication. The clinics degenerative spine treatments help discs regenerate and stabilize the spine.

On top of that, it provides lung & liver disease treatment as well as treatments for autism, cerebral palsy, diabetes, motor neuron disease, multiple sclerosis and immune disorders.

Theres even eye treatment, which reduces blurred vision & field of vision defects, improves night vision & enhances colour texture.

Photo Via: Stemcells 21

SC21 can even help with certain types of cancer by taking a clients blood and growing their natural killer cells (immunotherapy) over a 21-day period. Through various stimuli, their cytotoxicity is increased which kills cancer and virally-affected cells.

Paul says stem cell therapy should be looked at before undergoing any kind of invasive surgery. The type of medicine should certainly be an intervention before surgery. If you are looking at knee replacement, why not consider an injection of a biologic that would only take a couple of days and has the potential to remodel the cartilage, because once you perform surgery there is no going back.

SC21 also produces a wide range of stem-cell extract-based cosmetics and nutritional supplements, which are available at their medical centres and online under the brand SC21 Biotech.

The Thailand International Boat Show will feature Paul Collier and his team. Theyll be able to answer any of your questions about the cost, procedure, and treatment. On top of that, they will also assist you in educating yourself and managing your expectations so that you do not expect more than stem cell therapy can provide. If you want to get treatment, they will also provide you with a complete report on all treatments. SC21 is fully compliant with international regulations and guidelines.

http://www.stemcells21.com http://www.intellihealthplus.com

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What Are New Medical Solutions That Can Help Treat Patients? – iLounge

By daniellenierenberg

The biomedical field is constantly working to make new medical solutions that can help treat patients with various illnesses and conditions. Today, there are numerous medical solutions used today to help ease medical treatment for patients. These solutions include new medical devices, implants, software used to run medical equipment, and information technology systems.

The following are some of the most popular medical technologies that are used today:

Information technologies are another type of technology used today in medicine. For example, imaging systems let doctors examine patients like never before by allowing them to see inside a persons body without performing surgery first. One famous example of this type of medical solution is 3-D imaging software that uses pictures taken with an X-ray machine to give doctors a model to track health changes over time. Another example includes using information technology systems to control medical equipment or devices through smartphone computer programming or apps.

This type of technology allows doctors to use medical equipment with greater accuracy and helps make their work easier. For example, different types of imaging software help provide more transparent images for radiologists when they read X-rays and MRIs. This helps with making a diagnosis quicker. Thats why most hospitals would prefer to work with Wound Care, a web-based EHR tool. Such tools help record patient vitals and wound assessments to track each patients progress and provide better treatment.

These products can be used as medical solutions for people who want to check their health but dont want to visit a doctors office. Wearable health technologies include everything from smartwatches that measure heart rate and blood pressure functions to fitness trackers that help wearers monitor daily activity levels. Even Google has made its smart contact lenses that can track glucose levels for people with diabetes. However, these devices are designed specifically for individuals suffering from chronic diseases such as arthritis or Parkinsons disease in many cases.

Synthetic biology and genetic engineering tools are a technology used to treat illnesses or conditions that affect organs in the body. For example, if a patient has heart disease, they may need a new heart valve. In this case, doctors can use synthetic biology and genetic engineering tools to create a different kind of heart valve from those typically made from cow tissue. These valves have been tested on animals, and now researchers are testing them on humans as well.

Laboratory-grown organs are another medical solution used to help treat patients who need transplants for certain diseases or conditions that may have caused organ failure. A typical example is how stem cells taken from bone marrow can be turned into blood cells and then used to help treat patients with leukemia. Other types of laboratory-grown organs being tested in clinical trials today include partially functional livers and lungs grown from stem cells.

Medical equipment is another technology doctors can use when treating patients. For example, medical imaging devices like CT scanners and MRI machines help provide images of the bodys internal structures for diagnosis so doctors can see problems most other methods cannot detect. Another type of medical equipment includes surgical robots that can be moved by a computer program to perform surgery on a patient. This reduces the need for an incision since some procedures only require small openings or ones that heal very well without stitches or staples closing them up afterward.

Stem cells and stem cell therapies are a type of medical solution used to treat patients who have conditions that can be life-threatening or cause other severe complications. For example, patients with leukemia may need transplanted blood cells from healthy donors. In this case, doctors can use stem cells to develop those types of blood cells that will provide the best chance of curing the patients cancer without harming their body.

Other examples include using cord blood stem cells from newborns to make different kinds of healthy blood and immune system cells for older children and adults with certain diseases or using skin or other non-embryonic stem cells to make insulin-producing pancreatic beta cells for people diagnosed with diabetes Type 1.

Overall, biomedical technologies have been beneficial in making it easier for doctors to diagnose and treat their patients. Thanks to these technologies, many patients can live long, healthy lives with their illnesses or conditions under control. As technology continues advancing over time, even more, advanced solutions will come out, which should further help improve patient care. However, the use of new medical solutions must be approved by a doctor before being used on a patient.

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I Tried Know Beauty’s Bubble Oxygen Face Mask, and It Was a Fun Way to Boost Hydration – POPSUGAR

By daniellenierenberg

As POPSUGAR editors, we independently select and write about stuff we love and think you'll like too. If you buy a product we have recommended, we may receive affiliate commission, which in turn supports our work.

If Know Beauty sounds familiar, it's probably because the brand's founders are Vanessa Hudgens and Madison Beer. It's a skin-care line that examines your skin health holistically by looking at lifestyle factors and genetics. The brand wants its users to stop the haphazard trial and error and think about skin care in a smart yet simple way catering to your own needs. The product line has a gentle approach to treating skin concerns while still incorporating actives. It joins the ever-growing list of celebrity-owned beauty brands, and I was very intrigued to try it out.

Ever since I saw her sing her heart out in the premiere of High School Musical, I became an instant Hudgens fan. I can still belt out "Start of Something New." However, when she opened up about her journey with acne, it made me adore her even more. I dealt with acne as a teen and still do now. As I was scrolling through the site, the Bubbling Oxygen Mask ($22) piqued my interest, plus it was perfect for the drier months. Once I discovered that it was part of Hudgens's routine, I knew I had to test it out. Keep reading for my in-depth review.

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Scar Treatment Market: The Atrophic & Acne scars segment is projected to account for a dominant share of the market – BioSpace

By daniellenierenberg

According to a new market report published by Transparency Market Research Scar Treatment Market (By Scar Type: Atrophic & Acne Scars, Hypertrophic Scars and Keloids, Contracture Scars, Others (Stretch Marks), By treatment type (Topical Products (Creams, Gels, Silicone Sheets, Others (Sprays, Oils, etc.)), Laser Treatment (CO2 Lasers, Pulsed Dye Laser, Excimer Laser), Injectables, Others, By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) Global Industry Analysis, Size, Share, Growth, Trends & Forecast, 2019 2027. According to the report, the global scar treatment market was valued at US$ 15,805.4 Mn in 2019 and is projected to reach US$ 32,141.8 Mn by 2027, expanding at a high CAGR of 8.3% from 2019 to 2027. Increase in number of people suffering from skin problems across the world is anticipated to fuel the global scar treatment market during the forecast period.

Overview

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Increase in Incidence of Atrophic & Acne Scars and Hypertrophic Scars and Keloids to Boost Market

Topical Products Segment Dominates the Market

Request for Analysis of COVID-19 Impact on Scar Treatment Market - https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=12509

Hospital Pharmacies Segment to Expand at Fastest CAGR

North America to be Highly Lucrative Market for Scar Treatment

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Trend of Strategic Alliance with Local Companies to Strengthen Distribution Network and Expand Geographic Presence

Browse More Trending Reports by Transparency Market Research:

Stem Cells Market: A significant rise in the number of clinical application of stem cells and the advent of new treatments for chronic diseases are estimated to enhance the growth of the global stem cells market in the next few years. In addition to this, the rising investment by public as well as private organizations for research activities are likely to supplement the overall market growth in the near future.

D-dimer Testing Market: The concept of automation has extended to D-dimer testing as well, which is less labor intensive, rapid, and easy-to-use. Combination of various technologies has increased the yield and productivity. This technological revolution in D-dimer testing is expected to drive the market from 2017 to 2025.

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Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

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Scar Treatment Market: The Atrophic & Acne scars segment is projected to account for a dominant share of the market - BioSpace

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categoriaSkin Stem Cells commentoComments Off on Scar Treatment Market: The Atrophic & Acne scars segment is projected to account for a dominant share of the market – BioSpace | dataNovember 22nd, 2021
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PAOG Announces Pending Acquisition To Expand CBD IP Portfolio Scheduled For Early December

By Dr. Matthew Watson

Sandusky, OH, Nov. 19, 2021 (GLOBE NEWSWIRE) -- PAO Group, Inc. (OTC Pink: PAOG) today announced the company has finalized terms for the acquisition of a license to a patented cannabis extraction process that will expand the company’s existing CBD intellectual property.

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PAOG Announces Pending Acquisition To Expand CBD IP Portfolio Scheduled For Early December

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categoriaGlobal News Feed commentoComments Off on PAOG Announces Pending Acquisition To Expand CBD IP Portfolio Scheduled For Early December | dataNovember 22nd, 2021
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T2 Biosystems Announces Continued International Expansion into Taiwan with Exclusive Distribution Agreement

By Dr. Matthew Watson

LEXINGTON, Mass., Nov. 19, 2021 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced the execution of a territory exclusive distribution agreement in Taiwan.

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T2 Biosystems Announces Continued International Expansion into Taiwan with Exclusive Distribution Agreement

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Context Therapeutics® to Present Clinical Data on ONA-XR in Breast Cancer at 2021 San Antonio Breast Cancer Symposium

By Dr. Matthew Watson

Primary results from ONAWA (SOLTI-1802) trial of ONA-XR in early breast cancer to be presented in addition to updates from ongoing clinical trials of ONA-XR in metastatic breast cancer Primary results from ONAWA (SOLTI-1802) trial of ONA-XR in early breast cancer to be presented in addition to updates from ongoing clinical trials of ONA-XR in metastatic breast cancer

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Context Therapeutics® to Present Clinical Data on ONA-XR in Breast Cancer at 2021 San Antonio Breast Cancer Symposium

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European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

By Dr. Matthew Watson

Basel, 19 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has granted conditional marketing authorisation for Gavreto® (pralsetinib) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. Gavreto is the first and only precision medicine approved in the European Union (EU) for the first-line treatment of people with RET fusion-positive advanced NSCLC.1

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European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

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Explosive Growth Launches Kraspharma Into REMEDIUM TOP-5

By Dr. Matthew Watson

Nicosia, Cyprus, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Rafarma Pharmaceuticals, Inc. OTC:(RAFA) reports that PJSC Kraspharma at the end of 2020 entered the TOP-5 of the most dynamic and largest pharmaceutical companies in Russia for 2020, showing incredible growth rates with a net profit increase of 220.9% compared to 2019. Specifically, Kraspharma went from $5,563,056 (USD) at the end of 2019 to $17,853,905 at the end of 2020. The growth was featured in the ratings by the authoritative Russian industry publication "Remedium", published in Q3 of 2021.

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Explosive Growth Launches Kraspharma Into REMEDIUM TOP-5

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Arvinas and Pfizer Announce Updated Phase 1 Dose Escalation Data for ARV-471 to be Presented in Spotlight Poster Session at 2021 San Antonio Breast…

By Dr. Matthew Watson

NEW HAVEN, Conn. and NEW YORK, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) announced today that updated safety and efficacy data from the Phase 1 dose escalation trial of ARV-471, a novel oral estrogen receptor (ER)-targeting PROteolysis TArgeting Chimera (PROTAC®) protein degrader, will be presented in a spotlight poster-discussion session at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-10, 2021. ARV-471 is being jointly developed by Arvinas and Pfizer for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

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Arvinas and Pfizer Announce Updated Phase 1 Dose Escalation Data for ARV-471 to be Presented in Spotlight Poster Session at 2021 San Antonio Breast...

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