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Study shows COVID-19 can infect heart cellsand do serious damage in the process – Cardiovascular Business

By daniellenierenberg

A new study suggests COVID-19 has the potential to infect cardiaccells, causing changes in their ability to function after just 72 hours.

The researchers found that SARS-CoV-2, the virus behind COVID-19, was capable of infecting heart muscle cells created with stem cell technology and stored in a lab dish. They shared their findings in Cell Reports Medicine.

We not only uncovered that these stem cell-derived heart cells are susceptible to infection by novel coronavirus, but that the virus can also quickly divide within the heart muscle cells, first author Arun Sharma, PhD, a research fellow at the Cedars-Sinai Board of Governors Regenerative Medicine Institute in Los Angeles, said in a statement.

The infected heart cells changed their gene expression profile, the authors added, providing additional context about how the body attempts to combat the infection. And the stem cell-derived heart cells show potential as an effective way to identify and test new methods for treating COVID-19-related heart infections.

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Its not just the lungs: COVID-19 can affect the brain and heart of those infected, researchers say – WITI FOX 6 Milwaukee

By daniellenierenberg

LOS ANGELES As medical experts learn about the novel coronavirus, which continues to exhibit an array of ever-evolving symptoms and long-term effects, researchers have found that the deadly illness can have deleterious impacts on the heart and brain.

A recent study published on June 25 in the journalCell Reports Medicine, found that while COVID-19 is commonly known as a respiratory illness, the disease has also been known to instigate inflammatory responses in the body which can negatively affect the function of ones heart and brain.

According to the study, researchers observed SARS-CoV-2 infecting human heart cells that were grown from stem cells in a lab. Within 72 hours of infection, the virus managed to spread and replicate, killing the heart cells.

The researchers brought up the particularly alarming possibility that if COVID-19 can infect the heart cells in a laboratory setting, it could possibly infect those specific organs, prompting the need for a cardiac-specific antiviral drug screen program.

And those concerns are not unwarranted, according to doctors and other researchers who have been observing and studying the wide range of health problems and negative outcomes that appear to come with the not-yet-fully-known territory of the novel virus.

The most common coronavirus symptoms are fever, a dry cough and shortness of breath and some people are contagious despite never experiencing symptoms. But as the virus continues to spread, less common symptoms are being reported, including loss of smell, vomiting and diarrhea, along with a variety of skin problems and harmful neurological effects.

A recentreportfromDr. Robert Stevens, M.D., the associate director of the Johns Hopkins Precision Medicine Center of Excellence for Neurocritical Care, said that coronavirus patients are continuously experiencing a wide range of disconcerting effects on the brain.

Some of the neural symptoms, according to Johns Hopkins, include:

Patients are also having peripheral nerve issues, such as Guillain-Barr syndrome, which can lead to paralysis and respiratory failure, wrote Stevens. I estimate that at least half of the patients Im seeing in the COVID-19 units have neurological symptoms.

While medical experts have continuously repeated that more is still being discovered about the virus, Stevens listed some possibilities on how COVID-19, a respiratory illness, is making its way to the brain.

The first possible way is that the virus may have the capacity to enter the brain and cause a severe and sudden infection. Cases reported in China and Japan found the viruss genetic material in spinal fluid, and a case in Florida found viral particles in brain cells, Stevens wrote.

He added that viral particles in the brain and spine may occur when the virus enters the body through a patients bloodstream or nerve endings.

The second possibility is that the bodys immune system has an overreaction to the virus, causing severe inflammatory responses that cause organ and tissue damage.

The third theory is the erratic physiological changes the disease causes in the body, which involve extremely high fever and low oxygen levels in the blood, result in harmful effects to the brain.

Stevens added that there has been an abnormal observance of blood clotting that has caused some coronavirus patients to suffer strokes. A stroke could occur if a blood clot were to block or narrow arteries leading to the brain, he said.

Another illness that has been known to impact the brain in patients with COVID-19 is currently being studied by Dr. Mady Hornig, an immunologist and professor of epidemiology at Columbia University.

Hornig said that Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is an illness that has been found in patients who have recovered from coronaviruses such as SARS.

TheCenters for Disease Control and Preventioncites a 2015 report from the nations top medical advisory body, the Institute of Medicine, which says that an estimated 836,000 to 2.5 million Americans suffer from ME/CFS.

The CDC says that people with ME/CFS experience severe fatigue, sleep problems, as well as difficulty with thinking and concentrating while experiencing pain and dizziness.

Hornig said SARS-CoV-1 and MERS have been associated with longer-term difficulties, in which many people appeared to have symptoms of ME/CFS.

Hornig is currently researching the long-term effects of COVID-19, and has been confronted with an array of concerning symptoms that have persisted in patients, as well as herself.

She can personally attest to the variety of symptoms that have been reported in coronavirus patients, ever since she began to experience her own COVID-19 symptoms in April that have continued to impact her daily life for the past few months.

She has also experienced cardiac complications while dealing with the illness.

Since getting sick, Hornig said shes had to carry a pulse oximeter with her, a device which registers her pulse since she began to have tachycardia episodes when her fever began to decline. Tachycardia is a condition that can make a persons heart beat abnormally fast, reducing blood flow to the rest of the body,according to the Mayo Clinic.

Hornigs most recent episode was on June 22. Her pulse registered at 135 beats per minute, which she said occurred just from her sitting at her computer. She said a normal pulse for someone her age would be around 60-70 beats per minute.

The findings on the novel virus potential effects on the heart and brain come as the CDC continues to update itslistof coronavirus symptoms and high-risk conditions for COVID-19 complications.

Notably, the CDC also removed the specific age threshold from the older adult classification. CDC now warns that among adults, risk increases steadily as you age, and its not just those over the age of 65 who are at increased risk for severe illness, the agency wrote.

Johns Hopkins has noted that younger patients in their 30s and 40s are reportedly having strokes as a result of COVID-19.

It may have something to do with the hyperactive blood-clotting system in these patients, Stevens said. Another system that is hyper-activated in patients with COVID-19 is the endothelial system, which consists of the cells that form the barrier between blood vessels and body tissue. This system is more biologically active in younger patients, and the combination of hyperactive endothelial and blood-clotting systems puts these patients at a major risk for developing blood clots.

But Stevens cautioned that more conclusive data is needed before the medical community can say with assurance that younger people are particularly susceptible to strokes caused by the novel coronavirus.

It is also plausible that theres an increase in stroke in COVID-19 patients of all ages, Stevens said.

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WHO says living with COVID-19 to be new normal as global cases top 10 mln – WeForNews

By daniellenierenberg

Washington, July 2 : The overall number of global COVID-19 cases has increased to over 10.6 million, while the deaths have soared to more than 515,000, according to the Johns Hopkins University.

As of Thursday morning, the total number of cases increased to 10,667,217, while the fatalities stood at to 515,542, the Universitys Center for Systems Science and Engineering (CSSE) revealed in its latest update.

The US accounted for the worlds highest number of infections and fatalities with 2,685,806 and 128,061, respectively, according to the CSSE.

Brazil came in the second place with 1,448,753 infections and 60,632 deaths.

In terms of cases, Russia ranks third (653,479), and is followed by India (585,493), the UK (314,992), Peru (288,477), Chile (282,043), Spain (249,659), Italy (240,760), Mexico (231,770), Iran (230,211), Pakistan (213,470), France (202,981), Turkey (201,098), Germany (195,893), Saudi Arabia (194,225), South Africa (159,333), Bangladesh (149,258) and Canada (106,288), the CSSE figures showed.

The other countries with over 10,000 deaths are the UK (43,991), Italy (34,788), France (29,864), Mexico (28,510), Spain (28,364), India (17,400) and Iran (10,958).

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What is a stem cell or bone marrow transplant? | Stem cell …

By daniellenierenberg

You might have a stem cell or bone marrow transplant as part of your cancer treatment.

It is a treatment for some people with:

It is also a treatment for other blood conditions.

A transplant allows you to have high doses of chemotherapy and other treatments. The stem cellsare collected from the bloodstream or the bone marrow.

Stem cells are very earlycells made inthe bone marrow. Bone marrow is a spongy material that fills the bones.

These stem cells develop into red blood cells, white blood cells and platelets.

Red blood cells contain haemoglobin which carries oxygen around the body. White blood cells are part of your immune system and help to fight infection. Platelets help to clot the blood to prevent bleeding.

You have a stem cell transplant after very high doses of chemotherapy. You might have targeted drugs with the chemotherapy. You may also have radiotherapy to your whole body. This is called total body irradiation or TBI.

The radiotherapy and chemotherapy have a good chance of killing the cancercells. But it also kills the stem cells in your bone marrow.

Soyour team either collect:

After the treatment you have the stem cells into your bloodstream through a drip. The cells find their way back to your bone marrow where they start making blood cells again and your bone marrow slowly recovers.

Some people who have a donor transplant might have a mini transplant. This isalso called a reduced intensity conditioning (RIC) transplant.

You have lower doses of chemotherapy than in a traditional stem cell transplant. You might have this treatment if you are older (usually over 50 years),or not fit or well enough for a traditional transplant.

The main difference between a stem cell and bone marrow transplant is whether stem cells are collected from the bloodstream or bone marrow.

A stem cell transplant uses stem cells from your bloodstream, or a donors bloodstream. This is also called a peripheral blood stem cell transplant.

A bone marrow transplant uses stem cells from your bone marrow, or a donors bone marrow.

Stem cell transplants are the most common type of transplant. Bone marrow transplants are not used as much. This is because:

You might have a bone marrow transplant if collecting stem cells has been difficult in your situation.

The aim of your transplant will depend on your situation. Your doctor might explain that a transplant will try to cure your disease or control it for as long as possible.

With lymphoma, leukaemia and myeloma the aim is to put the cancer into remission. Remission means there is no sign of the cancer.

Your doctor might suggest a transplant if your disease:

Depending on your situation, you might have a transplant using:

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Bone Marrow Processing System Market Poised to Expand at a Robust Pace Over COVID-19 Crisis 2018 2025 – Kentucky Journal 24

By daniellenierenberg

Bone marrow aspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.Europe and North America spearheaded the market as of 2016, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

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In 2016, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.

Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others

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Impact of COVID 19 pandemic on Stem Cell Characterization and Analysis Tools Market Structure and Its Segmentation – 3rd Watch News

By daniellenierenberg

Stem cell characterization is the study of tissue-specific differentiation. Thera are various type of stem cell such as embryonic stem cell, epithelial stem cell and others. Further, various techniques are used to characterized stem cells such as immunological techniques, used for depiction of different population of stem cells. These techniques are generally based on immunochemistry using staining technique or florescent microscopy. Besides, stem cells characterization and analysis tools are used against target chronic diseases. In 2014, the San Diego (UCSD) Health System and Sanford Stem Cell Clinical Center at the University of California announced the launch of a clinical trial, in order to assess the safety of neural stem cellbased therapy in patients with chronic spinal cord injury.

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The factors driving the growth of stem cell characterization and analysis tools market due to increasing chronic disorders such as cancer, a diabetes and others. In addition, increasing awareness about among people about the therapeutic potency of stem cells characterization in the management of effective diseases is anticipated to increase the demand for stem cell characterization and analysis tools. Further, there are various technologies such as flow cytometry which is used to characterize the cell surface profiling of human-bone marrow and other related purposes are expected to increase the growth of stem cell characterization and analysis tools market. In addition, increasing investment by private and public organization for research activities are likely to supplement the market growth in near future.

On the other hand, the unclear guidelines and the technical limitation for the development of the product are expected to hamper the growth of stem cell characterization and analysis tools market.

Rapid increase in corona virus all around the world is expected to hamper the growth of stem cell characterization and analysis tools market. The virus outburst has become one of the threats to the global economy and financial markets. The impact has made immense decrease in revenue generation in the field of all healthcare industry growth for the market in terms of compatibility and it has led in huge financial losses and human life which has hit very hard to the core of developing as well as emerging economies in healthcare sector. It further anticipated that such gloomy epidemiological pandemic environment is going to remain in next for at least some months, and this is going to also affect the life-science market which also include the market of stem cell characterization and analysis tools market.

Based on the Products and Service Type, stem cell characterization and analysis tools market are segmented into:

Based on the Technology, stem cell characterization and analysis tools market are segmented into:

Based on the Applications, stem cell characterization and analysis tools market are segmented into:

Based on the End User, stem cell characterization and analysis tools market are segmented into:

Based on the segmentation, human embryonic stem cell is expected to dominate the market due to their indefinite life span and higher totipotency as compared to other stem cells. Further, on the basis of technology segmentations, cell production is anticipated to increase the demand for stem cell characterization and analysis tools due to their emerging applications for stem cells in drug testing in the management of the effective diseases. Furthermore, on the basis of application segmentations, oncology is expected to show significant growth rate due to increase in the number of pipelines products for the treatment of cancers or tumors. Based on the end user, pharmaceutical and biotechnology companies are expected to dominate the market due to rising global awareness about the therapeutics research activities.

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Geographically, the global stem cell characterization and analysis tools market is segmented into regions such as Latin America, Europe, North America, South Asia, East Asia Middle East & Africa and Oceania. North America is projected to emerge as prominent market in the global stem cell characterization and analysis tools market due to growing cases of target chronic diseases and increasing investments for research activities. Europe is the second leading region to dominate the market due to technological advancement and also surge in therapeutic activities, funded by government across the world. Asia-pacific is likely to witness maximum growth in near future due to increasing disposable income and with the development of infrastructure.

Some of the major key players competing in the global stem cell characterization and analysis tools market are Osiris Therapeutics, Inc., Caladrius Biosciences, Inc., U.S. Stem Cell, Inc., Astellas Pharma Inc., TEMCELL Technologies Inc., BioTime Inc., Cellular Engineering Technologies Inc., Cytori Therapeutics, Inc., and BrainStorm Cell Therapeutics Inc.

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Impact of COVID 19 pandemic on Stem Cell Characterization and Analysis Tools Market Structure and Its Segmentation - 3rd Watch News

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Rahul Gandhi to interact with nurses on July 1 – WeForNews

By daniellenierenberg

New York, July 1 : A team of US scientists, led by an Indian-origin researcher revealed that SARS-CoV-2 (coronavirus), the virus behind Covid-19, can infect heart cells in a lab dish.

This suggests it may be possible for heart cells in Covid-19 patients to be directly infected by the virus.

The discovery, published today in the journal Cell Reports Medicine, was made using heart muscle cells that were produced by stem cell technology.

We not only uncovered that these stem cell-derived heart cells are susceptible to infection by a novel coronavirus, but that the virus can also quickly divide within the heart muscle cells, said study researcher Arun Sharma from the Cedars-Sinai Board of Governors Regenerative Medicine Institute in the US.

Even more significant, the infected heart cells showed changes in their ability to beat after 72 hours of infection, Sharma added.Although many COVID-19 patients experience heart problems, the reasons remain unclear. Pre-existing cardiac conditions or inflammation and oxygen deprivation resulting from the infection have all been implicated.

But there has until now been only limited evidence the SARS-CoV-2 virus directly infects the individual muscle cells of the heart.The study also demonstrated human stem cell-derived heart cells infected by SARS-CoV-2 change their gene expression profile.This offers further confirmation the cells can be actively infected by the virus and activate innate cellular defence mechanisms in an effort to help clear-out the virus.

This viral pandemic is predominately defined by respiratory symptoms, but there are also cardiac complications, including arrhythmia, heart failure and viral myocarditis, said study co-author Clive Svendsen.

While this could be the result of massive inflammation in response to the virus, our data suggest that the heart could also be directly affected by the virus in Covid-19, Svendsen added.

Researchers also found that treatment with an ACE2 antibody was able to blunt viral replication on stem cell-derived heart cells, suggesting that the ACE2 receptor could be used by SARS-CoV-2 to enter human heart muscle cells.

By blocking the ACE2 protein with an antibody, the virus is not as easily able to bind to the ACE2 protein, and thus cannot easily enter the cell, said Sharma. This not only helps us understand the mechanisms of how this virus functions, but also suggests therapeutic approaches that could be used as a potential treatment for SARS-CoV-2 infection, he explained.

The study used human induced pluripotent stem cells (iPSCs), a type of stem cell that is created in the lab from a persons blood or skin cells. IPSCs can make any cell type found in the body, each one carrying the DNA of the individual. This work illustrates the power of being able to study human tissue in a dish, the authors wrote.

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Coronavirus: WHO warns the worst is yet to come – WeForNews

By daniellenierenberg

New York, July 1 : A team of US scientists, led by an Indian-origin researcher revealed that SARS-CoV-2 (coronavirus), the virus behind Covid-19, can infect heart cells in a lab dish.

This suggests it may be possible for heart cells in Covid-19 patients to be directly infected by the virus.

The discovery, published today in the journal Cell Reports Medicine, was made using heart muscle cells that were produced by stem cell technology.

We not only uncovered that these stem cell-derived heart cells are susceptible to infection by a novel coronavirus, but that the virus can also quickly divide within the heart muscle cells, said study researcher Arun Sharma from the Cedars-Sinai Board of Governors Regenerative Medicine Institute in the US.

Even more significant, the infected heart cells showed changes in their ability to beat after 72 hours of infection, Sharma added.Although many COVID-19 patients experience heart problems, the reasons remain unclear. Pre-existing cardiac conditions or inflammation and oxygen deprivation resulting from the infection have all been implicated.

But there has until now been only limited evidence the SARS-CoV-2 virus directly infects the individual muscle cells of the heart.The study also demonstrated human stem cell-derived heart cells infected by SARS-CoV-2 change their gene expression profile.This offers further confirmation the cells can be actively infected by the virus and activate innate cellular defence mechanisms in an effort to help clear-out the virus.

This viral pandemic is predominately defined by respiratory symptoms, but there are also cardiac complications, including arrhythmia, heart failure and viral myocarditis, said study co-author Clive Svendsen.

While this could be the result of massive inflammation in response to the virus, our data suggest that the heart could also be directly affected by the virus in Covid-19, Svendsen added.

Researchers also found that treatment with an ACE2 antibody was able to blunt viral replication on stem cell-derived heart cells, suggesting that the ACE2 receptor could be used by SARS-CoV-2 to enter human heart muscle cells.

By blocking the ACE2 protein with an antibody, the virus is not as easily able to bind to the ACE2 protein, and thus cannot easily enter the cell, said Sharma. This not only helps us understand the mechanisms of how this virus functions, but also suggests therapeutic approaches that could be used as a potential treatment for SARS-CoV-2 infection, he explained.

The study used human induced pluripotent stem cells (iPSCs), a type of stem cell that is created in the lab from a persons blood or skin cells. IPSCs can make any cell type found in the body, each one carrying the DNA of the individual. This work illustrates the power of being able to study human tissue in a dish, the authors wrote.

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Coronavirus: WHO warns the worst is yet to come - WeForNews

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Hitachi and ThinkCyte announce collaboration to develop an AI-driven cell analysis and sorting system – BioSpace

By daniellenierenberg

TOKYO, July 1, 2020 /PRNewswire/ --Hitachi, Ltd.(TSE: 6501, "Hitachi") and ThinkCyte, Inc. ("ThinkCyte") today announced that they have entered into a collaboration focused on developing an artificial intelligence (AI)-driven cell analysis and sorting system. Hitachi provides a broad range of solutions such as automated cell culture technologies to pharmaceutical companies in the value chain*1 of the regenerative medicine and cell therapy industry. Through the addition of this cell analysis and sorting system to the value chain, Hitachi continues contributing to cost reductions in the manufacturing of regenerative medicine and cell therapy products.Further, Hitachi and ThinkCyte are promoting collaboration with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to expedite the development of the system toward commercialization.

The practical applications of regenerative medicine and cell therapy using cells for treatment have been expanding rapidly with the first regulatory approval of CAR-T*2 therapy for leukemia in 2017 in the United States and 2019 in Japan. The global market for regenerative medicine and cell therapy is expected to grow from US$ 5.9 billion (JPY 630 billion) in 2020 to US$ 35.4 billion (JPY 3.8 trillion) in 2025*3. In order to scale up treatment using regenerative medicine and cell therapy products, it is critical to ensure consistent selection and stable supply of high quality cells in large quantities and at a low costs.

Hitachi has been providing large-scale automated induced pluripotent stem (iPS) cell culture equipment, cell processing facilities (CPFs), manufacturing execution systems(MES), and biosafety cabinets among other products to pharmaceutical companies and research institutes, and has developed a value chain to meet a variety of customer needs in the regenerative medicine and cell therapy industry. Hitachi has also been carrying out collaborative research projects with universities, research institutes, and other companies to develop core technologies for pharmaceutical manufacturing instruments and in vitro diagnostic medical devices, prototyping for mass production, and working on manufacturing cost reduction and the development of stable and reliable instruments.

ThinkCyte has been performing research and development focused on high-throughput single cell analysis and sorting technology to precisely analyze and isolate target cells. While such single cell analysis and sorting technologies are vital to life science and medical research, it has been thought impossible to achieve high-throughput cell sorting based on high-content image information of every single cell. ThinkCyte has developed the world's first Ghost Cytometrytechnology to achieve high-throughput and high-content single cell sorting*4and has been conducting collaborative research projects with multiple pharmaceutical companies and research institutes to utilize this technology in life science and medical fields.

Hitachi and ThinkCyte have initiated a joint development of the AI-driven cell analysis and sorting system based on their respective technologies, expertise, and know-how. By combining ThinkCyte's high-throughput and high-content label-free single cell sorting technology and Hitachi's know-how and capability to producing stably operative instruments on a large scale, the two companies will together develop a novel reliable system to enable high-speed label-free cell isolation with high accuracy, which has been difficult to achieve with the existing cell sorting techniques, and to realize stable, low-cost and large-scale production of cells for regenerative medicine and cell therapy.

Hitachi and ThinkCyte will further advance partnerships with pharmaceutical companies and research institutes that have been developing and manufacturing regenerative medicines and cell therapy products in Japan and other countries where demand is expected to be significant, such as North America, in order to make this technology a platform for the production of regenerative medicines and cell therapy products. At the same time, taking advantage of the high-speed digital processing technologies cultivated through the development of information and communication technology by the Hitachi group, Hitachi will integrate this safe and highly reliable instrument in its value chain for regenerative medicine and contribute to the growth of the regenerative medicine and cell therapy industry.

Note:

*1. Cell manufacturing processes, including cultivation, selection, modification, preservation, product quality control, etc.

*2. Chimeric Antigen Receptor T cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy.

*3. Division of Regenerative Medicine, Japan Agency for Medical Research and Development, The final report for market research on regenerative medicine and gene therapy (2020).

*4. S, Ota et al., Ghost Cytometry, Science, 360, 1246-1251 (2018).

About the AI-driven cell analysis and cell sorting technologyThinkCyte has developed high-throughput image-based cell sorting technology based on the Ghost Cytometry technology by integrating the principles of advanced imaging technology, machine learning, and microfluidics. By applying structured illumination to cell imaging, structural information of a single cell can be converted to one-dimensional waveforms for high-throughput data analysis. Based on the judgment of a machine-learning (AI) model developed using the waveform data, target cells are isolated in a microfluidic device with high throughput and with minimal damage to the cells.

This data analysis approach eliminates time-consuming image reconstruction processes and allows high-throughput image-based single cell sorting, enabling the discrimination of cells that were previously considered difficult to distinguish by the human eye. Conventional cell sorting methods rely on the use of labels such as cell surface markers for cell sorting; in contrast, ThinkCyte's technology can sort cells without such labels by employing this unique approach. In addition to the field of regenerative medicine and cell therapy, this technology can also revolutionize drug discovery and in vitrodiagnostics fields.

About Hitachi, Ltd.Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, is focused on its Social Innovation Business that combines information technology (IT), operational technology (OT) and products. The company's consolidated revenues for fiscal year 2019 (ended March 31, 2020) totaled 8,767.2 billion yen ($80.4 billion), and it employed approximately 301,000 people worldwide. Hitachi drives digital innovation across five sectors - Mobility, Smart Life, Industry, Energy and IT - through Lumada, Hitachi's advanced digital solutions, services, and technologies for turning data into insights to drive digital innovation. Its purpose is to deliver solutions that increase social, environmental and economic value for its customers. For more information on Hitachi, please visit the company's website at https://www.hitachi.com.

About ThinkCyte, Inc.ThinkCyte, headquartered in Tokyo, Japan, is a biotechnology company, which developsinnovative life science research, diagnostics,and treatmentsusingintegrated multidisciplinary technologies, founded in 2016. The company focuses on the research and development of drug discovery, cell therapy, and diagnostic platforms using its proprietary image-based high-throughput cell sorting technology In June 2019, the company was selected for J-Startup by the Ministry of Economy, Trade and Industry of Japan. For more information on ThinkCyte, please visit the company's website at https://thinkcyte.com.

ContactsHitachi, Ltd.Analytical Systems Division, Healthcare Division, Smart Life Business Management Divisionhttps://www8.hitachi.co.jp/inquiry/healthcare/en/general/form.jsp

ThinkCyte, Inc.https://thinkcyte.com/contact

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Cardiac Stem Cell – an overview | ScienceDirect Topics

By daniellenierenberg

Cardiosphere-Derived Cells

The formation of cardiospheres from human and murine heart tissue was first described in 2004 by Messina and coworkers [16]. It was demonstrated that, when placed in adherent plates, heart explants generated a layer of fibroblast-like cells over which small, phase-bright cells migrated. These phase-bright cells were collected and transferred to nonadherent plates where they originated three-dimensional structures named cardiospheres. Cardiospheres were clonogenic and when co-cultured with rat neonatal cardiomyocytes expressed troponin I and connexin 43. Additionally, there was visual evidence that cardiospheres showed synchronous contractions with cardiomyocytes. When transplanted into infarcted hearts, these cells started to express myosin heavy chain as well as -smooth muscle actin and platelet endothelial cell adhesion molecule, which resulted in functional improvement. Curiously, when the expression of surface molecules was analyzed by flow cytometry, cardiospheres showed a 25% expression of c-kit. Thus, it is possible that c-kit+ cells contribute to the characteristics observed in cardiospheres, explaining the similar findings between these two cardiac progenitor/stem cell types.

However, it was only in 2007 that Marbns group described cardiosphere-derived cells (CDCs) [19]. They slightly changed Messinas protocol by placing cardiospheres in adherent plates where cells were grown in monolayers instead of three-dimensional structures. The advantage of this step was that cell expansion in monolayers was easier and faster, which would facilitate future clinical use. Flow cytometry showed that c-kit expression was still present in similar levels to those described by Messina and coworkers. Additionally, high expression levels of CD105 and CD90 were found, indicating a mesenchymal phenotype. When co-cultured with rat neonatal cardiomyocytes, CDCs presented spontaneous intracellular calcium transients and action potentials, as well as INa, IK1 and ICa,L currents. In vivo, injection of CDCs in acute myocardial infarctions (MI) prevented further ejection fraction deterioration 3 weeks after MI when compared to placebo and fibroblast injected mice. In 2009, Marbns group also reported functional benefit and reduction of infarct size in a porcine animal model after CDC injection [37], a preclinical model that prompted a phase I clinical trial (CADUCEUS, ClinicalTrials.gov, Identifier NCT00893360).

Nonetheless, the usage of cardiospheres as a source of cardiac stem cells has been refuted. Andersen and coworkers showed that even though cardiospheres can be produced from heart specimens, they do not hold cardiomyogenic potential and simply represent aggregated fibroblasts [38]. This group also found cells that expressed cardiac contractile proteins, such as myosin heavy chain and troponin T, in cardiospheres. However, the findings were attributed to the presence of contaminating heart tissue fragments in the explant-derived cell suspension. By adding a filtration step in which explant-derived cells were passed through cell strainers prior to cardiosphere formation, the presence of cells expressing cardiac contractile proteins was eliminated. In addition, this group showed that phase-bright cells were of hematopoietic origin and did not organize into spheric structures, a characteristic attributed to the fibroblast-like cells.

In response to Andersens findings, Marbns group published a revalidation of the CDC isolation method [39]. Using a strategy identical to the one described by Hsieh and colleagues [8], cardiomyocytes were irreversibly labeled with GFP after a tamoxifen pulse (see Fig. 8.1). Isolation of CDCs from these transgenic mouse hearts did not reveal the presence of GFP+ cells, refuting the possibility that cardiac differentiation of CDCs was due to the presence of contaminating myocardial tissue fragments. Additionally, they reported that cardiospheres were consistently negative for CD45, indicating that CDCs do not contain cells of hematopoietic origin. The authors also emphasized that Andersen and coworkers used different isolation protocols, which could justify the discrepancies found in results.

Even though they demonstrated that CDCs expressed myosin heavy chain after transplantation into myocardial infarctions in mice [17], indicating that cardiomyogenic differentiation was possible in vivo, an additional mechanism was proposed to explain the improvement in cardiac function. Chimenti and colleagues studied the relative roles of direct regeneration versus paracrine effects promoted by human CDCs in a mouse infarction model [40]. The paracrine hypothesis has been used frequently to explain the beneficial effects observed with several types of adult stem cells or bone marrowderived cells used in cell therapy experiments. According to this hypothesis, stem cells could act secreting signaling molecules, which may influence cardiomyocyte survival and angiogenesis and could also recruit endogenous cardiac stem cells. Chimenti and coworkers demonstrated that CDCs secrete high levels of insulin growth factor-1 (IGF-1), hepatocyte growth factor (HGF), and vascular endothelial growth factor (VEGF). Moreover, using in vivo bioluminescence assays, the authors showed that no cells could be found in the heart 1 week after injection, even though functional improvement persisted until 3 weeks post-MI. Therefore, it seems that cell persistence is not important for functional improvement, strengthening the paracrine hypothesis. To address this issue, the authors quantified capillary density and viable myocardium analyzing the contributions of human (injected) and mouse (endogenous) cells to each of these variables 1-week post-MI [40]. They found that, for both variables, the contribution of endogenous cells was more prominent than that of injected cells. Hence, the release of factors seems to be more important than direct regeneration in the improvement of cardiac function after cell therapy with CDCs.

Recently, results of a phase I clinical trial using CDCs were published [41]. The safety of autologous intracoronary delivery of CDCs to patients 1.5 to 3 months after MI was evaluated. Cells were obtained from endomyocardial biopsies and cultured according to the protocols previously established by Eduardo Marbns group. Patients with a recent MI (less than 4 weeks) and left ventricular ejection fraction ranging from 25% to 45% were eligible for inclusion. Twelve months after cell therapy, patients treated with CDCs had a 12.3% decrease in scar size, whereas the control group had a 2.2% reduction, as measured by late enhancement after gadolinium MRI. However, no differences were detected in ejection fraction between cell-treated and control groups. It is important to note that this was a safety study; therefore, phase II double-blinded placebo-controlled clinical trials still need to be performed to access efficacy of therapy with CDCs in humans. Additionally, a more thorough cell biologic characterization of CDCs is required to understand provenience, molecular identity, and mechanism of action of these cells as potential cardioprotective agents.

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Coronavirus may infect heart cells of COVID-19 patients, scientists say – Outlook India

By daniellenierenberg

Los Angeles, Jul 1 (PTI) Researchers, including those of Indian-origin, have shown that the novel coronavirus can infect lab-grown cardiac muscle cells, indicating it may be possible for the virus to directly cause heart infection in COVID-19 patients.

The study, published in the journal Cell Reports Medicine, was based on experiments conducted in lab-grown heart muscle cells which were produced from unspecialised human stem cells.

"We not only uncovered that these stem cell-derived heart cells are susceptible to infection by novel coronavirus, but that the virus can also quickly divide within the heart muscle cells," said study co-author Arun Sharma from the Cedars-Sinai Board of Governors Regenerative Medicine Institute in the US.

"Even more significant, the infected heart cells showed changes in their ability to beat after 72 hours of infection," Sharma said.

Although many COVID-19 patients experience heart problems, the scientists said the reasons for these symptoms are not entirely clear.

They said pre-existing cardiac conditions, or inflammation and oxygen deprivation that result from the infection have all been implicated.

According to the scientists, there is only limited evidence available that the novel coronavirus, SARS-CoV-2, directly infects individual muscle cells of the heart.

The current study showed that SARS-CoV-2 can infect heart cells derived from human stem-cells and change how the genes in these cells helped make proteins.

Based on this observation, the scientists confirmed that human heart cells can be actively infected by the virus, activating innate cellular "defense mechanisms" in an effort to help clear out the virus.

Citing the limitations of the study, they said these findings are not a perfect replicate of what is happening in the human body since the research was carried out in lab-grown heart cells.

However, this knowledge may help investigators use stem cell-derived heart cells as a screening platform to identify new antiviral compounds that could alleviate viral infection of the heart, believes study co-author Clive Svendsen.

"This viral pandemic is predominately defined by respiratory symptoms, but there are also cardiac complications, including arrhythmias, heart failure and viral myocarditis," said Svendsen, director of the Regenerative Medicine Institute.

"While this could be the result of massive inflammation in response to the virus, our data suggest that the heart could also be directly affected by the virus in COVID-19," Svendsen said.

The scientists also found that treatment with an antibody protein could lock onto the human cell surface receptor ACE2 -- a known SARS-CoV-2 ''gateway'' into cells.

According to the researchers, the antibody treatment was able to blunt viral replication on the lab-grown heart cells, suggesting that the ACE2 receptor could be used by the virus to enter human heart muscle cells.

"By blocking the ACE2 protein with an antibody, the virus is not as easily able to bind to the ACE2 protein, and thus cannot easily enter the cell," Sharma said.

"This not only helps us understand the mechanisms of how this virus functions, but also suggests therapeutic approaches that could be used as a potential treatment for SARS-CoV-2 infection," he added.

In the study, the researchers also used human induced pluripotent stem cells, or iPSCs, which are a type of undifferentiated cells grown in the lab from a person''s blood or skin cells.

They said iPSCs can make any cell type found in the body, each one carrying the genetic material of the individual.

According to the scientists, tissue-specific cells created in this way are used for research, and for creating and testing potential disease treatments.

"It is plausible that direct infection of cardiac muscle cells may contribute to COVID-related heart disease," said Eduardo Marban, executive director of the Smidt Heart Institute in the US, and study co-author.

"This key experimental system could be useful to understand the differences in disease processes of related coronaviral pathogens, SARS and MERS," said Vaithilingaraja Arumugaswami, another co-author of the study from the University of California Los Angeles in the US. PTI VISVIS

Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI

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Researchers grow hairy skin from human stem cells

By daniellenierenberg

Building on years of groundbreaking discoveries in stem cell research, scientists from Indiana University School of Medicine and Harvard Medical School have determined how to grow hairy skin using human stem cellsdeveloping one of the most complex skin models in the world.

The study, published June 3 in Nature, shows that skin generated from pluripotent stem cells can be successfully grafted on a nude mouse to grow human skin and hair follicles. That discovery could lead to future studies in skin reconstruction, disease modeling and treatment.

This is the first study to show that human hair can be grown completely from stem cells in a dish, which has been a goal of the skin biology community for decades, said Karl Koehler, PhD, assistant professor of otolaryngologyhead and neck surgery at Harvard Medical School and Boston Childrens Hospital.

The team of researchers was led by Koehler, whos also an adjunct assistant professor of otolaryngologyhead and neck surgery at IU School of Medicine, and Jiyoon Lee, PhD, a research associate in Koehlers lab.

The groups findings originate from several years of stem cell research within the Department of OtolaryngologyHead and Neck Surgery at IU School of Medicine. In 2013, scientists created inner ear tissue from mouse embryonic stem cells using a three-dimensional cell culture method. In 2017, they developed a method to grow inner ear tissue from human stem cells, and in 2018, the researchers grew hairy skin in a dish using mouse stem cells, a scientific first.

Through the three-dimensional culture technique developed in past experiments, the team incubated human stem cells for about 150 days in a ball-shaped cluster of cells, called a skin organoid. The interior of the aggregate of cells represent the top layer of skin (the epidermis) and the outside of the cluster develops the bottom layer of skin (the dermis).

Weve developed a new cooking recipe for generating human skin that produces hair follicles after about 70 days in culture, Koehler said. When the hair follicles grow, the roots extend outward radially. Its a bizarre-looking structure, appearing almost like a deep-sea creature with tentacles coming out from it.

After the incubation period, researchers tested whether skin organoids could integrate on the skin of nude mice. More than half of the organoids they grafted on the mice grew human hair follicles. The skin organoid developed from culture is akin to fetal facial skin and hair, Koehler said.

The experiments show that organoid generated hairy skin can integrate into mouse skin, Koehler said, which suggests potential applications in skin and facial reconstruction. Physicians typically perform skin grafts in surgery, meaning the removal of skin from one area of the body to transplant on skin thats been wounded.

This could be a huge innovation, providing a potentially unlimited source of soft tissue and hair follicles for reconstructive surgeries, said Lee, the first author of the study.

Taha Shipchandler, MD, associate professor of clinical otolaryngologyhead and neck surgery at IU School of Medicine and one of the papers authors, specializes in facial plastic and reconstructive surgery. Skin regeneration is of great interest for treating patients, he said.

If we can harness this growth into a medium, and easily apply it to patients, it would change the way we treat many injuries or reconstructions, Shipchandler said. This would have a profound effect on the medical field.

The other potential uses of hairy skin organoids vary widely, from developing drug or gene therapies for congenital skin disorders to recreating the earliest stages of skin cancer formation. In addition, more research is needed to analyze the development of sensory neurons and Merkel cellsspecialized touch sensing cells of the skinbundled within the organoid hair follicles, Koehler said, adding that the neurons potentially mimic the nerves mediating touch sensations.

Were setting up experiments where we wiggle the hairs and see if the neurons activate, Koehler said, as proof of concept that our skin can respond to touch in some way.

This research was supported by the Ralph W. and Grace M. Showalter Trust, Indiana Clinical Translational Sciences Institute, the Indiana Center for Biomedical Innovation and the National Institutes of Health.

###

IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.

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Skin Regeneration and Rejuvenation | Harvard Stem Cell …

By daniellenierenberg

Whether through injury or simple wear and tear, the skins integrity and function can be easily compromised. Although this impacts billions of people worldwide, little is known about how to prevent skin degeneration.

The Harvard Stem Cell Institute (HSCI) Skin Program is committed to understanding why skin sometimes fails to heal or forms scars, as well as why skin inevitably becomes thin, fragile, and wrinkled with age. The Skin Programs ultimate goal is to identify new therapies for skin regeneration and rejuvenation.

Wound healing is a major problem for many older individuals. Furthermore, chronic, non-healing skin ulcers are a major source of health care costs and patient morbidity and mortality.

Human skin repairs itself slowly, via the formation of contractile scars which may cause dysfunction. In contrast, the axolotl salamander can readily regrow a severed limb, the spiny mouse has densely haired skin that heals with remarkable speed, and the skin of the growing human embryo can regenerate after trauma without the need for any scar formation. By studying these examples, scientists are finding clues for how to enhance skin healing through a more regenerative response.

During normal wound healing, scars form from dermal cells that align in parallel. But when this alignment is disrupted by a biodegradable scaffold that directs cells to grow in a random orientation, the cells follow the diverse differentiation program necessary for true regeneration.

HSCI scientists have also identified biomarkers for the key cells involved in skin regeneration, and are developing therapeutic strategies for their enrichment and activation. Ongoing clinical trials are using skin stem cells to treat chronic, non-healing ulcers, and early results are promising.

Additional approaches include 3D bioprinting, where skin stem cells are layered into a complex structure that mimics skin and could be potentially used for transplantation.

Skin aging can be thought of as a form of wounding, in which stem cells no longer maintain normal skin thickness, strength, function, and hair density. Understanding how to harness stem cells for scarless wound healing will also provide key insights into regenerating aged skin, a process termed rejuvenation. Multidisciplinary collaborators in the HSCI Skin Program are investigating the biological basis for how the skin ages over time and when exposed to ultraviolet radiation.

In addition to aging, skin stem cells also may mistake normal regions of the skin as wounds, then erroneously attempt to fill them. HSCI investigators are exploring whether this may be one of the underpinnings of psoriasis, a common and devastating disorder.

These areas of investigation are just the beginning. Skin stem cell biology has the potential to provide key insights into the mechanisms of regeneration for other organs in the body.

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The Two Types of Stem Cell Transplants for Cancer Treatment – DocWire News

By daniellenierenberg

Patients with cancer often incur bone marrow damage, resulting in the destruction of stem cells. Stem cell transplants are used to replenish lost or damaged cells that have been affected by cancer and depending on where the stem cells come from these, the procedure may be a bone marrow transplant (BMT), peripheral blood stem cell transplant, or a cord blood transplant.

Typically, in a stem cell transplant, physicians administer high doses of chemotherapy, occasionally in conjunction with radiation therapy, to kill all cancer cells. This is known as myeloablative therapy.

Here are the two main types of transplants, as outline by the American Cancer Society:

In an autologous stem cell transplant, the patient serves as their own donor. Auto means self, therefore this procedure means harvesting your own stem cells from either your blood or bone marrow, then freezing them for preservation. Following high-dose chemo and radiation therapy, the frozen cells are thawed and returned to the (self) donor. Autologous transplants are sometimes used for testicular cancer and brain tumors, but are mainly utilized to treat leukemia, lymphoma, and multiple myeloma. For the latter, autologous stem cell procedures offers patients a chance for achieving sustained remission. One advantage of autologous stem cell transplant is that youre getting your own cells back. When you getyour own stem cells back, you dont have to worry about them (called the engrafted cells or the graft) being rejected by your body, says the American Cancer Society.

Despite the benefits, as with all procedures, there are risks involved, including graft failure which occurs when the transplanted stem cells dont go into bone marrow fail to properly produce blood cells. A possible disadvantage of an autologous transplant is that cancer cells might be collected along with the stem cells and then later put back into your body, the ACS says, adding that another disadvantage of a autologous stem cell transplants is that your immune system is the same as it was before your transplant. This means the cancer cells were able to escape attack from your immune system before, and may be able to do so again.

But how exactly do physicians prevent any residual cancer cells from being transplanted with healthy cells? In a process known as purging, stem cells are treated before being infused back into the patients blood. Although purging carries its benefits, a potential downside, according to the ACS, is that normal cells may be lost during this process, which in turn could lead to unsafe levels of white blood cells as your body takes longer to produce normal blood cells. Cancer centers will also sometimes use in vivopurging, which involves not treating the stem cells, and instead administering anti-cancer drugs to patients post-transplant. The ACS notes, however, that the need to remove cancer cells from transplanted stem cells or transplant patients and the best way to do it continues to be researched.

Whereas autologous procedures infuse stem cells from your own body, allogeneic stem cell transplants use cells from a donor with a very similar tissue type (in many cases a relative, usually a sibling). In cases where the ideal donor is not a relative, physicians may opt to perform a matched unrelated donor (MUD) transplant, which as the ACS notes, are usually riskier than those with a relative who is a good match.

Allogeneic transplants comprise of the same process as autologous stem cell transplants where stem cells are harvested, frozen, and subsequently thawed and put back following high-dose chemo and/or radiation therapy. In some cases, the procedures involve the infusion of blood extracted from the placenta and umbilical cord of a newborn because the cord contains a high number of stem cells that quickly multiple. By 2017, an estimated 700,000 units (batches) of cord blood had been donated for public use. And, even more have been collected for private use. In some studies, the risk of a cancer not going away or coming back after a cord blood transplant was less than after an unrelated donor transplant, writes the ACS.

A benefit of an allogeneic transplant is that donor stem cells create their own immune cells, which may eliminate any residual cancer cells that remain after high-dose treatment, which is known as the graft-versus-cancer effect. Moreover, because the donor stem cells are free of cancer, donors can be asked to donate stem cells or white blood cells multiple times.

As with autologous stem cell procedures, this donor dependent transplant also carries risk. The transplant, or graft, might be destroyed by the patients body before reaching the bone marrow. Allogeneic stem cell transplants also augment the risk of graft-versus-host-disease, where cells from the donor attack healthy cells in the recipients body. Furthermore, despite the healthy cells being tested before transplant, allogeneic procedures still carry a certain risk of infections because, as the ACS writes, your immune system is held in check (suppressed) by medicines calledimmunosuppressivedrugs. Such infections can cause serious problems and even death.

Because theres a plethora of human leukocyte antigen (HLA) combinations, which are inherited from both parents, finding an exact donor match can often be an arduous task. The search usually starts at siblings, and theres a 25% chance of a sibling being a perfect match. In the event that a sibling does not match, the search moves onto extended family (and parents) who are less likely to match.

The ACS writes: As unlikely as it seems, its possible to find a good match with a stranger. To help with this process, the team will use transplant registries, like those listed here. Registries serve as matchmakers between patients and volunteer donors. They can search for and access millions of possible donors and hundreds of thousands of cord blood units.

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How stress contributes to the graying of hair – Galveston County Daily News

By daniellenierenberg

When you compare pictures of presidents who do not alter their hair color, they all leave office considerably grayer than when they started, which some link to the stress of the office.

Marie Antoinette syndrome is a condition in which scalp hair suddenly turns white. The name comes from the story that Marie Antoinettes hair turned white the night before she was to face the guillotine during the French Revolution.

The same thing happened to survivors of atomic bomb attacks during World War II. It has long been thought that genetics, aging and stress all contribute to developing gray hair.

New research has revealed how stress contributes to graying.

On average, humans have 100,000 hair follicles in their scalp, which produce hairs of one color or another. Hair color is determined by the types of melanin produced by cells called melanocytes. Melanocytes grow from melanocyte stem cells (MeSCs) inside the hair follicle.

With age, the number of MeSCs declines, leading to hair graying in stages from the occasional gray one, to salt and pepper, to gray and then white when all the MeSCs are gone. But how stress leads to gray hair has been a mystery.

It had been thought that stress-induced graying involved hormones such as corticosterone or autoimmune reactions. Scientists did experiments in mice and found that neither of those was the cause.

However, when they blocked the receptor for the fight-or-flight hormone, noradrenaline, they stopped hair graying in response to stress in mice. Finally, they had a clue.

The main source of noradrenaline is the adrenal glands. However, when the scientists removed the adrenal glands in mice, their hair still turned gray in response to stress. Another source of the hormone is the sympathetic nervous system (SNS), which is part of the autonomic nervous system that works to regulate many functions and parts of the body without us thinking about it.

The SNS controls the fight-or-flight response to stress to prepare the whole body for physical activity. SNS nerves and MeSCs are close together in the hair follicle, and blocking those SNS nerves prevented the hairs from turning gray in response to stress. Conversely, when the SNS nerves were over-activated, the mice went gray even without stress.

Normally, MeSCs are dormant unless hair is regrowing. In response to extreme stress, MeSCs reproduce and mature into melanocytes quickly. Large numbers of melanocytes then migrate from the follicle, leaving no MeSCs in the follicles and no melanocytes to provide the pigments that give hair its color. Once they are all gone, hair will never be its original color again.

This brings up the added question about other effects of stress, including a decline in immunity and the ability to fight off infections.

The SNS system also stimulates stem cells in the bone marrow to mature into the blood cells required to protect us from infections. Nearly every organ in the body contains stem cells, and stress could have an impact on those as well.

Medical Discovery News is hosted by professors Norbert Herzog at Quinnipiac University, and David Niesel of the University of Texas Medical Branch. Learn more at http://www.medicaldiscoverynews.com.

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G1 Therapeutics and Boehringer Ingelheim Announce Co-Promotion Agreement for Trilaciclib in Small Cell Lung Cancer in the United States and Puerto…

By daniellenierenberg

- Partnership leverages Boehringer Ingelheims oncology expertise to lead trilaciclib SCLC launch sales engagements- G1 to retain full development and commercialization rights and book revenue for trilaciclib-New Drug Application (NDA) for trilaciclib submitted in June 2020

RESEARCH TRIANGLE PARK, N.C. and RIDGEFIELD, Conn., June 30, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX) and Boehringer Ingelheim today announced that the companies have entered into a co-promotion agreement for trilaciclib in the United States and Puerto Rico. Under the terms of the three-year agreement, G1 and Boehringer Ingelheim will collaborate on the commercialization of trilaciclib for its first potential indication in small cell lung cancer (SCLC), with the Boehringer Ingelheim oncology commercial team, well-established in lung cancer, leading sales force engagement initiatives. Discovered and developed by G1, trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.

We believe that trilaciclib has the potential to benefit patients with cancer being treated with chemotherapy across a broad range of solid tumors, said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. Our clinical trials of trilaciclib in small cell lung cancer have demonstrated significant myelopreservation benefits, and we are excited to collaborate with Boehringer Ingelheims experienced commercial oncology team to bring this innovative therapy to patients with SCLC. In addition, this capital efficient launch structure provides us with the ability to make investments in a robust development program to assess trilaciclib in other solid tumors, including colorectal cancer and breast cancer.

Under the terms of the agreement, G1 will book revenue in the United States and Puerto Rico and retain global development and commercialization rights to trilaciclib. In the U.S. and Puerto Rico, G1 will lead marketing, market access and medical engagement initiatives; Boehringer Ingelheim will lead sales force engagements. G1 will make initial payments to Boehringer Ingelheim to cover start-up expenses and pre-approval initiatives to support a successful commercial launch. G1 will pay a promotion fee of a mid-twenties percentage of net sales in the first year of commercialization, which decreases to a low double-digit/high single-digit percentage in the second and third years of commercialization, respectively (subject to certain adjustments for sales above pre-specified levels to reward out-performance). There are no payments due by either party beyond the expiration of the three-year term of the agreement. The agreement does not extend to additional indications that G1 may pursue for trilaciclib.

Boehringer Ingelheims commitment to transform treatment expectations for the oncology community extends beyond research and drives us to explore innovative solutions for patients. We are pleased to be collaborating with G1 Therapeutics and applying our commercial strengths focused on lung cancer to support a new therapy for patients with clear synergies across customer audiences, said Kelli Moran, Senior Vice President, Specialty Care, Boehringer Ingelheim. This strategic agreement builds on Boehringer Ingelheims achievements in oncology and contributes to our long-term vision to give patients new hopeby taking cancer on.

G1 received Breakthrough Therapy Designation for trilaciclib from the U.S. Food and Drug Administration (FDA) in 2019 and submitted a New Drug Application (NDA) in June 2020. More than 25,000 people in the U.S. and Puerto Rico are diagnosed with SCLC each year. Approximately 90% of SCLC patients receive first-line chemotherapy treatment, and approximately 60% of those patients receive subsequent second-line chemotherapy treatment. Chemotherapy is an effective and important weapon against cancer. However,chemotherapy does not differentiate between healthy cells and cancer cells and kills both. One of the most common side effects of chemotherapy is myelosuppression the result of damage to stem cells in the bone marrow that produce white blood cells, red blood cells and platelets. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions. Immune cell damage may decrease the ability of the immune system to fight the cancer, as well as infection. Trilaciclib has the potential to be the first proactively administered myelopreservation therapy that can make chemotherapy safer and improve the patient experience.

Additional information regarding this agreement is disclosed in a Current Report on Form 8-K filed by G1 with the U.S. Securities and Exchange Commission (available here).

About TrilaciclibTrilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation based on positive myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with small cell lung cancer (SCLC). In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered prior to chemotherapy. In June 2020, G1 submitted a New Drug Application (NDA) for trilaciclib for myelopreservation in SCLC and began a study in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL. The company expects to initiate a Phase 3 trial in colorectal cancer in the fourth quarter of 2020.

About G1 TherapeuticsG1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

About Boehringer Ingelheim in OncologyCancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hopeby taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science.Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approachesto help combat many cancers.

About Boehringer IngelheimMaking new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities.Please visit http://www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives. For more information, please visit http://www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

G1 Therapeutics Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in theU.S. for trilaciclib in SCLC, trilaciclibs possibility to improve patient outcomes across multiple indications, rintodestrants potential to be best-in-class oral SERD, lerociclibs differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and the impact of pandemics such as COVID-19 (coronavirus), and are based on the companys expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the companys actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the companys filings with theU.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the companys ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the companys initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:Jeff MacdonaldG1 Therapeutics, Inc.Senior Director, Investor Relations & Corporate Communications919-907-1944jmacdonald@g1therapeutics.comSusan HolzBoehringer IngelheimDirector, Public Relations203-798-4265Susan.holz@boehringer-ingelheim.com

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Global Impact of Covid-19 on Hematology Instruments and Reagents Market to Witness Promising Growth Opportunities During 20202026 with Top Leading…

By daniellenierenberg

Latest Research Report: Hematology Instruments and Reagents industry

This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

Global Hematology Instruments and Reagents Market documents a detailed study of different aspects of the Global Market. It shows the steady growth in market in spite of the fluctuations and changing market trends. The report is based on certain important parameters.

Hematology instruments are machines that analyze blood. Used in medical labs, hematology instruments can do blood counts, detect proteins or enzymes, and help to diagnose illnesses or genetic defects.Hematology is the branch of medicine which deals with the study, diagnosis, and treatment of blood-related disorders. It diagnoses issues related to white blood cells, red blood cells, platelets, bone marrow, and lymph nodes. Hematology also deals with the liquid portion of blood known as plasma. Some blood-associated diseases are anemia, leukemia, myelofibrosis, blood transfusion, malignant lymphomas, and bone marrow stem cell transplantation.

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Hematology Instruments and Reagents Market competition by top manufacturers as follow: , Sysmex, Danaher, Nihon Kohden, Siemens, Abbott Laboratories, Boule Diagnostics, HORIBA, Diatron, Drew Scientific, EKF Diagnostics, Mindray, Roche

The risingtechnology in Hematology Instruments and Reagentsmarketis also depicted in thisresearchreport. Factors that are boosting the growth of the market, and giving a positive push to thrive in the global market is explained in detail. It includes a meticulous analysis of market trends, market shares and revenue growth patterns and the volume and value of the market. It is also based on a meticulously structured methodology. These methods help to analyze markets on the basis of thorough research and analysis.

The Type Coverage in the Market are: Hematology InstrumentsHematology Reagents

Market Segment by Applications, covers:Stand-Alone HospitalsCommercial OrganizationsClinical Testing LabsResearch Institutes

The research report summarizes companies from different industries. This Hematology Instruments and Reagents Market report has been combined with a variety of market segments such as applications, end users and sales. Focus on existing market analysis and future innovation to provide better insight into your business. This study includes sophisticated technology for the market and diverse perspectives of various industry professionals.

Hematology Instruments and Reagents is the arena of accounting worried with the summary, analysis and reporting of financial dealings pertaining to a business. This includes the training of financial statements available for public ingesting. The service involves brief, studying, checking and reporting of the financial contacts to tax collection activities and objects. It also involves checking and making financial declarations, scheming accounting systems, emerging finances and accounting advisory.

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Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaRest of Asia PacificCentral & South AmericaMiddle East & Africa

Report Highlights: Detailed overview of parent market Changing market dynamics in the industry In-depth market segmentation Historical, current and projected market size in terms of volume and value Recent industry trends and developments Competitive landscape Strategies of key players and products offered Potential and niche segments, geographical regions exhibiting promising growth A neutral perspective on market performance Must-have information for market players to sustain and enhance their market footprint

Access full Report Description, TOC, Table of Figure, Chart, [emailprotected] https://reportsinsights.com/industry-forecast/Hematology-Instruments-and-Reagents-Market-86225

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Global Impact of Covid-19 on Hematology Instruments and Reagents Market to Witness Promising Growth Opportunities During 20202026 with Top Leading...

To Read More: Global Impact of Covid-19 on Hematology Instruments and Reagents Market to Witness Promising Growth Opportunities During 20202026 with Top Leading…
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