In the current situation of restricted movement and reduced workforce, (due to COVID-19 Pandemic) new technologies have been developed to provide end-to-end automation in different sectors such as food processing. Automated systems are hired by the companies to ensure continued supply and manufacturing of products with the least manual interference

The advent of Health Information Technology (HIT) components such as electronic health records (EHR), hospital information systems (HIS), picture archiving and communication systems (PACS), and vendor neutral archives (VNA) has had just as transformational an impact on the overall healthcare sector as the concerns regarding security and privacy. Data theft, undue access to personal health records, and cyber-attacks are very real threats that the healthcare sector faces today.

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

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The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

The global market for myelofibrosis treatment is segmented on basis of treatment type, end user and geography:

As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

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On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

Some of the key market players in the global myelofibrosis treatment market are Incyte Corporation, Novartis AG, Celgene Corporation, Mylan Pharmaceuticals Ulc., Bristol-Myers Squibb Company, Eli Lilly and Company, Taro Pharmaceuticals Inc., AllCells LLC, Lonza Group Ltd., ATCC Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

Our unmatched research methodologies set us apart from our competitors. Heres why:PMRs set of research methodologies adhere to the latest industry standards and are based on sound surveys.We are committed to preserving the objectivity of our research.Our analysts customize the research methodology according to the market in question in order to take into account the unique dynamics that shape the industry.Our proprietary research methodologies are designed to accurately predict the trajectory of a particular market based on past and present data.PMRs typical operational model comprises elements such as distribution model, forecast of market trends, contracting and expanding technology applications, pricing and transaction model, market segmentation, and vendor business and revenue model.

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Global Myelofibrosis Treatment Market to Register Growth in Incremental Opportunity During the Forecast Period 2016 2022 - Cole of Duty

Bone Marrow Stem Cells Comments Off on Global Myelofibrosis Treatment Market to Register Growth in Incremental Opportunity During the Forecast Period 2016 2022 – Cole of Duty | May 26th, 2020

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NEW YORK, May 25, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that clinical outcomes of its allogeneic mesenchymal stem cell (MSC) medicine RYONCIL (remestemcel-L) in children and adults with steroid-refractory acute graft versus host disease (GVHD) have been published in three peer-reviewed articles and an accompanying editorial in the May issue of Biology of Blood and Marrow Transplantation, the official publication of the American Society for Transplantation and Cellular Therapy.

Mesoblast Chief Medical Officer Dr Fred Grossman said: Results from these three trials show a consistent pattern of safety and efficacy for RYONCIL (remestemcel-L) in patients with the greatest levels of inflammation and the most severe grades of acute GVHD. These clinical outcomes provide a compelling rationale for use of remestemcel-L in children and adults with other conditions associated with severe inflammation and cytokine release, including acute respiratory distress syndrome (ARDS) and systemic vascular manifestations of COVID-19 infection.

In the accompanying editorial, Dr Jacques Galipeau, Professor and Assistant Dean of Medicine at the Stem Cell & Regenerative Medicine Center at the University of WisconsinMadison and Chair of the International Society of Cell and Gene Therapy (ISCT) MSC Committee, concluded that after more than a decade of clinical study involving three distinct advanced trials, it appears that remestemcel-L might well have finally met the regulatory requirements for marketing approval in the United States for steroid refractory acute GVHD in children, and it is to be determined whether this industrial MSC product will find utility for adults afflicted by acute GVHD or other indications.

The trials highlighted in the three articles all evaluated the same treatment regimen of RYONCIL, with patients receiving twice weekly intravenous infusions of 2 million cells per kg body weight over a four-week period. RYONCIL was well-tolerated in all studies with no identified safety concerns. The three trials were:

1. Study 275: An Expanded Access Program in 241 children across 50 centers in eight countries where RYONCIL was used as salvage therapy for steroid-refractory acute GVHD in patients who failed to respond to steroid therapy as well as multiple other agents.

2. Study GVHD001/002: A Phase 3 single-arm trial in 55 children across 20 centers in the United States where RYONCIL was used as the first line of treatment for children who failed to respond to steroids for acute GVHD.

3. Study 280: A Phase 3 randomized placebo-controlled trial in 260 patients, including 28 children, across 72 centers in seven countries where RYONCIL or placebo were added to second line therapy in patients with steroid-refractory acute GVHD who failed to respond to steroid treatment.

About Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3 There are currently no FDA-approved treatments in the United States for children under 12 with steroid-refractory acute GVHD.

About RYONCILTM Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR-aGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

References 1. Niederwieser D, Baldomero H, Szer J. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplant 2016; 51(6):778-85.2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology 2011;2011:601953.3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation 2019;54(11):1805-1814.

About MesoblastMesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblast and its collaborators clinical studies; Mesoblast and its collaborators ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved; the potential benefits of strategic collaboration agreements and Mesoblasts ability to maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

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Clinical Outcomes Using RYONCIL (remestemcel-L) in Children and Adults With Severe Inflammatory Graft Versus Host Disease Published in Three Articles...

Bone Marrow Stem Cells Comments Off on Clinical Outcomes Using RYONCIL (remestemcel-L) in Children and Adults With Severe Inflammatory Graft Versus Host Disease Published in Three Articles… | May 25th, 2020

Market Expertz has very recently published a report on the Stem Cell Banking market, which delves deeper into a bunch of insightful as well as comprehensive information about the Stem Cell Banking industrys ecosystem. The research report on the Stem Cell Banking market covers both qualitative as well as quantitative details that focus entirely on the various parameters such as Stem Cell Banking market risk factors, challenges, industrial developments, new opportunities available in the Stem Cell Banking report. These factors are the ones that determine the functioning and trends in the forecasted period for the market.

This is the most recent report inclusive of the COVID-19 effects on the functioning of the market. It is well known that some changes, for the worse, were administered by the pandemic on all industries. The current scenario of the business sector and pandemics impact on the past and future of the industry are covered in this report.

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With the growing number of new players entering the Stem Cell Banking market, expansion in businesses is also improving. Then Stem Cell Banking report focuses on boosting a series of parameters such as revenue shares, optimizing cost structure, offering better services, Stem Cell Banking market demand or supply chain, development policies, which mainly maps to streamline business processes during the projected timeline.

The fundamental drivers, as well as restraints, are identified by the recent trends and historical milestones gathered by the Stem Cell Banking market. It also demonstrates the brief evaluation of the investments, Stem Cell Banking production, innovative technologies, and growth rate of the specific businesses.

Leading Stem Cell Banking manufacturers/companies operating at both regional and global levels:

Cord Blood Registry (CBR) Systems (US), Cordlife Group Limited (Singapore), Cryo-Cell International (US), ViaCord (US), Cryo-Save AG (Netherlands), LifeCell International (India), StemCyte (US), Global Cord Blood Corporation (China), Smart Cells International (UK), Vita34 AG (Germany), and CryoHoldco (Mexico).

The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.

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The creative advancements are investigated widely to understand the probable impact on the growth of the global Stem Cell Banking market.

The Stem Cell Banking market has been segmented into key segments such as product types, end-users, leading regions, and noteworthy players. The readers can assess detailed and strategical information about each segment. The Stem Cell Banking market report also includes a blend of statistics about sales, consumption rate, volume, value, gross margin, and more.

The segmentation included in the report is beneficial for readers to capitalize on the selection of appropriate segments for the Stem Cell Banking sector and can help companies in deciphering the optimum business move to reach their desired business goals.

product landscape:

Placental Stem Cells (PSCS), Adipose Tissue-Derived Stem Cells (ADSCS), Bone Marrow-Derived Stem Cells (BMSCS), Human Embryo-Derived Stem Cells , (HESCS), Dental Pulp-Derived Stem Cells (DPSCS)

Application landscape:

Sample Preservation and Storage, Sample Analysis, Sample Processing, Sample Collection and Transportation

End user landscape:

Personalized Banking Applications, Research, Clinical Application

The report includes accurately drawn facts and figures, along with graphical representations of vital market data. The research report sheds light on the emerging market segments and significant factors influencing the growth of the industry to help investors capitalize on the existing growth opportunities.

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Thus, with the rising adoption of the Stem Cell Banking market in the international sector, the industry for the global Stem Cell Banking market is expected to represent a predicted outlook during the forecast phase from 2020-2027. Additionally, the report on the Stem Cell Banking market delivers a systematic representation of the growth opportunities, Stem Cell Banking market dynamics, and the existing trends are anticipated to shape the growth of the Stem Cell Banking market across the globe.

Geographically, this report studies the top producers and consumers in these key regions:

North America

Europe

China

Japan

Southeast Asia

India

A conscious effort is made by the subject matter experts to analyze how some business owners succeed in maintaining a competitive edge while the others fail to do so makes the research interesting. A quick review of the realistic competitors makes the overall study a lot more interesting. Opportunities that are helping product owners size up their business further add value to the overall study.

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The Stem Cell Banking Market Research/Analysis Report addresses the following questions:

Read the full Research Report along with a table of contents, facts and figures, charts, graphs, etc. @ https://www.marketexpertz.com/industry-overview/2020-stem-cell-banking-global-market

To summarize, the global Stem Cell Banking market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Impact of Covid-19 on Stem Cell Banking Market 2020: Remarking Enormous Growth with Recent Trends | Cord Blood Registry (CBR) Systems (US), Cordlife...

Bone Marrow Stem Cells Comments Off on Impact of Covid-19 on Stem Cell Banking Market 2020: Remarking Enormous Growth with Recent Trends | Cord Blood Registry (CBR) Systems (US), Cordlife… | May 25th, 2020

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The killer is not the virus but the immune response.

The current pandemic is unique not just because it is caused by a new virus that puts everyone at risk, but also because the range of innate immune responses is diverse and unpredictable. In some it is strong enough to kill. In others it is relatively mild.

My research relates to innate immunity. Innate immunity is a persons inborn defense against pathogens that instruct the bodys adaptive immune system to produce antibodies against viruses. Those antibody responses can be later used for developing vaccination approaches. Working in the lab of Nobel laureate Bruce Beutler, I co-authored the paper that explained how the cells that make up the bodys innate immune system recognize pathogens, and how overreacting to them in general could be detrimental to the host. This is especially true in the COVID-19 patients who are overreacting to the virus.

Also read: All the Covid-19 symptoms you didnt know about

I study inflammatory response and cell death, which are two principal components of the innate response. White blood cells called macrophages use a set of sensors to recognize the pathogen and produce proteins called cytokines, which trigger inflammation and recruit other cells of the innate immune system for help. In addition, macrophages instruct the adaptive immune system to learn about the pathogen and ultimately produce antibodies.

To survive within the host, successful pathogens silence the inflammatory response. They do this by blocking the ability of macrophages to release cytokines and alert the rest of the immune system. To counteract the viruss silencing, infected cells commit suicide, or cell death. Although detrimental at the cellular level, cell death is beneficial at the level of the organism because it stops proliferation of the pathogen.

For example, the pathogen that caused the bubonic plague, which killed half of the human population in Europe between 1347 and 1351, was able to disable, or silence, peoples white blood cells and proliferate in them, ultimately causing the death of the individual. However, in rodents the infection played out differently. Just the infected macrophages of rodents died, thus limiting proliferation of the pathogen in the rodents bodies which enabled them to survive.

The silent response to plague is strikingly different from the violent response to SARS-CoV-2, the virus that causes COVID-19. This suggests that keeping the right balance of innate response is crucial for the survival of COVID-19 patients.

Also read: If I had Covid-19 am I immune? This is what scientists know so far

Heres how an overreaction from the immune system can endanger a person fighting off an infection.

Some of the proteins that trigger inflammation, named chemokines, alert other immune cells like neutrophils, which are professional microbe eaters to convene at the site of infections where they can arrive first and digest the pathogen.

Others cytokines such as interleukin 1b, interleukin 6 and tumor necrosis factor guide neutrophils from the blood vessels to the infected tissue. These cytokines can increase heartbeat, elevate body temperature, trigger blood clots that trap the pathogen and stimulate the neurons in the brain to modulate body temperature, fever, weight loss and other physiological responses that have evolved to kill the virus.

When the production of these same cytokines is uncontrolled, immunologists describe the situation as a cytokine storm. During a cytokine storm, the blood vessels widen further (vasolidation), leading to low blood pressure and widespread blood vessel injury. The storm triggers a flood of white blood cells to enter the lungs, which in turn summon more immune cells that target and kill virus-infected cells. The result of this battle is a stew of fluid and dead cells, and subsequent organ failure.

The cytokine storm is a centerpiece of the COVID-19 pathology with devastating consequences for the host.

When the cells fail to terminate the inflammatory response, production of the cytokines make macrophages hyperactive. The hyperactivated macrophages destroy the stem cells in the bone marrow, which leads to anemia. Heightened interleukin 1b results in fever and organ failure. The excessive tumor necrosis factor causes massive death of the cells lining the blood vessels, which become clotted. At some point, the storm becomes unstoppable and irreversible.

One strategy behind the treatments for COVID is, in part, based in part on breaking the vicious cycle of the cytokine storm. This can be done by using antibodies to block the primary mediators of the storm, like IL6, or its receptor, which is present on all cells of the body.

Inhibition of tumor necrosis factor can be achieved with FDA-approved antibody drugs like Remicade or Humira or with a soluble receptor such as Enbrel (originally developed by Bruce Beutler) which binds to tumor necrosis factor and prevents it from triggering inflammation. The global market for tumor necrosis factor inhibitors is US$22 billion.

Drugs that block various cytokines are now in clinical trials to test whether they are effective for stopping the deadly spiral in COVID-19.

Alexander (Sasha) Poltorak, Professor of Immunology, Tufts University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Also read: Covid vaccine research in India at nascent stage, breakthrough unlikely this year: Experts

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Coronavirus isnt the killer, our immune response is - ThePrint

Bone Marrow Stem Cells Comments Off on Coronavirus isnt the killer, our immune response is – ThePrint | May 25th, 2020

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.

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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.

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

Covid 19 Impact [emailprotected] https://www.trendsmarketresearch.com/report/covid-19-analysis/3184

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Bone Marrow Processing System Market: Development Factors and Investment Analysis by Leading Manufacturers - Cole of Duty

Bone Marrow Stem Cells Comments Off on Bone Marrow Processing System Market: Development Factors and Investment Analysis by Leading Manufacturers – Cole of Duty | May 24th, 2020

Bone marrow aspirationand 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.

Get More Information at Professional:https://www.trendsmarketresearch.com/report/sample/3374

Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants areconducted in Europe, and it is oneof the major factors contributing to the lucrative share in the cell harvesting system market.

In 2018, 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.

More Info of Impact Covid19 @ https://www.trendsmarketresearch.com/report/covid-19-analysis/3374

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Bone Marrow Processing Systems Market Quantitative Market Analysis, Current and Future Trends the COVID-19 - Cole of Duty

Bone Marrow Stem Cells Comments Off on Bone Marrow Processing Systems Market Quantitative Market Analysis, Current and Future Trends the COVID-19 – Cole of Duty | May 24th, 2020

The killer is not the virus but the immune response.

The current pandemic is unique not just because it is caused by a new virus that puts everyone at risk, but also because the range of innate immune responses is diverse and unpredictable. In some it is strong enough to kill. In others, it is relatively mild.

My research relates to innate immunity. Innate immunity is a persons inborn defense against pathogens that instruct the bodys adaptive immune system to produce antibodies against viruses. Those antibody responses can be later used for developing vaccination approaches. Working in the lab of Nobel laureate Bruce Beutler, I co-authored the paper that explained how the cells that make up the bodys innate immune system recognise pathogens, and how overreacting to them in general could be detrimental to the host. This is especially true in the Covid-19 patients who are overreacting to the virus.

I study inflammatory response and cell death, which are two principal components of the innate response. White blood cells called macrophages use a set of sensors to recognise the pathogen and produce proteins called cytokines, which trigger inflammation and recruit other cells of the innate immune system for help. In addition, macrophages instruct the adaptive immune system to learn about the pathogen and ultimately produce antibodies.

To survive within the host, successful pathogens silence the inflammatory response. They do this by blocking the ability of macrophages to release cytokines and alert the rest of the immune system. To counteract the viruss silencing, infected cells commit suicide, or cell death. Although detrimental at the cellular level, cell death is beneficial at the level of the organism because it stops proliferation of the pathogen.

For example, the pathogen that caused the bubonic plague, which killed half of the human population in Europe between 1347 and 1351, was able to disable, or silence, peoples white blood cells and proliferate in them, ultimately causing the death of the individual. However, in rodents the infection played out differently. Just the infected macrophages of rodents died, thus limiting proliferation of the pathogen in the rodents bodies which enabled them to survive.

The silent response to plague is strikingly different from the violent response to SARS-CoV-2, the virus that causes Covid-19. This suggests that keeping the right balance of innate response is crucial for the survival of Covid-19 patients.

Heres how an overreaction from the immune system can endanger a person fighting off an infection. Some of the proteins that trigger inflammation, named chemokines, alert other immune cells like neutrophils, which are professional microbe eaters to convene at the site of infections where they can arrive first and digest the pathogen.

Others cytokines such as interleukin 1b, interleukin 6 and tumor necrosis factor guide neutrophils from the blood vessels to the infected tissue. These cytokines can increase heartbeat, elevate body temperature, trigger blood clots that trap the pathogen and stimulate the neurons in the brain to modulate body temperature, fever, weight loss and other physiological responses that have evolved to kill the virus.

When the production of these same cytokines is uncontrolled, immunologists describe the situation as a cytokine storm. During a cytokine storm, the blood vessels widen further a process known an vasolidation leading to low blood pressure and widespread blood vessel injury. The storm triggers a flood of white blood cells to enter the lungs, which in turn summon more immune cells that target and kill virus-infected cells. The result of this battle is a stew of fluid and dead cells, and subsequent organ failure.

The cytokine storm is a centerpiece of the Covid-19 pathology with devastating consequences for the host.

When the cells fail to terminate the inflammatory response, production of the cytokines make macrophages hyperactive. The hyperactivated macrophages destroy the stem cells in the bone marrow, which leads to anemia. Heightened interleukin 1b results in fever and organ failure. The excessive tumor necrosis factor causes massive death of the cells lining the blood vessels, which become clotted. At some point, the storm becomes unstoppable and irreversible.

One strategy behind the treatments for Covid-19 is, in part, based on breaking the vicious cycle of the cytokine storm. This can be done by using antibodies to block the primary mediators of the storm, like IL6, or its receptor, which is present on all cells of the body.

Inhibition of tumor necrosis factor can be achieved with FDA-approved antibody drugs like Remicade or Humira or with a soluble receptor such as Enbrel originally developed by Bruce Beutler which binds to tumor necrosis factor and prevents it from triggering inflammation. The global market for tumor necrosis factor inhibitors is $22 billion.

Drugs that block various cytokines are now in clinical trials to test whether they are effective for stopping the deadly spiral in Covid-19.

Alexander (Sasha) Poltorak, Professor of Immunology, Tufts University.

This article first appeared on The Conversation.

Read the rest here:
What is a cytokine storm? And why is its prevention key to treating Covid-19? - Scroll.in

Bone Marrow Stem Cells Comments Off on What is a cytokine storm? And why is its prevention key to treating Covid-19? – Scroll.in | May 24th, 2020

COVID-19 is not an equal-opportunity illness. Older people and patients with chronic conditions are, on average, far more vulnerable to suffering serious illness and death from the disease than younger people without ongoing health problems. Although the data are not as clear, cancer patients are also among those vulnerable to the SARS-CoV-2 virus that causes COVID-19 and more likely to suffer its serious consequences.

Oncologists around the country, supported and informed by guidance from healthcare leaders and professional associations, are reviewing the available research and carefully weighing treatment decisions. Many patients, with their physicians, are wrestling with question of whether the risks associated with putting off their cancer treatment are greater than the risk of COVID-19.

Randall Oyer, M.D., a medical oncologist at Lancaster General Health, a health system in Lancaster, Pennsylvania, says that in addition to understanding that cancer patients are a vulnerable group, healthcare leaders need to recognize that cancer patients are at heightened risk of contracting COVID-19 in the hospital.

Oyer says research from early COVID-19 hot spots such as China, Italy and the Seattle area suggests that patients with lung, liver and some types of gastrointestinal tumors, as well as hematologic malignancies, are at greater risk of suffering COVID-19 than patients with other kinds of cancer. Sparse as these data may be, they should still guide decision-making by oncologists and healthcare leaders, Oyer says. Many professional associations are providing guidance to oncologists during the outbreak, including the Association of Community Cancer Centers (Oyer is the president), the American Society of Clinical Oncology, the American Society of Hematology, the American Society for Radiation Oncology and the American College of Surgeons.

Agility and collaboration

Patients with cancers of the lung, the liver and possibly the gastrointestinal system are at increased risk of COVID-19 because the SARS-CoV-2 virus attaches to the angiotensin-converting enzyme 2 (ACE2) that is highly expressed in these organs and system, explains Oyer. ACE2 paves the way to cancer cells in these areas and acts as a welcome mat for SARS-CoV-2, he says.

Its a different story with hematologic cancers, which include the leukemias, the lymphomas and multiple myeloma. The cancers themselves reduce immunity and make people vulnerable to infection because they interfere with the production of healthy levels of lymphocytes. In addition, the treatment of hematologic cancers targets the immune system and the bone marrow to get rid of the malignant cells, but it also affects noncancerous cells, further suppressing the patients immunologic defenses. Oyer describes the process as one in which the bouncers (been) removed from the door and cant defend against the virus.

Masumi Ueda, M.D., M.A., assistant medical director for inpatient blood and bone marrow transplant at the Seattle Cancer Care Alliance, a hospital in its namesake city, says patients with compromised immune systems should adhere to the core recommendations for preventing COVID-19: Wash your hands, and maintain social distancing. Aside from that, theres not much more than we can do in the absence of a vaccine, she says.

Ueda was the lead author of an article in the April 2020 issue of the Journal of the National Comprehensive Cancer Network describing the changes that the Seattle cancer hospital made in response to the COVID-19 outbreak. The title is telling: Managing Cancer Care During the COVID-19 Pandemic: Agility and Collaboration Toward a Common Goal. Ueda and her colleagues mingled advice with brief accounts of the steps they took to respond to COVID-19:

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Cancer Care in the Time of COVID-19 and After - Managed Healthcare Executive

Bone Marrow Stem Cells Comments Off on Cancer Care in the Time of COVID-19 and After – Managed Healthcare Executive | May 23rd, 2020

Courtesy of Alexander (Sasha) Poltorak, Tufts University

The killer is not the virus but the immune response.

The current pandemic is unique not just because it is caused by a new virus that puts everyone at risk, but also because the range of innate immune responses is diverse and unpredictable. In some it is strong enough to kill. In others it is relatively mild.

My research relates to innate immunity. Innate immunity is a persons inborn defense against pathogens that instruct the bodys adaptive immune system to produce antibodies against viruses. Those antibody responses can be later used for developing vaccination approaches. Working in the lab of Nobel laureate Bruce Beutler, I co-authored the paper that explained how the cells that make up the bodys innate immune system recognize pathogens, and how overreacting to them in general could be detrimental to the host. This is especially true in the COVID-19 patients who are overreacting to the virus.

I study inflammatory response and cell death, which are two principal components of the innate response. White blood cells called macrophages use a set of sensors to recognize the pathogen and produce proteins called cytokines, which trigger inflammation and recruit other cells of the innate immune system for help. In addition, macrophages instruct the adaptive immune system to learn about the pathogen and ultimately produce antibodies.

To survive within the host, successful pathogens silence the inflammatory response. They do this by blocking the ability of macrophages to release cytokines and alert the rest of the immune system. To counteract the viruss silencing, infected cells commit suicide, or cell death. Although detrimental at the cellular level, cell death is beneficial at the level of the organism because it stops proliferation of the pathogen.

For example, the pathogen that caused the bubonic plague, which killed half of the human population in Europe between 1347 and 1351, was able to disable, or silence, peoples white blood cells and proliferate in them, ultimately causing the death of the individual. However, in rodents the infection played out differently. Just the infected macrophages of rodents died, thus limiting proliferation of the pathogen in the rodents bodies which enabled them to survive.

The silent response to plague is strikingly different from the violent response to SARS-CoV-2, the virus that causes COVID-19. This suggests that keeping the right balance of innate response is crucial for the survival of COVID-19 patients.

Heres how an overreaction from the immune system can endanger a person fighting off an infection.

Some of the proteins that trigger inflammation, named chemokines, alert other immune cells like neutrophils, which are professional microbe eaters to convene at the site of infections where they can arrive first and digest the pathogen.

Others cytokines such as interleukin 1b, interleukin 6 and tumor necrosis factor guide neutrophils from the blood vessels to the infected tissue. These cytokines can increase heartbeat, elevate body temperature, trigger blood clots that trap the pathogen and stimulate the neurons in the brain to modulate body temperature, fever, weight loss and other physiological responses that have evolved to kill the virus.

When the production of these same cytokines is uncontrolled, immunologists describe the situation as a cytokine storm. During a cytokine storm, the blood vessels widen further (vasolidation), leading to low blood pressure and widespread blood vessel injury. The storm triggers a flood of white blood cells to enter the lungs, which in turn summon more immune cells that target and kill virus-infected cells. The result of this battle is a stew of fluid and dead cells, and subsequent organ failure.

The cytokine storm is a centerpiece of the COVID-19 pathology with devastating consequences for the host.

When the cells fail to terminate the inflammatory response, production of the cytokines make macrophages hyperactive. The hyperactivated macrophages destroy the stem cells in the bone marrow, which leads to anemia. Heightened interleukin 1b results in fever and organ failure. The excessive tumor necrosis factor causes massive death of the cells lining the blood vessels, which become clotted. At some point, the storm becomes unstoppable and irreversible.

One strategy behind the treatments for COVID is, in part, based in part on breaking the vicious cycle of the cytokine storm. This can be done by using antibodies to block the primary mediators of the storm, like IL6, or its receptor, which is present on all cells of the body.

Inhibition of tumor necrosis factor can be achieved with FDA-approved antibody drugs like Remicade or Humira or with a soluble receptor such as Enbrel (originally developed by Bruce Beutler) which binds to tumor necrosis factor and prevents it from triggering inflammation. The global market for tumor necrosis factor inhibitors is US$22 billion.

Drugs that block various cytokines are now in clinical trials to test whether they are effective for stopping the deadly spiral in COVID-19.

[Get facts about coronavirus and the latest research. Sign up for The Conversations newsletter.]

Alexander (Sasha) Poltorak, Professor of Immunology, Tufts University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Read more:
Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 - TheStreet

Bone Marrow Stem Cells Comments Off on Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 – TheStreet | May 23rd, 2020

Before he knew Anuroop, Vihaan (right) addressed him as the Superhero.

Vihaan is a bright and active 4-year-old boy. He is a thalassemia survivor. And just over a year ago, he desperately needed a bone marrow transplant.

Anuroop, is a young man from Kerala. He doesn't know Vihaan's family. He just felt that donating bone marrow for someone in need was the right thing to do after he got a call from Datri, a non-profit agency coordinating such donations.

Anuroop told NDTV, "Actually, it was a matter of choice. I got a call from Datri about one year ago and they discussed with me this matter. They said, 'A 4 year old child, he is suffering from Thalassemia. Maybe only you can save him.' But at that point, I was not sure that I would do it. But later, with the support of my family and people from Datri, I decided to do it."

Anuroop and Vihaan came face to face - on camera - for the first time ever on NDTV. Anuroop was clearly emotional as he saw images of an active Vihaan, flanked by his parents, grinning and waving at the screen. Bhavana, Vihaan's mother was emotional too as she set eyes for the first time on Anuroop, who has given the family life and hope.

She told NDTV, "He is the answer to all our prayers. When Vihaan was diagnosed when he was 6 months old, we didn't know how Vihaan is going to be. We didn't know what to do. And then we went to Dr Sunil Bhatt and we registered with Datri. They told us that the procedure of finding a match is very difficult. And then we found a donor so we just couldn't believe that we were blessed to find a donor. Those were anxious days. But yeah, glad now."

Asked how her son was doing, Bhavana said, "Young Vihaan is doing great, thanks to Dr Sunil, thanks to Anuroop and thanks to God's grace. Vihaan is doing well."

Looking at the screen in front of her which showed, Anuroop, Dr Bhatta and Gayathri Shenoy of Datri, she told her son '"Just say hi, Vihaan!" He did, with a cheery wave.

Anuroop was moved by the response. He said, "I'm super excited - I waited for too long. I waited for one year. From that day of donation, the whole family, he was always in my prayers. I'm super excited now. That's all."

Finding a matching donor in a case like this is a very difficult task. Vihaan's doctor, Dr Sunil Bhatt, is HoD, Paediatric Haematology, Oncology, Bone Marrow Transplantation at the Mazumdar Shaw Cancer Centre in Bengaluru. And this professional medical man admitted to the deep emotions he feels at such times when a donor meets a recipient. "It gives me goosebumps," he told NDTV.

"You do so many times, again and again, but every time when an unrelated donor meets a patient - it is always an emotional moment for all of us," he said.

"Vihaan was diagnosed with a disease called Thalassemia at six months of age. What happens in this disease is that they don't make their own blood. So they have to be given blood transfusions from outside every few weeks to sustain life and that is life-long. But what blood does is it brings its own complications along with it and many of those and unfortunately most of these children do not live more than second or third decade of life. So the only cure for this is bone marrow transplantation and as we all know for Bone Marrow Transplantation we need someone to donate for them. There has to be a healthy donor who can donate," he said.

To find a matching donor is far from easy. Dr Bhatt said, "Sometimes you'll find that in the families - the chances of that being 25-30 per cent. But 70 per cent of the patients who require transplants will not have anyone in their families to donate for them. So here comes the role of unrelated donor transplantations that means someone else in the same country, in the world who matches the patient. And the chances of that being one in 20,000 to one in a million. So it depends on what ethnic background you're from - South Indian is going to match South Indian, North Indian going to match North Indian - chances will be higher in your own ethnic community. And hence the registries play a huge role because they enrol these unrelated healthy donors, put them on their database and when patients like Vihaan require such transplantation we approach these registries and ask them if there is any donor in the registry who is matching our patient. If there is one, that person is requested to donate and they donate stem cells to save someone's life."

Datri helped coordinate this life saving procedure with its all-important database. Gayathri Shenoy, Head-Patient Relations of Datri told NDTV, "I represent Datri which is India's largest blood stem cell registry. We are 10 years old and we have about 4.4 lakh registered donors and 712 donations of that. But as you can imagine that is a very small number compared to the population of our country because there are so many patients who have blood cancer who are waiting for their Anuroop to show up."

Asked if it had been physically difficult to donate bone marrow, Anuroop said, "Physically not that hard - like I need some rest but it is not that hard. Anyone can do it anytime if they find a match. I didn't find it very difficult and all. I heard some cases like people will be hesitant to do something like this - but I didn't find anything that should people hesitate. It is an easy process and you would be given a general anaesthesia. You won't be knowing anything."

Bhavana said, We just wanted to say that everyday in our prayers all of these people have been there. We didn't know the donor - so he was just addressed as the Superhero Donor, because it was very difficult to make Vihaan understand. Dr. Sunil, Datri - I don't know what we would have done if it was not for Datri. So just feeling blessed.

Here is the original post:
When A Bone Marrow Donor Met His 4-Year-Old Recipient For The First Time - NDTV

Bone Marrow Stem Cells Comments Off on When A Bone Marrow Donor Met His 4-Year-Old Recipient For The First Time – NDTV | May 22nd, 2020

THE world's top sports stars are preferring to use stem cell treatment, instead of undergoing major surgery that could leave them out for months.

Cristiano Ronaldo, Rafael Nadal, and most recently Mike Tyson have all tried the therapy, which can cost anywhere from 4,000 to 15,000, when they've suffered injury.

Ailments that can be treated, include tendon inflammation, muscle strain, arthritis, degenerative disc disease, and even bone fractures.

And sportsman who have undergone stem cell therapy are benefitting from improved results, as well as a faster recovery time.

Collected from the blood from a newborn babys umbilical cord, the bone marrow or from body fat, stem cells are injected into an athletes' affected area.

They get to work by replenishing damaged cells from an injury or through wear and tear.

Stem cells also help reduce pain and inflammation, increase blood flow, and promote soft-tissue growth.

It helps the body to heal naturally, and means sports stars can potentially avoid going under the surgeon's knife.

When you're a top sports star, if you get injured the first thing you want to do is get back into the thick of action as quick as possible.

Unfortunately, many injuries can take a long time to heal, and will never allow the sportsman in question to return to the same level he/she was at before the injury.

That's where stem cell treatment is a game-changer.

Forget surgery, steroid injections, and lengthy physiotherapy, which don't always repair the issue at hand.

Stem cell treatments offer an alternative, albeit at a price, to have a non-surgical therapy that's non-evasive and, more importantly, heals the problem fast cutting out the need of rehabilitation.

Better still, some patients have reported that the therapy has not only reversed existing damage, but has strengthened cells against further damage.

Juventus star Ronaldo and Spanish tennis hero Nadal are all fans of stem cell treatment.

Back in 2016, when the Portuguese forward was playing for Real Madrid, he suffered a hamstring tear that threatened to keep him out of action of an important Champions League game against Manchester City.

Although he missed the first leg, he was back for the second - less than three weeks after suffering the problem.

That same year, Ronaldo tore a collateral ligament in his knee during Portugals Euro 2016 final against France.

Again, he turned to stem cell treatment and was back in training with Los Blancos just a month after his knee complaint.

Nadal's chronic knee problems forced him to take seven months off from tennis in 2013.

But stem cell treatment allowed the cartilage to repair. In the seven years since he's won six Grand Slams, there's been no setbacks from his troublesome knee and he appears as mobile as ever.

The Spaniard also cured a long-standing back problem with the therapy.

The former heavyweight champion, who is considering making a comeback, is the latest name to have tried stem cell treatment.

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It is not known what Tyson, 53, was suffering from - but he was happy to reveal all in an Instagram chat with basketball legend Shaquille O'Neal.

Iron Mike said: "You know what I had done? I had stem-cell research therapy.

"I feel like a different person but I can't comprehend why I feel this way. It's really wild what scientists can do."

Excerpt from:
Tyson, Ronaldo, and more sports stars who use stem cell treatment costing up to 15,000 to speed up healing - The Sun

Bone Marrow Stem Cells Comments Off on Tyson, Ronaldo, and more sports stars who use stem cell treatment costing up to 15,000 to speed up healing – The Sun | May 22nd, 2020

Leukaemia is the cancer of blood cells. Blood cells originate from HSCs, hematopoietic stem cells, in the bone marrow. Thereafter they undergo maturation process called hematopoiesis. Multipotent hematopoietic stem cells often undergo a process of differentiation while in maturation stage to give rise to progenitor cells of myeloid and lymphoid origin. These Myeloid cells include neutrophils, basophils, monocytes, macrophages, erythrocytes, dendritic cells, eosinophils, and megakaryocytes or platelets. While, Lymphoid cells include B cells, T cells and natural killer cells.

Recently in 2016, Global Leukaemia Therapeutics Market was valued at nearly USD 9.44 billion and is expected to grow at a CAGR of 4.1% between 2017 and 2022, accounting to market worth USD 11.97 billion by end of 2022.

The Final Report will cover the impact analysis of COVID-19 on this industry.

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Normally, the blood forming cells in the bone marrow produce leukocytes, that protects against viruses and bacteria. If these leukocytes get damaged and if they are left untreated they get accumulated in the body and invade in other parts like liver, spleen and central nervous system, hence damaging the entire body. The main reasons causing leukaemia are ionizing radiation, smoking, prior chemotherapy and Down syndrome.

Market Dynamics

Recently in 2016, Global Leukaemia Therapeutics Market was valued at nearly USD 9.44 billion and is expected to grow at a CAGR of 4.1% between 2017 and 2022, accounting to market worth USD 11.97 billion by end of 2022.

Global Leukaemia Therapeutics market is majorly driven by the growing number of incidences of target disease across the globe. Also, development of novel agents, advancements in technology and combination therapy with reduced side effects and better survival conditions are some other key factors that drives the Leukaemia Therapeutics Market.

However, the high cost of combination therapies and clinical trials coupled with post-treatment complications, adverse events and side effects are the major constraints that limit the growth of the market.Nevertheless, initiatives like increasing focus on healthcare and personalized medicine along with huge govt. investment & R&D in anti-leukaemia therapeutics research are sure short to boost the market growth in the near future.

Market SegmentationGlobal Leukaemia Therapeutics Market can be segmented as follows :Segmentation by TypeChronic leukaemiaChronic myeloid leukaemiaChronic lymphatic leukaemiaAcute leukaemiaAcute myeloid leukaemiaAcute lymphatic leukaemia

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Segmentation by TherapyBiological TherapyRadiation therapyChemotherapyTargeted therapy

Regional/Geographic AnalysisEurope, North America, Latin America, Asia-Pacific, Middle East & Africa are key market segments of global Leukaemia Therapeutics. North America is the leading region and is anticipated to remain one in the near future, over the forecast period. Demand for leukaemia therapeutics was highest in North America especially in the U.S attributing to increasing geriatric population and increased number of cases. While, Asia Pacific region along with Middle East, Africa and Latin America is expected to grow at moderate pace.

Key Players

The key players in global leukaemia therapeutics market includeF. Hoffmann-La Roche Ltd., Bristol-Myers Squibb, Amgen, Pfizer, Teva Pharmaceuticals, Novartis International AG., GlaxoSmithKline plc., Genzyme Corporation, AbbVie Inc. and others.

About UsKenneth Research is a reselling agency providing market research solutions in different verticals such as Automotive and Transportation, Chemicals and Materials, Healthcare, Food & Beverage and Consumer Packaged Goods, Semiconductors, Electronics & ICT, Packaging, and Others. Our portfolio includes set of market research insights such as market sizing and market forecasting, market share analysis and key positioning of the players (manufacturers, deals and distributors, etc), understanding the competitive landscape and their business at a ground level and many more. Our research experts deliver the offerings efficiently and effectively within a stipulated time. The market study provided by Kenneth Research helps the Industry veterans/investors to think and to act wisely in their overall strategy formulation.

Contact UsKenneth ResearchEmail:[emailprotected]Phone:+1 313 462 0609

Originally posted here:
Leukaemia Therapeutics Market is expected to grow at a CAGR of 4.1% between 2017 and 2022 - WaterCloud News

Bone Marrow Stem Cells Comments Off on Leukaemia Therapeutics Market is expected to grow at a CAGR of 4.1% between 2017 and 2022 – WaterCloud News | May 22nd, 2020

NantKwest, Inc. (NASDAQ: NK) today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product derived from human bone marrow. NantKwest has entered into an agreement with the National Marrow Donor Program (Be the Match) to provide donor material and has developed automated proprietary methods to expand and generate multiple dose forms utilizing a modular, closed system (GMP-in-a-box) from NantKwest affiliate ImmunityBio, Inc., to expand BM-Allo.MSCs, enabling the scalable manufacture and immediate distribution of cryopreserved BM-Allo.MSC product.

"There is an urgent need to develop broadly accessible treatment options for the devastating outcomes seen in the thousands of COVID-19 patients who are facing severe disease with ARDS and cytopathic storm," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. "While MSC-derived treatments have shown promise in treating patients with ARDS, including those with COVID-19, the ability to scale production to support the overwhelming patient need has been a challenge. Our proprietary GMP-in-a-Box enables the rapid and scalable manufacture of our fully human BM-Allo.MSC product, overcoming this previous limitation to advance a promising new treatment to those patients who are most in need. Due to our proprietary methods, we are well positioned to rapidly advance BM-Allo.MSC during the current wave of COVID-19, with an anticipated trial initiation in Q2."

BM-Allo.MSC is a bone marrow-derived allogenic MSC product being developed to attenuate the inflammatory processes that drive ARDS in severe COVID-19 patients. MSCs are multipotent progenitor cells that give rise to cell types responsible for tissue repair and may restore effective immune function and contribute to viral clearance. Prior work with allogeneic MSC products in patients with ARDS has shown that such treatment is safe and may reduce key markers of inflammatory processes.

Trial Design

The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting. The primary objectives of the study include overall safety and reduction in time on ventilator. The secondary objective will focus on the efficacy of BM-Allo.MSC in reducing the number of days patients require oxygen, duration of hospitalization, and mortality.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering off-the-shelf living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer and/or Covid-19. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells, as well as other therapeutics, as part of the NANT Cancer Vaccine platform as a cancer treatment and/or Covid-19 treatment.

Story continues

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Quarterly Report on Form 10-Q for the Quarter ended March 31, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200518005217/en/

Contacts

Jen HodsonJen@nant.com 562-397-3639

Read the rest here:
NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients - Yahoo...

Bone Marrow Stem Cells Comments Off on NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients – Yahoo… | May 21st, 2020

The killer is not the virus but the immune response.

The current pandemic is unique not just because it is caused by a new virus that puts everyone at risk, but also because the range of innate immune responses is diverse and unpredictable. In some it is strong enough to kill. In others it is relatively mild.

My research relates to innate immunity. Innate immunity is a persons inborn defense against pathogens that instruct the bodys adaptive immune system to produce antibodies against viruses. Those antibody responses can be later used for developing vaccination approaches. Working in the lab of Nobel laureate Bruce Beutler, I co-authored the paper that explained how the cells that make up the bodys innate immune system recognize pathogens, and how overreacting to them in general could be detrimental to the host. This is especially true in the COVID-19 patients who are overreacting to the virus.

I study inflammatory response and cell death, which are two principal components of the innate response. White blood cells called macrophages use a set of sensors to recognize the pathogen and produce proteins called cytokines, which trigger inflammation and recruit other cells of the innate immune system for help. In addition, macrophages instruct the adaptive immune system to learn about the pathogen and ultimately produce antibodies.

To survive within the host, successful pathogens silence the inflammatory response. They do this by blocking the ability of macrophages to release cytokines and alert the rest of the immune system. To counteract the viruss silencing, infected cells commit suicide, or cell death. Although detrimental at the cellular level, cell death is beneficial at the level of the organism because it stops proliferation of the pathogen.

For example, the pathogen that caused the bubonic plague, which killed half of the human population in Europe between 1347 and 1351, was able to disable, or silence, peoples white blood cells and proliferate in them, ultimately causing the death of the individual. However, in rodents the infection played out differently. Just the infected macrophages of rodents died, thus limiting proliferation of the pathogen in the rodents bodies which enabled them to survive.

The silent response to plague is strikingly different from the violent response to SARS-CoV-2, the virus that causes COVID-19. This suggests that keeping the right balance of innate response is crucial for the survival of COVID-19 patients.

Heres how an overreaction from the immune system can endanger a person fighting off an infection.

Some of the proteins that trigger inflammation, named chemokines, alert other immune cells like neutrophils, which are professional microbe eaters to convene at the site of infections where they can arrive first and digest the pathogen.

Others cytokines such as interleukin 1b, interleukin 6 and tumor necrosis factor guide neutrophils from the blood vessels to the infected tissue. These cytokines can increase heartbeat, elevate body temperature, trigger blood clots that trap the pathogen and stimulate the neurons in the brain to modulate body temperature, fever, weight loss and other physiological responses that have evolved to kill the virus.

When the production of these same cytokines is uncontrolled, immunologists describe the situation as a cytokine storm. During a cytokine storm, the blood vessels widen further (vasolidation), leading to low blood pressure and widespread blood vessel injury. The storm triggers a flood of white blood cells to enter the lungs, which in turn summon more immune cells that target and kill virus-infected cells. The result of this battle is a stew of fluid and dead cells, and subsequent organ failure.

The cytokine storm is a centerpiece of the COVID-19 pathology with devastating consequences for the host.

When the cells fail to terminate the inflammatory response, production of the cytokines make macrophages hyperactive. The hyperactivated macrophages destroy the stem cells in the bone marrow, which leads to anemia. Heightened interleukin 1b results in fever and organ failure. The excessive tumor necrosis factor causes massive death of the cells lining the blood vessels, which become clotted. At some point, the storm becomes unstoppable and irreversible.

One strategy behind the treatments for COVID is, in part, based in part on breaking the vicious cycle of the cytokine storm. This can be done by using antibodies to block the primary mediators of the storm, like IL6, or its receptor, which is present on all cells of the body.

Inhibition of tumor necrosis factor can be achieved with FDA-approved antibody drugs like Remicade or Humira or with a soluble receptor such as Enbrel (originally developed by Bruce Beutler) which binds to tumor necrosis factor and prevents it from triggering inflammation. The global market for tumor necrosis factor inhibitors is US$22 billion.

Drugs that block various cytokines are now in clinical trials to test whether they are effective for stopping the deadly spiral in COVID-19.

[Get facts about coronavirus and the latest research. Sign up for The Conversations newsletter.]

Read more:
Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 - The Conversation US

Bone Marrow Stem Cells Comments Off on Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 – The Conversation US | May 21st, 2020

Global Cell Therapy Technologies Marketwas valued US$ 12 billion in 2018 and is expected to reach US$ 35 billion by 2026, at CAGR of 12.14 %during forecast period.

The objective of the report is to present comprehensive assessment projections with a suitable set of assumptions and methodology. The report helps in understanding Global Cell Therapy Technologies Market dynamics, structure by identifying and analyzing the market segments and projecting the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, growth strategies, and regional presence. To understand the market dynamics and by region, the report has covered the PEST analysis by region and key economies across the globe, which are supposed to have an impact on market in forecast period. PORTERs analysis, and SVOR analysis of the market as well as detailed SWOT analysis of key players has been done to analyze their strategies. The report will to address all questions of shareholders to prioritize the efforts and investment in the near future to the emerging segment in the Global Cell Therapy Technologies Market.

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The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

Global Cell Therapy Technologies Market: Overview

Cell therapy is a transplantation of live human cells to replace or repair damaged tissue and/or cells. With the help of new technologies, limitless imagination, and innovative products, many different types of cells may be used as part of a therapy or treatment for different types of diseases and conditions. Celltherapy technologies plays key role in the practice of medicine such as old fashioned bone marrow transplants is replaced by Hematopoietic stem cell transplantation, capacity of cells in drug discovery. Cell therapy overlap with different therapies like, gene therapy, tissue engineering, cancer vaccines, regenerative medicine, and drug delivery. Establishment of cell banking facilities and production, storage, and characterization of cells are increasing volumetric capabilities of the cell therapy market globally. Initiation of constructive guidelines for cell therapy manufacturing and proven effectiveness of products, these are primary growth stimulants of the market.

DO INQUIRY BEFORE PURCHASING REPORT HERE:https://www.maximizemarketresearch.com/inquiry-before-buying//31531/

Global Cell Therapy Technologies Market: Drivers and Restraints

The growth of cell therapy technologies market is highly driven by, increasing demand for clinical trials on oncology-oriented cell-based therapy, demand for advanced cell therapy instruments is increasing, owing to its affordability and sustainability, government and private organization , investing more funds in cell-based research therapy for life-style diseases such as diabetes, decrease in prices of stem cell therapies are leading to increased tendency of buyers towards cell therapy, existing companies are collaborating with research institute in order to best fit into regulatory model for cell therapies.Moreover, Healthcare practitioners uses stem cells obtained from bone marrow or blood for treatment of patients with cancer, blood disorders, and immune-related disorders and Development in cell banking facilities and resultant expansion of production, storage, and characterization of cells, these factors will drive the market of cell therapy technologies during forecast period.

On the other hand, the high cost of cell-based research and some ethical issue & legally controversial, are expected to hamper market growth of Cell Therapy Technologies during the forecast period

AJune 2016, there were around 351 companies across the U.S. that were engaged in advertising unauthorized stem cell treatments at their clinics. Such clinics boosted the revenue in this market.in August 2017, the U.S. FDA announced increased enforcement of regulations and oversight of clinics involved in practicing unapproved stem cell therapies. This might hamper the revenue generation during the forecast period; nevertheless, it will allow safe and effective use of stem cell therapies.

Global Cell Therapy Technologies Market: Segmentation Analysis

On the basis of product, the consumables segment had largest market share in 2018 and is expected to drive the cell therapy instruments market during forecast period at XX % CAGR owing to the huge demand for consumables in cell-based experiments and cancer research and increasing number of new product launches and consumables are essential for every step of cell processing. This is further expected to drive their adoption in the market. These factors will boost the market of Cell Therapy Technologies Market in upcoming years.

On the basis of process, the cell processing had largest market share in 2018 and is expected to grow at the highest CAGR during the forecast period owing to in cell processing stage,a use of cell therapy instruments and media at highest rate, mainly in culture media processing. This is a major factor will drive the market share during forecast period.

Global Cell Therapy Technologies Market: Regional Analysis

North America to held largest market share of the cell therapy technologies in 2018 and expected to grow at highest CAGR during forecast period owing to increasing R&D programs in the pharmaceutical and biotechnology industries. North America followed by Europe, Asia Pacific and Rest of the world (Row).Scope of Global Cell Therapy Technologies Market

Global Cell Therapy Technologies Market, by Product

Consumables Equipment Systems & SoftwareGlobal Cell Therapy Technologies Market, by Cell Type

Human Cells Animal CellsGlobal Cell Therapy Technologies Market, by Process Stages

Cell Processing Cell Preservation, Distribution, and Handling Process Monitoring and Quality ControlGlobal Cell Therapy Technologies Market, by End Users

Life Science Research Companies Research InstitutesGlobal Cell Therapy Technologies Market, by Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in the Global Cell Therapy Technologies Market

Beckman Coulter, Inc. Becton Dickinson and Company GE Healthcare Lonza Merck KGaA MiltenyiBiotec STEMCELL Technologies, Inc. Terumo BCT, Inc. Thermo Fisher Scientific, Inc. Sartorius AG

MAJOR TOC OF THE REPORT

Chapter One: Cell Therapy Technologies Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cell Therapy Technologies Market Competition, by Players

Chapter Four: Global Cell Therapy Technologies Market Size by Regions

Chapter Five: North America Cell Therapy Technologies Revenue by Countries

Chapter Six: Europe Cell Therapy Technologies Revenue by Countries

Chapter Seven: Asia-Pacific Cell Therapy Technologies Revenue by Countries

Chapter Eight: South America Cell Therapy Technologies Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cell Therapy Technologies by Countries

Chapter Ten: Global Cell Therapy Technologies Market Segment by Type

Chapter Eleven: Global Cell Therapy Technologies Market Segment by Application

Chapter Twelve: Global Cell Therapy Technologies Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Cell Therapy Technologies Market Report at:https://www.maximizemarketresearch.com/market-report/global-cell-therapy-technologies-market/31531/

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Global Cell Therapy Technologies Market : Industry Analysis and Forecast... - Azizsalon News

Bone Marrow Stem Cells Comments Off on Global Cell Therapy Technologies Market : Industry Analysis and Forecast… – Azizsalon News | May 19th, 2020

MINNEAPOLIS & EL SEGUNDO, Calif.--(BUSINESS WIRE)--Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, and NantKwest (Nasdaq: NK), a next generation, clinical-stage immunotherapy company focused on harnessing the unique power of the immune system using natural killer (NK) cells to treat cancer and infectious diseases, today announced an agreement through which Be The Match BioTherapies is providing donor material for a NantKwest Phase 1b clinical trial to address acute respiratory distress syndrome (ARDS), one of the primary causes of COVID-19 deaths.

The agreement combines Be The Match BioTherapies ability to provide high-quality cellular source material from the worlds largest registry of volunteer donors with NantKwests capabilities in manufacturing off-the-shelf cell therapies. NantKwests allogeneic cell therapy is derived from human bone marrow and designed to treat the ARDS that results from severe COVID-19 cases. The therapy, called BM-Allo.MSC, uses mesenchymal stem cells (MSCs), multipotent progenitor cells known to have immunomodulatory properties, to reduce the lung inflammation associated with ARDS. Similar work in Europe with allogeneic MSC products in patients with COVID-19 and ARDS has demonstrated safety and efficacy in reducing inflammatory processes.

NantKwest recently announced FDA authorization of its investigational new drug (IND) application for BM-Allo.MSC and is moving rapidly to initiate a Phase 1b trial in patients with severe COVID-19. To expedite trial initiation, Be The Match BioTherapies is providing cryopreserved donor stem cell material from the Be The Match BioBank, a program of the National Marrow Donor Program/Be The Match. The accelerated access to material, combined with NantKwests scalable manufacturing processes, will allow for rapid distribution of BM-Allo.MSC to patients in need.

There is an immediate need for COVID-19 therapies across all stages of the disease, including for patients with ARDS, which is one of the most critical conditions caused by COVID-19, said Patrick Soon-Shiong, MD, Chairman and Chief Executive Officer of NantKwest. Thanks to the quality source material provided by Be The Match BioTherapies, we are prepared to rapidly scale manufacturing of this much-needed therapy, potentially saving numerous patients lives.

Through our teams unparalleled ability to identify, source and deliver high-quality donor material we have the opportunity to support the advancement of a cell therapy with potential to change the world. We are proud to partner with NantKwest to support our mission to save lives through cellular therapy and continue to make a difference for critically ill patients around the globe, said Chris McClain, Senior Vice President, Sales and New Business Development at Be The Match BioTherapies.

About Be The Match BioTherapies

Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program (NMDP)/Be The Match, and a research partnership with the CIBMTR (Center for International Blood and Marrow Transplant Research), the organization designs solutions that advance the development of cell and gene therapies across the globe.

Be The Match BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the Be The Match Registry, the worlds largest and most diverse registry of more than 22 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection and transplant centers worldwide, the organization develops, onboards, trains and manages expansive collection networks to advance cell therapies. Be The Match BioTherapies uses proven infrastructure consisting of regulatory compliance and managed logistics experts, as well as cell therapy supply chain case managers to successfully transport and deliver regulatory compliant life-saving therapies across the globe. Through the CIBMTR, Be The Match BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.

For more information, visit http://www.BeTheMatchBioTherapies.com or follow Be The Match BioTherapies on LinkedIn or Twitter at @BTMBioTherapies.

About NantKwest

NantKwest (Nasdaq: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com.

Excerpt from:
Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths - Business Wire

Bone Marrow Stem Cells Comments Off on Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths – Business Wire | May 19th, 2020

The study is anticipated to consist of approximately thirty patients with potential involvement of the NIH of Mexico in other CytoDyn trials

VANCOUVER, Washington, May 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be coordinating with the NIH of Mexico and providing leronlimab for a trial for the severe/critical COVID-19 population in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials.

CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 patients, which is a randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn is also enrolling a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population. CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S. Food and Drug Administration (FDA) and plans to provide clinical updates for this patient population later in the week.

We look forward to evaluating leronlimab as a treatment option for patients of COVID-19. We have seen the devastation of this disease on the citizens of Mexico and are looking forward to providing effective treatment options to mitigate the devastation of COVID-19, said Dr. Gustavo Reyes Tern, head of the Coordinating Commission of National Institutes of Health and High Specialty Hospitals of Mexico, an organization that coordinates the main institutions of medical care and public research in the country.

The NIH of Mexico is committed to help alleviate human suffering and mortality of Mexican citizens. The Metropolitan Area of the Valley of Mexico has a population of approximately 21.5 million people and the contagious nature of COVID-19 is relentless. We look forward to working with the NIH of Mexico to rapidly commence with the proposed study. We also believe that this study results, along with the ongoing Phase 2 study, could establish a path for quick approval in Mexico for use of leronlimab in COVID-19 patients, said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

Originally posted here:
CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19...

Bone Marrow Stem Cells Comments Off on CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19… | May 19th, 2020

18 May 2020

New research, in HIV positive patients being treated for blood cancer, has identified a critical time window after donor stem cell transplantation, during which the expanding donor cells are particularly vulnerable to being infected with HIV.

Patients with HIV who develop blood cancer may require treatment by allogeneic stem cell transplant, using bone marrow stem cells provided by a healthy donor. During a transplant, most of the patient's original immune cells are destroyed, and the immune system and blood cells are restored from the new donor stem cells.

'These results show a weak point that may explain why allogeneic stem cell transplants may not completely remove the virus from the body, despite a drastic reduction in the number of infected cells' saidsenior authorDr Julian Schulze zur Wiesch from the German Centre for Infection Research.

Stem cell transplantation in HIV positive patients has been the only medical intervention found to cure HIV (see BioNews 1039), however in nearly all cases HIV infection persists after transplantation.

In a new study it was discovered that immune cells generated from the donor stem cells are at risk of being infected with HIV during the first few weeks after transplantation.

In this study of 16 HIV positive participants with blood cancer, the researchers show that stem cell transplantation promotes reactivation of the virus within the patient's remaining original immune cells. This leads to some of the new immune cells becoming infected, thus 're-seeding' HIV within the host.

'Additional immunotherapy orgene therapy may be required to achieve ongoing, spontaneous control of HIV infection in people with HIV after allogeneic stem cell transplantation,' said Dr Schulze zur Wiesch.

This research was published in Science Translational Medicine.

Here is the original post:
Critical window for re-infection with HIV after stem cell transplantation - BioNews

Bone Marrow Stem Cells Comments Off on Critical window for re-infection with HIV after stem cell transplantation – BioNews | May 18th, 2020

EL SEGUNDO, Calif.--(BUSINESS WIRE)--NantKwest, Inc. (NASDAQ: NK) today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product derived from human bone marrow. NantKwest has entered into an agreement with the National Marrow Donor Program (Be the Match) to provide donor material and has developed automated proprietary methods to expand and generate multiple dose forms utilizing a modular, closed system (GMP-in-a-box) from NantKwest affiliate ImmunityBio, Inc., to expand BM-Allo.MSCs, enabling the scalable manufacture and immediate distribution of cryopreserved BM-Allo.MSC product.

There is an urgent need to develop broadly accessible treatment options for the devastating outcomes seen in the thousands of COVID-19 patients who are facing severe disease with ARDS and cytopathic storm, said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. While MSC-derived treatments have shown promise in treating patients with ARDS, including those with COVID-19, the ability to scale production to support the overwhelming patient need has been a challenge. Our proprietary GMP-in-a-Box enables the rapid and scalable manufacture of our fully human BM-Allo.MSC product, overcoming this previous limitation to advance a promising new treatment to those patients who are most in need. Due to our proprietary methods, we are well positioned to rapidly advance BM-Allo.MSC during the current wave of COVID-19, with an anticipated trial initiation in Q2.

BM-Allo.MSC is a bone marrow-derived allogenic MSC product being developed to attenuate the inflammatory processes that drive ARDS in severe COVID-19 patients. MSCs are multipotent progenitor cells that give rise to cell types responsible for tissue repair and may restore effective immune function and contribute to viral clearance. Prior work with allogeneic MSC products in patients with ARDS has shown that such treatment is safe and may reduce key markers of inflammatory processes.

Trial Design

The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting. The primary objectives of the study include overall safety and reduction in time on ventilator. The secondary objective will focus on the efficacy of BM-Allo.MSC in reducing the number of days patients require oxygen, duration of hospitalization, and mortality.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering off-the-shelf living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer and/or Covid-19. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells, as well as other therapeutics, as part of the NANT Cancer Vaccine platform as a cancer treatment and/or Covid-19 treatment.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Quarterly Report on Form 10-Q for the Quarter ended March 31, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

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NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients - Business...

Bone Marrow Stem Cells Comments Off on NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients – Business… | May 18th, 2020

Three arms of this trial will be leronlimab, remdesivir, and leronlimab + remdesivir

VANCOUVER, Washington, May 18, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be submitting a protocol to the U.S. Food and Drug Administration (FDA) for a factorial design trial to compare effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19.

Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA. Preliminary results from this patient population led to CytoDyns Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. CytoDyn plans to update the public regarding current eIND results later this week.

We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from COVID-19. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for COVID-19, said Jacob Lalezari, M.D., Chief Science Officer of CytoDyn.

Unfortunately, COVID-19 remains a global public health challenge, and its economic impact continues to devastate the world economy. With a second wave of potential cases threatening to surface in the fall and winter of 2020, it is more important than ever to be sure successful treatment options are available to protect the lives of patients. CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone, said, Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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