NEW YORK, July 06, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP.

The protocol was filed with the United States Food and Drug Administration (FDA) and provides physicians with access to remestemcel-L for an intermediate-size patient population1 under Mesoblasts existing Investigational New Drug (IND) application. According to the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

MIS-C is a life-threatening complication of COVID-19 in otherwise healthy children and adolescents that includes massive simultaneous inflammation of multiple critical organs and their vasculature. In approximately 50% of cases this inflammation is associated with significant cardiovascular complications that directly involve heart muscle and may result in decreased cardiac function. In addition, the virus can result in dilation of coronary arteries with unknown future consequences. Recent articles from Europe and the United States have described this disease in detail.2-5

Mesoblast Chief Medical Officer Dr Fred Grossman said: The extensive body of safety and efficacy data generated to date using remestemcel-L in children with graft versus host disease suggest that our cellular therapy could provide a clinically important therapeutic benefit in MIS-C patients, especially if the heart is involved as a target organ for inflammation. Use of remestemcel-L in children with COVID-19 builds on and extends the potential application of this cell therapy in COVID-19 cytokine storm beyond the most severe adults with acute respiratory distress syndrome.

Remestemcel-L Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases 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.

1.www.clinicaltrials.gov; NCT044564392.Lancet2020; May 7. DOI: https://doi.org/10.1016/S0140-6736(20)31094-13.Lancet. 2020; (May 13) https://doi.org/10.1016/S0140-6736(20)31103-X4.https://www.nejm.org/doi/full/10.1056/NEJMoa20217565.https://www.nejm.org/doi/full/10.1056/NEJMoa2021680

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. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. 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 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 should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts 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; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement. 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.

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Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19...

Cardiac Stem Cells Comments Off on Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19… | July 6th, 2020

Stem cells have been holding great promise for regenerative medicine for years. In the last decade, several studies have shown that this type of cell, which in Spanish is called mother cell because of its ability to give rise to a variety of different cell types, can be applied in regenerative medicine for diseases such as muscular and nervous system disorders, among others. Researchers and stem cell pioneers Sir John B. Gurdon and Shinya Yamanaka received the Nobel Prize in Physiology and Medicine in 2012 for this idea. However, one of the main limitations in the application of these cell therapies is the quality of the stem cells that can be generated in the laboratory, which impedes their use for therapeutic purposes.Now, a team from the Cell Division and Cancer Group of the Spanish National Cancer Research Centre (CNIO), led by researcher Marcos Malumbres, has developed a new, simple and fast technology that enhances in vitro and in vivo the potential of stem cells to differentiate into adult cells. The research results are published in The EMBO Journal.

In recent years, several protocols have been proposed to obtain reprogrammed stem cells in the laboratory from adult cells, but very few to improve the cells we already have. The method we developed is able to significantly increase the quality of stem cells obtained by any other protocol, thus favouring the efficiency of the production of specialised cell types, says Mara Salazar-Roa, researcher at the CNIO, first author of the article and co-corresponding author.

In this study, the researchers identified an RNA sequence, called microRNA 203, which is found in the earliest embryonic stages before the embryo implants in the womb and when stem cells still have their maximum capacity to generate all the different tissues. When they added this molecule to stem cells in the laboratory, they discovered that the cells ability to convert to other cell types improved significantly.

To corroborate this, they used stem cells of human and murine origin, and of genetically modified mice. The results were spectacular, both in mouse cells and in human cells. Application of this microRNA for just 5 days boosts the potential of stem cells in all scenarios we tested and improves their ability to become other specialised cells, even months after having been in contact with the microRNA, says Salazar-Roa.

According to the study, cells modified by this new protocol are more efficient in generating functional cardiac cells, opening the door to an improved generation of different cell types necessary for the treatment of degenerative diseases.

Malumbres, head of the CNIO Cell and Cancer Division Group, says: To bring this asset to the clinic, collaboration with laboratories or companies that want to exploit this technology is now necessary in each specific case. In this context, Salazar-Roa recently participated, in close collaboration with the CNIOs Innovation team, in prestigious innovation programs such as IDEA2 Global of the Massachusetts Institute of Technology (MIT) and CaixaImpulse of the la Caixa Foundation, from which they also obtained funding to start the development of this technology.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Quick and Simple Technology Enhances the Potential of Stem Cells To Differentiate Into Adult Cells - Technology Networks

Cardiac Stem Cells Comments Off on Quick and Simple Technology Enhances the Potential of Stem Cells To Differentiate Into Adult Cells – Technology Networks | July 6th, 2020

Canine Stem Cell Therapy Marketreport provides in-depth COVID19 impact analysis ofMarket Overview, Product Scope, Market Drivers, Trends, Opportunities,Market Driving Force and Market Risks. It also profile the topmost prime manufacturers (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) are analyzed emphatically by competitive landscape contrast, with respect toPrice, Sales,Capacity, Import, Export, Consumption, Gross, Gross Margin, Revenue and Market Share. Canine Stem Cell Therapy industry breakdown data are shown at the regional level, to show the sales, revenue and growth by regions.Canine Stem Cell Therapy Market describe Canine Stem Cell Therapy Sales Channel,Distributors, Customers, Research Findings and Conclusion, Appendix and Data Source.

Key Target Audience of Canine Stem Cell Therapy Market:Manufacturers of Canine Stem Cell Therapy, Raw material suppliers, Market research and consulting firms, Government bodies such as regulating authorities and policy makers, Organizations, forums and alliances related to Canine Stem Cell Therapy market.

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Summary of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Canine Stem Cell Therapy market foreach application, including-

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

On the basis of product,this report displays the sales volume, revenue (Million USD), product price, market share and growth rate ofeach type, primarily split into-

Allogeneic Stem Cells Autologous Stem cells

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Canine Stem Cell Therapy Market-Segmentation And Analysis By Recent Trends, Top 4 Manufactures -VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,...

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A team of researchers from Rice University has uncovered a promising strategy to generate vascular networks, one of the most daunting structures in the human body. Using powdered sugar and selective laser sintering, the researchers were able to build large structures from complex, branching, and intricate sugar networks that dissolve to create pathways for blood in lab-grown tissue.

This is the teams latest effort to build complex vascular networks for engineered tissues to show that they could keep densely packed cells alive for two weeks. The findings of their studypublished in the Nature Biomedical Engineering journalprove that developing new technologies and materials to mimic and recapitulate the complex hierarchical networks of vessels gets them closer to providing oxygen and nutrients to a sufficient number of cells to get a meaningful long-term therapeutic function.

One of the biggest hurdles to engineering clinically relevant tissues is packing a large tissue structure with hundreds of millions of living cells, said study lead author Ian Kinstlinger, a bioengineering graduate student at Rices Brown School of Engineering. Delivering enough oxygen and nutrients to all the cells across that large volume of tissue becomes a monumental challenge. Nature solved this problem through the evolution of complex vascular networks, which weave through our tissues and organs in patterns reminiscent of tree limbs. The vessels simultaneously become smaller in thickness but greater in number as they branch away from a central trunk, allowing oxygen and nutrients to be efficiently delivered to cells throughout the body.

Overcoming the complications of 3D printing vascularization has remained a critical challenge in tissue engineering for decades, as only a handful of 3D printing processes have come close to mimic the in vivo conditions needed to generate blood vessels. Without them, the future of bioprinted organs and tissues for transplantation will remain elusive. Many organs have uniquely intricate vessels, like the kidney, which is highly vascularized and normally receives a fifth of the cardiac output, or the liver, in charge of receiving over 30% of the blood flow from the heart. By far, kidney transplantation is the most common type of organ transplantation worldwide, followed by transplants of the liver, making it crucial for regenerative medicine experts to tackle vascularization.

Ian Kinstlinger with a blood vessel template he 3D printed from powdered sugar (Credit: Jeff Fitlow/Rice University)

In the last few years, extrusion-based 3D printing techniques have been developed for vascular tissue engineering, however, the authors of this study considered that the method presented certain challenges, which led them to use a customizedopen-source, modified laser cutter to 3D print the sugar templates in the lab of study co-authorJordan Miller, an assistant professor ofbioengineering at Rice.

Miller began work on the laser-sintering approach shortly after joining Rice in 2013. The 3D printing process fuses minute grains of powder into solid 3D objects, making possible some complex and detailed structures. In contrast to more common extrusion 3D printing, where melted strands of material are deposited through a nozzle, laser sintering works by gently melting and fusing small regions in a packed bed of dry powder. According to Miller, both extrusion and laser sintering build 3D shapes one 2D layer at a time, but the laser method enables the generation of structures that would otherwise be prone to collapse if extruded.

There are certain architecturessuch as overhanging structures, branched networks and multivascular networkswhich you really cant do well with extrusion printing, said Miller, who demonstrated the concept of sugar templating with a 3D extrusion printer during his postdoctoral studies at the University of Pennsylvania. Selective laser sintering gives us far more control in all three dimensions, allowing us to easily access complex topologies while still preserving the utility of the sugar material.

Assistant professor ofbioengineering at Rice University, Jordan Miller (Credit: Jeff Fitlow/Rice University)

Generating new 3D printing processes and biomaterials for vascularization is among the top priorities for the researchers at Millers Bioengineering Lab at Rice. The lab has a rich history of using sugar to construct vascular network templates. Miller has described in the past how sugar is biocompatible with the human body, structurally strong, and overall, a great material that could be 3D printed in the shape of blood vessel networks. His original inspiration for the project was an intricate dessert, even going as far as suggesting that the 3D printing process we developed here is like making a very precise creme brulee.

To make tissues, Kinstlinger chose a special blend of sugars to print the templates and then filled the volume around the printed sugar network with a mixture of cells in a liquid gel. Within minutes, the gel became semisolid and the sugar dissolved and flushed away to leave an open passageway for nutrients and oxygen. Clearly, sugar was a great choice for the team, providing an opportunity to create blood vessel templates because it is durable when dry, and it rapidly dissolves in water without damaging nearby cells.

A sample of blood vessel templates that Rice University bioengineers 3D printed using a special blend of powdered sugars. (Credit: B. Martin/Rice University)

In order to create the treelike vascular architectures in the study, the researchers developed a computational algorithm in collaboration with Nervous System, a design studio that uses computer simulation to make unique art, jewelry, and housewares that are inspired by patterns found in nature. After creating tissues patterned with these computationally generated vascular architectures, the team demonstrated the seeding of endothelial cells inside the channels and focused on studying the survival and function of cells grown in the surrounding tissue, which included rodent liver cells called hepatocytes.

The hepatocyte experiments were conducted in collaboration with the University of Washington (UW)s bioengineer and study co-author Kelly Stevens, whose research group specializes in studying these delicate cells, which are notoriously difficult to maintain outside the body.

This method could be used with a much wider range of material cocktails than many other bioprinting technologies. This makes it incredibly versatile, explained Stevens,an assistant professor of bioengineering in the UW College of Engineering, assistant professor of pathology in the UW School of Medicine and an investigator at the UW Medicine Institute for Stem Cell and Regenerative Medicine.

The results from the study allowed the team to continue their work towards creating translationally relevant engineered tissue. Using sugar as a special ingredient and selective laser sintering techniques could help advance the field towards mimicking the function of vascular networks in the body, to finally deliver enough oxygen and nutrients to all the cells across a large volume of tissue.

Miller considered that along with the team they were able to prove that perfusion through 3D vascular networks allows us to sustain these large liverlike tissues. While there are still long-standing challenges associated with maintaining hepatocyte function, the ability to both generate large volumes of tissue and sustain the cells in those volumes for sufficient time to assess their function is an exciting step forward.

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Rice Researchers 3D Print with Lasers and Sugar to Build Complex Vascular Networks - 3DPrint.com

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There has been a large push to the development of a coronavirus vaccine and antiviral medicines. Having observed promising premises for an effective vaccine, researchers are cautiously optimistic about its clinical launch. A widespread vaccine deployment within 1-2 years would effectively end the COVID-19 pandemic, as per the emerging scientific advances from the US and other countries. Dr D Samba Reddy, Professor, College of Medicine Texas A&M University Health Science Center, USA, explains how developments for a new vaccine and repurposed antiviral medicines can help combat the coronavirus crisis

The coronavirus pandemic has created huge challenges in our daily lives and great uncertainty worldwide. Our working environments, education, family lives, business and financial prosperity, and daily routines have been reshaped significantly, perhaps even permanently. The coronavirus disease 2019 (COVID-19) outbreak urgently requires new medicines for prevention and treatment. The 3-15 per cent mortality rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the strain of the virus that causes COVID-19, ranks as one of the deadliest respiratory viruses, especially in aged and vulnerable people with health risk conditions. To date, this virus has infected more than 11 million people and killed over 525,000 worldwide. Currently, there are no effective, US FDA-approved agents for the prevention and treatment of COVID-19.

Given the steady emergence of positive cases even under social distancing and extended lockdowns, many are desperately awaiting a vaccine or silver bullet treatment for COVID-19. Despite great mitigation efforts and huge economic sacrifices, the virus is asynchronously circulating in many countries including India, which is currently experiencing a rapid surge. Now, the US is experiencing a coronavirus resurgence; the number of daily new COVID-19 cases is hitting levels not seen since the early part of the pandemic. This virus is spreading in large part from asymptomatic persons who have been unknowing carriers. Two questions that frequently appear in many peoples minds are how long they should practise social distancing measures and when this pandemic situation will return to normalcy. For both questions, a vaccine would be our most concrete answer for preventing future infection and ultimately totally eradicating the coronavirus outbreak.

To fight this battle of a lifetime, scientists around the world are making rapid progress in the discovery of two types of medicines for coronavirus: vaccines to prevent the infection and antivirals to treat the infection. It normally takes 5 to 10 years to develop a vaccine or new drug, but due to the urgency of the COVID-19 pandemic, normal development activity and testing have been accelerated with some caveats.

A vaccine would be our most concrete answer

Vaccines are biological agents with a potential for immunological reactions or efficacy issues. They require extensive testing and safety trials the bottleneck in development time along with tedious production and scale-up for producing millions of doses of a formulated injectable product with optimal stability. Many top experts predict a COVID-19 vaccine could take 6-18 months to reach the market.

Currently, there are approximately 160 corona vaccines in development. These vaccines are being tested in ongoing clinical trials to prove their safety and effectiveness. Constantly-updated knowledge about virus strains and the science underlying neutralizing antibodies has provided a number of potential vaccine platforms or antigen components, such as the purified spike protein, envelope protein, recombinant viral vectors expressing the spike or other viral protein, RNA packaged within a vector such as lipid nanoparticles, and killed or inactivated virus particles. Immunization with these injectable components can produce high levels of neutralizing antibodies and protect against detrimental infection after exposure to the virus.

A realistic timeline for development and widespread vaccination

Currently, three vaccines have reached Phase 2 and would enter pivotal Phase 3 trials this summer. This timetable indicates rapid progress in advancing vaccines through clinical testing. The main hurdle for these solutions is proof-of-efficacy: the trials must demonstrate with certainty whether people who receive the vaccines develop COVID-19 after viral exposure at lower rates than those who get placebo or dummy injections. Successful clinical trials would eventually lead to the FDA approval of a vaccine. FDA approval represents the final phase of a bench-to-bedside journey for any new vaccine a long journey that begins within vitro or test tube studies to animal testing and clinical phase 13 trials. When its data demonstrates proof of safety and efficacy, the vaccine can earn FDA approval for marketing. Yet, there remain some uneasy questions regarding this process, particularly the possibility that a coronavirus vaccine is delayed or hits a roadblock. However, some solid research theory provides hope in light of such concerns.

As noted by NIH Director Dr Francis Collins in his blog, research has shown that patients who recover from COVID-19 produce small levels of antibodies to the virus, some of which are strongly neutralising, which indicates that some patients may be able to ward off reinfection. This premise suggests that the immune systems of people who survive COVID-19 may be primed to recognise SARS-CoV-2 and possibly thwart a second infection, which supports the potential feasibility of antibody-based vaccination. Regarding the durability of such a vaccine, the neutralising antibodies against SARS-CoV-2 are projected to last 15-18 months, based on the duration of antibody responses against other human coronaviruses. The lessons learned from SARS and MERS underscores the current vaccine approaches to the prevention of COVID-19.

Despite the potential viability of a vaccine for COVID-19, researchers remain cautiously optimistic about its efficacy and timeline, considering the hurdles yet to be overcome. Currently, in a global search for a COVID-19 vaccine, no clear winner has emerged yet. When a safe and effective corona vaccine is approved, a widespread vaccine deployment within 1-2 years will effectively end the COVID-19 crisis, as per the emerging scientific advances from the US. An international consortium is needed to coordinate such large-scale production and distribution around the globe. Thus, current projections indicate that the coronavirus pandemic will continue for 1-2 years, a critical timeline for development, deployment, and widespread vaccination.

Besides vaccines, there have been dedicated efforts to develop other pharmaceutical options for coronavirus, namely antivirals and immune modulators, some of which are now in clinical trials or have been approved for COVID-19.

The current race for repurposed antiviral medicines

Antivirals are medicines that act directly on coronavirus. The main advantage of an antiviral agent is that it can be given to treat asymptomatic person already infected with the coronavirus. Most antivirals are made of small molecules that can be synthesised in the lab and tested much faster than vaccines. In contrast to a vaccine that prevents infection, antivirals act more like bandages: they can alleviate the recovery and reduce the severity or risk of morbidity, but cannot prevent an infection from happening.

There are many antivirals under experimental and clinical trials for coronavirus infection. According to the University of Pennsylvanias CORONA database, 115 repurposed drugs have been used to treat COVID19 patients, with around a dozen which seem most promising. Like vaccines, FDA approval of antivirals represents the final phase of a big development journey from preclinical to clinical phase 1, 2 and 3 trials. When the data demonstrate compelling proof of safety and efficacy or favourable risk-benefit ratio, such new medicines can receive FDA approval for marketing. To address urgent needs, the FDA has granted emergency use authorization (EUA) for clinical testing and compassionate use of certain medicines for COVID-19, bypassing typical time- and sample-related roadblocks. This is helping scientists more quickly test existing drugs, and such repurposing is offering great hope in our COVID-19 fight. Some of the more notable explored treatments are detailed below.

Chloroquine and hydroxychloroquine (HCQ) have been proposed as new treatments for COVID-19. They have broad-spectrum effects against coronaviruses via multimodal mechanisms. Additionally, millions of people have safely used these medicines for malaria worldwide; however, they are not indicated in certain people with cardiac risk factors. Based on early positive indications of its benefits from pilot trials in China, chloroquine has been used for the treatment of COVID-19 in clinical trials or emergency use programs. HCQ, a safer version of chloroquine, is on the WHOs list of essential medicines a designation given for the safest and most effective medicines needed in a healthcare system. Based on reports of its antiviral effect against the coronavirus, HCQ was granted EUA status for use against COVID-19 by the FDA on April 7. It was tested as a specific treatment in the hospital setting and in clinical trials. Later, the Indian ICMR recommended HCQ as a prophylactic for healthcare personnel.

However, the safety of HCQ in COVID-19 patients is a topic of controversy, stemming from a scandal regarding the retraction of two papers about the negative safety of HCQ published in the top-ranked medical journals Lancet and NEJM. The retractions occurred on account of a lack of data integrity, making safety claims of HCQ still inconclusive. Additionally, the results of recent clinical trials show limited efficacy of HCQ therapy in COVID-19 patients. Therefore, the WHO and NIH have pulled out of HCQ trials due to questionable efficacy that has greatly diminished further interest in this drug. Effective June 22, the sponsoring company made the decision to stop and discontinue its sponsored HCQ clinical trial for COVID-19. They did not cite safety reasons. On June 15, the FDA revoked the EUA for emergency use of chloroquine and HCQ for COVID-19. As of June 25, the NIH treatment guidelines recommend against the use of chloroquineorHCQfor the treatment of COVID-19, except in a clinical trial.

Remdesivir is another repurposed antiviral drug with promising effects on coronavirus. It inhibits a viral protein called RNA-dependent RNA polymerase, which is vital for virus production. It has potent in vitro inhibitory activity against SARS-CoV-2. In real-world practice, however, it has shown mixed results. In early trials published in Lancet, remdesivir was not associated with clinical benefits in patients with severe COVID-19. On March 1, the FDA granted an EUA for emergency treatment of hospitalized patients with severe COVID-19. On April 29, in results from a pilot trial sponsored by the NIH, remdesivir was found to shorten the duration of illness by about 31% compared to placebo in hospitalised patients with severe COVID19. The data, now published in the New England Journal of Medicine, show that the drug shortened the course of illness from an average of 15 days to about 11 days. However, mortality rates were not significantly different (7 per cent drug vs 12 per cent placebo), indicating that remdesivir alone is not likely to be sufficient.

Currently, remdesivir is being tested in Phase 3 trials for severe infection, but it is not FDA-approved yet. It is given by intravenous infusion for up to a 10-day total course. On June 1, some early Phase 3 trial results became available, which indicated it has only small benefit in large samples. In this large trial, a group of moderately ill, hospitalized patients with 5-days therapy showed a modest improvement (76 per cent) compared to standard-of-care control (66 per cent). The other group on 10-days therapy did not show any significant improvement. There were no new safety risks identified in either group. Remdesivir is also only available intravenously, meaning it is only able to be administered in a clinical setting, which could limit its impact for ambulatory patients and persons staying at home with mild symptoms. So, the results of ongoing pivotal trials will determine its capacity for use against COVID-19.

The NIH treatment guidelines recommend the investigational new drug remdesivir for hospitalised patients with severe COVID-19. Those who are not intubated are to receive 5 days of remdesivir, while for mechanically ventilated patients or patients who have not shown improvement after 5 days of therapy, thetreatment can be extended to up to 10 days. Remdesivir is not recommended for the treatment of patients with mild or moderate COVID-19.

Other promising antivirals for COVID-19 include protease inhibitors (Lopinavir, Ritonavir), RNA polymerase inhibitors (Ribavirin, Favipiravir), viral fusion inhibitors (Arbidol), viral receptor entry inhibitors (Camostat), and anti-parasitic agents (Ivermectin). However, most of them are still in clinical trials. To accelerate trials and identify an effective drug, the WHO is coordinating an international Solidarity trial of the most promising antivirals for COVID-19, including Remdesivir, Lopinavir, Ritonavir and others.

On June 20, the Drugs Controller General of India (DCGI), the national drug regulation authority, approved the antiviral drug Favipiravir for the treatment of mild to moderate COVID-19. In a landmark development, an Indian generic pharma company received the approval for manufacturing and marketing of Favipiravir. Now, Favipiravir has become the first approved oral medication for the treatment of COVID-19 in India. Favipiravir, known for treating influenza in Japan, has a unique mechanism of action against the coronavirus. First, it is converted into an active phosphoribosylated form in host cells and serves as a substrate for viral RNA polymerase. Then, it inhibits the viral RNA polymerase, a key protein for viral replication in the body. In India, Favipiravir is available as prescription tablets for a 14-day therapy for mild to moderate infection. It offers broad coverage, including children, adults, the elderly, and people with health conditions. It is claimed to significantly improve symptoms in mild to moderate COVID-19 patients. Presently, it is still undertrials in the USA and other countries and not yet approved by the FDA for the treatment of COVID-19.

The hype about new antivirals needs to be verified by large, randomized trials or future meta-analysis. Some caution should be exercised on the boon of new antivirals, as we have learned harsh lessons from previous antivirals. The launching of generic versions of remdesivir and favipiravir is a highly positive development for supportive treatment. Yet, the results of ongoing or pivotal trials will decide the potential of these and other antivirals for COVID-19.

Immunity boosters as critical adjunct medicines for survival

Another class of treatment known as Immunity modulators have been proposed as adjunct therapies for symptomatic management of COVID-19, especially for at-risk populations (elderly, immunocompromised, very young, people with certain health conditions). Currently, there are no FDA-approved immunity boosters. Some experimental agents include interferons, cytokine inhibitors or monoclonal antibodies (Tacosilizumab, Sarilumab), and immunoglobulins. They are targeted to control the heightened immune response in COVID-19, principally to check the cytokine storm, a state of uncontrolled inflammation that can damage vital organs. Hence, anticytokines are considered as an alternative for combination therapy with antivirals. Tocilizumab, an injectable monoclonal antibody for use in autoimmune diseases such as rheumatoid arthritis, has shown in early trials to dampen the cytokine response in COVID-19 patients.

The WHO advisory says that corticosteroids, which suppress the immune response and cytokine storm, should not be used as they could delay recovery or increase morbidity. However, a recent study shows some benefits of dexamethasone in severely ill patients. Dexamethasone is the first drug to be shown to improve survival in severe COVID-19 patients. However, it did not appear to help mild or moderately infected patients. Consequently, the NIH guidelines panel recommends using dexamethasone (6 mg daily for up to 10 days) in patients with COVID-19 who are mechanically ventilated and in patients who require supplemental oxygen. Similar to the WHO, they recommend against using dexamethasone in patients with COVID-19 who do not require supplemental oxygen. There are insufficient data for the NIH panel to recommend either for or against any other immunomodulatory therapy in patients with severe COVID-19 disease. In patients with COVID-19 and severe or critical illness, there are insufficient data to recommend empiric broad-spectrum antimicrobial therapy in the absence of another indication.

Plasma therapy works

Plasma therapy or convalescent plasma has proven effective in reducing the severity or mortality of corona infection. In such immunoglobulin therapy, the liquid portion of the blood that has antibodies from recovered patients is given to patients with severe COVID-19. Although plasma therapy may help accelerate recovery, limited donor availability may limit the widespread use of the convalescent plasma.

A BCG vaccine is touted to reduce the impact of COVID-19 because it has beneficial nonspecific (off-target) effects strengthening the immune system and thereby reducing viremia after coronavirus exposure. A trial is underway to study if BCG vaccine can strengthen immune response, with consequent less severe infection or rapid recovery.

Some vitamins and nutraceuticals have been claimed to help against coronavirus infection. Currently, there is a lack of systematic studies evaluating these supplements in COVID-19 patients.

Stem cells are also touted as promising immune boosters to combat COVID-19, especially for critically ill patients. Stem cells are thought to slow down the immune response and prevent the body from damaging itself from cytokine storm. Such therapy is not yet proven effective or safe, so has not been approved for the treatment of COVID-19.

Herd immunity is a natural catastrophe

Herd immunity, while not touted as a solution for COVID-19 by any agency, is a natural process relevant when there are a massive surge and widespread hotspots in a town or city. Herd immunity is reached when the majority of a given population 70 to 90% becomes immune to the virus, either by recovery from infection or through vaccination. In that scenario, the virus does not spread to people who are not immune due to a lack of carriers. At its worst, catastrophic hotspots may have to rely on herd immunity if a vaccine is still not available in a timely fashion. However, how long immunity lasts varies depending on the coronavirus, and it is not yet known how long COVID-19 survivors might have that protection.

In the US, India, Brazil, and many other countries, there has been a rapid surge or resurgence of cases. About 40% of cases are asymptomatic, which may be driving the community spread. Besides social distance measures, widespread testing and isolation are critical steps in containing the virus. Pool testing could find asymptomatic persons quickly by strategically testing groups of people together. It could test more people with fewer tests in a much broader net and positive cases could be quickly isolated. Meanwhile, scientific experts are advising for the traditional mitigation toolsidentify, isolate and contact trace for curbing the spread and flattening the infection curve.

We will ultimately prevail

Lets follow the scientific guidelines for surviving the coronavirus pandemic. The primary mode of transmission is the airborne route. Infected persons, both asymptomatic and symptomatic, have the great potential to generate aerosol (from a sneeze, cough, breathing or talking) in the size range that can remain suspended in air and reach others when a healthy person inhales such contaminated air. Confining aerosols as close as possible to their point of generation is the first critical steps in the standard healthcare protocols. Aerosols represent a risk of both inhalation and contamination of surfaces, personal clothing and objects. Hence, confining aerosols reduces the extent of contamination and minimises potential exposure opportunities.

The ultimate goal of public health advisories and mitigation strategies (eg, social distancing, mask-wearing, good hygiene) is to reduce the risk of acquiring an infection and of spreading the virus onto others. Its a personal responsibility to adhere to safe practises at home, workplace and outside. A deeper awareness is critical to accomplish the two basic principles of biosafety from coronavirus: risk assessment and containment. To put this complex science into common practice, strive to follow two essential practices: (a) stay away from the bug, a vital precaution to avoid being exposed to the virus, and (b) stay healthy, a preemptive step to combat the corona disease. In essence, in the COVID-19 disease triangle, lets enforce an unfavourable environment for interaction between the host (human) and the bug (virus) a personal step to end the pandemic.

In summary, the US FDA to date has approved no therapies for coronavirus. COVID-19 pandemic is an unprecedented challenge for millions of people worldwide. Thus, aside from new diagnostic tests such as pool testing, development of novel antivirals and vaccines will remain highest-priority scientific research for the next few years. There is cautious optimism about the coronavirus vaccine, but it is too early to make concrete judgments. In the meantime, the two best ways to prevent coronavirus infection are to limit potential exposure and strengthen our health and immunity. It may even take a couple of years, but we will ultimately prevail.

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Scientific Race for New Medicines and Vaccines for COVID-19 - Express Healthcare

Cardiac Stem Cells Comments Off on Scientific Race for New Medicines and Vaccines for COVID-19 – Express Healthcare | July 6th, 2020

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

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

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

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

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

Cardiac Stem Cells Comments Off on Study shows COVID-19 can infect heart cellsand do serious damage in the process – Cardiovascular Business | July 2nd, 2020

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cardiac Stem Cells Comments Off on Its not just the lungs: COVID-19 can affect the brain and heart of those infected, researchers say – WITI FOX 6 Milwaukee | July 2nd, 2020

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

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

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

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

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

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

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

Cardiac Stem Cells Comments Off on WHO says living with COVID-19 to be new normal as global cases top 10 mln – WeForNews | July 2nd, 2020

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

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

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

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

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

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

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

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

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

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

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

Continue reading here:
Rahul Gandhi to interact with nurses on July 1 - WeForNews

Cardiac Stem Cells Comments Off on Rahul Gandhi to interact with nurses on July 1 – WeForNews | July 1st, 2020

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

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

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

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

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

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

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

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

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

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

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

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

Cardiac Stem Cells Comments Off on Coronavirus: WHO warns the worst is yet to come – WeForNews | July 1st, 2020

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

See more here:
Coronavirus may infect heart cells of COVID-19 patients, scientists say - Outlook India

Cardiac Stem Cells Comments Off on Coronavirus may infect heart cells of COVID-19 patients, scientists say – Outlook India | July 1st, 2020

Cardiosphere-Derived Cells

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

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

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

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

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

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

Link:
Cardiac Stem Cell - an overview | ScienceDirect Topics

Cardiac Stem Cells Comments Off on Cardiac Stem Cell – an overview | ScienceDirect Topics | July 1st, 2020

Febrero 2013

James T. Willerson, MD

James T. Willerson, MD,Texas Heart Institute

Heart and vascular disease (or cardiovascular disease, CVD) are the leading causes of death and disability in the world, despite a large proportion of it being preventable.

In the US alone, 82.6 million Americans have some form of CVD. Someone dies from CVD every 33 seconds. More than 40,000 children are born each year with a congenital heart defect.

One of the most promising new avenues for CVD treatment is the use of adult stem cells, to help heal and regenerate damaged hearts.

How can stem cells help the heart?

Stem cells are actually part of our natural circulating rescue system. They travel out of the bone marrow and patrol the circulation system looking for areas of injury to repair. We also have resident stem cells in every organ of the body.

Our first-in-the-world stem cell research at the the Stem Cell Center of the Texas Heart Institute, and subsequent clinical trials in humans, have shown that a patient's own stem cells, harvested from their bone marrow, can help generate new heart muscle tissues and blood vessels in hearts damaged by heart attacks or severe heart failure.

Advances in Stem Cells

After years of study, we have found that when people reach their early 60s, and they begin to have health issues with their bodies, their stem cells also lose their restorative powers. Subsequent research has shown, however, that certain specific cells can be taken from the body fat or bone marrow of healthy young individuals and may be used therapeutically in older patients without adverse immunological reaction. Clinical trials are ongoing and we are constantly learning more about this.

As a result of this work, the National Heart Lung and Blood Institute has established a nationwide consortium of leading medical and research institutions, the Cardiovascular Cell Therapy Research Network (CCTRN), to carry cardiac cell therapy research forward. We are very optimistic about the future of this type of stem cell therapy.

Building New Organs and Reversing Disease

Another area of great promise is the emerging field of regenerative medicine. Dr. Doris Taylor recently joined the Texas Heart Institute as Director of Regenerative Medicine Research. Through her pioneering work, we now have the capability to deplete animal and human hearts of all of their cellular structure and regenerate the "decellularized" scaffolds into healthy organs by the infusion of stem cells. These methods also work on other organs in the body. Many believe that these "bioartificial" organs are the early steps toward our ability to grow new organs for people using their own adult stem cells. We are optimistic that the technology will allow us to begin safe clinical trials in humans within only a few years.

In sum, many advances in stem cells, genetics, and regenerative medicine hold great promise and these fields are advancing rapidly. The next decade or more will undoubtedly be a golden age for progress. We are determined to push the field forward until heart and vascular disease are a thing of the past and our children have a more heart-healthy future ahead of them.

James T. Willerson, MD, is a living legend in cardiovascular medicine. He is the President and Medical Director of the Texas Heart Institute, and the immediate past President of the University of Texas Health Science Center in Houston. Dr. Willerson is a native Texan; he attend UT Austin, Baylor College of Medicine, Harvard Medical School, and trained at Massachusetts General Hospital in Boston. Dr. Willerson has received numerous honors and awards, including the Gold Heart Award, the highest award from the American Heart Association. He has been elected a Fellow in the Royal Society of Medicine of the UK, and made an Honorary Member of the Societies of Cardiology in Peru, Spain, Greece, Venezuela, and Chile. Dr. Willerson is currently President of the International Academy of Cardiovascular Sciences. There is also a swimming scholarship named for him at UT Austin.

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Stem Cells for Cardiac Patients

Cardiac Stem Cells Comments Off on Stem Cells for Cardiac Patients | June 29th, 2020

Cardiovascular diseases are the leading cause of mortality worldwide according to the World Health Organization, mainly due to the occurrence of coronary heart disease and stroke but also to congenital diseases. Because of the phenomenon of population aging and unhealthy ways of life which contribute to ...

Cardiovascular diseases are the leading cause of mortality worldwide according to the World Health Organization, mainly due to the occurrence of coronary heart disease and stroke but also to congenital diseases. Because of the phenomenon of population aging and unhealthy ways of life which contribute to increased risk factors, the number of death from cardiovascular diseases is expected to rise in the near future. So far the heart has been considered to be an organ composed of terminally differentiated cells and not capable of self-regeneration. However recent decisive advancements in this field of research provided evidence that cardiac tissues have the potential for a limited self-renewal. This novel concept thus expands the possibilities for cell-based therapies in the heart to replace dead cardiac muscle cells, since not only exogenous cells could be transplanted but also endogenous progenitor cells could be re-activated. The latest improvements in stem cell bioengineering enable scientists to produce cardiomyocytes from the differentiation of embryonic stem cell lines, but also from adult (animal and human) cells via the so-called induced pluripotent stem cells (iPSCs). The iPSC technology offers the unique opportunity to create cellular models of human adult diseases such as inherited arrhythmia, which proves useful for toxicity studies and drug design. Moreover many of these embryonic or adult cell lines could be considered as candidates for transplantation, provided they would be successful in surviving, migrating, differentiating, distributing, and aligning after engraftment, fundamental properties which still remain huge challenges according to recent studies. Indeed while human embryonic stem cell-derived cardiac myocytes are not yet satisfactory for regeneration of the myocardium in terms of safety and efficacy, the production of sufficient quantities of adult iPSC-derived cardiomyocytes would require immense costs. An alternative promising approach is the use of autologous bone marrow stem cells that can be injected in patients via intra-coronary or intra-myocardial delivery. More clinical trials will be necessary to determine whether this method provides real improvements in ischaemic heart disease. The scope of this Research Topic is to propose a platform of exchange and discussion for scientists interested in the utilisation of stem and progenitor cells for cardiac repair. Our emphasis will range from physiological aspects to bioengineering and clinical applications. Hence we aim at bringing ideas of collaboration and improvements, preliminary results and new perspectives, in order to start answering the following questions: 1)What would be the ideal cell type for therapy? 2)Are we ready yet for cell transplantation? 3)Can we make progress in the maturation of cardiomyocytes derived from stem cells? 4)Cell therapy or engineered heart tissue? For which disease?

Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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Heart repair, cardiac regeneration and stem cells ...

Cardiac Stem Cells Comments Off on Heart repair, cardiac regeneration and stem cells … | June 29th, 2020

SAN FRANCISCO, June 29, 2020 /PRNewswire/ --Entitled "Randomized, Double Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction: rationale, design and first interim analysis", the presentation provides an initial insight into patient outcomes of the trial that is currently ongoing in multiple centers. Patients included in this trial experienced a severe form of Myocardial Infarction known as STEMI. Soon after the initial intervention to re-establish adequate blood flow to the coronary arteries, patients begin a two-week treatment with Recardio's dutogliptin, a small molecule that enables sustained homing of mobilised stem cells to the site of cardiac injury. By releasing paracrine factors, stem cells have been shown to have significant repair and regenerative effects that improve healing and recovery of cardiac function after the infarction.

More information about the clinical program is available by visiting the "clinicaltrials.gov" website at the following link:https://clinicaltrials.gov/ct2/show/NCT03486080

About Recardio

Recardio Inc. is a clinical-stage life science company focusing ontherapies for cardiovascular, oncology and infectious diseases. The company is located in San Francisco, California, and hasoperations in the USA and Europe.The company's lead drug candidate, dutogliptin, is a DPP-IV inhibitor that has demonstrated significant effects in activating various chemokines like SDF-1, a protein that is critical for cardiac regeneration. In addition to its current Phase 2 cardiovascular clinical program, Recardio will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases including acute myocardial infarction and chronic heart failure, with the potential of improving heart function, quality of life and survival.

For more information, visit:http://www.recardio.eu/or contact[emailprotected]

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Interim Analysis of Recardio's Phase II Clinical Trial to Be Presented at the 2020 Congress of the European Society of Cardiology - PRNewswire

Cardiac Stem Cells Comments Off on Interim Analysis of Recardio’s Phase II Clinical Trial to Be Presented at the 2020 Congress of the European Society of Cardiology – PRNewswire | June 29th, 2020

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) compared with chemotherapy, the current standard of care. In the study, treatment with KEYTRUDA also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months [95% CI, 5.4-32.4] versus 8.2 months [95% CI, 6.1-10.2]).

Todays approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed KEYTRUDA monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

This approval was granted less than one month following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program. This review also was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. For this application, a modified Project Orbis was undertaken, and the FDA is collaborating with the Australian Therapeutic Goods Administration, Health Canada and Swissmedic on their ongoing review of the application.

Patients with unresectable or metastatic MSI-H colorectal cancer have historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options, said Luis A. Diaz, M.D., head of the division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. In patients who were treated with KEYTRUDA and responded (n=67) in the KEYNOTE-177 trial, 43% of patients experienced a duration of response lasting two years or longer. This approval helps address the unmet need to provide a new monotherapy treatment option for patients.

Data Supporting the Approval

The approval was based on data from KEYNOTE-177 (NCT02563002), a multi-center, randomized, open-label, active-controlled trial that enrolled 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. Microsatellite instability (MSI) or mismatch repair (MMR) tumor status was determined locally using polymerase chain reaction or immunohistochemistry, respectively. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible.

Patients were randomized 1:1 to receive KEYTRUDA 200 mg intravenously every three weeks or investigators choice of the following chemotherapy regimens given intravenously every two weeks:

Treatment with KEYTRUDA or chemotherapy continued until Response Evaluation Criteria in Solid Tumors (RECIST) v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. Patients treated with KEYTRUDA without disease progression could be treated for up to 24 months. Assessment of tumor status was performed every nine weeks. Patients randomized to chemotherapy were offered KEYTRUDA at the time of disease progression. The main efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, and overall survival (OS). Additional efficacy outcome measures were objective response rate (ORR) and duration of response (DOR).

Patients were enrolled and randomized to KEYTRUDA (n=153) or chemotherapy (n=154). The baseline characteristics of these 307 patients were: median age of 63 years (range, 24 to 93), 47% age 65 or older; 50% male; 75% White and 16% Asian; 52% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, and 48% had an ECOG PS of 1; and 27% received prior adjuvant or neoadjuvant chemotherapy. Among the 154 patients randomized to receive chemotherapy, 143 received chemotherapy per the protocol. Of these 143 patients, 56% received mFOLFOX6, 44% received FOLFIRI, 70% received bevacizumab plus mFOLFOX6 or FOLFIRI, and 11% received cetuximab plus mFOLFOX6 or FOLFIRI. The median follow-up time was 27.6 months (range, 0.2 to 48.3 months).

In this study, KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) and showed a median PFS of 16.5 months (95% CI, 5.4-32.4) compared with 8.2 months (95% CI, 6.1-10.2) for patients treated with chemotherapy. For PFS, in the KEYTRUDA arm, there were 82 patients (54%) with an event versus 113 patients (73%) in the chemotherapy arm. At the time of the PFS analysis, the OS data were not mature (66% of the required number of events for the OS final analysis). For patients treated with KEYTRUDA, the ORR was 44% (95% CI, 35.8-52.0), with a complete response rate of 11% and a partial response rate of 33%, and for patients treated with chemotherapy, the ORR was 33% (95% CI, 25.8-41.1), with a complete response rate of 4% and a partial response rate of 29%. Median DOR was not reached (range, 2.3+ to 41.4+) with KEYTRUDA versus 10.6 months (range, 2.8 to 37.5+) with chemotherapy. Based on 67 patients with a response in the KEYTRUDA arm and 51 patients with a response in the chemotherapy arm, 75% in the KEYTRUDA arm had a duration of response greater than or equal to 12 months versus 37% in the chemotherapy arm, and 43% in the KEYTRUDA arm had a duration of response greater than or equal to 24 months versus 18% in the chemotherapy arm.

Among the 153 patients with MSI-H or dMMR colorectal cancer treated with KEYTRUDA, the median duration of exposure to KEYTRUDA was 11.1 months (range, 1 day to 30.6 months). Adverse reactions occurring in patients with MSI-H or dMMR colorectal cancer were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer treated with KEYTRUDA as a single agent.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

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

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

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

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

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

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

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

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

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

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

Colorectal Cancer

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

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Tumor Mutational Burden-High (TMB-H)

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

Cutaneous Squamous Cell Carcinoma

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

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

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FDA Approves Merck's KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -...

Cardiac Stem Cells Comments Off on FDA Approves Merck’s KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -… | June 29th, 2020

Canine Stem Cell Therapy Market report provides (6 Year Forecast 2020-2026) including detailed Coronavirus (COVID-19) impact analysis on Market Size, Regional and Country-Level Market Size, Segmentation Market Growth, Market Share, Competitive Landscape, Sales Analysis and Value Chain Optimization. This Canine Stem Cell Therapy market competitive landscape offers details by topmost key manufactures (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) including Company Overview, Company Total Revenue (Financials), Market Potential, Presence, Canine Stem Cell Therapy industry Sales and Revenue Generated, Market Share, Price, Production Sites and Facilities, SWOT Analysis, Product Launch. For the period 2014-2020, this study provides the Canine Stem Cell Therapy sales, revenue and market share for each player covered in this report.

Key Target Audience of Canine Stem Cell Therapy Market: Manufacturers of Canine Stem Cell Therapy, Raw material suppliers, Market research and consulting firms, Government bodies such as regulating authorities and policy makers, Organizations, forums and alliances related to Canine Stem Cell Therapy market.

Get Free Sample PDF (including COVID-19 Impact Analysis, full TOC, Tables and Figures)of Canine Stem Cell Therapy[emailprotected]https://www.researchmoz.us/enquiry.php?type=S&repid=2081893

Synopsis of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry.

Based onProduct Type, Canine Stem Cell Therapy market report displays the manufacture, profits, value, and market segment and growth rate of each type, covers:

Allogeneic Stem Cells Autologous Stem cells

Based onend users/applications, Canine Stem Cell Therapy market report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate for each application, this can be divided into:

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

Canine Stem Cell Therapy Market: Regional analysis includes:

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The Canine Stem Cell Therapy Market Report Can Answer The Following Questions:

What are the Upstream Raw Materials And Manufacturing Equipment of Canine Stem Cell Therapy? What is the manufacturing process of Canine Stem Cell Therapy?

Who are the key manufacturers of Canine Stem Cell Therapy market? How are their operating situation (Capacity, Production, Price, Cost, Gross and Revenue)?

Economic impact on Canine Stem Cell Therapy industry and development trend of Canine Stem Cell Therapy industry.

What is the (North America, South America, Europe, Africa, Middle East, Asia, China, Japan) Production, Production Value, Consumption, Consumption Value, Import And Export of Canine Stem Cell Therapy?

What will the Canine Stem Cell Therapy Market Size and The Growth Rate be in 2026?

What are the key market trends impacting the growth of the Canine Stem Cell Therapy market?

What are the Canine Stem Cell Therapy Market Challenges to market growth?

What are the types and applications of Canine Stem Cell Therapy? What is the market share of each type and application?

What are the key factors driving the Canine Stem Cell Therapy market?

What are the Canine Stem Cell Therapy market opportunities and threats faced by the vendors in the Canine Stem Cell Therapy market?

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ResearchMozMr. Rohit Bhisey,Tel: +1-518-621-2074USA-Canada Toll Free: 866-997-4948Email:[emailprotected]

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Canine Stem Cell Therapy Market 2020-2026: Analysed By Business Growth, Development Factors, Applications, And Future Prospects - 3rd Watch News

Cardiac Stem Cells Comments Off on Canine Stem Cell Therapy Market 2020-2026: Analysed By Business Growth, Development Factors, Applications, And Future Prospects – 3rd Watch News | June 29th, 2020

Pune, Maharashtra, India, June 29 2020 (Wiredrelease) Data Bridge Market Research A New Business Intelligence Report released by Data Bridge Market Research with title Global Exosome Therapeutic Market size, share, growth, Industry Trends and Forecast 2027 has abilities to raise as the most significant market worldwide as it has remained playing a remarkable role in establishing progressive impacts on the universal economy. The Global Exosome Therapeutic Market Report offers energetic visions to conclude and study the market size, market hopes, and competitive surroundings. The research is derived through primary and secondary statistics sources and it comprises both qualitative and quantitative detailing. This report has been crafted as the result of persistent efforts lead by knowledgeable forecasters, innovative analysts and brilliant researchers who indulge in detailed and diligent research on different markets, trends and emerging opportunities in the successive direction for the business needs.

Download Exclusive Sample Report (350 Pages PDF with All Related Graphs & Charts) For Free@:https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-exosome-therapeutic-market

DBMR Analyses that the Exosome Therapeutic Market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

Increased number of exosome therapeutics as compared to the past few years will accelerate market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

KNOW YOUR OPTIONS IN THE FIGHT AGAINST COVID-19

The COVID-19 Pandemic has created bottlenecks across industry pipelines, sales funnels, and supply chain activities. This has created unprecedented budget pressure on company spending for industry leaders. This has increased requirement for opportunity analysis, price trend knowledge and competitive outcomes. Use the DBMR team to create new sales channels and capture new markets previously unknown. DBMR helps its clients to grow in these uncertain markets.

To Understand How COVID-19 Impact is covered in This Report. Get Sample Copy of the Report@https://www.databridgemarketresearch.com/request-covid-19/global-exosome-therapeutic-market

The Global Exosome Therapeutic market 2020 research provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Global Exosome Therapeutic Market Share analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. For each manufacturer covered, this report analyzes their Exosome Therapeutic manufacturing sites, capacity, production, ex-factory price, revenue and market share in global market.

Major Players in Global Exosome Therapeutic Market Include

evox THERAPEUTICSEXOCOBIOExopharmAEGLE TherapeuticsUnited Therapeutics CorporationCodiak BioSciencesJazz Pharmaceuticals, Inc.Boehringer Ingelheim International GmbHReNeuron Group plcCapricor TherapeuticsAvalon Globocare Corp.CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC.Stem Cells Group..

Complete Report is Available (Including Full TOC, List of Tables & Figures, Graphs, and Chart)@https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market

New Exosome Therapeutic Market Developments in 2019

In January 2019, Codiak BioSciences has collaborated with Jazz Pharmaceuticals, Inc. to develop and commercialize exosome therapeutics to treat cancer. The collaboration will help the company to address issues which have been often implicated in solid tumors and hematological malignancies.

In October 2018, Avalon GloboCare Corp. has collaborated with Weill Cornell Medicine to form standards in cGMP-grade for human endothelial cells sourced exosome which is significant for organ regeneration and vascular health and isolation and identification of exosomes sourced from tissue for liquid biopsy and clinical use. The collaboration will help the company to lead market as exosome isolation system as will be first in the world for standardization processing of cGMP-grade exosomes for clinical studies.

In July 2018, Capricor Therapeutics has formed collaboration with the U.S. Army Institute of Surgical Research (USAISR) to discover potential for CAP-2003 (exosomes) in order to address trauma-related conditions and injuries. The collaboration will help to test CAP-2003 as a tool for preservation of life.

This research is categorized differently considering the various aspects of this market. It also evaluates the current situation and the future of the market by using the forecast horizon. The forecast is analyzed based on the volume and revenue of this market. The tools used for analyzing the Global Exosome Therapeutic Market research report include SWOT analysis.

The Global Exosome Therapeutic segments and Market Data Break Down are illuminated below:

By Type (Natural Exosomes, Hybrid Exosomes

By Source (Dendritic Cells, Mesenchymal Stem Cells, Blood, Milk, Body Fluids, Saliva, Urine Others)

By Therapy (Immunotherapy, Gene Therapy, Chemotherapy)

By Transporting Capacity (Bio Macromolecules, Small Molecules

By Application (Oncology, Neurology, Metabolic Disorders, Cardiac Disorders, Blood Disorders, Inflammatory Disorders, Gynecology Disorders, Organ Transplantation, Others)

By Route of administration (Oral, Parenteral)

By End User (Hospitals, Diagnostic Centers, Research & Academic Institutes)

If you have any Enquiry please click here @https://www.databridgemarketresearch.com/inquire-before-buying/?dbmr=global-exosome-therapeutic-market

The Global Exosome Therapeutic Market in terms of investment potential in various segments of the market and illustrate the feasibility of explaining the feasibility of a new project to be successful in the near future. The core segmentation of the global market is based on product types, SMEs and large corporations. The report also collects data for each major player in the market based on current company profiles, gross margins, sales prices, sales revenue, sales volume, photos, product specifications and up-to-date contact information.

What are the strengths and weaknesses of the key vendors?

Definitively, this report will give you an unmistakable perspective on every single reality of the market without a need to allude to some other research report or an information source. Our report will give all of you the realities about the past, present, and eventual fate of the concerned Market.

Scope of the Exosome Therapeutic Market

The global exosome therapeutic market is segmented on the basis of countries into U.S., Mexico, Turkey, Hong Kong, Australia, South Korea, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua and Uruguay.

All country based analysis of the exosome therapeutic market is further analyzed based on maximum granularity into further segmentation. On the basis of type, the market is segmented into natural exosomes and hybrid exosomes. Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. On the basis of therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. On the basis of transporting capacity, the market is segmented into bio macromolecules and small molecules. On the basis of application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. On the basis of route of administration, the market is segmented into pa oral and parenteral. On the basis of end user, the market is segmented into hospitals, diagnostic centers and research & academic institutes and others.

Some Points from Table of Content:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Regulatory Scenario by Region/Country1.4 Market Investment Scenario Strategic1.5 Market Analysis by Type1.5.1 Global Exosome Therapeutic Market Share by Type (2020-2027)1.5.2 Type 11.5.3 Type 21.5.4 Other1.6 Market by Application1.6.1 Global Exosome Therapeutic Market Share by Application (2020-2027)1.6.2 Application 11.6.3 Application 21.6.4 Other1.7 Exosome Therapeutic Industry Development Trends under COVID-19 Outbreak1.7.1 Region COVID-19 Status Overview1.7.2 Influence of COVID-19 Outbreak on Exosome Therapeutic Industry Development

Global Market Growth Trends2.1 Industry Trends2.1.1 SWOT Analysis2.1.2 Porters Five Forces Analysis2.2 Potential Market and Growth Potential Analysis2.3 Industry News and Policies by Regions2.3.1 Industry News2.3.2 Industry Policies3 Value Chain of Exosome Therapeutic Market3.1 Value Chain Status3.2 Exosome Therapeutic Manufacturing Cost Structure Analysis3.2.1 Production Process Analysis3.2.2 Manufacturing Cost Structure of Exosome Therapeutic3.2.3 Labor Cost of Exosome Therapeutic3.3 Sales and Marketing Model Analysis3.4 Downstream Major Customer Analysis (by Region)

4 Players Profiles4.1 Player 14.1.1 Player 1 Basic Information4.1.2 Exosome Therapeutic Product Profiles, Application and Specification4.1.3 Player 1 Exosome Therapeutic Market Performance (2015-2020)4.1.4 Player 1 Business Overview4.2 Player 24.2.1 Player 2 Basic Information4.2.2 Exosome Therapeutic Product Profiles, Application and Specification4.2.3 Player 2 Exosome Therapeutic Market Performance (2015-2020)4.2.4 Player 2 Business Overview4.3 Player 34.3.1 Player 3 Basic Information4.3.2 Exosome Therapeutic Product Profiles, Application and Specification4.3.3 Player 3 Exosome Therapeutic Market Performance (2015-2020)4.3.4 Player 3 Business Overview4.4 Player 44.4.1 Player 4 Basic Information4.4.2 Exosome Therapeutic Product Profiles, Application and Specification4.4.3 Player 4 Exosome Therapeutic Market Performance (2015-2020)4.4.4 Player 4 Business Overview4.5 Player 54.5.1 Player 5 Basic Information4.5.2 Exosome Therapeutic Product Profiles, Application and Specification4.5.3 Player 5 Exosome Therapeutic Market Performance (2015-2020)

4.5.4 Player 5 Business Overview5 Global Exosome Therapeutic Market Analysis by Regions5.1 Global Exosome Therapeutic Sales, Revenue and Market Share by Regions5.1.1 Global Exosome Therapeutic Sales by Regions (2015-2020)5.1.2 Global Exosome Therapeutic Revenue by Regions (2015-2020)5.2 North America Exosome Therapeutic Sales and Growth Rate (2015-2020)5.3 Europe Exosome Therapeutic Sales and Growth Rate (2015-2020)5.4 Asia-Pacific Exosome Therapeutic Sales and Growth Rate (2015-2020)5.5 Middle East and Africa Exosome Therapeutic Sales and Growth Rate (2015-2020)5.6 South America Exosome Therapeutic Sales and Growth Rate (2015-2020)

11 Global Exosome Therapeutic Market Segment byTypes12 Global Exosome Therapeutic Market Segment by Applications13 Exosome Therapeutic Market Forecast by Regions (2020-2027)ContinuedComplete Report Is Available| Get Free TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market

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Exosome Therapeutic Market Size, 2020-New Technological Change Helping Market, Application, Driver, - PharmiWeb.com

Cardiac Stem Cells Comments Off on Exosome Therapeutic Market Size, 2020-New Technological Change Helping Market, Application, Driver, – PharmiWeb.com | June 29th, 2020

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

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Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe areVericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc.A large number of players are anticipated to enter the global market throughout the forecast period.

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Regenerative Medicine Market Analysis Growth Demand, Key Players, Share Size, and Forecast To 2025 - 3rd Watch News

Cardiac Stem Cells Comments Off on Regenerative Medicine Market Analysis Growth Demand, Key Players, Share Size, and Forecast To 2025 – 3rd Watch News | June 26th, 2020

Eustasis Psychiatric & Addiction Health

417-322-6622| 3600 S. National Ave., Springfield

Eustasis Psychiatric & Addiction Health is pleased to announce construction of their brand new site in the heart of Medical Mile, opening in July! There is expanded access to medication management, psychotherapy, testing and advanced treatment options.

Dr. Alok Jain and his wife Breanna Jain started the clinic in 2018 with the mission of providing the highest quality psychiatric care to all patients. Since then they have put together an amazing team of board-certified providers and support staff who have tirelessly served the Springfield community.

We wanted to build something really vital for our patients. A place that everyone could come, regardless of age or diagnosis, says Dr. Jain.

Dr. Alok Jain has been honored as a 417 Top Doctor every year since 2007 and is 2020's top psychiatrist. He is a board-certified psychiatrist, member of the American Psychiatric Association and has an extensive background in consultation-liaison psychiatry and psychopharmacology.

Eustasiss immediate-access site has provided patients with an unprecedented way to receive psychiatric care without delay. Their walk-in and be seen model is changing the face of psychiatry. The new location has eight providers and room for growth! They are providing the most state of the art modalities, including ADHD testing and esketamine.

It is super exciting, says Breanna Jain, CEO, PMHNP-BC. We have patients who come in all hours of the day, pediatric or adult, all payor sources. They will ask, You mean I can really be seen right now? We can proudly tell them of course! This is just the way we believe mental health should be done.

Both Dr. Jain and Breanna know that people need options in this community. Patients struggles are numerous, ranging from addiction, bipolar, ADHD, trauma, anxiety and more. The Jains like to think of Eustasis as a one-stop-shop.

There shouldnt be high levels of bureaucracy. This is what overwhelms patients. Barriers have no place when it comes to mental health, the Jains explain.

Eustasis is committed to helping patients find the optimal balance of emotions during these difficult times. They have expanded their hours and have both in person and telemedicine options available. They are always accepting new patients!

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Medical Professionals in the Ozarks - 417mag

Cardiac Stem Cells Comments Off on Medical Professionals in the Ozarks – 417mag | June 26th, 2020