Category Archives: Cell Medicine

Startling, never-before-seen images show that the new coronavirus hijacks proteins in our cells to create monstrous tentacles that branch out and may transmit infection to neighboring cells.

Thefinding, accompanied byevidence ofpotentially more effective drugs against COVID-19,was published Saturday in the journalCellby an international team of scientists.

Fluorescence microscopy image of human epithelial cells taken from the colon and infected with SARS-CoV-2, the virus, that causes COVID-19. The infected cells produce tentacles, known formally as filopodia ( in white) extending out from the cell surface containing viral particles (M protein in red).(Photo: Dr. Robert Gross, University of Freiburg)

By focusing on the fundamental behavior of the virus how it hijacks key human proteins and uses them to benefit itself and harm us the team wasable to identify a family of existing drugs called kinase inhibitors that appear to offerthe most effective treatment yet forCOVID-19.

"We've tested a number of these kinase inhibitors and some are better than remdesivir," said Nevan Krogan, one of more than 70authors of the new paper, and director of the Quantitative Biosciences Instituteat the University of California, San Francisco.

While remdesivir has yet to beapproved for use against COVID-19,U.S.regulatorsare allowing "emergency use" of the drug inhospitalized patients.

Krogan said tests ofkinase inhibitors showed some, including Gilteritnib and Ralimetinib, required lower concentrations thanremdesivir in order tokill off 50% of the virus.

The new study, whichinvolvedexperiments using cells from humans and othersfrom African green monkeys, shows that the virus known as SARS-CoV-2is especially adept at disrupting vital communications. These communicationstake place both withincells and from one cell to another.

Electron microscopy image of cells from the kidney of a female African green monkey that have been infected with SARS-CoV-2, the virus that causes COVID-19. Infected cells produce tentacles known formally as filopodia (orange) extending out from the cell surface to enable budding of viral particles (blue) and infection of nearby cells.(Photo: Dr. Elizabeth Fischer, NIAID/NIH)

"This paper shows just how completely the virus is able to rewire all of the signals going on inside the cell. That's really remarkable and it's something that occurs very rapidly (as soonas twohours after cells are infected)," said Andrew Mehle, an associate professor of medical microbiology and immunology at the University of Wisconsin-Madison.

The communicationssystemknown ascell signaling, allowscells to grow, and to detect and respond to outside threats. Errors in cell signaling can lead to such illnesses as cancer and diabetes.

RELATED:"Something we've never seen before: Scientists still trying to understand baffling, unpredictable coronavirus"

Mehle, who was not involved in the study, said the work shows that scientists are contending with a daunting enemy in thenew conronavirus. "These are highly efficient, evolutionarily-tuned machines that will make it very challenging to develop therapeutics," he said.

From early in the pandemic, Krogan and his colleagues have taken adifferentapproach from that of manyresearchers seeking treatments for the new virus.

Many scientists have been screeningthousands of drugs already approved for other uses to determine if theycan also be used to treat COVID-19.

"We're not doing that," Krogan said. "We're saying 'Let's understand the underlying biology behind how the virus infects us, and let's use that against the virus.'"

In thesearch for treatments, many scientists have homed inonkey proteins in the virus especially the Spike protein, which allowsthe viral cellsto attach themselves to human cells.

Fluorescence microscopy image of of human epithelial cells taken from the colon and infected with SARS-CoV-2, the virus that causes COVID-19.Viral N protein (red) hijacks human Casein Kinase II (green; co-localization in yellow) to putatively produce branching filopodia protrusions (white outline boxes) to enable budding of viral particles and infection of nearby cells.(Photo: Dr. Robert Gross, University of Freiburg)

Krogan and his team looked in the opposite direction, focusingon the human proteins, instead of those in the virus. Dozens ofhuman proteins play a critical role in the disease processbecause the virusneeds themto infect people and to make copies of itself.

There is an important advantage to developing treatments aimed atthe human, rather than the viral, proteins. Viral proteins can mutate causing them to develop resistance to the drugs targeted to them. Human proteins are far less likely to mutate.

In April,Krogan and his colleaguespublished a study in the journal Nature showing that332 human proteinsinteract with 27 viral proteins.

Feixiong Cheng, a PhD researcher who runs a lab at Cleveland Clinic Genomic Medicine Institute, called themapping ofinteractions between theseproteins "a novel" and "powerful" strategy for findingexisting drugs that might helpCOVID-19 patients.

RELATED:Two classes of drugs found that may treat COVID-19

In the new study, Krogan's international teamlooked deeper into the biology, focusing onhow the new coronavirus changes a complex process called phosphorylation. Thisprocess acts as a series ofon-off switches for differentcell activities, includinggrowth, division, deathand communicationwith one another.

"What they've done is really a fantastic next step," said Lynne Cassimeris, a professor of biological sciences at Lehigh University, explaining that the work builds on the previous paper and applies knowledge of cell biologygained over the last30 years.

"It's an amazing leap. We know that the virus has to be manipulating these human proteins. Now we have a list of what is changing over time."

Cassimeris said that mapping these changesallows researchers to seek drugs thatcan intervene at specific points.

The scientists found that on-off switcheschanged significantly in 40 of the 332 proteins that interact with the new coronavirus.

Thechanges occur because the viruseither dialsup or down49 enzymes called kinases. The dialing up or down ofkinases cause them to alter40 of the proteins that interact with virus.

Imagine the kinases as guards protecting our health until the new coronavirus turns them against us. In each case, however, the new study identified treatments that can stopthe virus from turningguards into assailants.

The virus most powerfully hijacks a kinase called CK2, which plays a key role in the basic frameof thecell as well asitsgrowth, proliferation and death.

This led the scientists to investigatea drug called Silmitasertib. Tests found this druginhibits CK2and eliminatesthe new coronavirus.

Electron microscopy image of cells from the kidney of a female African green monkey, which have been infected with SARS-CoV-2, the virus that causes COVID-19. Infected cells produce tentacles known formally as filopodia (blue) extending out from the cell surface to enable budding of viral particles (orange) and infection of nearby cells.(Photo: Dr. Elizabeth Fischer, NIAID/NIH)

They also found that the virus has a dramatic effect on a pathway a group of kinases that forma cascade a little like falling dominoes. The virus hijacksthis cascade so that the end result becomesa dangerous overreaction by ourimmune system.

The study's findingon this pathwaymay help to explainthe extreme overreaction acytokine storm that causes the immune system to kill both healthy anddiseased tissue, leadingtomore than half of the deaths from COVID-19.

RELATED:UW joins drug trial aimed at stopping haywire immune response

Here too, the scientists were able to identify treatments, including the experimental cancerdrug Ralimetinib, whichmay preventthe immune system overreaction.

Authors of the new study also found that the virus harms a family of kinasescalled CDKs. Theseplay roles incell growth and in the response toDNAdamage. An experimental drug called Dinaciclib may be effective in thwarting thisviral assault.

Finally, Krogan and his colleagues found that the virus also hijack a kinase that helps cells stay healthy in different environments and cleans out damaged cells.A small molecule called Apilimod targets this kinase and has been able to hinderthe virus in lab tests.

Krogan, who is also an investigator at the Gladstone Institutes at UCSF, said the strategy of examining the human kinases affected by the virus has provedfruitful.

"The kinases are a very druggable set of proteins in our cells," he said.

Email him at mark.johnson@jrn.com; follow him on Twitter: @majohnso.

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Study reveals images of the coronavirus forming tentacles in cells -- but monstrous discovery helps identify new treatment - Milwaukee Journal...

Lingjia Yu,1 Qi Fei,1 Jisheng Lin,1 Yong Yang,1 Yisheng Xu2

1Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, Peoples Republic of China; 2Orthopedics Department, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong 510120, Peoples Republic of China

Correspondence: Yong YangDepartment of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, Peoples Republic of ChinaEmail spineyang@126.comYisheng XuOrthopedics Department, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong 510120, Peoples Republic of ChinaEmail xuyishengdr@gzucm.edu.cn

Purpose: Bone tissue infections are a difficult problem in orthopedic surgery. Topical application of vancomycin and tobramycin powder has been proved to significantly reduce infection rates. However, the osteogenic effect of the topical application of these two antibiotics is unclear. In this study, the osteogenic effect of local delivery antibiotics on bone regeneration was investigated in vitro.Methods: Bone marrow stromal cells (BMSCs) were incubated in the presence of vancomycin (14.28g/mL), tobramycin (28.57g/mL), or vancomycin combined with tobramycin (vancomycin 14.28g/mL and tobramycin 28.57g/mL). Cell viability, proliferation, and migration were analyzed. The alizarin red staining as well as the alkaline phosphatase staining was investigated. Then, the quantitative real-time (qRT)-PCR of osteogenic mRNA expression levels were also evaluated.Results: The results showed that vancomycin combined with tobramycin has no adverse effect on the viability and proliferation of BMSCs. The topical application of vancomycin alone may interfere with the bone regenerative processes. However, the tobramycin can promote the osteogenic differentiation of BMSCs and also rescue the osteogenic potential of BMSCs inhibited by vancomycin both in vitro.Conclusion: From this in vitro study, local application of vancomycin combined with tobramycin does not affect the osteogenic potential of BMSCs.

Keywords: vancomycin, tobramycin, osteogenesis, bone regeneration

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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The Osteogenic Effect of Local Delivery of Vancomycin and Tobramycin o | IDR - Dove Medical Press

By softening a cells nucleus so that it can squeeze its way through dense connective tissues, a group of researchers believe theyve demonstrated a new way to help the body efficiently repair injuries. The team of researchers tested this theory by using a medication to inhibit enzymes in the nucleus of knees meniscus cells, which allowed the cells to move through environments that were previously impenetrable. This study is published inScience Advances.

The study focuses on cells in the meniscus, which is a thin layer of dense connective tissue in the human knee. However, the approach could prove effective beyond that specific area.

In this case, we studied how meniscus cell nuclei can be softened to promote their migration through meniscus tissues. We have also shown similar enhancement of cell migration in other types of connective tissues, such as tendons or the cartilage covering the ends of bones, says the studys first author,Su Chin Heo,anassistant professor of research of Orthopaedic Surgery, who works within theMcKay Orthopaedic Research Lab.

In the study, the teams saw that isolated meniscus cells that had been treated with the inhibitor drug trichostatin A were able to move through areas that were once thought to be impassible to reach defects in tissue. This is important becomes some of the repair methods used for injuries involve fibrous scaffolding, which can also be dense and impenetrable. These areas, too, could be infiltrated with the repair cells whose nuclei were softened, the study shows.

This story is by Frank Otto. Read more at Penn Medicine News.

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To heal meniscus injuries, researchers go to the heart of a cell - Penn: Office of University Communications

As we discussed in our last update on the Food and Drug Administrations Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will conclude the three-year period of enforcement discretion announced by the agency when it first articulated the policies and goals of this comprehensive framework. In particular, under the dual-track program announced in 2017, the Food and Drug Administration (FDA) has been focused on: (1) clarifying the regulatory criteria for product marketing through guidance and providing support to legitimate product developers through formal and informal interactions; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market.

None of the COVID-19-related operational updates provided by the FDA generally or by the Center for Biologics Evaluation and Research (CBER) in recent months has suggested that the November 2020 deadline will be extended or otherwise altered as a result of the ongoing public health emergency, even as certain other enforcement discretion policies have been put into place. Additionally, a recent editorial published by agency leadership and a noticeable increase in Warning/Untitled Letters to persons offering unapproved cellular therapy products, taken together, strongly suggest that folks in this industry that are currently operating outside of the applicable regulatory framework should not expect to be given any additional time to come into compliance.

June 2020 JAMA Editorial Strong Language and No Sign of a Deadline Extension

Multiple statements on the topic of regenerative medicine have been issued by the governing FDA Commissioner as well as CBER Director Peter Marks over the past several years, which indicates how important this area is to the agencys broader public health priorities at the start of the 21st century. The most recent salvo from agency leadership came in the form of an editorial published online by JAMA on June 17, 2020, authored by Dr. Marks and Commissioner Stephen Hahn, who has been in his new job for about six months. Their editorial includes some of the strongest language we have seen to date on the topic of unapproved regenerative medicine products. For example, Dr. Marks and Dr. Hahn state that [d]espite assertions by some individuals to the contrary, these products, whether autologous or allogeneic, are not inherently safe and may be associated with serious adverse consequences. They assert that [t]he increasing number of adverse events being reported following the widespread use of unapproved regenerative medicine therapies at hundreds of clinics across the country make it necessary for the FDA to act to prevent harm to individuals receiving them.

Drs. Marks and Hahn briefly highlight some of the enforcement that the agency has undertaken in this space since 2017 and ask for engagement from both clinicians and patients to help to ensure that instead of remaining unintentionally or intentionally hidden, potentially harmful unapproved regenerative medicine therapies are identified and removed from the market. They then provide basic guidelines for patients and caregivers to use when assessing whether a cellular therapy product is being offered in compliance with applicable laws and FDA regulations. Specifically, they recommend the following key considerations for anyone considering treatment with a cellular product:

Nothing in this newly-published editorial suggests that FDA/CBER will be taking its proverbial foot off the pedal to slow down its efforts towards further oversight of the private stem cell clinic industry after November 2020. To the contrary, the piece could represent one of the last informal warnings those businesses get from the agency before they receive a customized Warning or Untitled Letter or become subject to whatever increased enforcement activity the federal government initiates in this area in 2021 and beyond.

Relatively Large Number of Warning Letters Sent Since January 2020

We previously noted that FDA/CBER appeared to have increased the pace of issuing Warning and Untitled Letters to sellers of unapproved stem cell products during the second half of 2019, with many of those letters involving companies that processed and marketed unapproved umbilical cord blood-derived cellular products. We also reported that the agency had issued a Public Safety Notification on Exosome Products on December 6, 2019, informing the public of multiple reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. That safety alert also described the unscrupulous conduct of sellers of such products in forceful and direct language, similar to the language used by Dr. Marks and Commissioner Hahn in this months editorial piece.

Over the first half of this year, as we get yet closer to the November 2020 deadline for stem cell clinics and medical practitioners to come into compliance with federal law, there has been a more noticeable increase in the Warning/Untitled Letters issues regarding the marketing of unapproved products that put patients at risk. These include at least nine Untitled Letters issued since January 2020 (which can each be accessed from this CBER webpage) and at least two Warning Letters, one from March and one from June. The Warning Letters in particular include charges that the firms in question were violating current good manufacturing practices (CGMPs) and current good tissue practices (CGTPs) for human cells and tissue products, putting patient safety at risk.

Interestingly, the most recent FDA Warning Letter issued on June 4, 2020 not only cites the recipient for marketing unapproved stem cell products and an unapproved exosome product, but it also states that the unapproved exosome product was being marketed for the treatment and prevention of COVID-19 something the June 17 Marks/Hahn JAMA editorial alluded to generally as well. Given that there are currently no FDA-approved products to prevent or treat COVID-19, any such claims will automatically heighten the enforcement risk to a company or physician engaged in the sale of products for those intended uses.

In addition to the work being done by FDA, moreover, the Federal Trade Commission (FTC) has also been monitoring the commercial marketplace closely and taking various actions to protect consumers from fraudulent COVID-19 products, including a few marketed by stem cell clinics. So far this month, FTC announced on June 4, 2020 that it had issued a 35 warning letters and an additional 30 warning letters on June 18, 2020. The first batch of these FTC warning letters notably included one to a stem cell clinic that, among other things, had claimed that stem cells can be administered intravenously and by inhalation through a nebulizer to treat lung damage caused by COVID-19 without scientific evidence to support the efficacy claim, while the second batch included two letters addressed to marketers of stem cell products.

FDA and the FTC coordinate quite closely on consumer protection matters that implicate both agencies primary missions, as is apparent from the large number of COVID-19 Warning Letters that have been jointly issued by the two agencies since March 2020. So they may very well be coordinating more actively now on the monitoring of stem cell clinics and individual physicians offering unapproved cellular therapies to the general public, as the focus shifts to the next phase of the Comprehensive Regenerative Medicine Policy Framework. The next five or six months should offer everyone more insight into what the enforcement landscape is likely to evolve into once the FDAs enforcement discretion period ends in November. As always, well keep our readers apprised of any notable developments.

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Update on FDAs Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from CBER and a New JAMA...

Washington, DC, June 24, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), an international multi-stakeholder advocacy organization representing the regenerative medicine and advanced therapy sector, today announced a new virtual format for its annual Cell & Gene Meeting on the Mesa, which will take place October 12-16, 2020.

ARM's leadership and Board of Directors arrived at the decision to host the 2020 Cell & Gene Meeting on the Mesa virtually after consulting with numerous ARM members and gathering information from various health authorities. Ultimately, hosting the meeting virtually will be the safest and most inclusive solution, allowing attendees to connect with potential partners globally while avoiding any risk to safety.

This year's Cell & Gene Meeting on the Mesa will bring together senior executives from leading cell therapy, gene therapy, and tissue engineering companies worldwide, large pharma and biotech, institutional investors, academic research institutions, patient foundations and disease philanthropies, life science media, and more.

During this unprecedented period of social distancing, ARM continues to provide members with avenues to engage and connect, said ARM CEO Janet Lambert. Our virtual Meeting on the Mesa is an invaluable opportunity for stakeholders from across the sector to convene, to network, and to continue to work to ensure innovative cell and gene therapies reach patients in need.

The conference, which will now take place over five days, includes a virtual form of the meetings signature partnering system, expected to facilitate more than 3,000 one-to-one meetings between industry leaders. The program will include 15+ digital panels and workshops featuring key industry leaders discussing issues and trends in the regenerative medicine and advanced therapy sector, from market access to the latest discoveries in gene editing. Representatives from more than 80 prominent public and private companies will deliver on-demand presentations highlighting their clinical and commercial progress to interested partners and investors.

Additional event details will be updated regularly on the event website http://www.meetingonthemesa.com.

Registration is currently open, with discounted early-bird rates available through July 24. Registration is complimentary for investors and credentialed members of the media. To learn more and to register, please visitwww.meetingonthemesa.com. For members of the media interested in attending, please contact Kaitlyn (Donaldson) Dupont atkdonaldson@alliancerm.org.

For interested organizations looking to increase exposure to this fields top decision-makers via sponsorship, please contact Laura Stringham at lparsons@alliancerm.org for additional information.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory, and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors, and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visithttp://www.alliancerm.org.

Kaitlyn (Donaldson) Dupont

803-727-8346

kdonaldson@alliancerm.org

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The Alliance for Regenerative Medicine Announces Its 2020 Cell & Gene Meeting on the Mesa Goes Virtual - GlobeNewswire

The National Heart, Lung and Blood Institute awarded $3.05 million to researchers from theLawrence D. Longo, MD Center for Perinatal Biologyat Loma Linda University School of Medicine, allowing investigators to add a new element to their study portfolio of exploring the effects of oxygen deprivation or hypoxia on mother and baby during pregnancy.

Investigators will use the four-year grant toward the centers research project, titled "Gestational Hypoxia and Programming of Maternal, Fetal and Newborn Vascular Function. Starting in July 2020, researchers will use the funds to search for mechanisms causing pregnancy complications of preeclampsia and developmental programming of cardiovascular disease from gestational hypoxia.

Hypoxia during gestation has profound adverse effects on the mothers health and fetal development. Hypoxia is one of the most frequent and severe stresses on an organism's body regulation of metabolism, temperature, fluid composition, blood sugar, blood flow and blood pressure. Worldwide, more than 140 million people live at risk of hypoxia in high altitude environments.In addition, a large portion of pregnancy complications, including preeclampsia, smoking and placental insufficiency, expose the fetus to chronic hypoxia.

The studys principal investigator, Lubo Zhang, PhD, director of the Lawrence D. Longo Center for Perinatal Biology, said he and his team look forward to making additional strides toward meaningful discoveries that could be life-saving for families.

We are pleased and honored to receive this grant because the research it supports can change the lives of mothers and babies, Zhang said. The teams overall vision is to build on the centers prior accomplishments to formulate a highly innovative program for advancing and transforming the research field in the understanding maternal, fetal and newborn vascular function in response to hypoxia during gestation.

In addition to this new research project, the investigator team headed by Zhang is currently conducting four studies on the effects of hypoxia. Those studies are funded by a Program Project grant from the National Institutes of Health (NIH). In 2016, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, an NIH entity,awarded the center a $6.29 million grant to work on discoveries revealing oxygen deprivations effects on uterine blood flow, fetal cerebral circulation, and the impact of hypoxia on fat cell and metabolism.

Investigators found high altitude hypoxia during gestation decreased uterine blood flow and increased the mothers systemic arterial blood pressure. Researchers came to this conclusion after using an animal model of pregnant sheep acclimatized to high altitude above 10,000 feet. In addition to maternal cardiovascular complications, the studies revealed that newborn lambs at high altitude showed significantly increased risk of persistent pulmonary hypertension similar to humans. Investigators also found pregnancy complications and fetal hypoxia were associated with dysregulation of cerebral blood flow and increased risk of bleeding in the developing brain.

The five-year NIH grant will expire in March of 2021. With this looming expiration, the research team is looking forward to continue exploring the topic for another four years.

The new grant was secured with help from Congressman Pete Aguilar, U.S. representative for the congressional district.

Loma Linda University Health is a point of pride for our region, and the lifesaving research of Dr. Zhang and his team is exciting and inspiring, Aguilar said. As Vice Chair of the House Appropriations Committee, and LLUHs representative in Congress, Im proud to support their work and will continue to advocate for the funding that makes these groundbreaking studies possible.

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$3 million grant awarded to Loma Linda University School of Medicine researchers for maternal hypoxia study - Loma Linda University Health

he globalstem cell and regenerative medicines marketshould grow from $21.8 billion in 2019 to reach $55.0 billion by 2024 at a compound annual growth rate (CAGR) of 20.4% for the period of 2019-2024.

Report Scope:

The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

Request for Report Sample:https://www.trendsmarketresearch.com/report/sample/11723

Report Includes:

28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary

The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study

Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.

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Stem Cell And Regenerative Therapy Market : Segmentation, Industry Trends and Development size COVID-19 2024 - 3rd Watch News

Amsterdam, The Netherlands, June 25, 2020 Kiadis Pharma N.V. (Kiadis or the Company) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, and The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital (OSUCCC-James), today announced that the first patient has been enrolled and treated in a phase I, first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukemia (R/R AML) with off-the-shelf Natural Killer (NK) cells manufactured at the Cell Therapy laboratory at the OSUCCC-James using Kiadis FC21 and proprietary universal donor platforms. The trial is being conducted at the OSUCCC-James and is expected to provide valuable data to support Kiadis K-NK003 development program.

The phase I study, NCT04220684, will evaluate the NK cell product in up to 56 patients, ages 18 80 who have primary refractory AML, relapsed AML, or myelodysplastic syndromes (MDS). The goal of this study is to establish safety of the NK cell therapy for the induction of remission in patients with R/R AML or MDS and to determine the optimal dosing and overall response rate. Patients enrolled in the study will receive six doses of NK cells of 1 x 107 cells/kg to 1 x 108 cells/kg after receiving reinduction chemotherapy. The trial is expected to provide further clinical proof-of-concept of Kiadis K-NK003 product. Kiadis is supporting the Investigator-sponsored study through a collaborative research agreement with OSUCCC-James.

Sumithira Vasu, MBBS, the principal investigator of the clinical trial, hematologist and scientist, Medical Director of the Cell Therapy Lab at OSUCCC-James, and associate professor at the Ohio State College of Medicine says, This off-the-shelf universal donor NK cell therapy is an exciting new experimental treatment option for patients with R/R AML and MDS that allows us to infuse large numbers of hyperfunctional NK cells immediately when needed. Treating our first patient with this therapy is an important step in this ongoing clinical research.

Andrew Sandler, MD, chief medical officer of Kiadis commented, This trial uses a novel off-the-shelf, readily available NK cell product to treat a very sick and difficult-to-treat group of patients. We are very enthusiastic with the initiation of this trial and to be one step closer to bringing K-NK-cell therapies to a broad patient population across a potentially wide range of cancers.

Kiadis contacts

Dutch Translation/Nederlandse vertaling

Kiadis Pharma N.V. (Kiadis of de Onderneming) (Euronext Amsterdam en Brussel: KDS), een biofarmaceutisch bedrijf gericht op onderzoek in de klinische fase, en de Comprehensive Cancer Center Arthur G. James Cancer Hospital van de Ohio State University (OSUCCC-James), kondigen aan dat de eerste patint is behandeld in een fase-I klinische studie voor behandeling van patinten met recidiverende of refractaire acute myelode leukemie (R/R AML). De studie wordt uitgevoerd door de OSUCCC-James met NK-cellen geproduceerd in het Cell Therapy laboratorium aan de OSUCCC-James op basis van de Kiadis FC21- en universele-donorplatforms. De studie zal naar verwachting waardevolle gegevens leveren voor het K-NK003 product van Kiadis.

In de fase-I studie (NCT04220684) wordt het NK-celproduct gevalueerd bij maximaal 56 patinten van 18-80 jaar met primaire refractaire AML, recidiverende AML of myelodysplastische syndromen (MDS). Het doel van de studie is om veiligheid, inductie van remissie, optimale dosering en responspercentage met NK celtherapie vast te stellen bij deze patienten. Deelnemende patinten krijgen zes doseringen NK-cellen van 1 x 107 cellen/kg tot 1 x 108 cellen/kg. Kiadis ondersteunt de studie door middel van een onderzoeksovereenkomst met Ohio State University.

Dit persbericht vormt een vertaling van het gepubliceerde Engelstalige persbericht. Bij eventuele verschillen is de tekst van het Engelstalige persbericht altijd bepalend.

About Kiadis K-NK-cell Therapies Kiadis NK-cell programs consist of off-the-shelf and haplo donor cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies.

The Companys NK-cell PM21 particle technology enables improved ex vivo expansion and activation of anti-cancer cytotoxic NK-cells supporting multiple high-dose infusions. Kiadis proprietary off-the-shelf NK-cell platform is based on NK-cells from unique universal donors. The Kiadis off-the-shelf K-NK platform can make NK-cell therapy product rapidly and economically available for a broad patient population across a potentially wide range of indications.

Kiadis is clinically developing K-NK003 for the treatment of relapse/refractory acute myeloid leukemia. The Company is also developing K-NK002, which is administered as an adjunctive immunotherapeutic on top of HSCT and provides functional, mature and potent NK-cells from a haploidentical family member. In addition, the Company has pre-clinical programs evaluating NK-cell therapy for the treatment of solid tumors.

About Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Acute myelogenous leukemia (AML) is the most common type of acute leukemia in adults and has the lowest survival rate of all leukemias. AML relapse affects nearly half of all leukemia patients who achieved remission after initial treatment and can continue to occur several months to several years after treatment with the majority of relapses occurring within two to three years of the initial treatment. Patients with relapsed or refractory leukemia have limited treatment options and poor survival rates.

The goal of treatment for acute myeloid leukemia (AML) is to put the leukemia into complete remission and to keep it that way. Unlike conventional chemotherapy options, which primarily target dividing cells, immunotherapeutic therapies aim at directing an immune response against tumor cells. Natural Killer (NK) cells are effector lymphocytes of the innate immune system capable of exerting anti-AML activity. The K-NK cell platform is a cell-based immunotherapy to treat patients with advanced blood cancer.

About KiadisFounded in 1997, Kiadis is building a fully integrated biopharmaceutical company committed to developing innovative therapies for patients with life-threatening diseases. With headquarters in Amsterdam, the Netherlands, and offices and activities across the United States, Kiadis is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.

Kiadis is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at http://www.kiadis.com.

Forward Looking Statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis or, as appropriate, Kiadis officers current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or projections, or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the anticipated or implied developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Kiadis announces first patient enrolled in clinical study conducted at The Ohio State University in R/R AML with off-the-shelf K-NK cells from...

Newswise ITHACA, N.Y. When animal, insect or human embryos grow in a malnourished environment, their developing nervous systems get first pick of any available nutrients so that new neurons can be made.

In this process, called organ sparing, resources are preferentially delegated to the nervous system at the cost of less important organs or tissues.

New research now shows that developing nervous systems demonstrate this preferential growth even at the level of individual neurons. In a paper published in eLife June 22,Low FoxO expression in Drosophila somatosensory neurons protects dendrite growth under nutrient restriction,a team of Cornell researchers discovered the molecular mechanism that helps facilitate organ sparing on this cell-by-cell basis.

The phenomena we found is similar to the phenomena of the sparing of the brain, but there are very important differences, saidChun Han, senior author and a Nancy M. and Samuel C. Fleming Associate Professor in the Department of Molecular Biology and Genetics in the College of Agriculture and Life Sciences and in the Weill Institute for Cell and Molecular Biology. The neurons are protected at the growth level of individual neurons, and they become bigger and bigger by extending their branches.

Those branches are called dendrites. They form a system of elaborate arms that extend from neurons cellular bodies, and they can receive stimuli from the external environment.

Han and his team wanted to look at how nutrient deficiency affects the dendrite growth of individual neurons, and then examine what cellular sacrifices bodies make so that vital organs, including the brain, continue to develop.

They divided Drosophila (fruit fly) larva into groups receiving either a high- or low-yeast diet, simulating nutrient-rich and nutrient-poor environments. Then they observed how neural cells developed compared to neighboring skin cells on the body wall. They monitored the progress every 24 hours using confocal microscopy that uses lasers to light up fluorescent markers that label individual cells.

We have very beautiful markers that specifically label these populations of neurons, Han said. Every neuron is very clear to us down to every single branch.

The researchers observed that the neurons grew at a much higher rate than skin cells in the low-yeast environment. Skin cells grew faster when there was less competition for nutrients. Han and his team learned that this difference is due to a critical gene called FoxO an important regulator of cellular stress response.

FoxO is a gene thats expressed in pretty much most cells of the body, Han said. When the cells face low nutrients, FoxO puts a brake on the system and slows cell growth.

Whats particularly interesting about FoxO is that just because most cells have it, doesnt mean they all use it at the same time or under the same conditions. Hans team discovered that even during malnutrition, the Drosophila neurons expressed very little FoxO, whereas the epidermal cells expressed FoxO at much higher levels.

When there are fewer nutrients available, FoxO triggers a response in epidermal cells called autophagy, which tells the cell to self-destruct by consuming itself. However, the limited FoxO expression in neurons preserves individual neural cells and their dendrite growth.

And while humans have more complex systems than Drosophila, Han said that this research helps pave the way for investigating similar phenomenon in humans.

Our study reveals another layer of nervous system sparing under nutrient deficiency and discovers a novel mechanism by which neurons are protected. Han said. These findings may facilitate the development of better approaches to treat problems caused by malnutrition during early development.

Co-authors include Amy Poe, Ph.D. 18; graduate student Yineng Xu; Christine Zhang 19; Joyce Lei 21; Kailyn Li 17; and David Labib 20; they conducted research through theHan Labin the Weill Institute for Cell and Molecular Biology and the Department of Microbiology and Genetics. Poe is currently a postdoctoral researcher at the University of Pennsylvania Perelman School of Medicine; Li is currently in the Doctor of Medicine Program at Weill Cornell Medicine.

This research was supported by a Cornell startup fund and two grants from the National Institutes of Health.

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Neurons thrive even when malnourished - Newswise

SAN DIEGO and CALGARY, Alberta, June 25, 2020 /PRNewswire/ -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), today announced a new investigator-sponsored triple-negative breast cancer (TNBC) study to be managed by Rutgers Cancer Institute of New Jersey. The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC.

"We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication," said principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School. "Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment. Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment. Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC."

The newly announced IRENE study represents an expansion of Oncolytics' lead breast cancer program into a new disease subtype (TNBC). In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future pivotal studies by facilitating the patient selection process. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center, and is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte.

About IRENE

The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: http://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, purpose, timing and anticipated benefits of the IRENE study; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

Company ContactKirk Look, CFOOncolytics Biotech Inc.+1-403-670-7658klook@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthyLifeSci Advisors+1-212-915-2564tim@lifesciadvisors.com

View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-investigator-sponsored-phase-2-trial-evaluating-pelareorep-anti-pd-1-combination-treatment-in-triple-negative-breast-cancer-301083401.html

SOURCE Oncolytics Biotech Inc.

Company Codes: NASDAQ-NMS:ONCY, Toronto:ONC, Dusseldorf:ONY, Frankfurt:ONYN, Munich:ONYN, Stuttgart:ONYN

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Oncolytics Biotech Announces Investigator Sponsored Phase 2 Trial Evaluating Pelareorep-anti-PD-1 Combination Treatment in Triple-Negative Breast...