StemCell Therapy

The market is estimated to grow with a CAGR of 13. 5% from 2020-2027. The growth in North America is characterized by an increase in the demand for innovative products from biopharmaceutical and biotechnology companies, the presence of key market players, and extensive R&D conducted by various academic and research institutes.

New York, March 19, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "North America Cell Line Development Market to 2027 - Regional Analysis and Forecasts by Type ; By Product ; Application ; and Geography" - https://www.reportlinker.com/p05875892/?utm_source=GNW Moreover, increasing focus on advanced method incorporation in healthcare, government, and private initiatives for promotion of precision medicine and massive funds from government and private bodies for genomic research are further expected to stimulate growth and contribute to exceptional revenue generation for the cell line development market in North America.

The medical biotechnology has undergone revolutions as a result of various development programs, business strategies that helps to produce, discover, or alter various biomolecules and organisms through bioengineering approaches. The Biotech Startup Revolution has also assisted in promoting the new ventures holding promising and innovative ideas in the country and supported in maximizing the revenue generation and thus the economic position of North America in the global cell line development market.Moreover, the companies are performing various activities for the cell line development market, for instance, Selexis, Carestream Avacta, JSR Life Sciences has done recent developments for products.In 2019, the recombinant cell line segment held the most significant market share of the cell line development market, by type.This segment is also anticipated to dominate the market in 2027 owing to its popularity among manufacturers for the production of therapeutic recombinant proteins.

The hybridomas segment is anticipated to witness growth at a significant rate during the forecast period.The US cell line development market is dominated by intraoral media and reagent segment in 2019 with a considerable market share, by product.This segment is also predicted to dominate the market in 2027.

Also, media and reagent segment is anticipated to witness growth at a significant rate during the forecast period, 2020 to 2027, owing to the increasing research activities in biotechnology sector.In 2019, the bioproduction segment held a considerable market share of the cell line development market, by the application.This segment is also predicted to dominate the market in 2027 owing to higher demand of biologics.

However, the drug discovery segment is anticipated to witness growth at a significant rate during the forecast period.Some of the major primary and secondary sources for cell line development included in the report are American Society of Clinical Oncology, American Type Culture Collection, California Institute for Regenerative Medicine, and others.Read the full report: https://www.reportlinker.com/p05875892/?utm_source=GNW

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The North America cell line development market is expected to reach US$ 3,829.46 Mn in 2027 from US$ 1,393.32 Mn in 2018 - Yahoo Finance

ROCKVILLE, Md., March 18, 2020 /PRNewswire/ --Cellphire, Inc., the global leader in long-term stabilization and storage of platelets, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to start a Phase 2 clinical trial of Thrombosomes in bleeding patients with thrombocytopenia.

In July 2019, Cellphire successfully completed a Phase I clinical trial of its lead product, Thrombosomes, a platelet-based freeze-dried hemostatic. Utilizing its patented technology to stabilize and freeze-dry platelets, Cellphire is developing next-generation therapeutics to treat bleeding patients. Standard liquid platelets only have a 5- to 7-day shelf life, making inventory management difficult and can lead to widespread platelet shortages during public health emergencies. By contrast, Thrombosomes have a 3-year shelf life.

The objective of the multicenter Phase 2 study is to evaluate the safety and efficacy of infusing multiple doses of Thrombosomes in bleeding patients with thrombocytopenia due to primary bone marrow disorders or chemotherapy, immunotherapy radiation therapy, and/or refractory response to fresh platelet concentrate transfusion with or without splenomegaly (enlarged spleen).

"We are very excited to have FDA approval of our Phase 2 clinical trial," said G. Michael Fitzpatrick, Ph.D., Cellphire's President. "Thrombosomes have the potential to increase the availability of a platelet-based hemostatic product throughout the United States, especially when standard liquid platelets are not available. The product's 3-year shelf life and ease of storage could allow for stockpiling, which supports national preparedness for times of potential shortages."

The Thrombosomes project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201300021.

About Cellphire

Cellphire, Inc. is a biotechnology company developing next-generation therapeutics. The company is applying its proprietary cell stabilization technology to all cell types, including platelets, to develop lifesaving products. Its lead product is Thrombosomes, a freeze-dried hemostatic derived from human platelets. Cellphire's technology has potential applications across a wide range of medical applications from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine. For more information, visit http://www.cellphire.com.

View original content:http://www.prnewswire.com/news-releases/cellphire-begins-phase-2-trial-of-thrombosomes-in-bleeding-thrombocytopenic-patients-301026462.html

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Cellphire Begins Phase 2 Trial of Thrombosomes in Bleeding Thrombocytopenic Patients - Benzinga

New Jersey, United States: A qualitative research study accomplished by Verified Market Research titled 2020-2026 Global and Regional Regenerative Medicine Market: Industry Production, Sales and Consumption Status and Prospects Professional Market Research Report is the most up to date report which comprises the latest trends that influence the market competition in the forecast period from 2020 to 2026. The report presents different market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. Primarily, the report introduces market demands and the present position of the Regenerative Medicine market.The report completes the value chain and downstream and upstream essentials.

Global Regenerative Medicine Market was valued at USD 19.10 Billion in 2018 and is expected to witness a growth of 22.72% from 2019-2026 and reach USD 98.10 Billion by 2026.

Our expert analyst has categorized the market into product type, application/end-user, and geography. All the segments are analyzed based on their market share, growth rate, and growth potential. The growth potential, market share, size, and prospects of each segment and sub-segment are portrayed in the report. This thorough evaluation of the segments would help the players to focus on revenue-generating areas of the Regenerative Medicine Market.

A number of leading manufacturers mention in the Regenerative Medicine Market research report are focusing on expanding operations in regions, as they exhibit potential business opportunities. The Regenerative Medicine Market report classifies the market dynamics and trends in the global and regional market considering several aspects including technology, supplies, capacity, production, profit, and price.

Regenerative Medicine Market: Research Methodology

1. Primary Research:

2. Secondary Research:

During our Secondary research, we collect information from different sources such as databases, regulatory bodies, gold and silver-standard websites, articles by recognized authors, certified publications, white papers, investor presentations and press releases of companies, and annual reports.

Data collection module is used for data collection and analysis of the base year. The market data is analyzed and estimated using statistical models and systematic market. The main research methodology used for the preparation of reports, including data mining, primary (industry experts) validation and top-down analysis, market overview and guidance, the company market share analysis, measurement standards, and analysis of the stock sellers.

Vendor Competitive Analysis:

The report focuses on the strategies considered by the market participants to gain a major share in the Regenerative Medicine market. Through this, the competitors will get an overview of the competitive landscape so they can make business decisions. Leading players working in the global market are analyzed with their company information, product profile, product specification, picture, capacity, production, price, cost, global investment plans, and supply-demand scenarios.

Regenerative Medicine Market Regional Coverage

The Middle East and Africa (GCC Countries and Egypt)North America (the United States, Mexico, and Canada)South America (Brazil etc.)Europe (Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

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Table of Content

1 Introduction of Regenerative Medicine Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Regenerative Medicine Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Regenerative Medicine Market, By Deployment Model

5.1 Overview

6 Regenerative Medicine Market, By Solution6.1 Overview

7 Regenerative Medicine Market, By Vertical

7.1 Overview

8 Regenerative Medicine Market, By Geography8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Regenerative Medicine Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Tags: Regenerative Medicine Market Size, Regenerative Medicine Market Trends, Regenerative Medicine Market Forecast, Regenerative Medicine Market Growth, Regenerative Medicine Market Analysis, Regenerative Medicine Market Business Opportunities and Regenerative Medicine Market Outlook

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Regenerative Medicine Market 2020 Demand with Global Forecast by Top Leading Players: Organogenesis Osiris Therapeutics, Vericel Corporation, Stryker...

Regenerative Medicine Industry Market Forecast 2020-2026

The Global Regenerative Medicine Industry Market research report provides and in-depth analysis on industry- and economy-wide database for business management that could potentially offer development and profitability for players in this market. It offers critical information pertaining to the current and future growth of the market. It focuses on technologies, volume, and materials in, and in-depth analysis of the market. The study has a section dedicated for profiling key companies in the market along with the market shares they hold.

The report consists of trends that are anticipated to impact the growth of the Regenerative Medicine Industry Market during the forecast period between 2020 and 2026. Evaluation of these trends is included in the report, along with their product innovations.

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The Report Covers the Following Companies:company 1company 2company 3company 4company 5company 6company 7company 8company 9

By Types:Type 1Type 2Type 3

By Applications:Application 1Application 2Application 3

Furthermore, the report includes growth rate of the global market, consumption tables, facts, figures, and statistics of key segments.

By Regions:

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Years Considered to Estimate the Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2026

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About UpMarketResearch:Up Market Research (https://www.upmarketresearch.com) is a leading distributor of market research report with more than 800+ global clients. As a market research company, we take pride in equipping our clients with insights and data that holds the power to truly make a difference to their business. Our mission is singular and well-defined we want to help our clients envisage their business environment so that they are able to make informed, strategic and therefore successful decisions for themselves.

Contact Info UpMarketResearchName Alex MathewsEmail [emailprotected]Organization UpMarketResearchAddress 500 East E Street, Ontario, CA 91764, United States.

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Regenerative Medicine Industry Market: Global Analysis Of Key Manufacturers, Dynamics & Forecast 2020-2026 - News Times

DUBLIN, Feb. 27, 2020 /PRNewswire/ -- The "Stem Cell Banking - Market Analysis, Trends, and Forecasts" report has been added to ResearchAndMarkets.com's offering.

The growing interest in regenerative medicine which involves replacing, engineering or regenerating human cells, tissues or organs, will drive market growth of stem cells. Developments in stem cells bioprocessing are important and will be a key factor that will influence and help regenerative medicine research move into real-world clinical use. The impact of regenerative medicine on healthcare will be comparable to the impact of antibiotics, vaccines, and monoclonal antibodies in current clinical care. With the global regenerative medicine market poised to reach over US$45 billion by 2025, demand for stem cells will witness robust growth.

Another emerging application area for stem cells is in drug testing in the pharmaceutical field. New drugs in development can be safely, accurately, and effectively be tested on stem cells before commencing tests on animal and human models. Among the various types of stem cells, umbilical cord stem cells are growing in popularity as they are easy and safe to extract. After birth blood from the umbilical cord is extracted without posing risk either to the mother or the child. As compared to embryonic and fetal stem cells which are saddled with safety and ethical issues, umbilical cord is recovered postnatally and is today an inexpensive and valuable source of multipotent stem cells. Until now discarded as waste material, umbilical cord blood is today acknowledged as a valuable source of blood stem cells. The huge gap between newborns and available cord blood banks reveals huge untapped opportunity for developing and establishing a more effective banking system for making this type of stem cells viable for commercial scale production and supply. Umbilical cord and placenta contain haematopoietic blood stem cells (HSCs). These are the only cells capable of producing immune system cells (red cells, white cells and platelet).

HSCs are valuable in the treatment of blood diseases and successful bone marrow transplants. Also, unlike bone marrow stem cells, umbilical cord blood has the advantage of having 'off-the-shelf' uses as it requires no human leukocyte antigen (HLA) tissue matching. Developments in stem cell preservation will remain crucial for successful stem cell banking. Among the preservation technologies, cryopreservation remains popular. Development of additives for protecting cells from the stresses of freezing and thawing will also be important for the future of the market. The United States and Europe represent large markets worldwide with a combined share of 60.5% of the market. China ranks as the fastest growing market with a CAGR of 10.8% over the analysis period supported by the large and growing network of umbilical cord blood banks in the country. The Chinese government has, over the years, systematically nurtured the growth of umbilical cord blood (UCB) banks under the 'Developmental and Reproductive Research Initiation' program launched in 2008. Several hybrid public-private partnerships and favorable governmental licensing policies today are responsible for the current growth in this market.

Competitors identified in this market include:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/vgxw4q

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Global Stem Cell Market Poised for Strong Growth as Global Regenerative Medicine Market Poised to Reach US$45 billion by 2025 - PRNewswire

SINGAPORE, Feb. 27, 2020 /PRNewswire/ -- Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments, today announced that the Company's investigational CD30-directed autologous chimeric antigen receptor T cell (CD30 CAR-T) therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL). Tessa expects to initiate its pivotal Phase II multi-site trial in the fourth quarter of 2020.

"The RMAT designation speaks to the strength of the data in two independent Phase I/II trials, which show promising efficacy and a strong safety profile of the therapy in Hodgkin lymphoma patients whose disease had failed to respond to other available therapies," said Ivan D. Horak, M.D., President of Research and Development at Tessa Therapeutics. "We look forward to working closely with the FDA as we advance our trial at multiple sites in North America and work to bring this potentially transformative treatment option to patients."

The RMAT designation is supported by clinical data from two independent CD30 CAR-T Phase I/II studies in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma conducted by Baylor College of Medicine (NCT02917083) and University of North Carolina Lineberger Comprehensive Cancer Center (NCT02690545). Both studies demonstrated objective response rates of more than 70%, with 18 patients achieving complete response out of 27 patients treated with CD 30 CAR-T with lymphodepleting chemotherapy as of November 2019.

Dr Horak added: "As part of our longer-term R&D program, we are also developing an allogeneic CD30-CAR Epstein-Bar Virus-Specific T cell (CD30-CAR EBVST) therapy product that combines the unique properties of VSTs and CD30 CARs, in an effort to develop off-the-shelf cell therapies intended to treat a range of hematologic malignancies and solid tumors."

RMAT designation is designed to facilitate development and expedite review of cell therapies and other qualifying regenerative medicines intended to treat a serious or life-threatening disease or condition; and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. Advantages include all the benefits of the FDA's Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval and satisfy post-approval requirements.

More information on Tessa's CD30 CAR-T therapy pivotal Phase II clinical trial is available at: https://clinicaltrials.gov/ct2/show/NCT04268706.

-End -

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa's fast-growing clinical pipeline includes two investigational autologous cell therapies in late-stage clinical development for nasopharyngeal cancer and classical Hodgkin lymphoma. Combining the unique properties of Virus-Specific T cells (VSTs) and CD-30 Chimeric Antigen Receptors (CD30-CARs), Tessa is also emerging with a new approach to cancer cell therapy through the development of a novel, allogeneic platform technology. The platform holds potential for the creation of off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa's strategic partnerships with leading US academic centers and manufacturing and supply chain capabilities across Asia and the United States, have enabled the company to successfully deliver cell therapies on a global scale, creating a fully integrated approach to the treatment of cancer.

For more information on Tessa, please visit http://www.tessatherapeutics.com.

SOURCE Tessa Therapeutics

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Tessa Therapeutics Announces US FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to its CD30 CAR-T Cell Therapy for the Treatment...

St. Paul, MN, February 27, 2020 --(PR.com)-- Recombinetics (RCI) today announced a collaborative research project with University of Texas Southwestern (UTSW) to identify key factors that improve the efficiency of generating interspecies chimera between pigs and humans. This near-term goal will benefit the long-term objective of advancing regenerative medicine through the reliable production of therapeutic human cells, tissues and organs using blastocyst complementation. This would create a more reliable supply of live-saving transplantable organs on demand that is not reliant on human donors.

This collaboration will leverage the expertise of RCI in producing inter-species chimeras, specifically using the blastocyst complementation method, where the host species is mutated to ablate a crucial organ or lineage, and the human donor cells are populating the missing niche. Our plan is to understand the relationship between human and pig cells through development and utilize gene editing to improve the survival, engraftment and differentiation of the donor human cells in the specific niche. These technologies could very well hold the crucial step that move us towards producing human components in bio-incubators.

Project efforts will be led by Ohad Gafni, Ph.D., RCIs Director of Stem Cell Technologies and Jun Wu, Ph.D., Assistant Professor at UT Southwestern Medical Center.

Scientists have struggled to produce inter species chimera due to poor survival and engraftment of the injected donor cells in the host environment. In this collaboration, we will combine in vitro and in vivo studies to enhance the efficiency of producing pig: human chimeras as a foundation for producing therapeutic human cells, tissues, and organs, says Dr. Gafni.

About RecombineticsFounded in 2008, Recombinetics (RCI) is producing gene-edited animals for biomedical and food production purposes and is generating commercial and collaborative revenues. RCIs technology platform supports three business lines: Acceligen (precision breeding to enhance health, well-being and productivity in food animals and aquaculture); Surrogen (gene-edited swine models of human diseases for biomedical research and pre-clinical trials by pharmaceutical and medical device companies); and Regenevida (development of human regenerative products including cells, tissues and organ products in swine models for exotransplantation to humans). Learn more at Recombinetics.com.

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Recombinetics Announces Collaboration with University of Texas Southwestern to Advance Regenerative Medicine Through Therapeutic Cell, Tissue, and...

Aspire Regenerative

SAN DIEGO (PRWEB) February 27, 2020

Dr. Ryan McNally, the medical director of Aspire Regenerative, is the featured guest on Dr. Hanisha Patels natural health podcast, Mahan Health. The episode, New Year, Younger You?, focuses on the latest developments in medicine and technology that promote aging well and gracefully. It is currently available on all major podcast platforms.

During the lively and informative episode, Dr. McNally shares his expertise in the field of regenerative medicine and how it can help rejuvenate healthy tissues. The ultimate goal of these therapies is to slow down the progression of aging and prolong overall wellness. Subjects that Dr. McNally explores during the podcast include stem cell therapy, platelet-rich plasma (PRP) therapy, and products derived from fetal tissue found in cord blood, placental tissue, and perinatal fluid. One of the most promising new areas of regenerative medicine that Dr. McNally discusses is stem cell derived-exosome therapy, which uses the part of a cell that is rich in growth factors.

Dr. McNally is responsible for guiding the vision of Aspire Regenerative, a state-of-the-art facility in San Diego that delivers integrative and technologically advanced medical care. He also oversees the development and implementation of science, research, and technology at Aspire. Dr. McNally is a licensed naturopathic doctor with multiple certifications in regenerative medicine, aesthetics, and injection therapies. In addition, he is a faculty member at the Academy of Integrative Health and Medicine and an adjunct faculty member at Bastyr University California, where he formerly served as chief medical officer. A sought-after speaker at conferences and universities, Dr. McNally also publishes articles in peer-reviewed professional journals and frequently serves as a guest expert for podcasts, magazines, and newspapers.

About Aspire Regenerative: Aspire Regenerative is a state-of-the-art medical practice offering personalized regenerative treatments and integrative therapies to help patients reach their goals and achieve the best possible results. We have reinvented medical care by incorporating the principle of cell and tissue regeneration, which translates to youthful and vibrant function. Our in-depth expertise and collaboration with researchers allow us to integrate innovative technology into individualized patient care with therapies that are safe and effective. For more information, visit https://aspireregenerativehealth.com/.

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Aspire Regenerative Medical Director Featured on New Podcast - PR Web

One in 14 Ontarians can expect to be diagnosed with colorectal cancer in their lifetime. COURTESY OF ED UTHMAN/FLICKR

University of Toronto scientists have identified a key protein as a common factor in the growth of many different types of colorectal cancer tumours, according to research published in the Journal of Cell Biology. Colorectal cancer develops in the colon or rectum. In Ontario, it is also the second most fatal cancer, and one in 14 Ontarians can expect to be diagnosed with this form of cancer in their lifetime.

In past research, scientists have linked the excessive accumulation of beta-catenin, a protein with crucial functions in cell development, to the expression of genes that drive tumour proliferation. Research has associated 80 per cent of colorectal cancers with gene mutations that greatly increase the production of beta-catenin.

The co-authors of the study have identified another protein, Importin-11, as the compound that enables beta-catenin transportation to the nucleus of the human cell. Cancer therapies that inhibit this transport could be a promising way to treat colorectal cancer.

Fundamental research provides new knowledge for cancer therapies

The Varsity spoke to Dr. Stephane Angers, a co-author of the study and an associate professor at U of Ts Department of Biochemistry. Angers lab has spent a considerable amount of time studying biological pathways the series of chemical changes during cellular development that give cells their final functions.

Angers noted that Monika Mis, the lead author of the study and a PhD student, uncovered the role of Importin-11 in colorectal cancer in Angers lab. Mis used the gene-editing CRISPR-Cas9 technology to screen genes in colorectal cancer calls to identify a novel gene, IPO11, which encodes for the protein Importin-11.

Current treatment options for colorectal cancer include surgery, chemotherapy, and other radiation therapy. Although this discovery is still in its fundamental stages, blocking the transport of beta-catenin holds great promise for developing new therapies.

As Angers put it, It provides new ammunition, new possibilities, and new knowledge that could lead in the future to new therapies, but it is very much at the discovery level at this point.

More research required to develop therapies

Further research could involve drug discovery and widen the scope of Importin-11 function in various cells. Researchers may also find it valuable to analyze existing data about colorectal cancer. The goal is to understand how the mutations affect tumour formation and develop therapies that harness this knowledge.

Angers lab is also investigating other potential applications of the Wnt pathway, a specific biological pathway associated with beta-catenin. A particularly interesting aspect is its role in regenerative medicine, which is the study of restoring human cells, tissues, and organs.

We think that with new molecules that we have developed we can now activate the pathway in order to promote the regenerative abilities of tissues, noted Angers.

Tags: biology, cancer, medicine, oncology

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New ammunition uncovered by U of T researchers to develop colorectal cancer treatment - Varsity

For many people, the concept of a shorter workweek is enticing. After all, it can be difficult to find enough time for the things we love.

Is it reasonable then, in our quest for happiness, to begin working less? Advocates of a shorter workweek would agree, but these policies have yet to be widely-adopted.

Todays chart plots data from the World Happiness Report 2019 and the OECD to determine if theres any correlation between a countrys happiness and average hours worked per person.

The unhealthy side effects of working long hours are well established. In extreme cases, however, symptoms can extend beyond the usual stress and fatigue.

For example, the American Heart Association found that people under the age of 50 had a higher risk of stroke when working over 10 hours a day for a decade or more. Another study, conducted across 14 countries, concluded that people who worked long hours were 12% more likely to become excessive drinkers.

If working longer days is so harmful to our well-being, what happens if we work fewer hours instead?

The tables below list the happiest countries as well as the unhappiest countries in the OECD; happiness scores range from 0 to 10, with a 10 representing the best life possible.

Based on the data, there appears to be some degree of correlation between a persons happiness and the amount of hours they work.

Heres how the five happiest countries stack up:

The five happiest countries each work over 100 hours less than the OECD average. Compare this to the five least happiest countries:

Coincidentally, all five of the least happiest countries work more hours than the OECD average, up to over 264 hours in the case of Greece.

Happiness is multifaceted, though, and we should avoid drawing conclusions from a single variable. For instance, the World Happiness Report 2019 calculates happiness scores based on eight distinct metrics:

With these in mind, we can make a few additional observations.

Four of the five happiest OECD countries are located in the Nordics, a region known for low corruption rates and robust social safety nets. On the other end of the scale, economic hardship is a recurring theme among the OECDs least happiest countries. The falling Turkish lira and Greeces debt crisis are two significant examples.

To properly measure the happiness-boosting potential of a shortened workweek, it seems we need to isolate its effects.

Employers are now experimenting with shorter work schedules to see if happier employees are in fact better employees.

Perpetual Guardian, a New Zealand-based estate planning firm, trialed a four-day workweek for two months with no changes to compensation.

The trial was hailed as a success. Employee stress levels fell by 7 percentage points while overall life satisfaction rose by 5 percentage points. Perhaps most impressive is the fact that productivity remained the same.

Employees designed a number of innovations and initiatives to work in a more productive and efficient manner.

Helen Delaney, University of Auckland

Following the trial, the firms founder expressed interest in implementing the four-day workweek on a permanent basis.

Filimundus, a Sweden-based software studio, trialed a six-hour workday in 2014. Staff reception was positive, and the company has since adopted it permanently.

There were trade-offs, however. While staff enjoyed more time for their private lives, productivity across different departments saw mixed results.

We did see some decrease in production for some staff, mostly our artists, but an increase in production for our programmers. So money-wise, in costs, it evened out.

Linus Feldt, CEO

Interestingly, the studio also trialed a seven-hour workday, and saw no positive effects.

Public healthcare workers in Gothenburg, Sweden, trialed a six-hour workday for two years. Similar to the first case, compensation was unchanged.

While the trial achieved good resultsstaff experienced lower stress levels and patients received a higher level of carethe policy was unsustainable.

Its far too expensive to carry out a general shortening of working hours within a reasonable time frame.

Daniel Bernmar

17 additional staff were hired to compensate for the shorter workdays, increasing the local governments payroll by $738,000. The city council did note, however, that lower unemployment costs offset this increase by approximately 10%.

These experiments are garnering attention from around the world.

Even Japan, a country known for its overtime culture, is getting in on the action. Microsoft offices in the East Asian country tested a four-day workweek in August 2019, and reported happier staff, as well as an impressive 40% boost in productivity.

While the results of these early experiments are indeed promising, theyve exposed the nuances that exist between industries and job types, and the need for further trials. One thing is certain thoughshorter workweek policies should not be interpreted as a one size fits all solution for happier lives.

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Ranked: The Most Innovative Economies in the World - Visual Capitalist

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical (ASX: AVH) (NASDAQ: RCEL), a global regenerative medicine company, announced that management will present at the Cowen 40th Annual Health Care Conference in Boston. The presentation is being made on 4 March 2020 from 9:20 a.m. to 9:50 a.m. EST at the Boston Marriott Copley Place hotel. Interested parties may access a webcast of the presentation on the Investors section of the companys website at: https://www.avitamedical.com/investors.

Authorised for release by the Chief Financial Officer of Avita Medical Limited.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

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AVITA Medical to Present at the Cowen 40th Annual Health Care Conference - Business Wire

Research into alternative stem cell sources has identified urine derived renal progenitor cells (UdRPCs) as a possible option for use in regenerative kidney therapies in the future.

Scientists have demonstrated their protocol for the reproducible isolation of kidney stem cells from human urine. These urine derived renal progenitor cells (UdRPCs) could be used to provide easier access to stem cells for regenerative kidney therapies and modelling diseases for R&D.

A shortage of donor organs and the risks and pain associated with bone marrow stem cell extractions and third trimester amniotic fluid collection have encouraged researchers to find alternative sources of stem cells. According to scientists, several laboratories have indicated urine could be an alternative source, at least for kidney stem cells, so the researchers from Heinrich Heine University-Duesseldorf (HHU) Germany,set out to complete a comprehensive molecular and cellular analysis of these cells.

UdRPCs should be considered as the choice of renal stem cells for facilitating the study of nephrogenesis, nephrotoxicity, disease modelling and drug development

Their study, published in Scientific Reports, revealed that UdRPCs isolated from ten individuals express both markers typically seen in bone marrow-derived mesenchymal stem cells (MSCs) and renal stem cells. The renal stem cell markers, according to the paper, allow UdRPCs to be differentiated into cell types present in the kidney, eg, podocytes and the proximal and distal tubules. The study also showed that these progenitor cells have similar properties to amniotic fluid-derived stem cells (AFCs).

Wasco Wruck, bioinformatician and co-author of the study, said: It is amazing that these valuable cells can be isolated from urine and comparing all the genes expressed in UdRPCs with that derived from kidney biopies we could confirm their renal and renal progenitor cell properties and origin.

According to Martina Bohndorf, a study co-author, UdRPCs can also be easily and efficiently reprogrammed into induced pluripotent stem cells using a non-viral integration-free and safe method.

Dr James Adjaye, study senior author and professor at the Institute for Stem Cell Research and Regenerative Medicine (ISRM) in the medical faculty of HHU, revealed that one of the most promising options in the near future is the use of transplantable renal stem cells (UdRPCs) for treatment of kidney diseases as a complementary option to kidney organs. He concluded that human UdRPCs should be considered as the choice of renal stem cells for facilitating the study of nephrogenesis, nephrotoxicity, disease modelling and drug development.

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Kidney stem cells isolated from urine could be regenerative therapies - Drug Target Review

CLEARWATER, Fla., Feb. 4, 2020 /PRNewswire/ --Florida Spine Institute (FSI)is the leading, and one of the most trusted, medical facilities specializing in pain management, neurology, surgery, physical medicine and rehabilitationin Tampa Bay. FSI offers a comprehensive wellness program with a multi-disciplinary spine care team, and board-certified diagnostic, medical, and surgical specialists that provide the most advanced care available. All patient consultations and most treatments are done on a single campus.

The state-of-the-art treatment modalities offered range from physical therapy and a variety of injections to procedures including radiofrequency ablation, spinal cord stimulation implants, toKetamine treatmentsand regenerative medicinesuch as stem cell treatments. Each patient's treatment is customized for the best results.

The Florida Spine Institute has a team of elite spine, neuro, and orthopedic surgeonswho combine surgical skills with experience for the most accurate and effective treatment. Our focus is on minimally invasive spine surgical techniques, motion preservation surgery, cervical and lumbar disc replacement surgery, as well as disc restoration.

FSI offers physical medicine and rehabilitation, a branch of medicine emphasizing the prevention, diagnosis, and treatment of nerve, muscle, bone and brain disorders. The Florida Spine Institute also has a friendly and relaxed in-house MRI imaging center, saving our patients valuable time to access this sophisticated procedure.

Neurologytreats disorders of the nervous system which include the brain and spinal cord, and the peripheral nervous system. Our staff neurologistis board certified by the American Board of Psychiatry & Neurology, the American Board of Electrodiagnostic Medicine, and the American Academy of Balance Medicine. He specializes in the treatment of headache, stroke, and epilepsy.

Botox injections, an FDA-approved treatment, has been safely used for treating various medical conditions since 1989, including muscle spasms, myofascial pain, headache, and back and neck pain. Our physicians can use Botox injections in a safe and effective manner to help ease your pain.

A relatively new cutting-edge treatment, Radiofrequency Ablation (RFA), is often favored over laser spine surgery because it utilizes smaller needles, so it is less invasive and is covered by insurance. RFA is used to treat not only neck and back pain, but also hip and knee pain.

IV Ketamine Infusion Therapy is the latest breakthrough treatment that is producing extraordinary results. Ketamine blocks receptors in the brain that, when overstimulated, are responsible for releasing chemicals that cause inflammation of the nervous system. IV Ketamine treatment has been found to be very effective in treating Depression, Pain, CRPS, PTSD, Fibromyalgia, Lyme Disease and more with excellent results.

Regenerative medicine is a game-changing area of medicine with the potential to heal damaged tissues and organs, offering solutions and hope for people who have conditions that might otherwise be thought to be beyond repair. The Florida Spine Institute offers cutting-edge regenerative medicine therapies that can help you feel better. From stem cell therapy to amniotic tissue treatments, we have a solution that is customized for you.

For more information, please visit http://www.floridaspineinstitute.comor call 727-797-7463

If you have questions regarding treatments with IV Ketamine, please visit http://www.ivketamine.comor call 727-KETAMINE or 727-538-2646.

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With promising results on its first rheumatological protein therapies, Dianomi is strategically expanding upon its core technology to deliver next-generation nucleic acid therapies

MADISON, Wis., Feb. 11, 2020 /PRNewswire/ --Dianomi Therapeutics Inc. today announced that it has licensed a second suite of intellectual property (IP) from the Wisconsin Alumni Research Foundation (WARF), expanding the use of its Mineral Coated Microparticle (MCM) technology into nucleic acid therapy.

Dianomi's core MCM technology mimics the natural, inherent properties of mineralized tissues to stabilize and control the release of active drug molecules and improve their therapeutic function, thus addressing common limitations of artificial polymer-based drug delivery systems. The newly acquired IP covers compositions and methods for delivering nucleic acid-based therapies and has broad utility across nucleic acid fields, including DNA, mRNA and RNAi applications.

Developed at the University of WisconsinMadison by William Murphy, Ph.D., a UW-Madison professor of biomedical engineering and orthopedics and rehabilitation, the MCM technology in combination with nucleic acids has demonstrated favorable results, both in vitro and in vivo. In early animal studies, results of mRNA delivery indicated enhanced transfection and localized sequestration of the gene product, promising a potentially potent and sustained therapeutic effect.

"Dianomi has demonstrated success in developing and optimizing MCM delivery for biologics and other small molecules," said Murphy, co-founder and chief scientific officer of Dianomi. "I look forward to Dianomi's expansion into the area of nucleic acid therapy, building upon the early results of our nucleic acid delivery in regenerative medicine applications."

The newly licensed IP includes issued U.S. patents as well as pending U.S. and international patent applications.Dianomi retains exclusive, global rights to pursue nucleic acid therapeutics independently and to build out its commercialization and development programs with other institutions and therapeutic entities.

"This new suite of intellectual property expands the capability of Dianomi's core technology into new indications and markets having significant commercial and clinical interest," said Martin Ostrowski, chief operations officer and general counsel of Dianomi. "We're thrilled to strengthen our relationship with WARF and continue developing the platform applicability of our technological and clinical programs to improve patient care."

Dianomi's first product is a tailored interleukin-1 receptor antagonist (IL-1Ra) for osteoarthritis, which utilizes Dianomi's MCM technology to provide sustained drug delivery. Dianomi intends to develop its own internal candidates while pursuing collaborative opportunities in a number of clinical indications, including cardiovascular, rheumatological, oncology, vaccines, regenerative medicine, neuromuscular and spinal degeneration, and general health and wellbeing.

About Dianomi

Dianomi Therapeutics is a biopharmaceutical company focused on optimizing the therapeutic profile of biologics, small molecules and nucleic acids to improve patient dosing, safety and efficacy. The company is advancing a pipeline of next-generation treatments for rheumatological disease states, initially targeting osteoarthritis and pain. The company's proprietary Mineral Coated Microparticle (MCM) technology mimics the ability of human bones and teeth to store and protect biologics, and provides greatly improved, sustained delivery of active biologics and other molecules. For more information on the company, please visit http://www.dianomitx.com.

About WARF

The Wisconsin Alumni Research Foundation (WARF) helps steward the cycle of research, discovery, commercialization and investment for the University of WisconsinMadison. Founded in 1925 as an independent, nonprofit foundation, WARF manages more than 2,000 patents and an investment portfolio of $2.7 billion as it funds university research, obtains patents for campus discoveries and licenses inventions to industry. For more information, visitwarf.organd viewWARF's Cycle of Innovation.

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Joleen Rau Rau Communications 234030@email4pr.com(608) 209-0792

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Jeanan Yasiri Moe Director of Strategic Communications (608) 960-9892

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Dianomi Therapeutics Exclusively Licenses Nucleic Acid Technologies from the Wisconsin Alumni Research Foundation (WARF) - Yahoo Finance

The Global Stem Cells Group (GSCG) is set to sponsor the XI Congreso Mundial de Medicina Antienvejecimiento y Longevidad (World Conference of Anti-Aging and Longevity Medicine) to be held in Mexico City, Mexico on February 16-18, 2020.

The medical congress is expected to attract over 450 physicians and researchers from across the world interested in anti-aging and longevity practices and medical innovations. Over 30 speakers are slated to share information with attendees on a wide range of topics on how to lead a long, healthy life and improve longevity.

The GSCG is set to share a number of its latest innovations with congress attendees, including its newly released GCell technology device. This cutting-edge tool utilizes micrograft technology to harness the natural and powerful restorative capabilities of adipose tissues. Because it is FDA compliant, the device allows physicians across the globe to continue practicing adult stem cells-based procedures.

Additional benefits of GCell technology include shorter treatment times, delivering in-office treatments in around 30 minutes with local anesthesia, as well as less fat collection compared to existing treatments (15 mL versus 50 mL). GCell technology holds exciting implications across a range of medical specialties, including orthopedics, dermatology, cosmetic gynecology, aesthetics, and hair loss.

In addition to its GCell technology, the GSCG will also feature its newest line of stem cells products derived from first-tissue exosomes. Cellgenic Flow Exosomes utilizes the latest science and research available in cellular therapies to deliver a non-surgical approach to creating regenerative responses in a broad range of treatments. The product utilizes exosomes, which replicate the signals given out by stem cells, versus actual stem cells. Exosomes play a pivotal role in cell-to-cell communication and are involved in a wide range of physiological processes. These particles transfer critical bioactive molecules such as proteins, mRNA, and miRNA between cells and regulate gene expression in recipient cells.

The XI Congreso Mundial de Medicina Antienvejecimiento y Longevidad is one of the worlds premier events connecting physicians and researchers with todays most innovative treatments and technologies utilizing regenerative medicine, said Benito Novas, CEO of the GSCG. As a worldwide leader in training, education, and innovative products in the field of regenerative medicine, the GSCG is pleased to sponsor this congress and share its exciting new portfolio of products with physicians from across the world.

To learn more about the Global Stem Cells Group and all of the groups latest news and innovations, visit http://www.stemcellsgroup.com/

About Global Stem Cells Group

Global Stem Cells Group (GSCG) is a worldwide network that combines seven major medical corporations, each focused on furthering scientific and technological advancements to lead cutting-edge stem cell development, treatments, and training. The united efforts of GSCGs affiliate companies provide medical practitioners with a one-stop hub for stem cell solutions that adhere to the highest medical standards.

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Mexico City Medical Congress to Showcase the Global Stem Cells Group's Latest Innovations - PRUnderground

Indiana University has appointed Simran Trana as the university's first associate vice president of its Innovation and Commercialization Office.

The ICO identifies, protects and commercializes technology that comes from discoveries and innovations born from IU research. In recent years, under the umbrella of IU's Office of the Vice President for Research, the ICO has restructured to better serve IU inventors and those seeking to partner in bringing IU innovations to the public.

The new position of associate vice president reflects the university's increased focus on facilitating faculty innovation and the translation of innovations into the marketplace to serve the public. Among Trana's responsibilities will be enhancing strategic alliances with private- and public-sector partners and expanding the commercialization of IU discoveries and inventions, ensuring a service-oriented gateway for all members of the IU community seeking assistance with innovation and entrepreneurship.

Trana began her new IU role on Feb. 10.

"Having success in both industry and higher education, Simran brings the right mix of skills and experience to work with IU inventors and industry partners to shorten the time between discovery and the marketplace," said Fred H. Cate, IU vice president for research. "I am delighted that we will have the benefit of Simran's leadership to enhance delivery of the positive outcomes of IU research to Hoosiers and beyond."

Trana has 15 years of experience in product and business development, licensing and venture creation. She spent the past 10 years with Dow AgroSciences, now called Corteva Agriscience, the Agriculture Division of DowDuPont. Trana held multiple roles during this time, managing strategic research collaborations, technology licensing, intellectual property and portfolio development, new product launches, and licensing and corporate development. From 2001 to 2008, she served as director of technology commercialization for the Purdue Research Foundation, which manages and licenses intellectual property for Purdue University.

"Indiana University researchers and entrepreneurs have a long history of driving scientific innovation that impacts global progress and plays a key role in enhancing the well-being of Indiana residents and the Indiana economy," Trana said. "Knowing well that lives have and will be saved, or drastically improved, through access to new IU inventions or treatments, I am eager to get started."

Trana holds a master's degree in plant genetics from Punjab Agricultural University and a master of business administration from University of Ottawa.

She was selected for the new role at IU following a nationwide search involving university leaders:

The committee also included IU faculty inventors:

The Indiana University Innovation and Commercialization Office is tasked with the protection and commercialization of technology emanating from innovations by IU researchers. Since 1997, IU research has generated almost 3,200 inventions resulting in more than 4,800 global patent applications. These discoveries have generated more than $145 million in licensing and royalty income, including more than $115 million in funding for IU departments, labs and inventors.

Indiana University's world-class researchers have driven innovation and creative initiatives that matter for 200 years. From curing testicular cancer to collaborating with NASA to search for life on Mars, IU has earned its reputation as a world-class research institution. Supported by $680 million in 2019 from our partners, IU researchers are building collaborations and uncovering new solutions that improve lives in Indiana and around the globe.

Nicole Wilkins is executive director of research communications in the Office of the Vice President for Research.

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Simran Trana appointed associate vice president of Innovation and Commercialization Office - IU Newsroom

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Newswise A UCLA-led study reveals a new role for a gene thats associated with autism spectrum disorder, intellectual disability and language impairment.

The gene, Foxp1, has previously been studied for its function in the neurons of the developing brain. But the new study reveals that its also important in a group of brain stem cells the precursors to mature neurons.

This discovery really broadens the scope of where we think Foxp1 is important, said Bennett Novitch, a member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLAand the senior author of the paper. And this gives us an expanded way of thinking about how its mutation affects patients.

Mutations in Foxp1 were first identified in patients with autism and language impairments more than a decade ago. During embryonic development, the protein plays a broad role in controlling the activity of many other genes related to blood, lung, heart, brain and spinal cord development. To study how Foxp1 mutations might cause autism, researchers have typically analyzed its role in the brains neurons.

Almost all of the attention has been placed on the expression of Foxp1 in neurons that are already formed, said Novitch, a UCLA professor of neurobiology who holds the Ethel Scheibel Chair in Neuroscience.

In the new study published in Cell Reports, he and his colleagues monitored levels of Foxp1 in the brains of developing mouse embryos. They found that, in normally developing animals, the gene was active far earlier than previous studies have indicated during the period when neural stem cells known as apical radial glia were just beginning to expand in numbers and generate a subset of brain cells found deep within the developing brain.

When mice lacked Foxp1, however, there were fewer apical radial glia at early stages of brain development, as well as fewer of the deep brain cells they normally produce. When levels of Foxp1 were above normal, the researchers observed more apical radial glia and an excess of those deep brain cells that appear early in development.In addition, continued high levels of Foxp1 at later stages of embryonic development led to unusual patterns of apical radial glia production of deep-layer neurons even after the mice were born.

What we saw was that both too much and too little Foxp1 affects the ability of neural stem cells to replicate and form certain neurons in a specific sequence in mice, Novitch said. And this fits with the structural and behavioral abnormalities that have been seen in human patients.

Some people, he explained, have mutations in the Foxp1 gene that blunt the activity of the Foxp1 protein, while others have mutations that change the proteins structure or make it hyperactive.

The team also found intriguing hints that Foxp1 might be important for a property specific to the developing human brain.The researchers also examined human brain tissue and discovered that Foxp1 is present not only in apical radial glia, as was seen in mice, but also in a second group of neuralstem cells called basal radial glia.

Basal radial glia are abundant in the developinghuman brain, but absent or sparse in the brains of many other animals, including mice.However, when Novitchs team elevated Foxp1 function in the brains of mice, cells resembling basal radial glia were formed. Scientists have hypothesized that basal radial glia also are connected to the size of the human brain cortex: Their presence in large quantities in the human brain may help explain why it is disproportionately larger than those of other animals.

Novitch said that although the new research does not have any immediate implications for the treatment of autism or other diseases associated with Foxp1 mutations, it does help researchers understand the underlying causes of those disorders.

In future research, Novitch and his colleagues are planning to study what genes Foxp1 regulates in apical radial glia and basal radial glia, and what roles those genes play in the developing brain.

The studys first author is Caroline Alayne Pearson, a UCLA assistant project scientist. Other authors are from the University of Texas at Austin, the University of Alabama at Birmingham and the University of Puerto Rico.

The study was funded by the National Institutes of Health, the California Institute for Regenerative Medicine, the Cancer Prevention and Research Institute of Texas, the University of Texas at Austins Marie Betzner Morrow Centennial Endowment and the UCLA Broad Stem Cell Research Centers Research Award Program, including support from the Binder Foundation.

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Gene associated with autism also controls growth of the embryonic brain - Newswise

Paul Mischel (right) is one of six researchers suing the Ludwig Institute for Cancer Research for tapering down its funding.

By Michael PriceFeb. 7, 2020 , 7:10 PM

Alleging that a leading cancer funder is slashing their support in an unethical and reckless way, six prominent cancer researchers at the University of California, San Diego (UCSD), have filed a lawsuit to compel it to continue its current level of support. The suit, filed quietly in November 2019 and amended last week, contends that the Ludwig Institute for Cancer Research(LICR) is gradually drawing down its funding for cancer prevention and treatment research to the six plaintiffs, in order to close its 29-year-old San Diego branch by 2023.

In a statement, LIRC confirmed it is winding down the San Diego branchbut stressed that, [i]n implementing this decision, the Ludwig Institute is honoring its contractual obligations. LICR also said it plans to respond to the lawsuits specific allegations in due course.

The six plaintiffs, Don Cleveland, Arshad Desai, Richard Kolodner, Paul Mischel, Karen Oegema, and Bing Ren, primarily study tumor biology and cancer genomics, though some work more broadly, including Cleveland, who is also known for research on Huntingtondisease. In addition to funding from LICR, they receive substantial support from the National Institutes of Health (NIH), the California Institute for Regenerative Medicine, the Breakthrough Prize, and other sources.

LICR, a nonprofit organization based in New York City and Zurich, nowoversees nine research centers at universities and research hospitals around the world, including seven in the United States. According to figures from the institute, it has committed some $2.5 billion to cancer research since its founding in 1971. Scientists working at its research centers are co-employed as faculty members of LICR and their host institutions, with LICR partially funding the scientists work. In return, LICR earns revenue from patents and licensing agreements related to the scientists work. The San Diego branch is hosted by UCSD. According to figures cited in the lawsuit, between 2013 and 2018, LICR provided the university between $11.5 million and $13.2 million annually, including more than $3 million annually for research activities.

Jeremy Rich, a neuro-oncologist at the UCSD School of Medicine who has collaborated with LICR scientists, says the plaintiffs are the victims of a relationship between UCSD and LICR that has been in a downward spiral for years. The university, he says, doesnt see LICRas one of its own. The deteriorating relationship has fomented doubt about where the scientists loyalties lie, he says. Unfortunately for the investigators, theyre caught between two institutions, he says. It is a tragic thing for cancer research. Our enemies are not one another, but cancer.

The lawsuit, filed by six of the seven principal investigators at the branch, says that the LICR board of directors told the plaintiffs in a May 2018 meeting that it planned to close the branch at the end of 2023, when the researchers contracts end. The complaint saysLICR informed the researchers it would impose a substantially reduced level of funding beginning in 2019 and provide a tapering research budget while the scientists transitioned their research programs elsewhere. Since 2016, LICR has closed branches in Brussels;Melbourne, Australia;So Paulo;Stockholm;and Uppsala, Sweden.

By tapering their funding, the plaintiffs argue, LICR is breaching its agreement to provide future financial support for continuous, active conduct of medical research towards a cure for cancer at UCSD. The plaintiffs ask the court to make LICR continue to fundtheir research programs through 2023 at levels comparable to previous years. They also seek rights to the intellectual property they have generated, which would prevent LICR from filing patents on their work.

In addition, the scientists accuse LICR leadership of damaging their professional reputations. LICR, the lawsuit says, asserted in reckless, unjustified and unsupported public statementsthat the Plaintiffs were not performing cancer research at a level on par with their seniority and the funding.The lawsuit does not detail those statements, however.

Webster Cavenee, a former director of the LICR San Diego branch and current director of an LICR research program at UCSD for central nervous system cancers, declined to discuss the details of the lawsuit, but told ScienceInsider, the San Diego branch was measurably the most recognized and honored branch in the institute.

These scientists are renowned, says David Brenner, UCSD vice chancellor for health sciences, in a statement. They have won numerous awards and garnered significant acclaim from both their peers and the world at large. They have made major contributions in all aspects of cancer science and medicine, from basic research to clinical care, and their work is not yet done.

A UCSD spokesperson confirmed that because each of the researchers is a faculty member, termination of their Ludwig support does not terminate their UC San Diego faculty status, and they will continue to occupy the same space at university faculty. Its unclear how a closing of the branch and tapering of LICR funding might affect funding from NIH or other agencies.

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Major cancer institute sued by its own researchers over 'tapering' funding - Science Magazine

NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).

In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.

Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible.

This is a key turning point in ourworktowardprovidingALSpatientswith a potential new therapy,said ChaimLebovits, President and CEO ofBrainStorm. We commend the FDA foritscommitmentto the ALS communityandtofacilitating the development, and we ultimately hope, the approvalofNurOwn.The entire BrainStorm team is grateful for the ongoing and conscientious collaboration in the quest to beat ALS.

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, stated, The entire team at BrainStorm has collectively worked to ensure that we conduct the finest, science-based clinical trials. We had the opportunity to communicate with Senior Leadership at the FDA and discuss how we can work together to navigate the approval process forward along a novel pathway. We appreciate their willingness and receptiveness to consider innovative approaches as we all seek to better serve the urgent unmet medical needs of the ALS community.

Brian Wallach, Co-Founder of I AM ALS stated: There is nothing more important to those living with ALS than having access to therapies that effectively combat this fatal disease. We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. We were privileged to represent the patient voice at this meeting and are truly grateful to the company and the FDA for this critical agreement. This is a truly important moment of hope and we look forward to seeing both the Phase III data and the hopeful approval of NurOwn as soon as is possible.

About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

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Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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Katie Gallagher | Account Director, PR and MarketingLaVoieHealthScience Strategic CommunicationsO: 617-374-8800 x109M: 617-792-3937kgallagher@lavoiehealthscience.com

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BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn Regulatory Pathway for Approval in ALS - Yahoo Finance

10 February 2020

A study, published in Cell Reports, investigating when and how human stem cells develop into egg and sperm cells could one day help generate lab-grown gametes to treat infertility.

Human pluripotent stem cells can evolve into germ cells, which are the precursor cells for gamete development. By growing these human germ cells in vitro, the theory is that gametes engineered in a laboratory setting could someday be used, instead of natural eggs and sperm, in IVF treatment.

The research conducted within the Eli and Edythe Broad Centre of Regenerative Medicine and Stem Cell Research at University of California, Los Angeles (UCLA) provides great hope for those who are unable to produce gametes naturally,including thosewhose fertility has been affected by injury, illness or medical treatment.

'With donated eggs and sperm, the child is not genetically related to one or both parents. To treat patients who want a child who is genetically related, we need to understand how to make germ cells from stem cells, and then how to coax those germ cells into eggs or sperm'Dr Amander Clark, lead author of the study at UCLA, explained.

'Right now, if your body doesn't make germ cells, then there's no option for having a child that's biologically related to you. What we want to do is use stem cells to be able to generate germ cells outside the human body so that this kind of infertility can be overcome.'

In previous studies, scientists have been able to grow similarinduced pluripotent stem calls (iPS cells), and develop them into human skin cells and blood cells. The researchers, in collaboration with Massachusetts Institute of Technology, analysed the hundreds of thousands of genes active when both human embryonic stem cells and iPS cells transition to germ cells.

The data obtained allowed the researchers to firstly formulate when the germ cells are likely to form, which was between 24-48 hours after starting differentiation, and secondly which lineages of the differentiating stem cells give rise to the germ cells.

They also found that the activation and manifestation of germ cells was identical when developed from embryonic stem cells and iPS cells. This information was essential as they needed to ensure that the in vitro environment they had created was mimicking the molecular signals of the testis and ovaries to give hope for successful sperm and egg cell development.

Dr Clark stated: 'This tells us that the approach we're using to begin the process of making germ cells is on the right track. Now we're poised to take the next step of combining these cells with ovary or testis cells.'

Although current research is far from generating gametes, the end goal is that one day scientists are able to use a patient's skin cells to form stem cells, which can be programmed into egg or sperm cells to be used in fertility treatment.

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Lab-grown eggs and sperm a step closer - BioNews