First COVID-19 Convalescent Plasma DonorCanadian Blood Services begins collecting plasma donations from people who have recovered from COVID-19 as…

VANCOUVER, British Columbia, April 29, 2020 (GLOBE NEWSWIRE) -- Canadian Blood Services is proud to be part of CONCOR, a national clinical trial to test the safety and effectiveness of COVID-19 convalescent plasma as a possible treatment to help patients infected with the virus. Today, the national blood authority and operator collected its first COVID-19 convalescent plasma donation in Vancouver.

Im delighted to be able to help out a really good cause. I have been an active blood donor for 15 years. Im pleased my unfortunate situation can help somebody else. I think Im doing a little bit of good out of all this. says Jerry Glubisz, Canadian Blood Services first COVID-19 convalescent plasma donor.

Canadian Blood Services is establishing a national convalescent plasma collection program. The blood operator is now recruiting potential convalescent plasma donors across the country through its new online registry.

Convalescent plasma may help patients recover from COVID-19, but this has not yet been proven. Well-designed clinical trials, like CONCOR, will help provide the necessary information about whether this is a safe and effective treatment option for patients, says Dr. Dana Devine, chief scientist with Canadian Blood Services. Were making an important contribution to research on a global scale that could help patients in Canada and around the world.

Over the next few weeks more convalescent plasma donors, like Jerry Glubisz, may donate at one of 11 Canadian Blood Services donor centres that have the capability to collect blood components, like plasma, through a process called apheresis. These donor centres are located in Vancouver, Calgary, Edmonton, Saskatoon, Regina, Winnipeg, London, Hamilton, Toronto, Ottawa and Halifax.

Initially, all convalescent plasma donations will be supplied to Canadian physicians caring for patients with COVID-19 in the context of the CONCOR trial and under the authorization of Health Canada.

Including both of Canadas public blood operators (Canadian Blood Services and Hma-Qubec), there are 10 research teams and more than 50 hospitals across the country currently participating in CONCOR. Patient involvement in the clinical trial will be determined by their treating physician at a participating hospital in consultation with the patient and/or the patients family. Patients with COVID-19 who are looking for more information on convalescent plasma as a treatment option are encouraged to visit CONCOR1.ca.

While Canadian Blood Services has officially started collecting convalescent plasma, these donations must still undergo all necessary testing and processing before being issued for use by physicians, as per blood safety and quality standards. Transfusions of convalescent plasma are expected to begin within a few weeks when the trial begins.

A convalescent plasma donation is the same as a plasma donation; however, a specific donor is needed for this clinical trial. In addition to meeting Canadas current plasma donor eligibility criteria, convalescent plasma donors must be younger than 67 years of age, previously confirmed positive for COVID-19 by a laboratory test, and fully recovered from the virus and symptom free for at least 28 days to participate. Donors must also live within driving distance of a donor centre located in one of the aforementioned cities. Anyone who meets these requirements is encouraged to join Canadian Blood Services online registry. Additional testing will be done at the time of collection to ensure there are adequate antibodies against the COVID-19 virus in the donors plasma to be part of the trial.

Registered convalescent plasma donors who may be eligible are being contacted now and all convalescent plasma donation appointments are being booked as donors are qualified to participate by Canadian Blood Services Centre for Innovation which oversees research and development for the organization.

Canadian Blood Services is not accepting walk-in donors for any of its collection programs during the pandemic.

Media assets

As per current physical distancing measures, media are not permitted to visit Canadian Blood Services donor centres. To ensure media have access to assets necessary to provide coverage, raw footage and an uncut interview with Canadian Blood Services first convalescent plasma donor will be made available.

Web-based interviews with Mr. Glubisz and with convalescent plasma donors in other areas of Canada may also be arranged through Canadian Blood Services.

Please contact media@blood.ca for more information.

About Canadian Blood Services

Canadian Blood Services is a not-for-profit charitable organization. Regulated by Health Canada as a biologics manufacturer and primarily funded by the provincial and territorial ministries of health, Canadian Blood Services operates with a national scope, infrastructure and governance that make it unique within Canadian healthcare. In the domain of blood, plasma and stem cells, we provide services for patients on behalf of all provincial and territorial governments except Quebec. The national transplant registry for interprovincial organ sharing and related programs reaches into all provinces and territories, as a biological lifeline for Canadians.

About Canadian Blood Services Research Activities

Canadian Blood Services, through its Centre for Innovation, conducts and supports research projects in key priority areas that span the translational continuum from bench to bed side. The focus is on transfusion science and medicine but also related fields such as cellular therapies (in particular hematopoietic stem cell transplantations) and organ and tissue transplantation. Our research findings are published in peer-reviewed journals or directly shared with stakeholders.

Instrumental to our research efforts are discovery and applied research laboratories led by university-affiliated Canadian Blood Services staff scientists, as well as our medical experts and adjunct scientists. Complementing these core research teams, the Centre for Innovation facilitates a national and international research network of blood system experts through competitive research funding opportunities, collaborations and contract research.

/CanadasLifeline@CanadasLifeline1 888 2DONATE

FOR MORE INFORMATIONTEL. 1-877-709-7773EMAILmedia@blood.ca

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Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS – Pulmonology Advisor

Home Topics Lung Infection

Mesoblast announced data from a phase 2/3 trial evaluating remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Patients were treated with a variety of experimental agents prior to receiving remestemcel-L. Findings from the study showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of patients (n=9/12) were able to successfully come off ventilator support at a median of 10 days. There have been 7 patients discharged from the hospital as of now.

Mesoblast Chief Executive Dr. Silviu Itescu stated: The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

Additionally, the Food and Drug Administration recently accepted for Priority Review the Biologics License Application of remestemcel-L for the treatment of steroid-refractory acute graft vs host disease. The Company expects to launch remestemcel-L in 2020 if approved.

For more information mesoblast.com.

This article originally appeared on MPR

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Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 – Latest Herald

Stem Cell Therapy market describes in-depth assessments and professional studies of the current and future status of the market worldwide, including valuable facts and figures. Stem Cell Therapy markets enhance this growth trend by providing information on new opportunities and market drivers, trends and future technologies. This report defines scope, coverage, production and CAGR (%) according to type, share, revenue status and outlook, capacity, consumption, market drivers, production status and outlook and opportunities, exports, imports, emerging market / national growth rates. This report provides a 360-degree overview of the industrys competitive environment. The Stem Cell Therapy market report evaluates key regions (countries) with a large market share during the forecast period.

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The research in its endeavor to present an unbiased presentation of the Stem Cell Therapy market, complete with multi-faceted documentation of various market forces that collectively lend enormous growth impetus to the Stem Cell Therapy market. This report further reinforces vital statistical data on technological marvels that under prevailing circumstances direct growth in the Stem Cell Therapy market. A holistic understanding on PESTEL and SWOT analysis are also tagged in the report to unearth peculiarities of the Stem Cell Therapy market.

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Furthermore, Report provides the deep analysis about the impact of domestic and global players on market, trade regulation, value chain optimization, and opportunities analysis for new present as well as new players, recent developments, strategic market growth analysis, area marketplace expanding, product launches, technological innovations and many more. The study report of global Stem Cell Therapy market can be split on the basis of key segments such as product type, application, key companies and key regions. Also the growth of the global Stem Cell Therapy market can be projected on the basis of segments and calculation for sales by application and type of the product in terms of volume and value.

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

This market ready research offering on Stem Cell Therapy market is a go-to synopsis that highlights on all the core developments simultaneously dominant across all regional hubs in the Stem Cell Therapy market and their subsequent implications on holistic growth trajectory of Stem Cell Therapy market globally. The report is aimed at answering all the relevant queries pertaining to the target market based on which successful business decisions could be rapidly applied, favoring uncompromised growth in the Stem Cell Therapy market.

The report also lends light on competition spectrum, highlighting core market participants who are identified as frontline players in Stem Cell Therapy market as highlighted by this research. In its bid to equip players with real time understanding of the various operational factors dominant across regions, the research elaborating on Stem Cell Therapy market also houses crucial data on various geographical hubs identified in Stem Cell Therapys market as presented.

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Cancer Stem Cell Therapies: Mapping the Future Growth Potential – Communal News

The objective of the ongoing R&D in this domain is to develop novel CSC directed treatments that can combat complications, such as off-target toxicities and disease relapse, associated with the current standard of care treatments.TheCancer Stem Cell Therapies Market, 2017-2030report examines the current landscape and the future outlook of the growing pipeline of products targeting CSCs.Some of the most interesting insights from our study are presented below.

CSCs have Garnered a Lot of Interest Across Different PlatformsIncreasing chatter on social media, and the fact that over 9,000 scientific articles have been published in the last few years, indicate the growing interest in this domain

A Robust Pipeline Offers Significant Future PotentialWith two commercialized drugs and close to 150 clinical/preclinical molecules, the field has evolved significantly over time and has several promising candidate therapies

A Healthy Mix of Small Molecules and Biologics, The growing pipeline features both small molecule and biologic product candidates, which are being developed to target a number of cancer stem cell regulatory pathways

Being Designed for Novel Targets, Reinforces the Underlying PromiseSpecifically, over 70 clinical-stage molecules are being investigated to tap opportunities across different types of cancer

The US and the EU are Key Innovation HubsBoth big and small pharma players are actively involved; the US and EU are currently leading the research efforts

The Market is Expected to Witness Rapid Growth in the Mid-Long TermAfter the approval and launch of multiple late-phase product candidates, the market is expected to grow at a rapid pace

The Opportunity is Likely to be Well Distributed Across Indications and TargetsThe emergence of effective therapeutic strategies will result in better opportunities in the long term as more drugs get approved for a diverse range of indications

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Macomb County doctor charged health care fraud over COVID-19 treatments – Detroit Free Press

The founder of Allure Medical Spa, the Shelby Township business raided by federal officials last week, is accused of health care fraud that includes using the COVID-19 pandemic "as an opportunity to bill insurers for Vitamin-C infusions fraudulently represented as COVID-19 treatments and preventative measures."

Dr. Charles Mok is the only defendant listed in the 47-page complaint unsealed Tuesday in U.S. District Court in Detroit. The 56-year-old Washington Township man is charged with health care fraud and conspiracy to commit health care fraud in the complaint dated Friday.

His attorney, Mark Kriger, had no comment Tuesday morning.Mok is scheduled for an initial appearance in court at 1 p.m. Tuesday.

The complaint discusses multiple millions of dollars in billings to Medicare from Jan. 1, 2018 to April 7 of this year.

It alleges that Mok engaged in a scheme to defraud prior to and during the coronavirus pandemic through the submission of false and fraudulent claims to Medicare for payment related to the treatment of varicose veins.

The complaint also states he failed to observe appropriate protocols at the clinic to minimize the spread of the virus.

A cooperating witness, who is an employee, was aware of five employees who tested positive for the virus but continued to work and treat patients at Allure, according to the complaint.

Federal Bureau of Investigations evidence response team members head into the building where Allure Medical's office is in Shelby Township, Michigan on Thursday, April 23, 2020.The Federal Bureau of Investigations raided Allure Medical for an alleged "federal violation."(Photo: Eric Seals, Detroit Free Press)

FBI investigators raided the location near 26 Mile and Van Dyke last Thursday. TheU.S. Department of Health and Human Services was part of the task force.

More: FBI raids Allure Medical Spa in Shelby Township for alleged fraudulent COVID-19 treatments

A woman who answered the phone at the Allure Medical location the day of the raid she did not have anyone available to talk with a Free Press reporter. Messages left at the location and via email that day were not returned.

Allure Medical has eight locations in Michigan, as well as offices in Florida, Kentucky, North Carolina and South Carolina, according to its website.

It statedthe Shelby Township location offers varicose vein treatment, hormone replacement therapy, dermatology, stem cell therapy, cosmetics and weight loss services.

The building where Allure Medical's office is in Shelby Township, Michigan on Thursday, April 23, 2020.The Federal Bureau of Investigations raided Allure Medical for an alleged "federal violation."(Photo: Eric Seals, Detroit Free Press)

According to SRQ Magazine, Allure Medical was offering high-dose intravenous vitamin C therapy to front-line employees who are at risk of contracting the virus and to existing COVID-19 patients. Front-line workers are identified as those who include hospital staff, police and first responders, and grocery store employees.

The magazine quoted Mok as saying We are using high-dose IV vitamin C to help support people's immune systems and to help those with the virus recover quicker. We want to provide this treatment to those who need it, regardless of their ability to pay."

The magazine statedthat Allure Medical won't treat sick people at the same time as those who are healthy.

Contact Christina Hall: chall@freepress.com. Follow her on Twitter: @challreporter.

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The impact of the coronavirus on the Platelet Rich Plasma and Stem Cell Alopecia Treatment Market Volume Analysis, size, share and Key Trends…

Analysis of the Global Platelet Rich Plasma and Stem Cell Alopecia Treatment Market

The recent market study suggests that the global Platelet Rich Plasma and Stem Cell Alopecia Treatment market is expected to grow at a CAGR of ~XX% between 2019 and 2029 and reach a value of ~US$XX by the end of 2029.

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The Platelet Rich Plasma and Stem Cell Alopecia Treatment market study offers a detailed understanding of the consumption, demand, and pricing structure of each product.

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Companies Mentioned in the Report

The report also profiles major players operating in the global platelet rich plasma & stem cell alopecia treatment market based on various attributes, such as company overview, financial overview, pipeline portfolio, product portfolio, business strategies, and recent developments. The players covered in the report include Kerastem, Eclipse, Regen Lab SA, Stemcell Technologies, Inc., RepliCel Life Sciences, Histogen, Inc., and Glofinn Oy.

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Stem Cell Therapy Market Revenue, Demands and Gross Margin, Forecasts to 2026 (Based on 2020 COVID-19 Worldwide Spread) – Jewish Life News

GlobalStem Cell Therapy Market, delivering a must-read report for industry stakeholders wanting to understand the strategic landscape of this burgeoning sector. Readers will find an in-depth analysis of the market and how it will impact existing traditional markets, as well as insights into future development and opportunities across the globe.

MarketInsightsReports has announced the addition of the Global Stem Cell Therapy Market Research Report 2020 The report focuses on global major leading players with information such as company profiles, product picture and specification.

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Key Players:

Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix), request free sample for complete list of companies.

The leading players of industry, their market share, product portfolio, company profiles are covered in this report. The competitive market scenario among players will help the industry aspirants in planning their strategies.

Summary

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

In the last several years, global stem cell therapy market developed fast at a average growth rate of 46.81%.

Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 100 countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Stem Cell Therapy market in 2020.

COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.

The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.This report also analyses the impact of Coronavirus COVID-19 on the Stem Cell Therapy industry.

Stem Cell Therapy Market Segmentation by types, Applications and regions:

Market Segment by Type covers:

Autologous

Allogeneic

Market Segmented by Applications:

Musculoskeletal Disorder

Wounds & Injuries

Cornea

Cardiovascular Diseases

Others

Market Segment by Regions:

North America (the United States, Canada, and Mexico)Europe (Germany, France, UK, Russia, and Italy)Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)South America (Brazil, Argentina, Colombia, etc.)

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These segments are thoroughly evaluated on an individual basis and a team of analysts has ensured to give a crystal clear idea about various lucrative segments of the industry. This detailed analysis using segmentation by providing precise results on industry-related markets.

The report also analyzed the evolution of industry trends. Several macroeconomic factors such as Gross domestic product (GDP) and the increasing inflation rate is expected to affect directly or indirectly in the development of the industry.

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Customization of the Report:This report can be customized as per your needs for additional data up to 3 companies or 3 countries or nearly 40 analyst hours.

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Somatic Driver Mutations Leading to Endometrial Cancer Occur Early in Life – Cancer Therapy Advisor

Home Cancer Topics Gynecologic Cancer

Whole-genome DNA sequencing studies of normal endometrial glandulartissue have revealed the frequent presence of somatic driver mutations in cancer-relatedgenes. These findings were published in Nature.

While the acquisition of mutations overtime is believed to be a characteristic of all somatic cells, data are limitedon how it occurs in normal tissues.Nevertheless, the study authors noted that [t]he characterizationof the mutational landscapes of normal tissues isadvancing our understanding of the succession of intermediate neoplastic stages between normalcells and the cancers that originate fromthem.

One of the rationales for focusing on theendometrium of the uterus was related to its highly dynamic physiology duringthe reproductive years in response to fluctuating hormone levels, as well asits composition of stromal cells covered by a surface epithelium that iscontiguous with embedded glandular epithelium. Although the contiguity of thesurface epithelial sheet and the glandular tissue is disrupted duringmenstruation, it is subsequently restored by stem cells within retained embeddedglands.

In this study, 292 normal endometrialglands were isolated using laser-capture microdissection from 28 women between theages of 19 and 81 years. Comparisons of whole-exome DNA sequencing results forthese tissues with matched specimens of other types of normal tissue from thesame individual were used to identify somatic mutations in the endometrialglandular tissue. Corresponding data on patient age and parity allowed for theexploration of these factors on the rate and timing of somatic driver mutationsin normal glandular tissue of the endometrium.

Some of the keyfindings of this study included the following:

In their concluding remarks, the study authors noted that their results show that mutational landscapes differ markedly between normal tissues perhaps shaped by differences in their structure and physiology and indicate that the procession of neoplastic change that leads to endometrial cancer is initiated early in life.

Reference

Moore L, Leongamornlert D, Coorens THH, et al. The mutational landscape of normal human endometrial epithelium [published online April 22, 2020]. Nature. doi: 10.1038/s41586-020-2214-z

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Stem Cell Therapy Shows 83% Survival in COVID-19 Patients Dependent on Ventilator – HospiMedica

Ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) who were treated with intravenous infusions of an allogeneic mesenchymal stem cell product candidate had a survival rate of 83%.

The allogeneic mesenchymal stem cell product candidate remestemcel-L from Mesoblast Limited (Melbourne, Australia) was administered within the first five days under emergency compassionate use at New York Citys Mt Sinai hospital during the period March-April 2020. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at Mt Sinai hospital. 75% of the patents successfully came off ventilator support within a median of 10 days, in contrast to only 9% of ventilator-dependent COVID-19 patients being able to come off ventilators with standard of care treatment and only 12% survival in ventilator-dependent COVID-19 patients at two major referral hospital networks in New York during the same time period. These poor outcomes are consistent with earlier published data from China where mortality rates of over 80% were reported in patients with COVID-19 and moderate/severe ARDS.

The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS, said Mesoblast Chief Executive Dr. Silviu Itescu. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators, said Mesoblast Chief Medical Officer Dr Fred Grossman. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS.

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Stem Cell Therapy Shows 83% Survival in COVID-19 Patients Dependent on Ventilator - HospiMedica

Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory…

CRANFORD, N.J., April 27, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc.. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS.

The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. NC-MSCs are mesenchymal stem cells derived from a single donor's fibroblasts that have been dedifferentiated into an induced pluripotent stem cell (iPSC) master cell bank, thereby avoiding the need to source additional donor cells. The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy. Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.

The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability, and efficacy of NC-MSCs in patients with moderate to severe ARDS due to COVID-19. The proposed trial, a Phase 1b/2 clinical trial, is titled "A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to SARS-CoV-2 Disease (COVID-19)," or "MARCO". The primary objectives of this study are to evaluate the safety and efficacy of NoveCite cells as a treatment for subjects with moderate-to-severe ARDS due to COVID-19 and to identify therapeutic doses.

"MSCs have an established track-record of clinical safety, and have shown promise in the treatment of inflammatory lung disease," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus, Inc. "Our research has shown that the NoveCite cells, being derived from mRNA-reprogrammed iPSCs, secrete higher levels of immunomodulatory proteins than donor-derived MSCs, and have unique manufacturing advantages."

"We believe we have the key elements in place from a clinical design and manufacturing point of view to evaluate this novel cell therapy approach to deal with the current pandemic," said Myron Holubiak, Chief Executive Officer of Citius. "ARDS is a very serious complication for many patients suffering from COVID-19, and is believed to account for about 80% of the deaths in ventilated patients. There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management. Literature from previous investigational studies with MSCs in the treatment of lung injuries support the idea that MSCs could prove effective in treating COVID-19-related ARDS. We look forward to our FDA discussions and are excited to be at the cusp of what could be a novel and effective therapy for ARDS."

About Acute Respiratory Distress Syndrome (ARDS)ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Coronavirus Treatment Acceleration Program (CTAP)In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 will benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Novellus, Inc.Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.

Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the ability to access the FDA's CTAP program for the MARCO trial; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and our Phase III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing our product candidates, including any licensed from Novellus, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677 x105ascott@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.

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Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory...