Newswise LOS ANGELES (June 16, 2020) Children's Hospital Los Angeles (CHLA) ranks again among the nations premier destinations for pediatric care, according to the U.S. News & World Report Best Children's Hospitals annual list released today.

CHLA not only retained its national No. 5 ranking in U.S. News Honor Roll of Best Childrens Hospitalswhich recognizes institutions with the most outstanding pediatric clinical careit continued its four-year streak of being the highest-scoring childrens hospital in the entire Western United States.

To make U.S. News & World Reports prestigious Best Childrens Hospitals Honor Roll, one must demonstrate the strongest achievements in clinical excellence, with a matchless team of expert, compassionate specialists committed to research and education as well as protocols that drive safety and quality and consistently lead to the best health outcomes for patients, says CHLA President and Chief Executive Officer Paul S. Viviano. "This honor affirms the work of every CHLA team member and our belief that when parents choose Childrens Hospital Los Angeles, they are choosing the best care for kids."

Every year, U.S. News scores nearly every major hospital and health system in the country and ranks them according to performance benchmarks, peer review, certifications, and other data provided by the hospital and third-party measurements of excellence. Children's hospitals are ranked separately from other facilities due to the specialized expertise, equipment and facilities required to care for infants, children and youth.

This year, U.S. News surveyed 118 pediatric medical centers, including hospitals that are freestanding or part of a larger institution. CHLA improved its ranking over last year in seven of the 10 pediatric specialty categories the survey considers, including a number two ranking for Neonatal Care. In all, the hospital earned top-10 recognition in seven of those categories:

CHLA has an organization-wide commitment to providing our patients the care they need no matter their circumstances, says CHLA Chief Medical Officer James Stein, M.D., MSc. "Our clinical teams often treat the most acute cases that are outside the scope or expertise of other childrens hospitals in California, and being named a Top-5 childrens hospital in the U.S. is a testament to the clinicians and staff who work every day to make sure each child receives the best care and experience possible.

Founded in 1901, Children's Hospital Los Angeles is a pediatric academic medical center built around its mission of creating hope and building healthier futures for children. Renowned for its world-class clinical care, leading-edge research and one of the largest and most successful pediatric training programs in the countryall while being the pediatric safety net hospital for the entire regionCHLA now sees more than 600,000 patient visits annually between its main hospital and five neighborhood care clinics.

CHLA physicians, nurses and clinical staff provide compassionate and lifesaving pediatric care for patients ranging from infants to young adults, hailing from all 50 states and more than 75 countries. Clinical care is led by physicians who are faculty members of the Keck School of Medicine of USC. Many of the hospital's achievements in care are made possible through a cohesive relationship between clinical experts at the bedside and the basic, translational, and clinical research conducted in The Saban Research Institute of CHLA.

In the past year, CHLA has had several notable achievements, including:

U.S. News and World Report works with research firm RTI International to develop its annual Best Children's Hospitals list, a collaboration between hospitals and the magazine to benchmark the performance of childrens hospitals for the benefit of parents and their children. The survey evaluates hundreds of data points, including patient survival and surgical complication rates; staffing, technology and special services; infection prevention and delivery of care; reputation among peer physicians nationwide (i.e. Where would the best pediatric specialists send their kids?); how involved parents are in their childrens care; and many other measurements of excellence.

U.S. News Media Group, the parent of U.S. News & World Report, announced the 2020-21 hospital rankings online at 12:01 a.m. EST on Tuesday, June 16. For additional information, please visit the Best Childrens Hospitals Honor Roll and specialty rankings page at usnews.com/childrenshospitals.

About Children's Hospital Los Angeles Founded in 1901,Children's Hospital Los Angelesis ranked the topchildrens hospital in California andfifth in the nation for clinical excellence with its selection to the prestigious U.S. News & World Report Honor Roll of childrens hospitals. Clinical care is led by physicians who are faculty members of the Keck School of Medicine of USC through an affiliation dating from 1932.The hospitalalso leads thelargest pediatric residency training program at a freestanding childrens hospital of its kind in the western United States.TheSaban Research Instituteof Childrens Hospital Los Angeles encompasses basic, translational and clinical research conducted at CHLA. The hospitals Global Health Program facilitates services for international patients from more than 75 countries. To learn more, follow us on Facebook, Instagram, LinkedIn and Twitter, and visit our blog for families (CHLA.org/blog) andour research blog (ResearCHLABlog.org).

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Children's Hospital Los Angeles Ranked No. 1 Children's Hospital in the Western U.S., No. 5 Nationally for Second Straight Year - Newswise

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COVID-19 impact will also be included and considered for forecast.

Global Thalassemia Treatment Market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Market Opportunities, Competitive Analysis, Regional and Country Level.

Thalassemia Treatment Market Size Covers Global Industry Analysis, Size, Share, CAGR, Trends, Forecast And Business Opportunity.

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Global Thalassemia Treatment Market 2018-2024Brandessence Market Research is working on a new report titleGlobal Thalassemia Treatment Market: Global Size, Trends, Competitive, Historical & Forecast Analysis, 2018-2024?. Rise in number of altered Thalassemia genes, increase in awareness about the disease and high adoption of chelation therapy & blood transfusion for treatment by doctors as well as patients arelikely to enhance the growth of Global Thalassemia Treatment Market.

Scope of Global Thalassemia Treatment Market Reports

Thalassemia is aninherited blood disorder in which the body makes an abnormal form of hemoglobin.People having Thalassemia disease are unable to make sufficient hemoglobin which causes severe anemic conditions.Hemoglobin is found in red blood cells and transports oxygen to all parts of the body. When there is insufficient hemoglobin in the red blood cells, oxygen cannot get to all parts of the body. Organs demand oxygen and are unable to function properly.There are two primary types of Thalassemia disease such as Alpha Thalassemia disease and Beta Thalassemia disease.Alpha Thalassemia results in a formation of additional beta globins, which leads to the formation of beta-globin tetramers (4) called Hemoglobin H.

Beta Thalassemia causesadditionalformation of alpha globins, which develops alpha globin tetramers (a4) that store in the erythroblast (immature red blood cell).Thalassemia is caused by mutations in the DNA of cells that make hemoglobin.

Factors that increase risk of Thalassemia include Family history of thalassemia and certain ancestry.Possible complications of Thalassemia includeIron overload, Infections, Bone deformities, splenomegaly, slowed growth rate of child and Heart problems.

Thalassemia signs and symptoms include Fatigue, Weakness, Pale or yellowish skin, Facial bone deformities, slow growth, abdominal swelling, Dark urine, chest pain,cold hands and feet, poor feeding, greater susceptibility to infections. Diagnosis of Thalassemia includesa complete blood count (CBC), a reticulocyte count,Iron count, Genetic testing and prenatal testing. Treatment of Thalassemia depends on the type and severity of Thalassemia such as Blood transfusions, Bone marrow or stem cell transplant, Surgery and Gene therapy.

Global Thalassemia Treatment Market has been segmented on the basis ofType of Treatment, Diagnosis, End usersand Geography. On the basis of Type of TreatmentGlobal Thalassemia Treatment Market is classified into Blood Transfusion, Chelating Therapy, Bone Marrow Transplant, Stem Cell Transplant, Surgery, Gene Therapy and Others.On the basis of DiagnosisGlobal Thalassemia Treatment Market is classified into Perinatal Testing, Prenatal Testing, Pre-Implantation and Other.On the basis of the End user the Global Thalassemia Treatment Market is classified into Hospitals, Biotechnological Laboratories, Diagnostic Laboratories, Educational Research Institutes, Pharmaceutical Industries and others.

The regions covered in Global Thalassemia Treatment Market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, Global Melanoma Drug Market sub divided in to U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.

Key Players for Global Thalassemia Treatment Market Reports

Global Thalassemia Treatment Market reports cover prominent players like Bluebird bio Inc., Acceleron Pharma Inc., Novartis AG, Celgene Corporation, Shire plc, Bellicum Pharmaceuticals, GlaxoSmithKline Plc, Celgene,Lonza group, Alnylam Pharmaceuticals Inc., Calimmune Inc., CRISPR Therapeutics, Editas Medicine Inc., Errant Gene Therapeutics LLC, Gamida Cell Ltd, Gilead Sciences Inc., Incyte Corp, Ionis Pharmaceuticals Inc., IRBM Science Park SpA, Johnson & Johnson, Kiadis Pharma NV, La Jolla Pharmaceutical Company, Merck & Co Inc., PharmaEssentia Corp, Protagonist Therapeutics Inc., Sangamo Therapeutics Inc., Zydus Cadila Healthcare Ltd, Genorama Ltd, HiMedia Laboratories, DiagCor Bioscience Inc. Ltd and Tosoh Bioscience Inc.

Global Thalassemia Treatment Market Dynamics

Increase in awareness about the disease and technological expansions are likely to raise the adoption of gene therapies. Also Rising Prevalence of Thalassemia, Increase in Pharmaceutical R&D Spending, Increasing Spending on Stem Cell Research, Rising Healthcare Expenditure and Rising Asian Population will boost theGlobal Thalassemia Treatment Market. Treatment of Thalassemia is mostly restricted to regular blood transfusions and iron chelation therapy.Moreover, High operation cost of sophisticated clinical and preclinical imaging systems, High cost of maintenance andless life span of accessoriesalso restraining theGlobal Thalassemia Treatment Market.Yearlyspending for treatment of Thalassemia ranged from $ 108 to 432, depending on type of treatment with average cost per blood transfusion was $ 5.22.2. Average 18.5%14.3 of the total annual income was spent on the treatment for Thalassemia. Drugs prescribed for Thalassemia mostly cures symptoms and side effects such as anemia, iron overload, slow growth of children and vitamin deficiency.Occurrence of Thalassemia is reported to increase steadily over the years across different regions. This can be due to population migration, intermarriages, genetic as well as environmental factors prompting the condition and its implications.Systematic Drugs under Pipeline, Rising Scope for Gene Therapy and increasing awareness towards Thalassemia are some opportunities in the forecast period for theGlobal Thalassemia Treatment Market.

Global Thalassemia Treatment MarketRegional Analysis

North America have largest share ofGlobal Thalassemia Treatment Market. It is mainly driven by quickly increasing immigrant population from tropical regions, rising number of population with Thalassemia carrier gene and rise in birth rates due to variation of genes among the population in the U.S.There are some prenatal tests available on the market to determine the possibility of alpha thalassemia including both invasive and non-invasive technique.

The alpha thalassemia testing market has aemergent trend in the countries with traditional groups like Mediterranean countries, African countries and few countries in Asia Pacific. Furthermore, in Asia Pacific region the growth in similar community marriage practices and high fertility ratewith alpha thalassemia patients have been detected. This is expected to raiseacceptance of blood transfusion and chelation therapy treatments during the forecast period.A latestimprovement in the testing of alpha Thalassemia may determine the risk of the disease by in vitro examination of the embryo. While there are various such tests available in theGlobal Thalassemia Treatment Market but lack of awareness leads to the neglect and delayed diagnosis of the diseased state.

Most frequently prone area for alpha thalassemia is Mediterranean countries, African countries, and Southeast Asian countries. Thalassemia trait practically affects 6% to 35% of the population in these ethnic groups. Middle East & Africa is likely to be the fastest risingGlobal Thalassemia Treatment Market during the forecast period.

Key Benefits for Global Thalassemia Treatment Market Reports

Global Thalassemia Treatment Market report covers in depth historical and forecast analysis.Global Thalassemia Treatment Market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Global market sale (K Units), Global market Drivers, Market Restraints, Market opportunities, Competitive Analysis, Regional and Country Level.Global Thalassemia Treatment Market report helps to identify opportunities in market place.Global Thalassemia Treatment Market report covers extensive analysis of emerging trends and competitive landscape.Global Thalassemia Treatment Market Segmentation

Global Thalassemia Treatment Market: By Type of Treatment Analysis

Blood TransfusionChelating TherapyBone Marrow TransplantStem Cell TransplantSurgeryGene TherapyOtherGlobal Thalassemia Treatment Market: By Diagnosis Analysis

Perinatal TestingPrenatal TestingPre-ImplantationOtherGlobal Thalassemia Treatment Market: By End user Analysis

HospitalsBiotechnological LaboratoriesDiagnostic LaboratoriesEducational Research InstitutesPharmaceutical IndustriesOtherGlobal Thalassemia Treatment Market: By Regional & Country Analysis

North AmericaU.S.MexicoCanadaEuropeUKFranceGermanyItalyAsia PacificChinaJapanIndiaSoutheast AsiaLatin AmericaBrazilThe Middle East and AfricaGCCAfricaRest of Middle East and AfricaNeed a PDF of the global market report? Visit: https://industrystatsreport.com/Request/Sample?ResearchPostId=57&RequestType=Methodology

Table of Content:

Market Overview: The report begins with this section where product overview and highlights of product and application segments of the Global Thalassemia Treatment Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company: Here, the competition in the Worldwide Global Thalassemia Treatment Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data: As the name suggests, this section gives the sales data of key players of the Global Thalassemia Treatment Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the Global Thalassemia Treatment Market.

Market Status and Outlook by Region: In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the Global Thalassemia Treatment Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User: This section of the research study shows how different end-user/application segments contribute to the Global Thalassemia Treatment Market.

Market Forecast: Here, the report offers a complete forecast of the Global Thalassemia Treatment Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion: This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

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We publish market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students.

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2025 Projection: Thalassemia Treatment Market Analysis by SWOT, Investment, Future Growth and Major Key Players 2020 to 2026 - Cole of Duty

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Specialty pharmaceutical company Race Oncology (ASX: RAC) has reported positive data from an investigator-initiated Phase II clinical trial of historical cancer drug Bisantrene on patients with relapsed or refractory acute myeloid leukaemia.

Conducted at the Sheba Medical Centre in Israel, the open-label, single-agent trial studied 10 patients who, on average, had failed three prior lines of treatment.

Bisantrene was found to be well tolerated with no unexpected or serious toxicities, the company reported.

After a single course of treatment, the drug demonstrated an overall clinical response rate of 40%, with one patient progressing to complete remission and three achieving partial remission.

One patient was bridged to allogeneic stem cell transplantation (where cells are donated to the patient from a genetically-matched donor) and there were no removals or withdrawals from the study during treatment.

The drug also had marked activity in four patients with extramedullary (outside of the bone marrow) acute myeloid leukaemia such as leukemia cutis, chloromas, and central nervous system disease which has historically been difficult to treat.

The most frequently reported serious adverse events were thrombocytopaenia (low blood platelets) and mucositis (mouth ulcers), both of which were expected side effects of anthracyline and anthracene chemotherapeutics.

One patient experienced transient grade one kidney toxicity and there were no liver toxicities observed.

Race said there were no anaphylactoid-type reactions observed in any patient over the course of treatment. This type of reaction was a serious adverse event regularly observed in the historical trials.

Relapsed or refractory acute myeloid leukaemia remains a significant therapeutic challenge.

While meaningful gains have been achieved in recent years with the introduction of new targeted drugs, published studies claim the clinical outcomes remain unsatisfactory.

Bisantrene is a small molecule cancer drug related to anthracyclines the most widely-used class of chemotherapy drugs.

Unlike anthracyclines, it has a greatly reduced risk of cardiotoxicity (heart damage), meaning it can be used with patients who have reached their cardiotoxic limit with anthracyclines, or cannot tolerate anthracyclines due to existing heart conditions, age or other factors.

Bisantrene was tested in more than 40 phase II clinical trials during the 1980s and 1990s with up to $200 million put into its development, before it was lost in a series of big pharmaceutical mergers.

Race clinical advisory board chairman and international authority in clinical leukaemia and stem cell research, Professor Borje Andersson, said the trial confirmed historical results which used a different formulation of Bisantrene.

While Bisantrene had been demonstrated in the 1980s as an effective salvage drug against acute myeloid leukaemia, the [clinical] data we had was old, he said.

It was important for us to study it by todays standards using the current formulation, so we could confirm whether our strategy of repurposing this drug is sound.

We also wanted to confirm that Bisantrene could still generate a meaningful response rate in a highly-frail patient population with heavily pre-treated acute myeloid leukaemia, Professor Andersson added.

The study saw a reduction in the leukaemic disease burden and an overall response rate in 40% of the patients.

While we must study the drug further, it appears that with this kind of response, Bisantrene-based therapy may have the potential to serve as an important bridge to allogeneic stem cell transplantation in patients who otherwise have few therapeutic options, Professor Andersson said.

Race chief scientific officer Dr Daniel Tillett said a key focus of Phase II clinical trial was to determine Bisantrenes safety in a modern context.

These results are pleasing from a safety and activity perspective, particularly given the clinically-challenging patient population included in the trial, he said.

It was encouraging to see the drugs tolerability profile compared favourably with other commonly-used chemotherapy agents such as anthracyclines, while the side effects were in keeping with what we would expect to see with all chemotherapeutics of this class, Dr Tillett added.

Professor Andersson said the trial found Bisantrene to be an agent with an acceptable safety profile and promising anti-leukaemic activity.

As this was an open-label, single-agent trial, we can be confident that it was the Bisantrene exposure which generated the positive results, he said.

The patient cohort had advanced acute myeloid leukaemia and had previously failed an average of three lines of therapy, so they were always going to be tough to treat, but a 40% overall response rate after only a single course of treatment markedly exceeded our expectations.

It is a hugely promising result and one which reinforces our development plans for this drug, Professor Andersson added.

A follow-up study combining Bisantrene with other anti-leukaemic drugs is currently in the advanced planning stages.

At mid-morning, shares in Race Oncology were up 53.97% to $0.485.

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Race Oncology confirms positive results from Bisantrene drug trial on patients with advanced acute myeloid leukaemia - Small Caps

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Much has changed in the last 12 months. Its a new decade and a whole new world. Even before Covid-19 obliterated normal, long-held conventions were collapsing faster than a tweetstorm. The very idea of masculinity has been rightly redrawn and recast, but theres not yet a definition we can all agree on. From this uncertainty has come not a movement, exactly, but certainly a move toward something were calling soft power. Its about gaining strength through vulnerability, bringing empathy to the fore, seeking to understand rather than impose. With the daily news dominated by sociopolitical Sturm und Drang, consideration has become commanding.

So what is style in this new world order? Strong-shouldered suits and immaculately shined oxfords, long the international uniform of success, dont quite speak the right language today. Its not that the power suit is deadmore that its current incarnation has evolved in tune with our notion of what strength is.

Its a shift that designers presaged months ago. The best new menswear traffics in a similarly soft kind of power,a more nuanced take on the trappings that have always given men an authoritative sense of style. Theyre pieces that maintain the decorum of traditional tailoring but knock the starch out of it with fluid construction, downy textiles, soothing colors. When in doubt, Brunello Cucinelli (the epitome of soft power in many ways) is there for you. So too Herms, Gabriela Hearst and newcomer Saman Amel.

After months in lockdown, we are all craving humanity, and how we present ourselves to the world has become especially meaningful. Consider Jason Momoa, the hulking he-man of Aquaman, who, at this years Golden Globes, strolled the red carpet in an emerald velvet Tom Ford dinner jacket teamed with an Art Decoinspired Cartier brooch. Very much a soft-power MVP move.

Theres a new generation who is pushing at the boundaries of menswear, and while we arent advocating for pussy- bow blouses (but rock on, Harry Styles), what can we learn from their adventures? That now, more than ever, is the time to express yourself, whether that means a scarf in a daring silk rather than your usual cashmere, or a dramatically peaked lapel to imbue a classic blue blazer with a frisson of attitude. Above any sartorial flourish, though, it will be the little thingsthe weave of a sweater, the topstitching on a shirt, that human touchthat telegraph real style savvy. Quiet luxury, stealth wealthwhatever it is you call it, it has never been less cool to be the loudest guy in the room.

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The Best of the Best in Style for 2020 Robb Report - Robb Report

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Like many states, the UK government has committed to supporting disruptive innovations.1 These are considered to hold greater potential for economic growth and development than incremental advances in established technologies. Within this broad strategy the bioeconomy, the area of industrial activity based on commercialising life sciences research is given a particular importance. The bioeconomy includes sectors like biofuels, agricultural biotechnology, and medical biotechnology.2 In the latter case, advances in medical biotechnologies hold promise for treating, and even curing, serious and chronic diseases as well as driving growth and prosperity. Regenerative medicine (RM), the biotechnology-based use of cells, tissues, and genes as medicinal products, is certainly disruptive in that they differ in important ways from traditional pharmaceuticals and medical devices.3

The UK has taken a number of policy measures to support the development of the RM industry. The Regenerative Medicine Platform funding schemes promote and co-ordinate academic translational research. The Catapult centres, including the Cell and Gene Therapy Catapult, the Medicines Discovery Catapult and the High Value Manufacturing Catapult, provide advice, facilities and infrastructure to support businesses, especially Small and Medium-sized Enterprises (SMEs); with potential to contribute to the RM value chain. The Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Office offers a RM advice service to help academic and commercial developers navigate the complex regulatory framework for biological therapies, while the recent Accelerated Access Review proposed a raft of measures to speed up the regulatory timeline for transformative new therapies more generally.4

However, it does not necessarily follow that all parts of the biomedical sector will be equally disrupted by any given RM technology, nor that all RM technologies will be disruptive in exactly the same way.5 The ESRC-funded Biomodifying Technologies project6 analysed three case studies of biotechnologies with disruptive potential: gene-editing which allows faster, more accurate genetic modification, induced pluripotent stem cell (iPSC) technology that allows an ordinary skin or blood cell to be turned into a stem cell capable of producing any tissue type in the human body, and 3D bioprinting which can produce three-dimensional structures made from living tissues.

Gene editing and iPSC are advances on earlier generations of genetic engineering and stem cell technologies. They align reasonably well with the existing skill sets, goals, equipment, and techniques of researchers working in both academic and commercial settings. They are not especially disruptive at the level of basic research. Bioprinting requires skills, tools and techniques from engineering, materials chemistry, computer-aided design, biology, and medicine. This has necessitated greater disruption in the form of organisational change, to create new research groups and foster collaborative learning across disciplines.

For all three technologies, there are also well-established pathways to extract near-term value from basic research: peer-reviewed publications, patent applications, and the market for reagents, tools, and equipment. Each case demonstrates clear growth in the number of papers, patents, and reagent/equipment sales, although the rate of acceleration is greatest for CRISPR-based gene editing and slowest for bioprinting.

The pathways to realise longer-term, clinical, and economic value are less well established for RM. The healthcare sector is seen as particularly resistant to disruptive innovations, due to the lengthy regulatory process and powerful incumbent firms, which have historically been wary of investing in RM.7 The process of scaling laboratory protocols for cell or gene-based therapies into industrial procedures, taking products through clinical trials to establish safety and efficacy, and securing reimbursement, is every bit as experimental and involves as much learning by trial and error as exploratory laboratory research, but with much higher financial stakes. Interest from incumbents appears to be growing, as recent years have seen an increase in the number of cell or gene-based therapies reaching the market. However, there is no off the shelf manufacturing solution, as different RM products have different attributes: in the industry there is a popular idiom the product is the process. This means that the acceleration seen at the basic R&D stage does not unproblematically translate into speedy translation further down the pathway.

Rather, initial clinical applications of gene editing, iPSC and bioprinting are targeted at a more limited range of niche applications. The niches for each technology are shaped by a number of critical factors. Smaller tissues, such as the eye require fewer replacement cells or lower titres of gene editing vector, which are more manageable with current manufacturing capacity. The challenges of manufacturing at scale, combined with high anticipated costs, combine to make narrowly defined subsets of disease categories, with high unmet need, a preferred route for commercial development, especially where there is potential for a disruptive new product to demonstrate significant Quality of Life gains over the current standard of care.

Indications that draw on procedures, standards and requirements established for previous therapies are seen as less risky and thus promising clinical targets. Gene editing to treat thalassemia and other blood disorders builds on decades of clinical expertise with the bodys haematopoietic (blood-forming) system, gained by treating leukaemia patients. Even treatments that were not ultimately successful such as foetal stem cell transplants for Parkinsons disease (PD) can provide expertise with clinical trials and regulation to support a next-generation iPSC-based cell therapy for PD.

While the government has rightly been wary of picking winners, as particular niches for early clinical adoption of biomodifying technologies become apparent they may require specific, targeted support, to complement the broader support for the field already provided by polices described above. Innovations in related fields such as biomaterials and automation, potentially supported by the High Value Manufacturing Catapult, are likely to improve manufacturing capacity and speed over time. These innovations may be relatively incremental in the manufacturing phase but could have disruptive effects further down the value chain at the clinical delivery phase, as greater supply makes biomodifying RM therapies accessible to less tightly defined patient cohorts. The next policy challenge will be to provide targeted support for clinical delivery whilst avoiding lock-in to infrastructure or procedures that would inhibit the evolution of the field over time.

The research underpinning this piece was supported by the Economic and Social Research Council grant number ES/P002943/1 and the Leverhulme Trust grant number RPG-2017-330

References

1 Department for Business, Industry and Industrial strategy (2017) Industrial Strategy: building a Britain fit for the future. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/730048/industrial-strategy-white-paper-web-ready-a4-version.pdf

2 Department for Business, Industry and Industrial strategy (2018) Bioeconomy strategy: 2018 to 2030. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761856/181205_BEIS_Growing_the_Bioeconomy__Web_SP_.pdf

3 Open Access Government (2019) The promises and challenges of biomodifying technologies for the UK https://www.openaccessgovernment.org/biomodifying-technologies/68041/

4 Accelerated Access Review (AAR). (2016). Final Report: Review of Innovative Medicines and Medical Technologies. London: The Crown.

5 Joyce Tait & David Wield (2019) Policy support for disruptive innovation in the life sciences, Technology Analysis & Strategic Management, DOI: 10.1080/09537325.2019.1631449

6 Open Access Government (2019) The promises and challenges of biomodifying technologies for the UK https://www.openaccessgovernment.org/biomodifying-technologies/68041/

7 Joyce Tait & David Wield (2019) Policy support for disruptive innovation in the life sciences, Technology Analysis & Strategic Management, DOI: 10.1080/09537325.2019.1631449

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Targeted policy support for emerging biomedical innovations - Open Access Government

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The Hematopoietic Stem Cells Transplantation (HSCT) Market research report enhanced worldwide Coronavirus COVID19 impact analysis on the market size (Value, Production and Consumption), splits the breakdown (Data Status 2014-2020 and 6 Year Forecast From 2020 to 2026), by region, manufacturers, type and End User/application. This Hematopoietic Stem Cells Transplantation (HSCT) market report covers the worldwide top manufacturers like (Kite Pharma, Thermo Fisher Scientific, CellGenix Technologie Transfer, Cesca Therapeutics, R&D Systems) which including information such as: Capacity, Production, Price, Sales, Revenue, Shipment, Gross, Gross Profit, Import, Export, Interview Record, Business Distribution etc., these data help the consumer know about the Hematopoietic Stem Cells Transplantation (HSCT) market competitors better. It covers Regional Segment Analysis, Type, Application, Major Manufactures, Hematopoietic Stem Cells Transplantation (HSCT) Industry Chain Analysis, Competitive Insights and Macroeconomic Analysis.

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Hematopoietic Stem Cells Transplantation (HSCT) Market report offers comprehensive assessment of 1) Executive Summary, 2) Market Overview, 3) Key Market Trends, 4) Key Success Factors, 5) Hematopoietic Stem Cells Transplantation (HSCT) Market Demand/Consumption (Value or Size in US$ Mn) Analysis, 6) Hematopoietic Stem Cells Transplantation (HSCT) Market Background, 7) Hematopoietic Stem Cells Transplantation (HSCT) industry Analysis & Forecast 20202026 by Type, Application and Region, 8) Hematopoietic Stem Cells Transplantation (HSCT) Market Structure Analysis, 9) Competition Landscape, 10) Company Share and Company Profiles, 11) Assumptions and Acronyms and, 12) Research Methodology etc.

Scope of Hematopoietic Stem Cells Transplantation (HSCT) Market:Hematopoietic stem cell transplants (HSCT) present to a valid treatment for several congenital and other hematopoietic system disorders, post chemotherapy, and immune sensitive diseases. HSCT is also preferred for replacement of cellular components and deficient cells. The indications for HSCT thus are wide; the most frequent indication as per reported by Worldwide Network for Blood and Marrow Transplantation Group (WNBT) (2013) is lymphoproliferative disorder (53.2% of all HSCT), 12% of whom received allogeneic and the rest received autologous transplant. Plasma cell disorders are the most frequent indication in this group. A multitude of literature published by researchers and organizations demonstrate that autologous transplant own a greater edge against allogeneic HSCT.

Over 30 years of studies in the field of blood-forming stem cells i.e. hematopoietic stem cells (HSC), researchers have developed significant understanding to use HSCs as a therapy. At present, no type of stem cell, adult, embryonic or fetal has attained such sufficient status. Hematopoietic stem cell transplantation (HSCT) is now routinely used for treating patients with malignant and non-malignant disorders of blood and the immune system. Currently, researchers have observed that through animal studies HSCs have the ability to form other cells such as blood vessels, muscles, and bone. Further application of this approach it may eventually be able to treat a wide array of conditions and replace ailing tissues. However, despite the vast experience with HSCs, researchers face major barriers in expanding their use beyond the replacement of immune and blood cells.

Hematopoietic stem cells are unable to proliferate and differentiate in-vitro. Researchers have yet to evolve an accurate method to differentiate stem cells from other cells derived from blood or bone marrow. Once such technical barriers are overcome, the avenues for realizing the full potential of HSCT. The type of transplant a person receives depends on several different factors, including the type and course of the disease, availability of suitable donors, and the patients overall health. There are three different sources of hematopoietic stem cells such as bone marrow, peripheral blood stem cells, and umbilical cord blood. The stem cell source used for a given transplant depends upon the underlying disease, the type of transplant (allogeneic or autologous), and size of the patient.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate foreach application.

Leukemia Lymphoproliferative Disorders Solid Tumors Non-Malignant Disorders Others

On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.

Autologous Transplant Allogenic Transplant

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Geographically, the report includes the research on production, consumption, revenue, Hematopoietic Stem Cells Transplantation (HSCT) market share and growth rate, and forecast (2020-2026) of the following regions:

Important Hematopoietic Stem Cells Transplantation (HSCT) Market Data Available In This Report:

Strategic Recommendations, Forecast Growth Areasof the Hematopoietic Stem Cells Transplantation (HSCT) Market.

Challengesfor the New Entrants,TrendsMarketDrivers.

Emerging Opportunities,Competitive Landscape,Revenue Shareof Main Manufacturers.

This Report Discusses the Hematopoietic Stem Cells Transplantation (HSCT) MarketSummary; MarketScopeGives A BriefOutlineof theHematopoietic Stem Cells Transplantation (HSCT) Market.

Key Performing Regions (APAC, EMEA, Americas) Along With Their Major Countries Are Detailed In This Report.

Company Profiles, Product Analysis,Marketing Strategies, Emerging Market Segments and Comprehensive Analysis of Hematopoietic Stem Cells Transplantation (HSCT) Market.

Hematopoietic Stem Cells Transplantation (HSCT) Market ShareYear-Over-Year Growthof Key Players in Promising Regions.

What is the (North America, South America, Europe, Africa, Middle East, Asia, China, Japan)production, production value, consumption, consumption value, import and exportof Hematopoietic Stem Cells Transplantation (HSCT) market?

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Hematopoietic Stem Cells Transplantation (HSCT) Market Trends and Forecast Analysis by Business Manufactures and Product Type-Kite Pharma, Thermo...

Bone Marrow Stem Cells Comments Off on Hematopoietic Stem Cells Transplantation (HSCT) Market Trends and Forecast Analysis by Business Manufactures and Product Type-Kite Pharma, Thermo… | June 15th, 2020

Prophecy Market Insights has recently published a Cell Therapy Manufacturing report which represents the latest industry data and future trends, allowing users to recognize the products and driving revenue growth and profitability of the market.

The report offers a broad analysis of key segments, key drivers, regions, and leading market players. The report contains an analysis of different geographical areas and presents a competitive scenario to promote leading market players, new entrants, and investors determine emerging economies. The key highlights offered in the report would benefit market players to formulate strategies for the future and gain a strong position in the Cell Therapy Manufacturing market.

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The Cell Therapy Manufacturing report begins with a brief introduction which contains a market overview of the industry followed by its market size and research scope. Further, the report provides an overview of market segmentation, for example- type, application, and region. The drivers, restraints, and opportunities for the market are also mentioned, along with current policies and trends in the industry. The Cell Therapy Manufacturing market also covers PEST analysis for the market. Thisanalysisprovides information based on four external factors (political, economic, social and technological) in relation to your business situation. Basically, it helps to understand how these factorswillaffect the performance and activities of your business in the long-term. The report describes the growth rate of each segment in-depth with the help of charts and tables. Moreover, various regions related to the growth of the Cell Therapy Manufacturing market are analyzed in the report. These regions include North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America.

Segmentation Overview:

Cell Therapy Manufacturing market report states the overview, historical data along with size, share, growth, demand, and revenue of the global industry. In this research report, there is an accurate analysis of the current and upcoming opportunities in the market by explaining the fastest and largest growing segments across regions. The survey report includes vast investigation of the geographical scene of the Cell Therapy Manufacturing market, which is manifestly arranged into the localities

Australia, New Zealand, Rest of Asia-Pacific

The study presents the performance of each player active in the Cell Therapy Manufacturing market. It also provides a summary and highlights the current advancements of each player in the market along with its SWOT analysis. The information provided in the research report is a great source for study investors and stakeholders interested in the market. In addition, the report offers insights on buyers, suppliers, and merchants in the market. There is a comprehensive analysis of consumption, market share, and growth rate of each application is offered for the historic period.

Cell Therapy ManufacturingMarket Key Players:

harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

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Cell Therapy Manufacturing Market: Regional Analysis and Strategies in Forecasted Period 2020-2030 - 3rd Watch News

Bone Marrow Stem Cells Comments Off on Cell Therapy Manufacturing Market: Regional Analysis and Strategies in Forecasted Period 2020-2030 – 3rd Watch News | June 15th, 2020

A recent market intelligence study titled Global Autologous Stem Cell Based Therapies Market 2020 by Company, Type and Application, Forecast to 2025 integrated from various professional and trusted sources include a detailed examination of this vertical that is anticipated to accrue substantial proceeds during the predicted timeline from 2020 to 2025. The report provides valuable insights concerning the market size, share, and growth rate of the global Autologous Stem Cell Based Therapies market. The report delivers creditable perceptions with respect to industry size, revenue approximations, sales volume, and more. The research gives knowledge about market players, segments, revenue, profit, restrain, share, size, etc.

The report experts have analyzed various companies to understand the products and/services relevant to the global Autologous Stem Cell Based Therapies market. The report includes information such as gross revenue, production and consumption, average product price, and market shares of key players. The fundamental opinions regarding the market landscape, emerging and high-growth sections of the market, high-growth regions, and market drivers, restraints, and also market chances have collectively included in the report. Many of the circumstances have been taken into consideration to get the best at high-quality data and particular knowledge of the market in upcoming years (forecast) from 2020 to 2025.

DOWNLOAD FREE SAMPLE REPORT: https://www.marketsandresearch.biz/sample-request/67562

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

The report offers a comprehensive understanding of market dynamics across key regions, namely North America (United States, Canada and Mexico), Europe (Germany, France, United Kingdom, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), Middle East & Africa (Saudi Arabia, UAE, Egypt and South Africa).

Product-wise the global market is segmented by spread (regional footprint), and consumption. And, the products include: Embryonic Stem Cell, Resident Cardiac Stem Cells, Umbilical Cord Blood Stem Cells

Basis, separate end-use segments, the market study delves into demand trends for each. The major end-use segments that the market study includes are: Neurodegenerative Disorders, Autoimmune Diseases, Cardiovascular Diseases

Market segment by manufacturers, this report covers: Regeneus, US STEM CELL, INC., Mesoblast, Med cell Europe, Pluristem Therapeutics Inc, Tigenix, Brainstorm Cell Therapeutics

The noted growth rate and proceeds acquired by each region throughout the forecast timeline are also discussed in the report. The study on global Autologous Stem Cell Based Therapies market foresees over the predicted timeline and constitutes additional particulars concerning the market dynamics like the factors influencing industry landscape, challenges, and probable growth opportunities existing in this vertical are presented in the report.

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Global Autologous Stem Cell Based Therapies Market 2020 Growth, Industry Trends, Sales Revenue, Size by Regional Forecast to 2025 - 3rd Watch News

Cardiac Stem Cells Comments Off on Global Autologous Stem Cell Based Therapies Market 2020 Growth, Industry Trends, Sales Revenue, Size by Regional Forecast to 2025 – 3rd Watch News | June 15th, 2020

VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--Jun 15, 2020--

AVITA Medical Limited ACN 058 466 523 ( Company ) is pleased to announce that shareholders today voted in favour of the scheme of arrangement to effect a redomiciliation of the Company and its subsidiaries ( Avita Group ) from Australia to the United States of America ( Scheme ), under which AVITA Therapeutics, Inc. ( Avita US ), a company incorporated in the State of Delaware in the United States of America, will become the parent company of the Avita Group.

Voting results of Scheme Meeting

In accordance with ASX Listing Rule 3.13.2 and section 251AA(2) of the Corporations Act 2001 (Cth), the Company advises that the resolution to approve the Scheme (set out in the Notice of Scheme Meeting contained in Appendix F of the Scheme Booklet) was passed on a poll by the requisite majorities of shareholders.

The voting results of the Scheme Meeting are attached to this announcement.

The Scheme will not be effective unless and until:

The Second Court Hearing is scheduled to be held at 9.30am (AEST) on Monday, 22 June 2020. If the Court approves the Scheme, the Company expects to lodge the Court orders with ASIC on Tuesday, 23 June 2020.

The expected timetable for implementation of the Scheme is set out below:

Event

Indicative Date

Second Court Hearing

22 June 2020

Effective Date for the Scheme

Last day of trading of the Companys shares on the ASX

23 June 2020

Listing of Avita US on the ASX

Trading of Avita US Chess Depositary Interests ( CDIs ) commences on the ASX on a deferred settlement basis

24 June 2020

Record Date (for determining the entitlements of shareholders of the Company to Avita US shares or Avita US CDIs)

7.00pm (AEST) on 25 June 2020

Last day of trading of the Companys American Depositary Shares ( ADSs ) on NASDAQ

Last day of trading of Avita US CDIs on the ASX on a deferred settlement basis

29 June 2020

Implementation Date

The shares of the Company are transferred to Avita US and Avita US shares or Avita US CDIs are issued to eligible shareholders of the Company

29 June 2020

Listing of Avita US on NASDAQ

Trading of Avita US shares commences on NASDAQ

Promptly following the Implementation Date

Trading of Avita US CDIs commences on the ASX on a normal basis

30 June 2020

The above dates are indicative only and are subject to change. The Scheme remains subject to satisfaction or, where applicable, waiver of the conditions precedent to the Scheme (as set out in the Scheme Implementation Agreement).

Any changes to the above dates will be announced to the ASX and NASDAQ and via news release, and will also be notified on the Companys website ( http://www.avitamedical.com ).

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 RES REGENERATIVE EPIDERMAL SUSPENSION, 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.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This announcement 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 announcement 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 announcement 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 announcement. 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 announcement speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.

The following information is provided in accordance with section 251AA of the Corporations Act 2001 (Cth).

Resolution details

Instructions given to validly appointed proxies (as at proxy close)

Number of votes cast on the poll

Resolutionresult

Resolution

For

Against

Proxysdiscretion

Abstain

For

Against

Abstain*

Carried / notcarried

That pursuant to and in accordance with section 411 of the Corporations Act 2001 (Cth), the scheme of arrangement proposed between the Company and the holders of its ordinary shares, the terms of which are described in the Scheme Booklet, of which the notice convening this meeting forms part, is approved, and the Board is authorised to agree to such alterations or conditions as are thought fit by the Court and, subject to approval of the Scheme by the Court, to implement the Scheme with any such alterations or conditions.

916,721,976

97.19%

20,950,290

2.22%

5,588,418

0.59%

3,786,450

N/A

926,498,581

97.75%

21,357,290

2.25%

3,876,450

N/A

Carried

Number of shareholders voting on the poll

For

Against

Abstain*

1,345

89.73%

154

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AVITA Medical Limited Proposed Redomiciliation to the United States of America - Results of Scheme Meeting - Manchestertimes

Skin Stem Cells Comments Off on AVITA Medical Limited Proposed Redomiciliation to the United States of America – Results of Scheme Meeting – Manchestertimes | June 15th, 2020

In short: sometimes. As much as wed like to give you a straight answer, hair loss and regrowth (on any part of the body) is a tricky thing thats influenced by many factors. However, heres what we know about eyebrow hair.

First up, if you want to see what your full regrowth is, it takes time: Generally, 4-6 weeks is when you'll experience what most brow specialists refer to as a full regrowth, however, there are people who tend to see growth up to 8-10 weeks. Then there are those who see very nominal growth beyond. I've had certain clients who we've been patient with letting their brows grow in and over the course of a year they saw little bits come in very slowly that were small, brow expert Joey Healy tells us. The majority of your regrowth will be seen in 4-6 weeks, sometimes 8."

So if youve given your strands a good several weeks to do their thing, and you are still seeing gaps, thinner areas, or the like, are they gone forever? Unfortunately, maybe. Repeatedly pulling out hairvia wax or tweezersis hard on the follicle. Do this too much, and the follicle becomes damaged and dies. Once that happens, the hair will never be able to grow back.

"Brows can thin over time as we age, but oftentimes brows thin even more as a result of over-plucking or over-tweezing," board-certified dermatologist Whitney Bowe, M.D. has previously told mbg. "Plucking, tweezing, threading, and waxing all pull the hair from the root, and there's only so much trauma each root can take. Repeating these insults to our hair root over time increase the likelihood that some hairs will never regrow, as too much damage has been done to the base of the root where the stem cells live."

So this means if you've been shaping your brows months, years, or decadesthere might not be much you can really do to turn back the clock.

Most people are surprised to learn that their brows have real limitations of regrowth, especially if you've been shaping your brows for a long period of time, saysHealy. You might be surprised how wimpy the new growth is even after waiting 8-10 weeks so yes, there is value to seeing what their maximum capacity is, but letting them regrow does not mean they are going to be back to the natural brows of your youth or they are not going to return to the natural brows you had before you starting shaping them.

Another issue is scar tissue, notes Healy: Know that hair will not grow on a burn or a scar either. For example, if you had a brow piercing or trauma to the skin that created a scar, no amount of time is going to cover that because the hair follicle is compromised when the brow is scarred.

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Do Brows Grow Back? It Depends But Here's What You Can Do To Help - mindbodygreen.com

Skin Stem Cells Comments Off on Do Brows Grow Back? It Depends But Here’s What You Can Do To Help – mindbodygreen.com | June 15th, 2020

THE HAGUE, Netherlands, June 12, 2020 /PRNewswire/ -- Treatment of childhood cancer is a success story, particularly for acute lymphoblastic leukemia (ALL). More than 90% of ALL patients below 18 years of age are rescued with contemporary chemotherapy. However, the remaining 10% have resistant or reoccurring leukemia and require alternative treatment regimens. One of the most powerful leukemia therapies is hematopoietic stem cell transplantation from a donor (allogeneic HSCT). Approximately 50-80% of pediatric ALL patients that receive allogeneic HSCT are cured, 20% experience leukemic reoccurrence (relapse), and 10% die from complications.

Allogeneic HSCT is a multistep procedure:

Identify a suitable donor, i.e., a compatible sibling or unrelated person.

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Therefore, a large consortium of pediatric transplant experts initiated a global study to investigate whether chemotherapy-based conditioning could substitute TBI. The study is called FORUM (For Omitting Radiation Under Majority Age) and had to be stopped because chemotherapy-based conditioning had significantly poorer outcomes (i.e., lower overall survival rates) than the combination of TBI and chemotherapy. The researchers will now perform prospective monitoring to better define the advantages and limitations of various conditioning approaches.

Presenter: Dr Christina PetersAffiliation: Stem Cell Transplantation Unit, St. Anna Children's Hospital, Vienna, AustriaAbstract: #S102 TBI OR CHEMOTHERAPY BASED CONDITIONING FOR CHILDREN AND ADOLESCENTS WITH ALL: A PROSPECTIVE RANDOMIZED MULTICENTER-STUDY "FORUM" ON BEHALF OF THE AIEOP-BFM-ALL-SG, IBFM-SG, INTREALL-SG AND EBMT-PD-WP

Excerpt from:
Combined irradiation and chemotherapy better prepares children for stem cell transplantation than chemotherapy alone - DOTmed HealthCare Business News

Bone Marrow Stem Cells Comments Off on Combined irradiation and chemotherapy better prepares children for stem cell transplantation than chemotherapy alone – DOTmed HealthCare Business News | June 14th, 2020

The global stem cell banking market was valued at $1,986 million in 2016, and is estimated to reach $6,956 million by 2023, registering a CAGR of 19.5% from 2017 to 2023. Stem cell banking is a process where the stem cell care isolated from different sources such as umbilical cord and bone marrow that is stored and preserved for future use. These cells can be cryo-frozen and stored for decades. Private and public banks are different types of banks available to store stem cells.

Top Companies Covered in this Report: Cord Blood Registry, ViaCord, Cryo-Cell, China Cord Blood Corporation, Cryo-Save, New York Cord Blood Program, CordVida, Americord, CryoHoldco, Vita34

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Increase in R&D activities in regards with applications of stem cells and increase in prevalence of fatal chronic diseases majorly drive the growth of the global stem cell banking market. Moreover, the large number of births occurring globally and growth in GDP & disposable income help increase the number of stem cell units stored, which would help fuel the market growth. However, legal and ethical issues related to stem cell collections and high processing & storage cost are projected to hamper the market growth. The initiative taken by organizations and companies to spread awareness in regards with the benefits of stem cells and untapped market in the developing regions help to open new avenues for the growth of stem cell banking market in the near future.

The global stem cell banking market is segmented based on cell type, bank type, service type, utilization, and region. Based on cell type, the market is classified into umbilical cord stem cells, adult stem cells, and embryonic stem cells. Depending on bank type, it is bifurcated into public and private. By service type, it is categorized into collection & transportation, processing, analysis, and storage. By utilization, it is classified into used and unused. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Table Of Content

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET OVERVIEW

CHAPTER 4: STEM CELL BANKING MARKET, BY CELL TYPE

CHAPTER 5: STEM CELL BANKING MARKET, BY BANK TYPE

CHAPTER 6: STEM CELL BANKING MARKET, BY SERVICE TYPE

CHAPTER 7: STEM CELL BANKING MARKET, BY UTILIZATION

CHAPTER 8: STEM CELL BANKING MARKET, BY REGION

CHAPTER 9: COMPANY PROFILES

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Stem Cell Banking Market will Generate Massive Revenue to $6,956 million by 2023 | Cord Blood Registry, ViaCord, Cryo-Cell, China Cord Blood...

Bone Marrow Stem Cells Comments Off on Stem Cell Banking Market will Generate Massive Revenue to $6,956 million by 2023 | Cord Blood Registry, ViaCord, Cryo-Cell, China Cord Blood… | June 14th, 2020

The ALS Association and I AM ALS have awarded BrainStorm Cell Therapeutics $500,000 to support an amyotrophic lateral sclerosis (ALS) biomarker study based on the biotechnology companys pivotal trial into its NurOwn therapy.

Specifically, the combined grant $400,000 is from the ALS Association will be used to gain insights from data as well as tissue and blood samples collected from patients enrolled in the Phase 3 clinical trial (NCT03280056) that is measuring NurOwns safety and effectiveness.

As part of the award, BrainStorm agreed to share data and samples with the ALS community to potentially advance other ALS research, and to have trial results independently validated.

By assessing how NurOwn interacts with brain and spinal cord targets, the hope is the study produces a deeper understanding of crucial biomarkers associated with treatment response. A biomarker is any measurable body substance that changes over time, and that correlates with treatment response.

If it works the way its intended, the study is expected to help inform scientists broader understanding of ALS biomarkers.

This grant to BrainStorm marks an important step forward in establishing how exactly NurOwn works in the body, Calaneet Balas, ALS Association president and CEO, said in a press release. This research is also important to our overall pursuit of identification and validation of ALS biomarkers. We hope NurOwn is ultimately proven effective in treating ALS, and we stand ready to support BrainStorm in its plan to apply for a biologics license for NurOwn.

NurOwn is a cell-based therapy that usesmesenchymal stem cells (MSCs), which are extracted from a patients own bone marrow. These cells have the ability to generate different cell types. After extraction, MSCs are expanded in the lab and matured into cells that produce high levels ofneurotrophic factors, which are compounds that promote nervous tissue growth and survival. The converted cells are then reintroduced into the body via an injection into muscles or the spinal canal.

A Phase 2 trial (NCT02017912) found NurOwn to be safe and to significantly slow disease progression in a subset of ALS patients with fast-advancing disease. The Phase 3 trial is evaluating the safety and effectiveness of three administrations every two months of NurOwn into the spinal canal, when compared with a placebo.

The Phase 3 trials chief goal is to confirm the effectiveness of NurOwn as measured by the amyotrophic lateral sclerosis functional rating scale (ALSFRS-R), a score of abilities such as swallowing, speech, handwriting, or walking.

Despite the COVID-19 pandemic, patient dosing in the trial is expected to be complete by next month. The study is fully enrolled with 200 participants across six U.S. sites. All patients have been given at least two of three doses. A summary of important findings will be announced later this year.

This critical research study involves one of the largest and most robust clinical trial collectors of [cerebrospinal fluid] biomarkers, said Chaim Lebovits, BrainStorm CEO. Data generated from this study will increase our understanding of how NurOwn therapy impacts ALS disease progression, and may identify patients who benefit the most from this form of therapy. We also hope that this research study will benefit the broader ALS community as we collectively advance toward our shared goal of delivering much-needed treatments, he said.

Danielle Carnival, CEO of I AM ALS, said the ALS community is at a pivotal time in terms of treatment research.

We need to move with urgency in all of our efforts to deliver treatments and cures for ALS, she said. This biomarker research will help us more expeditiously understand the effectiveness of NurOwn, while possibly unlocking discoveries that provide clues for other promising treatments.

Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours dElegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled Belle of the Concours.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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BrainStorm Receives $500K to Support ALS Study of NurOwn Therapy - ALS News Today

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You can count the R&D execs at AbbVie among the believers in Genmabs bispecific platform tech.

Moving beyond the Allergan buyout, AbbVie refocused on its cancer drug pipeline, shelling out $750 million in cash and promising up to $3.15 billion more in milestones 60% for development and regulatory goals to ally itself on a slate of 7 development and discovery programs.

At the front of the queue is the early-stage drug epcoritamab, a CD3xCD20 bispecific from its DuoBody collection. Theres also DuoHexaBody-CD37 and DuoBody-CD3x5T4. And then AbbVie gets to pick and choose from among the discovery work at Genmab for 4 more, with AbbVie adding in its own contributions in the pairing up to come.

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Sure, Bit Bio got some significant cash for its cell coding work. But it's the insiders who are backing them that will garner the attention -...

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DetailsCategory: VaccinesPublished on Saturday, 13 June 2020 12:40Hits: 488

ACE-CL-001 trial showed an overall response rate of 97% with a sustained safety profile for previously untreated patients after more than four years

In pivotal ASCEND trial, 82% of patients with relapsed or refractory disease treated with Calquence remained progression free at 18 months vs. 48% for comparators

LONDON, UK I June 12, 2020 I Detailed results from both the Phase II ACE-CL-001 trial and the pivotal Phase III ASCEND trial showed the long-term efficacy and tolerability of Calquence (acalabrutinib) in chronic lymphocytic leukaemia (CLL), one of the most common types of adult leukaemia.1,2,3

The results will be presented during the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress, 11 to 14 June 2020.

In the single-arm ACE-CL-001 trial, 86% of CLL patients treated with Calquence as a 1st-line monotherapy remained on treatment at a median follow up of more than four years. The trial showed an overall response rate of 97% (7% complete response; 90% partial response) and a 100% overall response rate in subgroups of patients with high-risk disease characteristics, including genomic aberrations (17p deletion and TP53 mutation), immunoglobulin mutation status (unmutated IGHV), and complex karyotype. Safety findings showed no new long-term issues.1,4

In the final analysis of ASCEND, an estimated 82% of patients with relapsed or refractory CLL treated with Calquence remained alive and free from disease progression at 18 months compared with 48% of patients on rituximab combined with idelalisib or bendamustine.2 The trial previously met the primary endpoint of Independent Review Committee-assessed progression-free survival at the interim analysis.5

Richard R. Furman, Director of the CLL Research Center, Weill Cornell Medicine said: These data demonstrate no new safety concerns for acalabrutinib, confirming its ability to safely provide meaningful, long-term clinical benefit for patients with treatment-naive and relapsed or refractory disease. The safety profile of acalabrutinib makes treatment to progression an important and plausible option for patients.

Jos Baselga, Executive Vice President, Oncology R&D said: These long-term data reaffirm that Calquence delivers a durable response with a favourable safety profile for chronic lymphocytic leukaemia patients. Patients with chronic lymphocytic leukaemia are typically 70 years or older with comorbidities and often require treatment over a long time, making the sustained safety and efficacy profile highly relevant to their quality of life.

Results from the Phase II ACE-CL-001 trial informed the development of the pivotal Phase III ELEVATE TN trial, which, along with findings from the Phase III ASCEND trial, formed the basis for the US approval of Calquence for the treatment of patients with CLL or small lymphocytic lymphoma (SLL).

Calquence in previously untreated CLL: 4.4-year follow-up from Phase II trial (abstract #S163)

The Phase II ACE-CL-001 trial investigated safety and efficacy of Calquence (100mg twice-daily [n=62] or 200mg once-daily [n=37]) in previously untreated patients with CLL.1 On 1 May 2015, patients receiving the 200mg dosing regimen were switched to the 100mg regimen.1

Key data from the Calquence Phase II ACE-CL-001 trial1

CI, confidence interval; CR, complete response; DoR, duration of response; EFS, event free survival; TTR, time to response; NR, not reached; ORR, overall response rate; PR, partial response

Response rates were 100% in each subgroup of patients with high-risk disease characteristics (unmutated IGHV [n=57], 17p deletion [n=9], TP53 mutation [n=9], and complex karyotype [n=12]), and reduction in lymph node disease was noted in all patients tested (n=97).1

At the time of data cut-off, 85 (86%) patients receiving Calquence remained on treatment. Six patients discontinued treatment due to adverse events (AEs) and three patients discontinued for progressive disease (PD). No patient discontinued Calquence due to bleeding events, hypertension, or atrial fibrillation. Incidence of AEs generally diminished with time on the trial. The most common AEs (40%) of any grade in the trial were diarrhoea (52%), headache (45%), upper respiratory tract infection (44%), arthralgia (42%), and contusion (42%). All-grade and Grade 3 events of clinical interest included infection (84% and 15%, respectively), bleeding events (66%, 3%), hypertension (22%, 11%), leukopenia (9%, 9%), and thrombocytopenia (3%, 1%). Atrial fibrillation (all grades) occurred in 5% of patients with Grade 3 occurring in 2%. Second primary malignancies (SPM) excluding non-melanoma skin (all grades) occurred in 11% of patients.1 Serious adverse events (SAEs) were reported in 38% of patients. SAEs occurring in more than two patients included pneumonia (n=4) and sepsis (n=3).1

Final results of Calquence Phase III ASCEND trial in relapsed or refractory CLL (abstract #S159)

ASCEND was a global, randomised, multicentre, open-label, Phase III trial that investigated the efficacy and safety of Calquence (100mg twice-daily) versus investigators choice of rituximab combined with idelalisib (IdR) or bendamustine (BR) in patients with relapsed or refractory CLL.2

Key data from the final analysis of the Calquence Phase III ASCEND trial2

BR, rituximab in combination with bendamustine; CI, confidence interval, DoR, duration of response; HR, hazard ratio; IdR, rituximab in combination with idelalisib; INV, investigator; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival

Sixteen per cent of patients on Calquence, 56% of patients on IdR, and 17% of patients on BR discontinued treatment because of AEs. Common AEs occurring in greater than 15% of patients of any grade in the Calquence arm of the trial included headache (22%), neutropenia (21%), diarrhoea (20%), upper respiratory tract infection (20%), cough (16%), and anaemia (16%). Events of clinical interest for Calquence versus controls included atrial fibrillation (all grade, 6% and 3%, respectively), major haemorrhage (all grade, 3% in both arms), infections (Grade 3, 20% and 25%, respectively), and SPM excluding non-melanoma skin cancer (all grade, 5% and 2%, respectively). SAEs (any grade) occurred in 33% of patients receiving Calquence, 56% of IdR patients, and 26% of BR patients.2

Chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is one of the most common types of leukaemia in adults, with an estimated 105,000 new cases globally in 2016 and 21,040 new cases in the US in 2020, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.3,6,7,8 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.3 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets.3 This could result in anaemia, infection, and bleeding.3 B-cell receptor signalling through Brutons tyrosine kinase is one of the essential growth pathways for CLL.

Calquence

Calquence(acalabrutinib) is a next-generation, selective inhibitor of Brutons tyrosine kinase (BTK).Calquencebinds covalently to BTK, thereby inhibiting its activity.4,9 In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.4

Calquenceis approved for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in nine countries and for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in 14 countries. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluatingCalquencein 23 company-sponsored clinical trials.Calquenceis being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrm macroglobulinaemia, follicular lymphoma, and other haematologic malignancies.

AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca's main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.

Media

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

References

1. Byrd JC, et al. Acalabrutinib in Treatment-Nave Chronic Lymphocytic Leukemia: Mature Results From Phase 2 Study Demonstrating Durable Remissions and Long-Term Tolerability. Abstract S163 presented at the Virtual Edition of the 15th European Hematology Association (EHA) Annual Meeting. Available online. Accessed June 2020.

2. Ghia P, et al. Acalabrutinib (Acala) vs Idelalisib plus Rituximab (IdR) or Bendamustine plus Rituximab (BR) in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): ASCEND Final Results. Abstract S159 presented at the Virtual Edition of the 15th European Hematology Association (EHA) Annual Meeting. Available online. Accessed June 2020.

3. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available online. Accessed June 2020.

4.Calquence(acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.

5. Ghia P, et al. ASCEND Phase 3 Study of Acalabrutinib vs Investigators Choice of Rituximab Plus Idelalisib (IdR) or Bendamustine (BR) in Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL). Abstract LB2606 at the 2019 European Hematology Association (EHA) Annual Meeting. Available online. Accessed June 2020.

6. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.

7. American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Available online. Accessed June 2020.

8. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.

9. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor.J Hematol Oncol. 2016;9(21).

SOURCE: AstraZeneca

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This was reprinted with permission from Joe Boggs, OSU

Poison hemlock (Conium maculatum) and wild parsnip (Pastinaca sativa) are two of our nastiest non-native weeds found in Ohio. Poison hemlock is one of the deadliest plants in North America. Wild parsnip can produce severe, painful blistering. Both are commonly found growing together.

Poison hemlock and wild parsnip are members of the carrot family, Apiaceae. The old name for the family was Umbelliferae which refers to the umbel flowers. They are a key family feature with short flower stalks rising from a common point like the ribs on an umbrella.

Poison hemlock produces white flowers on stalks that create a more rounded look; perhaps a bit more like an umbrella. Wild parsnip has intense yellow flowers with the stalks producing a more flat-topped appearance.

Both are biennial weeds meaning that it takes two years for plants to produce seed. The seeds currently being produced will give rise to plants that spend their first year as low-growing basal rosettes. The plants produce a long, thick taproot while in this stage.

During their second year, plants "bolt" by producing erect, towering stalks and multi-branched stems topped with umbel flowers. Mature wild parsnip plants may top 6' tall while poison hemlock plants can tower to as much as 8 - 10' tall. Both are prolific seed producers

Wild parsnip plants have leaves that look vaguely like celery, another member of the carrot family. Mature plants have a single, thick, deeply grooved, greenish-yellow stem that sprouts lateral branches topped with flowers.

All stages of poison hemlock plants have bluish-green leaves that are 3-4 times pinnately compound. The deeply cut parsley-like leaflets have sharp points. Flowering plants have hairless, light-green to bluish-green stems that are covered with obvious reddish-purple blotches. However, the blotches may occasionally coalesce to cause stems to appear an almost solid color.

What are the Risks?

Poison hemlock plants contain highly toxic piperidine alkaloid compounds which cause respiratory failure and death in mammals. The roots are more toxic than the leaves and stems; however, all parts of the plant including the seeds should be considered dangerous.

The toxins must be ingested or enter through the eyes or nasal passages to induce poisoning; they do not cause skin rashes or blistering. Regardless, this plant should not be handled because sap on the skin can be rubbed into the eyes or accidentally ingested while handling food.

Wild parsnip sap contains psoralen which presents a completely different mode of action compared to the piperidine alkaloids in poison hemlock sap. Psoralen acts as a photosensitizing compound by inhibiting DNA synthesis in epidermal cells which kills these light-shielding cells responsible for protecting us from long-wave ultraviolet radiation (LWUVR) bombarding us in sunlight.

Severe blistering occurs when affected skin is exposed to LWUVR. The synergistic effect is called phytophotodermatitis (a.k.a. Berloque dermatitis) and the burn-like symptoms, as well as skin discoloration, may last for several months.

However, connecting skin blistering to exposure to wild parsnip sap can be a challenge. It takes around 24 hours for symptoms to first appear after exposure to LWURV and severe blistering typically doesn't peak until 48 -72 hours. The time required for symptoms to appear after exposure to the sap means the effect may be disconnected from the cause.

Another challenge with connecting the dots is that wild parsnip commonly grows in and around other weeds, particularly poison hemlock (Conium maculatum). Gardeners who are exposed to wild parsnip sap while weeding a mixed-patch may mistakenly blame the poison hemlock for their ultimate misery.

To Mow, or Not to Mow

The potential for poisonings from poison hemlock sap and the extreme skin reaction to the wild parsnip sap means these non-native invasive weeds should not be allowed to grow where they can be easily contacted by people. However, mechanical control through mowing, weed trimming, or hand-pulling is problematic. Certainly, wild parsnip presents a much higher risk with reports of sap spattered by mowers and string trimmers producing phytophotodermatitis on exposed arms and legs of equipment operators.

Still, mowing provides one option for managing poison hemlock and to a lesser degree wild parsnip. However, timing is everything: plants should be mowed in the spring once they've bolted but prior to the appearance of flowers. Waiting until after flowering presents a risk the cut flowers will still mature to seed.

Chemical Control: Case Study

A strong case can be made for herbicides providing the most effective and safest approach to managing both poison hemlock and wild parsnip.

Wild parsnip and poison hemlock are both susceptible to non-selective post-emergent herbicides such as glyphosate (e.g. Roundup). However, "non-selective" means all plants - both good and bad - may be killed and there is a considerable downside to killing the competition as well as the targeted weeds.

Post-emergent herbicides do not affect seeds. Thus, "herbicidal openings" that occur when all plants are killed provide the perfect opportunity for more wild parsnip and/or poison hemlock to spring forth from previously deposited seed. Thus, it's important to have a plan for establishing competitive plants after the wild parsnip dies off such as over-seeding with grasses.

Selective post-emergent herbicides that will preserve competitive plants, particularly grasses, while removing poison hemlock and wild parsnip include 2, 4-D, clorpyralid (e.g. Transline), metsulfuron (e.g. Escort XP), and some 2 and 3-way products such as Triamine (2,4-D + MCPA). However, timing is equally important. Apply after the spring emergence of the targeted weeds but before flowering.

For more information, contact the Pulaski County Extension Service at 606-679-6361. Learn about timely events or things to do in your home gardens by becoming a fan of Pulaski County Horticulture on Facebook, or following @hortagentbeth on Twitter, kyplants on Instagram, and Pulaski County Horticulture YouTube channel.

The Pulaski Co Extension office is open to the public by appointment only through the month of June. Extension employees are still on the job and can be reached via office phone. Read the entire directive on the Pulaski County Cooperative Extension website at pulaski.ca.uky.edu.

The Lake Cumberland Master Gardeners are temporarily out of pine straw. Another load will be coming soon.

Educational programs of Kentucky Cooperative Extension serve all people regardless of economic or social status and will not discriminate on the basis of race, color, ethnic origin, national origin, creed, religion, political belief, sex, sexual orientation, gender identity, gender expression, pregnancy, marital status, genetic information, age, veteran status, or physical or mental disability.

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Poison hemlock and wild parsnip, A couple of bad actors - Commonwealth Journal's History

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When Eoin OBrien found out he had a rare form of cancer, he was told he would have died within a week had he not gone to hospital.

Now, five years on, the dad of four is remarkably free of the disease.

Eoins life changed in May 2015 when he went to A&E with chest pains.

He was diagnosed with Hodgkins lymphoma, which causes abnormal growth of cells in the lymphatic system.

Due to fluid build-up, Eoins heart would have suffocated within days had he not been treated.

And after half a decade of pain and suffering, he is finally in remission.

The news came on his wife Karens birthday, making it all the more special for the pair and their daughters Sophie, 13, Abbie, 11, Maddie, eight, and three-year-old Emelie.

Karen said: To say that that was the best news ever would be an understatement, I would rather be told that 10 times over than even win the lotto.

Eoin was only 31 when he was diagnosed following a hospital visit after he started getting pains in his chest.

Doctors drained three-and-a-half litres of fluid from his chest and found a tumour between his lungs and heart.

After his first round of chemo didnt work, Eoin found a lump on his neck.

He was started on a higher dose of chemo which was, in his wife Karens opinion, the hardest one on him.

She explained: Eoin got the moon-face, he got the cancer look. Darkness under the skin of his eyes and that.

The pair hoped this treatment was working but were disappointed again when doctors told them it hadnt.

Two years later in 2017, when Karen was pregnant with Emelie, Eoin still wasnt responding to treatments.

He was due to go into hospital after his daughter was born for a planned stem cell transplant which was later cancelled.

The pair fought to get Eoin immunotherapy, which slowed down but didnt cure his cancer.

In 2019, he was told he could get an allogeneic stem cell transplant from a donor. Karen explained: So on the 6th of November, which we now class as Eoins re-birthday, he was given the transplant and he became so, so bad.

Eoin was at the stage where he wanted to give up. He didnt want to live anymore, he didnt want to go through it anymore.

Results of a scan in February had alarming results which left the two terrified the cancer had spread.

Thankfully, it was only an infection.

Eoin was hospitalised for six weeks and due to the coronavirus, wasnt allowed outside or to have visitors.

In May, the pair were given the news his transplant worked.

Karen said: Theres been a lot of ups and a lot of downs but were finally out the other side, so hopefully we can look forward to many, many years cancer-free.

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Vitamin C Face Serum Triple Strength Anti Aging, Wrinkle & Brightening Facial Care Antioxidant Rich, Hydrating, Softening & Even Skin Tone Treatment Made With Niacinamide & Glycolic Acid 1 oz Price, Features and Real Customers Reviews.

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LOS ANGELES, United States: QY Research has recently published a report, titled COVID-19 Impact on Global Progenitor Cell Product, Market Insights and Forecast to 2026.The market research report is a brilliant, and much-needed resource for companies, stakeholders, and investors interested in the global COVID-19 Impact on Progenitor Cell Product market. It informs readers about key trends and opportunities in the global COVID-19 Impact on Progenitor Cell Product market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global COVID-19 Impact on Progenitor Cell Product market.

Key companies operating in the global COVID-19 Impact on Progenitor Cell Product market include , NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI Progenitor Cell Product

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Key companies operating in the global COVID-19 Impact on Progenitor Cell Product market include , NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI Progenitor Cell Product

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TOC

1 Study Coverage1.1 Progenitor Cell Product Product Introduction1.2 Market Segments1.3 Key Progenitor Cell Product Manufacturers Covered: Ranking by Revenue1.4 Market by Type1.4.1 Global Progenitor Cell Product Market Size Growth Rate by Type1.4.2 Pancreatic progenitor cells1.4.3 Cardiac Progenitor Cells1.4.4 Intermediate progenitor cells1.4.5 Neural progenitor cells (NPCs)1.4.6 Endothelial progenitor cells (EPC)1.4.7 Others1.5 Market by Application1.5.1 Global Progenitor Cell Product Market Size Growth Rate by Application1.5.2 Medical care1.5.3 Hospital1.5.4 Laboratory1.6 Coronavirus Disease 2019 (Covid-19): Progenitor Cell Product Industry Impact1.6.1 How the Covid-19 is Affecting the Progenitor Cell Product Industry 1.6.1.1 Progenitor Cell Product Business Impact Assessment Covid-19 1.6.1.2 Supply Chain Challenges 1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Progenitor Cell Product Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-19 1.6.3.1 Government Measures to Combat Covid-19 Impact 1.6.3.2 Proposal for Progenitor Cell Product Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered 2 Executive Summary2.1 Global Progenitor Cell Product Market Size Estimates and Forecasts2.1.1 Global Progenitor Cell Product Revenue 2015-20262.1.2 Global Progenitor Cell Product Sales 2015-20262.2 Progenitor Cell Product Market Size by Region: 2020 Versus 20262.2.1 Global Progenitor Cell Product Retrospective Market Scenario in Sales by Region: 2015-20202.2.2 Global Progenitor Cell Product Retrospective Market Scenario in Revenue by Region: 2015-2020 3 Global Progenitor Cell Product Competitor Landscape by Players3.1 Progenitor Cell Product Sales by Manufacturers3.1.1 Progenitor Cell Product Sales by Manufacturers (2015-2020)3.1.2 Progenitor Cell Product Sales Market Share by Manufacturers (2015-2020)3.2 Progenitor Cell Product Revenue by Manufacturers3.2.1 Progenitor Cell Product Revenue by Manufacturers (2015-2020)3.2.2 Progenitor Cell Product Revenue Share by Manufacturers (2015-2020)3.2.3 Global Progenitor Cell Product Market Concentration Ratio (CR5 and HHI) (2015-2020)3.2.4 Global Top 10 and Top 5 Companies by Progenitor Cell Product Revenue in 20193.2.5 Global Progenitor Cell Product Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.3 Progenitor Cell Product Price by Manufacturers3.4 Progenitor Cell Product Manufacturing Base Distribution, Product Types3.4.1 Progenitor Cell Product Manufacturers Manufacturing Base Distribution, Headquarters3.4.2 Manufacturers Progenitor Cell Product Product Type3.4.3 Date of International Manufacturers Enter into Progenitor Cell Product Market3.5 Manufacturers Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Progenitor Cell Product Market Size by Type (2015-2020)4.1.1 Global Progenitor Cell Product Sales by Type (2015-2020)4.1.2 Global Progenitor Cell Product Revenue by Type (2015-2020)4.1.3 Progenitor Cell Product Average Selling Price (ASP) by Type (2015-2026)4.2 Global Progenitor Cell Product Market Size Forecast by Type (2021-2026)4.2.1 Global Progenitor Cell Product Sales Forecast by Type (2021-2026)4.2.2 Global Progenitor Cell Product Revenue Forecast by Type (2021-2026)4.2.3 Progenitor Cell Product Average Selling Price (ASP) Forecast by Type (2021-2026)4.3 Global Progenitor Cell Product Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Breakdown Data by Application (2015-2026)5.1 Global Progenitor Cell Product Market Size by Application (2015-2020)5.1.1 Global Progenitor Cell Product Sales by Application (2015-2020)5.1.2 Global Progenitor Cell Product Revenue by Application (2015-2020)5.1.3 Progenitor Cell Product Price by Application (2015-2020)5.2 Progenitor Cell Product Market Size Forecast by Application (2021-2026)5.2.1 Global Progenitor Cell Product Sales Forecast by Application (2021-2026)5.2.2 Global Progenitor Cell Product Revenue Forecast by Application (2021-2026)5.2.3 Global Progenitor Cell Product Price Forecast by Application (2021-2026) 6 North America6.1 North America Progenitor Cell Product by Country6.1.1 North America Progenitor Cell Product Sales by Country6.1.2 North America Progenitor Cell Product Revenue by Country6.1.3 U.S.6.1.4 Canada6.2 North America Progenitor Cell Product Market Facts & Figures by Type6.3 North America Progenitor Cell Product Market Facts & Figures by Application 7 Europe7.1 Europe Progenitor Cell Product by Country7.1.1 Europe Progenitor Cell Product Sales by Country7.1.2 Europe Progenitor Cell Product Revenue by Country7.1.3 Germany7.1.4 France7.1.5 U.K.7.1.6 Italy7.1.7 Russia7.2 Europe Progenitor Cell Product Market Facts & Figures by Type7.3 Europe Progenitor Cell Product Market Facts & Figures by Application 8 Asia Pacific8.1 Asia Pacific Progenitor Cell Product by Region8.1.1 Asia Pacific Progenitor Cell Product Sales by Region8.1.2 Asia Pacific Progenitor Cell Product Revenue by Region8.1.3 China8.1.4 Japan8.1.5 South Korea8.1.6 India8.1.7 Australia8.1.8 Taiwan8.1.9 Indonesia8.1.10 Thailand8.1.11 Malaysia8.1.12 Philippines8.1.13 Vietnam8.2 Asia Pacific Progenitor Cell Product Market Facts & Figures by Type8.3 Asia Pacific Progenitor Cell Product Market Facts & Figures by Application 9 Latin America9.1 Latin America Progenitor Cell Product by Country9.1.1 Latin America Progenitor Cell Product Sales by Country9.1.2 Latin America Progenitor Cell Product Revenue by Country9.1.3 Mexico9.1.4 Brazil9.1.5 Argentina9.2 Central & South America Progenitor Cell Product Market Facts & Figures by Type9.3 Central & South America Progenitor Cell Product Market Facts & Figures by Application 10 Middle East and Africa10.1 Middle East and Africa Progenitor Cell Product by Country10.1.1 Middle East and Africa Progenitor Cell Product Sales by Country10.1.2 Middle East and Africa Progenitor Cell Product Revenue by Country10.1.3 Turkey10.1.4 Saudi Arabia10.1.5 U.A.E10.2 Middle East and Africa Progenitor Cell Product Market Facts & Figures by Type10.3 Middle East and Africa Progenitor Cell Product Market Facts & Figures by Application 11 Company Profiles11.1 NeuroNova AB11.1.1 NeuroNova AB Corporation Information11.1.2 NeuroNova AB Description, Business Overview and Total Revenue11.1.3 NeuroNova AB Sales, Revenue and Gross Margin (2015-2020)11.1.4 NeuroNova AB Progenitor Cell Product Products Offered11.1.5 NeuroNova AB Recent Development11.2 StemCells11.2.1 StemCells Corporation Information11.2.2 StemCells Description, Business Overview and Total Revenue11.2.3 StemCells Sales, Revenue and Gross Margin (2015-2020)11.2.4 StemCells Progenitor Cell Product Products Offered11.2.5 StemCells Recent Development11.3 ReNeuron Limited11.3.1 ReNeuron Limited Corporation Information11.3.2 ReNeuron Limited Description, Business Overview and Total Revenue11.3.3 ReNeuron Limited Sales, Revenue and Gross Margin (2015-2020)11.3.4 ReNeuron Limited Progenitor Cell Product Products Offered11.3.5 ReNeuron Limited Recent Development11.4 Asterias Biotherapeutics11.4.1 Asterias Biotherapeutics Corporation Information11.4.2 Asterias Biotherapeutics Description, Business Overview and Total Revenue11.4.3 Asterias Biotherapeutics Sales, Revenue and Gross Margin (2015-2020)11.4.4 Asterias Biotherapeutics Progenitor Cell Product Products Offered11.4.5 Asterias Biotherapeutics Recent Development11.5 Thermo Fisher Scientific11.5.1 Thermo Fisher Scientific Corporation Information11.5.2 Thermo Fisher Scientific Description, Business Overview and Total Revenue11.5.3 Thermo Fisher Scientific Sales, Revenue and Gross Margin (2015-2020)11.5.4 Thermo Fisher Scientific Progenitor Cell Product Products Offered11.5.5 Thermo Fisher Scientific Recent Development11.6 STEMCELL Technologies11.6.1 STEMCELL Technologies Corporation Information11.6.2 STEMCELL Technologies Description, Business Overview and Total Revenue11.6.3 STEMCELL Technologies Sales, Revenue and Gross Margin (2015-2020)11.6.4 STEMCELL Technologies Progenitor Cell Product Products Offered11.6.5 STEMCELL Technologies Recent Development11.7 Axol Bio11.7.1 Axol Bio Corporation Information11.7.2 Axol Bio Description, Business Overview and Total Revenue11.7.3 Axol Bio Sales, Revenue and Gross Margin (2015-2020)11.7.4 Axol Bio Progenitor Cell Product Products Offered11.7.5 Axol Bio Recent Development11.8 R&D Systems11.8.1 R&D Systems Corporation Information11.8.2 R&D Systems Description, Business Overview and Total Revenue11.8.3 R&D Systems Sales, Revenue and Gross Margin (2015-2020)11.8.4 R&D Systems Progenitor Cell Product Products Offered11.8.5 R&D Systems Recent Development11.9 Lonza11.9.1 Lonza Corporation Information11.9.2 Lonza Description, Business Overview and Total Revenue11.9.3 Lonza Sales, Revenue and Gross Margin (2015-2020)11.9.4 Lonza Progenitor Cell Product Products Offered11.9.5 Lonza Recent Development11.10 ATCC11.10.1 ATCC Corporation Information11.10.2 ATCC Description, Business Overview and Total Revenue11.10.3 ATCC Sales, Revenue and Gross Margin (2015-2020)11.10.4 ATCC Progenitor Cell Product Products Offered11.10.5 ATCC Recent Development11.1 NeuroNova AB11.1.1 NeuroNova AB Corporation Information11.1.2 NeuroNova AB Description, Business Overview and Total Revenue11.1.3 NeuroNova AB Sales, Revenue and Gross Margin (2015-2020)11.1.4 NeuroNova AB Progenitor Cell Product Products Offered11.1.5 NeuroNova AB Recent Development11.12 CDI11.12.1 CDI Corporation Information11.12.2 CDI Description, Business Overview and Total Revenue11.12.3 CDI Sales, Revenue and Gross Margin (2015-2020)11.12.4 CDI Products Offered11.12.5 CDI Recent Development 12 Future Forecast by Regions (Countries) (2021-2026)12.1 Progenitor Cell Product Market Estimates and Projections by Region12.1.1 Global Progenitor Cell Product Sales Forecast by Regions 2021-202612.1.2 Global Progenitor Cell Product Revenue Forecast by Regions 2021-202612.2 North America Progenitor Cell Product Market Size Forecast (2021-2026)12.2.1 North America: Progenitor Cell Product Sales Forecast (2021-2026)12.2.2 North America: Progenitor Cell Product Revenue Forecast (2021-2026)12.2.3 North America: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.3 Europe Progenitor Cell Product Market Size Forecast (2021-2026)12.3.1 Europe: Progenitor Cell Product Sales Forecast (2021-2026)12.3.2 Europe: Progenitor Cell Product Revenue Forecast (2021-2026)12.3.3 Europe: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.4 Asia Pacific Progenitor Cell Product Market Size Forecast (2021-2026)12.4.1 Asia Pacific: Progenitor Cell Product Sales Forecast (2021-2026)12.4.2 Asia Pacific: Progenitor Cell Product Revenue Forecast (2021-2026)12.4.3 Asia Pacific: Progenitor Cell Product Market Size Forecast by Region (2021-2026)12.5 Latin America Progenitor Cell Product Market Size Forecast (2021-2026)12.5.1 Latin America: Progenitor Cell Product Sales Forecast (2021-2026)12.5.2 Latin America: Progenitor Cell Product Revenue Forecast (2021-2026)12.5.3 Latin America: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.6 Middle East and Africa Progenitor Cell Product Market Size Forecast (2021-2026)12.6.1 Middle East and Africa: Progenitor Cell Product Sales Forecast (2021-2026)12.6.2 Middle East and Africa: Progenitor Cell Product Revenue Forecast (2021-2026)12.6.3 Middle East and Africa: Progenitor Cell Product Market Size Forecast by Country (2021-2026) 13 Market Opportunities, Challenges, Risks and Influences Factors Analysis13.1 Market Opportunities and Drivers13.2 Market Challenges13.3 Market Risks/Restraints13.4 Porters Five Forces Analysis13.5 Primary Interviews with Key Progenitor Cell Product Players (Opinion Leaders) 14 Value Chain and Sales Channels Analysis14.1 Value Chain Analysis14.2 Progenitor Cell Product Customers14.3 Sales Channels Analysis14.3.1 Sales Channels14.3.2 Distributors 15 Research Findings and Conclusion 16 Appendix16.1 Research Methodology16.1.1 Methodology/Research Approach16.1.2 Data Source16.2 Author Details

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Trending: Progenitor Cell Product Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 - Weekly Wall

Cardiac Stem Cells Comments Off on Trending: Progenitor Cell Product Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 – Weekly Wall | June 14th, 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) announced that new data from its ongoing Phase 1/2 HGB-206 study of investigational LentiGlobin gene therapy for adult and adolescent patients with sickle cell disease (SCD) show a near-complete reduction of serious vaso-occlusive crises (VOCs) and acute chest syndrome (ACS). These data are being presented at the Virtual Edition of the 25th European Hematology Association (EHA25) Annual Congress.

Vaso-occlusive crises (VOCs) are the painful, life-threatening episodes that are the primary clinical manifestation of sickle cell disease. The nearly complete elimination of VOCs that we saw in this study is impressive and demonstrates the potential of LentiGlobin for SCD as a treatment for this serious disease, said David Davidson, M.D., chief medical officer, bluebird bio. These results illustrate the type of outcomes we believe are needed to provide truly meaningful improvements for people living with sickle cell disease. In addition, the improvement of laboratory measures of hemolysis and red cell physiology, with nearly pan-cellular distribution of the anti-sickling HbAT87Q, suggest LentiGlobin for SCD may substantially modify the causative pathophysiology of SCD. We are pleased to have reached a general agreement with the FDA on the clinical data required to support a submission for LentiGlobin for SCD and we plan to seek an accelerated approval. We look forward to working with the entire SCD community to bring forward a disease modifying option for patients.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS). HbS causes red blood cells to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and unpredictable, painful VOCs. For adults and children living with SCD, this means painful crises and other life altering or life-threatening acute complicationssuch as ACS, stroke and infections. If patients survive the acute complications, vasculopathy and end-organ damage, resulting complications can lead to pulmonary hypertension, renal failure and early death; in the U.S. the median age of death for someone with sickle cell disease is 43 - 46 years.

As a physician treating sickle cell for over 10 years, the excruciating pain crises that my patients suffer from is one of the most challenging and frustrating aspects of this disease, said presenting study author Julie Kanter, M.D., University of Alabama at Birmingham. The promising results of this study, which show patients have an almost complete elimination of VOCs and ACS, suggest LentiGlobin for SCD has real potential to provide a significant impact for people living with sickle cell disease.

LentiGlobin for SCD was designed to add functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once patients have the A-T87Q-globin gene, their red blood cells can produce anti-sickling hemoglobin, HbAT87Q, that decreases the proportion of HbS, with the goal of reducing sickled red blood cells, hemolysis and other complications.

As of March 3, 2020, a total of 37 patients have been treated with LentiGlobin for SCD to-date in the HGB-205 (n=3) and HGB-206 (n=34) clinical studies. The HGB-206 total includes: Group A (n=7), B (n=2) and C (n=25).

HGB-206: Group C Updated Efficacy Results

In Group C of HGB-206, 25 patients were treated with LentiGlobin for SCD and have up to 24.8 months of follow-up (median of 12.1; min.-max.: 2.824.8 months). Results from Group C are as of March 3, 2020 and include efficacy data for 16 patients who had at least a Month 6 visit, and safety data for 18 patients, which includes two patients who were at least six months post-treatment but results from a Month 6 visit are not available.

In 16 patients with six or more months of follow-up, median levels of gene therapy-derived anti-sickling hemoglobin, HbAT87Q, were maintained with HbAT87Q contributing at least 40% of total hemoglobin. At last visit reported, total hemoglobin ranged from 9.6 16.2 g/dL and HbAT87Q levels ranged from 2.7 9.4 g/dL. At Month 6 the production of HbAT87Q was associated with a reduction in the proportion of HbS in total hemoglobin. Patients had a median of 60% HbS. All patients in Group C were able to stop regular blood transfusions and remain off transfusions at three months post-treatment.

There was a 99.5% mean reduction in annualized rate of VOC and ACS among the 14 patients who had at least six months of follow-up and a history of VOCs or ACS, defined as four or more VOC or ACS events in the two years prior to treatment. These 14 patients had a median of eight events in the two years prior to treatment (min.-max.: 4 28 events).

There were no reports of serious VOCs or ACS at up to 24 months post-treatment in patients with at least six months of follow-up (n=18). As previously reported, one non-serious Grade 2 VOC was observed in a patient approximately 3.5 months post-treatment with LentiGlobin for SCD.

In sickle cell disease, red blood cells become sickled and fragile, rupturing more easily than healthy red blood cells. The breakdown of red blood cells is hemolysis and this process occurs normally in the body. However, in sickle cell disease hemolysis happens too quickly due to the fragility of the red blood cells, which results in hemolytic anemia.

Patients treated with LentiGlobin for SCD demonstrated improvement in key markers of hemolysis, which are indicators of the health of red blood cells. Lab results assessing these indicators were available for the majority of the 18 patients with 6 months of follow-up. The medians for reticulocyte counts (n=15), lactate dehydrogenase (LDH) levels (n=13) and total bilirubin (n=16) improved compared to screening and stabilized by Month 6. In patients with Month 24 data (n=5) these values approached the upper limit of normal by Month 24. These results suggest treatment with LentiGlobin for SCD is improving biological markers of sickle cell disease.

Assays were developed by bluebird bio to enable the detection of HbAT87Q and HbS protein in individual red blood cells as well as to assess if HbAT87Q was pancellular, present throughout all of a patients red blood cells. Samples from a subset of patients in Group C were assessed. In nine patients who had at least six months of follow-up, the average proportion of red blood cells positive for HbAT87Q was greater than 70%, and on average more than 85% of red blood cells contained HbAT87Q at 18 months post-treatment, suggesting near-complete pancellularity of HbAT87Q distribution.

HGB-206: Group C Safety Results

As of March 3, 2020, the safety data from all patients in HGB-206 are generally reflective of underlying SCD and the known side effects of hematopoietic stem cell collection and myeloablative conditioning. There were no serious adverse events related to LentiGlobin for SCD, and the non-serious, related adverse events (AEs) were mild-to-moderate in intensity and self-limited.

One patient with a history of frequent pre-treatment VOE, pulmonary and systemic hypertension, venous thrombosis, obesity, sleep apnea and asthma had complete resolution of VOEs following treatment, but suffered sudden death 20 months after treatment with LentiGlobin for SCD. The patients autopsy revealed cardiac enlargement and fibrosis, and concluded the cause of death was cardiovascular, with contributions from SCD and asthma. The treating physician and an independent monitoring committee agreed this death was unlikely related to LentiGlobin for SCD gene therapy.

The presentation is now available on demand on the EHA25 website:

About HGB-206

HGB-206 is an ongoing, Phase 1/2 open-label study designed to evaluate the efficacy and safety of LentiGlobin gene therapy for SCD that includes three treatment cohorts: Groups A (n=7), B (n=2) and C (n=25). A refined manufacturing process that was designed to increase vector copy number (VCN) and improve engraftment potential of gene-modified stem cells was used for Group C. Group C patients also received LentiGlobin for SCD made from HSCs collected from peripheral blood after mobilization with plerixafor, rather than via bone marrow harvest, which was used in Groups A and B of HGB-206.

LentiGlobin for Sickle Cell Disease Regulatory Status

bluebird bio reached general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a Biologics Licensing Application (BLA) submission for LentiGlobin for SCD will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint with at least 18 months of follow-up post-treatment with LentiGlobin for SCD. Globin response will be used as a key secondary endpoint.

bluebird bio anticipates additional guidance from the FDA regarding the commercial manufacturing process, including suspension lentiviral vector. bluebird bio announced in a May 11, 2020 press release it plans to seek an accelerated approval and expects to submit the U.S. BLA for SCD in the second half of 2021.

About LentiGlobin for Sickle Cell Disease

LentiGlobin for sickle cell disease is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

LentiGlobin for SCD received orphan medicinal product designation from the European Commission for the treatment of SCD.

The U.S. FDA granted orphan drug designation, regenerative medicine advanced therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for SCD.

LentiGlobin for SCD is investigational and has not been approved in any geography.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel for -thalassemia or LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders, including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition; cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash., Durham, N.C., and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

LentiGlobin and bluebird bio are trademarks of bluebird bio, Inc.

bluebird bio Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys development and regulatory plans for the LentiGlobin for SCD product candidate, and the companys intentions regarding the timing for providing further updates on the development of the product candidate. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the COVID-19 pandemic and resulting impact on our operations and healthcare systems will affect the execution of our development plans or the conduct of our clinical studies; the risk that even if LentiGlobin for SCD addresses ACS and VOC events, that it may not address progressive organ damage experienced by patients with SCD; the risk that the efficacy and safety results observed in the patients treated in our prior and ongoing clinical trials of LentiGlobin for SCD may not persist or be durable; the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in when treating additional patients in our ongoing or planned clinical trials; the risk that the HGB-206 and HGB-210 clinical studies as currently contemplated may be insufficient to support regulatory submissions or marketing approval in the United States and European Union; the risk that regulatory authorities will require additional information regarding our product candidate, resulting in a delay to our anticipated timelines for regulatory submissions, including our application for marketing approval. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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New Data Show Near Elimination of Sickle Cell Disease-Related Vaso-Occlusive Crises and Acute Chest Syndrome in Phase 1/2 Clinical Study of bluebird...

Cardiac Stem Cells Comments Off on New Data Show Near Elimination of Sickle Cell Disease-Related Vaso-Occlusive Crises and Acute Chest Syndrome in Phase 1/2 Clinical Study of bluebird… | June 13th, 2020