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Bone Marrow Processing Systems Market With Industry Overview, Supply Chain, Key Players, & Analysis To 2025 – Guru Online News

By daniellenierenberg

Bone marrow aspirationand trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.

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Europe and North America spearheaded the market as of 2018, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants areconducted in Europe, and it is oneof the major factors contributing to the lucrative share in the cell harvesting system market.

In 2018, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.

Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.

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Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others.

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Bone Marrow Processing Systems Market With Industry Overview, Supply Chain, Key Players, & Analysis To 2025 - Guru Online News

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Arthritis drugs available on the NHS help stop the spread of breast cancer to bones – The Sun

By daniellenierenberg

ARTHRITIS drugs available on the NHS help stop the spread of breast cancer, a study suggests.

They blocked secondary tumours fuelled by a bone marrow protein called interleukin 1-beta, researchers found.

1

In tests, just 14 per cent of mice treated with arthritis drug anakinra developed secondary tumours in the bone, compared with 42 per cent in a control group.

Other arthritis drugs canakinumab and sulfasalazine had similar effects, the Manchester University and Sheffield University researchers found.

Dr Rachel Eyre told journal Nature Communications: We will now look to see if similar processes are also involved in breast cancer growing in organs such as the liver and lungs.

The study was largely funded by charity Breast Cancer Now.

According to Breast Cancer Now, around 55,000 women and 370 men are diagnosed with breast cancer each year, making it the UK's most common cancer.

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About 11,500 women die from the disease each year, almost all from tumours that have spread to other parts of the body.

Breast cancer most commonly spreads to the bones, brain, lungs or liver.

Breast cancer stem cells are thought to be responsible for the spread of the disease, with previous research suggesting healthy cells released certain molecules to help the cancer stem cells settle and grow in new locations.

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Breaking News: Cardiol Therapeutics Announces Clinical Steering Committee for Phase 2 International Trial in Acute Myocarditis Using CardiolRx(TM) 100…

By daniellenierenberg

Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF), a leader in the production of pharmaceutical cannabidiol (CBD) products and in the development of innovative cannabidiol medicines for heart disease, is pleased to announce the formation of the Clinical Steering Committee (CSC) for a Phase 2 international trial in acute myocarditis using the Companys CardiolRx100 cannabidiol formulation.

The CSC, which comprises key opinion leaders in acute myocarditis from North America and Europe, recently met during the American Heart Associations Scientific Sessions in Philadelphia held November 16th to 18th. The role of the CSC is to advise on the trial design, provide overall supervision of the trial, and ensure that it is being conducted in accordance with the principles of Good Clinical Practice. The CSC has oversight of the protocol, any protocol amendments, and provides advice to the investigators on all aspects of the trial.

Acute myocarditis is characterized by inflammation of the heart muscle (myocardium). The most common cause is viral infection of the heart tissue which is initially responsible for the inflammation. In a significant number of cases, perhaps due to an autoimmune process, the inflammation persists with ongoing myocardial damage and depressed heart function. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Symptoms include chest pain, fatigue, shortness of breath, and arrhythmias. Because of the progressive damage to heart cells, heart failure develops (defined as the inability of the heart to pump sufficient blood to meet the needs of the body). The study will use left ventricular ejection fraction (LVEF) as one measure of heart function.

CardiolRx100 is Cardiol Therapeutics pure pharmaceutically (cGMP) produced high concentration cannabidiol formulation that is THC free (<10ppm). Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, Cardiol believes there is an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug. In the United States, an orphan drug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. In the U.S. and the European Union, orphan drugs are eligible for accelerated marketing approvals and companies developing orphan drugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the drug developer has sole rights to market the drug.

Cardiol has assembled eight highly distinguished thought leaders in cardiology from North America and Europe to oversee and guide our acute myocarditis trial that is being planned at world leading heart institutes, including the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, and Charit University Medicine Berlin, stated David Elsley, President and CEO of Cardiol Therapeutics. The U.S. orphan drug program was successfully utilized to accelerate the first FDA approval of cannabidiol for the treatment of two pediatric epilepsy orphan diseases. We see a similar opportunity with our international trial in acute myocarditis to fast track the development of our CardiolRx formulation for a serious cardiovascular orphan disease for which there is currently no accepted standard of care.

Members of Cardiols Acute Myocarditis CSC include:

Dennis M. McNamara, MD (Chair)

Dr. Dennis McNamara is a Professor of Medicine at the University of Pittsburgh. He is also the Director of the Heart Failure/Transplantation Program at the University of Pittsburgh Medical Center. Dr. McNamara received his undergraduate/graduate education at Yale University, New Haven, Connecticut, and Harvard Medical School, Boston, Massachusetts, respectively. He completed his internship, residency, and cardiology fellowship at Massachusetts General Hospital in Boston. McNamaras current research interests include etiology and pathogenesis of dilated cardiomyopathies; inflammatory syndromes of cardiovascular disease; myocardial recovery in recent onset non-ischemic primary cardiomyopathy; etiology and management of peripartum cardiomyopathy; and genetic modulation of outcomes in cardiovascular disease.

Leslie T. Cooper, Jr., MD (Co-Chair)

Dr. Leslie T. Cooper, Jr., is a general cardiologist and the chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine, as well as chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Florida. Dr. Coopers clinical interests and research focus on clinical and translational studies of rare and undiagnosed cardiomyopathies, myocarditis, and inflammatory cardiac and vascular diseases, such as giant cell myocarditis, cardiac sarcoidosis, eosinophilic myocarditis, and Takayasus arteritis. He has published over 130 original peer-reviewed papers, as well as contributing to and editing books on myocarditis. In addition to his clinical and research work, Dr. Cooper is a fellow of the American College of Cardiology, the American Heart Association, the European Society of Cardiology Heart Failure Association, the International Society for Heart and Lung Transplantation, and the Society for Vascular Medicine and Biology. He is also the founder and former president of the Myocarditis Foundation and continues to serve on its Board of Directors.

Arvind Bhimaraj, MD

Dr. Arvind Bhimaraj is a specialist in Heart Failure and Transplantation Cardiology and is Assistant Professor of Cardiology, Institute for Academic Medicine, at Houston Methodist and at Weill Cornell Medical College, NYC. He has been Co-Director of the Heart Failure Research Laboratory at Houston Methodist since 2016. His area of focus is anti-fibrotic mechanisms and how to promote recovery of a damaged heart. Dr. Bhimaraj was a Heart Failure Fellow at the Cleveland Clinic from July 2010 to September 2011. Dr. Bhimaraj also specializes in Interventional Cardiology, is board certified in Cardiovascular Disease, and the author of numerous cardiovascular publications.

Matthias Friedrich, MD

Dr. Matthias Friedrich is Full Professor with the Departments of Medicine and Diagnostic Radiology at the McGill University in Montreal and Chief, Cardiovascular Imaging at the McGill University Health Centre. He is also Professor of Medicine at Heidelberg University in Germany. Dr. Friedrich earned his MD at the Friedrich-Alexander-University Erlangen-Nrnberg, Germany. He completed his training as an internist and cardiologist at the Charit University Medicine Center, Humboldt University in Berlin. Dr. Friedrich founded one of the first large Cardiovascular Magnetic Resonance centres in Germany at the Charit University Hospital in Berlin. After his move to Canada, from 2004 to 2011, he was Director of the Stephenson Cardiovascular MR Centre at the Libin Cardiovascular Institute of Alberta and Professor of Medicine within the Departments of Cardiac Sciences and Radiology at the University of Calgary, Canada. From 2011 to 2015, he directed the Philippa and Marvin Carsley Cardiovascular MR Centre at the Montreal Heart Institute and was Michel and Renata Hornstein Chair in Cardiac Imaging at the Universit de Montral.

Peter Liu, MD

Dr. Peter Liu is the Chief Scientific Officer and Vice President, Research, of the University of Ottawa Heart Institute, and Professor of Medicine and Physiology at the University of Toronto and University of Ottawa. He was the former Scientific Director of the Institute of Circulatory and Respiratory Health at the Canadian Institutes of Health Research, the major federal funding agency for health research in Canada. Prior to that role, he was the inaugural Director of the Heart & Stroke/Lewar Centre of Excellence in Cardiovascular Research at University of Toronto. Dr. Liu received his MD from the University of Toronto, and postgraduate training at Harvard University. His laboratory investigates the causes and treatments of heart failure, the role of inflammation, and the identification of novel biomarkers and interventions in cardiovascular disease. Dr. Liu has published over 300 peer-reviewed articles in high impact journals and received numerous awards in recognition of his research and scientific accomplishments.

Wai Hong Wilson Tang, MD

Dr. Wai Hong Wilson Tang is the Advanced Heart Failure and Transplant Cardiology specialist at the Cleveland Clinic in Cleveland, Ohio. Dr. Tang is also the Director of the Cleveland Clinics Center for Clinical Genomics; Research Director, and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine in the Sydell and Arnold Miller Family Heart & Vascular Institute at the Cleveland Clinic. He attended and graduated from Harvard Medical School in 1996, having over 23 years of diverse experience, especially in Advanced Heart Failure and Transplant Cardiology. Dr. Tang is affiliated with many hospitals including the Cleveland Clinic and cooperates with other doctors and physicians in medical groups including The Cleveland Clinic Foundation.

Barry Trachtenberg, MD

Dr. Barry H. Trachtenberg is a cardiologist specializing in heart failure and cardiac transplantation. He is also the director of the Michael DeBakey Cardiology Associates Cardio-Oncology program, an evolving field devoted to prevention and management of cardiovascular complications of cancer therapies such as chemotherapy and radiation. His clinical experience includes heart failure and heart transplantation, mechanical support pumps, and cardio-oncology. He has contributed to multiple publications related to advanced heart failure, cardiac transplantation, regenerative therapies, and ventricular assist devices. Dr. Trachtenberg is a member of the American Heart Association, the International Society for Heart and Lung Transplantation, the Heart Failure Society of America, and the International CardiOncology Society of North America.

Carsten Tschpe, MD

Dr. Carsten Tschpe is Professor of Medicine and Cardiology and Vice Director of the Department of Internal Medicine and Cardiology, Charit University Medicine Berlin. He received his doctorate in medicine in 1993 and has over 140 peer-reviewed publications, including overview and book articles, and 120 international original articles. His research interests include inflammatory cardiomyopathy, diabetic cardiopathy, and ischemic cardiopathy. He also includes diastolic dysfunction, endothelial dysfunction, peptide systems, and experimental and clinical studies in cardiology and stem cells in his research studies. For his outstanding research work, Dr. Tschpe was awarded the prestigious Arthur Weber Prize by the German Cardiac Society Cardiovascular Research.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (TSX: CRDL)(OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Companys lead product, CardiolRx, is designed to be one of the safest and most consistent CBD formulations on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free. The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.

In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical CBD and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visitwww.cardiolrx.com.

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Stem Cell Therapy Market to Surge at a Robust Pace in Terms of Revenue Over 2025 – The Denton Chronicle

By daniellenierenberg

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market to Surge at a Robust Pace in Terms of Revenue Over 2025 - The Denton Chronicle

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European Commission Approves Two New Regimens of Merck’s KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent…

By daniellenierenberg

This disease is especially debilitating since it can be highly visible and affect a patients appearance and their daily functions, such as eating and speaking, said Professor Kevin Harrington, investigator for KEYNOTE-048, professor of biological cancer therapies at The Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust. Considering the great need for new treatment options, we are encouraged by todays KEYTRUDA approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment.

This approval allows marketing of the KEYTRUDA monotherapy and combination regimen in all 28 EU member states plus Iceland, Lichtenstein and Norway.

KEYTRUDA is now the first anti-PD-1 treatment option in the first-line setting for metastatic or unresectable recurrent head and neck cancer, a disease that has been treated the same way in the EU for more than a decade, said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. The European Commission approval underscores our commitment to transforming the way cancer is treated around the world.

Data Supporting the European Approval

This approval is based on data from the Phase 3 KEYNOTE-048 trial, a multi-center, randomized, open-label, active-controlled trial conducted in 882 patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies. Randomization was stratified by tumor PD-L1 expression (Tumor Proportion Score [TPS] 50% or <50%), HPV status (positive or negative), and ECOG Performance Status (PS) (0 vs. 1). The dual primary endpoints were OS and progression-free survival (PFS). Patients were randomized 1:1:1 to one of the following treatment arms:

Treatment with KEYTRUDA continued until RECIST v1.1-defined progression of disease as determined by the investigator, unacceptable toxicity or a maximum of 24 months.

Efficacy Results for KEYTRUDA as Monotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)

Endpoint

KEYTRUDA

n=257

Standard

Treatment*

n=255

OS

Number (%) of patients with event

197 (77%)

229 (90%)

Median in months (95% CI)

12.3 (10.8, 14.3)

10.3 (9.0, 11.5)

Hazard ratio (95% CI)

0.74 (0.61, 0.90)

p-Value

0.00133

PFS

Number (%) of patients with event

228 (89%)

237 (93%)

Median in months (95% CI)

3.2 (2.2, 3.4)

5.0 (4.8, 6.0)

Hazard ratio (95% CI)

1.13 (0.94, 1.36)

p-Value

0.89580

ORR

Objective response rate (95% CI)

19.1% (14.5, 24.4)

35% (29.1, 41.1)

Complete response

5%

3%

Partial response

14%

32%

p-Value

1.0000

Duration of Response

Median in months (range)

23.4 (1.5+, 43.0+)

4.5 (1.2+, 38.7+)

% with duration 6 months

81%

36%

*

Cetuximab, platinum, and 5-FU

Based on the stratified Cox proportional hazard model

Based on stratified log-rank test

Response: Best objective response as confirmed complete response or partial response

Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)

Efficacy Results for KEYTRUDA plus Chemotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)

Endpoint

KEYTRUDA +

Platinum Chemotherapy +

5-FU

n=242

Standard

Treatment*

n=235

OS

Number (%) of patients with event

177 (73%)

213 (91%)

Median in months (95% CI)

13.6 (10.7, 15.5)

10.4 (9.1, 11.7)

Hazard ratio (95% CI)

0.65 (0.53, 0.80)

p-Value

0.00002

PFS

Number (%) of patients with event

212 (88%)

221 (94%)

Median in months (95% CI)

5.1 (4.7, 6.2)

5.0 (4.8, 6.0)

Hazard ratio (95% CI)

0.84 (0.69, 1.02)

p-Value

0.03697

ORR

Objective response rate (95% CI)

36% (30.3, 42.8)

36% (29.6, 42.2)

Complete response

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European Commission Approves Two New Regimens of Merck's KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent...

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New Process can 3D Print Living Cells with Precision and Speed – DesignNews

By daniellenierenberg

3D bioprinting has come a long way in recent years, with scientists using living tissue to print organs as complex as human skin. Researchers in Austria have unveiled an advancement with a process that can integrate living cells into structures at unprecedented speeds and resolution.

TU Wien developed the new technique using a novel bioink that allows cells to be embedded in a 3D matrix and printed with micrometer precision. The technique performs at a speed of one meter per second, much faster than past methods.

Images show living cells spreading in a 3D scaffold -- from left to right: week 1, week 3 week 5. Top: 3D setup, bottom: one layer only. The process was developed by researchers at TU Wien to create precision bioprinting. (Source: TU Wien)

"Using these 3D scaffolds, it is possible to investigate the behavior of cells with previously unattainable accuracy, said Aleksandr Ovsianikov, head of the 3D Printing and Biofabrication research group at the Institute of Materials Science and Technology at TU Wien. It is possible to study the spread of diseases, and if stem cells are used, it is even possible to produce tailor-made tissue in this way.

Exact Science

To successfully bioprint cells that can turn into living tissue with various characteristics, its key to process the cells in a certain way. While there are many techniques for 3D bioprinting, not all are created equal, said Ovsianikov. Some methods are imprecise or only allow a very short time window in which the cells can be processed without being damaged, while others have material challenges.

He noted that the behavior of a cell behaves depends crucially on the mechanical, chemical and geometric properties of its environment. "The structures in which the cells are embedded must be permeable to nutrients so that the cells can survive and multiply, said Ovsianikov. But it is also important whether the structures are stiff or flexible, whether they are stable or degrade over time.

The team can print 3D objects at microscopically fine resolutions, but using living cells at this size has been challenging. "You need liquids or gels that solidify precisely where you illuminate them with a focused laser beam, Ovsianikov noted. However, these materials must not be harmful to the cells, and the whole process has to happen extremely quickly.

Speeding the Process

To solve this issue, TU Wien researchers have been using what are called two-photon polymerization methods, which use a chemical reaction that is only initiated when a molecule of the material simultaneously absorbs two photons of a laser beam with particularly high intensity. At the point of photon absorption, the substance hardens, while it remains liquid everywhere else, which makes this method best suited to produce extremely fine structures with high precision.

While this allows for high resolution, its a rather slow processtypically in the range of micrometers or a few millimeters per second. This means the cells could die before printing is complete.

Now using the scaffolds, researchers have developed a method that fabricates cell-friendly materials at greater speeds. This means they can print a structure in just a few hours, giving cells a good chance of surviving and developing further. "Our method provides many possibilities to adapt the environment of the cells," said Ovsianikov.. Depending on how the structure is built, it can be made stiffer or softer.

He added that even fine, continuous gradients are possible. In this way, it is possible to define exactly how the structure should look in order to allow the desired kind of cell growth and cell migration. The process can also alter the laser intensity to determine how easily the structure will be degraded over time.

Based on the research, the team has created a company, UPNano, to further develop this technique and create bioprinting innovations. They also published a paper on their work in the journal Advanced Healthcare Materials.

Elizabeth Montalbano is a freelance writer who has written about technology and culture for more than 20 years. She has lived and worked as a professional journalist in Phoenix, San Francisco and New York City. In her free time she enjoys surfing, traveling, music, yoga and cooking. She currently resides in a village on the southwest coast of Portugal.

January 28-30:North America's largest chip, board, and systems event,DesignCon, returns to Silicon Valleyfor its 25th year!The premier educational conference and technology exhibition, this three-day event brings together the brightest minds across the high-speed communications and semiconductor industries, who are looking to engineer the technology of tomorrow. DesignCon is your rocket to the future. Ready to come aboard?Register to attend!

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Chemotherapy and constant pills but DWP tells Hull man Kye Eastwood ‘you’re fit for work’ – Hull Daily Mail

By daniellenierenberg

A young Hull man whose life was saved by the generous people of Hull after being diagnosed with terminal cancer says he is looking forward to the future.

In 2014, Kye Eastwood, now 28, faced an unimaginable battle after being told there was nothing more UK doctors could do for him in his battle against Hodgkins Lymphoma - but there was hope.

The people of Hull heroically clubbed together and raised 46,000 within a month, paying for ground breaking - and life-saving - stem cell - treatment in Maryland, US.

Now, five years on, Kye and his fianc Chanelle Urquhart, 24, of Kingswood, are looking forward to their lives together - after what Kye has described as one of the most difficult years of his life.

Although the pioneering treatment cleared Kye of cancer, Kye has ongoing health issues. He is still undergoing chemotherapy and he is unable to work.

Despite this, he was told he was not allowed his PIP (Personal Independence Payment) benefits from the Department for Work and Pensions (DWP) after he underwent an eligibility assessment.

He said the report was "all wrong", stating he could do a number of things he could not do, which meant he was deemed fit for work.

He said: The report said I had a healthy complexion - that is completely wrong in the first place because of the vitiligo (pigmentation of the skin) I have.

Chanelle said he also split open a sore on his back trying to lift his arms further above his head during the assessment and it still needs treatment months later.

Although he has since had his benefits reinstated after the report was proved to be wrong, the trauma of living without any income and the strain it put on him for months has taken its toll.

He said: Someone came around in March theyd decided I was poorly enough for them to come to me rather than me go to them. I was on my cycle of chemo at the time and having massive allergic reactions.

Everything in the report was wrong and the woman who came didnt even look at any of the medical evidence and made out that I could move more.

"What the report said was not reflective of what happened in the meeting. We got a letter saying I wasnt entitled and why, and the report shed sent off.

Kye appealed and received another assessment and a complaint was put into the DWP by Chanelle, who sent pictures of Kyes skin and statements from every one of his doctors and specialists who see him in Rotherham.

Three months later, Kyes benefits were reinstated.

Chanelle said: He was three months without them, which help with his mobility. He was struggling to get to Rotherham, the treatment which ultimately keeps him alive.

She added the complaint has been escalated and is being looked at by an independent case examiner.

A DWP spokesman said: "We have apologised to Mr Eastwood for the confusion over his reapplication for PIP. It was resolved promptly and he is in receipt of all the benefits he is entitled to."

Chanelle said Kye would love nothing more than to go back to work but he needs something flexible that could work around treatment and hospital appointments.

She said: He was always working before the cancer and would love to go back to work and do things but its trying to find something he would be able to do safely, and something that would work around his health problems.

Kye added: I dont know an employer that would want me to be off at least a week every month while I go to my appointments.

During Kye's treatment the couple flew back and forth to Washington for a period of seven months and were able to stay at the amazing centre along with other families of people having treatment there.

During the time between treatments, they were able to explore the country and while staying in San Antonio in 2015 when they had been together for just six months, Kye proposed.

Chanelle said: At the time it happened, we hadnt been together for very long but we didnt know if he was going to survive. We instantly clicked and it was obvious it was going to work out.

Kye said: I knew I was going to do it. Wed known each other for years.

Five years later and they are still going strong - Chanelle even got to be the one to tell Kye he was cancer-free.

She said: He was in America and Id had to stay at home because I couldnt get the time off work.

"Theyd done a scan and the doctor had emailed me and told me he was completely clear. I was in Morrisons and was crying. I was trying to call him but he didnt have any signal.

I got through to him and just said, your cancer has completely gone'. Then he went to the car and told his mum.

Despite the relief at being given the all clear, Kye has faced difficulty during his recovery and still suffers side effects from all of his treatments.

Not long after he was told he was in remission, he started to suffer with a condition called Graft Versus Host Disease (GvHD).

The disease is classed as a medical complication of receiving of transplanted tissue from a different person such as Kyes stem cell treatment.

The white blood cells left in the donated tissue only recognise the receiver as foreign and begin to attack the receivers cells.

This has left Key with patches of dry skin on his body. His skin is thinner and he has vitiligo, which changes the pigment and colour.

Kye said: It started with a bit of itchy skin and I had a dry patch that wouldnt go away and we went for blood tests and they kept coming back really abnormal, my liver levels were through the roof.

Chanelle said: That was quite worrying as its quite dangerous and they were trying all sorts of things.

He now goes to Rotherham every week for treatment for the GvHD, and is on daily chemotherapy tablets.

He says he has tried a lot of different treatments but at the moment, this combination is working - although doctors are looking at other methods.

The GvHD in itself keeps the cancer at bay so doctors want to try and find a healthy balance.

Chanelle said: Hes hooked up to a machine that removes a certain volume of blood cells, which they separate. They give him his red blood cells back and treat the white blood cells with a UV light before putting them back in his body."

As well as GvHD Kye suffers with fatigue, breathlessness, bad sinuses and says he is now going deaf.

He has tried to get back to his fitness level before the cancer, even trying out BMXing, but he tires easily and becomes weak.

Despite all of the stress and heartache throughout this year, the pair are now looking forward to the future.

Kye said: Chanelle wants to finish her degree and get a job and a nice house. Were quite different to a lot of people who get engaged and start planning a wedding straight away. Weve got all the time in the world.

Ill have to be five years in remission before no more check ups, but the scares are always there.

They always will be, Chanelle added.

Kye and Chanelle say a few years down the line, they are still hugely grateful to the people of Hull for helping them to save his life.

Chanelle said: We would like to say thank you to everyone who contributed any money, or shared the story, or got involved in any of the fundraisers.

"They are what made this possible and have given Kye this second chance at life and they are why he is still here.

He was on palliative care and was going to die he probably wouldnt have made it to Christmas.

Kye said: It feels like such a long time ago. Im definitely looking forward to 2020."

Sophie Corcoran is a reporter for Hull Live and the Hull Daily Mail. Her interests include positive news, news about homelessness, court news and breaking news.

You can follow all the latest stories on her Facebook page here , her Twitter page here or on the Hull Live website here.

You can also call her on 01482 315174 or email sophie.corcoran@reachplc.com

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Chemotherapy and constant pills but DWP tells Hull man Kye Eastwood 'you're fit for work' - Hull Daily Mail

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10 promising ways to prevent, diagnose and treat Alzheimer’s – ISRAEL21c

By daniellenierenberg

November is Alzheimers Awareness Month. Its a fitting time to look at the latest Israeli advances in preventing, diagnosing and treating the progressive and incurable brain disorder.

Alzheimers disease (AD) is the most common cause of the 9.9 million new cases of dementia diagnosed each year worldwide. The disease primarily strikes the elderly population, affecting 30 percent of those over age of 85.

AD impacts memory, thinking and language skills, and even the ability to carry out simple tasks.

The disease occurs when a protein called amyloid beta aggregates in brain tissues. These protein clumps kill nerve cells, leading to damage in the brain-function mechanisms.

Here are 10 examples of promising Israeli approaches reported within the past two years alone.

PREVENTION

Various genetic, lifestyle and environmental factors can put a person at risk for AD. Among them are diabetes, high blood pressure, obesity, smoking, depression, cognitive inactivity or low education, and physical inactivity.

Preventing the onset of AD is the focus of these approaches:

Eitan Okun, Alzheimers disease researcher at Bar-Ilan University. Photo: courtesy

Most vaccines work by mounting an immune response toward a weakened pathogen to boost the immune systems ability to fight the real pathogen.

Okuns approach primes the body to attack amyloid beta protein clumps in the brain, the signature sign of AD.

Following experiments on mice, Okun is preparing for human trials on people at known risk of developing the disease in their 50s or younger: those genetically inclined toward Alzheimers and people with Down syndrome.

These critical trials will determine whether the vaccine actually works in humans, said Okun. Depending on the success rate and side effects from [human] testing, we will be able to know how much more time is needed to make the vaccine available on a global scale.

Okun also is investigating new ways to diagnose AD earlier and more accurately using advanced MRI (magnetic resonance imaging) technologies to detect initial signs of amyloid protein aggregation in the brain.

BGU Prof. Alon Friedman has invented a new treatment to prevent neurological diseases. Photo courtesy of Dr. Merav Shamir

Introduced by BGN Technologies of Ben-Gurion University of the Negev, the novel therapy hinges on the fact that a malfunctioning BBB allows neurotoxic blood products to enter the brain and cause damage leading to neurological diseases.

The lab of Prof. Alon Friedman discovered that treating the BBB at early stages can protect the brain and prevent disease development.

Their proposed treatment would combine Memantine and Losartan, which have been shown in preclinical studies to protect the integrity of the BBB when administered together. Partners are being sought to continue development.

Prof. Ester Segal of the Technion. Photo: courtesy

They reported on this advance in a recent cover story of the journal Small.

Nanoscale silicon chips invented in Prof. Ester Segals lab allow for the direct insertion of neural growth factor protein into the brain and its gradual release into the target tissue, bypassing the BBB (see above). Afterward delivering all the therapeutic protein loaded onto them, the chips safely dissolve.

In a series of experiments, we showed in mice that the two ways of delivering the platform into the brain led to the desired result, said Technion doctoral student Michal Rosenberg.

Our technology has also been tested in a cellular model of Alzheimers disease and indeed, the protein release has led to rescuing the nerve cells.

DIAGNOSIS

PET scans and spinal taps are now the gold standard for diagnosing AD. Theyre both expensive and carry risks.

Cheaper, noninvasive tests being developed in Israel also could be critical in providing a much earlier diagnosis, when treatment would be most effective.

Thats because the same beta-amyloid proteins that clump in the brain of AD patients appear in the retina of the eyes up to 15 years before the onset of AD symptoms.

RetiSpec developed the retinal scanner at the Ontario Brain Institute in Canada. Clinical studies are ongoing in Israel and Canada.

In October, RetiSpec received the Alzheimers Drug Discovery Foundations Diagnostics Accelerator Award to fund continued development of its hyperspectral imaging technology.

This could allow doctors to compare brain scans taken over time from the same patient, and to differentiate between healthy and diseased brain tissue, without resorting to invasive or dangerous procedures such as brain tissue biopsies, explained lead researcher Dr. Aviv Mezer.

Clara is based on a relatively recent understanding that AD affects the brains orientation system before it affects memory.

The overlap between how the self is oriented to the world and the brain mechanisms that are disturbed by Alzheimers disease is astonishing, Arzy told ISRAEL21c.

Clara asks patients questions about themselves and their relationships to people, places and events. It then compares that information to a baseline and generates a computer-based test tailored for the individual that can diagnose very early Alzheimers.

The team from Dr. Shahar Arzys computational neuropsychiatry lab at Hadassah Hebrew University Medical Center in Jerusalem. Photo: courtesy

According to a study Arzys team published in the Proceedings of the National Academy of Sciences and in the American Psychological Associations journal Neuropsychology, Clara is 95 percent accurate.

Clara is now in the midst of a five-year test at Harvard to compare data generated by the system with data from AD markers taken via amyloid PET scan, quantitative and functional MRI and other neuropsychological tests.

Jaul and Oded Meiron (a cognitive neuroscientist who heads the Electrophysiology and Neuro-cognition Lab in Herzogs Clinical Research Center for Brain Sciences) published an articlein the Journal of Alzheimers Disease outlining their discovery of the link between the two conditions.

The reason is that the abnormal changes in the brain that lead to dementia are happening in other parts of the body, including the skin. Skin tissue and brain tissue derive from the same embryonic stem cells.

Jaul and Meiron are working with an American company to develop a test to identify a biomarker for abnormal cell density in the skin of dementia patients. They hope that this skin test could pinpoint an individuals type and stage of dementia. The biomarkers show the most promise in identifying AD, they say.

TREATMENT

A variety of approved medications for AD including Exelon, developed in Israel cannot cure or stop the progression of the disease. They only relieve or delay AD symptoms, such as memory loss and confusion.

A few Israeli pharmaceuticals under development aim to improve Alzheimer treatment options.

Breathing in pure oxygen in a pressurized room or chamber stimulates the release of growth factors and stem cells, which promote healing.

This revolutionary treatment for Alzheimers disease uses a hyperbaric oxygen chamber, which has been shown in the past to be extremely effective in treating wounds that were slow to heal, said lead researcher Prof. Uri Ashery.

Asherys group tested the therapy on a mouse model of Alzheimers disease. The treatment was found to reduce behavioral deficiencies compared to control mice.

Remarkably, the treatment also reduced plaque pathology and neuroinflammation in the test mice by about 40 percent.

Further research will investigate the underlying mechanisms of the therapy and evaluate its beneficial effects in Alzheimer patients.

Yotam Nisemblat, CEO of ProteKt Therapeutics. Photo: courtesy

Incubated at FutuRx in Ness Ziona, ProteKt was spun out of PKR kinase inhibitor research by University of Haifa Prof. Kobi Rosenblum. Inhibition of the enzyme PKR is a unique idea for improving memory consolidation.

Protein aggregation tends to increase with age and can lead to neurodegeneration because proteins can adopt an erroneous configuration, where theyre misfolded, explains Prof. Martin Kupiec.

The paper he and his colleagues published in Molecular Cell describes how removing glucose from a particular aggregated protein made the blob dissolve.

If the results can be replicated in more complex proteins, scientists will have a new research avenue toward treatments that could reverse the neurodegenerative effect of protein aggregates, Kupiec says.

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Lineage Cell Therapeutics Provides Update on SCiStar Clinical Study and OPC1 Spinal Cord Injury Program – Business Wire

By daniellenierenberg

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cellular therapies for unmet medical needs, today provided an update on OPC1, the Companys oligodendrocyte progenitor cell (OPC) therapy currently being tested in a Phase I/IIa clinical trial, the SCiStar Study, for the treatment of acute spinal cord injury (SCI). Lineage reported positive results from the ongoing SCiStar study of OPC1, where the overall safety profile of OPC1 has remained excellent with robust motor recovery in upper extremities maintained through Year 2 patient follow-ups available to date. Additionally, OPC1 manufacturing has been completely transferred to the Companys cGMP manufacturing facility in Israel and manufacturing process improvements are planned to continue throughout 2020. Moreover, Lineage intends to meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program around the middle of 2020.

We remain extremely excited about the potential for OPC1 to provide enhanced motor recovery to patients with spinal cord injuries. We are not aware of any other investigative therapy for SCI which has reported as encouraging clinical outcomes as OPC1, particularly with continued improvement beyond 1 year, stated Brian M. Culley, CEO of Lineage Cell Therapeutics. Overall gains in motor function for the population assessed to date have continued, with Year 2 assessments measuring the same or higher than at Year 1. For example, 5 out of 6 Cohort 2 patients have recovered two or more motor levels on at least one side as of their Year 2 visit whereas 4 of 6 patients in this group had recovered two motor levels as of their Year 1 visit. To put these improvements into perspective, a one motor level gain means the ability to move ones arm, which contributes to the ability to feed and clothe oneself or lift and transfer oneself from a wheelchair. These are tremendously meaningful improvements to quality of life and independence. Just as importantly, the overall safety of OPC1 has remained excellent and has been maintained 2 years following administration, as measured by MRIs in patients who have had their Year 2 follow-up visits to date. We look forward to providing further updates on clinical data from SCiStar as patients continue to come in for their scheduled follow up visits.

SCiStar Study Clinical Update

- Overall safety profile of OPC1 to date is excellent for Year 2 follow-ups available to date (21 patients)

- Motor level improvements

- Upper Extremity Motor Score (UEMS)

OPC1 Clinical Program Update

About the SCiStar Clinical Study

The SCiStar Study is an open-label, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in 25 patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had essentially lost all movement below their injury site and experienced severe paralysis of the upper and lower limbs. AIS-A patients had lost all motor and sensory function below their injury site, while AIS-B patients had lost all motor function but may have retained some minimal sensory function below their injury site. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions as measured by upper extremity motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations at 30, 60, 90, 180, 270, and 365 days after injection of OPC1.

About OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) therapy currently being tested in a Phase I/IIa clinical trial known as SCiStar for the treatment of acute spinal cord injuries. OPCs are naturally-occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. The clinical development of the OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of acute SCI and has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to planned manufacturing process improvements and meetings with regulatory agencies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 14, 2019 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results – BioSpace

By daniellenierenberg

TEL AVIV, Israel, Nov. 19, 2019 /PRNewswire/ --Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today reported financial and operating results for the third quarter ended September 30, 2019 and provided a corporate update.

Recent Highlights

"Our clinical and regulatory teams remained focused during the third quarter and the more recent positive developments position us to achieve our goals, both in the U.S. and Israel," commented Dr. Shai Yarkoni, Chief Executive Officer. "In the U.S., the IND approval is a significant achievement and represents our first-ever FDA IND in the U.S., with Washington University School of Medicine. In Israel, our Phase 1/2 clinical study of ApoGraft is progressing slowly and we expect to complete the recruitment around the end of the year."

"With our prudent use of cash during the third quarter and the anticipated cash usage needs over the coming quarters, we continue to believe we have the resources to execute our clinical and regulatory plans for the foreseeable future," said Eyal Leibovitz, Chief Financial Officer.

ThirdQuarter 2019 Financial Results:

*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2019 (U.S. $1 = NIS 3.482).

Strategic Review Progress Update

On May 16, 2019, the Company disclosed that it commenced plans to explore strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, including in other business fields than the Company's in-licensing, or other strategic transaction involving the Company or its assets. The Company continues to evaluate business development opportunities and will keep investors informed as they mature or warrant investor disclosure.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; or maintain its current operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current efforts to explore new strategic alternatives; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Nine months

ended

Nine months ended

Three months ended

September 30,

September 30,

September 30,

2019

2019

2018

2019

2018

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and per

share data)

Research and development expenses

2,743

9,551

9,473

2,465

4,125

General and administrative expenses

2,249

7,832

11,001

2,768

3,929

Operating loss

4,992

17,383

20,474

5,233

8,054

Financial expenses (income) due towarrants exercisable into shares

(2,303)

(8,020)

(2,935)

(910)

(1,320)

Other financial expenses (income), net

393

1,369

(1,177)

489

64

Total comprehensive loss

3,082

10,732

16,362

4,812

6,798

Loss per share:

Basic and diluted loss per share

0.015

0.051

0.127

0.021

0.052

Basic and diluted loss per ADS

0.30

1.02

2.54

0.42

1.04

Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share

208,771,303

208,771,303

129,139,278

224,087,799

130,192,799

Cellect Biotechnology Ltd.

Consolidated Balance Sheet Data

ASSETS

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These Scientists May Have Found a Cure for ‘Bubble Boy’ Disease – Smithsonian.com

By daniellenierenberg

On the morning of April 25, 2018, in Fort Wayne, Indiana, Omarion Jordan came into the world ten-fingers-and-toes perfect. His mother, Kristin Simpson, brought her dark-haired newborn home to a mostly empty apartment in Kendallville, about 30 miles to the north. Shed just moved in and hadnt had time to decorate. Her son, however, had everything he needed: a nursery full of toys, a crib, a bassinet and a blue octopus blanket.

Still, within his first couple of months, he was plagued by three different infections that required intravenous treatments. Doctors thought he had eczema and cradle cap. They said he was allergic to his mothers milk and told her to stop breastfeeding. Then, not long after he received a round of standard infant vaccinations, his scalp was bleeding and covered with green goop, recalled the first-time mother, who was then in her late teens. She took him to the hospital emergency room, where, again, caregivers seemed puzzled by the babys bizarre symptoms, which didnt make any sense until physicians, finally, ordered the right blood test.

What they learned was that Omarion was born with a rare genetic disorder called X-linked severe combined immunodeficiency (SCID), better known as the bubble boy disease. Caused by a mutated gene on the X chromosome, and almost always limited to males, a baby born with X-linked SCID, or SCID-X1, lacks a working immune system (hence the unusual reaction to vaccination). The bubble boy name is a reference to David Vetter, a Texas child born with SCID-X1 in 1971, who lived in a plastic bubble and ventured out in a NASA-designed suit. He died at 12, but his highly publicized life inspired a 1976 TV movie starring John Travolta.

Today, technological advances in hospitals provide a kind of bubble, protecting SCID-X1 patients with controlled circulation of filtered air. Such safeguards are necessary because a patient exposed to even the most innocuous germs can acquire infections that turn deadly. As soon as Omarion tested positive for the disorder, an ambulance carried him to Cincinnati Childrens Hospital in nearby Ohio and placed him in isolation, where he remained for the next few months. I had no idea what would happen to him, his mother recalled.

Approximately one in 40,000 to 100,000 infants is born with SCID, according to the Centers for Disease Control and Prevention. Only about 20 to 50 new cases of the SCID-X1 mutationwhich accounts for about half of all SCID casesappear in the United States each year. For years, the best treatments for SCID-X1 have been bone marrow or blood stem cell transplantations from a matched sibling donor. But fewer than 20 percent of patients have had this option. And Omarion, an only child, was not among them.

As it happened, medical scientists at St. Jude Childrens Research Hospital in Memphis, Tennessee, were then developing a bold new procedure. The strategy: introduce a normal copy of the faulty gene, designated IL2RG, into a patients own stem cells, which then go on to produce the immune system components needed to fight infection. Simpson enrolled Omarion in the clinical study and Cincinnati Childrens Hospital arranged a private jet to transport her and her son to the research hospital, where they stayed for five months.

St. Jude wasnt the first to try gene therapy for SCID-X1. Nearly 20 years ago, researchers in France reported successfully reconditioning immune systems in SCID-X1 patients using a particular virus to deliver the correct gene to cells. But when a quarter of the patients in that study developed leukemia, because the modified virus also disrupted the functioning of normal genes, the study was halted and scientists interested in gene therapy for the disorder hit the brakes.

At St. Jude, experts led by the late Brian Sorrentino, a hematologist and gene therapy researcher, set out to engineer a virus delivery vehicle that wouldnt have side effects. They started with a modified HIV vector emptied of the virus and its original contents, and filled it with a normal copy of the IL2RG gene. They engineered this vector to include insulators to prevent the vector from disturbing other genes once it integrated into the human genome. The goal was to insert the gene into stem cells that had come from the patients own bone marrow, and those cells would then go on to produce working immune system cells. It was crucial for the viral vector to not deliver the gene to other kinds of cellsand thats what the researchers observed. After gene therapy, for example, brain cells do not have a correct copy of the gene, explained Stephen Gottschalk, who chairs St. Judes Department of Bone Marrow Transplantation and Cellular Therapy.

In the experimental treatment, infants received their re-engineered stem cells just 12 days after some of their bone marrow was obtained. They went through a two-day, low-dose course of chemotherapy, which made room for the engineered cells to grow. Within four months, some of the babies were able to fight infections on their own. All eight of the initial research subjects left the hospital with a healthy immune system. The remarkably positive results made news headlines after being published this past April in the New England Journal of Medicine. Experimental gene therapy frees bubble boy babies from life of isolation, the journal Nature trumpeted.

So far, the children who participated in that study are thriving, and so are several other babies who received the treatmentincluding Omarion. As a physician and a mom, I couldnt ask for anything better, said Ewelina Mamcarz, lead author of the journal article and first-time mother to a toddler nearly the same age as Omarion. The children in the study are now playing outside and attending day care, reaching milestones just like my daughter, Mamcarz says. Theyre no different. Mamcarz, who is from Poland, came to the United States to train as a pediatric hematologist-oncologist and joined St. Jude six years ago.

Other medical centers are pursuing the treatment. The University of California, San Francisco Benioff Childrens Hospital is currently treating infant patients, and Seattle Childrens Hospital is poised to do the same. Moreover, the National Institutes of Health has seen success in applying the gene therapy to older patients, ages 3 to 37. Those participants had previously received bone marrow transplants from partially matched donors, but theyd been living with complications.

In the highly technical world of medicine today, it takes teamwork to achieve a breakthrough, and as many as 150 peoplephysicians, nurses, regulators, researchers, transplant coordinators and othersplayed a role in this one.

Sorrentino died in November 2018, but hed lived long enough to celebrate the trial results. In the early 90s, we thought gene therapy would revolutionize medicine, but it was kind of too early, said Gottschalk, who began his career in Germany. Now, nearly 30 years later, we understand the technology better, and its really starting to have a great impact. We can now develop very precise medicine, with very limited side effects. Gottschalk, who arrived at St. Jude a month before Sorrentinos diagnosis, now oversees the hospitals SCID-X1 research. Its very, very gratifying to be involved, he said.

For now the SCID-X1 gene therapy remains experimental. But with additional trials and continued monitoring of patients, St. Jude hopes that the therapy will earn Food and Drug Administration approval as a treatment within five years.

Simpson, for her part, is already convinced that the therapy can work wonders: Her son doesnt live in a bubble or, for that matter, in a hospital. He can play barefoot in the dirt with other kids, whatever he wants, because his immune system is normal like any other kid, she said. I wish there were better words than thank you.

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Call for better drug to be approved for sufferers of rare blood cancer – The Age

By daniellenierenberg

I could barely think, because all the small blood vessels in my head were getting this thick blood pumping through.

In addition to bad headaches and crippling fatigue, PV sufferers are also prone to blood clots, which can pose a separate health risk.

According to the Leukaemia Foundation, PV is diagnosed in an estimated 250 Australians each year, and is one of three types of blood cancers called MPNs.

Associate Professor Steven Lane says the longer-lasting the version of interferon, the greater the effect it appears to have on PV.

Standard treatment for the condition is old-fashioned bloodletting to help thin the blood, combined with drugs that target the bone marrow, where the cancers stem cells are located.

Associate Professor Steven Lane, who is the head of QIMR Berghofers Cancer Program and a Royal Brisbane and Womens Hospital clinical haematologist, said the current most effective drug on the market in Australia was a form of interferon, a protein-based anti-cancer drug.

However, the form used most widely had to be taken up to three times a week, which, given the drug will often have to be used for the rest of the patients life, was not ideal.

A long-acting version of the drug has now been approved for use in Australia that only needs to be given once a week we call it the long-acting version of the drug, Dr Lane said.

Theres actually an even longer-acting version of the drug, an ultra-long-acting version, which has been approved in Europe but not Australia, and wed like to see that approved here.

Thats because Dr Lanes recent research into PVs response to drug therapy found that, in mice, the longer-acting the version of interferon, the better the effect on reducing the cancer symptoms.

People need to remain on this drug for a long time, and it actually doesnt usually start having an effect for six months, he said.

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And as you increase the duration of action of the drug, not only is it more convenient for the people who need to inject themselves with it, it appears to be more effective as well.

Ms Chapman switched to the long-acting version of interferon around a year ago, and said she finally felt a sudden improvement in her condition just three months ago, just ahead of her 50th birthday in December, and her daughters 21st.

When youve been living with this for 12 or 13 years, you sometimes forget what its like to feel normal, she said.

I would love to get access to the ultra-long-acting version it would be wonderful to have even fewer injections, and better control over the disease as well.

The QIMR research has been published in the journal Leukemia.

Our journalists abide by a set of reporting guidelines when writing about medical research. If you would like to read them click here.

Stuart Layt covers health, science and technology for the Brisbane Times. He was formerly the Queensland political reporter for AAP.

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Autologous Stem Cell And Non Stem Cell Based Therapies Market Opportunity Analysis and Industry Forecast up to 2026 – Guru Online News

By daniellenierenberg

Autologous stem cell and non-stem cell based therapiesinvolve an individuals cell to be cultured and then re-introduced to the donors body. These therapies do not use foreign organism cells and are therefore free from HLA incompatibility, disease transmission, and immune reactions.Increasing demand for the new therapies in the field of regenerative medicine is directly facilitating the growth of autologous stem cell and non-stem cell based therapies market. Furthermore, since the risk to transplantation surgeries is significantly reduced in these therapies, they are increasingly being preferred for treatment of bone marrow diseases, aplastic anemia, multiple myeloma, non-Hodgkins lymphoma, Hodgkins lymphoma, Parkinsons disease, thalassemia, and diabetes.

Moreover, rising incidents of cancer, diabetes and cardiovascular diseases along with growing geriatric population is another factor attributed for its high growth. However, side-effects of autologous stem cell and non-stem cell based therapies such as nausea, infection, hair loss, vomiting, diarrhea, etc. are expected to affect the market to an extent. High cost is another factor that can act as challenge to autologous stem cell and non-stem cell based therapies market. In spite of this, less risk post transplantation surgeries and favorable tax reimbursement policies are anticipated to reduce the impact of these limitation during the forecast period.Autologous stem cell and non-stem cell based therapies market can be segmented on the basis of application, end-user, and region.

In terms of application, the autologous stem cell and non-stem cell based therapies market can be segmented into blood pressure (BP) monitoring devices, intracranial pressure (ICP) monitoring devices, and pulmonary pressure monitoring devices.

In terms of end-user, the market can be segmented into ambulatory surgical center and hospitals. By region, the market can be segmented into North America, Europe, Asia Pacific, Middle East and Africa and South America. Amongst all, Asia Pacific is anticipated to be the most attractive market owing to favorable reimbursement policies in the region.The players operating in autologous stem cell and non-stem cell based therapies market are limited. They are consistently involved in research and development activities for product development to keep up with the growing competition, thereby aiding the growth of autologous stem cell and non-stem cell based therapies market across the world.

The major players operating in autologous stem cell and non-stem cell based therapies market are Regennex, Antria(Cro), Bioheart, Orgenesis Inc., Virxys corporation , Dendreon Corporation, Tigenix, Georgia Health Sciences University, Neostem Inc, Genesis Biopharma, Brainstorm Cell Therapeutics, Tengion Inc., Fibrocell Science Inc., Opexa Therapeutics Inc, Regeneus Ltd, and Cytori Inc., among others.

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Adipose Derived Stem Cell Therapy Market New Business Opportunities and Investment Research Report – Bishop’s Cleeve Bulletin

By daniellenierenberg

Adipose Derived Stem Cell Therapy Market Report 2018-2026includes a comprehensive analysis of the present Market. The report starts with the basic Adipose Derived Stem Cell Therapy industry overview and then goes into each and every detail.

Adipose Derived Stem Cell Therapy Market Report contains in depth information major manufacturers, opportunities, challenges, and industry trends and their impact on the market forecast. Adipose Derived Stem Cell Therapy also provides data about the company and its operations. This report also provides information on the Pricing Strategy, Brand Strategy, Target Client, Distributors/Traders List offered by the company.

Description:

Adipose derived stem cells (ADSCs) are stem cells derived from adipocytes, and can differentiate into variety of cell types. ADSCs have multipotency similar to bone marrow mesenchymal stem cells, thus ADSCs substitute for bone marrow as a source of stem cells. Numerous manual and automatic stem cell separation procedures are adopted in order to separate adipose stem cells (ASCs) from adipose tissue. Flow cytometry can also be used to isolate ADSCs from other stem cells within a cell solution.

Get Request Sample Copy of Research Report @ https://www.coherentmarketinsights.com/insight/request-sample/2357

Important Features that are under offer & key highlights of the report:

1) What all regional segmentation covered? Can the specific country of interest be added?Currently, the research report gives special attention and focus on the following regions:North America (U.S., Canada, Mexico), Europe (Germany, U.K., France, Italy, Russia, Spain etc), South America (Brazil, Argentina etc) & Middle East & Africa (Saudi Arabia, South Africa etc)** One country of specific interest can be included at no added cost. For inclusion of more regional segment quote may vary.

2) What all companies are currently profiled in the report?The report Contain the Major Key Players currently profiled in this market.** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

3) Can we add or profiled new company as per our need?Yes, we can add or profile new company as per client need in the report. Final confirmation to be provided by the research team depending upon the difficulty of the survey.** Data availability will be confirmed by research in case of a privately held company. Up to 3 players can be added at no added cost.

4) Can the inclusion of additional Segmentation / Market breakdown is possible?Yes, the inclusion of additional segmentation / Market breakdown is possible to subject to data availability and difficulty of the survey. However, a detailed requirement needs to be shared with our research before giving final confirmation to the client.** Depending upon the requirement the deliverable time and quote will vary.

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Keyplayers :

Adipose Derived Stem Cell Therapy Market competition by top manufacturers/players, with Adipose Derived Stem Cell Therapy sales volume, Price (USD/Unit), Revenue (Million USD) and Market Share for each manufacturer/player; the top players including: BioRestorative Therapies, Inc., Celltex Therapeutics Corporation, Antria, Inc., Cytori Therapeutics Inc., Intrexon Corporation, Mesoblast Ltd., iXCells Biotechnologies, Pluristem Therapeutics, Inc., Thermo Fisher Scientific, Inc., Tissue Genesis, Inc., Cyagen US Inc., Celprogen, Inc., and Lonza Group, among others.

Adipose Derived Stem Cell Therapy Market Dynamics in the world mainly, the worldwide 2018-2026 Adipose Derived Stem Cell Therapy Market is analyzed across major global regions. CMI also provides customized specific regional and country-level reports for the following areas:

Region Segmentation:

North America (USA, Canada and Mexico)Europe (Germany, France, UK, Russia and Italy)Asia-Pacific (China, Japan, Korea, India and Southeast Asia)South America (Brazil, Argentina, Columbia etc.)Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Key questions answered in the report:

1. What will the market growth rate of Adipose Derived Stem Cell Therapy market in 20262. What are the key factors driving the global Adipose Derived Stem Cell Therapy market3. Who are the key manufacturers in Adipose Derived Stem Cell Therapy market space?4. What are the market opportunities, market risk and market overview of the Adipose Derived Stem Cell Therapy market?5. What are sales, revenue, and price analysis by types and applications of Adipose Derived Stem Cell Therapy market?6. What are sales, revenue, and price analysis by regions of Adipose Derived Stem Cell Therapy industry?

Further in the report, the Adipose Derived Stem Cell Therapy market is examined for Sales, Revenue, Price and Gross Margin. These points are analyzed for companies, types, and regions. In continuation with this data, the sale price is for various types, applications and region is also included. The Adipose Derived Stem Cell Therapy industry consumption for major regions is given. Additionally, type wise and application wise figures are also provided in this report.

Ask Query for more details @ https://www.coherentmarketinsights.com/insight/talk-to-analyst/2357

In this study, the years considered to estimate the market size of 2018-2026 Adipose Derived Stem Cell Therapy Market are as follows:History Year: 2015-2017Base Year: 2017Estimated Year: 2018Forecast Year 2018 to 2026

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Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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U.S. stem cell clinic offering unapproved therapies brings direct-to-consumer marketing to Ottawa – Ottawa Citizen

By daniellenierenberg

Just a few months after Health Canada began cracking down on private clinics offering unapproved stem cell therapies, at least one U.S. clinic has moved in to fill the vacuum with direct marketing to Canadian consumers.

The clinic from Burlington, Vermont, even offers shuttle buses to transport people from Ottawa to the clinic four hours away for treatment it suggests will end joint pain, among other things. Lunch and dinner are free, but each injection costs $6,880. Two for $10,880.

The treatments, using umbilical cord-derived mesenchymal stem cells, are not approved in either Canada or the United States. Health Canada warns that Canadians who travel abroad for stem cell treatments may put themselves at risk.

While stem cells, which were discovered at the University of Toronto in 1961 by James Till and Ernest McCulloch, promise to revolutionize many treatments and could offer breakthroughs for diseases, almost all are still considered experimental and have yet to be proven safe or effective. Clinical trials on numerous potential stem cell therapies are under way, including in Ottawa.

While research progresses, private stem cell clinics have popped up around the world making promises for treatments not yet proven safe or effective.

A 2018 study by Leigh Turner of the University of Minnesota Center for Bioethics found 43 clinics offering stem cell treatments in Canada and 750 in the U.S. Earlier this year, Health Canada sent Canadian clinics, including some in Ottawa, cease-and-desist letters.

Clinics in Vermont, near the Canadian border, appear to have ramped up marketing to Canadians since then. One clinic has been holding back-to-back seminars. Another says it stopped marketing in Canada after receiving a warning from Health Canada.

There have been cases of harm as a result of treatments, including two women who had permanent damage to their sight after stem cells were injected into their eyes at a Florida clinic. Other patients have been infected with unsterilized equipment and others have developed tumours at the site of stem cell injections.

A common harm, critics say, is exploitation.

Dr. Michael Rudnicki is director of the regenerative medicine program and Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute, says of stem cell therapy claims: If it sounds too good to be true, it probably is too good to be true.jpg

Health officials say the clinics are misusing the promise of stem cell therapy to exploit vulnerable patients.

These patients are in pain and they are suffering and they are looking for help and they are being exploited, said Dr. Michael Rudnicki, director of the regenerative medicine program and Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute.

If it sounds too good to be true, it probably is too good to be true.

At a recent seminar at a west-end Ottawa hotel meeting room, Roseanna Ammendolea of the Vermont Center for Regenerative Medicine told a packed room that her clinic and others like it had successfully treated people for pain related to arthritis, neuropathy and other ailments that affected joints using mesenchymal stem cells from umbilical cords. The stem cells, she claimed, are both effective and safe, saying there had been no issues with cell rejection.

We will not give injections if we feel that this injection will not be beneficial to our patients. This is why we are so successful.

Participants, including some who walked with canes and others who talked about being in pain and having mobility issues, were shown videos of people described as Canadian clients who claimed the treatments worked. One man said it was probably the best money I have spent in my life as far as my health. Another said she would do it again in a heartbeat and was able to do things she hadnt been able to do earlier.

They were also shown a slide showing long wait times for hip and knee replacements in Ontario, We are not a priority, she said. Where does that leave us? Participants werent told exactly how the stem cells were supposed to work, but claimed they had successfully improved pain and mobility issues in clients.

What the seminar goers werent told is that, even in the U.S., the treatment is not covered by health insurance because it remains unproven.

The U.S. Federal Drug Administration has issued a warning to consumers not to use cell therapies that are unapproved or unproven.

Stem cells have been called everything from cure-alls to miracle treatments. But dont believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures and confirm whats really being offered before you consider anytreatment, the FDA said in a statement.

The only stem-cell-based products that are FDA-approved for use in the United States are blood-forming stem cells derived from cord blood for limited use in patients with disorders affecting the body system that is involved in the production of blood. Bone marrow is also used for these treatments, but is generally not regulated by the FDA for that use.

Health Canada has granted market authorization for a stem cell therapy to treat graft-versus-host disease and two cell-based gene therapies to treat certain cancers. Most cell therapies are still experimental.

I totally understand the skepticism of it, Doug Argento, who works at the Vermont Center for Regenerative Medicine, said in a telephone interview, but the fact is that things that are approved now and medically paid for were seen as renegade 20 or 30 years ago.

The treatment employs technology developed by Neil Riordan, founder, chairman and chief science officer of the Stem Cell Institute in Panama, using human umbilical cord tissue-derived mesenchymal stem cells. There are 41 such clinics across the U.S. Riordan also played a role in the development of a nutritional product called Stem-Kine, which producers claim without scientific backing increases the number of stem cells circulating in a persons body.

The stem cells injected in the clinic, Argento said, are from umbilical cord tissue as a result of caesarean births to reduce risk of infection.

Rudnicki, of The Ottawa Hospital Research Institute, says there is no evidence that these sorts of cells are regenerative at all. It would not pass muster in Canada.

The public has to understand that there are people out to remove them from their money.

Rudnicki says he regularly receives inquiries from people desperate to get stem cell treatments. He says he tries to connect them with clinical trials that they might be able to participate in.

Rudnicki noted there were multiple clinical trials in Canada, including treatments of autoimmune diseases, trials involving treatment for Type 1 diabetes and others.

But the use of these inappropriate cell types for treating arthritis and joints and so on is certainly not approved by Health Canada and would not be allowed in Canada under the regulations.

There is some evidence that injections of some stem cell products might have a temporary positive impact on inflammation, he said, but it will not be regenerative and will not restore function to joints. They are being sold a bill of goods.

Leigh Turner of the University of Minnesota Center for Bioethics, meanwhile, says the explosion in clinics offering unproven stem cell therapies in the U.S. is a marketplace that traffics in misrepresentation. It is easy to see how people are taken advantage of and scammed.

It is also difficult to find out about physical harms being done to patients.

There are no safety studies. We dont have good data. But we do know there have been some serious harms.

Stem cell therapies have the potential to become standard treatment in some areas, but they are not there yet, Turner said.

Businesses are tapping into genuine human suffering, desperation and also hope.

Turner also noted there was an excellent chance that the vials of liquid being injected into patients did not actually contain stem cells.

Dr. Jonathan Fenton of another stem cell clinic in Burlington, the Vermont Regenerative Medicine, said he had complained about the new clinic, the Vermont Center for Regenerative Medicine, which has a similar name and employs hard-sell tactics, he said.

His clinic takes bone marrow from patients hips and injects it. The procedure is done the same day. He says he regularly sees Canadian patients for bone marrow aspiration therapy and platelet-rich plasma treatments, using their own blood. The treatments, he says, speed healing and are allowed in the U.S. The use of bone marrow aspiration is neither proven nor allowed in Canada.

Fenton, who is secretary-treasurer of the American Academy of Orthopedic Medicine, acknowledged many people offering stem cell treatments are not doing it to the highest ethical standards.

He has filed complaints with state officials over clinics selling unsafe or fraudulent treatments. I have asked the state and federal judiciary to close down this clinic for committing fraud.

He said his platelet and bone marrow treatments were covered by a major Vermont health insurer because they saw the cost of benefits were going down and patients were requiring fewer surgeries.

He said he was told by Health Canada that he could not market in Canada. Representatives of the Vermont Center for Regenerative Medicine, meanwhile, said they had discussions with Health Canada about what they could and could not say when marketing in Canada before holding seminars in Ottawa and Halifax.

We have looked at the information provided and have not identified any immediate non-compliance with advertising regulations pertaining to Canadian health products, a Health Canada spokesperson said, adding that the agency was continuing to assess.

Back at a west-end Ottawa hotel, some participants in the seminar, including a retired pharmacist, said they were considering getting the treatments. But its expensive.

Another participant said he was skeptical. They seemed very sketchy when I went online.

epayne@postmedia.com

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CNST Stock Is Particularly Risky After Its Recent Run – Investorplace.com

By daniellenierenberg

In my view, few investment sectors are as frustrating as the pharmaceutical industry. One moment, you could be riding high on bullish momentum. The next, you could be staring at unfathomable losses. For stakeholders of Constellation Pharmaceuticals (NASDAQ:CNST), though, theyre enjoying the positive end of this dynamic. Year to date, CNST stock is up a blistering 846%.

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Most of these bonkers gains came within the last two months. Since the beginning of October, Constellation Pharmaceuticals stock has jumped nearly 400%. And in this month alone, CNST is up over 68%. Seemingly, this company has no downside, inspiring others to jump aboard this extreme momentum name. Should you follow suit?

Unlike other speculative gambles, a fundamental case exists for the massive skyrocketing of CNST stock. Among the underlying companys therapies is an experimental drug called CPI-0610, a treatment for myelofibrosis. According to pharma giant Celgenes (NASDAQ:CELG) website, myelofibrosis is a rare blood cancer. Only 5,000 people in the U.S. are diagnosed with the illness each year.

Further, myelofibrosis starts in the stem cells of the bone marrow, leading to the production of faulty blood cells. Prior efforts in treating this illness have not produced substantive results. However, Constellations CPI-0610 has performed exceptionally well in a phase II study; hence, the massive surge in Constellation Pharmaceuticals stock.

In fact, all four patients that participated in the study responded positively to the drug. Because of the positive data that came from the clinical trial, Constellation will expand the study to include more patients. This, of course, suggests supreme confidence in the CPI-0610 therapy, and that could ultimately represent a paradigm-shifting breakthrough.

Still, I think you should consider the long road ahead before jumping aboard CNST stock.

By their very nature, rare diseases are difficult to address. And among this class of debilitating conditions, myelofibrosis is particularly nasty. According to Dr. Ruben Mesa, myelofibrosis is a variable disease. This means that medical doctors must apply custom-tailored treatments for different patients.

Thus, while Constellation may have won the initial round in its Phase II study, the real work is coming ahead. With many more test subjects, the chances that CPI-0610 could be considered ineffective or even adverse jump significantly.

In other words, the enthusiasm were seeing now with CNST stock could quickly go the other way.

Theres also the little matter of the economics and politics of addressing myelofibrosis. As you might imagine, combating rare diseases without financial incentives wouldnt make much economic sense. But the Orphan Drug Act, passed in 1983, encouraged pharmaceuticals to address rare diseases through various incentive programs.

Unfortunately, like anything involving government action, good intentions gave way to hellish results. Pharmaceuticals gamed the system the Orphan Drug Act created, pocketing massive profits for rare-disease therapies. Since the patients had no recourse in this monopolized environment, they (and their insurance companies) foot the bill.

Underlining the current bullish thesis for CNST stock is the idea that Constellation will become the only viable myelofibrosis player. Celgene is trying but is coming up short. Essentially, Constellation can charge what they want for their drug if theyre successful.

But even if they are successful and thats a huge if the political environment for price-gouging pharmaceuticals is extremely unfavorable.

No matter how great a scientific achievement Constellation has made, diving into Constellation Pharmaceuticals stock seems risky. With shares gaining 400% in the past month and a half, most of the good news is surely baked in.

Of course, we could hear even better results once the company expands its myelofibrosis study. But that too is a risky perspective.

For those who are not familiar with the pharmaceutical industry, I highly recommend reading Dr. Mario Beauregards book Brain Wars. Among the many topics that Dr. Beauregard covers, a central motif is the mysteries of the mind. Compelling evidence indicates that our mental state can generate healing.

But a flipside to this concept is that an alarming number of pharmaceuticals fail the placebo test; that is, many if not most drugs are no more effective than patients belief in their efficacy.

Soon, well see how good CPI-0610 really is. For those that cant handle extreme price swings, you should stay away from Constellation Pharmaceuticals stock.

As of this writing, Josh Enomoto did not hold a position in any of the aforementioned securities.

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CytoDyn Announces Acceptance of Leronlimab (PRO 140) Data for Presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) in…

By daniellenierenberg

Independent data from the PRESTIGIO Registry Study Group in Italy shows leronlimab inhibits multi-drug resistant HIV-1 viruses in Heavily Treatment-Experienced (HTE) patients

VANCOUVER, Washington, Nov. 18, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that an abstract from the PRESTIGIO Registry Study Group showing that leronlimab was effective at inhibiting multi-drug resistant HIV-1 isolates from HTE patients was accepted for presentation at CROI. The HTE HIV-1-infected patients harbored documented 4-class resistances and were enrolled in the Italian PRESTIGIO Registry Study Group. The authors conclude that, in HTE patients with multi-drug resistance to HIV-1, all CCR5 tropic strains were fully susceptible to PRO 140.

PRESTIGIO is an Italian registry (http://www.registroprestigio.com) involving 40 clinical centers throughout Italy, coordinated by the IRCCS San Raffaele Hospital (Milan). The registry is performing medical research in a study involving HTE HIV-1-infected patients with a documented 4-class drug resistance (multi-drug resistance MDR), including novel treatment approaches.

This completely independent research study on clinical isolates from patients with documented 4-class drug resistances demonstrates that leronlimab may play a key role in patients with very limited therapeutic options, stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. This is further support for our belief that leronlimab is positioned to change the treatment paradigm in HIV therapy, Dr. Pourhassan concluded.

This data, co-authored by Stefano Rusconi, M.D., et al., University of Milan, on behalf of the PRESTIGIO Registry Study Group, will be presented at the March 8-11, 2020 CROI meeting at the Hynes Convention Center, Boston, MA.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including non-alcoholic steatohepatitis (NASH). Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays a vital role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. CytoDyn is conducting additional research with leronlimab in the setting of oncology and NASH with plans to conduct further clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD. Blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a crucial role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication, which, if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients. Some patients on leronlimab monotherapy have viral suppression for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements but, their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Nader Pourhassan, Ph.D.President & CEOnpourhassan@cytodyn.com

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CytoDyn Announces Acceptance of Leronlimab (PRO 140) Data for Presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) in...

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Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts – TheNewsCrunch

By daniellenierenberg

Gallant Stem Cell Therapy For Dogs is one of the product companies to be featured on Shark Tank Season 11 Episode 8. The story behind the birth of Gallant Stem Cell Therapy For Dogs is pretty interesting. Here are some of the unknown facts about Gallant and its founders, Aaron Hirschhorn.

Aaron Hirschhorn is the founder and former-CEO of the popular dog-sitting marketplace DogVacay. Aaron is a noted entrepreneur with more than 20 years of experience in building companies and investing in them. DogVacay app was launched in 2013 and Aaron managed to raise $47 million from his erstwhile investors.

Aaron was the finalist in the Ernst & Young Entrepreneur of the Year Award 2016. In April 2017, Aarons DogVacay app merged with Rover.com and eventually went on to become a $1 billion pet services marketplace.

Trouble struck Aarons life when he suffered a massive back injury and was forced to undergo stem cell treatment which yielded amazing results to his surprise. Aaron, being an ardent dog lover wondered why this cutting-edge medical technology of stem cell transplants cannot be applied to dogs.

As a result, Gallant was born in the middle of 2018. According to Gallant, Your pups stem cells haveincredible healing power. Extract and store these powerful cells during your pets spay/neuter, so that you can unleash their potential when your best friend needs it most.

Ever since its inception, the mission of Gallant stem cell therapy is to help pets live a healthier life and make use of the epic technology of stem cell therapy in saving the lives of tons of dogs.

Dogs enter their senior years around 7 and begin feeling the effects of aging as early as 4! Traditional methods of treatment for injury and age-related conditions are expensive and can have harmful side effects. Stem cells are incredible natural healers. However, up to 99% of stem cells are lost over time due to aging. This forms the bottomline of Gallants business problem.

Gallant raised $7 million investment in August 2019.

https://gallant.com/

From the moment you entrust Gallant with your dogs stem cells, were actively invested in their long-term health and well-being. Working in tandem with you and your veterinarian, we will collect and store these powerful cells now, so down the road we can help to treat the most common health problems your dog may face. We will also update you on new and potentially life-changing treatments as they become available.

Pick your pups stem cell storage plan you dont have to have a spay/neuter procedure scheduled yet! You can always add that in later. Our proprietary process requires no additional training, so any veterinarian you trust to alter your dog is qualified. Ahead of your dogs spay/neuter, we will connect with your vet and send our collection kit directly to their office.

2. Collect

On the big day, we align with your vet before the procedure and arrange for a courier. During your dogs spay/neuter procedure, your veterinarian will take out the stem cell-rich reproductive tissue they would normally discard into the collection kit.

3. Preserve

Once the tissue is received by our scientists, we send confirmation to both you and your veterinarian. Your dogs tissue is first inspected for quality before isolating the stem cells. The stem cells are then counted and frozen in liquid nitrogen to preserve their potency in our secure, state-of-the-art laboratory. Once this process is complete, you and your veterinarian will be notified that your pets stem cells are safely stored. The cells are then monitored by our team to ensure they stay perfectly preserved.

4. Treat

Your pets stem cells are at the ready to be sent to your veterinarian if/when treatment is needed. Treatments are out-patient procedures and cost about $300. A stem cell procedure is not painful to your pet and does not require anesthesia to administer.

Gallants stem cell therapy is receiving a lot of exciting reviews online. The therapy has been successful in saving scores of dogs with conditions like osteoarthritis, skin conditions, chronic dry eye.

Gallant is offering a $395 off discount for using the code SHARKTANK

How did Gallant fare in Shark Tank Season 11? What did the Sharks have to tell about it? Did Gallant Get a Deal on Shark Tank? More information to be updated soon in this post.

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Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts - TheNewsCrunch

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Everything you need to know about Victoria Beckhams first skincare product launching tomorrow – Evening Standard

By daniellenierenberg

The latest lifestyle, fashion and travel trends

He is one of the most googled names in beauty, and she, one of the most prominent figures in fashion.

It was therefore a fitting match for Victoria Beckham to join forces with Augustinus Bader the notoriously publicity-shy director of stem cell biology and cell technology at the University of Leipzig for her first foray in to skincare.

Bader became a household beauty name in February 2018, after the launch of his cult-product The Cream caused convulsions of desire to ripple throughout the beauty industry thanks to its ultra-hydrating and restorative qualities.

And so when looking for a scientific collaborator to join her on her endeavour in to skincare, it seemed a natural fit for the two to merge theircomplementingareas of expertise.

The Cell Rejuvenating Priming Moisturizer (Victoria Beckham Beauty)

Cue the result of the pairing: Victoria Beckham Beautys Cell Rejuvenating Priming Moisturizer.

The moisturiser is the new-and-improved iteration of the Morning Aura Primer Beckham launched as part of her collaboration with Este Lauder in 2016.

The product, which Beckham has re-developed with the help of 59-year-old Bader, is a multifunctional cream thatclaims to prime, impart a glow and also to repair.

Commenting on the collaborative beauty effort, Beckham took to her Instagram page to note: It has been a dream to develop, with Augustinus, a priming moisturizer that works to improve the health of my skin and gives that fresh, natural glow that I love.

Meanwhile Bader said: "It was an honour to collaborate with Victoria for her first Skin launch. I'm excited to share some of our skincare benefits in this product. It's the first product of its kind to care for your skin cells while also preparing your skin for makeup application."

A celebrity facialist has revealed VB's 9-step daily skincare routine

This marks the first skincare product 45-year-old Beckham has launched under her beauty line, which she debuted to critical-acclaim in September, alongside the brands co-founder, Sarah Creal.

Victoria Beckham Beauty has the tagline Luxury Performance, Clean Beauty, and is refusing to pigeonhole itself as just a beauty brand, instead referring to itself as clean beauty movement.

Cell Rejuvenating Priming Moisturizer costs 92 for 30ml and launches tomorrow exclusively at victoriabeckhambeauty.com and augustinusbader.com.

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Oncology drugs market is expected to grow at a CAGR of 12.7% over the forecast period owing to rising number of pipeline cell-therapy products, says…

By daniellenierenberg

Global oncology drugs market was estimated to be US$ 119 billion in 2018 is expected to reach US$ 350.01 billion by 2027, growing at an estimated CAGR of 12.7% over the forecast period.

Cancer is a disease, which involves the abnormal growth of cells that results in the formation of a tumor. However benign tumors are not cancers. The abnormal tumor cells have the tendency to spread to other local tissues and may also spread to different parts of body through blood and lymphatic system. Different types of cancers such as lung cancer, colorectal, breast cancer, and others are predominant among the populace. Treatment of cancer depends upon the stages of the disease progression. Chemotherapy is majorly used in the earlier stages whereas other therapy options such as targeted therapy drugs, immunological therapy drugs are used in late stage.

Request For Sample Copy of This Report:https://www.absolutemarketsinsights.com/request_sample.php?id=273

The detailed research study provides qualitative and quantitative analysis of the global oncology drugs market. The market has been analyzed from demand as well as supply side. The geographical analysis done emphasizes on each of the major countries across North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

Key Findings of the Report:

Enquiry Before Buying This Report:https://www.absolutemarketsinsights.com/enquiry_before_buying.php?id=273

Key Market Segments of Oncology drugs market are:

By Indication

Oncology drugs Market By Treatment

Oncology drugs Market By Geography

For more information ask our experts@https://www.absolutemarketsinsights.com/reports/Oncology-Drugs-Market-2019-2027-273

About Absolute Markets Insights:Contact Us:Company: Absolute Markets InsightsContact Name: Shreyas TannaPhone: +91-740-024-2424Email id:sales@absolutemarketsinsights.comWebsite:https://www.absolutemarketsinsights.com

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Oncology drugs market is expected to grow at a CAGR of 12.7% over the forecast period owing to rising number of pipeline cell-therapy products, says...

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