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Researchers have found a way, in mice and human tissue, to regenerate the cartilage that eases movement between bones.

Loss of this slippery and shock-absorbing tissue layer, called articular cartilage, is responsible for many cases of joint pain and arthritis, which afflicts more than 55 million Americans.

The researchers can envision a time when people are able to avoid getting arthritis in the first place by rejuvenating their cartilage before it is badly degraded.

Nearly 1 in 4 adult Americans suffer from arthritis, and far more are burdened by joint pain and inflammation generally.

The researchers figured out how to regrow articular cartilage by first causing slight injury to the joint tissue, then using chemical signals to steer the growth of skeletal stem cells as the injuries heal.

Cartilage has practically zero regenerative potential in adulthood, so once its injured or gone, what we can do for patients has been very limited, says co-senior author Charles K.F. Chan, assistant professor of surgery at Stanford Universitys School of Medicine.

Its extremely gratifying to find a way to help the body regrow this important tissue, Chan says.

The work builds on previous research that resulted in isolation of the skeletal stem cell, a self-renewing cell that is also responsible for the production of bone, cartilage and a special type of cell that helps blood cells develop in bone marrow.

Articular cartilage is a complex and specialized tissue that provides a slick and bouncy cushion between bones at the joints. When this cartilage is damaged by trauma, disease, or simply thins with age, bones can rub directly against each other, causing pain and inflammation, which can eventually result in arthritis.

Damaged cartilage can be treated through a technique called microfracture, in which tiny holes are drilled in the surface of a joint. The microfracture technique prompts the body to create new tissue in the joint, but the new tissue is not much like cartilage.

I realized the only way to understand the process was to look at what stem cells are doing after microfracture.

Microfracture results in what is called fibrocartilage, which is really more like scar tissue than natural cartilage, says Chan. It covers the bone and is better than nothing, but it doesnt have the bounce and elasticity of natural cartilage, and it tends to degrade relatively quickly.

The most recent research arose, in part, through the work of surgeon and lead author Matthew Murphy, a visiting researcher at Stanford who is now at the University of Manchester.

I never felt anyone really understood how microfracture really worked, Murphy says. I realized the only way to understand the process was to look at what stem cells are doing after microfracture.

For a long time, Chan says, people assumed that adult cartilage did not regenerate after injury because the tissue did not have many skeletal stem cells that could be activated. Working in a mouse model, the team documented that microfracture did activate skeletal stem cells. Left to their own devices, however, those activated skeletal stem cells regenerated fibrocartilage in the joint.

But what if the healing process after microfracture could be steered toward development of cartilage and away from fibrocartilage?

The researchers knew that as bone develops, cells must first go through a cartilage stage before turning into bone. They had the idea that they might encourage the skeletal stem cells in the joint to start along a path toward becoming bone, but stop the process at the cartilage stage.

The researchers used a powerful molecule called bone morphogenetic protein 2 (BMP2) to initiate bone formation after microfracture, but then stopped the process midway with a molecule that blocked another signaling molecule important in bone formation, called vascular endothelial growth factor (VEGF).

What we ended up with was cartilage that is made of the same sort of cells as natural cartilage with comparable mechanical properties, unlike the fibrocartilage that we usually get, Chan says. It also restored mobility to osteoarthritic mice and significantly reduced their pain.

As a proof of principle that this might also work in humans, the researchers transferred human tissue into mice that were bred to not reject the tissue, and were able to show that human skeletal stem cells could be steered toward bone development but stopped at the cartilage stage.

The next stage of research is to conduct similar experiments in larger animals before starting human clinical trials. Murphy points out that because of the difficulty in working with very small mouse joints, there might be some improvements to the system they could make as they move into relatively larger joints.

The first human clinical trials might be for people who have arthritis in their fingers and toes. We might start with small joints, and if that works we would move up to larger joints like knees, Murphy says.

Right now, one of the most common surgeries for arthritis in the fingers is to have the bone at the base of the thumb taken out. In such cases we might try this to save the joint, and if it doesnt work we just take out the bone as we would have anyway. Theres a big potential for improvement, and the downside is that we would be back to where we were before.

One advantage of their discovery is that the main components of a potential therapy are approved as safe and effective by the FDA, says co-senior author Michael Longaker, professor of surgery.

BMP2 has already been approved for helping bone heal, and VEGF inhibitors are already used as anti-cancer therapies, he says. This would help speed the approval of any therapy we develop.

Joint replacement surgery has revolutionized how doctors treat arthritis and is very common: By age 80, 1 in 10 people will have a hip replacement and 1 in 20 will have a knee replaced. But such joint replacement is extremely invasive, has a limited lifespan and is performed only after arthritis hits and patients endure lasting pain.

The researchers say they can envision a time when people are able to avoid getting arthritis in the first place by rejuvenating their cartilage in their joints before it is badly degraded.

One idea is to follow a Jiffy Lube model of cartilage replenishment, Longaker says. You dont wait for damage to accumulateyou go in periodically and use this technique to boost your articular cartilage before you have a problem.

The work appears in the journal Nature Medicine.

Support for the research came from the National Institutes of Health, the California Institute for Regenerative Medicine, the Oak Foundation, the Pitch Johnson Fund, the Gunn/Olivier Research Fund, the Stinehart/Reed Foundation, The Siebel Foundation, the Howard Hughes Medical Institute, the German Research Foundation, the PSRF National Endowment, National Center for Research Resources, the Prostate Cancer Research Foundation, the American Federation of Aging Research, and the Arthritis National Research Foundation.

Source: Stanford University

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Method regrows cartilage to cushion bones - Futurity: Research News

SAN DIEGO Cystinosis is a disease that slowly and aggressively attacks your organs, tissues, muscles, bones, eyes, even your brain.

It's a genetic disorder with no cure.

And right now, the only option for treatment is an army of pills to slow it down but missing even one dose can be devastating.

Now one man is "patient one", the first to try a new treatment that may save thousands of lives.

21-year old Jordan Janz is living with the rare, unrelenting disorder.

"I was diagnosed at eight months old and basically have been living with it my whole life."

In Jordan, cystine, an amino acid, gets trapped in his cells.

When cystine levels rise, crystals build up all over the body leaving a trail of damage... even causing him to vomit up to 13 times a day.

"It's not how strong you are physically," he said.

"I think it's how strong you are mentally when you come into this."

Traditional cystinosis treatments aim to slow the build up of cystine inside cells.

In order to do that Jordan takes 56 pills each day, but now he hopes to change that, Jordan is the first patient to test a unique gene therapy.

UC San Diego professor Stephanie Cherquie's took stem cells from Jordan's bone marrow, re-engineered the cells, introduced genes that will produce cystinosin, then reinfused Jordan with his own cystinosin-producing cells.

"So, then these cells become a source of healthy stem cells for the rest of the life of the patient," said Stephanie.

Jordan had to take chemo twice a day, but he hasn't let that scare him away.

"I'm doing this obviously for other cystinosis families, right?," said Jordan.

Hoping that many others after him will now get the chance at a better, longer life.

For those born with cystinosis who make it into adulthood, the average lifespan is around 28 years old.

We're told Jordan Janz is making a good recovery. though it is still too soon to tell his long-term prognosis.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

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YOUR HEALTH: When the body turns to crystals - WQAD.com

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Few of the companies that are covered in the report.

Regen Biopharma IncChina Cord Blood CorpCBR Systems IncEscape Therapeutics IncCryo-Save AGLonza Group LtdPluristem Therapeutics IncViaCord Inc

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AllogeneicAutologous

By Applications:

Peripheral Blood Stem Cells Transplant (PBSCT)Bone Marrow Transplant (BMT)Cord Blood Transplant (CBT)

By Geographical Location:Asia Pacific: China, Japan, India, and Rest of Asia PacificEurope: Germany, the UK, France, and Rest of EuropeNorth America: The US, Mexico, and CanadaLatin America: Brazil and Rest of Latin AmericaMiddle East & Africa: GCC Countries and Rest of Middle East & Africa

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Hematopoietic Stem Cell Transplantation (HSCT) Supply Chain Analysis

Hematopoietic Stem Cell Transplantation (HSCT) Pricing Analysis

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Global Hematopoietic Stem Cell Transplantation (HSCT) Market Size, Analytical Overview, Growth Factors, Demand, Trends And Forecast To 2026 -...

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

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As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

Some of the key market players in the global myelofibrosis treatment market are Incyte Corporation, Novartis AG, Celgene Corporation, Mylan Pharmaceuticals Ulc., Bristol-Myers Squibb Company, Eli Lilly and Company, Taro Pharmaceuticals Inc., AllCells LLC, Lonza Group Ltd., ATCC Inc. and others.

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Demand for Myelofibrosis Treatment Market to Witness Rapid Surge During the Period 2016 2022 - Scientect

Background:Microfracture is a surgical technique that involves creating multiple holes of 3-4 mm depth in the subchondral bone to recruit stem cells in the bone marrow to the lesion, inducing fibrocartilage repair and knee cartilage regeneration. Recently, it has been reported that increasing the exposed area of the lower cartilaginous bone (drilling a lot of holes) increases the outflow of stem cells, which is expected to affect the physical properties of the subchondral bone when the exposed area is large. The purpose of this study was to analyse the effect of the distance between the holes in the microfracture procedure on the structural stability of the osteochondral bone using a finite element method.

Methods:In this study, lateral aspects of the femoral knee, which were removed during total knee arthroplasty were photographed using microtomography. The model was implemented using a solitary walks program, which is a three-dimensional simplified geometric representation based on the basic microtomography data. A microfracture model was created by drilling 4 mm-deep holes at 1, 1.5, 2, 2.5, 3, 4, and 5 mm intervals in a simplified three-dimensional (3D) geometric femoral model. The structural stability of these models was analysed with the ABAQUS program. We compared the finite element model (FEM) based on the microtomography image and the simplified geometric finite element model.

Results:Von Mises stress of the subchondral bone plate barely increased, even when the distance between holes was set to 1 mm. Altering the distance between the holes had little impact on the structural stability of the subchondral bone plate. Safety factors were all below 1.

Conclusions:Although we did not confirm an optimal distance between holes, this study does provide reference data and an epidemiological basis for determining the optimal distance between the holes used in the microfracture procedure.

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The effect of distance between holes on the structural stability of subchondral bone in microfracture surgery: a finite element model study - DocWire...

Neutrophils are the warriors of the immune system. They are always ready to spring to action to help heal injuries or fight off disease. Unless, that is, something goes wrong in their developmental process.Immature neutrophils arent all warriors they can be dangerous turncoats. High levels of immature neutrophils in the bloodstream can be a tell-tale sign of cancer and may even be a biomarker for COVID-19.

Now scientists at La Jolla Institute for Immunology (LJI) have tracked down the rare stem cells that generate neutrophils in human bone marrow. This research, published in Immunity, gives researchers a potential path for intervening in diseases where neutrophil development goes awry.

We have identified the stem cells that are the early origins of neutrophils, the most abundant blood cell type in humans, says Huy Dinh, Ph.D., a former LJI postdoctoral associate who recently moved to a faculty position at The University of WisconsinMadison. Dinh led the study with LJI Professor Catherine C. Hedrick, Ph.D. Knowing how human neutrophils develop is especially relevant today because immature neutrophils have been found to be elevated in both the blood and lungs of severe COVID-19 patients.

Despite their importance, neutrophils have proven very hard to study. They dont hold up well outside the body, and the stem cells that make them are even harder to investigate because they only live in bone marrow.

In 2018, the Hedrick Lab reported the discovery of a group of progenitor stem cells that give rise to mature neutrophils. These progenitors sole job was to generate neutrophils, yet they appeared to also promote tumor growth. The researchers believed that detecting these progenitors could give doctors a better way to catch early cancer cases. But first, the team needed to know a lot more about neutrophil development.

The new research revealed a progenitor cell type that exists even earlier in human neutrophil development. Dinh, a past SPARK Award recipient, together with Tobias Eggert, Ph.D., a LJI visiting scientist and Melissa Meyer, Ph.D., a LJI postdoc, who served as the co-first authors in the study, spearheaded the effort to use a tool called cytometry by time-of-flight (CyTOF) to distinguish these rare cells from other types of immune progenitor cells. This work also made it possible for the researchers to identify more specific protein markers on this early progenitor cell surface.

The discovery of these protein markers was important because until now, scientists have used only a few of markers to track neutrophils over time. The new study gives scientists specific markers for tracking neutrophil development from day one.

The researchers also found that cases of skin and lung cancers are often accompanied by a flood of immature neutrophils including the early progenitor cells into the bloodstream. These immature neutrophils change as they interact with tumor cells, though the researchers arent sure yet how these changes affect cancer progression.

Dinh likens the stages of neutrophil development to the cars on a train. The early progenitors are like the train engine, keeping everything going smoothly along the track to maturity. Cancer shakes everything up, and immature neutrophils jump off the track before they reach maturity. Its like the train is falling apart, Dinh says.

Neutrophil development has been in the news recently due to the COVID-19 pandemic, as studies have shown immature neutrophils are also more abundant in some patients with COVID-19. Dinh and Hedrick think perhaps the threat of the virus prompts the body to churn out neutrophils too quickly, again forcing immature cells off the track to maturity.

We need to study this phenomenon further to see if these neutrophils can be tied to case prognosis or if they can be a drug target for COVID-19, says Dinh.

The researchers hope to continue their work to discover the exact mechanisms that stop neutrophils from reaching maturity. Knowing the earliest cell that gives rise to neutrophils is really critical for trying to target and control these cells, says Hedrick. But we dont know exactly how to do that yet.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Researchers Get First-Ever Look at a Rare but Vital Stem Cell in Humans - Technology Networks

This article was originally published here

Stem Cell Rev Rep. 2020 Aug 22. doi: 10.1007/s12015-020-10033-6. Online ahead of print.

ABSTRACT

Therapeutic clinical and preclinical studies using cultured cells are on the rise, especially now that the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern, in January, 2020. Thus, this study aims to review the outcomes of ongoing clinical studies on stem cells in Severe Acute Respiratory Syndrome (SARS), Acute Respiratory Distress Syndrome (ARDS), and Middle East Respiratory Syndrome (MERS). The results will be associated with possible applications to COVID-19. Only three clinical trials related to stem cells are considered complete, whereby two are in Phase 1 and one is in Phase 2. Basically, the ongoing studies on coronavirus are using mesenchymal stem cells (MSCs) derived from bone marrow or the umbilical cord to demonstrate their feasibility, safety, and tolerability. The studies not related to coronavirus are all in ARDS conditions; four of them are in Phase 1 and three in Phase 2. With the COVID-19 boom, many clinical trials are being carried out using different sources with an emphasis on MSC-based therapy used to inhibit inflammation. One of the biggest challenges in the current treatment of COVID-19 is the cytokine storm, however MSCs can prevent or mitigate this cytokine storm through their immunomodulatory capacity. We look forward to the results of the ongoing clinical trials to find a treatment for the disease. Researchers around the world are joining forces to help fight COVID-19. Stem cells used in the current clinical studies are a new therapeutic promise for COVID-19 where pharmacological treatments seem insufficient.Graphical Abstract.

PMID:32827081 | DOI:10.1007/s12015-020-10033-6

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Review of Trials Currently Testing Stem Cells for Treatment of Respiratory Diseases: Facts Known to Date and Possible Applications to COVID-19 -...

Steadman Philippon Research Institute has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health. Steadman Philippon Research Institutes Chief Scientific Officer Johnny Huard, Ph.D. will serve as the principal investigator.

Marc J. Philippon, M.D., who serves as managing partner of The Steadman Clinic and co-chair of SPRI and Scott Tashman, Ph.D., director of biomedical engineering at SPRI, will serve as co-principal investigators. The clinical trials are expected to begin enrolling in the fall of 2020.

The award, administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, ranks as one of the most significant in SPRIs history, both in size and recognition. Given the potential of regenerative medicine to enhance human health and treat disease, the United States Congress included a provision in the 21st Century Cures Act a law passed in December 2016 to accelerate medical discovery and innovation to support the NIH-established Regenerative Medicine Innovation Project.

The Regenerative Medicine Innovation Project aims to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for protecting patient safety during the conduct of research.

This is a really great honor for SPRI, said Huard in a news release. Past recipients of these RMIP awards have been Albert Einstein College of Medicine, Boston Childrens Hospital, Columbia University Health Sciences, Childrens Hospital of Philadelphia, Harvard University, University of Colorado Denver and Yale University.So, we are in very good company.

Huard first came to Vail in 2015 and has served as the director of the Center for Regenerative Sports Medicine in addition to his role as the institutes chief scientific officer.

The grant anticipates over $2.8 million from the NIH and requires a 1:1 match from SPRI over the next five years, pending availability of federal funds. The clinical trials and resulting publications and reports will take place over the next five years. A generous SPRI benefactor committed to fund the first year of the match, and Dr. Huard is hopeful that with the NIH matching the funds, more philanthropists will be inspired to become involved in this groundbreaking project.

Our donors have been so generous in supporting all that we do here at SPRI, Huard said. And I am very grateful and confident that we will raise the funds necessary to complete these trials over the next five years.

The trial is entitled, The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis. Huard explains in laypersons terms:

The idea behind the trial is to delay osteoarthritis in the knee, Huard said. Our goal is to delay the need for that first knee replacement in a patient for as long as we can. Over time SPRI intends to expand this area of research to other joints including hip and shoulder.

This clinical trial is designed to determine whether senolytic and/or antifibrotic agents will improve the beneficial effect of bone marrow stem cells for the treatment of symptomatic knee osteoarthritis. The trial will include four groups, totaling 100 patients, to investigate the teams hypothesis that the use of these agents will improve patient outcomes.

One of the great things that I love about this particular clinical trial is that we are actively involving our orthopedic surgeons and our biomotion lab staff as well, Huard said. This will truly be a team effort over the next five years.

Those world-class surgeons are led by Dr. Philippon, considered one of the worlds foremost orthopedic surgeons. The biomotion lab is under the direction of Dr. Tashman. The contributions of these two leaders and the talented roster of surgeons, clinicians and technicians in their departments will be critical to the success of the upcoming clinical trials. SPRIs Center for Outcomes-Based Orthopaedic Research and its director, Grant Dornan, are also participating in this project by contributing the statistical outcomes.

Dr. Philippon is not only a world-class surgeon but he is also an innovator, Huard said. He always wants to improve and is still willing to try new things to enhance patient outcomes. Dr. Tashman is the same way. Like everyone here at SPRI and The Steadman Clinic, they are embracing the cutting-edge technology available to them and finding new and better ways to treat patients and, most importantly, reduce patients recovery time and get them back to their active lives as quickly and safely as possible.

Huard notes that the rare combination of a globally recognized research institute like SPRI and a world-class orthopedic surgery clinic like The Steadman Clinic in the same building is one of the key factors in the awarding of this RMIP grant.

Weve got something here in Vail that many other research institutes dont have, Huard said. We have one of the worlds finest orthopedic clinics right next door, working hand-in-hand with us every day.

Dr. Huard and Dr. Tashman along with Suzanne Liv Page, J.D., our director of grants and contracts have worked diligently to prepare and gain acceptance of this grant proposal from the NIH, Philippon said. Our surgeons here at The Steadman Clinic eagerly await the opportunity to participate in the trial. Johnny, Scott and their staff have put SPRI into position to undertake major trials and studies like this one and we are all very honored that the NIH has given SPRI this incredible opportunity.

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Steadman Philippon Research Institute receives prestigious matching grant from the National Institutes of Health - Vail Daily News

The researchers wanted to turn those awakened stem cells into cartilage. The recipe that worked was to treat the stem cells with bone morphogenetic protein, which is used to help fuse bones.

The scientists also used a drug called Avastin, which prevents the stem cells from getting a blood supply. Unlike bone and bone marrow, cartilage has no blood supply, and the drug helped stimulate the stem cells to turn into cartilage.

The investigators provided the drugs directly to the ends of bones, putting them in a gel.

The cartilage that grew in the mice not only looked like normal but lasted for four months, a quarter of the animals lifetimes. Dr. Chan and Dr. Longaker envision a time when doctors will be able to resurface arthritic joints or, even better, to treat people who are just beginning to develop arthritis, perhaps staving off the sort of damage that even joint replacements cannot fix.

If the strategy works in humans, then early treatment may be the best approach, Dr. Marx said.

Arthritis deforms joints and changes bones, he said. By the time people have hips or knees replaced, irreversible damage may be done. Legs may be bowed, bones damaged.

You cannot totally turn back the clock, Dr. Marx said. At that point, he said, adding cartilage will not fix it.

He worries, though, that orthopedists may not wait for rigorous studies the method of awakening the dormant cells is relatively simple, and the drugs required are already on the market.

Faced with a patient with aching knees, orthopedists may be tempted to say, Lets try this. You dont have much to lose, Dr. Marx noted.

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Cartilage Is Grown in the Arthritic Joints of Mice - The New York Times

The research, analysis and estimations about the market have been performed with the steadfast knowledge in this Cord Stem Cell Banking Market report. This market report helps to obtain information about all the above factors by giving actionable market insights and comprehensive market analysis. Analysis and discussion of important industry trends, market size, sales volume, and market share are also estimated in this market report. To achieve maximum return on investment (ROI), its very fundamental to figure out market parameters such as brand awareness, market landscape, possible future issues, industry trends & customer behaviour where this Cord Stem Cell Banking Market report comes into picture.

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Global Cord Stem Cell Banking Market report gives clear idea to Healthcare industry in regard with what is already available in the market, what market anticipates, the competitive environment, and what to be get done to surpass the competitor. This market report serves a great purpose of better decision making and achieving competitive advantage. The report supports in evaluating brand awareness, market landscape, possible future issues, industry trends and customer behaviour with which refined business strategies can be fixed. Cord Stem Cell Banking Market report has been comprised of a significant data along with future forecast and detailed analysis on a global and regional level.

Global Cord stem cell banking market is estimated to reach USD 13.8 billion by 2026 registering a healthy CAGR of 22.4%. The increasing number of parents storing their childs cord blood, acceptance of stem cell therapeutics, high applicability of stem cells are key driver to the market.

Few of the major market competitors currently working in the globalcord stem cell banking marketareCBR Systems, Inc., Cordlife, Cells4Life Group LLP, Cryo-Cell International, Inc., Cryo-Save AG, Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS PLUS., Cryoviva India, Global Cord Blood Corporation, National Cord Blood Program, Vita 34, ReeLabs Pvt. Ltd., Regrow Biosciences Pvt. Ltd. , ACROBiosystems., Americord Registry LLC., New York Blood Center, Maze Cord Blood, GoodCell., AABB, Stem Cell Cryobank, New England Cryogenic Center, Inc. among others

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Market Definition: Global Cord Stem Cell Banking Market

Cord stem cells banking is nothing but the storing of the cord blood cell contained in the umbilical cord and placenta of a newborn child. This cord blood contains the stem cells which can be used in future to treat disease such as leukemia, thalassemia, autoimmune diseases, and inherited metabolic disorders, and few others.

Segmentation: Global Cord Stem Cell Banking Market

Cord Stem Cell banking Market : By Storage Type

Cord Stem Cell banking Market : By Product Type

Cord Stem Cell banking Market : By Service Type

Cord Stem Cell banking Market : By Indication

Cord Stem Cell banking Market : By Source

Cord Stem Cell banking Market : By Geography

Key Developments in the Cord Stem Cell banking Market:

Cord Stem Cell banking Market : Drivers

Cord Stem Cell banking Market : Restraint

Scope of the Cord Stem Cell banking Market Report :

The report shields the development activities in the Cord Stem Cell banking Market which includes the status of marketing channels available, and an analysis of the regional export and import. It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments. This will benefit the reports users, that evaluates their position in Cord Stem Cell banking market as well as create effective strategies in the near future.

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Cord Stem Cell Banking Market with High CAGR in Coming Years | Global Players Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS...

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So-called scientific breakthroughs are often in the headlines, but in reality, ground-breaking medical innovations adhere to a slow process characterised by cautious clinical experimentation and gradual but continuous improvement before reaching patients. After years of effort, gene therapy looks set to become a routine medical approach to address serious unmet medical need.

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There are two types of gene therapy approved for commercial use today. The first, in vivo, uses a modified virus, administered directly into the body to correct the target cells original genetic defect. The second, ex vivo, takes the patients own cells away from their body for genetic modification with a virus and then puts them back into the patient. Ex vivo gene therapy is dominated by two cell types; CD34+ haematopoietic stem cells (bone marrow stem cells) that can be modified to correct certain genetic disorders, and cytotoxic T-cells that can be altered and trained to kill cancerous cells.

The cell and gene therapy industry in the UK is supported by the formation and growth of many companies with promising assets in clinical development. This thriving biotech community is also supported by a robust and prosperous contingent of specialist manufacturing companies. These companies were key to the recent national covid-19 vaccine manufacturing response because the process for making genetically modified adenovirus such as the SARs-COV-02 vaccine, (as developed at the Oxford University Jenner Institute), is very similar to the process for making viruses for gene therapy.

UK leadership in gene therapy is no accident. As specified in our National Industrial Strategy, the UKs many research councils, in particular the Medicines Research Council, are active in funding the development and translation of treatments. In the UK right now, there are approximately 127 clinical trials testing new cell and gene therapy medicines, which represents 12 per cent of the global total. The government is readying the NHS to support these trials and transition these treatments into more common use through funding of the Advanced Therapy Treatment Centres (ATTC), a multiyear multi-million-pound project coordinated by the Cell and Gene Therapy Catapult and comprising centres of excellence throughout the UK.

In the UK right now, there are approximately 127 clinical trials testing new cell and gene therapy medicines, which represents 12 per cent of the global total. The government is readying the NHS to support these trials

The ATTCs aim to develop and harmonise adoption of the one and done treatment paradigm by developing the appropriate frameworks and systems to support clinical adoption of these novel therapies. The ATTCs and the NHS are also working in partnership to develop novel medicines assessment and reimbursement paradigms which fairly recognise the ultra-long-term medical benefits that can accrue from a one-time gene therapy treatment. Increased adoption of gene therapy, which is proving to be an approach that can reduce the long-term healthcare burden of chronic disease management, has the potential to significantly lighten the NHS resources required for support of several chronic conditions.

As a future example of the UK commitment to gene therapies, we are also leading the practical application of genetic sequencing (genomics). Formation of the National Genomic Test Directory and support for the 100,000 genomes project by Genomics England are critical steps to improve the diagnosis of patients and identification of a new wave of one-off treatments that could be capable of delivering long-term clinical benefit.

Cell and gene therapies are a revolution in medicine and have even been described as the future of the healthcare system. When you consider that 80 per cent of rare diseases have a genetic component, these treatments could transform the prospects of thousands of people living with these conditions, creating a more economically sustainable and brighter future for them and their families.

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A bright future for genomics and gene therapy in the UK - Health Service Journal

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

Multiple Studies Suggest Lasting Immunity to COVID-19 After Infection

Although probably not enough time has passed to know definitively, several studies are now suggesting that even mild cases of COVID-19 stimulate lasting immune responses, not only in disease-fighting antibodies, but in B- and T-cells.

Things are really working as theyre supposed to, Deepta Bhattacharya, an immunologist at the University of Arizona, and an author of one of the studies, told The New York Times.

Its difficult, probably impossible, to predict how long those immune responses will last, but many of the researchers believe the results are promising for long-term protection.

This is exactly what you would hope for, Marion Pepper, an immunologist at the University of Washington and an author of a study currently being reviewed by the journal Nature. All the pieces are there to have a totally protective immune response.

Pepper notes that the protective effects cant be completely evaluated until there is proof that people exposed to the virus a second time can fight it off. But the data suggests the immune system is indeed able to fight resistance a second time. Some of this qualification comes from unconfirmed reports of people being reinfected by the virus.

Antibody responses are typically relatively short-lived, disappearing from the blood weeks or months after being produced. Generally, the majority of the B-cells that produce antibodies die off, too. But the body keeps some longer-lived B-cells that are able to manufacture virus-fighting antibodies should the immune system be triggered by re-exposure to the virus. Some stay in the bloodstream while others wait in the bone marrow where they manufacture small numbers of antibodies that can sometimes be observed years, even decades later. Several studies, some by Bhattacharya and Pepper, have identified antibodies at low levels in the blood months after people recovered from COVID-19.

The antibodies decline, but they settle in what looks like a stable nadir, Bhattacharya said. These have been observed about three months after symptoms show up. The response looks perfectly durable.

Additional studies, including one published in the journal Cell, have isolated T-cells from recovered patients that can attack SARS-CoV-2. In laboratory studies, the T-cells produced signals to fight the virus and cloned themselves in large numbers to fight the potential infection.

This is very promising, said Smita Iyer, an immunologist at the University of California, Davis, who was not involved in the new studies, but has researched immune responses to the novel coronavirus in rhesus macaques. This calls for some optimism about herd immunity, and potentially a vaccine.

It's still has not been definitely determined if milder cases of COVID-19 will lead to long-term or even medium-term immunity. There have been some studies that suggest it does not and some newer studies suggesting it does. Iyer notes that the recent paper indicates, You can still get durable immunity without suffering the consequences of infection.

This idea is reinforced by Eun-Hyung Lee, an immunologist at Emory University who was not involved in these studies. He told The New York Times, Yes, you do develop immunity to this virus, and good immunity to this virus. Thats the message we want to get out there.

Why Seasonal Flu Vaccines Only Last a Year

As most everyone knows, flu vaccines only last about a year. Some of this is related to viral mutations. But in fact, the actual immunity itself caused by the vaccine does not appear to last longer than a year, even though the flu vaccine increases the number of antibody-producing cells specific for the flu in the bone marrow. Researchers out of Emory Vaccine Center found that for most newly-generated plasma cell lineages, between 70 and 99% of the cells were gone after one year, but that the levels of antibody-secreting cells in blood correlated with long-term response in the bone marrow.

Gut Bacteria Can Help Immuno-Oncology Therapies

Researchers with the University of Calgary identified gut bacteria that help our immune system fight cancerous tumors. This also helped provide more information about why immunotherapy works in some cases, but not others. By combining immunotherapy with specific microbial therapy, they believe they can help the immune system and immunotherapy be more effective in treating three types of cancer: melanoma, bladder and colorectal cancers. They found that specific bacteria were essential for immunotherapy to work in colorectal cancer tumors in germ-free mice. The bacteria produced a small molecule called inosine that interacts directly with T-cells and together with immunotherapy.

An Online Calculator to Predict Stroke Risk

Scientists at the University of Virginia Health System developed an online tool that measures the severity of a patients metabolic syndrome, a mix of conditions that includes high blood pressure, abnormal cholesterol levels and excess body fat. With it, they can then predict the patients risk for ischemic stroke. The study discovered that stroke risk increased consistently with metabolic syndrome severity even in patients that did not have diabetes. The tool is available for free at https://metscalc.org/.

A Link Between Autism and Cholesterol

Researchers at Harvard Medical School, Massachusetts Institute of Technology (MIT) and Northwestern University identified a subtype of autism that is the result of a cluster of genes that regulate cholesterol metabolism and brain development. They believe this information can help design precision-targeted therapies for this specific type of autism and improve screening efforts for earlier diagnosis of autism. They analyzed the DNA from brain samples that they then confirmed with the medical records of autistic individuals. They found that children with autism and their parents had significant alterations in lipid blood. However, there is much more to be understood, emphasizing the complexity of autism, which is affected by a variety of genetic and environmental factors.

Researchers Grow First Functioning Mini Human Heart Model

Investigators with Michigan State University grew the first miniature human heart model in the laboratory that is complete with all primary heart cell types and a functioning structure of chambers and vascular tissue. They utilized induced pluripotent stem cells which were obtained from consenting adults and created a functional mini heart in a few weeks. The primary value was in giving them an unprecedented view into how a fetal heart develops.

In the lab, we are currently using heart organoids to model congenital heart diseasethe most common birth defect in humans affecting nearly 1% of the newborn population, said Aitor Aguirre, senior author and assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.

Another area of focus is that improving on the final organoid will help with future research. Current heart organoids are not identical yet to human hearts and so are flawed in their use as research models.

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Research Roundup: Lasting Immunity to COVID-19 and More - BioSpace

The research study on Global Cell Therapy Manufacturing market 2019 presents an extensive analysis of current Cell Therapy Manufacturing market size, drivers, trends, opportunities, challenges, as well as key Cell Therapy Manufacturing market segments. Further, it explains various definitions and classification of the Cell Therapy Manufacturing industry, applications, and chain structure.In continuation of this data, the Cell Therapy Manufacturing report covers various marketing strategies followed by key players and distributors. Also explains Cell Therapy Manufacturing marketing channels, potential buyers and development history. The intent of global Cell Therapy Manufacturing research report is to depict the information to the user regarding Cell Therapy Manufacturing market forecast and dynamics for the upcoming years.The Cell Therapy Manufacturing study lists the essential elements which influence the growth of Cell Therapy Manufacturing industry. Long-term evaluation of the worldwide Cell Therapy Manufacturing market share from diverse countries and regions is roofed within the Cell Therapy Manufacturing report. Additionally, includes Cell Therapy Manufacturing type wise and application wise consumption figures.

The Final Report will cover the impact analysis of COVID-19 on this industry.

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After the basic information, the global Cell Therapy Manufacturing Market study sheds light on the Cell Therapy Manufacturing technological evolution, tie-ups, acquisition, innovative Cell Therapy Manufacturing business approach, new launches and Cell Therapy Manufacturing revenue. In addition, the Cell Therapy Manufacturing industry growth in distinct regions and Cell Therapy Manufacturing R&D status are enclosed within the report.The Cell Therapy Manufacturing study also incorporates new investment feasibility analysis of Cell Therapy Manufacturing. Together with strategically analyzing the key micro markets, the report also focuses on industry-specific drivers, restraints, opportunities, and challenges in the Cell Therapy Manufacturing market.

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Global Cell Therapy Manufacturing Market Segmentation 2019:The study also classifies the entire Cell Therapy Manufacturing market on basis of leading manufacturers, different types, various applications and diverse geographical regions.Overall Cell Therapy Manufacturing market is characterized by the existence of well-known global and regional Cell Therapy Manufacturing vendors. These established Cell Therapy Manufacturing players have huge essential resources and funds for Cell Therapy Manufacturing research as well as developmental activities. Also, the Cell Therapy Manufacturing manufacturers focusing on the development of new Cell Therapy Manufacturing technologies and feedstock. In fact, this will enhance the competitive scenario of the Cell Therapy Manufacturing industry.

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

Based on Therapy Type, the Cell Therapy Manufacturing market is categorized into: Allogeneic Cell Therapy Autologous Cell Therapy

Based on Technology, the Cell Therapy Manufacturing market is categorized into: Somatic Cell Technology Cell Immortalization Technology Viral Vector Technology Genome Editing Technology Cell Plasticity Technology 3D Technology

Based on Source, the Cell Therapy Manufacturing market is categorized into: IPSCs Bone Marrow Umbilical Cord Adipose Tissue Neural Stem Cells

Based on Application, the Cell Therapy Manufacturing market is categorized into: Musculoskeletal Cardiovascular Gastrointestinal Neurological Oncology Dermatology Other

Global Cell Therapy Manufacturing Market Regional Analysis:The companies in the world that deals with Cell Therapy Manufacturing mainly concentrate following regions.North America, Europe, Asia Pacific, Latin America, and Middle East & AfricaGlobal Cell Therapy Manufacturing Industry Report Covers following Topics:01: Cell Therapy Manufacturing Market Overview02: Global Cell Therapy Manufacturing Sales, Revenue (value) and Market Share by Players03: Cell Therapy Manufacturing Market Sales, Revenue (Value) by Regions, Type and Application (2014-2018)04: Region wise Top Players Cell Therapy Manufacturing Sales, Revenue and Price05: worldwide Cell Therapy Manufacturing Industry Players Profiles/Analysis06: Cell Therapy Manufacturing Cost Analysis07: Industrial Chain, Cell Therapy Manufacturing Sourcing Strategy and Downstream Buyers08: Cell Therapy Manufacturing Marketing Strategy Analysis, Distributors/Traders09: Cell Therapy Manufacturing Industry Effect Factors Analysis10: Global Cell Therapy Manufacturing Market Forecast (2019-2026)11: Cell Therapy Manufacturing Research Findings and Conclusion12: Appendix

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Worldwide Cell Therapy Manufacturing Market Different Analysis:Competitors Review of Cell Therapy Manufacturing Market: Report presents the competitive landscape scenario seen among top Cell Therapy Manufacturing players, their company profile, revenue, sales, business tactics and forecast Cell Therapy Manufacturing industry situations.Production Review of Cell Therapy Manufacturing Market: It illustrates the production volume, capacity with respect to major Cell Therapy Manufacturing regions, application, type, and the price.

Sales Margin and Revenue Accumulation Review of Cell Therapy Manufacturing Market: Eventually explains sales margin and revenue accumulation based on key regions, price, revenue, and Cell Therapy Manufacturing target consumer.

Supply and Demand Review of Cell Therapy Manufacturing Market: Coupled with sales margin, the report depicts the supply and demand seen in major regions, among key players and for every Cell Therapy Manufacturing product type. Also interprets the Cell Therapy Manufacturing import/export scenario.

Other key reviews of Cell Therapy Manufacturing Market: Apart from the above information, correspondingly covers the company website, number of employees, contact details of major Cell Therapy Manufacturing players, potential consumers and suppliers. Also, the strengths, opportunities, Cell Therapy Manufacturing market driving forces and market restraints are studied in this report.

Highlights of Global Cell Therapy Manufacturing Market Report:* This report provides in detail analysis of the Cell Therapy Manufacturing and provides market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2019 2029.* It also elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for world Cell Therapy Manufacturing market.* This study also provides key insights about Cell Therapy Manufacturing market drivers, restraints, opportunities, new product launches, approvals, regional outlook, and competitive strategies adopted by the leading Cell Therapy Manufacturing players.* It profiles leading players in the worldwide Cell Therapy Manufacturing market based on the following parameters company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies and future plans.* Insights from Cell Therapy Manufacturing report would allow marketers and management authorities of companies to make an informed decision with respect to their future product launches, market expansion, and Cell Therapy Manufacturing marketing tactics.* The world Cell Therapy Manufacturing industry report caters to various stakeholders in Cell Therapy Manufacturing market. That includes investors, device manufacturers, distributors and suppliers for Cell Therapy Manufacturing equipment. Especially incorporates government organizations, Cell Therapy Manufacturing research and consulting firms, new entrants, and financial analysts.*Various strategy matrices used in analyzing the Cell Therapy Manufacturing market would provide stakeholders vital inputs to make strategic decisions accordingly.Global Cell Therapy Manufacturing Market Report Provides Comprehensive Analysis of Following: Cell Therapy Manufacturing Market segments and sub-segments Industry size & Cell Therapy Manufacturing shares Cell Therapy Manufacturing Market trends and dynamics Market Drivers and Cell Therapy Manufacturing Opportunities Supply and demand of world Cell Therapy Manufacturing industry Technological inventions in Cell Therapy Manufacturing trade Cell Therapy Manufacturing Marketing Channel Development Trend Global Cell Therapy Manufacturing Industry Positioning Pricing and Brand Strategy Distributors/Traders List enclosed in Positioning Cell Therapy Manufacturing Market.

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Moreover, the report organizes to provide essential information on current and future Cell Therapy Manufacturing market movements, organizational needs and Cell Therapy Manufacturing industrial innovations. Additionally, the complete Cell Therapy Manufacturing report helps the new aspirants to inspect the forthcoming opportunities in the Cell Therapy Manufacturing industry. Investors will get a clear idea of the dominant Cell Therapy Manufacturing players and their future forecasts.

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Cell Therapy Manufacturing Market 2020 Report Including COVID-19 Impact Analysis and Forecast till 2029 - Scientect

Dr. Johnny Huard will be the Principal Investigator on five-year clinical trial that focuses on Bone Marrow Stem Cell treatments to delay onset of osteoarthritis in the knee

VAIL, Colorado, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Steadman Philippon Research Institute (SPRI) has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health (NIH). SPRI Chief Scientific Officer Johnny Huard, Ph.D. will serve as the principal investigator. Marc J. Philippon, M.D., who serves as managing partner of The Steadman Clinic and co-chair of SPRI and Scott Tashman, Ph.D., director of biomedical engineering at SPRI, will serve as co-principal investigators. The clinical trials are expected to begin enrolling in the Fall of 2020.

The award, administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, ranks as one of the most significant in SPRIs history, both in size and recognition. Given the potential of regenerative medicine to enhance human health and treat disease, the United States Congress included a provision in the 21st Century Cures Act a law passed in December 2016 to accelerate medical discovery and innovation to support the NIH-established Regenerative Medicine Innovation Project (RMIP). The RMIP aims to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for protecting patient safety during the conduct of research.

This is a really great honor for SPRI, said Dr. Huard, who first came to Vail in 2015 and has served as the director of the Center for Regenerative Sports Medicine in addition to his role as the institutes chief scientific officer. Past recipients of these RMIP awards have been Albert Einstein College of Medicine, Boston Childrens Hospital, Columbia University Health Sciences, Childrens Hospital of Philadelphia, Harvard University, University of Colorado Denver and Yale University.So, we are in very good company.

The grant anticipates over $2.8 million from the NIH and requires a 1:1 match from SPRI over the next five years, pending availability of federal funds. The clinical trials and resulting publications and reports will take place over the next five years. A generous SPRI benefactor committed to fund the first year of the match, and Dr. Huard is hopeful that with the NIH matching the funds, more philanthropists will be inspired to become involved in this groundbreaking project.

Our donors have been so generous in supporting all that we do here at SPRI, said Dr. Huard, and I am very grateful and confident that we will raise the funds necessary to complete these trials over the next five years.

The trial is entitled,The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis. Huard explains in laypersons terms:

The idea behind the trial is to delay osteoarthritis in the knee, said Huard. Our goal is to delay the need for that first knee replacement in a patient for as long as we can. Over time SPRI intends to expand this area of research to other joints including hip and shoulder.

This clinical trial is designed to determine whether senolytic and/or antifibrotic agents will improve the beneficial effect of Bone Marrow Stem Cells for the treatment of symptomatic knee osteoarthritis. The trial will include four groups, totaling 100 patients, to investigate the teams hypothesis that the use of these agents will improve patient outcomes.

One of the great things that I love about this particular clinical trial is that we are actively involving our orthopaedic surgeons and our biomotion lab staff as well, said Dr. Huard. This will truly be a team effort over the next five years.

Those world-class surgeons are led by Dr. Philippon, considered one of the worlds foremost orthopaedic surgeons. The biomotion lab is under the direction of Dr. Tashman. The contributions of these two leaders and the talented roster of surgeons, clinicians and technicians in their departments will be critical to the success of the upcoming clinical trials. SPRIs Center for Outcomes-Based Orthopaedic Research and its director Grant Dornan are also participating in this project by contributing the statistical outcomes.

Story continues

Dr. Philippon is not only a world-class surgeon but he is also an innovator, added Dr. Huard. He always wants to improve and is still willing to try new things to enhance patient outcomes. Dr. Tashman is the same way. Like everyone here at SPRI and The Steadman Clinic, they are embracing the cutting-edge technology available to them and finding new and better ways to treat patients and, most importantly, reduce patients recovery time and get them back to their active lives as quickly and safely as possible.

Huard notes that the rare combination of a globally recognized research institute like SPRI and a world-class orthopaedic surgery clinic like The Steadman Clinic in the same building is one of the key factors in the awarding of this RMIP grant.

Weve got something here in Vail that many other research institutes dont have, said Huard. We have one of the worlds finest orthopaedic clinics right next door, working hand-in-hand with us every day.

Dr. Huard and Dr. Tashman along with Suzanne Liv Page, J.D., our director of grants and contracts have worked diligently to prepare and gain acceptance of this grant proposal from the NIH, said Dr. Philippon. Our surgeons here at The Steadman Clinic eagerly await the opportunity to participate in the trial. Johnny, Scott and their staff have put SPRI into position to undertake major trials and studies like this one and we are all very honored that the NIH has given SPRI this incredible opportunity.

For further information or other inquiries about The Steadman Clinic or Steadman Philippon Research Institute, contact Lynda Sampson, Vice President of External Affairs (lsampson@sprivail.org).

Link to current SPRI clinical trials - https://www.sprivail.org/about-us/clinical-trials

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Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health - Yahoo Finance

NEW YORK, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast Chief Medical Officer Dr Fred Grossman said: Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by todays outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant.

The ODAC is an independent panel of experts that evaluates efficacy and safety of data and makes appropriate recommendations to the FDA.Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made solely by the FDA, and the recommendations by the panel are non-binding. RYONCIL has been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch RYONCIL in the United States in 2020.

Pediatric transplant physician Dr Joanne Kurtzberg, the Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Pediatric Blood and Marrow Transplant Program at Duke University Medical Center, said: This devastating condition has an extremely poor prognosis and there are no FDA-approved options for children under the age of 12. The clinical studies I have directed have demonstrated the potential for this treatment to fill a significant unmet medical need.

Conference CallAn audio webcast can be accessed via https://webcast.boardroom.media/mesoblast-limited/20200813/NaN5f3237e85300840019de909d

The archived webcast is also available on the Investor page of the Companys website http://www.mesoblast.com

About Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3 There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.

About RYONCILTM Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

1. Niederwieser D, Baldomero H, Szer J. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplant 2016; 51(6):778-85. 2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology 2011;2011:601953. 3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation 2019;54(11):1805-1814

About MesoblastMesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any decision that the FDA may make based upon the recommendation of the ODAC in relation to the efficacy of remestemcel-L), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

Excerpt from:
U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil) for Efficacy in Children With Steroid-Refractory Acute Graft Versus...

Company Announcement

Copenhagen, Denmark; August 20, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. A supplemental Biologics License Application (sBLA) for this indication was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen), in February 2020. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that multiple myeloma patients in the U.S. will now have yet another treatment option as this is the eighth overall U.S. FDA approval for DARZALEX and the fifth in the relapsed/refractory setting. In addition, DARZALEX is now the first CD38 antibody approved for use in combination with carfilzomib, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies. CANDOR was an Amgen-sponsored study, co-funded by Janssen Research & Development, LLC. EQUULEUS was sponsored by Janssen Research & Development, LLC.

About the CANDOR studyThe Phase 3 trial (NCT03158688) was a randomized, open-label study that included 466 patients with multiple myeloma who had relapsed after 1 to 3 prior therapies. Patients were randomized to receive either DKd or carfilzomib and dexamethasone (Kd) alone. In the daratumumab treatment arm, patients received 8 milligrams per kilogram (mg/kg) on days 1 and 2 of cycle 1, then 16 mg/kg once weekly for the remaining doses of the first 2 cycles, then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. In both treatment arms carfilzomib was dosed twice weekly (20 mg/m2 on cycle 1 days 1 and 2 and 56 mg/m2 beginning on cycle 1 day 8 and thereafter) and dexamethasone was given weekly (40 mg orally or via IV infusion). The primary endpoint of the study was progression free survival (PFS).

About the EQUULEUS (MMY1001) Study The Phase 1b EQUULEUS (NCT01998971) study was an open label, multi-cohort trial that evaluated the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma. Among the regiments evaluated, the combination of DKd compared to Kd alone was studied in 85 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy using a once-weekly dosing regimen. DKd was evaluated at a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward.

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

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DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra and Kesimpta are trademarks of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 National Cancer Institute. "A Snapshot of Myeloma." Available at http://www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016. 3 Globocan 2018. United States of America Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.5 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 20166 DARZALEX Prescribing information, September 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf Last accessed September 20197 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.

Company Announcement no. 38CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces Janssen Granted US FDA Approval for DARZALEX (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or...

Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims

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By: Sruthy Iype  Aug. 20, 2020

Dexurs analysis of Medicare claims data showed that on an average, Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma (MM) compared to Darzalex and Empliciti which have 9 claims per patient. The analysis was based on a sample of Medicare patients between Jan 2019 and Dec 2019, and looked at the J code usage of the drugs for the condition.The number of claims per patient data is a proxy for the number of injections / IV infusions / doses required by a patient. The study also tries to contrast the usage of these medications across three diagnosis categories- MM patients who have not achieved remission (C9000), MM patients in remission (C9001), and MM patients in relapse (C9002).

Multiple myeloma is a form of blood cancer that involves the neoplastic proliferation of plasma cells, a type of white blood cells formed within the bone marrow. While the earlier stages of the disease tend to be asymptomatic, patients may experience symptoms like bone pain, bleeding, frequent infections, and anemia with progression of the cancer. Although there is no cure for MM, a number of treatment options including chemotherapy, stem cell transplantation, radiation therapy, and targeted therapy, can help in managing the progression of the disease and relieving the symptoms.

The drugs considered under this study are targeted therapies approved for the treatment of adult patients with multiple myeloma, alone or in combination with other medication. Unlike chemotherapy, these drugs specifically target the cancer cells and the mechanisms that support their growth, promising better results and fewer adverse effects. Kyprolis (carfilzomib) and Velcade (bortezomib) are proteasome inhibitors that can trigger apoptosis in cancer cells by blocking the action of proteasome, an enzyme complex that is critical in the regulation of cell-cycle. Darzalex (daratumumab) and Empliciti (elotuzumab) are monoclonal antibodies that enable the immune system to identify and kill cancer cells by targeting specific proteins on the cell surface.

The average usage of drug per patient was seen to be highest among MM patients who had not achieved remission, and least among MM patients in remission. An exception to this trend was Kyprolis, which had similar usage among patients in remission and patients in relapse, with the former having a marginally higher number of claims per patient.

Amgens Kyprolis had an average of 15.9 claims per patient in a year. The proteasome inhibitor indicated for the treatment of patients with relapsed/refractory MM, is used as a monotherapy, or as a combination therapy along with dexamethasone, or lenalidomide and dexamethasone.

Velcade, manufactured by Millennium Pharmaceuticals/Takeda Oncology in the U.S, had an average of 13.8 claims per patient in a year. It was noted to have the largest share of claims among the drugs, across the three diagnosis categories for multiple myeloma. Approved for the treatment of newly diagnosed and relapsed/refractory myeloma, the drug is used alone or as a part of combination therapies.

Darzalex, a CD38-directed cytolytic antibody by Janssen Biotech, had an average of 9.9 claims per patient in a year for MM. It is indicated for the treatment of MM as a monotherapy or in combination with other drugs including lenalidomide, dexamethasone, and bortezomib.

Bristol-Myers Squibbs Empliciti had an average of 9.3 claims per patient. It is a SLAMF7-directed immunostimulatory antibody approved for the treatment of MM in combination with lenalidomide and dexamethasone, or pomalidomide and dexamethasone

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Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims - Dexur

Patient enrollment to commence immediately

VANCOUVER, Washington, Aug. 20, 2020 (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 the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very pleased with the MHRAs confidence in leronlimab to initiate enrollment of patients in the U.K. for our current CD12 protocol. CytoDyn recently requested fast track approval from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data. We believe leronlimab has multiple opportunities for several clinical indications and we are very optimistic about our future based upon how far we have advanced this drug in about 5 years. In addition, we plan to file a BLA for HIV in the U.K. within the next 4 weeks.

About Coronavirus Disease 2019CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is believed to typically transmit person-to-person through respiratory droplets. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with 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 NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral 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 could 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 may play a role in tumor invasion, metastases, and tumor microenvironment control. 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 aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial 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 late-stage 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 critical 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 successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA has agreed to provide written responses to the Companys questions concerning its recent Biologics License Application by September 4, 2020, in lieu of a Type A teleconference meeting for this HIV combination therapy.

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. If successful, it 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. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains 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. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys 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.

CYTODYN CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

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After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.'s MHRA Accepts CytoDyn's Request to Enroll...

This Placental Stem Cells (PSCS) Market report is an outcome of persistent efforts lead by knowledgeable forecasters, innovative analysts and brilliant researchers who carries out detailed and diligent research on different markets, trends and emerging opportunities in the consecutive direction for the business needs. The report also estimates CAGR (compound annual growth rate) values along with its fluctuations for the definite forecast period. The report provides key measurements, status of the manufacturers and is a significant source of direction for the businesses and organizations. While generating this Placental Stem Cells (PSCS) Market research report, customer satisfaction is kept on the utmost priority.

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Placentalstem cells(PSCS) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to growing at a CAGR of 10.25% in the above-mentioned forecast period. Increasing awareness regarding the benefits associates with the preservation of placental derived stem cells will boost the growth of the market.

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Adoption of advances and novel technologies that will lead to the storage and preservation of stem cells, technological advancement in the field of biotechnology, introduction of hematopoietic stem cell transplantation system and growing number of diseases which will helps in accelerating the growth of the placental stem cells (PSCS) market in the forecast period of 2020-2027. Surging number of applications from emerging economies along with rising awareness among the people will further boost many opportunities that will led to the growth of the placental stem cells (PSCS) market in the above mentioned forecast period.

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Placental stemcells(PSCS) market is analysed and market size insights and trends are provided by country, service type and application as referenced above.

The countries covered in the placental stem cells (PSCS) market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the bone marrow-derived stem cells (BMSCS) market due to the increasing stem cell procedure along with preferences of private stem cell banking over public and surging network of stem cell banking services.

The country section of the placental stem cells (PSCS) market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Placental stem cells (PSCS) market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for placental stem cells (PSCS) market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the placental stem cells (PSCS) market. The data is available for historic period 2010 to 2018.

Competitive Landscape and Placental Stem Cells (PSCS) Market Share Analysis

Placental stem cells (PSCS) market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to placental stem cells (PSCS) market.

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Placental Stem Cells (PSCS) Market 2020-2027 Reporting And Evaluation of Recent Industry Developments || Leading Players StemCyte India Therapeutics...

In 2014, Clive Webb returned home from one of his regular judo training sessions a sport he has been avidly practising since he was 13 years old and started experiencing severe back pain. Initially he brushed it off, thinking he had pulled a muscle. When the pain persisted, Clive decided to make an appointment with his doctor who soon discovered that he had stress fractures in seven of his vertebrae. A few days later, Clive was diagnosed with multiple myeloma, a little-known and incurable cancer of the plasma cells. He was just 55 years old.

The diagnosis hit close to home. I figured it out prior to being told what was wrong because my father had been diagnosed with myeloma in 1996, and he had had very similar symptoms, Clive recalled.

In May 2014, Clive underwent extensive chemotherapy to prepare for a stem cell transplant. In October of the same year, he was thrilled to find out that the procedure was a success and that he was in remission. Since then, Clive has been responding well to a drug maintenance regime. There have been so many amazing advances in treatment since Clives fathers passing, explained Clives wife, Yvette. Were hopeful for what the future holds.

Now with his condition relatively stable, Clive is extremely grateful to be alive. He has resumed physiotherapy in the gym, gardening, and taking walks with Yvette. He credits this to the life-saving treatments that he has access to, the outstanding care he gets from health professionals, and to the love and support of his wife. The couple is now eager to do what they can to help others living with the disease.

After attending the Hamilton Multiple Myeloma March last year, they joined the Hamilton and District Multiple Myeloma Network support group. The couple is more intent than ever to raise as much awareness and funds for myeloma as they can. As such, they will once again be participating in the 3rd annual Hamilton Multiple Myeloma March with their team, the Myeloma Movers, on Saturday, September 12, at 9 am, at the Edgewater Pavilion. The in-person, live event will be in full compliance with COVID-19 health and safety measures. Clive, Yvette, and their fellow Hamilton Marchers have set their fundraising goal at $40,000 to help further critical research for this deadly blood cancer that affects nine new Canadians every day.

To learn more about how this event will be working, please click here: https://secure3.convio.net/myecad/site/TR?fr_id=1233&pg=entry&s_locale=en_CA

About Myeloma

Multiple myeloma, also known as myeloma, is the second most common form of blood cancer. Myeloma affects a type of immune cell called the plasma cell, found in the bone marrow. Every day, nine Canadians are diagnosed, yet in spite of its growing prevalence, the disease remains relatively unknown. While there is no cure, people with myeloma are living longer and better lives, thanks to recent breakthroughs in treatment. To find the cure, more funding and research are required. To learn more, or to donate, please visit http://www.myeloma.ca.

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Hamiltonian with Incurable Cancer is Helping Researchers Get One Step Closer to a Cure at the 3rd Annual Hamilton Multiple Myeloma March - The Bay...