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Advancing patient care through innovative orthopaedics – SciTech Europa

By daniellenierenberg

Founded in 1958, the AO foundation is a medically guided, not-for-profit organisation led by an international group of surgeons specialised in the treatment of trauma and disorders of the musculoskeletal system. Today, the AO has a global network of over 200,000 health care professionals. Each year it offers over 830 educational events around the world, which are supported by nearly 9,000 faculty and are attended by over 58,000 participants. It has 20,000 surgeon members working in the fields of trauma, spine, craniomaxillofacial (CMF), veterinary, and reconstructive surgery.

The Mission of the AO foundation is promoting excellence in patient care and outcomes in trauma and musculoskeletal disorders. The focus of the AO clinical divisions, clinical unit, and Institutes, is on producing new concepts for improved fracture care, delivering evidence-based decision making, guaranteeing rigorous concept and product approval as well as timely and comprehensive dissemination of knowledge and expertise. The AO is made up from four clinical divisions (AOTrauma, AOSpine, AOCMF, AOVET), one clinical unit (AORecon), and four institutes the AO Research Institute Davos (ARI), AO Education Institute, AO Clinical Investigation & Documentation and AO Technical Commission (AOTK).

AO Research Institute Davos (ARI) is both the academic arm and the translational arm of the AO foundation. In its work to further the AO foundations mission (promoting excellence in patient care and outcomes in trauma and musculoskeletal disorders), ARIs purpose is to advance patient care through innovative orthopaedic research and development.

The goals of ARI include: Contribute high quality applied preclinical research and development (exploratory and translational) focused towards clinical applications/solutions; investigate and improve the performance of surgical procedures, devices and substances; foster a close relationship with the AO medical community, academic societies, and universities; and provide research environment / research mentorship / research support for AO clinicians.

Our Bone Regeneration focus area looks at bone healing in response to fracture involving a complex sequence of dynamic events, directed by numerous different cell types and growth factors. A critical factor for bone repair is the maintenance, or effective restoration, of an adequate blood supply, which is necessary to provide the damaged tissue with oxygen, nutrients and growth factors, as well as immune cells and mesenchymal stem cells required to repair the damage and induce new bone formation. Although bone generally has a high regenerative capacity, in some cases this inherent bone healing is compromised, which results in delaying healing or non-union of the bone fracture with increased health care costs and reduced quality of life issues for affected patients.

While a variety of risk factors have been identified that predispose a patient to an increased risk of developing delayed bone healing or non-union, it is currently not possible to identify specific at-risk patients at an early stage. Using in vitro, in vivo and microfluidic technologies, the aim of the Bone Regeneration Focus Area is to gain a greater understanding of the cellular interactions and mediators, including immunoregulation, underlying such impaired healing responses. By determining how cells such as immune cells, mesenchymal stem cells and endothelial cells normally interact during the repair process, and how this process is altered during impaired healing, we can then identify key mediators of the healing process. Our goal is to use tissue engineering and regenerative medicine approaches to promote bone healing, aimed at restoring bone integrity and its effective biomechanical properties.

In terms of this focus area, we aim at investigating the potential mechanisms leading to intervertebral disc (IVD) damage and evaluating novel biological treatment methods for IVD repair and regeneration. Acute and chronic damage to the IVD are major causes of low back pain. However, the factors that contribute to the loss of function of the IVD and the underlying pathophysiology are still poorly understood. We have established a whole IVD organ culture system with the ability to maintain entire discs with the endplates for several weeks under controlled nutrient and mechanical loading conditions.

Within this bioreactor, the beneficial or detrimental effects of nutrition, mechanical forces, and/or biochemical factors on disc cell viability and metabolic activity can be investigated. We have developed various defect and degeneration models, allowing us to design and evaluate appropriate biological treatment strategies. These include implantation of cells, delivery of anabolic, anti-catabolic or anti-inflammatory molecules, biomaterials or a combination thereof. Data from ex vivo models are also correlated to in vivo observations to identify molecular markers of IVD damage or degeneration.

To study the potential of new therapies for articular cartilage repair and regeneration, a bioreactor system applying multiaxial load to tissue-engineered constructs or osteo-chondral explants has been established. The bioreactor mimics the load and motion characteristics of an articulating joint. Chondral and osteochondral defect and disease models enable us to test tailored treatments under physiologically relevant mechanically loaded ex-vivo conditions. Cell- and material-based therapies as well as chondrogenic or anti-inflammatory factors are under investigation for cartilage repair and regeneration.

Biomaterials for skeletal repair can provide structural and mechanical features for the filling of defects, but also be a carrier for drugs, cells and biological factors. One of our goals is the development of 3D structures for bone, disc and cartilage tissue engineering, using tailored polymers and composites manufactured with additive manufacturing processes.

Our experience lies in the design of biocompatible, biodegradable polymers and their processing with controlled architecture and embedded biologics. A second field of research investigates the preparation of hyaluronan, a natural occurring biopolymer, based biomaterials which can be used to deliver drugs and cells. These injectable biodegradable materials have considerable potential in infection prophylaxis and tissues repair. We are also developing innovative technologies for the structuration and assembly of tissue-like matrices aiming to mimic for example, biological matrix mechanical and structural anisotropy. Additive manufacturing technologies will lead to the development of patient specific implants that can be tailor made to each individual case.

The Stem Cell focus area is particularly interested in stem cell therapies for bone and cartilage that could be applied within a clinical setting. We are increasingly investigating donor variation with the aim to predictively identify the potency of cells from individual donors. In the search for biomarkers to determine patient specific healing potential, exosomes and non-coding RNA sequences such as miRNA are increasingly being used as a diagnostic and therapeutic tool. The development of a serum-based biomarker approach would dramatically improve patient specific clinical decisions.

We also aim to investigate the role of mechanical and soluble factors in the activation of mesenchymal stem cells, and the promotion of differentiation and tissue repair. We can induce chondrogenic differentiation of human MSCs purely by mechanical stimulation and this is leading to new insights into cell behavior under loading conditions. Mechanical forces can be applied by way of rehabilitation protocols and are able to modify stem cell and immune cell function. Such studies are forming the basis of the emerging field of regenerative rehabilitation. In addition to the effect of load on direct differentiation, it is known that biomechanical stimulation can modulate the cell secretome. Investigating these changes could lead to the identification of new targets that may be present during articulation. This offers new avenues for potential clinical therapies.

The Musculoskeletal Infection team focusses their research activities on Fracture-Related Infection (FRI), with goals to optimise antibiotic prophylaxis, reduce the burden of therapeutic interventions, and study the impact of co-administered medication on infection. Our studies include preclinical in vitro and in vivo studies, as well as an increasing focus on observational studies in human patients.

In collaboration with ARI colleagues in the preclinical testing facility, we now have models that can mimic an open fracture, with a chronology and fixation that more accurately reflects clinical reality. Further advancements in our animal models in the past year include the controlled delivery of antimicrobials via the use of programmable, implantable pumps to more precisely control antibiotic dosing. In addition, we have investigated in more detail the use of anti-inflammatory medication in our animal studies and found it can have a major impact on treatment outcome, and so will be a focus for future studies with clear relevance for trauma patients. The preclinical evaluation of novel anti-infective interventions under Good Laboratory Practice (GLP) conditions has also continued in the past year, with two novel antimicrobial intervention studies performed in this space in the past year.

On the in vitro side, we have begun to develop an in vitro model for Staphylococcus aureus infection that has the potential to include human immune system cell-lines. This can not only reduce future animal studies but will also allow us to test interventions in a human-specific system. The antibiotic loaded hydrogel that has been in testing in ARI for several years, has now also been tested against MRSA biofilms and continues to be superior to aqueous solutions of antibiotics. In patient samples, we have made our first preparations for a study on the impact of antibiotic therapy on the human gut and skin microbiome. This is an under explored area of immense potential for bone health and will be a multi-year investigation with expert collaborations internationally.

A Fracture-Related Infection (FRI) consensus meeting in Davos in December 2016 achieved consensus on the fundamental features of FRI, and a proposal for defining the presence of FRI was reached. The establishment of this definition offers the opportunity to standardise preclinical research, improves the reporting of clinical studies and finally of course also aids in the decision-making during daily clinical practice. In the following 18 months, the expert group shifted attention to the next phase, validating the diagnostic criteria and develop treatment principles for FRI and a consensus on diagnosis and treatment principles for FRI.

In reflecting the greater complexity of this question, and to engage with other professional organisations, the group has grown to include external partners. Joining the ARI, AOTrauma and the AOTK Anti-Infection task force (AITF), is the European Bone and Joint Infection Society (EBJIS), the Orthopaedic Trauma Association (OTA), and the Pro-Implant Foundation, as well as a broadened panel of experts with extensive clinical experience in FRI. A first meeting of the expert group took place in Zrich in February. Prior to the meeting, the group was asked to review and consider the published literature on FRI, within nine specific concepts that were then presented for discussion in dedicated sessions during the meeting. The meeting engaged 35 experts and key opinion leaders in the field of FRI. Recommendations were developed on diagnosis and treatment of FRI. These guiding principles will be made available through scientific publications and an AO Bone Infection App.

Internal fracture fixation existed but only in individual hospitals and not globally, that is where ARI and AO came in and rolled this out globally and invented many new additions to this. ARI invented compression plates, minimal invasive surgery for trauma (plates, screws, nails etc.), locking plates for fractures close to articulating joints and for osteoporotic patients.

Currently tissue engineering and regenerative medicine (TERM) is in the research stage of its life cycle and has not really translated into routine surgical practice in orthopaedics. The combination of cells and biomaterials however has great potential in repair. The main issues are again regulatory, and the best way forward would be to develop techniques that can be applied in a single surgery within the operation room. Anything beyond this window and outside the operation room will take a significant amount of time to get approval and will likely not be surgeon friendly and obviously will be very costly.

TERM has its biggest potential in orthopaedics in the areas of cartilage repair (delaying classic orthopaedics), disc regeneration (back pain being one of the largest problems globally) and in bone this could be in large bone defects, but not a major area in fracture repair, where appropriate mechanical stimulation can be used to drive the repair to optimum levels and speed (which is also in the research stage). TERM has also potential in tendon and ligament repair.

Imaging and biomarkers for diagnostics and therapy (Theranostics) will be important in early detection of diseases or complications and then to prevent further development of the disease, delaying the time until classic orthopaedics is required. This may go beyond stopping the disease and towards tissue regeneration. The earlier the detection, the more potential for TERM.

The main challenges for a researcher are in translation and the fact that large companies today exist in a more complex regulatory environment, which means they are inclined to be very risk averse. This means in practice they need to see evidence of benefits or proof-of-concept in a clinical setting. The researchers in turn need to have greater awareness of these regulatory issues relating to medical development and CE approved manufacturers, than in the past. The increasingly complex regulatory environment of course has a greater impact on small companies and spin-offs, and can be seen as having a dampening effect on innovation development. Incremental innovations or solutions to niche problems will struggle to get the funding needed to carry them through the regulatory approval process. Researchers do benefit from this too, since in an environment in which companies are inclined to be more risk averse, they place a higher premium on solutions or concepts that have been through a rigorous clinical testing process. In orthopedics, we are approaching an innovation plateau with metals, and new technologies (such as tissue engineering, which is showing good results in research at present) still need to kick in to date little has translated to the patient in this field. 3D printing may have a place in spine or craniomaxillofacial areas, but offers little benefits to trauma in the most common areas for fracture repair. Surgeons who promote patient specific implants (PSI) in joint replacement have little proof that this offers clear improvements compared to current well-tested and proven joint replacement implants. The seamless integration of digitisation and robotic help into the patient treatment work-flow is another area to grow to help the surgeons in their daily practice.

Prof R. Geoff Richards

Director

AO Research Institute Davos

geoff.richards@aofoundation.org

Tweet @AOFoundation

https://www.aofoundation.org/Structure/research/exploratory-applied-research/research-institute/Pages/exploratory-applied-research.aspx

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Advancing patient care through innovative orthopaedics - SciTech Europa

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Introducing: iPSC Collection from Tauopathy Patients – Alzforum

By daniellenierenberg

23 Oct 2019

A multi-institutional group, including members of the Tau Consortium, unveiled a stem cell tool kit for scientists studying primary tauopathies. In the November 12 issue of Stem Cell Reports, researchers co-led by Celeste Karch ofWashington University, St. Louis, and Alison Goate and Sally Temple of Icahn School of Medicine in New York, describe a collection of fibroblasts, induced pluripotent stem cells, and neural precursor cells. The cells come from 140 skin samples, some given by donors with richly documented clinical histories who carry pathogenic MAPT mutations or risk variants. Others come from noncarrier family members, patients with a sporadic tauopathy, and cognitively normal controls. The set includes induced pluripotent stem cell lines from 31 donors and 21 CRISPR-engineered isogenic lines. The cells are available to other researchers for study.

These types of high-quality repositories are becoming increasingly important for the scientific community, Clive Svendsen of the Cedars-Sinai Medical Center in Los Angeles wrote to Alzforum.

This is the way the field is going, agreed Lawrence Golbe of CurePSP, New York. Golbes organization funds research into progressive nuclear palsy (PSP) and related disorders, and collaborates with the Tau Consortium on other projects. Enthusiastic about the resources potential, Golbe hopes CurePSP grantees will get an automatic pass to use the cells.

Choice Mutations. Cells in the new iPSC collection carry some of the most common MAPT mutations, covering a wide range of clinical and neuropathological phenotypes of frontotemporal lobe dementia (FTLD)-Tau. [Courtesy of Karch et al., 2019.]

Tauopathies have proven difficult to study in animal models, in part because unlike other neuropathologies, they seem to afflict only humans (Heuer et al., 2012). Moreover, while adult human brains express approximately equal amounts of the tau spliced isoforms 3R and 4R, rodents produce almost exclusively 4R (Trabzuni et al., 2012). This is problematic. For example, leading proposals to explain how tau mutations cause disease point to abnormalities in splicing and microtubule binding, which differ between isoforms. The models we had been focusing on were not capturing the complexity of MAPT in human cells, said first author Karch. As a result, human induced pluripotent stem cells (iPSCs) have been gaining popularity in the field. The NINDS Human Cell and Data Repository is helping meet the demand by offering iPSC lines derived from 10 patients harboring MAPT mutations.

However, Karch and her collaborators think the field could benefit from a larger and more diverse collection of human cells, including isogenic iPSC lines. To accomplish this, they collected skin samples from 140 people carrying MAPT pathogenic mutations or risk variants, non-mutation carriers, and patients with sporadic PSP or corticobasal syndrome (CBS), most with comprehensive clinical histories. Although a few cells came from the NINDS repository, most came from patients participating in longitudinal studies at the Memory and Aging Center at the University of California, San Francisco, and the Knight Alzheimer Disease Research Center at WashU. The clinical records of most of these patients include detailed neurological and neuropathological workups, as well as fluid biomarkers and neuroimaging data collected from MRI, A-PET, and tau-PET studies.

To capture a broad range of phenotypes associated with some of the most common MAPT mutations, the authors created 36 fibroblast lines and 29 iPSC lines from individuals carrying the P301L, S305I,IVS10+16, V337M, G389R, and R406W mutations, as well as from carriers of the A152T variant, which increases the risk for both PSP and CBS (image above). The latter could be particularly useful for dissecting the mechanisms that underlie the phenotypic differences between the two diseases. The researchers also obtained iPSC lines from two noncarrier family members, and two people who suffered from autopsy-confirmed sporadic PSP. In addition, they stored fibroblast lines from 12 patients with sporadic PSP, five with CBS, 10 with a mixed PSP/CBS presentation, and 69 cognitively normal controls.

Biopsies are available for 27 of the 31 patients whose cells were used to generate iPSCs, and autopsy data for seven, including the two cases of sporadic PSP.

Importantly, the researchers edited 21 iPSC lines using CRISPR/Cas 9. They corrected cells with these mutations: MAPT IVS10+16,P301L, S305I, R406W, and V337M. Conversely, they inserted into control iPSCs these mutations: R5H, P301L,G389R, S305I, or S305S.

The authors also created a stem cell line carrying MAPT P301S,a mutation commonly overexpressed in tauopathy mouse models but not present in the available donors, by editing the P301L line. Isogenic lines are so powerful, particularly in these diseases which are so variable in their onset and progression, even within the same family, said Karch. Gnter Hglinger and Tabea Strauss at the German Center for Neurodegenerative Disease (DZNE) in Munich agreed. Having a pool of cell lines with different disease-linked mutations and risk variants from several individuals and their isogenic control cells is an excellent resource for the research community to enlighten disease mechanisms, they wrote (full comment below).

Several of the reported lines have already starred in recent studies of tauopathy mechanisms and candidate therapies (e.g., Sep 2019 conference news; Nakamura et al., 2019; Hernandez et al., 2019; Silva et al., 2019).

Karch and colleagues have partially differentiated some of the iPSCs and stored them as neural progenitor cells (NPCs), so that researchers can relatively easily thaw, expand, and differentiate them into neurons. These NPCs have proved useful for large-scale functional-genomics studies, proteomics, and genetic modifier screens (e.g., Cheng et al., 2017; Boselli et al., 2017;Tian et al., 2019).

In addition, the authors inserted a neurogenin-2 transgene into two healthy controls and two MAPT mutant stem cells, P301L and R406W. Neurogenin-2 enables low-cost, large-scale differentiation of stem cells into homogenous excitatory neurons. These transgenic cells are particularly useful for high-throughput drug screens (Wang et al., 2017; Sohn et al., 2019).

Researchers can request all the reported cells online at http://neuralsci.org/tau. They must provide a summary of experimental plans, an institutional material transfer agreement, and a nominal fee to cover maintenance and distribution costs. Karch said the process resembles that of the Coriell Institute and the NINDS repository. Our goal is to share with as few hurdles as possible, she said.

While the authors are still reprogramming fibroblasts they have already collected, they also plan to add more causative mutations, generate more isogenic lines, and obtain more cells from members of the same families to help shed light on phenotypic variability. In addition, Karch said, she hopes repository users will resubmit lines with new modifications they generate.

Jeffrey Rothstein, Johns Hopkins University, Baltimore, welcomed the new resource. I think it is great they have assembled this collection, he said. Rothstein founded and co-directs the Answer ALS research project, which has amassed 600 iPSC lines from controls and patients with amyotrophic lateral sclerosis (ALS).

Rothstein suggested the tauopathy collection may want to prioritize adding cells from donors with the most common form of disease, that is, sporadic. His group aims to generate 1,000 iPSC lines, with a large fraction representing sporadic diseasealso the most common form of ALSto identify the most prevalent disease subtypes. One strategy that has helped his group build their collection, he said, is using peripheral blood mononuclear cells instead of fibroblasts to create iPSCs. More donors are willing to donate blood than have a piece of skin punched out. In addition, iPSCs derived from blood cells are genetically more stable, he noted.

Rothstein emphasized the importance of assembling a large collection of healthy controls. Although isogenic controls are of great value, he cautioned they can be subject to artifacts. One problem is that the cell population can change due to selective pressures during CRISPR editing (Budde et al., 2017). To address this, Karch and colleagues are collecting not only modified iPSC clones, but also control clones that have gone through the editing pipeline but remain unmodified.

Stem-cell users studying tauopathies face another challenge: iPSC-derived neurons express primarily the fetal isoform of tau, 3R0N. However, citing a study that shows three-dimensional neuronal cultures switch to the adult profile relatively quickly (Miguel et al., 2019), Hglinger and Strauss wrote, [It] allows us to be optimistic that current challenges of this model system can be overcome in the future.Marina Chicurel

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The extracellular matrix, and how it keeps you in tip top shape – ZME Science

By daniellenierenberg

Would you live in a city without streets? Or in a flat with no walls? Probably not and the cells in our bodies expect the same level of comfort. Today, were taking a look at the tissues that create and maintain an ideal working environment for our tissues: the extracellular matrix.

Weve had a look at the differences between animal and plant cells before (heres a refresher). One of the key differences between them is that plants reinforce their cells with thick, sturdy walls. These walls are why plant tissues such as wood can get so resilient. However, the reverse of the coin is that it also limits plant cells somewhat: a muscle made out of wood wouldnt be very effective.

Animals need cells that can perform a wide variety of activities, but these cells also need biological and mechanical support to perform their tasks. Thats where the extracellular matrix, or ECM, comes in.

The ECM is a complex mix of proteins and carbohydrates that fills the spaces between cells; it is comprised of the basement membrane and interstitial matrix. Going forward, Ill use the term ECM quite loosely to mean both the extracellular matrix and the interstitial matrix. If I dont mention the basement membrane specifically, Im probably talking about the interstitial matrix (as its the more dynamic and frankly more interesting half of the topic).

Think of the basement membrane as a sheet of plastic wrap the body stretches over every individual tissue or organ to keep everything tidy and in place. This membrane is made up of two layers of cells and its quite fibrous and hard to rip.

The interstitial matrix is, for lack of a better term, the goo that our cells live in. Most of the time, it looks and feels a bit like a clear gel. Its produced by the cells themselves, which secrete and release certain compounds around them.

The simplest definition of the extracellular matrix is that it represents the sum of non-cellular components present within all tissues and organs. As we go forward, keep in mind that the ECM isnt the same everywhere.

Although, fundamentally, the ECM is composed of water, proteins, and polysaccharides, each tissue has an ECM with a unique composition and topology that is generated during tissue development, Christian Frantz, Kathleen M. Stewart, Valerie M. Weaver, 2010.

Collagen, the most abundant protein in mammals, is the main component of the ECM. Outside the cell, collagen binds with carbohydrate molecules and assembles into long molecules called collagen fibrils. These fibrils extend through the ECM and lend flexibility and strength to the material, acting similarly to the role of rebar in reinforcing concrete (which is tough but inflexible). Collagen fibrils are flexible and tough to break, so theyre used to bind together the rest of the ECM. In humans, genetic disorders that affect collagen (such as Ehlers-Danlos syndrome) cause tissues to become fragile and tear easily.

While the ECM contains a wide range of proteins and carbohydrates, another important set of compounds alongside collagen are proteoglycans (groups of proteins tied to simple sugars). Proteoglycans come with many shapes and functions, depending on which proteins and sugars theyre made of, and perform a wide range of tasks in the ECM. They can also bind to each other, to collagen (forming cartilage), or to hyaluronic acid, making them even more versatile. As a rule of thumb, proteoglycans act as fillers and regulate the movement of molecules through the ECM among other functions.

Their overall structure looks like a tree: the sugar part of the polyglycans are twigs set on a branch (the protein), which ties to a trunk made out of polysaccharide (many-sugar) molecules. A class of proteins in the membranes of cells, called integrins, serve as connection ports between the membrane and material in the ECM (such as collagen fibers and proteoglycan-polysaccharide bundles). Beneath the membrane, integrins tie into the cells support girders (the cytoskeleton).

The type of ECM Ive described so far is your run of the mill variety that youll find in skin, around muscle fibers, in adipose tissue (fat), and so on. But each tissue has an ECM that fully supports its function blood plasma is the interstitial matrix of blood. Unlike the ECM of muscles, for example, which is meant to reduce friction and wear in the tissue, blood plasma primarily works as a medium to carry blood cells around. Blood vessels are coated with a basement membrane, and together, they form the ECM of blood. Each type of animal connective tissue has its own type of ECM, even bone.

Seeing as there are many types of ECM out there, it stands to reason that there are many functions they perform. However, by and large, there are a few functions that all ECMs fulfill.

The first and perhaps most important function is that they provide support to tissues, segregate (separate) them, and that they mediate intercellular communication. The ECM is also what regulates a cells dynamic behavior i.e. whether a cell moves around, and how. The ECM keeps cells in place so we dont simply unravel. The connections formed between the ECM and integrins on a cells membrane also function as signaling pathways.

It is also essential for the good functioning of tissues at large. The ECM creates and maintains the proper environmental conditions for cells to develop, multiply, and form functioning tissues. While the exact details are still unknown, the ECM has been found to cause tissue regrowth and healing after injury. In human fetuses, for example, the extracellular matrix works with stem cells to grow and regrow all parts of the human body. Fetuses can regrow anything that gets damaged in the womb, but since babies cant, we suspect that the matrix loses this function after full development. Researchers are looking into applying it for tissue regeneration in adults.

The ECM can also act as a storage space for various compounds. In joints, it contains more hyaluronic acid which in turn absorbs water and acts as a mechanical cushion. ECMs can also store a wide range of cellular growth factors and release them as needed. This allows our bodies to activate cell growth on a dime when needed without having to produce and ship these factors to a certain area.

It also seems to impact cell differentiation and gene expression. Cells can switch genes on or off depending on the elasticity of the ECM around them. Cells also seem to want to migrate towards stiffer areas of the ECM generally (durotaxis) from less-firm ones.

The ECM isnt very well known today, and it definitely goes unsung. But no matter how you cut it, it is a key part of biology as we know it today. Without it, both animals and plants would be formless, messy blobs quite literally. And I dont know about you but I love it when my tissues stay where theyre supposed to, the way theyre supposed to.

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The food of tomorrow the latest innovations from Europe’s foodtech sector – EU-Startups

By daniellenierenberg

The 4.5 trillion global food industry is currently being influenced by numerous developments. From how food is designed, grown to how its consumed, the next generation of foodtech entrepreneurs are fighting for its piece of the pie. In the meantime, funding for food tech has skyrocketed and according to a report from Dealroom.co, foodtech has created 35 unicorns globally, with a combined value of 169 billion, of which 30 billion from Europe.

Few innovations introduced by European startups are currently shaping the future of food and give us a glimpse of what the future holds for the food industry.

The Magic of Food Science

One of the most interesting developments in the food industry is the introduction of new origins of food. Have you ever imagined that food could actually be made of electricity, air and water? Well, the Finnish company Solar Foods is here to make you believe it. They have produced a nutrient-rich protein, Solein, with air, water, and electricity as its main resources, laced with bacteria. Solar Foods makes Solein by extracting CO from the air using carbon-capture technology, and then combines it with water, nutrients and vitamins, using 100 percent renewable solar energy. Science fiction? Not so much. More like science fact. The end product looks and tastes like wheat flour, with 50% protein content and 510 % fat and 2025 % carbs. Producing Solein is entirely free from agriculture it doesnt require arable land or irrigation and isnt limited by climate conditions, said Solar Foods. And the best part of it? It will never run out.

Changing the way we source ingredients brings us to the next big thing in food science meat grown in a lab. Lab-grown meat is slowly becoming an alternative food option. A few years ago, Mosa Meat got the worlds attention when it announced the first-ever lab-grown meat burger from cow cells. The spin-off company from Maastricht University introduced the cultured meat in Europe and now, one of the newest companies to enter the market is Higher Steaks. Using state-of-the-art cell culture techniques, the UK-startup develops cell-based meat that has the potential to use 99% less land, 96% less water, 45% less energy and has up to 96% less greenhouse gas emissions, all the while tasting as conventional meat. The company uses stem cells obtained via a small blood sample or a skin patch and patented protocols licensed exclusively from its American university partners, allowing them to reprogramme stem cells into tissues like muscle and fat. A single blood sample could allow indefinite production of many meat products, its website states. Around the world, the demand for clean meat is consistently growing. Optimistically, their pork sausages will reach the market by 2021.

Diet for One and the Birth of Personalised Nutrition

One of the biggest advantages of nutrition in the modern age is personalisation. The basic idea is very simple: we all love food, but which food is good for us? Nutrino can give you the answer. The company unlocks the potential of nutritional data and provides its users with smart, personalised analyses of how their bodies interact with the foods they eat. By using machine learning and artificial intelligence, Nutrinos platform collects, processes, and analyses food-related data from its users, matches it with their ever-growing nutritional database and defines an individualised nutrition profile, called FoodPrint. By knowing your own FoodPrint, you will never again question what to eat. Closely related to the idea of eating the food that suits you best is the freedom to choose it. But in todays hectic world, we often forget about its importance.

Luckily, we have Gousto. Providingusers with 40 recipes on a weekly basis, this cook-at-home meal kit service delivers to your doorstep correctly portioned fresh ingredients matched to each recipe of your choice. Backed by an AI recipe recommendation tool, cooking at home has never been easier. Gousto has setanambitious target of delivering 400 million balanced and nutritious meals by 2025. As consumers growingrequest towards greater convenience in eating fresh foods and leading healthier lives increases, Gousto will reach its goal in no time.The same applies for Frichti, the most-funded food startup in France. Aiming to become the second kitchen of Parisians, Frichti offers healthy, seasonal meals at affordable prices, coupled with a fast delivery service. Now their recipe for success is expanding across Europe.

Innovations in Food Creation: 3D Food Printing

As the world goes digital, its time to digitise our kitchens as well. A Spanish startup called Natural Machines has introduced to the world a 3D food printer by the name of Foodini. Foodini uses fresh ingredients loaded into stainless steel capsules to make foods like pizza, pasta, quiche, pancakes or brownies. Not to be mistaken, a real pizza will not come of Foodini, but the dough for the pizza will be as it was prepared by an Italian grandmother. Foodini simply manages the difficult and/or time-consuming parts of handmade food preparation that often discourage people from cooking at home. The decorative potential of the device is also worth mentioning. From everyday foods to elaborate creations, each piece is visually appealing, inviting Michelin-star restaurants to boost their culinary creativity and elevate the restaurant experience.

The Rise of the Functional Beverage

One bottle. One meal. This is the new norm across Europe. Feed has made sure of that. The French startup has introduced a nutritionally complete and convenient meal packed in a bottle, containing just the right amount of protein, essential fats, carbohydrates, vitamins and minerals. All the nutrients ones body needs. Just add some water, shake it a bit and drink it. Feed is a new form of nutrition that offers you freedom. Healthy, convenient and economical, Feed will simplify your life,said Anthony Bourbon, CEO of Feed. Feed is vegan, gluten-free, lactose-free, GMO-free, nut-free and comes in the form of nutrition bars (100g), drinks (500ml), drink mixes and other products. Holding the reputation of delivering quick nutrition, it seems like meal replacements are here to stay. This just might be the end of food, as we know it.

The Future of Dining is Delivery

Welcome to Keatz, the virtual restaurant without guests. Under the slogan We cook, you enjoy. Keatz has been operating since 2016 as the latest addition to the restaurant delivery marketplace. As one of the pioneers of the Ghost restaurants concept, Keatz is up and running thanks to the ongoing popularity of food delivery platforms. Currently it operates a total of 10 virtual restaurants in Berlin, Munich, Madrid, Amsterdam and Barcelona, focusing exclusively on food made for delivery, with minimal capital expenditure and time. Their idea is rather simple. Why should you do groceries and spend time cooking if you can get a great meal delivered in 20 minutes? Living in an on-demand society, consumers are expecting to get what they need whenever they want, and wherever they want. Food is no exception to that.

Fixing Food Loss with Technology

1.3 billion tonnes of food is wasted every year, taking an enormous toll on the planet. At the same time, hunger remains one of the most urgent development challenges of our time. Luckily,consumers are becoming more environmentally conscious and plus, now they have technology to help them distribute the leftovers. This is what Karma is doing. Helping restaurants, cafes and shops to distribute their surplus food to Karma users who get to buy food at half price or more. By making a shared platform on which customers and food providers co-exist and benefit from each other, Karma has found an effective solution for tackling the issue of food waste. A win -win situation.Over 550 tonnes of food have so far been rescued and counting

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Report on Operations 2018-2019: Strategic acquisition and strong closing of the year – BioSpace

By daniellenierenberg

CELLINK publishes the quarterly report for the period 1st of June 2019 31st of August 2019 and for the full year of operations 2018-2019. The report is available on the company's website: https://cellink.com/investors/ This press release presents a summary of the report.

Fourth quarter

Full year

Events during the quarter (Jun. 2019-Aug. 2019)

Events during the other financial year (Sept. 2018-May 2019)

Events after the end of the period

For further information, please contact:

Erik Gatenholm, CEO Gusten Danielsson, CFO

Phone: EU +46 73 267 00 00 Phone: +46 70 991 86 04US +1 (650) 515 5566 US +1 (857) 332 2138

Email: eg@cellink.com Email: gd@cellink.com

Important information

This information is such information as CELLINK AB is required to disclose under the EU Market Abuse Regulation. The information was submitted for publication on October 24, 2019 at. 08:30 CET.

This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.

About CELLINK

CELLINK is the leading 3D bioprinter provider and the first bioink company in the world. We focus on developing and commercializing bioprinting technologies to allow researchers to print human organs and tissues for pharmaceutical and cosmetic applications. Founded in 2016 and active in more than 50 countries, CELLINK is changing the future of medicine as we know it. Visit http://www.cellink.com to learn more. CELLINK is listed on Nasdaq First North Growth Market under CLNK. Erik Penser Bank AB is the companys certified adviser, available by phone at +46 846 383 00 and by email at certifiedadviser@penser.se.

at: certifiedadviser@penser.se.

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European Commission Approves Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement…

By daniellenierenberg

DetailsCategory: AntibodiesPublished on Friday, 25 October 2019 10:03Hits: 345

PRINCETON, NJ, USA I October 24, 2019 I Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W) or 480 mg infused over 60 minutes every four weeks (Q4W) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

The approval of Opdivo two and four-week flat dosing schedule in the adjuvant melanoma setting is an important milestone for patients across the European Union who now have additional treatment flexibility, said Ralu Vlad, Pharm.D, development team lead, product design and delivery, Bristol-Myers Squibb. Bristol Myers-Squibb is committed to empowering patients with cancer and their families to regain control of their lives through more flexible treatment options that fit their individual needs.

About Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has been increasing steadily for the last 30 years. In the United States, 91,270 new diagnoses of melanoma and more than 9,320 related deaths are estimated for 2018. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanoma is mostly curable when treated in its very early stages; however, survival rates are roughly halved if regional lymph nodes are involved. Patients in the United States diagnosed with advanced melanoma classified as Stage IV historically have a five-year survival rate of 15% to 20% and a 10-year survival of 10% to 15%.

Adjuvant Therapy in Melanoma

Melanoma is separated into five staging categories (Stages 0- IV) based on the in-situ feature, thickness and ulceration of the tumor, whether the cancer has spread to the lymph nodes, and how far the cancer has spread beyond lymph nodes.

Stage III melanoma has generally reached the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized) and requires surgical resection of the primary tumor as well as the involved lymph nodes. Some patients may also be treated with adjuvant therapy. Despite surgical intervention, most patients experience disease recurrence and progress to metastatic disease.

Bristol-Myers Squibb: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the bodys own immune system to help restore anti-tumor immune response. By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivos leading global development program is based on Bristol-Myers Squibbs scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Companys Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO

OPDIVO (nivolumab) as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Checkmate Trials and Patient Populations

Checkmate 037previously treated metastatic melanoma; Checkmate 066previously untreated metastatic melanoma; Checkmate 067previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032small cell lung cancer; Checkmate 025previously treated renal cell carcinoma; Checkmate 214previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039classical Hodgkin lymphoma; Checkmate 141recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275urothelial carcinoma; Checkmate 142MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040hepatocellular carcinoma; Checkmate 238adjuvant treatment of melanoma.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol-Myers Squibb further expanded the companies strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

SOURCE: Bristol-Myers Squibb

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New funding to test personalised treatment for aplastic anaemia – Pharmafield

By daniellenierenberg

Patients with ultra-rare bone marrow disease are set to benefit from 1.15m grant from LifeArc and The Aplastic Anaemia Trust. The grant will support researchers from Kings College London and Kings College Hospital to test a personalised treatment for aplastic anaemia patients who have not responded to available therapies

The grant has been awarded to investigate the potential of a novel type of personalised cellular therapy to reverse the ultra-rare condition aplastic anaemia (AA). The results of this research could give new hope to people living with a severe, life-limiting form of this condition.

The grant will fund a clinical trial to investigate the safety and efficacy of using a patients own T-reg cells to restore the blood-making function of the bone marrow. This follows laboratory-based research from the team of scientists where T-reg cells from a patients own blood were collected, selected for activity and multiplied. In a test tube, these cells prevented the immune system from attacking the patients bone marrow stem cells.

AA is an ultra-rare life-threatening illness caused by the bone marrow failing to make enough of all three types of blood cells red blood cells, white blood cells and platelets. Only around 100-150 people in UK are diagnosed per year, affecting all ages but most commonly people between the ages of 10 to 20 years old and those over the age of 60 years.

People with the illness are at greater risk of infections, bleeding, and can experience extreme fatigue, which leaves them unable to carry out simple daily tasks that most people take for granted. Around one in three patients with severe AA fail to respond to existing drug treatments and the other option a bone marrow transplant is reliant on finding a suitable donor, requires life-long treatment with immunosuppression therapy and is unsuccessful in one in three people.

The trial at Kings College London and Kings College Hospital will run for three years and aims to recruit nine patients. A blood sample of the patients T-reg cells will be extracted, purified and grown in the lab before being given back to them in a higher concentration. As patients with AA are more susceptible to infection, this personalised treatment approach is more likely to avoid the risk of severe infection and inflammation.

Professor Ghulam Mufti, Department of Haematological Medicine at Kings College London and Kings College Hospital, and lead study investigator said: For patients with this ultra-rare disease, were looking for the first time at a personalised medicine approach where their own immune cells could be used to alter their disease. In AA there is a reduction in the number of T-regs and most of the ones that the AA patients do have are non-functional. Weve seen success in the laboratory by selecting and bolstering the number of functional T-reg cells. Now, with funding from LifeArc and the AAT, we can investigate the potential of this approach in treating AA patients who currently have very limited treatment options.

Dr Catriona Crombie, LifeArcs Head of Philanthropic Fund explained why the charity had approved the funding: LifeArc set up the Philanthropic fund to support translational research into rare diseases, where there is less interest from commercial organisations. Patients with AA can have limited treatment options; this opportunity with Kings College London, Kings College Hospital and the AAT has the potential to transform the lives of patients living with a severe form of the disease.

Grazina Berry, Chief Executive of the AAT said: AA can severely impact a persons quality of life. Through AATs close work with Kings College London and Kings College Hospital as a specialist centre of clinical care and research in AA, we identified the project with the most potential to directly benefit patients who are currently at a loss for solutions. We are delighted to have partnered with LifeArc and Kings College London and Kings College Hospital to progress this ground-breaking work, which could potentially enable people living with severe AA to once again lead a normal life.

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Rocket’s gene therapy shows long-term efficacy in rare blood disorder – MedCity News

By daniellenierenberg

A gene therapy for a rare blood disorder has shown what the manufacturer calls the first evidence of long-term improvement associated with the disease.

New York-based Rocket Pharmaceuticals said Thursday that it had presented long-term follow-up data from the Phase I/II study of RP-L102, its gene therapy for Fanconi anemia, at the annual congress of the European Society of Cell and Gene Therapy in Barcelona, Spain. The company said it represented the first evidence of long-term improvement and stabilization in blood counts and durable mosaicism among patients who received the therapy without the use of the conditioning regimens normally used for allogeneic stem cell transplants, which the company calls Process A.

Shares of Rocket were up slightly on the Nasdaq following the news. RP-L102 is a lentiviral vector-based gene therapy. Most other gene therapies in development, and both of the currently marketed ones Spark Therapeutics Luxturna (voretigene neparvovec-rzyl) and Novartis Zolgensma (onasemnogene abeparvovec-xioi) are adeno-associated viral vector-based.

According to the data, representing four of nine patients, there were improved blood counts and long-term bone marrow mitomycin C (MMC) resistance, thereby indicating durable phenotypic correction. The data met or exceeded a 10 percent threshold that the company said the Food and Drug Administration and European Medicines Agency had agreed to for its upcoming Phase II registration study, for which it plans to start enrolling patients by the end of the year.

FA is a rare, genetic bone marrow failure disorder, half of whose patients are diagnosed before the age of 10, while about 10 percent of patients are diagnosed as adults, according to the National Organization for Rare Disorders. It is often associated with progressive deficiency of production of red and white blood cells and platelets in the bone marrow and can eventually lead to certain solid and liquid tumor cancers. It occurs in 1-in-136,000 births and is more common among Ashkenazi Jews, Spanish Roma and black South Africans.

These results indicate the feasibility of engraftment in FA patients using autologous, gene corrected [hematopoietic stem cells] in the absence of any conditioning regimen, said Dr. Juan Bueren, scientific director of the FA gene therapy program at Spains Center for Energy, Environmental and Technological Research, in a statement. This indicates the potential of this therapeutic approach as a definitive hematologic treatment, while avoiding the burdensome side effects associated with allogeneic transplant, including the risk of post-transplant mortality and a substantially higher risk of head and neck cancer.

Photo: virusowy, Getty Images

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Worlds first cell atlas of developing liver created by Cambridge scientists – Cambridge Independent

By daniellenierenberg

The worlds first cell atlas of the human developmental liver has been created, giving fresh insight into how the blood and immune systems develop in the foetus.

A high-resolution resource, it will aid our understanding of normal development and efforts to tackle diseases that can form during development, such as leukaemia and immune disorders.

The cell atlas maps how the cellular landscape within the developing liver changes between the first and second trimesters of pregnancy, including how stem cell from the liver seed other tissues, supporting the high demand for oxygen required for growth.

Researchers from the Wellcome Sanger Institute in Hinxton, the Wellcome MRC Cambridge Stem Cell Institute, University of Cambridge, Newcastle University and their collaborators created the atlas by using single cell technology to analyse 140,000 liver cells and 74,000 skin, kidney and yolk sac cells.

In adults, it is bone marrow that is primarily responsible for the creation of blood and immune cells in a process called haematopoiesis.

In early embryonic life, the yolk sac and liver play a key role in creating these cells, which then seed peripheral tissues such as skin, kidney and ultimately bone marrow.

But until now, the precise process of how blood and immune systems develop in humans has been unknown.

Isolating cells from the developing liver, the researchers were able to identify them by what genes they were expressing and discover what the cells looked like.

They tagged haematopoietic cells in sections of developmental liver using heavy metal markers in order to map them to their location.

Prof Muzlifah Haniffa, a senior author of the study from Newcastle University and senior clinical fellow at the Wellcome Sanger Institute, said: Until now research in this area has been a little bit like blindfolded people studying an elephant, with each describing just a small part of it.

This is the first time that anyone has described the whole picture, how the blood and immune systems develop in such detail. Its been an extraordinary, multidisciplinary effort that is now available as a tool for the whole scientific community.

The scientists learned that during foetal development, mother haematopoietic stem cells stay in the liver. But the liver alone cannot supply enough red blood cells, so the next generation daughter cells called progenitor cells travel to other tissues, maturing in places such as the skin. Thee, they develop into red blood cells to help meet the high demand for oxygen in the developing foetus.

Dr Elisa Laurenti, a senior author from the Wellcome MRC Cambridge Stem Cell Institute and the Department of Haematology at the University of Cambridge, said: We knew that as adults age our immune system changes. This study shows how the livers ability to make blood and immune cells changes in a very short space of time, even between seven and 17 weeks post-conception.

If we can understand what makes the stem cells in the liver so good at making red blood cells, it will have important implications for regenerative medicine.

The study, published in Nature, also involved the mapping of genes involved in immune deficiencies to reveal which cells were expressing them.

It is known that gene mutations can lead to immune disorders such as leukaemia.

A better understanding of the development of healthy liver functions could aid our understanding of how to treat such conditions.

The work is part of the ambitious effort to create the first complete Human Cell Atlas.

Dr Katrina Gold, genetics and molecular sciences portfolio manager at Wellcome, said: Our immune system is vital in helping to protect us from disease, yet we know very little about how immune cells develop and behave in the early embryo. This study is hugely important, laying a critical foundation for future research that could help improve our understanding of disorders linked to the early immune system, such as childhood leukaemias.

The Human Cell Atlas has the potential to transform our understanding of health and disease and were excited to see these first discoveries from our Wellcome-funded multidisciplinary team of scientists.

Dr Sarah Teichmann, a senior author from the Wellcome Sanger Institute, University of Cambridge and co-chair of the Human Cell Atlas organising committee, said: The first comprehensive cellular map of the developmental liver is another milestone for the Human

Cell Atlas initiative.

The data is now freely available for anyone to use and will be a great resource to better understand healthy cellular development and disease-causing genetic mutations.

Read more

Asthma treatment hope as Human Cell Atlas project creates first map of lungs

Sanger Institute scientist helps unveil blueprint for extraordinary Human Cell Atlas

AstraZeneca and Cancer Research UK launch joint Functional Genomics Centre in Cambridge

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United Therapeutics Receives Permit For Cell Therapy Facility Build-Out At Mayo – Pharmaceutical Online

By daniellenierenberg

The build-out is estimated at $9.5M.

United Therapeutics received a building permit Tuesday for a $9.5M build-out of its cell therapy facility on the second floor of Mayo Clinics Discovery and Innovation Building.

The 21,843-square-foot space will house an automated stem cell manufacturing site, which is one of the first of its kind in the country. The Whiting-Turner Contracting Co. is the project contractor.

The technology, approved by the FDA in 2018, allows the Mayo Clinic Center for Regenerative Medicine to produce cells from the bone marrow of a stem cell donor in large enough quantities to be used as treatments in clinical trials. It allows for the treatment of multiple patients at the same time.

Construction began in 2017 on the $32.4M building at 14221 Kendall Hench Drive. It held a grand opening in August.

The first floor houses three ex-vivo lung perfusion surgical suites used for lung restoration, another form of regenerative medicine. It turns donor lungs, which previously would have previously been unusable, into viable transplant organs. United Therapeutics also collaborates with Mayo Clinic on lung restoration.

The third floor houses the Life Sciences Incubator for biotech entrepreneurs, which offers coworking space, wet labs, business resources, networking and entrepreneurial training.

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BrainStorm Cell Therapeutics to Present at the Dawson James Securities 5th Annual Small Cap Growth Conference – BioSpace

By daniellenierenberg

NEW YORK, Oct. 25, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced that it will be presenting at the Dawson James Securities 5th Annual Small Cap Growth Conference, being held on October 28-29, 2019 at the Wyndham Grand Hotel in Jupiter, Florida.

Preetam Shah, PhD, MBA, Chief Financial Officer is scheduled to present on Tuesday, October 29th at 3:40 p.m. Eastern Time, in Track 2 - Preserve Ballroom B, with one-on-one meetings to be held throughout the conference.

Chaim Lebovits, President and CEO of BrainStorm said, We are pleased to have the opportunity to have Dr. Shah present at the Dawson James Small Cap Growth Conference. Dr. Shah, joined BrainStorm in September 2019, and we look forward to having him present the Companys growth strategy and future to a wide audience of accreditied investors.

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

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

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

CONTACTS

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

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

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Imago BioSciences Preliminary Data from Ongoing Phase 2 Study of IMG-7289 for the Treatment of Myelofibrosis to be Presented at the 61st American…

By daniellenierenberg

SAN FRANCISCO--(BUSINESS WIRE)--Imago BioSciences, Inc., a clinical-stage biotechnology company focused on the treatment of myeloproliferative neoplasms (MPN) and related bone marrow diseases, announced today that preliminary data from its ongoing Phase 2 study of IMG-7289 (bomedemstat) in patients with myelofibrosis (MF) has been selected for an oral presentation at the American Society of Hematology (ASH) Annual Meeting, on December 9 in Orlando, Florida. The abstract will be published November 6, and the presentation will include results updated from those in the abstract.

Kristen Pettit, M.D., assistant professor at the University of Michigan and investigator in the study at the Rogel Cancer Center in Ann Arbor, will present both preliminary results from Phase 2a, as well as initial data from patients from the Phase 2b expansion. The objectives of the study are to evaluate the safety and efficacy of IMG-7289 (bomedemstat) in up to 75 patients at sites in Australia, the US, UK and Europe. In this study, bomedemstat is administered orally once-daily as monotherapy in adult patients with intermediate-2 or high-risk MF resistant to or intolerant of ruxolitinib.

The FDA recently approved a second JAK2 inhibitor but the majority of patients with myelofibrosis will eventually lose the benefit of those treatments, said Dr. Pettit. Patients have an urgent need for new treatments that manage their symptoms. We continue to be encouraged by the bomedemstat data we see in this clinical investigation.

Imago Presentation

Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Myelofibrosis. Session: 634. Myeloproliferative Syndromes: Clinical: Emerging and Novel Targeted TherapiesSession Date: Monday, December 9, 2019Session Time: 7:00 AM - 8:30 AM ESTPresentation Time: 7:45 AM ESTRoom: Orange County Convention Center, W304EFGH

About IMG-7289

IMG-7289 (bomedemstat) is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A). LSD1 is an enzyme regulating both cytokine expression and myeloid differentiation and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, bomedemstat demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancy models, including the myeloproliferative neoplasms encompassing myelofibrosis, essential thrombocythemia and polycythemia vera. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to bomedemstat for the treatment of myelofibrosis. An international Phase 2b study of bomedemstat for the treatment of myelofibrosis remains ongoing (Clinicaltrials.gov NCT03136185). Additional clinical studies in hematologic disorders will begin in 2020.

About Imago BioSciences

Imago BioSciences is a clinical-stage, venture-backed pharmaceutical company whose investors include a fund managed by Blackstone Life Sciences, Frazier Healthcare Partners, Omega Funds, Amgen Ventures, MRL Ventures Fund, HighLight Capital, Pharmaron, Greenspring Associates and Xeraya Capital as well as other corporate and venture investors. Imago is focused on improving the management of malignant and life-threatening diseases of the bone marrow with a focus on the myeloproliferative neoplastic disorders including myelofibrosis, essential thrombocythemia and polycythemia vera. The company is based in California.

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Plant of the week: Plant thought to boost milk production now used for skin eruptions – Cyprus Mail

By daniellenierenberg

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Regenerative Medicine Market Industry Outlook, Growth Prospects and Key Opportunities – Health News Office

By daniellenierenberg

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

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Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

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Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe are Vericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc. A large number of players are anticipated to enter the global market throughout the forecast period.

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ReNeuron Presents Positive Data at the 27th Annual Congress of the European Society of Gene and Cell Therapy on Lead Cell Line – PRNewswire

By daniellenierenberg

PENCOED, Wales, Oct. 23, 2019 /PRNewswire/ --ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce that new data relating to its CTX stem cell platform will be presented today at the 27th Annual Congress of the European Society of Gene and Cell Therapy(ESGCT), a leading scientific conference taking place this week in Barcelona, Spain.

Dr. Steve Pells, Principal Investigator at ReNeuron, will present new data showing the phenotypic stability and scalability of a mesenchymal stem cell line derived from the Company's proprietary, conditionally immortalized, human neural stem cell line (CTX) following re-programming to a pluripotent state.

The Company has previously presented data demonstrating that its CTX stem cell line, currently undergoing clinical evaluation for the treatment of stroke disability, can be successfully and rapidly re-programmed to an embryonic stem cell-like state enabling differentiation into any cell type. In essence, this means that the Company is able to take its neural stem cells back to being stem cells that can be made to develop into any other type of stem cell including bone, nerve, muscle and skin.

The new data being presented today show for the first time that these CTX-iPSCs (induced pluripotent stem cells) can indeed be differentiated along different cell lineages to generate, for example, mesenchymal stem cell lines. Further, the mesenchymal stem cell lines generated can be grown at scale by virtue of the Company's conditional immortalization technology, enabling the efficient production of clinical-grade cell therapy candidates.

These results are particularly encouraging as they demonstrate that CTX, a well-characterized, clinical-grade neural stem cell line, could be used to produce new conditionally immortalized allogeneic (i.e. non-donor-specific) cell lines from any of the three primary germ cell layers which form during embryonic development. ReNeuron is currently exploring the potential to develop further new allogeneic cell lines as potential therapeutic agents in diseases of unmet medical need for subsequent licensing to third parties.

Further information about the conference may be found at:

https://www.esgct.eu/congress/barcelona-2019.aspx

"The data we are presenting at the ESGCT Annual Congress represent a significant advance in the use of cell re-programming to generate new allogeneic cell lines as potential therapeutic candidates," commented Dr. Randolph Corteling, Head of Research at ReNeuron. "Importantly, the maintenance of the immortalization technology within these new cell lines may allow for the scaled production of 'off the shelf' allogeneic stem cells, such as haematopoietic stem cells as a potential alternative approach to those cancer immunotherapies currently in development that rely on the use of the patient's own T-cells."

About ReNeuronReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop 'off the shelf' stem cell treatments, without the need for immunosuppressive drugs. The Company's lead clinical-stage candidates are in development for the blindness-causing disease, retinitis pigmentosa, and for disability as a result of stroke. ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that would otherwise be unable to reach their site of action. ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. For further information visit http://www.reneuron.com.

ENQUIRIES:

ReNeuron

+44 (0)20 3819 8400

Olav Helleb, Chief Executive Officer

Michael Hunt, Chief Financial Officer

Buchanan (UK)

+44 (0) 20 7466 5000

Mark Court, Tilly Abraham

Argot Partners (US)

Stephanie Marks, Claudia Styslinger

Stifel Nicolaus Europe Limited

+1 212 600 1902

+44 (0) 20 7710 7600

Jonathan Senior, Stewart Wallace, Ben Maddison (NOMAD and Joint Broker)

N+1 Singer

+44 (0) 20 7496 3000

Aubrey Powell, James Moat, Mia Gardner

(Joint Broker)

SOURCE ReNeuron Group plc

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ReNeuron Presents Positive Data at the 27th Annual Congress of the European Society of Gene and Cell Therapy on Lead Cell Line - PRNewswire

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Stem Cell Therapy Market Latest Report with Forecast to 2025 – Health News Office

By daniellenierenberg

Stem Cell Therapy Market: Snapshot

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

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

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

Global Stem Cell Therapy Market: Overview

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

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

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Global Stem Cell Therapy Market: Key Trends

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

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

Global Stem Cell Therapy Market: Market Potential

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

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

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

Global Stem Cell Therapy Market: Regional Outlook

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

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

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Global Stem Cell Therapy Market: Competitive Analysis

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

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

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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What is aplastic anemia? Symptoms, causes, and treatment – Medical News Today

By daniellenierenberg

Aplastic anemia is a medical condition that damages stem cells in a person's bone marrow. These cells are responsible for making red blood cells, white blood cells, and platelets, which are vital to human health.

Doctors believe various conditions can cause aplastic anemia, while the disease itself ranges in severity from mild to life threatening.

Medical advancements mean that aplastic anemia is more treatable than ever. In this article, learn more about this rare medical disorder.

When a person has aplastic anemia, their bone marrow does not create the blood cells it needs. This causes them to feel ill and increases their risk of getting infections.

Doctors also call aplastic anemia bone marrow failure.

Doctors do not know exactly how many people in the United States have aplastic anemia.

According to the National Organization for Rare Disorders (NORD), doctors diagnose approximately 500 to 1,000 cases every year. It is most common in older children, teenagers, and young adults.

Researchers believe that most cases of aplastic anemia are due to the immune system attacking healthy bone marrow cells, according to NORD.

Doctors have also identified some of the possible causes of this immune system response, including:

However, doctors usually cannot pinpoint the underlying cause in most aplastic anemia cases.

When the cause is unknown, doctors refer to the condition as idiopathic aplastic anemia.

Symptoms of aplastic anemia include:

These symptoms may be severe. Some people may have heart-related symptoms, such as chest pain.

A doctor will start by asking about a person's symptoms and their medical history.

They will usually use a blood test known as a complete blood count (CBC) to evaluate a person's red blood cells, white blood cells, and platelets. If all three of these components are low, a person has pancytopenia.

A doctor may also recommend taking a sample of bone marrow, which comes from a person's pelvis or hip.

A laboratory technician will examine the bone marrow. If a person has aplastic anemia, the bone marrow will not have typical stem cells.

Aplastic anemia can also have similar symptoms as other medical conditions, such as myelodysplastic syndrome and paroxysmal nocturnal hemoglobinuria. A doctor will want to rule out these conditions.

Sometimes, a person with other medical conditions can develop aplastic anemia. These conditions include:

If a person has these conditions, a doctor will recognize that they are more likely to get aplastic anemia.

Doctors usually have two goals when treating aplastic anemia. The first is to reduce the person's symptoms, and the second is to stimulate the bone marrow to create new blood cells.

People with aplastic anemia can receive blood and platelet transfusions to correct low blood counts.

A doctor may also prescribe antibiotics as a person needs white blood cells to fight infections. Ideally, these drugs will prevent infections until a person can build more new white blood cells.

Doctors usually recommend a bone marrow transplant to stimulate new cell growth in the long term.

For this, a doctor may first prescribe chemotherapy medications to kill off abnormal bone marrow cells that are affecting a person's overall bone marrow function.

Next, a doctor performs a bone marrow transplant by injecting the bone marrow into a patient's body.

Ideally, the individual will receive bone marrow from a close family member. However, even a sibling donor is only a match in 2030% of cases.

People can also receive bone marrow from someone who is not related to them if doctors can find a compatible donor.

Some people cannot tolerate bone marrow transplants, especially older adults, and those having difficulty recovering from chemotherapy. Others may not be able to find a donor that matches their bone marrow. In these instances, a doctor can prescribe immunosuppressive therapy.

Immunosuppressive medicines suppress the immune system, which ideally stops it from attacking healthy bone marrow cells. Examples of these medications include antithymocyte globulin (ATG) and cyclosporine.

According to NORD, an estimated one-third of people with aplastic anemia do not respond to immunosuppressive drugs.

If this is the case, doctors may consider other treatments, such as hematopoietic stem cell transplantation and a medication called eltrombopag (Promacta).

Those with aplastic anemia may face complications due to their disease as well as their treatment.

Sometimes, a person's body rejects a bone marrow transplant. Doctors call this graft-versus-host disease or GVHD.

GVHD can make a person feel extremely ill and can cause symptoms that include:

According to 2015 research, about 15% of aplastic anemia patients who receive immunosuppressive therapy will develop myelodysplastic syndromes or acute myeloid leukemia.

These conditions can develop years after a person's initial diagnosis.

Some people do not respond to aplastic anemia treatments. When this is the case, they are more vulnerable to infections that can be life threatening.

The outlook for a person with aplastic anemia depends on many factors, including:

A doctor will discuss a person's treatment outlook when considering the various therapies.

Aplastic anemia damages stem cells in a person's bone marrow. The bone marrow makes red blood cells, white blood cells, and platelets, which are all essential for the body.

A person with aplastic anemia may experience severe anemia symptoms. Treatment may include chemotherapy, stem cell transplants, and immunotherapy.

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A Discussion With Jennifer Delgado on Life After Cancer and Weathering the Storm – Thrive Global

By daniellenierenberg

JenniferDelgado grew up in St. Louis, Missouri. She attended Webster University, whereshe received her Bachelor of Arts in Media Communications. She then went to MississippiState University, where she received a Bachelor of Science in Geosciences witha concentration in Broadcast Meteorology.

In 2006,Jennifer Delgado worked as a morning and noon meteorologist for WTVR-TV inRichmond, Virginia. Then in 2008, she began working at CNN International inAtlanta, Georgia, as their primary meteorologist, as well as a fill-inmeteorologist on all CNN networks. In 2010, she won a Peabody Award for CNNscoverage on the Deepwater Horizon oil spill in the Gulf of Mexico.

In 2013,Delgado was hired as a co-host of AMHQ (Americas Morning Headquarters) at TheWeather Channel. She anchored continuous coverage of breaking news and weatherevents, including live interviews with state and local officials, experts andresidents. She was also their fill-in co-host of Wake-Up with Al.

JenniferDelgado began freelancing as a meteorologist/anchor for WXIA-TV in 2017. Shepresented weathercasts every six minutes during a two-hour morning newscast andproduced weathercasts for radio, web, and the 24-hour weather channel.

Two yearsago, Jennifer Delgado was diagnosed with blood cancer. She underwent treatmentand received a bone marrow/stem cell transplant. Since the transplant, she hasbeen receiving treatment at the Emory Winship Cancer Institute and advocatingfor cancer awareness and more bone marrow donors.

No one is ever prepared tohear the words, you have cancer. It literally blew up my world. I had to stopworking because beating cancer became my full-time job. I knew something waswrong for months based on my symptoms. I was tiredall the time, my bones were aching, had migraines, vertigo andconfusion. Dealing with any illness is stressful, especially if you arent ableto work. Some people say cancer changed their life for the better; however, Idont want to credit cancer for anything positive. It was a wake-up call. Lifeis short, and you have to enjoy every moment.

I immediately went into adeep depression. I hid and only shared the news with my close friends andfamily. I was trying to hide the awful chemo port in my chest and made excuses for my appearanceand fatigue. It was very stressful. I think anyone dealing with a seriousmedical condition should reach out to people going through the same battle. I got some amazing tips from fellow blood cancersurvivors on Instagram and Facebook support groups. I have formed many closebonds and when I am feeling down they completely understand. Cancer patients caneasily go through their savings in a short amount of time. I was lucky to haveamazing health insurance but not everyone is that fortunate. There is a lot of grant money out there forpeople struggling financially. The Leukemia & Lymphoma Society is anamazing organization and helps patients with everything from financial help,information on clinical trials etc.

If you are strong enough, Isay its important to be your own health advocate. You know your body best. Ialso suggest if you have one, reaching out to a friend or family member whoworks in medicine (nurse, PA, doctor) to be your medical advocate. The advocatecan come to your appointments or even join a conference call during yourappointments when you need help understanding your treatment options. I waslucky to have both my mom and one of my best friends to help me interpreteverything. Never be afraid to ask your doctor questions, and dont forgetabout the physicians assistant, who often has more availability.

I was going back and forthto the doctor for nearly a year, and they keep dismissing my symptoms. At onepoint, one doctor told me to take probiotics. I finally decided it was time toget a second opinion when I was having trouble walking. Luckily, I found Dr.Drew Freilich, whom I credit with saving my life. He recognized that mysymptoms were severe and insisted that I needed an MRI. Thats how theydiscovered I had a blood cancer that was attacking my bones. I could havebecome disabled if I had waited longer to get help. If you know something iswrong, you have to be persistent about getting answers.

I know it sounds clich, butmy friends, family, and neighbors. They all took excellent care of me. Theydrove me to the hospital for chemotherapy or bone marrow biopsies. My friends were great and woulddrop by to bring me food or help clean up myhouse.

I know it may sound sillybut my dogs really helped keep my spirits up. Quite often, it was just me and the dogs and duringisolation. I truly believe that pets are healing, and studies show that havingone improves your mental health. There were several weeks when I had to be awayfrom my dogs because my immune system was too weak. I was lucky enough to havegreat friends watch my fur babies. I even tried to convince my friends to driveby Emory Hospital so that I could see them.

I would say you have to bepositive. It seems like its a long way away, and you wonder at times whetheror not everything you did is going to pay off when you finally get toremission. So, I think you have to be positive because you get very paranoid. Ibelieve positive thinking can be healing and improve your health. Keeping inmind that everyones journey is different, I think its also important to see apsychologist or therapist. Sometimes its easier to share your real concernswith a stranger. We always try and put on a brave face for family and friends.

Aftereverything, I felt like I had to give back to the cancer community and EmoryWinship Cancer Center. I got my dogs certified to be Happy Tails therapydogs, and now we visit patients battling cancer while they are getting chemo.Its amazing and emotional all at the same time. Many times, patients will say,your puppy made my day.

Iam also trying to raise awareness for the need of more bone marrow donors.Right now, the majority of donors come from Europe. It would be awesome if morepeople would register to be a bone marrow donor. Its a simple swab test. Ithink its a small price to pay, considering more than 170,000 people arediagnosed with blood cancer every year. Check out Be The Match or The Leukemia& Lymphoma Society.

I am not going to sugarcoatit, staying motivated is extremely challenging and a daily battle. I thinkevery cancer survivor questions, why did this happen to me? Is it gone? How longwill I stay in remission? It can be quite depressing, but you have to live forthe day and stick to a routine. I try to remind myself that there is a reasonwhy I am still alive, and I want to give back to others who are struggling.

Everything. I had months ofchemo to get my cancer level down enough to collect my stem cells for thetransplant. I wondered constantly, will I be in remission? And then once Iwas in remission, how long will I stay in remission before I relapse? Whenyoure dealing with blood cancers, most have no cure. So, theres always thatchance of relapse, and youre always worrying about it.

I did six rounds of chemobefore I was even ready to get a transplant. The stem cell transplant wassomething I was dreading because of the high dose of chemotherapy and losing myhair. That can be a very difficult experience, especially for women. After thosesix rounds, they collected my stem cells, which is not a fun process. Then theyprepped me, and I had the transplant.

After, I was in isolation atthe hospital for three weeks. Then I went home, and I was still under isolationfor another 100+ days. I felt like I was ready to lose my mind. During thistime, your white blood cells are regenerating, which means you dont have animmune system, and you suffer from extreme fatigue and pain. Walking up a shortflight of stairs would wipe me out. I couldnt eat salads, fruits, basicallyanything raw. When I left the house, Id have to wear a mask to protect myimmune system. I really hated that because everyone would stare and pretty muchknew I had cancer.

However, to put a positivespin on it, because of my time in isolation at home, I really felt my creativejuices start to flow. I began brainstorming and thinking of a lot of differentthings because life is short, and the cancer was my wake-up call.

So, my best advice duringthat period is to make a reading list and binge-watch shows on Netflix. I readthe Game of Thrones series. Iliterally had a calendar counting down to 100 days. Thats also the time whenyour hair finally starts to grow back!

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A Discussion With Jennifer Delgado on Life After Cancer and Weathering the Storm - Thrive Global

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Ewing sarcoma: Causes, symptoms, and treatment – Medical News Today

By daniellenierenberg

Ewing sarcoma is a form of bone cancer that usually affects children and adolescents.

Ewing sarcoma can be very aggressive, but the cells tend to respond well to radiation therapy. Ideally, doctors will diagnose the cancer before it has spread.

According to the National Library of Medicine, an estimated 250 children in the United States receive a diagnosis of Ewing sarcoma each year.

In this article, learn more about Ewing sarcoma, including the symptoms, causes, and treatment options.

Ewing sarcoma is a rare type of cancer that usually starts in the bone typically in the pelvis, chest wall, or legs and occurs mostly in children and teenagers.

Dr. James Ewing first described Ewing sarcoma in 1921. He identified cancer cells that looked different than the cells in osteosarcoma, another type of bone tumor.

Doctors may also refer to this cancer type as the Ewing family of tumors. These tumors have distinct cells that usually respond well to radiation treatments.

This rare cancer type accounts for just 1.5% of all childhood cancers and is the second most common bone cancer type in childhood, after osteosarcoma.

Although researchers are unsure why some people develop Ewing sarcoma, they have identified mutations in certain genes in the tumor cells that cause this cancer.

These include the EWSR1 gene on chromosome 22 and the FLI1 gene on chromosome 11.

These genetic mutations occur spontaneously during a person's lifetime. The individual does not inherit them from a family member.

There are no known risk factors for Ewing sarcoma that make one person more likely than another to develop this cancer.

Ewing sarcoma can cause the following symptoms:

An estimated 87% of Ewing sarcomas are sarcoma of the bone. The other types form in the soft tissues, such as cartilage, that surround the bones.

Ewing sarcoma can spread to other areas of the body. Doctors call this process metastasis.

Areas that the cancer can spread to include other bones, bone marrow, and the lungs.

Doctors categorize Ewing sarcoma as one of three types according to its extent:

Before diagnosing Ewing sarcoma, a doctor will take a person's full medical history and ask them what symptoms they are having, when they noticed them, and what makes them better or worse. They will also perform a thorough physical exam, focusing on the area of concern.

A doctor will usually recommend an imaging study to view the bone or bones. These tests include:

If it looks as though a tumor may be present, a doctor will perform a biopsy, which involves taking a sample of bone tissue. They will send this tissue to a laboratory, where a specialist called a pathologist will check it for the presence of cancerous cells.

A doctor may also order blood tests, a bone marrow biopsy, and other scans when necessary. These tests can help determine whether the cancer has spread to other locations.

A doctor will work with a team of cancer specialists and surgeons to recommend and implement particular treatments.

Possible treatments for Ewing sarcoma include:

Doctors may use a combination of treatments depending on how far the cancer has spread and a person's overall health.

Research into new treatments for Ewing sarcoma is ongoing. Some doctors may inform their patients about clinical trials, which help test new treatments.

Possible complications of Ewing sarcoma include:

If Ewing sarcoma has spread to other areas of the body, it can be life threatening. For this reason, it is vital for a doctor to evaluate any symptoms as quickly as possible.

According to the American Academy of Orthopaedic Surgeons, an estimated two-thirds of people in whom cancer has not spread to other areas of the body survive at least 5 years after their diagnosis.

People who are more likely to have positive outcomes include those who have:

The likelihood of successful treatment is different for every individual, so people should speak to a doctor about their or their child's expected outlook.

Ewing sarcoma is a rare type of cancer that mostly affects young people.

When doctors detect it early enough, the condition usually responds well to treatment.

Anyone who notices signs or symptoms of Ewing sarcoma, such as a bone that breaks for no apparent reason or a painful lump or swelling, should speak to a doctor.

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BrainStorm Cell Therapeutics’ President and CEO to be Featured as Keynote Speaker at Cell Series UK 2019 – GlobeNewswire

By daniellenierenberg

NEW YORK, Oct. 24, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced, Chaim Lebovits, President and CEO, will serve as a Keynote Speaker at Cell Series UK.Cell Series UK, will be held October 29-30, 2019, at London Novotel West, London, UK. The Conference, organized by Oxford Global, is one of the foremost events in Europe focused on regenerative medicine and cellular innovation.

Ralph Kern MD, MHSc, Chief Operating and Chief Medical Officer of Brainstorm, who will also participate at Cell Series UK stated, We are very pleased to have Chaim Lebovits presenting at this prestigious conference where global leaders in stem cell and regenerative medicine will have the opportunity to learn more about NurOwn and the critical research being conducted by the Company. Mr. Lebovits Keynote Address, Stem Cell Therapeutic Approaches For ALS, will be presented to leading members of the scientific and business community including potential partners and investors.

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

AboutBrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

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

CONTACTS

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

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

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BrainStorm Cell Therapeutics' President and CEO to be Featured as Keynote Speaker at Cell Series UK 2019 - GlobeNewswire

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