How 3D Printing Is Turning Each And Every Industry On Its Head – SafeHaven.com

Calling all carnivores: ever thought about getting a meat printer? Of hand-crafting delectable beef steaks at home from plant proteins, that have the same texture, appearance, and flavor as real meat, only without the distasteful killing part?

3D-printed steaks and chicken could be on the menu in European restaurants as early as 2020, with home-spun meat printers available to the consumer within a few more years. Israel-based Redefine Meat is already using advanced food formulations along with proprietary 3D printing technology to make what it calls the holy grail of alt-meat,reports Tech Radar Pro.

The idea sounds absurd, but its not so far-fetched, as three-dimensional printing technology goes in directions no-one could dream of, prior to the launch of 3D printing in the 1980s.

Uses

Put simply, 3D printing is a progression of 2D printing, where a third dimension is added to the printing of images on a flat surface (a regular ink-jet printer), adding depth and allowing the printer cartridge to move in all directions. A digital file is first created using modeling software, then sent to the printer, depositing layers of the chosen material - often plastic or wax - to build up the final product. Other printing materials include plastics, powders, filaments, paper, and even human or animal cells - used in the cutting-edge new field of bioprinting.

3D printing is also referred to as additive manufacturing because objects are made by injection-molding them to the desired size and shape, versus traditional manufacturing which invariably entails loading material into a machine to be cut to the required dimensions. With additive manufacturing, material is added, layer upon layer, without creating waste/ scrap.

3D Printer employs agood analogy for 3D printing, describing the process as similar to baking a multi-layered cake:

3D printers use a variety of very different types of additive manufacturing technologies, but they all share one core thing in common: they create athree dimensionalobject by building it layer by successive layer, until the entire object is complete. Its much like printing in two dimensions on a sheet of paper, but with an added third dimension: UP. The Z-axis.

Each of these printed layers is athinly-sliced, horizontal cross-section of the eventual object. Imagine a multi-layer cake, with the baker laying down each layer one at a time until the entire cake is formed. 3D printing is somewhat similar, but just a bit more precise than 3D baking.

Formerly known as stereolithography, 3D printing was invented in 1983 by Chuck Hull, co-founder of 3D Systems. Frustrated by how long it took to make small, custom parts, Hull suggested using his furniture companys UV lamps to create parts by curing photosensitive resin, layer by layer. Calling the technology stereolithography, Hull applied for a patent and was issued one in 1986.

Two years later, start-up 3D Systems manufactured the first 3D printer, the SLA-1.

It took over 30 years for the technology to become mainstream, but now 3D printing can be done by anyone with access to a base-model 3D printer, which can be purchased for under $500.

Among the more interesting items that have been 3D-printed are prosthetic limbs, fabricated firearms, electrical vehicles, steel parts (Caterpillar introduced thefirst 3D-printed excavatorin 2017), quick-build homes, parts for combat aircraft, spacecraft, and even decorative chocolates.

Relativity Space is 3D-printing rockets at its Los Angeles headquarters.

According to Wired,youll find four of the largest metal 3D printers in the world, churning out rocket parts day and night. The latest model of the companys proprietary printer, dubbed Stargate, stands 30 feet tall and has two massive robotic arms that protrude like tentacles from the machine. The Stargate printers will manufacture about 95 percent, by mass, of Relativitys first rocket, named Terran-1. The only parts that wont be printed are the electronics, cables, and a handful of moving parts and rubber gaskets.

Z-Morph Bloglists five more really cool, recently-printed 3D-printed objects:

Methods

From its mid-80s beginning, a number of 3D printing technologies have emerged.

The first, known asStereolithography (SLA), concentrates a beam of ultraviolet light onto the surface of a vat filled with liquid photocurable resin. The laser beam draws out the 3D model one layer at a time, with each slice hardening as the light hits the resin. The solidified structure is gradually dragged up by a lifting platform, while the laser continues to form a different pattern for each layer to create the desired shape of the object.

Digital Light Processing (DLP)is similar toStereolithography, butuses more conventional light sources. A liquid crystal display allows for a large amount of light to be projected onto the surface of the object being printed, and for the resin to harden quickly.

Fused Deposition Modeling (FDM)was invented in the late 1980s. The object is made by extruding a stream of melted thermoplastic material to form layers. The layers harden and fuse together almost immediately after leaving the extrusion nozzle.

InSelective Layer Sintering (SLS), powdered materials instead of liquid photopolymer is drawn from the vat, including polystyrene, ceramics, glass, nylon and metals such as steel, titanium, aluminum and silver. A layer of powdered material is placed on top of the previous layer using a roller and then the powdered material is fused or sintered according to a certain pattern.

PolyJetphotopolymershoots out a photopolymer liquid, similarly to an ink-jet printer, which is hardened with a UV light. This technology acquired by Stratasys allows for various materials and colors to be incorporated into single prints, and at high resolutions.

WithSyringe Extrusion, virtually any material with a creamy viscosity such as clay, cement or silicone, can be 3D-printed using syringe extruders. The syringe is heated or not heated, depending on the material.

Other variants of these technologies includeSelective Laser Melting (SLM),Electron Beam Melting (EBM)which uses an electron beam instead of a laser, andLaminated Object Manufacturing (LOM), where layers of paper, plastic or metal, coated with adhesive, are successively glued together and cut to shape.

Market

Sales related to 3D printing, including printers, materials and services, will move past $US2.7 billion in 2019 and hit $3 billion in 2020according to Deloitte Global, with a CAGR of 12.5%. Comparing that to the $12 trillion in global manufacturing revenues indicates the amount of growth potential in 3D printing and bioprinting.

The consulting firm explains that companies across multiple industries are increasingly using 3D printing for more than just rapid prototyping:

3D printers todayare capable of printinga greater variety of materials (which mainly means more metal printing and less plastic printing, although plastic will likely still predominate); they print objects faster than they used to, and they can print larger objects (build volume). A steady stream of new entrants is expanding the market. 3D printing is considered an essential ingredient in Industry 4.0, the marriage of advanced production and operations techniques with smart digital technologies that is being heralded as the Fourth Industrial Revolution.

Deloitte notes the number of materials used in 3D printing has more than doubled from five years ago, with mixed-material printers becoming more common. 3D printers are also about twice as fast in 2019 as they were in 2014.

It says the biggest shift is from plastic to metal printing: Plastic is fine for prototypes and certain final parts, but the trillion-dollar metal-parts fabrication market is the more important market for 3D printers to address. Plastics share of the 3D printing industry fell from 88 to 65% in 2017-18, and metal rose from 28 to 36%.

A recent technology called binder jet metal printing could halve the time required to produce each part, compared to the relatively slow and expensive selective laser sintering (SLS) method, states Deloitte.

Size capabilities are improving too. A few yearsagoa high-end metal printer could only build an object 10x10x10 cm or one cubic liter. In 2019 metal printers with the capacity to print 30x30x30 cm are available.

Companies

As 3D printing technology continues to advance, more and more companies are forming, eager to get in on the action. Three of the largest are Stratasys, 3D Systems and Proto Labs; these companies offer 3D printers and services to help manufacturers move prototypes into production.

Based in Minnesota,Stratasyshas over 600 granted or pending additive manufacturing patents, including for the FDM,Polyjetand WDM 3D printing technologies. Among the sectors Stratasys serves are healthcare, aerospace, automotive and education. The companyssubsidiaries include MakerBot,GrabCAD,RedEyeOnDemand and Solid Concepts.

Asmentioned3D Systemswas first out of the gate with a 3D printer, back in 1988. Along with pioneering stereolithography, 3D Systems has also developed selective laser sintering, multi-jet printing, film-transfer imaging, color jet printing, direct metal printing, and plastic jet printing. Divided into three business units - products, materials and services - 3D Systems offers small desk-top printers, metal printers and commercial printers that print in plastics and other materials.

Also headquartered in Minnesota isProto Labs, established in 1999. Building on automated solutions to develop plastic and metal parts used in manufacturing, in 2014 Proto Labs launched an industrial-grade 3D printing service, enabling software developers and engineers to quickly move prototypes into production. The company acquired Rapid Manufacturing in 2017 to further its efforts in sheet metal fabrication. It currently has 2,300 employees in 12 manufacturing hubs.

3D bioprinting - the next big thing in medical investing

According to the United Network for Organ Sharing, every day 21 people in the United States die waiting for an organ, and over 120,000 people are on organ transplant waiting lists.

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The situation is worse in Canada. While Spain has 43 donors per million people, the US has 26, Britain has 21, and Canada has just 20. Out of 4,500 Canadians waiting for an organ, about 260 will die each year, according toThe Organ Project. Thats five deaths per week.

Imagine if, instead of waiting for an organ from another person - possibly a relative but likely a stranger - you could walk into a doctors office and have one manufactured, with your cells. It sounds far-fetched, but the technology now exists for the tailor-made transplantation of organs through brand-new medicine called 3D bioprinting.

What is 3D bioprinting?

3D printing is a progression of 2D printing, where a third dimension is added to the printing of images on a flat surface (a regular ink-jet printer), adding depth and allowing the printer cartridge to move in all directions. A digital file is first created using modeling software, then sent to the printer, depositing layers of the chosen material - often plastic or wax - to build up the final product.

Among the more interesting items that have been 3D-printed are prosthetic limbs, fabricated firearms, electrical vehicles, steel parts (Caterpillar introduced thefirst 3D-printed excavatorin 2017), quick-build homes, parts for combat aircraft and spacecraft, and even decorative chocolates.

Bioprinting operates on the same principle as regular 3D printing but instead of plastic, wax or other matter, bioprinters deposit layers of living cells to build structures like blood vessels or skin tissue. The cells are taken from an animal or a human being and cultivated until there are enough to create bio-ink which is then loaded into the printer using mechanical syringes. Adult stem cells can also be utilized.

Key to the process is a dissolvable gel which acts as a kind of incubator for the cells to multiply - like an embryo growing in a womb. Researchers may also plant cells around 3D scaffolds made of biodegradable polymers or collagen, allowing them to develop into functional tissue. The cells use their inherent properties to seek out similar cells to join with. Researchersare able tocontrol the shape into which the cells form, and the printer builds the final structure.

After the tissues are fully grown and shaped, they are placed into a recipients body. The hope is that the 3D-printed object becomes as much a part of the patients body as the cells he or she was born with.

There are currently five common methods of 3D bioprinting:

- Inkjet bioprinting: Droplets of bio-ink are deposited, layer by layer, onto a culture plate. Cells that can help fight breast cancer have been successful printed using inkjet bioprinting.

- Extrusion bioprinting: Polymer or hydrogel is loaded in syringes and dispensed via pneumatic- or screw-driven force, onto a building platform. The motion is controlled by a computer. Extrusion bioprinting offers lower resolution than inkjet bioprinting but the fabrication speed is considerably higher, allowinganatomically-shapedobjects to be generated.

- Laser-assisted bioprinting: A laser is used to deposit the biomaterials into a receptor via a tape covered with biological material. The laser irradiates the tape, causing the biological material to evaporate and reach the receptor in the form of droplets. The droplets contain a biopolymer that acts as an adhesive to help the cells to grow. This high-resolution bioprinting method is being used in a partnership between French bioprinting companyPoietisand LOral to recreate a hair follicle that could lead to a cure for baldness.

- Stereolithography: Stereolithographic bioprinting uses a digital micro-mirror to direct ultraviolet light onto the printing surface. Light directed by the micro-mirrors triggers the formation of molecular bonds, which cause light-sensitive hydrogels to form into solid material.

- Bioprinting with acoustic waves: Using a device that allows cells to be manipulated with acoustic waves, researchers can manipulate where the waves will meet along three axes. The waves then form a trap that captures the cells, which are collected to create 3D patterns.

How far has it progressed?

Some of the most advanced work on bioprinting has been done at the Wake Forest Institute for Regenerative Medicine in California. One of the first major structures that Wake Forestbioprintedwas a human bladder. Made from cells extracted from a patient with a poor-functioning bladder, the 3D-printed bladder was successfully transplanted. The project built on custom-grown bladders that had previously been transplanted into seven patients suffering from spina bifida, a birth defect that affects the spinal cord.

Wake Forest staffers have also created an outer human ear, and implantedbioprintedskin, bone and muscle on laboratory animals that successfully grew into surrounding tissue.

The institutes director, AnthonyAtala, sees bioprinting astotalytransforming the relationship between the transplant patient and doctor, in much the same way that Dell changed the way consumers interacted with the computer company that sold PCs tailored to each customers unique needs. Patients could order replacement parts in much the same way they might order a new clutch for their Mazda.

Youd have companies that exist to process cells, create constructs, tissue. Your surgeon might take a CT scan and a tissue sample and ship it to that company,Atalasaid in afeature article on bioprinting in Smithsonian Magazine.

The company would then ship the organ back a week or so later, ready for implantation. Welcome to the new world of regenerative medicine: the plug and play human body.

Related: Ousted Uber CEO Cashes Out $500 Million In Stock

Atalasaid the technology is developing to the point where researchers are almost able to replicate simple organs like the outer ear and the trachea (windpipe). Importantly, there are no real surgical challenges, he told Smithsonian.

Challenges

The holy grail of 3D bioprinting would be to come up with a viable kidney for transplant. ProfessorAtala, of the Wake Forest Institute, created the first small-scalebioprintedkidney in 2002. However,Atalais the first to admit that his machine-produced kidney is nowhere near at the level it needs to be for a human transplant. A TED TalkAtalagave in 2011 about bioprinting, which culminated with a dramatic display of an object - really an over-sized bean - became controversial when the press gotaholdof it and printed enthusiastic, but wrong, stories about the technology eliminating the need for a kidney transplant.

Another potential roadblock is the cost. No-one yet knows what it would cost tobioprintand transplant a human organ on demand, and how accessible the procedure would be to the masses of patients requiring a transplant. And while there have been successful bioprinted organ transplants, there havent been enough to determine how well the human body will accept the new tissue or artificial organ.

Finally, one shouldnt underestimate the complexity and level of difficulty involved. Aspharmaforumpoints out, A complex network of cells, tissues, nerves and structures in a human organ need to be correctly positioned with a highest precision for it to function properly. From arranging the thousands of tiny capillaries in a liver, to printing a heart that beats, it is a long, difficult process.

Skin

Wake Forest is working on a skin-cell printer capable of printing live skin cells directly onto a burn wound. The procedure could replace skin-grafting, a procedure where healthy skin is harvested from an unburnt part of a patients body. Skin grafting can be hard to heal from, and in severe burn cases, there isnt enough healthy skin left to use.

This new printing technique only needs a patch of skin 10% the size of the burn, that is used to grow enough cells for 3D printing. The wound is then scanned for size and depth, information which the printer uses to print skin cells at the proper depths to cover the wound.

In 2017 scientists in Madrid created a prototype of a 3D bioprinter that can create functional human skin. The printer is adequate for transplanting skin and for testing cosmetic, chemical and pharmaceutical products,ScienceDaily reported.

Hearts

At the Texas Heart Institute in Houston, researchers are working with decelluarized pig hearts. The organs have been stripped of muscle and other living tissue, but the original architecture is intact. The idea is to use decelluarized pig hearts, repopulated with bioprinted human cells, for implantation into humans. Sofarthe institute has succeeded in injecting pig hearts with living bovine cells, then inserted them into cows where they worked successfully next to a cows heart.

Already, patients with a defective heart valve can have a pigs valve or a mechanical valve implanted. Doris Taylor, director of the institutes regenerative medicine research program, says thedecelluarizedmethod gets around the tricky process of printing at the extremely high resolution required for highly vascularized (containing many blood vessels) organs like the heart.

The tech is going to have to improve a great deal before were able tobioprinta kidney or a heart, and get blood to it, and keep it alive, Taylor told Smithsonian.

More recent developments though are moving in that direction. In 2016 Harvard researchers 3D-printed the first heart-on-a-chip. The tiny device contains living human heart cells that mimic the hearts functions.

In 2018, 3D printingstartupBioLife4D successfully produced human tissue in the form of a cardiac patch - derived from a patients white blood cells with multiple cell types contained in the human heart.According to pharmaforum, its another step towards bioprinting major organs for transplant.

Scientists at the American Friends of Tel Aviv University havereportedly 3D-printed a fully-vascularized heartusing fat cells from a donor. The fat cells were partially cultured and re-programmed into heart cells. This early-stage technology has only been able to print a heart the size of a rabbits, but researchers hope to test the printed hearts in other animals.

Ovaries

Northwestern University in Illinois debuted a 3D-printed ovary using the acoustic waves method described above, and in Sweden, researchers have successfully created human cartilage tissue, also using acoustic waves.

Thyroids

Russian scientists aboard the International Space Stationsuccessful bioprinted the first organ in space: a mouses thyroid. Spaces zero-gravity environment enables organs and tissues to mature faster than on Earth.

Bones/ cartilage

A team from the UKs Swansea University has apparently developed a bioprinting process that uses regenerative material to create an artificial bone matrix. The technology could replace bone grafting, a surgical procedure that replaces missing or damaged bones with synthetic materials. Unlike bone grafting, which doesnt allow new bone tissues to form, thus limiting mechanical integrity, 3D-printed bones are capable of fusing with, and even replacing over time, a patients natural bones.

Cartilage printing could revolutionize joint care through a hand-held cartilage printing device calledBioPen. Built by Australian researchers, theBioPencontains stem cells derived from a patients fat, which create custom scaffolds of living material into failing joints much like 3D-printed bones. So farBioPenhas only been tested on sheep but developers plan to accelerate it to regenerate functional human cartilage.

Corneas

Finally, a group of researchers in South Korea has 3D-printed prototype corneas fromdecelluarizedcorneal stroma and stem cells. Unlike artificial corneas currently available, made of substances like synthetic polymer which resist incorporation into the eye, printed corneas are made to mimic the material within natural corneas. The invention could replace the need for donors and synthetic corneas in cataract surgery and other sight complications.

Investment opportunity

3D bioprinting has come a long way since ProfessorAtalasfirst artificial bladder in 2002. At Ahead of the Herd, we think it is the next big thing in regenerative medicine. Science always starts out with experimentation, sometimes many years of it, before the technologies are commercialized. We want our subscribers to bewell awareof 3D bioprintings potential, putting them in a position to get in early to companies that are offeringbioprintedproducts.

While there are currently a handful of bioprinting firms, we see an entire ecosystem of small firms developing, with each focusing on a different aspect, technology or part of the body. It will not take 10 years for start-up pub-cos to IPO, seeking money to develop their technologies.

Currently valued at USD$685 million, within the next six years,the global bioprinting market is expected to expand by a CAGR of 26.2%, reaching $4.4 billion by 2026. The United States and Canada are the industry leaders, making bioprinting an ideal new sector for North America-focused investors.

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How 3D Printing Is Turning Each And Every Industry On Its Head - SafeHaven.com

BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security Holders – Market Exclusive

BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security HoldersItem 5.07 Submission of Matters to a Vote of Security Holders.

On November 13, 2019, BioRestorative Therapies, Inc. (the Company) held a Special Meeting of Stockholders (the Special Meeting). The following is a listing of the votes cast for and against, as well as abstentions, with respect to the matters voted upon at the Special Meeting. At the Special Meeting, the Companys stockholders (i) approved an amendment to the Companys Certificate of Incorporation to increase the number of shares of common stock authorized to be issued by the Company from 150,000,000 to 300,000,000, (ii) approved amendments to the Certificate of Incorporation of the Company, and authorized the Board of Directors of the Company to select and file one such amendment, to effect a reverse stock split of the Companys common stock at a ratio of not less than 1-for-2 and not more than 1-for-100, with the Board of Directors of the Company having the discretion as to whether or not the reverse stock split is to be effected, and with the exact ratio of any reverse stock split to be set at a whole number within the above range as determined by the Companys Board of Directors in its discretion (the Reverse Stock Split Proposal), which Reverse Stock Split Proposal revises the reverse stock split ratio approved by the Companys stockholders on May 30, 2019 and (iii) authorized the Board of Directors of the Company, in its discretion, to reduce the number of shares of common stock authorized to be issued by the Company in proportion to the percentage decrease in the number of outstanding shares of common stock resulting from the reverse split (or a lesser decrease in authorized shares of common stock as determined by the Companys Board of Directors in its discretion).

(d) Exhibits.

3.1 Certificate of Amendment of Certificate of Incorporation of the Company

About BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX)

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, involving adult (non-embryonic) stem cells. The Company offers human and plant stem cell derived cosmetic and skin care products. Its programs relate to the treatment of disc/spine disease and metabolic disorders and include Disc/Spine Program (brtxDISC) and Metabolic Program (ThermoStem). Its curved needle device (CND) is a needle system with a curved inner cannula to allow access to difficult-to-locate regions for the delivery or removal of fluids and other substances. The CND is intended to deliver stem cells and/or other therapeutic products or material to the interior of a human intervertebral disc, the spine region, or other areas of the body. The device relies on the use of pre-curved nested cannulae that allows the cells or material to be deposited in the posterior and lateral aspects of the disc to which direct access is not possible due to outlying structures.

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BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security Holders - Market Exclusive

Global Cell Expansion Market 2019 is predicted to reach an excellent valuation of by 2024 – Galus Australis

According to this Cell Expansion report, the key market players are making moves like product launches, joint ventures, developments, mergers and acquisitions which has influence on the market and healthcare Industry as a whole and also affecting the sales, import, export, revenue and CAGR values.

With Cell Expansion Market report you can build a strong organization and make better decisions that take your business on the right track. This report is a valuable source of assistance for companies and individuals that offers industry chain structure, business strategies and proposals for new project investments. This report introduces top to bottom evaluation of the Healthcare industry including empowering technologies, key trends, market drivers, challenges, standardization, regulatory landscape, opportunities, future guide, value chain, ecosystem player profiles and strategies. This industry analysis report speaks in detail about the manufacturing process, type and applications.

Some of the eminent industry players operating in Cell Expansion Market are BD, Merck KGaA, TERUMO BCT, INC., Lonza, Beckman Coulter, Inc., Cyto-Matrix Inc., ReNeuron Group plc, pluristem, NexImmune, RepliCel, TC BioPharm, GE Healthcare, Thermo Fisher Scientific, Inc., Corning Incorporated, Miltenyi Biotec, STEMCELL Technologies Inc., Danaher, CellProthera and others

The Global Cell Expansion Market is accounted for USD 11.43 billion and market is growing at a CAGR of 17.8% by the end of 2024.

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Cell expansion which deals with the production of cells from single cell, is used in therapeutic development, drug screening, and microlevel research of cells. Recently, cell expansion is widely used for improving transplantation and in the treatment of various diseases including rheumatoid arthritis, diabetes, and others.

The increasing prevalence of chronic diseases combined with the increase in research activities are the main factors driving the market for cellular expansion. Furthermore, technological advances in cellular expansion devices and the growth of public healthcare investment are the factors driving the market for cellular expansion. Furthermore, it is expected that even economic tools for cell-based research will promote the market for cell expansion during the forecast period.

The global cell expansion market is highly fragmented and is based on new product launches and clinical results of products. Hence the major players have used various strategies such as new product launches, clinical trials, market initiatives, high expense on research and development, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of cell expansion market for global, Europe, North America, Asia Pacific and South America.

Key Segmentation of Global Cell Expansion Market

By product, global cell expansion market is segmented into

consumables and

instruments

Consumables are further sub segmented into reagents, media, & serum and disposables.

Disposables are again sub segmented into bioreactor accessories, tissue culture flasks and others.

Instruments are segmented into cell expansion supporting equipment, bioreactors and automated cell expansion systems.

Cell Expansion Supporting Equipment can be further sub segmented into flow cytometers, centrifuges, cell counters and others.

Bioreactors can be further sub segmented into perfusion bioreactors and microcarrier bioreactors.

Microcarrier Bioreactors can be sub segmented into anchorage-dependent and anchorage independent.

On the basis of application, global cell expansion market is segmented into

regenerative medicine,

stem cell research,

oncology and

cell-based research and others

On the basis of cell type, global cell expansion market is segmented into

human cells and

animal cells

Human cells can be further sub segmented into stem cells and differentiated cells. Stem cells are sub segmented into adult stem cells, embryonic stem cells and induced pluripotent stem cells.

Based on end user, global cell expansion market is segmented into

pharma & biotech companies,

research institutes,

cell banks and others

On the basis of geography, global cell expansion market report covers data points for 28 countries across multiple geographies such as

North America & South America,

Europe,

Asia-Pacific, and

Middle East & Africa

Some of the major countries covered in this report are U.S., Canada, Germany, France, U.K., Netherlands, Switzerland, Turkey, Russia, China, India, South Korea, Japan, Australia, Singapore, Saudi Arabia, South Africa, and Brazil among others. In 2017, North America is expected to dominate the market.

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Table of Contents: Global Cell Expansion Market

Major Highlights of TOC:

Chapter One: Cell Expansion Market Industry Overview

1.1 Cell Expansion Industry

1.1.1 Overview

1.1.2 Products of Major Companies

1.2 Cell Expansion Market Segment

1.2.1 Industry Chain

1.2.2 Consumer Distribution

1.3 Price & Cost Overview

Chapter Two: Cell Expansion Market Demand

2.1 Segment Overview

2.1.1 APPLICATION 1

2.1.2 APPLICATION 2

2.1.3 Other

2.2 Cell Expansion Market Size by Demand

2.3 Cell Expansion Market Forecast by Demand

Chapter Three: Cell Expansion Market by Type

3.1 By Type

3.1.1 TYPE 1

3.1.2 TYPE 2

3.2 Cell Expansion Market Size by Type

3.3 Cell Expansion Market Forecast by Type

Chapter Four: Major Region of Cell Expansion Market

4.1 Cell Expansion Sales

4.2 Cell Expansion Revenue & market share

Chapter Five: Major Companies List

Chapter Six: Conclusion

Get TOC at https://databridgemarketresearch.com/toc/?dbmr=global-cell-expansion-market

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Global Cell Expansion Market 2019 is predicted to reach an excellent valuation of by 2024 - Galus Australis

Hip osteoarthritis: 6 ways to treat it – Medical News Today

Osteoarthritis, sometimes called "wear and tear" arthritis, is a common degenerative condition. Doctors can treat osteoarthritis with medication and surgery. People can also manage their symptoms with different exercises and stretches.

Osteoarthritis is the most widespread form of arthritis. The Arthritis Foundation estimate that in excess of 30 million people in the United States have osteoarthritis.

Although osteoarthritis can occur in any joint, it commonly affects the weight-bearing joints, such as the knees and hips.

Read on to find out more about osteoarthritis of the hip. We discuss what causes the condition, how doctors diagnose it, and the different ways to treat it.

Treatments for osteoarthritis focus on reducing pain and improving mobility. Effective ways to treat osteoarthritis include the following:

Pain management is essential for people living with hip osteoarthritis. People can treat mild to moderate pain with over-the-counter pain relievers, such as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs).

People who have moderate to severe osteoarthritis may experience more intense pain. In such cases, prescription pain relief may be necessary.

Some people may require medications to help slow the progression of arthritis or reduce some of the symptoms. Examples of such drugs include:

Corticosteroids

Corticosteroids control inflammation by mimicking the effects of cortisol, a hormone that regulates the immune system.

People can take oral corticosteroid tablets. Doctors can also inject corticosteroids directly into the hip joint. However, corticosteroid injections offer only temporary pain relief. People will require additional injections going forward.

Hyaluronic acid injections

Another potential treatment for osteoarthritis is an injection of hyaluronic acid into the hip joint or another joint that osteoarthritis is affecting.

In 2019, the Food and Drug Administration (FDA) approved a hyaluronic acid injection for treating osteoarthritis of the knee.

Although some doctors have used the injection to treat osteoarthritis of the hip, the FDA has not yet approved it for this use.

Hyaluronic acid injections do not affect everyone in the same way. Some people do not experience any pain relief after receiving the injection. However, approximately 30% of people stay pain free for up to two years, according to the Arthritis Foundation.

Physical therapists are trained healthcare professionals who specialize in diagnosing and treating conditions that limit mobility. People with hip osteoarthritis may benefit from physical therapy sessions.

During the initial session, the therapist will assess the person's physical condition and any specific mobility problems they have. They will then devise a set of tailored exercises to help improve mobility.

The therapist teaches people how to perform each exercise so that they can safely continue their treatment at home. They may also recommend additional treatment options, such as braces, walkers, or hot and cold therapy.

Some people experience severe hip pain or stiffness that significantly affects their quality of life. These people may benefit from surgery.

There are two main surgical options for hip osteoarthritis:

Hip resurfacing

This procedure involves trimming or shaving away damaged bone on the femoral head. The femoral head is the upper end of the thigh bone, which sits inside the hip socket.

After removing the damaged bone, the surgeon covers the femoral head with metal. The surgeon also fits a metal cup inside the hip socket.

Total hip replacement

During this procedure, a surgeon replaces the entire hip joint, including the femoral head and the socket. In their place, the surgeon fits artificial components made of metal, plastic, or ceramic.

Each surgical option carries benefits and risks. A doctor will guide people through the available options before deciding on the best treatment to pursue.

Stem cells are cells that have the potential to develop into a range of different cell types. Researchers are currently looking into whether stem cell therapies could help to replace and regenerate damaged tissues within the human body.

Mesenchymal stem cells are stem cells that can develop into bone and cartilage, among other types of tissue. According to a 2018 review, mesenchymal stem cells could help to repair damaged cartilage and reduce inflammation in knee osteoarthritis.

However, stem cell therapy is not yet ready for use in clinical settings. Advances in gene editing techniques may help overcome many of the limitations currently facing stem cell therapy.

Exercises that may help manage symptoms of hip osteoarthritis include:

Stretching every day can also help to improve flexibility and relieve joint stiffness and pain. Consider the following stretches:

Sitting hip flexion

Sit-stand

Hip opener

Forward fold

People can also perform this stretch from a seated position:

Cartilage is a rubber-like tissue that covers the ends of the bones in the joints. Here, it acts as a cushion that prevents the end of one bone from rubbing against the end of an adjoining one. It also provides lubrication that allows the joint to move easily and painlessly.

In osteoarthritis, the cartilage inside the joints wears away, causing two or more bones to rub together. This process results in joint inflammation, swelling, and pain.

The risk of osteoarthritis increases with age. As people grow older, the cartilage cushions between their joints slowly deteriorate. The symptoms of discomfort and pain tend to worsen as the cartilage continues to break down.

To diagnose hip osteoarthritis, a doctor will take a person's medical history and carry out a physical examination of the joints. The doctor may also order the following diagnostic tests:

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Hip osteoarthritis: 6 ways to treat it - Medical News Today

Cocker spaniel with cancer to receive stem cells from mother living 4,000 miles away – Fox News

A 6-year-old cocker spaniel in California that was recently diagnosed with cancer is slated to receive stem cells from her mother living 4,000 miles away in the United Kingdom.

Coco the cocker spaniel gave birth to a litter of puppies six years ago. One of those puppies, Millie, was adopted by Serena and Andrew Lodge, who now live in San Francisco. They may live across the world from each other, but the mother and daughter will soon be reunited for the rare treatment, reported South West News Service, or SWNS, a British news agency.

CHEAPER MEDICATION FOR DOGS WITH SEPARATION ANXIETY NOW APPROVED, FDA SAYS

Coco, left, and daughter, Millie. (SWNS)

The transplant will occur at the North Carolina State Veterinary Hospital in Raleigh. The facility isreportedly one of only a few animal hospitals in the world to offer the treatment, which involves taking healthy stem cells from Cocos bone marrow and injecting them intoMillies.

"Serena and Andrew started chemo on Millie three months ago but they've been told the only chance they'll have of curing her is if they find a positive donor so she can have a transplant, said Cocos owner, Robert Alcock, 52. He arrived with Coco in North Carolina on Wednesday.

Millie while in an animal hospital. (SWNS)

"They contacted us, and we sent some blood samples for testing, along with samples from one of Coco's other pups, he added. They both came back positive but because Coco is Millie's mother the vet said she would be a better match."

"Coco will go into hospital on Sunday for the procedure and then the cells will be donated on Monday, he continued, noting the Lodges have paid for everything.

Robert Alcock and his cocker spaniel, Coco. (SWNS)

BLACK LAB GIVES BIRTH TO 13 PUPPIES, SHOCKS OWNERS: 'THEY WERE JUST FLYING OUT'

Coco is expected to make a full recovery following the procedure. However, there is only a 50 percent chance Millie will be cured even if the treatment is successful, according to SWNS.

Stem cell therapy for pets is costly, typically setting an owner back between $2,000 and $3,000, according to Pet WebMD.

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Cocker spaniel with cancer to receive stem cells from mother living 4,000 miles away - Fox News

Gracell Announces Five Presentations at the Annual Meeting of American Society of Hematology (ASH) – BioSpace

SHANGHAI and SUZHOU, China, Nov. 15, 2019 /PRNewswire/ --Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell therapy company, today announced five presentations to be delivered at the upcoming American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, held from December 7-10.

The presentations centre on Gracell's breakthrough FasTCARtechnology, and other two platform technology in four product categories used in the treatment of hematological malignancies, each with well-defined objectives, including:

The four product candidates are currently being studied in ongoing phase I clinical trials conducted by Gracell, Hebei Yanda Lu Daopei Hospital, and Xinqiao Hospital of AMU, and six other hospitals nationwide in China.

"These clinical studies demonstrated Gracell's product development strategy and strong capabilities to bring multiple novel therapies through clinical investigations," said Dr. William CAO, CEO of Gracell. "These invaluable data provides guidance for and enhance our confidence in pipeline selection."

Oral presentations:

A Feasibility and Safety Study of a New CD19-Directed Fast CAR-T Therapy for Refractory and Relapsed B cell Acute Lymphoblastic LeukemiaAbstract #825Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Therapeutics StrategiesPresenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei HospitalLocation: Orange County Convention Center, Tangerine 1 (WF1), Level 2Time: 5:00 pm, Monday, December 9, 2019https://ash.confex.com/ash/2019/webprogram/Paper121751.html

Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic LeukemiaAbstract #284Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Novel TherapiesPresenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei HospitalLocation: Orange County Convention Center, W224, Level 2Time: 4:15pm, Saturday, December 7, 2019https://ash.confex.com/ash/2019/webprogram/Paper126429.html

Poster presentations:

CD19-Directed Fast CART Therapy for Relapsed/Refractory Acute Lymphoblastic Leukemia: From Bench to BedsideAbstract #1340Session Name: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster IPresenter: Cheng Zhang, M.D., Xinqiao Hospital of AMULocation: Orange County Convention Center, Hall B, Level 25:30-7:30 pm, Saturday, December 7, 2019https://ash.confex.com/ash/2019/webprogram/Paper128006.html

A Bcma and CD19 Bispecific CAR-T for Relapsed and Refractory Multiple MyelomaAbstract # 3147Session Name: 653. Myeloma: Therapy, excluding Transplantation: Poster IIPresenter: Hua Zhang, PhD., Gracell Biotechnology Ltd., Shanghai, China, Shanghai, ChinaLocation: Orange County Convention Center, Hall B, Level 26:00 PM-8:00 pm, Sunday, December 8, 2019https://ash.confex.com/ash/2019/webprogram/Paper131056.html

Role of Donor-Derived CD19.CAR-T Cells in Treating Patients That Relapsed after Allogeneic Hematopoietic Stem Cell TransplantationAbstract #4561Session Name: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster IIIPresenter: Cheng Zhang, M.D., Xinqiao Hospital of AMULocation: Orange County Convention Center, Hall B, Level 26:00-8:00 pm, Monday, December 9, 2019https://ash.confex.com/ash/2019/webprogram/Paper128262.html

About FasT CAR-19

FasT CAR-19, or GC007F, is an investigational CD19-targeted CAR-T cell therapy for adolescent and adult patients with refractory or relapsed B-ALL, as well as aggressive non-Hodgkin lymphoma. Thanks to Gracell's patented FasTCAR technology, the bioprocessing time for GC007F has been significantly reduced from two weeks to 24 hours with substantially lower cost. The improved CAR-T cell fitness resulted in superior proliferation capabilities, potency, and extensive bone marrow migration making GC007F a potential best-in-class therapy for refractory or relapsed B-ALL.

About Dual CAR-19-22

Dual CAR-19-22, or GC022, is an investigational CAR-T cell therapy redirected to target CD19 and CD22, in treating patients with CD19+, or/and CD22+ relapsed/refractory B-ALL. A low toxicity with dose-dependent high CR rate including patients who previously treated with CD19 CAR-T cells were observed.

About Dual CAR-BCMA-19

Dual CAR-BCMA-19, or GC012, is an investigational CAR-T cell therapy redirected to target BCMA and CD19, in treating patients with BCMA+, or/and CD19+ relapsed/refractory multiple myeloma. Previous research shows CD19 could express on the myeloma progenitor cells, while BCMA is a well validated target for MM.

About Donor CAR-19

Donor CAR-19, or GC007G, is an investigational CD19 targeted CAR-T cell therapy manufactured in use of donor's lymphocytes. The objective of this study is to further investigate and better understand the safety and efficacy of donor derived CAR-T cells in treatment of relapsed and refractory B-ALL patients.

About B-ALL

B-ALL is a sub-type of acute lymphoblastic leukemia, although rare, is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50[1]. In 2015, ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide[2]. It is also the most common cause of cancer and death from cancer among children. ALL is typically treated initially with chemotherapy aimed at bringing about remission. This is then followed by further chemotherapy carried out over several years.

About MM

Myeloma begins when a plasma cell becomes abnormal. The abnormal cell divides to make copies of itself. These abnormal plasma cells are called myeloma cells. In time, myeloma cells collect in the bone marrow. They may damage the solid part of the bone. When myeloma cells collect in several of your bones, the disease is called "multiple myeloma." This disease may also harm other tissues and organs, such as the kidneys. Myeloma cells make antibodies called M proteins and other proteins. These proteins can collect in the blood, urine, and organs[3].

About Gracell

Gracell Biotechnologies Co., Ltd. ("Gracell") is a clinical-stage biopharma company, committed to developing highly reliable and affordable cell gene therapies for cancer. Gracell is dedicated to resolving the remaining challenges in CAR-T, such as high production costs, lengthy manufacturing process, lack of off-the-shelf products, and inefficacy against solid tumors. Led by a group of world-class scientists, Gracell is advancing FasTCAR, TruUCAR (off-the-shelf CAR), Dual CAR and Enhanced CAR-T cell therapies for leukemia, lymphoma, myeloma, and solid tumors.

CONTACT:

Linc HE Associate Director of Business Developmentsunwei.he@gracellbio.com

Dr. William Cao Founder, Chairman and CEOwilliam.cao@gracellbio.com

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SOURCE Gracell

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Gracell Announces Five Presentations at the Annual Meeting of American Society of Hematology (ASH) - BioSpace

Broncos Briefs: CB Bryce Callahan headed to surgery to replace bent screw in foot – Longmont Times-Call

Cornerback Bryce Callahans first year with the Broncos will end without appearing in a game.

Coach Vic Fangio said after practice Friday that Callahan will be placed on injured reserve and will need foot surgery to replace a bent screw that was initially installed last December.

Signed to a three-year, $21 million contract in March to serve as the No. 2 corner behind Chris Harris, Callahan was shut down after getting stepped on in practice July 27. He was a limited practice participant five times in Weeks 1-2 before being shut down for 4-6 weeks after receiving stem-cell treatment.

Callahans last attempt to practice was Tuesday.

Receiver Tim Patrick (hand) will be activated from injured reserve to take Callahans roster spot for Sundays game at Minnesota.

It isnt clear if Callahan getting stepped on bent the screw or just made the injury worse and too much to overcome.

Part of this operation is to put a screw in there to promote healing, Fangio said. The bent screw caused him a lot of discomfort and pain.

Fangio said Callahan will have surgery soon.

Right tackle JaWuan James (knee) and tight end Jeff Heuerman (knee) are listed as doubtful. Receiver DaeSean Hamilton, who injured his knee in Thursdays practice, did limited work Friday and said he will be available to play.

The Vikings ruled out defensive tackle Linval Joseph (knee), right guard Josh Kline (concussion), receiver Adam Thielen (hamstring) and safety Anthony Harris (groin).

Punt return shake-up? The Broncos claimed defensive back/returner Cyrus Jones off waivers from Baltimore on Wednesday.

Special teams coordinator Tom McMahon said Jones run skill on tape, was intriguing.

He gets downhill and makes good decisions, McMahon said. He came in here and hit the ground running.

Will Jones rotate punt returns with Diontae Spencer?

Well have to see, McMahon said. Thats for (the Vikings) to find out.

McGoverns near homecoming. Broncos center Connor McGovern grew up in Fargo, N.D., about three-plus hours from Minneapolis, so this weekends trip to play the Vikings is as close as hell come to a homecoming game.

My parents are getting a whole bunch of tickets, he said. Its like going home. It will be fun.

Growing up, McGovern said he was initially a Green Bay fan because of defensive end Reggie White.

When he was done, I thought I might as well be a Vikings fan since everybody I knew was a Vikings fan and those are the games I watched, said McGovern, who added that his favorite player became running back Adrian Peterson.

Preparing for Allen. The Vikings have one game of video to game plan for Broncos quarterback Brandon Allen.

Its a little harder because of that reason, Vikings coach Mike Zimmer said. You first prepare for the offense and then you prepare for the players so well try and do the best job we can.

I thought (Allen) did a nice job (against Cleveland). He got out of the pocket, he made a lot of good throws and it looked like he settled down after maybe the first series. I think they did a nice job of getting to the plays that he likes and then he made some good throws.

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Broncos Briefs: CB Bryce Callahan headed to surgery to replace bent screw in foot - Longmont Times-Call

Leading Alternative Healing Director of Total Health Institute Reviews and Receives 3rd Fellowship in Stem Cell Therapy – Financialbuzz.com

Chicago, IL, Nov. 14, 2019 (GLOBE NEWSWIRE) Dr. Keith Nemec the clinic director ofTotal Health Institute in Chicago has received yet another fellowship in his advanced research. Most recently Dr. Nemec received his fellowship in Stem Cell Therapy to add to his other fellowships in Regenerative Medicine and Integrative Cancer Therapies.

Dr. Nemec has overseen patient care for the last thirty-five years at Total Health Institute which is an alternative and integrative medical facility. Total Health Institute has seen over 10,000 patients who have traveled from around the world to seek Dr. Nemecs guidance in their healing journey.

Total Health Institute uses unique approach developed by Dr. Nemec called theSystems Sequence Approach to balance cellular communication between the cells, tissues, organs, glands and systems of the body. Dr. Nemec explains It is like knowing the combination to open the lock to complete healing. To open this lock, you must not only know the right systems to balance but also in the right sequence.

Dr. Keith Nemec is very excited about the research in stem cells and stem cell therapy that is why he focused his concentration in this area. According to Dr. Nemec All health and healing starts at the stem cell level. Whether a person has cancer, autoimmune disease or chronic diseases of aging they are all involving stem cells. In cancer, an inflammatory environment has mutated a normal stem cell into a cancer stem cell which is not killed with either chemotherapy nor radiation. This is why many times with conventional cancer treatment alone one tends to see improvements for a season but then return the cancer stem cell retaliates with a vengeance. Dr. Nemec also states Since all cells come from a base stem cell then the answer to all chronic disease can be found in activating the stem cells to produce an anti-inflammatory niche and continual healthy cell renewal.

Dr. Nemec is a member of the American Academy of Anti-Aging Medicine which is the largest and most prestigious group of Regenerative and Anti-Aging Medicine doctors in the world. He received his masters degree in Nutritional Medicine from Morsani College of Medicine. He has also published 5 books including: The Perfect Diet, The Environment of Health and Disease, Seven Basic Steps to Total Health and Total Health = Wholeness. Dr. Nemec has also published numerous health articles including: The Single Unifying Cause of All Disease and The answer to cancer is found in the stem cell and for 18 years he hosted the radio show Your Total Health in Chicago AM1160.

Total Health Institute boasts all 5 starreviews on RateMDs, an A+ rating onBBBand is top rated on Manta.

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Leading Alternative Healing Director of Total Health Institute Reviews and Receives 3rd Fellowship in Stem Cell Therapy - Financialbuzz.com

Celgene Receives CHMP Positive Opinion for REVLIMID (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously…

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of REVLIMID (lenalidomide) in combination with rituximab (anti-CD20 antibody) (R) for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). If approved by the European Commission (EC), R2 will be the first combination treatment regimen for patients with FL that does not include chemotherapy.

Since its initial approval in 2007, REVLIMID has continued to demonstrate its benefits across a range of serious blood disorders in Europe and a CHMP positive opinion for this combination with rituximab is very good news for patients with follicular lymphoma. We look forward to the European Commission decision, said Tuomo Ptsi, President of Hematology/Oncology for Celgene Worldwide Markets.

In FL, a subtype of indolent NHL, the immune system is not functioning optimally.1,2 When this dysfunction occurs, the immune system either fails to detect or attack cancerous cells.1,2 Rituximab is a monoclonal antibody that targets the CD 20 antigen on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab causes B-cell lysis. Lenalidomide is an immunomodulator that increases the number and activation of T and natural killer (NK) cells, resulting in the lysis of tumor cells. The R2 combination regimen acts by complementary mechanisms to help the patients immune system to find and destroy the cancer cells.3

Given the incurable nature of FL2, a high unmet medical need exists for the development of novel treatment options with new mechanisms of action and a tolerable safety profile to help improve progression-free survival (PFS) especially in the setting of previously treated FL.

The estimated incidence of NHL in Europe was 100,055 cases in 2018; FL accounts for approximately 25% of all NHL cases and is the most common form of indolent NHL.3,4,5

Chemotherapy is a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment, said Prof. John Gribben, President of EHA and Centre for Haemato-Oncology, Barts Cancer Institute, in England The combination of REVLIMID and rituximab could represent a new, chemotherapy-free treatment option for patients with previously treated follicular lymphoma.

The CHMP positive opinion is based primarily on results from the randomized, multi-center, double-blind, Phase 3 AUGMENT study, which evaluated the efficacy and safety of the R combination versus rituximab plus placebo in patients with previously treated FL (n=295).6,7 Additionally, findings from the MAGNIFY study were included as support for the safety and the efficacy of lenalidomide plus rituximab in patients with relapsed or refractory FL, including rituximab refractory FL patients.8

The CHMP reviews applications for all member states of the European Union (EU), as well as Norway, Liechtenstein, and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the REVLIMID Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

About Follicular Lymphoma

Lymphoma is a blood cancer that develops in lymphocytes, a type of white blood cell in the immune system that helps protect the body from infection.9 There are two classes of lymphoma Hodgkins lymphoma and non-Hodgkins lymphoma (NHL) each with specific subtypes that determine how the cancer behaves, spreads and should be treated.3,10,11 Other differentiating factors of lymphomas are what type of lymphocyte is affected (T cell or B cell) and how mature the cells are when they become cancerous.11

Follicular lymphoma is the most common indolent (slow-growing) form of NHL, accounting for approximately 25% of all Non-Hodgkin lymphoma (NHL) patients.5,12 Most patients present with advanced disease usually when lymphoma-related symptoms appear (e.g., nodal disease, B symptoms, cytopenia) and receive systemic chemoimmunotherapy.5 While follicular lymphoma patients are generally responsive to initial treatment, the disease course is characterized by recurrent relapses over time with shorter remission periods.13

About AUGMENT

AUGMENT is a Phase 3, randomized, double-blind clinical trial evaluating the efficacy and safety of REVLIMID (lenalidomide) in combination with rituximab (R) versus rituximab plus placebo in patients with previously treated follicular lymphoma (FL). AUGMENT included patients diagnosed with Grade 1, 2 or 3a FL, who were previously treated with at least 1 prior systemic therapy and two previous doses of rituximab. Patients were documented relapsed, refractory or progressive disease following systemic therapy, but were not rituximab-refractory.6,7

The primary endpoint was progression-free survival, defined as the time from date of randomization to the first observation of disease progression or death due to any cause. Secondary and exploratory endpoints included overall response rate, durable complete response rate, complete response rate, duration of response, duration of complete response, overall survival, event-free survival and time to next anti-lymphoma therapy.6,7

About REVLIMID

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation. REVLIMID as combination therapy is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMID is approved in Europe for the treatment of patients with mantle cell lymphoma (MCL) and in the United States for the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS

REVLIMID REMS Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID as maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction

Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision

Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment

Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy

Early Mortality in Patients with MCL: In another MCL study, there was an increase in early deaths (within 20 weeks), 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L)

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

DRUG INTERACTIONS

Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS.

Please see full SmPC for further information.

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Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

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Celgene Receives CHMP Positive Opinion for REVLIMID (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously...

New Cell Therapy Improves Memory and Stops Seizures Following TBI – University Herald

Irvine, Calif. - November 14, 2019 - Researchers from the University of California, Irvine developed a breakthrough cell therapy to improve memory and prevent seizures in mice following traumatic brain injury. The study, titled "Transplanted interneurons improve memory precision after traumatic brain injury," was published today inNature Communications.

Traumatic brain injuries affect 2 million Americans each year and cause cell death and inflammation in the brain. People who experience a head injury often suffer from lifelong memory loss and can develop epilepsy.

In the study, the UCI team transplanted embryonic progenitor cells capable of generating inhibitory interneurons, a specific type of nerve cell that controls the activity of brain circuits, into the brains of mice with traumatic brain injury. They targeted the hippocampus, a brain region responsible for learning and memory.

The researchers discovered that the transplanted neurons migrated into the injury where they formed new connections with the injured brain cells and thrived long term. Within a month after treatment, the mice showed signs of memory improvement, such as being able to tell the difference between a box where they had an unpleasant experience from one where they did not. They were able to do this just as well as mice that never had a brain injury. The cell transplants also prevented the mice from developing epilepsy, which affected more than half of the mice who were not treated with new interneurons.

"Inhibitory neurons are critically involved in many aspects of memory, and they are extremely vulnerable to dying after a brain injury," said Robert Hunt, PhD, assistant professor of anatomy and neurobiology at UCI School of Medicine who led the study. "While we cannot stop interneurons from dying, it was exciting to find that we can replace them and rebuild their circuits."

This is not the first time Hunt and his team has used interneuron transplantation therapy to restore memory in mice. In 2018, the UCI team used a similar approach, delivered the same way but to newborn mice, to improve memory of mice with a genetic disorder.

Still, this was an exciting advance for the researchers. "The idea to regrow neurons that die off after a brain injury is something that neuroscientists have been trying to do for a long time," Hunt said. "But often, the transplanted cells don't survive, or they aren't able to migrate or develop into functional neurons."

To further test their observations, Hunt and his team silenced the transplanted neurons with a drug, which caused the memory problems to return.

"It was exciting to see the animals' memory problems come back after we silenced the transplanted cells, because it showed that the new neurons really were the reason for the memory improvement," said Bingyao Zhu, a junior specialist and first author of the study.

Currently, there are no treatments for people who experience a head injury. If the results in mice can be replicated in humans, it could have a tremendous impact for patients. The next step is to create interneurons from human stem cells.

"So far, nobody has been able to convincingly create the same types of interneurons from human pluripotent stem cells," Hunt said. "But I think we're close to being able to do this."

Jisu Eom, an undergraduate researcher, also contributed to this study. Funding was provided by the National Institutes of Health.

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New Cell Therapy Improves Memory and Stops Seizures Following TBI - University Herald