The market analysis and insights included in the Cosmetic Skin Care market report presents key statistics on the market status of global and regional manufacturers and is an essential source of guidance which provides right direction to the companies and individuals interested in the industry. To prosper in this competitive market place, businesses are highly benefited if they adopt innovative solutions such as this Cosmetic Skin Care market research report. This wide-ranging market research report acts as a backbone for the success of business in any sector. The market drivers and restraints have been explained in the report with the use of SWOT analysis.

Global cosmetic skin care marketis set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Increasing self-consciousness among population and rising demand for anti- aging skin care products are the factor for the market growth.

Global Cosmetic Skin Care Market By Product (Anti-Aging Cosmetic Products, Skin Whitening Cosmetic Products, Sensitive Skin Care Products, Anti-Acne Products, Dry Skin Care Products, Warts Removal Products, Infant Skin Care Products, Anti-Scars Solution Products, Mole Removal Products, Multi Utility Products), Application (Flakiness Reduction, Stem Cells Protection against UV, Rehydrate the skins surface, Minimize wrinkles, Increase the viscosity of Aqueous, Others), Gender (Men, Women), Distribution Channel (Online, Departmental Stores and Convenience Stores, Pharmacies, Supermarket, Others), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026 ;

Complete report on Global Cosmetic Skin Care Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

Market Definition: Global Cosmetic Skin Care Market

Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.

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Market Segmentations:

Global Cosmetic Skin Care Market is segmented on the basis of

Market Segmentations in Details:

By Product

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North America

Europe

Asia-Pacific

South America

Middle East & Africa

Competitive Analysis: Global Cosmetic Skin Care Market

Global cosmetic skin care market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of cosmetic skin care market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

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COSMETIC SKIN CARE MARKET ENHANCEMENT AND ITS GROWTH PROSPECTS FORECAST 2019 TO 2026 - Reporting 99

Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases. Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.

North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.

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Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.

Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market.

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Some of the major companies operating in the global cardiac rhythm management market are Medtronic, Abbott Laboratories, Boston Scientific, St. Jude Medical, Altera, and Sorin. Other companies with significant presence in the global cardiac rhythm management market include

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Cardiac Rhythm Management Market to Witness Rapid Increase in Consumption During 2015 2021 - Lake Shore Gazette

Motor neuron disease is a degenerative condition which destroys the nerve cells (motor neurons) in the brain and spinal cord, which control movement, speech, swallowing and breathing. The most common type of motor neuron disease is amyotrophic lateral sclerosis (ALS), which affects around 5,000 people in the UK at any one time.A new study found that in this disease, the motor neurons in the brain and spinal cord become sick and die when a protein, called TDP-43, misfolds and accumulates in the wrong place within the motor neurons. Conversely, when this happens in a type of cell that supports motor neurons, called astrocytes, these cells appear comparatively resistant and survive.

When these two types of cells are close together, the more-resistant astrocytes are able to protect motor neurons from the misfolded protein. This rescue-mechanism helps the motor neurons, which are needed to control muscles, live longer.

The role astrocytes have played in dealing with toxic forms of TDP-43 in motor neurons has not been previously well documented in motor neuron disease. Its exciting that weve now found that they may play an important protective role in the early-stages of this disease, explains Phillip Smethurst, lead author. This has huge therapeutic potential finding ways to harness the protective properties of astrocytes could pave the way to new treatments. This could prolong their rescue function or find a way to mimic their behavior in motor neurons so that they can protect themselves from the toxic protein.

This research also established a new model for studying motor neuron disease. This new method more closely resembles the disease in patients as it uses healthy human stem cells, derived from skin cells, and spinal cord tissue samples donated by patients with motor neuron disease, collected post-mortem.

It is thanks to the selfless donations from people with motor neuron disease, that we were able to study the interplay between motor neurons and astrocytes in conditions that closely resemble what happens in humans. These human cell models are a powerful tool for further studies of motor neuron disease and in the hunt for effective therapies. explains Katie Sidle, co-senior author.

For the first time, we have been able to create a model of sporadic motor neuron disease by essentially transferring the toxic TDP-43 protein from post-mortem tissue into healthy human stem cell-derived motor neurons and astrocytes in order to understand how each cell type responds to this insult, both in isolation and when mixed together. The insights made in this work are testament to the power of creative collaboration and interdisciplinarity. It is through many years working together as a group of clinicians, pathologists, stem cell biologists, protein biochemists and other experts, and with a joint aim of increasing knowledge about motor neuron disease (to ultimately help find a cure), that these results have been possible, says Rickie Patani, co-senior author.ReferenceSmethurst et al. (2020) Distinct responses of neurons and astrocytes to TDP-43 proteinopathy in amyotrophic lateral sclerosis. Brain. DOI: https://doi.org/10.1093/brain/awz419

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

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Astrocytes Show Protective Role in Early-stage ALS - Technology Networks

10 February 2020

A study, published in Cell Reports, investigating when and how human stem cells develop into egg and sperm cells could one day help generate lab-grown gametes to treat infertility.

Human pluripotent stem cells can evolve into germ cells, which are the precursor cells for gamete development. By growing these human germ cells in vitro, the theory is that gametes engineered in a laboratory setting could someday be used, instead of natural eggs and sperm, in IVF treatment.

The research conducted within the Eli and Edythe Broad Centre of Regenerative Medicine and Stem Cell Research at University of California, Los Angeles (UCLA) provides great hope for those who are unable to produce gametes naturally,including thosewhose fertility has been affected by injury, illness or medical treatment.

'With donated eggs and sperm, the child is not genetically related to one or both parents. To treat patients who want a child who is genetically related, we need to understand how to make germ cells from stem cells, and then how to coax those germ cells into eggs or sperm'Dr Amander Clark, lead author of the study at UCLA, explained.

'Right now, if your body doesn't make germ cells, then there's no option for having a child that's biologically related to you. What we want to do is use stem cells to be able to generate germ cells outside the human body so that this kind of infertility can be overcome.'

In previous studies, scientists have been able to grow similarinduced pluripotent stem calls (iPS cells), and develop them into human skin cells and blood cells. The researchers, in collaboration with Massachusetts Institute of Technology, analysed the hundreds of thousands of genes active when both human embryonic stem cells and iPS cells transition to germ cells.

The data obtained allowed the researchers to firstly formulate when the germ cells are likely to form, which was between 24-48 hours after starting differentiation, and secondly which lineages of the differentiating stem cells give rise to the germ cells.

They also found that the activation and manifestation of germ cells was identical when developed from embryonic stem cells and iPS cells. This information was essential as they needed to ensure that the in vitro environment they had created was mimicking the molecular signals of the testis and ovaries to give hope for successful sperm and egg cell development.

Dr Clark stated: 'This tells us that the approach we're using to begin the process of making germ cells is on the right track. Now we're poised to take the next step of combining these cells with ovary or testis cells.'

Although current research is far from generating gametes, the end goal is that one day scientists are able to use a patient's skin cells to form stem cells, which can be programmed into egg or sperm cells to be used in fertility treatment.

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Lab-grown eggs and sperm a step closer - BioNews

In our regular feature #TheBrand, Bazaars beauty team look into an exciting and efficacious brand taking the beauty industry by storm. This time, its an under-the-radar skincare line gaining traction for its transformative effects.

The latest brand making beauty editors fawn is surprisingly buzz-free. Theres no celebrity founder, attention-seeking packaging, or heavily filtered Instagram account. The brands website is unassuming, and stockists are scarce. So, why is everyone clamouring for iS Clinical, and is it worth the search? Here, we reveal the story behind beautys quietest game-changer.

Founded in 2002 by biochemist Bryan Johns and Alec Call and still privately owned iS Clinical is part of the Innovative Skincare umbrella, which creates products focused on pure, pharmaceutical-grade ingredients. The transformative effects of these meticulously created products made the brands professional treatments an awards-circuit mainstay, yet the buzz didnt quite reverberate across the pond.

Warming Honey Cleanser

30.99

Reparative Moisture Emulsion

66.99

Youth Complex

31.99

Cleansing Complex

29.99

Cue a few choice (not paid-for) endorsements from some enviably glossy influencers think Rosie Huntington-Whiteley, January Jones and celebrity facialist Shani Darden and iS Clinical has become the under-the-radar skincare line of the moment.

iS Clinical doesnt look like the type of brand to be touting buzzwords such as botanical and natural. In fact, it looks veritably like something youd only expect to find lining the white walls of a dermatologists office.

But the formulas in these gimmick-free blue bottles are actually a force of nature, combining highly active, plant-derived extracts (and omitting fragrance and parabens), to directly tackle specific skin concerns.

The brands skincare ethos comprises four steps: cleanse, treat, hydrate and protect, and the range offers products in each category for a variety of specific skin types. Every one is conceptualised and produced in-house, with no third-party involvement, meaning you wont' find a 'dupe' or replica anywhere else.

High-grade ingredients think plant-derived acids, vitamins A to E, stem cells and ceramides are combined to deliver the most notable results in the least amount of time. Users of the brands star serum (more on that later) have reported visible improvements in a matter of days.

The brands scientific approach is founded on the biological principle of xenohormesis: the concept that stressed plants produce bioactive compounds, which pass on stress-resistance and survival benefits to the people who consume (or apply) them.

While the brand offers a specific range for each skin type, theres one hero product that has made more waves than most. Praised in particular by those with acne and rough skin texture, the Active Serum is widely hailed as the product to solve the most persistent of breakouts, while fading scars and hyperpigmentation.

According to Dr. Charlene DeHaven M.D, clinical director of iS Clinical, the cult following is due to the unique combination of four naturally occurring acids that do more than just treat blemishes.

Sugar cane (a source of glycolic acid) and bilberry fruit extract (a source of lactic acid) both encourage gentle exfoliation of the outer layers of the epidermis, without dehydrating the skin. Willow bark extract (containing salicylic acid) deep-cleanse the pores, while kojic-acid rich mushroom extract has powerful antibacterial and antimicrobial properties, she explains. The addition of arbutin makes this serum a powerful tool in fading pigmentation, too combined with the kojic acid, it inhibits melanin-producing enzymes, therefore fading post-inflammatory pigmentation.

Active Serum

63.99

C Eye Advance+

44.99

Youth Serum

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Pro-Heal Serum Advance+

15.00

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BEST ACNE-REDUCING FACIALRejuran Healer+ Laser Peel$737 for 60 minutes, Priv ClinicAt the heart of this facial is polynucleotide, a biopolymer molecule highly compatible with the human body. Delivered into the skin via a series of micro injections, it reportedly helps repair damaged skin cells, boost collagen synthesis, reduce sebum production and even out the skins moisture-oil balance. The miniscule punctures in the skin also trigger its natural wound-healing response, boosting cellular turnover. Some light swelling may appear post-treatment, but it goes away within 24 hours. Meanwhile, skin is visibly suppler, and looks smoother and healthier.

BEST ANTI-AGEING FACIALInstant Youth ProgrammeFrom $260 for 75 minutes, EstheClinicBehold the ultimate helping hand to counter the signs of mature skin. Each treatment is uniquely tailored to your specific skin type and needs, with subsequent sessions building on and enhancing the effects of prior treatments to maximise collagen production for firmer skin. By using the latest in aesthetic technology alongside EstheClinics specially selected cosmeceutical products, the signs of ageing are thus tackled from the inside out, with effects continuing to last up to four months after completing the programme.

BEST ANTI-BLEMISH FACIALTetra+ $398 per session, The Aesthetics Medical ClinicThis four-in-one treatment features a symphony of lasers with varying wavelengths to tackle multiple issues in just one sitting. A pigment wavelength breaks down melanin clusters to improve discoloration; a custom fractional laser refines texture; a superficial wavelength zaps clogged pores clean; and a long-pulse wavelength stimulates collagen production. Expect minimal to no downtimeand a smoother complexion in no time at all.

BEST BRIGHTENING FACIALRejuvenation Laser and Stem Cell Infusion$1,888 for five sessions, The Aesthetics Medical ClinicCombining two laser machinesQ Switch and yellow laserthat work in tandem to give you radiant, glowy skin, this also removes dirt, dead skin cells, oil and superficial hair, so skin is not only brightened, but also clearer and cleaner. The laser also helps to regulate oil production and reduce pigmentation, while the potent 80percent stem cell-derived serum delivers proteins, growth factors and cytokines intoskin to help boost regeneration and repair.

BEST CLEANSING FACIALJet Set$129 for 30 minutes, EPIONIdeal as a maintenance facial for time-strapped individuals, this express purifying solution rejuvenates weary skin in 30 minutes. A highpressure aqua jet peel gently sweeps away any build-up of dry and dead skin, before an ultrasonic deep cleanse purges pores of dirt, sebum and impurities. Jet technology is then used to infuse skin with potent actives with intense hydrating and brightening benefits.

Related article:BAZAAR Spa Awards 2020: Best Face Therapies To Transform And Pamper Your Skin

BEST DETOXIFYING FACIALVitamin C Infusion$288 for 45 minutes, Simply AestheticsBid adieu to skin woes such as open pores, blemishes, pigmentation and dullness with a super-potent dose of medical-grade vitamin C, which smooths and revitalises the skin. Besides getting rid of pore-clogging impurities that can make the skin appear dull or lacklustre, the facial also stimulates the dermal cells to actively produce collagen in order to regain that plump, fresh-faced radiance.

BEST EXPRESS FACIALIDS Electro Infusion (IEI)$280 for 45 minutes, IDS AestheticsGreat as a lunchtime facial, this uses a combination of electronic-magnetic pulses and LED light to brighten and firm skin. Designed to tackle various skin conditionspigmentation, fine lines, wrinkles, dryness, dullnessthis quickie facial is deemed a universal beauty enhancer and works its magic in less than an hour.

BEST EYE LIFT TREATMENTSygmaLift Eyes$670 for 60 minutes, Clifford AestheticsWhether its eyebags or dark circles that no concealer can hide, the root causes of your undereye issues are sussed out with a consultation in order to tailor an effective treatment. SygmaLift therapy, which utilises high-intensity focused ultrasound technology, is then applied to the under-eye area to contract the connective tissues deep within to tighten and smooth skin. The end resulta marked improvement in the appearance of under-eye bags, sagginess, discoloration and linestakes years off your face!

BEST HYDRATING FACIALHydraFacial$250 for 35 minutes, Dr Kevin Chua Medical & AestheticsThis all-in-one treatment starts off with a deep cleanse, and an exfoliating cocktail of salicylic and glycolic acids to break up pore-clogging impurities, allowing the HydraPeel Tip to essentially vacuum out sebum, product build-up, blackheads and dirt, before infusing skin with intensive serums to replenish hydration levels and provide antioxidant protection.

BEST LIFTING & FIRMING FACIALThermage FLX$5,350 for 90 minutes, Priv ClinicWant to reduce the look of fine lines, wrinkles, sagging skin and other signs of ageing, or simply delay their dreaded appearance? Promising just that is the Thermage FLX, which uses radio frequency to stimulate cell regeneration and collagen production. This newgen treatment is optimised for improved comfort and more controlled delivery, and the results from one session is said to last for months.

BEST PORE-REFINING FACIAL3D Deep Pore Cleansing Facial$588 for 90 minutes, Aesthetics Central ClinicFlawless skin can now be had with this signature treatment that utilises a patented device called 50 Micron Jet Technology, where high-pressure micro-jets of water gently push out the sebum and impurities trapped in pores. As the pores are being cleaned out, the machine delivers a serum, designed to lift and tighten skin while encouraging microcirculation, deep into the skin.

BEST REJUVENATING FACIALPicoWay RESOLVE $650 for 30 minutes, Dr Kevin Chua Medical & AestheticsSo named for the technology where laser pulses are delivered in picosecondsa unit of measurement that refers to one trillionth of a seconda PicoWay facial sends small bursts of intense laser energy deep into the skin to stimulate its natural healing abilities. The short pulsations mean that less heat is emitted during the procedure, so you neednt worry about post-treatment burns. Benefits of the treatment, which is suitable for most skin types, include plumper, suppler skin with improved tone and texture.

Related article:Spa Awards 2020 Best Rejuvenating Facial: PicoWay RESOLVE

BEST RESURFACING FACIALPico Fractional Laser Treatment$300 for 60 minutes, Calvin Chan Aesthetic & Laser ClinicVia short but intense pulses of laser energy delivered deep into the dermis, the skin is transformed from the inside out as new collagen and elastin is produced to significantly improve the appearance of pitted acne scars, pigmentation and wrinkles. And if youre worried about downtime, dont. The surface of the skin is left intact while the deep tissue heals, which means theres no recovery time involved.

BEST SHAPING & TIGHTENING FACIALBiologique Recherche Remodeling Face $380 for 90 minutes, Freia AestheticsThis kicks off with a 60-minute booster customised to your skins needs, followed by a proprietary massage that promotes blood flow and stimulates the lymph nodes for a detoxifying effect. The Remodelling Face machine then uses a bespoke blend of electric, galvanic and high-frequency currents to enhance the benefits of the preceding steps, and deliver product actives deeper and more efficiently into skin for a supreme lifting, tightening and plumping effect.

BEST SOOTHING FACIALSeriously Soothing $209 for 90 minutes, EPIONLiving up to its name, this hydrates and calms thirsty skin with a side of sensitivity. Ultrasonic energy is first used to give skin a deep cleanse. This is followed by a dose of much-needed hyaluronic acid and the application of a soothing face mask. The final step: LED red light therapy to help stimulate collagen production and reduce redness or inflammation.

Related article:Cindy Crawford Shows How She Stays Fabulous At Every Age In Our February Issue

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Spa Awards 2020: Best Specialised Solutions Tackle Every Skin Concern - Harper's Bazaar Singapore

CORPUS CHRISTI, Texas In today's world, millions are spent on cosmetic surgery to keep that healthy glow everywhere we go. However, if you don't have thousands of dollars to pay for it, there are other, more safe alternatives that are non-surgical.

A few years ago I started noticing that no matter how much sleep I got, I just didn't look as fresh as I did when I was younger. I thought maybe it was time to talk to a professional about how I could get back that youthful appearance.

Stress, the daily rigor of life, and gravity all take their toll on the face, and there's nothing wrong with admitting you need a little help to look and feel a little better.

I visited with Dr. Vijay Bingdingdavale, a local cosmetic surgeon, to address my concerns and explore some options. The first thing he suggested was injections to relax my forehead area.

"That'll lift the eyebrows as well. What happens is when we inject these two areas, your eyebrows come a little bit higher, and giving you more of a refreshed look," Dr. Bingdingdavale said.

Then adding fullness to the upper cheeks would bring some balance to my face.

"You see how when you have a little bit more cheek fullness it harmonizes the face? It lifts this and fill this in as well," Dr. Bingdingdavale said.

Using fat transfer as opposed to artificial fillers has an additional benefit.

"We see this a lot, because there are stem cells in the fat, it makes the overlying skin more refreshed and more young-looking," Dr. Bingdingdavale said.

In the end, that's what we all want -- a more refreshed appearance even if we don't get our eight hours every night.

You can catch Dr. Vijay Bingdingdavale on First Edition on Sundays discussing skin care and healthy living.

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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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Newswise A UCLA-led study reveals a new role for a gene thats associated with autism spectrum disorder, intellectual disability and language impairment.

The gene, Foxp1, has previously been studied for its function in the neurons of the developing brain. But the new study reveals that its also important in a group of brain stem cells the precursors to mature neurons.

This discovery really broadens the scope of where we think Foxp1 is important, said Bennett Novitch, a member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLAand the senior author of the paper. And this gives us an expanded way of thinking about how its mutation affects patients.

Mutations in Foxp1 were first identified in patients with autism and language impairments more than a decade ago. During embryonic development, the protein plays a broad role in controlling the activity of many other genes related to blood, lung, heart, brain and spinal cord development. To study how Foxp1 mutations might cause autism, researchers have typically analyzed its role in the brains neurons.

Almost all of the attention has been placed on the expression of Foxp1 in neurons that are already formed, said Novitch, a UCLA professor of neurobiology who holds the Ethel Scheibel Chair in Neuroscience.

In the new study published in Cell Reports, he and his colleagues monitored levels of Foxp1 in the brains of developing mouse embryos. They found that, in normally developing animals, the gene was active far earlier than previous studies have indicated during the period when neural stem cells known as apical radial glia were just beginning to expand in numbers and generate a subset of brain cells found deep within the developing brain.

When mice lacked Foxp1, however, there were fewer apical radial glia at early stages of brain development, as well as fewer of the deep brain cells they normally produce. When levels of Foxp1 were above normal, the researchers observed more apical radial glia and an excess of those deep brain cells that appear early in development.In addition, continued high levels of Foxp1 at later stages of embryonic development led to unusual patterns of apical radial glia production of deep-layer neurons even after the mice were born.

What we saw was that both too much and too little Foxp1 affects the ability of neural stem cells to replicate and form certain neurons in a specific sequence in mice, Novitch said. And this fits with the structural and behavioral abnormalities that have been seen in human patients.

Some people, he explained, have mutations in the Foxp1 gene that blunt the activity of the Foxp1 protein, while others have mutations that change the proteins structure or make it hyperactive.

The team also found intriguing hints that Foxp1 might be important for a property specific to the developing human brain.The researchers also examined human brain tissue and discovered that Foxp1 is present not only in apical radial glia, as was seen in mice, but also in a second group of neuralstem cells called basal radial glia.

Basal radial glia are abundant in the developinghuman brain, but absent or sparse in the brains of many other animals, including mice.However, when Novitchs team elevated Foxp1 function in the brains of mice, cells resembling basal radial glia were formed. Scientists have hypothesized that basal radial glia also are connected to the size of the human brain cortex: Their presence in large quantities in the human brain may help explain why it is disproportionately larger than those of other animals.

Novitch said that although the new research does not have any immediate implications for the treatment of autism or other diseases associated with Foxp1 mutations, it does help researchers understand the underlying causes of those disorders.

In future research, Novitch and his colleagues are planning to study what genes Foxp1 regulates in apical radial glia and basal radial glia, and what roles those genes play in the developing brain.

The studys first author is Caroline Alayne Pearson, a UCLA assistant project scientist. Other authors are from the University of Texas at Austin, the University of Alabama at Birmingham and the University of Puerto Rico.

The study was funded by the National Institutes of Health, the California Institute for Regenerative Medicine, the Cancer Prevention and Research Institute of Texas, the University of Texas at Austins Marie Betzner Morrow Centennial Endowment and the UCLA Broad Stem Cell Research Centers Research Award Program, including support from the Binder Foundation.

SEE ORIGINAL STUDY

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Gene associated with autism also controls growth of the embryonic brain - Newswise

Scientists using a new motor neuron disease (MND) model have shown astrocytes may protect neurons from toxic TDP-43 protein aggregates in the early stages of disease.

Researchers have discovered that astrocytes can protect motor neurons in the central nervous system (CNS) from the toxicity of misfolded protein, TDP-43, in sporadic motor neuron disease (MND). The team suggest this rescue mechanism could be harnessed to slow disease progression, particularly in amyotrophic lateral sclerosis (ALS).

The study, published in Brain, demonstrated that this neurodegenerative disease is caused by accumulation of TDP-43 in motor neurons, resulting in cell death. However, the scientists noted that TDP-43 accumulation in neural support cells, called astrocytes, does not cause death. Instead they appear comparatively resistant.

According to the paper, when the two cell types are together, astrocytes protect motor neurons from the protein aggregates, promoting their survival. The researchers from the Francis Crick Institute and University College London, both UK, suggest that these cells may therefore be supporting motor neurons early on in sporadic MND. They called this a rescue mechanism.

when the two cell types are together, astrocytes protect motor neurons from the protein aggregates, promoting their survival

The role astrocytes have played in dealing with toxic forms of TDP-43 in motor neurons has not been previously well documented in motor neuron disease. Its exciting that weve now found that they may play an important protective role in the early-stages of this disease, explains Phillip Smethurst, lead author and former postdoc in the Human Stem Cells and Neurodegeneration Laboratory at the Crick. This has huge therapeutic potential finding ways to harness the protective properties of astrocytes could pave the way to new treatments. This could prolong their rescue function or find a way to mimic their behaviour in motor neurons so that they can protect themselves from the toxic protein.

In order to conduct this research, the team created a new model for MND, which more closely resembles the disease in patients. In the model they took healthy adult stem cells and exposed them to the toxic TPD-43 protein using post-mortem spinal cord tissue samples donated by patients with MND.

For the first time, we have been able to create a model of sporadic motor neuron disease by essentially transferring the toxic TDP-43 protein from post-mortem tissue into healthy human stem cell-derived motor neurons and astrocytes in order to understand how each cell type responds to this insult, both in isolation and when mixed together, said Dr Rickie Patani, co-senior author, group leader of the Human Stem Cells and Neurodegeneration Laboratory at the Crick and Professor of Human Stem Cells and Regenerative Neurology at UCL Queen Square Institute of Neurology.

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Astrocytes could be harnessed to protect motor neurons in MND - Drug Target Review

CALGARY, Alberta, Feb. 10, 2020 (GLOBE NEWSWIRE) -- Hemostemix Inc. (Hemostemix or the Company) (TSXV: HEM; OTC: HMTXF) is pleased to announce the appointment of Dr. Ronnie Hershman, M.D., F.C.C.S., to its Board of Directors. Dr. Hershman is a successful, practicing cardiologist with over three decades of experience. Dr. Hershman graduated Magna Cum Laude from the Sophie Davis Center for Biomedical Research in 1980 and received his medical degree from Mount Sinai Medical Center in 1982. He then continued his medical and cardiovascular training at Mt. Sinai Medical Center.

Dr. Hershman has been an Invasive Cardiologist since 1987 and was involved in many clinical trials for emerging catheter technologies. He was a pioneer in performing laser-assisted coronary angioplasty, starting in private practice on Long Island in 1989. Presently the Medical Director of NYU Langone Long Island Cardiac Care he built and manages a large medical practice, employing cutting-edge technology and continues his practice for patients with cardiovascular and peripheral vascular diseases, employing a non-invasive therapy for patients with intractable Angina and Congestive Heart Failure.

Dr. Hershman has also been an entrepreneur and investor for more than two decades. He has been involved in life science investing and consulting for several years and previously or currently serves on the boards of medical biotechnology companies Solubest, Ltd., TheraVitae Inc., Nasus Pharma, SanoNash and Optivasive. He also serves as an advisor to a latestage, life science venture capital company that has funded 24 companies to-date. Dr. Hershman is now an investor in OurCrowd, Ltd., a leading crowd funding company and is the Co-Founder and CEO of HealthEffect, LLC and CLiHealth, LLC, SoLoyal and Nasus Pharma along with SanoNash.

Dr. Hershman continues to evaluate new medical technologies in the USA and Israel. His main interests lie in bringing improved medical technologies from the bench to the clinic, quickly and globally. He is actively seeking to commercialize technologies that improve lives and cure illnesses in the most effective and cost efficient manner.

Stem Cell therapies are the future in so many chronic illnesses and Hemostemix is an exciting company with a lot of promise in providing solutions and therapeutic options for many patients with critical Cardiovascular illnesses and ischemia, commented Dr. Hershman. As an investor and Board Member, I hope to assist in advancing these therapies further and create optimal value for patients and shareholders, alike, he said.

Dr. Hershman is replacing Mr. Yari Nieken and Mr. Bryson Goodwin who both resigned from their positions with the Company effective February 10, 2020. Ms. Natasha Sever has also resigned from the position of CFO. The Company will look for suitable replacements for both CEO and CFO positions and Mr. Smeenk will act as the interim CEO until a replacement is hired. The Company thanks Bryson, Yari and Natasha for their service and wishes them well in their future endeavors.

It is a great pleasure to welcome Dr. Hershman to the Board of Directors, said David Wood, Chairman, as he compliments us with his broad medical experience, biotechnology and business investment acumen and counsel.

I am honored and delighted to welcome Dr. Hershman to the Board of Directors and I very much look forward to his counsel, said Thomas Smeenk, President.

The Company also announces that on January 9, 2020, J.M. Wood Investment Inc. (JMWI) sent the Company a Notice of Default and Demand for the immediate repayment of the Companys previously announced convertible debenture and demand loan. Based on the repayment conditions of the debts, the Company took the position the January 9th notice was premature. On January 24th, JMWI made an application to the Court of Queens Bench of Alberta for the issuance of an order appointing a receiver. The Company responded with a 347 page affidavit including appendices, sworn on January 30th by David Wood, Chairman. The application was heard on January 31st by Madame Justice Horner, who granted a consent order to adjourn the JMWI receivership application to February 20, 2020 to enable the Company to close its financing; granted an order appointing Grant Thornton as inspector; granted an order that the costs of the application of January 31st would only be payable by the Company if the application proceeds on February 20th. On February 6, 2020 cross examinations on the Affidavits of David Wood and JMWI were heard.

Story continues

Also, on February 3, 2020 the Company received an action from Aspire Health Science, LLC filed with the Ninth Judicial Circuit Court for Orange County, State of Florida, in connection with the Amended and Restated License Agreement rescinded by Hemostemix on December 5, 2019 due to Aspires failure to meet the Condition Precedent of paying US$1,000,000 within 30 business days of September 30, 2019. The Company believes the action is frivolous, without merit, and it intends to vigorously defend its position.

The Company intends to effect repayment of the secured debts and it will provide a further update to the market at that time. Although the Company is optimistic that it will be successful in raising sufficient funds to meet its obligations, there can be no assurance that the financing will close as anticipated or within the time frames required.

ABOUT HEMOSTEMIX INC.

Hemostemix is a publicly traded autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other heart conditions. ACP-01 has been used to treat over 300 patients, including no-option end-stage heart disease patients, and it has been the subject of four open label phase II clinical studies which proved its safety and efficacy.

On October 21, 2019, the Company announced the results from its presentation from its Phase II CLI trial abstract presentation entitled Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years. The Companys clinical trial for CLI is ongoing at 20 clinical sites in North America and 56 of 95 subjects have been enrolled to-date.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy. For more information, please visit http://www.hemostemix.com.

Contact:

Thomas Smeenk, President & CEO Suite 1150, 707 7th Avenue S.W.Calgary, Alberta T2P 3H6Tel: 905-580-4170

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words expects, plans, anticipates, believes, intends, estimates, projects, potential, and similar expressions, or that events or conditions will, would, may, could, or should occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Companys ability to fund operations and access the capital required to continue operations and repay its secured debts, the Companys stage of development, the ability to complete its current CLI clinical trial, complete a futility analysis and the results of such, future clinical trials and results, long-term capital requirements and future developments in the Companys markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Companys operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise. Additional information identifying risks and uncertainties are contained in the Companys filing with the Canadian securities regulators, which filings are available at http://www.sedar.com.

Link:
Hemostemix Announces the Appointment of Dr. Ronnie Hershman to the Board of Directors and Provides a Corporate Update - Yahoo Finance

Autologous stem cell and non-stem cell based therapies is a significant therapeutic intervention that makes use of an individuals cells which are then cultured and reintroduced into the donor patients body. In the context of China-US trade war and global economic volatility and uncertainty, it will have a big influence on this market. Autologous Stem Cell and Non-Stem Cell Based Therapies Report by Material, Application, and Geography Global Forecast to 2023 is a professional and comprehensive research report on the worlds major regional market conditions, focusing on the main regions (North America, Europe and Asia-Pacific) and the main countries (United States, Germany, United Kingdom, Japan, South Korea and China).

In this report, the global Autologous Stem Cell and Non-Stem Cell Based Therapies market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2023, growing at a CAGR of XX% during the period 2019 to 2023.

The report firstly introduced the Autologous Stem Cell and Non-Stem Cell Based Therapies basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

The major players profiled in this report include:U.S. STEM CELL, INC.Brainstorm Cell TherapeuticsCytoriDendreon CorporationFibrocellLion BiotechnologiesCaladrius BiosciencesOpexa TherapeuticsOrgenesisRegenexxGenzymeAntriaRegeneusMesoblastPluristem Therapeutics IncTigenixMed cell EuropeHolostemMiltenyi Biotec

The end users/applications and product categories analysis:On the basis of product, this report displays the sales volume, revenue (Million USD), product price, market share and growth rate of each type, primarily split into-Embryonic Stem CellResident Cardiac Stem CellsAdult Bone MarrowDerived Stem CellsUmbilical Cord Blood Stem Cells

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Autologous Stem Cell and Non-Stem Cell Based Therapies for each application, including-Neurodegenerative DisordersAutoimmune DiseasesCancer and TumorsCardiovascular Diseases

Table of Contents

Part I Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Overview?Chapter One Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Overview1.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Definition1.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Classification Analysis1.2.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Classification Analysis1.2.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Classification Share Analysis1.3 Autologous Stem Cell and Non-Stem Cell Based Therapies Application Analysis1.3.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Application Analysis1.3.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Main Application Share Analysis1.4 Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Chain Structure Analysis1.5 Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Overview1.5.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Product History Development Overview1.5.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Product Market Development Overview1.6 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Market Comparison Analysis1.6.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Import Market Analysis1.6.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Export Market Analysis1.6.3 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Main Region Market Analysis1.6.4 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Market Comparison Analysis1.6.5 Autologous Stem Cell and Non-Stem Cell Based Therapies Global Market Development Trend Analysis

Chapter Two Autologous Stem Cell and Non-Stem Cell Based Therapies Up and Down Stream Industry Analysis2.1 Upstream Raw Materials Analysis2.1.1 Proportion of Manufacturing Cost2.1.2 Manufacturing Cost Structure of Autologous Stem Cell and Non-Stem Cell Based Therapies Analysis2.2 Down Stream Market Analysis2.2.1 Down Stream Market Analysis2.2.2 Down Stream Demand Analysis2.2.3 Down Stream Market Trend Analysis

Part II Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Industry (The Report Company Including the Below Listed But Not All)

Chapter Three Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis3.1 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Product Development History3.2 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Competitive Landscape Analysis3.3 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Market Development Trend

Chapter Four 2014-2019 Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast4.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview4.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis4.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview4.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage4.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption4.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Five Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Key Manufacturers Analysis5.1 Company A5.1.1 Company Profile5.1.2 Product Picture and Specification5.1.3 Product Application Analysis5.1.4 Capacity Production Price Cost Production Value5.1.5 Contact Information5.2 Company B5.2.1 Company Profile5.2.2 Product Picture and Specification5.2.3 Product Application Analysis5.2.4 Capacity Production Price Cost Production Value5.2.5 Contact Information5.3 Company C5.3.1 Company Profile5.3.2 Product Picture and Specification5.3.3 Product Application Analysis5.3.4 Capacity Production Price Cost Production Value5.3.5 Contact Information5.4 Company D5.4.1 Company Profile5.4.2 Product Picture and Specification5.4.3 Product Application Analysis5.4.4 Capacity Production Price Cost Production Value5.4.5 Contact InformationChapter Six Asia Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend6.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview6.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis6.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview6.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage6.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption6.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Part III North American Autologous Stem Cell and Non-Stem Cell Based Therapies Industry (The Report Company Including the Below Listed But Not All)

Chapter Seven North American Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis7.1 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Product Development History7.2 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Competitive Landscape Analysis7.3 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Market Development Trend

Chapter Eight 2014-2019 North American Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast8.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview8.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis8.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview8.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage8.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption8.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Nine North American Autologous Stem Cell and Non-Stem Cell Based Therapies Key Manufacturers Analysis9.1 Company A9.1.1 Company Profile9.1.2 Product Picture and Specification9.1.3 Product Application Analysis9.1.4 Capacity Production Price Cost Production Value9.1.5 Contact Information9.2 Company B9.2.1 Company Profile9.2.2 Product Picture and Specification9.2.3 Product Application Analysis9.2.4 Capacity Production Price Cost Production Value9.2.5 Contact InformationChapter Ten North American Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend10.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview10.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis10.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview10.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage10.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption10.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Part IV Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Analysis (The Report Company Including the Below Listed But Not All)

Chapter Eleven Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis11.1 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Product Development History11.2 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Competitive Landscape Analysis11.3 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Market Development Trend

Chapter Twelve 2014-2019 Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast12.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview12.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis12.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview12.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage12.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption12.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Thirteen Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Key Manufacturers Analysis13.1 Company A13.1.1 Company Profile13.1.2 Product Picture and Specification13.1.3 Product Application Analysis13.1.4 Capacity Production Price Cost Production Value13.1.5 Contact Information13.2 Company B13.2.1 Company Profile13.2.2 Product Picture and Specification13.2.3 Product Application Analysis13.2.4 Capacity Production Price Cost Production Value13.2.5 Contact InformationChapter Fourteen Europe Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend14.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview14.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis14.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview14.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage14.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption14.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Part V Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels and Investment Feasibility

Chapter Fifteen Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Development Proposals Analysis15.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Status15.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Characteristic15.3 Autologous Stem Cell and Non-Stem Cell Based Therapies Marketing Channels Development Trend15.2 New Firms Enter Market Strategy15.3 New Project Investment Proposals

Chapter Sixteen Development Environmental Analysis16.1 China Macroeconomic Environment Analysis16.2 European Economic Environmental Analysis16.3 United States Economic Environmental Analysis16.4 Japan Economic Environmental Analysis16.5 Global Economic Environmental Analysis

Chapter Seventeen Autologous Stem Cell and Non-Stem Cell Based Therapies New Project Investment Feasibility Analysis17.1 Autologous Stem Cell and Non-Stem Cell Based Therapies Market Analysis17.2 Autologous Stem Cell and Non-Stem Cell Based Therapies Project SWOT Analysis17.3 Autologous Stem Cell and Non-Stem Cell Based Therapies New Project Investment Feasibility Analysis

Part VI Global Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Conclusions

Chapter Eighteen 2014-2019 Global Autologous Stem Cell and Non-Stem Cell Based Therapies Productions Supply Sales Demand Market Status and Forecast18.1 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview18.2 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis18.3 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview18.4 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage18.5 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption18.6 2014-2019 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Nineteen Global Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Development Trend19.1 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Overview19.2 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Production Market Share Analysis19.3 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Demand Overview19.4 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Supply Demand and Shortage19.5 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Import Export Consumption19.6 2019-2023 Autologous Stem Cell and Non-Stem Cell Based Therapies Cost Price Production Value Gross Margin

Chapter Twenty Global Autologous Stem Cell and Non-Stem Cell Based Therapies Industry Research Conclusions

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Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020: Industry Analysis By Emerging Trends, Key Companies, Regional Outlook and...

BOTHELL, Wash. and TOKYO, Feb. 10, 2020 /PRNewswire/ --Seattle Genetics, Inc.(Nasdaq: SGEN) and Astellas Pharma Inc.(TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced updated results from the phase 1b/2 clinical trial EV-103 in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. Forty-five patients were treated with the combination of PADCEV (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy. After a median follow-up of 11.5 months, the study results continue to meet outcome measures for safety and demonstrate encouraging clinical activity for this platinum-free combination in a first-line setting. Updated results will be presented during an oral session on Friday, February 14 at the 2020 Genitourinary Cancers Symposium in San Francisco (Abstract #441). Initial results from the study were presented at the European Society of Medical Oncology Congress in September 2019.

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,2

"Cisplatin-basedchemotherapy is the standard treatment for first-line advanced urothelial cancer; however, it isn't an option for many patients,"said Jonathan E. Rosenberg, M.D., Medical Oncologist and Chief, Genitourinary Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York."I'm encouraged by these interim results, including a median progression-free survival of a year for patients who received the platinum-free combination of PADCEV and pembrolizumab in the first-line setting."

In the study, 58 percent (26/45) of patients had a treatment-related adverse event greater than or equal to Grade 3: increase in lipase (18 percent; 8/45), rash (13 percent; 6/45), hyperglycemia (13 percent; 6/45) and peripheral neuropathy (4 percent; 2/45); these rates were similar to those observed with PADCEV monotherapy.3Eighteen percent (8/45) of patients had treatment-related immune-mediated adverse events of clinical interest greater than or equal to Grade 3 that required the use of systemic steroids (arthralgia, dermatitis bullous, pneumonitis, lipase increased, rash erythematous, rash maculo-papular, tubulointerstitial nephritis, myasthenia gravis). None of the adverse events of clinical interest were Grade 5 events. Six patients (13 percent) discontinued treatment due to treatment-related adverse events, most commonly peripheral sensory neuropathy. As previously reported, there was one death deemed to be treatment-related by the investigator attributed to multiple organ dysfunction syndrome.

The data demonstrated the combination of PADCEV plus pembrolizumab shrank tumors in the majority of patients, resulting in a confirmed objective response rate (ORR) of 73.3 percent (33/45; 95% Confidence Interval (CI): 58.1, 85.4) after a median follow-up of 11.5 months (range,0.7 to 19.2). Responses included 15.6 percent (7/45) of patients who had a complete response (CR)and 57.8 percent (26/45) of patients who had a partial response. Median duration of response has not yet been reached (range 1.2 to 12.9+ months). Eighteen (55%) of 33 responses were ongoing at the time of analysis, with 83.9% of responses lasting at least 6 months and 53.7% of responses lasting at least 12 months (Kaplan-Meier estimate).The median progression-free survival was 12.3 months (95% CI: 7.98, -) and the 12-month overall survival (OS) rate was 81.6 percent (95% CI: 62 to 91.8 percent); median OS has not been reached.

"These updated data are encouraging and provide support for the recently initiated phase 3 trial EV-302 that includes an arm evaluating PADCEV in this platinum-free combination in the first-line setting," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

"These additional results support continued evaluation of PADCEV in combination with other agents and at earlier stages of treatment for patients withurothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.

About the EV-103 TrialEV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.

The dose-escalation cohort and expansion cohort A include locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin-based chemotherapy. Patients were dosed in a 21-day cycle, receiving an intravenous (IV) infusion of enfortumab vedotin on Days 1 and 8 and pembrolizumab on Day 1. At the time of this initial analysis, 45 patients (5 from the dose-escalation cohort and 40 from the dose-expansion cohort A) with locally advanced and/or metastatic urothelial cancer had been treated with enfortumab vedotin (1.25 mg/kg) plus pembrolizumab in the first-line setting.

The primary outcome measure of the cohorts included in this analysis is safety. Key secondary objectives related to efficacy include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression free survival (PFS) and overall survival (OS). DoR,PFS and OS are not yet mature.

Additional cohorts in the EV-103 study will evaluate enfortumab vedotin:

More information about PADCEV clinical trials can be found at clinicaltrials.gov.

About Bladder and Urothelial CancerIt is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020.5 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.6 Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.7

The recommended first-line treatment for patients with advanced urothelial cancer is a cisplatin-based chemotherapy. For patients who are ineligible for cisplatin, such as people with kidney impairment, a carboplatin-based regimen is recommended. However, fewer than half of patients respond to carboplatin-based regimens and outcomes are typically poorer compared to cisplatin-based regimens.8

About PADCEV PADCEV (enfortumabvedotin-ejfv) was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.9

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.2,9Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).9PADCEV is co-developed by Astellas and Seattle Genetics.

Important Safety Information

Warnings and Precautions

Adverse ReactionsSerious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab AbnormalitiesIn one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.

Drug Interactions

Specific Populations

For more information, please see the full Prescribing Information for PADCEV here.

About Seattle GeneticsSeattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in people's lives. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit https://www.seattlegenetics.comand follow @SeattleGenetics on Twitter.

About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en.

About the Astellas and Seattle Genetics CollaborationSeattle Genetics and Astellas are co-developing enfortumab vedotin-ejfv under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.

Seattle Genetics Forward-Looking StatementsCertain statements made in this press release are forward looking, such as those, among others, relating to the EV-103 and EV-302 clinical trials; clinical development plans relating to enfortumab vedotin; the therapeutic potential of enfortumab vedotin; and its possible safety, efficacy, and therapeutic uses, including in the first-line setting. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that ongoing and subsequent clinical trials of enfortumab vedotin may fail to establish sufficient efficacy; that adverse events or safety signals may occur and that adverse regulatory actions or other setbacks could occur as enfortumab vedotin advances in clinical trials even after promising results in earlier clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

1 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.2 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.3 Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol 2019;37(29):2592-600.4 ClinicalTrials.gov. A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103). https://clinicaltrials.gov/ct2/show/NCT03288545.5 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed 01-23-2020.6National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: bladder cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed 05-01-2019.7International Agency for Research on Cancer. Cancer Tomorrow: Bladder. http://gco.iarc.fr/tomorrow. 8 National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. Version 4; July 10, 2019. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.9 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.

SOURCE Astellas

http://www.seattlegenetics.com

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Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV (enfortumab vedotin-ejfv) in Combination with Immune Therapy...

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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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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Regenerative Medicine Market Analysis Trends, Growth Opportunities, Size, Type, Dynamic Demand and Drives with Forecast to 2025 - Jewish Life News

Press Release

Gosselies, Belgium, 11February 2020, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapies to address high unmet medical needs in orthopaedics and bone diseases, announces that the Company will today present at the Annual Meeting of the Orthopaedic Research Society (ORS), in Phoenix (Arizona), USA.

The Annual ORS Meeting is the yearly summit organised by the international Orthopaedic Research Society, gathering scientists, clinicians and entrepreneurs to advance musculoskeletal research and orthopaedic care. In the oral presentation, Bone Therapeutics will highlight additional preclinical in vitro and in vivo results demonstrating the potent osteogenic properties of its allogeneic bone-forming cell therapy platform, ALLOB, to promote bone-formation and improve fracture healing in relevant models.

ALLOB is the Companys allogeneic product that consists of human bone-forming cells derived from cultured bone marrow mesenchymal stem cells of healthy adult donors, and is manufactured through a proprietary, scalable production process. ALLOB successfully completed two Phase II studies in two indications and the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the PhaseIIb clinical trial in patients with difficult-to-heal tibial fractures.

Presentation Details:

Title: ALLOB, A Ready-to-use and Injectable Cryopreserved Allogenic Cell Therapy Product Derived from Bone Marrow Mesenchymal Stem Cells, Displays Potent Osteoinductive and Osteogenic Properties, Leading to Enhanced Bone Fracture HealingSpeaker: Sandra Pietri, PhD Associate Director R&D, Bone TherapeuticsSession: Podium Session 58 Bone Cell Signaling and TreatmentsDate: Tuesday, 11 February 2020Time: 8:00am 9:00am MST (4pm 5 pm CET)Location: Room West 301D, Phoenix Convention Center, Phoenix, Arizona, USA

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering Phase III development for the treatment of pain in knee osteoarthritis. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) to start the pivotal Phase III program has been submitted to the regulatory authorities in Europe and the trial is expected to start in Q1 2020.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the promising Phase IIa efficacy and safety results for ALLOB, the Company has started the CTA submission procedure with the regulatory authorities in Europe to start the Phase IIb clinical trial with ALLOB in patients with difficult-to-heal fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

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Contacts

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Consilium Strategic CommunicationsMarieke VermeerschTel: +44 (0) 20 3709 5701bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics to present preclinical data on the osteogenic properties of ALLOB in bone repair at the Annual Meeting of the Orthopaedic Research...

NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).

In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.

Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible.

This is a key turning point in ourworktowardprovidingALSpatientswith a potential new therapy,said ChaimLebovits, President and CEO ofBrainStorm. We commend the FDA foritscommitmentto the ALS communityandtofacilitating the development, and we ultimately hope, the approvalofNurOwn.The entire BrainStorm team is grateful for the ongoing and conscientious collaboration in the quest to beat ALS.

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, stated, The entire team at BrainStorm has collectively worked to ensure that we conduct the finest, science-based clinical trials. We had the opportunity to communicate with Senior Leadership at the FDA and discuss how we can work together to navigate the approval process forward along a novel pathway. We appreciate their willingness and receptiveness to consider innovative approaches as we all seek to better serve the urgent unmet medical needs of the ALS community.

Brian Wallach, Co-Founder of I AM ALS stated: There is nothing more important to those living with ALS than having access to therapies that effectively combat this fatal disease. We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. We were privileged to represent the patient voice at this meeting and are truly grateful to the company and the FDA for this critical agreement. This is a truly important moment of hope and we look forward to seeing both the Phase III data and the hopeful approval of NurOwn as soon as is possible.

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 NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean 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 theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

Safe-Harbor Statement

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 PRPhone: +1.646.677.1839sean.leous@icrinc.com

Or

Katie Gallagher | Account Director, PR and MarketingLaVoieHealthScience Strategic CommunicationsO: 617-374-8800 x109M: 617-792-3937kgallagher@lavoiehealthscience.com

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BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn Regulatory Pathway for Approval in ALS - GlobeNewswire

NEW YORK, Feb. 10, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company will hold a conference call to update shareholders on financial results for the fourth quarter and full year ended December 31, 2019, and provide a corporate update, at 8:00 a.m., Eastern Time, on Tuesday, February 18, 2020.

BrainStorms President & CEO, Chaim Lebovits, will present the full year 2019 corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD, Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com and questions should be submitted by 5:00 p.m., Eastern Time, Monday, February 17 2020.

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the Investors & Media page of BrainStorms website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

A webcast replay of the conference call will be available for 30 days on the Investors & Media page of BrainStorms website:

About NurOwn

NurOwn (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 as well as through its own patents, patent applications and proprietary know-how. 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 Statement

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

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: 862-397-8160pshah@brainstorm-cell.com

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

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BrainStorm Cell Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Provide a Corporate Update - BioSpace

Methionine is an amino acid found in meat, eggs, and dairy. Its absorbed by T-cells that are part of our immune system. Those cells are also believed to be the immune cells that attack our myelin, creating the nerve damage that results in multiple sclerosis.

In this study, mice eating less methionine had a reduced number of a certain type of T-cell, which led to a delay in disease onset and progression. The researchers believe reducing methionine intake can actually dampen the immune cells that cause disease, leading to better outcomes.

Changing a persons diet to reduce the amount of methionine (amino acid found in food) could delay the development and progression of inflammatory and autoimmune disorders, including multiple sclerosis (MS).

That finding was described in the study Methionine Metabolism Shapes T Helper Cell Responses through Regulation of Epigenetic Reprogramming, published recently in the journal Cell Metabolism.

Click here to read the full story.

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Unlike hematopoietic stem cell transplants, in which stem cells are removed from a patients bone marrow and later infused back into the bloodstream, mesenchymal stem cell transplants (MSCT) collect those stem cells from the patients spinal column and return them there. This study concludes that MSCT is safe and that cells delivered into the spinal cord produced a significantly slower disease progression rate than did cells delivered into the bloodstream.

Transplanting patients ownmesenchymal stem cellsis a safe therapeutic approach and can delay disease progression in people with MS, a meta-analysis review shows.

The study also showed that cells transplanted to the spinal cord (intrathecal injection) were associated with significantly slower disease progression rates, compared to cells delivered into the bloodstream.

Click here to read the full story.

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Why do neurologists often use spinal taps when determining whether someone has MS? This study provides one of the reasons.

People with MS have a more diverse set of immune cells in their cerebrospinal fluid (CSF), the fluid that bathes the central nervous system, but no such diversity is seen in their blood, a study reports. Instead, MS causes changes in the activation of immune cells in the blood.

The distinct set of immune cells in MS patients CSF shows enrichment of pro-inflammatory cells that promote disease severity in MS mouse models.

Click here to read the full story.

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Heres encouraging news about a possible treatment that can lower the number of brain lesions in someone with MS. Keep in mind this is only a Phase 2 trial. A Phase 3 trial isnt expected until later this year. However, a news release from research sponsor Sanofisays, This molecule may be the first B-cell-targeted MS therapy that not only inhibits the peripheral immune system, but also crosses the blood-brain barrier to suppress immune cells that have migrated into the brain.

The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint a significant reduction in the number of new lesions visible on a brain imaging scan in a Phase 2 trial in people with MS, study results show.

SAR442168, formerly known as PRN2246, is an oral, small molecule being co-developed by Principia Biopharmaand Sanofi Genzyme. It works by inhibiting Brutons tyrosine kinase (BTK), a protein important for the proliferation of immune cells, particularly B-cells. By blocking BTK, it is expected that SAR442168 can reduce inflammation that damages the nervous system in people with MS.

Click here to read the full story.

Did you know that some of my columns from The MS Wire are now available as audio briefings? You can listen to them here.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.

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MS News that Caught My Eye Last Week: Methionine, MSCT, Spinal... - Multiple Sclerosis News Today

UNIVERSITY PARK, Pa. Seamlessly correcting defects in the face, mouth and skull is highly challenging because it requires precise stacking of a variety of tissues including bone, muscle, fat and skin. Now, Penn State researchers are investigating methods to 3D bioprint and grow the appropriate tissues for craniomaxillofacial reconstruction.

A five-year grant from the National Institutes of Health's National Institute of Dental and Craniofacial Research, will allow a team of researchers to explore the use of stem cells, biomaterials and differentiation factors to match the complex tissues of the face and head directly bioprinted during surgery.

"With the advance in 3D bioprinting, in-place reconstruction of composite tissues for craniomaxillofacial repair has recently become feasible as 3D bioprinting enables complex tissue heterogeneity in an anatomically accurate and cosmetically appealing manner," said Ibrahim T. Ozbolat, Hartz Family Career Development Associate Professor of Engineering Science and Mechanics, and principal investigator on the project.

The researchers are looking at ways to bioprint appropriate tissues directly into a subject to correct damage or defects. They will first investigate, in an immunodeficient rat model, bone tissue bioprinting. Next, they will investigate multilayered skin tissue which include adipose fat and dermis/epidermis skin tissue. They will look at the impact of differentiation factors and how fat influences the growth of skin tissue.

Finally, they will look at three-layer composite tissues that include bone, fat and skin layers to determine how vascularization occurs in both soft and hard tissue regeneration.

"We have formed a complementary collaboration that merges essential domain knowledge in bioprinting, regenerative medicine, craniomaxillofacial surgery, plastic surgery, gene therapy, gene delivery, bone mechanics and bone and skin biology with the depth necessary to propel this work," said Ozbolat.

To meet these needs, the team consists of co-investigators, Elias Rizk, associate professor of neurosurgery; Dino Ravnic, assistant professor of surgery, and Thomas Samson, associate professor of surgery, both in the Division of Plastic Surgery and Greg Lewis, assistant professor of orthopedics and rehabilitation, all in the College of Medicine; and Daniel Hayes, associate professor of biomedical engineering.

The goal of the project is to produce an advanced bioprinting technology that shows the complex interactions between layers of engineered tissues and provide an understanding of how localized delivery of differentiation factors will impact craniomaxillofacial reconstruction.

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$2.8M grant to fund bioprinting for reconstruction of face, mouth, skull tissues - Penn State News

A new study on how and when the precursors to eggs and sperm are formed during development could help pave the way for generating egg and sperm cells in the lab to treat infertility.

The study, publishedin the journal Cell Reports, describes the way in which human stem cells evolve into germ cells, the precursors for egg and sperm cells.

Right now, if your body doesnt make germ cells then theres no option for having a child thats biologically related to you, said Amander Clark, the studys lead author, a member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA. What we want to do is use stem cells to be able to generate germ cells outside the human body so that this kind of infertility can be overcome.

It is estimated that infertility affects 10% of the U.S. population, and infertility rates have increased over the past several decades because more people are waiting longer to have children. Many forms of infertility can be treated using procedures that join egg and sperm together outside the body, such as in vitro fertilization and intracytoplasmic sperm injection. But for people whose bodies dont produce eggs or sperm because of chemotherapy, radiation, genetics or other unexplained causes those treatments arent an option unless a donor provides the eggs or sperm.

With donated eggs and sperm, the child is not genetically related to one or both parents, said Clark, who also is a UCLA professor and chair of molecular cell and developmental biology. To treat patients who want a child who is genetically related, we need to understand how to make germ cells from stem cells, and then how to coax those germ cells into eggs or sperm.

In developing male and female embryos, a subset of pluripotent stem cells cells that have the potential to become nearly every type of cell in the body become germ cells that will later generate eggs or sperm. Researchers previously demonstrated the ability to make similar stem cells in a laboratory, called induced pluripotent stem cells, or iPS cells, from a persons own skin or blood cells.

Clark and her colleagues used technology that enables them to measure the active genes in more than 100,000 embryonic stem cells and iPS cells as they generated germ cells. Collaborators at the Massachusetts Institute of Technology developed new algorithms to analyze the massive amounts of data.

The experiments revealed a detailed timeline for when germ cells form: They first become distinct from other cells of the body between 24 and 48 hours after stem cells start differentiating into cell types that will ultimately make up all the specialized cells in the adult body.

Clark said that information would help scientists focus their efforts on that particular timeframe in future studies, in order to maximize the number of germ cells they can create.

The study also revealed that the germ cells come from two different populations of stem cells amnion cells, which are located in the fluid and membrane that surrounds the embryo during pregnancy, as well as gastrulating cells from the embryo itself.

When the researchers compared the germ cells derived from embryonic stem cells with those derived from iPS cells in the lab, they found that the patterns by which genes were activated were nearly identical.

This tells us that the approach were using to begin the process of making germ cells is on the right track, Clark said. Now were poised to take the next step of combining these cells with ovary or testis cells.

That next step is critical because molecular signals from ovary or testis tissue are what signal germ cells to mature into eggs and sperm.

If the approach were to be incorporated into a future treatment for infertility, scientists might eventually be able to use a patients own skin cells to form stem cells that can be coaxed into both germ cells and ovarian or testis tissue and those cell types might be able to be used to generate a persons own eggs or sperm in the lab.

Were going in the right direction but it will take a lot of new innovations to solve infertility related to the loss of germ cells, Clark said.

The techniques described above were used in laboratory tests only and have not been tested in humans or approved by the Food and Drug Administration as safe and effective for use in humans.

The research was supported by the National Institutes of Health and a Broad Stem Cell Research Center Innovation Award.

Media Contact

Mirabai Vogt-James310-983-1163mvogt@mednet.ucla.edu

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Research could be step toward lab-grown eggs and sperm to treat... - ScienceBlog.com