Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues and tumors, wherein their toxicity, impurity, and other aspects are studied.

With the growing number of successful stem cell therapy treatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

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Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

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Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market Highlights On Future Development 2025 - Science In Me

Limbs regenerate, embryos grow, and cancers invade.

In each of these processes, cells change dramatically. Betty Hay studied fascinating biological phenomena, relentlessly asking questions with her students and colleagues to understand how cellsbehaved. By the end of her life, she had made enormous research contributions in developmental biology, on top ofcommitting herself to mentoring the next generation of scientists and advocating for more representation of women in science.

She made significant contributions towards understanding cell and developmental biology

Betty Hay began as an undergraduate at Smith College in 1944. She lovedher first biology course and started working for Meryl Rose, a professor at Smith who studied limb regeneration in frogs. I was self-motivated and very attracted to science, she saidin an interview in 2004, Meryl at that time was working on regeneration and by the end of my first year at Smith I was also studying regeneration.

Hay regarded Rose as a significant scientific mentor in her life and followed his advice to apply for medical school instead of graduate school. She ended up attending Johns Hopkins School of Medicine for her medical degree while continuing her research on limb regeneration over the summers with Rose at Woods Holes Marine Biological Laboratory. She stayed at Johns Hopkins after to teach Anatomy and became an Assistant Professor in 1956.

The year after, she moved her studiesto Cornell Universitys Medical College as an Assistant Professor to learn how to use the powerful microscopes located there. Her goal was to use transmission electron microscopy (TEM), a method of taking high-resolution images, toseehow salamanders could regenerate an amputated limb. Nothing couldve kept me from going into TEM, she said later.

With her student, Don Fischman, they concluded that upon amputation, cells with specialized roles,known as differentiated cells and thought to be unchangeable, were able to de-differentiate and become unspecialized stem cells again. These cells without an assigned role could then have the freedom to adopt whatever new roles they required to regenerate a perfectly new limb.

Already making leaps in figuring out an explanation for the process of limb regeneration, Hay turned her attention from salamanders to bird eyes when she moved to Harvard University. She studied the outermost layer of cells on the cornea, known as the cornea epithelium. With the help of a postdoctoral scholar in her lab, Jib Dobson, and a faculty colleague, Jean-Paul Revel, they isolated, grew, and took pictures of cornea epithelium cells and demonstrated the epithelial cells could produce collagen.

Collagen is the main type of protein that weaves together to form the extracellular matrix, a connective tissue (the matrix) found outside of cells (extracellular). The collagen in the extracellular matrix provide structure, acting as a foundation for connective tissues and organs such as skin, tendons, and ligaments. Other scientists in the field were skeptical of the conclusion. They thought that one dedicated cell produced collagen, and nothing else.They dismissed the idea that cells in the cornea could somehow do the same. Despite their doubt, Hay, along with postdoctoral scholar Steve Meier, continued their studies. In 1974, they further showed that not only could epithelial cells produce collagen and extracellular matrix in different organ systems, but that the matrix could also tell other cells what type of cell to become.

She was a committed educator and mentor

Kathy Svoboda and Marion Gordon, two colleagues of hers, wrote about Betty Hay and described her not only as a superb cell and developmental biologist, but also as an educator and beloved mentor.

Limb regeneration in salamanders

Russell et al BMC Biology 2017

She was dedicated to teaching and influenced the careers of many junior and early-career scientists. In addition to working with and training her students to produce successful research and results, others mentioned how she would take the time to introduce students in her department to more established and prominent scientists in the field of cell biology. These actions reflected her belief that every student was worthy of being heard and introduced.

She held influential positions and advocated for more representation of women in science

At the time of her graduation from Johns Hopkins in 1952, she was one of only four women in her graduating class of 74 people. Afterwards, she experienced frequent moves for her career, going from Baltimore, to New York, to Boston. Despite how difficult it felt moving alone and leaving her personal relationships behind every time, she felt it was necessary for her career. In her mind, she strongly believed her research always came first, fueled by her intense desire to find answers, using the scientific approach.

She went on to serve as president for multiple professional societies, such as the American Association of Anatomists, the American Society for Cell Biology, and the Society for Developmental Biology, demonstrating her commitment to leadership and service. In two of these societies, she was the first woman to ever hold the position.

In 1975, she became the first female chair of what is now the Department of Cell Biology at Harvard University and held that position for 18 years. Even with these impressive milestones, she acknowledged one of her biggest obstacles to be achieving acceptance in the male professional world.

In 2004 and nearing retirement, Betty Hay would go on to say, I am very glad to see in my lifetime the emergence of significantly more career women in science, in an interview with editor-in-chief Fiona Watt for the Journal of Cell Science, this so enriches the intellectual power being applied to the field of cell biology.

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Meet Betty Hay, the scientist who saw how cells grow and limbs regenerate - Massive Science

Located on the Tufts University Medford, MA campus, this new donor center will enable delivery of fresh blood, leukopaks and buffy coats for COVID-19, cell and gene therapy research within hours of collection

WESTBURY, N.Y., April 6, 2020 /PRNewswire/ --BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the opening of its new blood donor center on the Tufts University campus in Medford, MA to support academic and pharmaceutical researchers involved in COVID-19, cell and gene therapy research.

"BioIVT wants to play a leading role in supporting COVID-19 research efforts and blood donations are a vital resource for the research and development of new therapies, vaccines, and diagnostics. We have many years' experience developing blood products, including blood-derived immune cells for cell and gene therapy research, and we want to make that expertise count," said BioIVT CEO Jeff Gatz. "Researchers recognize and appreciate BioIVT's rapid response and commitment to high quality, fresh blood products and this new donor center will allow us to offer those attributes and services to additional US clients."

BioIVT's new Boston blood donor center is its seventh. The company has similar facilities located in California, Tennessee and Pennsylvania to serve US clients and in London, UK for EU-based clients.

"While the initial focus at our Boston donor center will be on delivering fresh blood, leukopaks and buffy coats within hours of collection, we plan to add more capabilities and donors over time," said Jeff Widdoss, Vice President of Donor Center Operations at BioIVT.

Leukopaks, which contain concentrated white blood cells, are used to help identify promising new drug candidates, assess toxicity levels, and conduct stem cell and gene therapy research. They are particularly useful for researchers who need to obtain large numbers of leukocytes from a single donor.

BioIVT blood products can be supplied with specific clinical data, such as the donor age, ethnicity, gender, BMI and smoking status. Its leukopaks are also human leukocyte antigen (HLA), FC receptor and cytomegalovirus typed. HLA typing is used to match patients and donors for bone marrow or cord blood transplants. FC receptors play an important role in antibody-dependent immune responses.

COVID-19-related Precautions Blood donor centers are considered essential businesses and will remain open during the COVID-19 quarantine. BioIVT is taking additional safety measures to protect both blood donors and its staff during this difficult time. It has instituted several social distancing measures, including increasing the space between chairs in the waiting room and between donor beds, and limiting the entrance of non-essential personnel. The screening rooms are disinfected between donors and all areas of the center continue to be cleaned at regular intervals.

As soon as each blood donor signs their informed consent form, their temperature is taken. If they have a fever, their appointment is postponed, and they are referred to their physician. Any donor who develops COVID-19 symptoms after donating blood is required to inform the center immediately.

All BioIVT blood collections are conducted under institutional review board (IRB) oversight and according to US Food and Drug Administration (FDA) regulations and American Association of Blood Banks (AABB) guidelines.

Those who would like to donate blood at BioIVT's new Boston-area donor center should call 1-833-GO-4-CURE or visit http://www.biospecialty.com to make an appointment.

Further information about the products available from BioIVT's new donor center can be found at https://info.bioivt.com/ma-donor-ctr-req.

About BioIVTBioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit http://www.bioivt.com or follow the company on Twitter @BioIVT.

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BioIVT Opens New Blood Donor Center to Support Boston-area Research into COVID-19 Therapies, Vaccines and Diagnostics - Yahoo Finance

NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has accepted for priority review the Companys Biologics License Application (BLA) filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.

A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has advised that they are planning to hold an Advisory Committee Meeting to discuss this application.

Mesoblast Chief Executive Dr Silviu Itescu stated: There is a critical need to improve survival outcomes in children suffering from the more advanced stages of this devastating disease. The acceptance of the BLA represents an important milestone for the Company. Mesoblast is on track in its preparation for the potential launch of RYONCIL, including meeting its target inventory build and commercial team roll-out.

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

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

References

About Mesoblast Mesoblast Limited(Nasdaq: MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to theUnited States Food and Drug Administration(FDA) to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched inthe United Statesin 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized inJapanandEuropeby Mesoblasts licensees, and the Company has established commercial partnerships inEuropeandChinafor certain Phase 3 assets.

Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.

Mesoblast has locations inAustralia,the United StatesandSingaporeand is listed on theAustralian Securities Exchange(MSB) and on the Nasdaq (MESO). For more information, please seewww.mesoblast.com, LinkedIn:Mesoblast Limitedand Twitter: @Mesoblast

Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward- looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact: Julie Meldrum Corporate Communications T: +61 3 9639 6036 E: julie.meldrum@mesoblast.com

Schond Greenway Investor RelationsT: +1 212 880 2060E: schond.greenway@mesoblast.com

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FDA ACCEPTS MESOBLAST'S BIOLOGICS LICENCE APPLICATION FOR RYONCIL AND AGREES TO PRIORITY REVIEW - GlobeNewswire

NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA). The grant enables Brainstorm to continue development of advanced cellular manufacturing capabilities, furthers development of MSC-derived exosomes as a novel therapeutic platform, and will ultimately enable Brainstorm to expand the therapeutic pipeline in neurodegenerative disorders.

BrainStorm's CEO Chaim Lebovits, commented, "The Israel Innovation Authority's support of our programs provides further validation for the potential of our treatments to help patients suffering from neurodegenerative disorders. The continued financial support for our research and development will further our ability to execute our strategic objectives, as we finalize our Phase 3 pivotal trial with NurOwn in ALS patients and advance our cellular technology pipeline."

The IIA has supported BrainStorm Cell Therapeutics Ltd. since 2007, providing grants totaling approximately 11.4 million USD in support of the development of NurOwn and other projects. BrainStorm will be required to pay mid-single digit royalties to the IIA based on sales of the products, up to a total of the cumulative amount of IIA grants received plus accumulated interest.

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.

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AboutBrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the 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 theU.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.

CONTACTSInvestor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.comMedia:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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BrainStorm Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority - Yahoo Finance

Disclosure: Dr Henderson is the president and principal owner of The Synaptic Space, a neuroimaging consulting firm, and owner of Neuro-Luminance Corporation. Please see the listed studies for a full list of disclosures.

During the last 20 years, a large body of research has accumulated on the beneficial effects of infrared light in the range of 600 to 1000 nm. Infrared light can activate mitochondria, which in turn stimulate second messenger systems, DNA transcription, and growth factors.1,2 As a result, new synapses are formed, circuits regrow, and pluripotent stem cells differentiate into neurons.

Animal studies have shown that infrared photobiomodulation (PBM) may reduce the size and severity of brain injury and stroke, as well as diminish damage and physiological symptoms in depression, posttraumatic stress disorder (PTSD), Parkinson disease, and Alzheimer disease.1,3-6 Michael Hamblin, PhD, from the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, a leader in the field, describes PBM as the use of red or near-infrared light to stimulate, heal, regenerate, and protect tissue that has either been injured, is degenerating, or else is at risk of dying.1

Generally in medicine we shy away from the word heal when referring to the brain, and regenerate stirs vague recollections of Frankenstein. Nevertheless, early findings in mouse models of brain injury and disease have spawned a different sort of monster in the commercial world. The internet is now loaded with companies offering infrared LED helmets or pads for the treatment of traumatic brain injury (TBI) and other brain disorders, often based on exaggerated claims about healing the brain. Exorbitant prices in the thousands of dollars are charged for a device that can be made for less than $30. As a result, the public is misled and the potential scientific benefits of infrared light are sullied.

It is time to separate fact from fiction. Yes, infrared light can induce the cellular events described here, reduce the size of stroke injury or TBI in mouse models, and protect neurons from neurotoxins. But is treating a human with a 0.5-W LED the same as treating a mouse? Certainly not! When it comes to infrared light treatment, it is all a matter of getting there: the infrared light must be able to penetrate all the overlying tissue to reach the brain.

Can Infrared Light Reach the Brain?

Can 0.5-W LEDs penetrate human scalp and skull to reach the brain? The answer is No.2 My colleague, Larry Morries, DC, and I showed that these LEDs did not even penetrate 2 mm of human skin. In contrast, our laser device, which emits infrared light in the range of 10 to 15 W, was able to effectively penetrate human tissue. We found that 33% of our 10-W infrared laser energy penetrated 2 mm of human skin and delivered from 1.2% to 2.4% of the energy from our device 3 cm into the brain. These data were replicated in a study by Juanita Anders, PhD, and colleagues at the Uniformed Services University of Health Sciences.7

The human scalp and skull provide a significant barrier. Infrared light energy needs to be in the range of 0.9 to 15 J/cm2 at the target tissue to activate mitochondria and other cellular events.2-3,8-9 Even if a 0.5-W LED only had to penetrate the skull to reach the surface of the brain, it could only deliver 0.0064 J/cm2, or 1/140th of the minimum energy necessary to induce PBM.10 No energy would be expected to reach the depths of the brain needed to treat stroke, Parkinson disease, Alzheimer disease, or many brain injuries. Although more than 40% of the incident light from a light source may penetrate mouse skull, only 4.2% penetrates human skull.8,10

There is a hairier problem facing LED devices: human hair blocks infrared light. More than 98% of infrared light can be blocked by 2 mm of hair (ie, 9.764 W of a 10-W beam of 810 nm infrared light is absorbed by human hair).11 If 98% of the energy from a 0.5-W LED is absorbed by hair, 80% to 90% is absorbed by 2 mm of skin, and 96% of incident energy is attenuated by skull, then claims of neurophysiological benefits of LED-based devices become highly questionable.

Another misconception propagated by companies selling LED-based devices is that multiple LEDs somehow increase light penetration, even though each LED projects light on its own path. For example, 100 0.5-W LEDs do not generate 50 W on the brain, they generate 0.5 W on 100 spots.11 The argument that light scattering in the brain provides the cumulative value of multiple LEDs also falls apart if nothing can get through the overlying tissues.

Given that a small percentage (<1%) of incident infrared light gets through human scalp and skull, we must question the results of human trials of LEDs. Studies demonstrated small yet almost insignificant positive effects, and the benefits are generally transient.12 In contrast, our protocol yields persistent and robust clinical changes in patients with TBI, PTSD, and depression.

Treating TBI, PTSD, and Depression with Infrared Light

Our patented multi-Watt Neuro-Luminance approach involves transcranial infrared laser treatment (NILT), and in 2015 we published an initial open-label trial of 10 subjects with mild to moderate TBI.13 After a course of 10 NILT treatments (20 treatments in a subset of 4 patients), all patients experienced significant clinical improvement of symptoms, including headaches, cognitive problems, sleep disturbances, irritability, and depression. In telephone interviews every 6 months after treatment, patients report sustained improvements.12

An open-label clinical trial (n=39) of multi-Watt Neuro-Luminance demonstrated effectiveness for depression.4 Overall, 92% of patients responded and 82% remitted, which is notably better than the response rate for oral antidepressants. Patients saw benefits within 4 treatments, and some achieved resolution of depressive symptoms within 8 treatments. In follow-up telephone interviews, patients report sustained improvements. Similarly, in our unpublished data, using a protocol of 20 treatments, each lasting 24 minutes, over the course of 9 weeks, 20 patients with PTSD treated with multi-Watt NILT experienced reduced hyperarousal, anxiety, sleep disturbance, and nightmares.

LED Photobiomodulation in Comparison

Naeser and colleagues15 treated 2 patients with TBI daily for approximately 1 hour by applying 3 separate LED cluster heads (2 head; 1 foot). The first patient, who was 7 years post-TBI and had significant postconcussive symptoms, received weekly treatments over the course of 7 months and then daily treatments at home for more than 6 years. The patient experienced transient benefits, and if treatment was stopped, symptoms returned within 2 weeks.15 The second patient received daily treatments, and in 4 months, most symptoms improved, allowing her to return to work. This patient also noted that symptoms returned if treatments were stopped for more than 1 week.15

In an open-label study,16 11 patients with TBI and persistent cognitive dysfunction were treated for 18 sessions, each lasting 20 minutes, over the course of 6 weeks. At follow-up, there had been a significant effect on attention, inhibition, verbal learning and memory, and long-delay free recall.16 The LED treatment led to mild improvement in 3 of 5 cases of depression.

In 12 patients with TBI treated with 220 0.5-W LEDs for 18 sessions, each lasting 20 minutes, over the course of 6 weeks, there was significant improvement in psychological testing results (P =.45).17 However, the study did not correct for multiple comparisons, instead using parallel paired t-tests, which could exaggerate findings.18 PTSD has received considerably less attention.19,20

Cassano and colleagues21 described a 5-W laser treatment of 4 patients with depression. In a double-blind, sham-controlled extension of their initial findings, subjects in the treatment group received 16 treatments, each lasting 30 minutes, over the course of 8 weeks.22 In 13 completers, Hamilton-D-17 scores separated the treatment group from sham controls (mean score, 15.74.41 vs 6.17.86; P =.031). In contrast, in our open-label trial of a 13-W laser, the mean Hamilton-D-17 score decreased from baseline (mean score, 21.485.24 to 6.05.12; P =6.4510-13).23

Table. Case series, open-label, and double-blind studies of infrared light therapy for TBI, PTSD, and depression

Alternative Explanation for Clinical Response to LED Brain Treatments

Researchers, along with the human PBM field, need to reconsider the potential mechanisms underlying the meager improvements derived from LED-based devices. The light from LED devices may not penetrate beyond the skin, but could induce central nervous system benefits via a remote or systemic effect in irradiated skin, dubbed remote photobiomodulation.24

Infrared irradiation can have remote or indirect effects on tissue that has not been irradiated. For example, Braverman and colleagues25 demonstrated this indirect effect by creating matching skin lesions on the left and right dorsum of a rabbit, treating 1 side with infrared light. Both lesions showed accelerated healing relative to nonirradiated controls. Rochkind and colleagues26 demonstrated that remote PBM could occur in the peripheral nervous system and the central nervous system. After bilateral sciatic nerve crush, 1 side was irradiated with infrared light and the other side was not. Nerves on both sides showed enhanced recovery of function, and the number of anterior horn motor neurons was greater on both sides compared with nonirradiated controls.

Ganeshan and colleagues27 irradiated the dorsum and hind limbs of a rat with infrared light (670 nm) before injection of a neurotoxin (MPTP) and demonstrated reduced loss of dopaminergic neurons in rodents treated with indirect PBM to the skin compared with untreated controls. Given the overwhelming evidence that low-power LEDs do not penetrate the brain, it is more likely that the benefits of LED-based devices result from an effect mediated by the skin, where most, if not all, of the infrared energy is absorbed. In other words, LED-based devices may be working by remote PBM.

Conclusions

The excitement about the potential of infrared light therapy is not merely that it does not involve taking a pill. There is considerable enthusiasm about its potential to treat conditions such as TBI, dementia, and Parkinson disease. In our excitement, we must not overlook the unique physical limitations of light. Similarly, we must not imbue infrared light with magical powers. Infrared light can only work if it reaches target tissue.

Thus, a sharp divide can be drawn between LED-based treatment technologies, which offer minimal results and may not even reach the brain, and multi-Watt technologies that demonstrably reach the brain and offer lasting clinical benefit. Potentially, infrared light may prove to be effective for numerous neuropsychiatric conditions. However, for infrared light to work on the brain, it must be able to reach the brain.

References

1. Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016;6:113-124.

2. Henderson TA, Morries, LD. Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain? Neuropsychiatr Dis Treat. 2015;11:2191-2208.

3. Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012;40(2):516-533.

4. Henderson TA, Morries LD. Multi-Watt near-infrared phototherapy for the treatment of comorbid depression: an open-label single-arm study. Front Psychiatry. 2017;8:187.

5. Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning on lights to stop neurodegeneration: the potential of near infrared light therapy in Alzheimers and Parkinsons disease. Front Neurosci. 2016;11;9:500.

6. Hamblin MR. Photobiomodulation for Alzheimers disease: has the light dawned? Photonics. 2019;6(3):77.

7. Tedford CE, DeLapp S, Jacques S, Anders J. Quantitative analysis of transcranial and intraparenchymal light penetration in human cadaver brain tissue. Lasers Surg Med. 2015;47(4):312-322.

8. Ando T, Xuan W, Xu T, et al. Comparison of therapeutic effects between pulsed and continuous wave 810-nm wavelength laser irradiation for traumatic brain injury in mice. PLoS One. 2011;6(10):e26212.

9. Yip KK, Lo SC, Leung MC, So SK, Tang CY, Poon DM. The effect of low-energy laser irradiation on apoptotic factors following experimentally induced transient cerebral ischemia. Neuroscience. 2011;190:301-306.

10. Lapchak PA, Boitano PD, Butte PV, et al. Transcranial near-infrared laser transmission (NILT) profiles (800 nm): systematic comparison in four common research species. PLoS One. 2015;3;10(6):e0127580.

11. Henderson TA, Morries LD. Near-infrared photonic energy penetration principles and practice. In: Hamblin, MR and Huang YY, eds. Photobiomodulation and the Brain: Low-level Laser (Light) Therapy in Neurology and Neuroscience. London: Academic Press; 2019.

12. Morries LD, Henderson TA. Treatment of traumatic brain injury with near-infrared light. In: Hamblin, MR and Huang YY, eds. Photobiomodulation and the Brain: Low-level Laser (Light) Therapy in Neurology and Neuroscience. London: Academic Press; 2019.

13. Morries LD, Cassano P, Henderson TA. Treatments for traumatic brain injury with emphasis on transcranial near-infrared laser phototherapy. Neuropsychiatr Dis Treat. 2015;11:2159-75.

14. Connolly KR, Thase ME. If at first you dont succeed: a review of the evidence for antidepressant augmentation, combination and switching strategies. Drugs. 2011;71(1):43-64.

15. Naeser MA, Saltmarche A, Krengel MA, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011;29(5):351-358.

16. Naeser MA, Zafonte R, Krengel MH, et al. Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study. J Neurotrauma. 2014;31(11):1008-1017.

17. Hipskind SG, Grover FL Jr, Fort TR, et al. Pulsed transcranial red/near-infrared light therapy using light-emitting diodes improves cerebral blood flow and cognitive function in veterans with chronic traumatic brain injury: a case series. Photobiomodul Photomed Laser Surg. 2019;37(2):77-84.

18. Henderson TA, Morries LD. Infrared light cannot be doing what you think it is doing (re: DOI: 10.1089/photob.2018.4489). Photobiomodul Photomed Laser Surg. 2019;37(2):124-125.

19. Schiffer F, Johnston AL, Ravichandran C, et al. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009;5:46.

20. LED light therapy to improve cognitive & psychosocial function in TBI-PTSD veterans. ClinicalTrials.gov. NCT02356861. https://clinicaltrials.gov/ct2/show/NCT02356861. Accessed February 29, 2020.

21. Cassano P, Cusin C, Mischoulon D, et al. Near-infrared transcranial radiation for major depressive disorder: proof of concept study. Psychiatry J. 2015;2015:352979.

22. Cassano P, Petrie SR, Mischoulon D, et al. Transcranial photobiomodulation for the treatment of major depressive disorder. The ELATED-2 Pilot Trial. Photomed Laser Surg. 2018;36(12):634-646.

23. Henderson TA, Morries LD. Multi-Watt near-infrared phototherapy for the treatment of comorbid depression: an open-label single-arm study. Front Psychiatry. 2017;8:187.

24. Gordon LC, Johnstone DM. Remote photobiomodulation: an emerging strategy for neuroprotection. Neural Regen Res. 2019;14(12):2086-2087.

25. Braverman B, McCarthy RJ, Ivankovich AD, Forde DE, Overfield M, Bapna MS. Effect of helium-neon and infrared laser irradiation on wound healing in rabbits. Lasers Surg Med. 1989;9(1):50-58.

26. Rochkind S, Rousso M, Nissan M, Villarreal M, Barr-Nea L, Rees DG. Systemic effects of low-power laser irradiation on the peripheral and central nervous system, cutaneous wounds, and burns. Lasers Surg Med. 1989;9(2):174-182.

27. Ganeshan V, Skladnev NV, Kim JY, Mitrofanis J, Stone J, Johnstone DM. Pre-conditioning with remote photobiomodulation modulates the brain transcriptome and protects against MPTP insult in mice. Neuroscience. 2019;400:85-97.

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Infrared Laser Treatment of TBI, PTSD, and Depression: An Expert Perspective - Psychiatry Advisor

- Novellus's patented mRNA-based cell-reprogramming technology creates unique mesenchymal stem cells (MSCs) with superior immunomodulatory properties and manufacturing advantages over primary adult donor-derived MSCs - much greater supply and faster scale-up

- MSCs prevent and suppress cytokine storm believed to be the cause of the severe inflammation of ARDS and now seen in COVID-19 patients

CRANFORD, N.J., April 1, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.

"ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven COVID-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process," said Citius Chief Executive Officer Myron Holubiak.

Novellus Chief Science Officer Matt Angel, PhD, stated, "Using our mRNA-based cell-reprogramming technology, Novellus can provide a near-unlimited supply of MSCs for treating patients with ARDS, including those critically ill from COVID-19. These will be allogeneic ('off-the-shelf') cells that in vitro have demonstrated much greater expansion potential and much higher immunomodulatory protein expression than donor-derived MSCs. We are excited to employ our technology to such an urgent medical crisis and believe that our MSCs represent an ideal source of cells to be used in this extremely important development effort."

Holubiak added, "No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus's iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible."

About ARDSAcute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain, particularly while inhaling, and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Novellus, Inc.Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.

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Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and our Phase III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing our product candidates, including any licensed from Novellus, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677ascott@citiuspharma.com

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Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19...

TORONTO, March 31, 2020 /CNW/ - The Gairdner Foundation is pleased to announce the 2020 Canada Gairdner Award laureates, recognizing some of the world's most significant biomedical research and discoveries. During these challenging times, we believe it is important to celebrate scientists and innovators from around the world and commend them for their tireless efforts to conduct research that impacts human health.

2020 Canada Gairdner International AwardThe five 2020 Canada Gairdner International Award laureates are recognized for seminal discoveries or contributions to biomedical science:

Dr. Masatoshi TakeichiSenior Visiting Scientist, RIKEN Center for Biosystems Dynamics Research, Kobe, Japan; Professor Emeritus, Kyoto University, Kyoto, Japan

Dr. Rolf KemlerEmeritus Member and Director, Max Planck Institute of Immunobiology and Epigenetics, Freiburg, Germany

Awarded "For their discovery, characterization and biology of cadherins and associated proteins in animal cell adhesion and signalling."

Dr. Takeichi

The Work: The animal body is made up of numerous cells. Dr. Takeichi was investigatinghow animal cells stick together to form tissues and organs, and identified a key protein which he named 'cadherin'.Cadherin is present on the surface of a cell and binds to the same cadherin protein on the surface of another cell through like-like interaction, thereby binding the cells together. Without cadherin, cell to cell adhesion becomes weakened and leads to the disorganization of tissues. Dr. Takeichi found that there are multiple kinds of cadherin within the body, each of which are made by different cell types, such as epithelial and neuronal cells. Cells with the same cadherins tend to cluster together, explaining the mechanism of how different cells are sorted out and organized to form functional organs.

Further studies by Dr. Takeichi's group showed that cadherin function is supported by a number of cytoplasmic proteins, includingcatenins, and their cooperation is essential for shaping of tissues. His studies also revealed that the cadherin-dependent adhesion mechanism is involved in synaptic connections between neurons, which are important for brain wiring.

Dr. Kemler

The Work: Dr. Kemler, using an immunological approach, developed antibodies directed against surface antigens of early mouse embryos. These antibodies were shown to prevent compaction of the mouse embryo and interfered with subsequent development. Both Dr. Kemler and Dr. Takeichi went on to clone and sequence the gene encoding E-cadherin and demonstrate that it was governing homophilic cell adhesion.

Dr. Kemler also discovered the other proteins that interact with the cadherins, especially the catenins, to generate the machinery involved in animal cell-to-cell adhesion. This provided the first evidence of their importance in normal development and diseases such as cancer. It has been discovered that cadherins and catenins are correlated to the formation and growth of some cancers and how tumors continue to grow. Beta catenin is linked to cell adhesion through interaction with cadherins but is also a key component of the Wnt signalling pathway that is involved in normal development and cancer. There are approximately 100 types of cadherins, known as the cadherin superfamily.

Dr. Takeichi

The Impact: The discovery of cadherins, which are found in all multicellular animalspecies, has allowed us to interpret how multicellular systems are generated and regulated. Loss of cadherin function has been implicated as the cause of certain cancers, as well as in invasiveness of many cancers. Mutations in special types of cadherin result in neurological disorders, such as epilepsy and hearing loss. The knowledge of cadherin function is expected to contribute to the development of effective treatments against such diseases.

Dr. Kemler

The Impact: Human tumors are often of epithelial origin. Given the role of E-cadherin for the integrity of an epithelial cell layer, the protein can be considered as a suppressor of tumor growth. The research on the cadherin superfamily has had great impact on fields as diverse as developmental biology, cell biology, oncology, immunology and neuroscience. Mutations in cadherins/catenins are frequently found in tumors. Various screens are being used to identify small molecules that might restore cell adhesion as a potential cancer therapy.

Dr. Roel NusseProfessor & Chair, Department of Developmental Biology; Member, Institute for StemCell Biology andRegenerativeMedicine, Stanford University, School of Medicine.Virginia and Daniel K. Ludwig Professor of Cancer Research. Investigator, Howard Hughes Medical Institute

Awarded"For pioneering work on the Wnt signaling pathway and its importance in development, cancer and stem cells"

The Work: Dr. Nusse's research has elucidated the mechanism and role of Wnt signaling, one of the most important signaling systems in development. There is now abundant evidence that Wnt signaling is active in cancer and in control of proliferation versus differentiation of adult stem cells, making the Wnt pathway one of the paradigms for the fundamental connections between normal development and cancer.

Among Dr. Nusse's contributions is the original discovery of the first Wnt gene (together with Harold Varmus) as an oncogene in mouse breast cancer. Afterwards Dr. Nusse identified the Drosophila Wnt homolog as a key developmental gene, Wingless. This led to the general realization of the remarkable links between normal development and cancer, now one of the main themes in cancer research. Using Drosophila genetics, he established the function of beta-catenin as a mediator of Wnt signaling and the Frizzleds as Wnt receptors (with Jeremy Nathans), thereby establishing core elements of what is now called the Wnt pathway. A major later accomplishment of his group was the first successful purification of active Wnt proteins, showing that they are lipid-modified and act as stem cell growth factors.

The Impact: Wnt signaling is implicated in the growth of human embryos and the maintenance of tissues. Consequently, elucidating the Wnt pathway is leading to deeper insights into degenerative diseases and the development of new therapeutics. The widespread role of Wnt signaling in cancer is significant for the treatment of the disease as well. Isolating active Wnt proteins has led to the use of Wnts by researchers world-wide as stem cell growth factors and the expansion of stem cells into organ-like structures (organoids).

Dr. Mina J. Bissell Distinguished Senior Scientist, Biological Systems and Engineering Division, Lawrence Berkeley National Laboratory; Faculty; Graduate Groups in Comparative Biochemistry, Endocrinology, Molecular Toxicology and Bioengineering, University of California Berkeley, Berkeley, CA, USA

Awarded "For characterizing "Dynamic Reciprocity" and the significant role that extracellular matrix (ECM) signaling and microenvironment play in gene regulation in normal and malignant cells, revolutionizing the fields of oncology and tissue homeostasis."

The Work: Dr. Mina Bissell's career has been driven by challenging established paradigms in cellular and developmental biology. Through her research, Dr. Bissell showed that tissue architecture plays a dominant role in determining cell and tissue phenotype and proposed the model of 'dynamic reciprocity' (DR) between the extracellular matrix (ECM) and chromatin within the cell nucleus. Dynamic reciprocity refers to the ongoing, bidirectional interaction between cells and their microenvironment. She demonstrated that the ECM could regulate gene expression just as gene expression could regulate ECM, and that these two phenomena could occur concurrently in normal or diseased tissue.

She also developed 3D culture systems to study the interaction of the microenvironment and tissue organization and growth, using the mammary gland as a model.

The Impact:Dr. Bissell's model of dynamic reciprocity has been proven and thoroughly established since its proposal three decades ago and the implications have permeated every area of cell and cancer biology, with significant implications for current and future therapies. Dr. Bissell's work has generated a fundamental and translationally crucial paradigm shift in our understanding of both normal and malignant tissues.

Her findings have had profound implications for cancer therapy by demonstrating that tumor cells can be influenced by their environment and are not just the product of their genetic mutations. For example, cells from the mammary glands grown in two-dimensional tissue cultures rapidly lose their identity, but once placed in proper three-dimensional microenvironments, they regain mammary form and function. This work presages the current excitement about generation of 3D tissue organoids and demonstrates Dr. Bissell's creative and innovative approach to science.

Dr. Elaine FuchsHoward Hughes Medical Institute Investigator and Rebecca C. Lancefield Professor and Head of the Robin Chemers Neustein Laboratory of Mammalian Cell Biology and Cell Biology; The Rockefeller University, New York, NY, USA

Awarded"For her studies elucidating the role of tissue stem cells in homeostasis, wound repair, inflammation and cancer."

The Work: Dr. Fuchs has used skin to study how the tissues of our body are able to replace dying cells and repair wounds. The skin must replenish itself constantly to protect against dehydration and harmful microbes. In her research, Fuchs showed that this is accomplished by a resident population of adult stem cells that continually generates a shell of indestructible cells that cover our body surface.

In her early research, Fuchs identified the proteins---keratinsthat produce the iron framework of the skin's building blocks, and showed that mutations in keratins are responsible for a group of blistering diseases in humans. In her later work, Fuchs identified the signals that prompt skin stem cells to make tissue and when to stop. In studying these processes, Fuchs learned that cancers hijack the fundamental mechanisms that tissue stem cells use to repair wounds. Her team pursued this parallel and isolated and characterized the malignant stem cells that are responsible for propagating a type of cancer called "squamous cell carcinoma." In her most recent work, she showed that these cells can be resistant to chemotherapies and immunotherapies and lead to tumor relapse.

The Impact: All tissues of our body must be able to replace dying cells and repair local wounds. Skin is particularly adept at performing these tasks. The identification and characterization of the resident skin stem cells that make and replenish the epidermis, sweat glands and hair provide important insights into this fountain of youth process and hold promise for regenerative medicine and aging. In normal tissues, the self-renewing ability of stem cells to proliferate is held in check by local inhibitory signals coming from the stem cells' neighbours. In injury, stimulatory signals mobilize the stem cells to proliferate and repair the wound. In aging, these normal balancing cues are tipped in favour of quiescence. In inflammatory disorders, stem cells become hyperactivated. In cancers, the wound mechanisms to mobilize stem cells are hijacked, leading to uncontrolled tissue growth. Understanding the basic mechanisms controlling stem cells in their native tissue is providing new strategies for searching out refractory tumor cells in cancer and for restoring normalcy in inflammatory conditions.

2020 John Dirks Canada Gairdner Global Health AwardThe 2020 John Dirks Canada Gairdner Global Health Award laureate is recognized for outstanding achievements in global health research:

Professor Salim S. Abdool KarimDirector of CAPRISA (Centre for the AIDS Program of Research in South Africa), the CAPRISA Professor in Global Health at Columbia University, New York and Pro Vice-Chancellor (Research) at the University of KwaZulu-Natal, Durban, South Africa

Professor Quarraisha Abdool KarimAssociate Scientific Director of CAPRISA, Professor in Clinical Epidemiology, Columbia University, New York and Professor in Public Health at the Nelson Mandela Medical School and Pro Vice-Chancellor (African Health) at the University of KwaZulu-Natal, Durban, South Africa

Awarded"For their discovery that antiretrovirals prevent sexual transmission of HIV, which laid the foundations for pre-exposure prophylaxis (PrEP), the HIV prevention strategy that is contributing to the reduction of HIV infection in Africa and around the world."

The Work: UNAIDS estimates that 37 million people were living with HIV and 1.8 million people acquired HIV in 2017. In Africa, which has over two thirds of all people with HIV, adolescent girls and young women have the highest rates of new HIV infections. ABC (Abstinence, Be faithful, and use Condoms) prevention messages have had little impact - due to gender power imbalances, young women are often unable to successfully negotiate condom use, insist on mutual monogamy, or convince their male partners to have an HIV test.

In responding to this crisis, Salim and Quarraisha Abdool Karim started investigating new HIV prevention technologies for women about 30 years ago. After two unsuccessful decades, their perseverance paid off when they provided proof-of-concept that antiretrovirals prevent sexually acquired HIV infection in women. Their ground-breaking CAPRISA 004 trial showed that tenofovir gel prevents both HIV infection and genital herpes. The finding was ranked inthe "Top 10 Scientific Breakthroughs of 2010" by the journal, Science. The finding was heralded by UNAIDS and the World Health Organization (WHO) as one of the most significant scientific breakthroughs in AIDS and provided the first evidence for what is today known as HIV pre-exposure prophylaxis (PrEP).

The Abdool Karims have also elucidated the evolving nature of the HIV epidemic in Africa, characterising the key social, behavioural and biological risk factors responsible for the disproportionately high HIV burden in young women. Their identification of the "Cycle of HIV Transmission", where teenage girls acquire HIV from men about 10 years older on average, has shaped UNAIDS policies on HIV prevention in Africa.

The impact: CAPRISA 004 and several clinical trials of oral tenofovir led tothe WHO recommending a daily tenofovir-containing pill for PrEP as a standard HIV prevention tool for all those at high risk a few years later. Several African countries are among the 68 countries across all continents that are currently making PrEP available for HIV prevention. The research undertaken in Africa by this South African couple has played a key role in shaping the local and global response to the HIV epidemic.

2020 Canada Gairdner Wightman AwardThe 2020 Canada Gairdner Wightman Award laureate is a Canadian scientist recognized for outstanding leadership in medicine and medical science throughout their career:

Dr. Guy Rouleau Director of the Montreal Neurological Institute-Hospital (The Neuro); Professor & Chair of the Department of Neurology and Neurosurgery, McGill University; Director of the Department of Neuroscience, McGill University Health Center

Awarded "For identifying and elucidating the genetic architecture of neurological and psychiatric diseases, including ALS, autism and schizophrenia, and his leadership in the field of Open Science."

The Work: Dr. Rouleau has identified over 20 genetic risk factors predisposing to a range of brain disorders, both neurological and psychiatric, involving either neurodevelopmental processes or degenerative events. He has defined a novel disease mechanism for diseases related to repeat expansions that are at play in some of the most severe neurodegenerative conditions. He has significantly contributed to the understanding of the role of de novo variants in autism and schizophrenia. In addition, he has made important advances for various neuropathies, in particular for amyotrophic lateral sclerosis (ALS) where he was involved in the identification of the most prevalent genetic risk factors -which in turn are now the core of innumerable ALS studies worldwide.

Dr. Rouleau has also played a pioneering role in the practice of Open Science (OS), transforming the Montreal Neurological Institute-Hospital (The Neuro) into the first OS institution in the world. The Neuro now uses OS principles to transform research and careand accelerate the development of new treatments for patients through Open Access, Open Data, Open Biobanking, Open Early Drug Discovery and non-restrictive intellectual property.

The Impact: The identification of genetic risk factors has a number of significant consequences. First, allowing for more accurate genetic counselling, which reduces the burden of disease to affected individuals, parents and society. A revealing case is Andermann syndrome, a severe neurodevelopmental and neurodegenerative condition that was once relatively common in the Saguenay-Lac-St-Jean region of Quebec. Now this disease has almost disappeared from that population. Second, identifying the causative gene allows the development of treatments. For instance, his earlier work on a form of ALS linked to the superoxide dismutase-1 gene (SOD1) opened up studies which are now the focal point of phase 2 clinical studies showing great promise.

Byactingasalivinglabforthelast coupleofyears,TheNeuroisspearheading the practice of OpenScience (OS).TheNeurois alsoengagingstakeholdersacross Canadawiththegoal of formalizinganational OSallianceforthe neurosciences.Dr.Rouleau'sworkinOScontributesfundamentallytothetransformationoftheveryecosystemofsciencebystimulatingnewthinkingandfosteringcommunitiesofsharing.InspiredbyTheNeuro'svision,theglobalsciencecommunityisreflecting oncurrentresearchconventionsandcollaborativeprojects,andthemomentumforOSisgainingafootholdinorganizationsandinstitutionsinallcornersoftheearth.

About the Gairdner Foundation:

The Gairdner Foundation was established in 1957 by Toronto stockbroker, James Gairdner to award annual prizes to scientists whose discoveries have had major impact on scientific progress and on human health. Since 1959 when the first awards were granted, 387scientists have received a Canada Gairdner Award and 92 to date have gone on to receive the Nobel Prize.The Canada Gairdner Awards promote a stronger culture of research and innovation across the country through our Outreach Programs including lectures and research symposia. The programs bring current and past laureates to a minimum of 15 universities across Canada to speak with faculty, trainees and high school students to inspire the next generation of researchers. Annual research symposia and public lectures are organized across Canada to provide Canadians access to leading science through Gairdner's convening power.

http://www.gairdner.org

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2020 Canada Gairdner Awards Recognize World-renowned Scientists for Transformative Contributions to Research That Impact Human Health - Benzinga

Researchers at Stanford University report that they can rejuvenate human cells by reprogramming them back to a youthful state. They hope that the technique will help in the treatment of diseases, such as osteoarthritis and muscle wasting, that are caused by the aging of tissue cells.

A major cause of aging is thought to be the errors that accumulate in the epigenome, the system of proteins that packages the DNA and controls access to its genes. The Stanford team, led by Tapash Jay Sarkar, Dr. Thomas A. Rando and Vittorio Sebastiano, say their method, designed to reverse these errors and walk back the cells to their youthful state, does indeed restore the cells vigor and eliminate signs of aging.

In their report, published on Tuesday in Nature Communications, they described their technique as a significant step toward the goal of reversing cellular aging and could produce therapies for aging and aging-related diseases.

Leonard P. Guarente, an expert on aging at M.I.T., said the method was one of the most promising areas of aging research but that it would take a long time to develop drugs based on RNA, the required chemical.

The Stanford approach utilizes powerful agents known as Yamanaka factors, which reprogram a cells epigenome to its time zero, or embryonic state.

Embryonic cells, derived from the fertilized egg, can develop into any of the specialized cell types of the body. Their fate, whether to become a skin or eye or liver cell, is determined by chemical groups, or marks, that are tagged on to their epigenome.

In each type of cell, these marks make accessible only the genes that the cell type needs, while locking down all other genes in the DNAs. The pattern of marks thus establishes each cells identity.

As the cell ages, it accumulates errors in the marking system, which degrade the cells efficiency at switching on and off the genes needed for its operations.

In 2006 Dr. Shinya Yamanaka, a stem-cell researcher at Kyoto University, amazed biologists by showing that a cells fate could be reversed with a set of four transcription factors agents that activate genes that he had identified. A cell dosed with the Yamanaka factors erases the marks on the epigenome, so the cell loses its identity and reverts to the embryonic state. Erroneous marks gathered during aging are also lost in the process, restoring the cell to its state of youth. Dr. Yamanaka shared the 2012 Nobel Prize in medicine for the work.

But the Yamanaka factors are no simple panacea. Applied to whole mice, the factors made cells lose their functions and primed them for rapid growth, usually cancerous; the mice all died.

In 2016, Juan Carlos Izpisua Belmonte, of the Salk Institute for Biological Studies in San Diego, found that the two effects of the Yamanaka factors erasing cell identity and reversing aging could be separated, with a lower dose securing just age reversal. But he achieved this by genetically engineering mice, a technique not usable in people.

In their paper on Tuesday, the Stanford team described a feasible way to deliver Yamanaka factors to cells taken from patients, by dosing cells kept in cultures with small amounts of the factors.

If dosed for a short enough time, the team reported, the cells retained their identity but returned to a youthful state, as judged by several measures of cell vigor.

Dr. Sebastiano said the Yamanaka factors appeared to operate in two stages, as if they were raising the epigenomes energy to one level, at which the marks of aging were lost, and then to a higher level at which cell identity was erased.

The Stanford team extracted aged cartilage cells from patients with osteoarthritis and found that after a low dosage of Yamanaka factors the cells no longer secreted the inflammatory factors that provoke the disease. The team also found that human muscle stem cells, which are impaired in a muscle-wasting disease, could be restored to youth. Members of the Stanford team have formed a company, Turn Biotechnologies, to develop therapies for osteoarthritis and other diseases.

The study is definitively a step forward in the goal of reversing cellular aging, Dr. Izpisua Belmonte said.

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Turning Back the Clock on Aging Cells - The New York Times

A team of University of California, Irvine researchers have published the first comprehensive overview of the major changes that occur in mammalian skin cells as they prepare to heal wounds. Results from the study provide a blueprint for future investigation into pathological conditions associated with poor wound healing, such as in diabetic patients.

"This study is the first comprehensive dissection of the major changes in cellular heterogeneity from a normal state to wound healing in skin," said Xing Dai, PhD, a professor of biological chemistry and dermatology in the UCI School of Medicine, and senior author. "This work also showcases the collaborative efforts between biologists, mathematician and physicists at UCI, with support from the National Institute of Arthritis & Musculoskeletal & Skin Diseases-funded UCI Skin Biology Resource-based Center and the NSF-Simons Center for Multiscale Cell Fate Research.

The study, titled, "Defining epidermal basal cell states during skin homeostasis and wound healing using single-cell transcriptomics," was published this week inCell Reports.

"Our research uncovered at least four distinct transcriptional states in the epidermal basal layer as part of a 'hierarchical-lineage' model of the epidermal homeostasis, or stable state of the skin, clarifying a long-term debate in the skin stem cell field," said Dai.

Using single-cell RNA sequencing coupled with RNAScope and fluorescence lifetime imaging, the team identified three non-proliferative and one proliferative basal cell state in homeostatic skin that differ in metabolic preference and become spatially partitioned during wound re-epithelialization, which is the process by which the skin and mucous membranes replace superficial epithelial cells damaged or lost in a wound.

Epithelial tissue maintenance is driven by resident stem cells, the proliferation and differentiation dynamics of which need to be tailored to the tissue's homeostatic and regenerative needs. However, our understanding of tissue-specific cellular dynamics in vivo at single-cell and tissue scales is often very limited.

"Our study lays a foundation for future investigation into the adult epidermis, specifically how the skin is maintained and how it can robustly regenerate itself upon injury," said Dai.

Link:
Study reveals how skin cells prepare to heal wounds - Jill Lopez

Gerlinde R. Van de Walle, DVM, Ph.D., co-lead for the study.

DURHAM, N.C. (PRWEB) March 26, 2020

Researchers have potentially made a breakthrough in the war on antibiotic-resistant superbugs including MRSA, which kills an estimated 20,000 people in the United States alone each year with a new discovery whose details are published today in STEM CELLS Translational Medicine. The study, by researchers at The Baker Institute for Animal Health, at Cornells College of Veterinary Medicine, demonstrates for the first time that mesenchymal stromal cells (MSCs) are an effective weapon against bacteria in biofilm.

Biofilms are thin, slimy films made up of bacteria that can attach to skin wounds, teeth and other surfaces, creating the opportunity for infections to flourish. These highly structured cellular communities offer bacteria shelter from harmful factors, helping them resist antibiotics, mutate rapidly and evade the immune system.

MSCs help kill the bacteria through the secretion of enzymes, called proteases, that break the peptide bonds of proteins and cause biofilm to destabilize. This in turn increases the effectiveness of antibiotics that previously werent working, as the bacteria are no longer being protected by the biofilm, explained Gerlinde R. Van de Walle, DVM, Ph.D., who led the study along with Charlotte Marx, DVM, Ph.D.

Other recent studies, including one by the Cornell team, have shown that MSCs can inhibit the growth of bacteria associated with chronic infections by secreting antimicrobial peptides. But these studies were conducted primarily on planktonic bacteria, which are individually floating bacteria cells. Thus, information on the effects on biofilms was largely lacking, Dr. Marx said.

The current study explores how MSC secretome, delivered as conditioned medium, performs against various wound-related bacterial pathogens. It also looks at the mechanisms that affect bacterial biofilms. The experiments were performed in vitro, using equine MSC. We use equine MSC in our work since the horse represents a physiologically relevant model for human wound healing and offers a readily translatable model for MSC therapies in humans, Dr. Van de Walle explained.

The researchers began by showing that equine MSC secretome inhibits the growth of four types of planktonic bacteria that commonly colonize skin wounds. Encouraged by the results, they next sought to determine the effect of the MSC secretome on these same bacterial strains in biofilms, which is the predominant way bacteria invade wounds. They looked at how the MSCs affected biofilm formation, then repeated the experiments on biofilms that were already established. Finally, they turned their attention to the bacteria strain responsible for MRSA.

Dr. Marx reported the results. Our salient findings, she said, were that factors secreted by equine MSC impaired both planktonic and biofilms including MRSA as well as disrupted mature biofilms generated by these bacteria. Importantly, we found that these effects resulted from a protease-dependent mechanism.

Dr. Van de Walle added, We also found that MSC-secreted factors allowed previously ineffective antibiotic treatments to become more effective at reducing bacterial survival. In light of the rise of antibiotic-resistant bacterial strains as an increasing global health threat, our findings provide the rationale for using the MSC secretome as a complementary treatment for bacterial infections.

Outcomes from this study highlight for the first time that the secretome from mesenchymal stem cells significantly reduces the formation of bacterial infections, including the antibiotic resistant MRSA, said Anthony Atala, M.D., Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. Antibiotic resistance has long been a concern and this research highlights some promising new tactics.

###

The full article, The mesenchymal stromal cell (MSC) secretome impairs methicillin-resistant S. aureus (MRSA) biofilms via cysteine protease activity in the equine model, can be accessed at https://stemcellsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/sctm.19-0333.

About STEM CELLS Translational Medicine: STEM CELLS Translational Medicine (SCTM), co-published by AlphaMed Press and Wiley, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices. SCTM is the official journal partner of Regenerative Medicine Foundation.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS (http://www.StemCells.com), celebrating its 38th year, is the world's first journal devoted to this fast paced field of research. The Oncologist (http://www.TheOncologist.com), also a monthly peer-reviewed publication, entering its 25th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

About Wiley: Wiley, a global company, helps people and organizations develop the skills and knowledge they need to succeed. Our online scientific, technical, medical and scholarly journals, combined with our digital learning, assessment and certification solutions, help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 200 years, we have delivered consistent performance to our stakeholders. The company's website can be accessed at http://www.wiley.com.

About Regenerative Medicine Foundation (RMF): The non-profit Regenerative Medicine Foundation fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honouring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives.

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Study offers potential breakthrough in the war on antibiotic-resistant superbugs - PR Web

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.

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 areVericel 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 Demand, Growth, Opportunities and Analysis Of Top Key Player Forecast To 2025 - Daily Science

A study published in STEM CELLS Translational Medicine, by researchers at The Baker Institute for Animal Health, at Cornell's College of Veterinary Medicine, demonstrates for the first time that mesenchymal stromal cells (MSCs) are an effective weapon against bacteria in biofilm.

DURHAM, N.C., March 26, 2020 /PRNewswire-PRWeb/ -- Researchers have potentially made a breakthrough in the war on antibiotic-resistant superbugs including MRSA, which kills an estimated 20,000 people in the United States alone each year with a new discovery whose details are published today in STEM CELLS Translational Medicine. The study, by researchers at The Baker Institute for Animal Health, at Cornell's College of Veterinary Medicine, demonstrates for the first time that mesenchymal stromal cells (MSCs) are an effective weapon against bacteria in biofilm.

Biofilms are thin, slimy films made up of bacteria that can attach to skin wounds, teeth and other surfaces, creating the opportunity for infections to flourish. These highly structured cellular communities offer bacteria shelter from harmful factors, helping them resist antibiotics, mutate rapidly and evade the immune system.

"MSCs help kill the bacteria through the secretion of enzymes, called proteases, that break the peptide bonds of proteins and cause biofilm to destabilize. This in turn increases the effectiveness of antibiotics that previously weren't working, as the bacteria are no longer being protected by the biofilm," explained Gerlinde R. Van de Walle, DVM, Ph.D., who led the study along with Charlotte Marx, DVM, Ph.D.

Other recent studies, including one by the Cornell team, have shown that MSCs can inhibit the growth of bacteria associated with chronic infections by secreting antimicrobial peptides. "But these studies were conducted primarily on planktonic bacteria, which are individually floating bacteria cells. Thus, information on the effects on biofilms was largely lacking," Dr. Marx said.

The current study explores how MSC secretome, delivered as conditioned medium, performs against various wound-related bacterial pathogens. It also looks at the mechanisms that affect bacterial biofilms. The experiments were performed in vitro, using equine MSC. "We use equine MSC in our work since the horse represents a physiologically relevant model for human wound healing and offers a readily translatable model for MSC therapies in humans," Dr. Van de Walle explained.

The researchers began by showing that equine MSC secretome inhibits the growth of four types of planktonic bacteria that commonly colonize skin wounds. Encouraged by the results, they next sought to determine the effect of the MSC secretome on these same bacterial strains in biofilms, which is the predominant way bacteria invade wounds. They looked at how the MSCs affected biofilm formation, then repeated the experiments on biofilms that were already established. Finally, they turned their attention to the bacteria strain responsible for MRSA.

Dr. Marx reported the results. "Our salient findings," she said, "were that factors secreted by equine MSC impaired both planktonic and biofilms including MRSA as well as disrupted mature biofilms generated by these bacteria. Importantly, we found that these effects resulted from a protease-dependent mechanism."

Dr. Van de Walle added, "We also found that MSC-secreted factors allowed previously ineffective antibiotic treatments to become more effective at reducing bacterial survival. In light of the rise of antibiotic-resistant bacterial strains as an increasing global health threat, our findings provide the rationale for using the MSC secretome as a complementary treatment for bacterial infections."

"Outcomes from this study highlight for the first time that the secretome from mesenchymal stem cells significantly reduces the formation of bacterial infections, including the antibiotic resistant MRSA," said Anthony Atala, M.D., Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. "Antibiotic resistance has long been a concern and this research highlights some promising new tactics."

###

The full article, "The mesenchymal stromal cell (MSC) secretome impairs methicillin-resistant S. aureus (MRSA) biofilms via cysteine protease activity in the equine model," can be accessed at https://stemcellsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/sctm.19-0333.

Story continues

About STEM CELLS Translational Medicine: STEM CELLS Translational Medicine (SCTM), co-published by AlphaMed Press and Wiley, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices. SCTM is the official journal partner of Regenerative Medicine Foundation.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS (http://www.StemCells.com), celebrating its 38th year, is the world's first journal devoted to this fast paced field of research. The Oncologist (http://www.TheOncologist.com), also a monthly peer-reviewed publication, entering its 25th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

About Wiley: Wiley, a global company, helps people and organizations develop the skills and knowledge they need to succeed. Our online scientific, technical, medical and scholarly journals, combined with our digital learning, assessment and certification solutions, help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 200 years, we have delivered consistent performance to our stakeholders. The company's website can be accessed at http://www.wiley.com.

About Regenerative Medicine Foundation (RMF): The non-profit Regenerative Medicine Foundation fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honouring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives.

SOURCE STEM CELLS

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Study offers potential breakthrough in the war on antibiotic-resistant superbugs - Yahoo Finance

During this process the cells not only shed any memories of their previous identities, but they revert to a younger state. They accomplish this transformation by wiping their DNA clean of the molecular tags that not only differentiate, say, a skin cell from a heart muscle cell, but of other tags that accumulate as a cell ages.

Recently researchers have begun to wonder whether exposing the adult cells to Yamanaka proteins for days rather than weeks could trigger this youthful reversion without inducing full-on pluripotency. In fact, researchers at the Salk Institute for Biological Studies found in 2016 that briefly expressing the four Yamanaka factors in mice with a form of premature aging extended the animals life span by about 20%. But it wasnt clear whether this approach would work in humans.

Sarkar and Sebastiano wondered whether old human cells would respond in a similar fashion, and whether the response would be limited to just a few cell types or generalizable for many tissues. They devised a way to use genetic material called messenger RNA to temporarily express six reprogramming factors the four Yamanaka factors plus two additional proteins in human skin and blood vessel cells. Messenger RNA rapidly degrades in cells, allowing the researchers to tightly control the duration of the signal.

The researchers then compared the gene-expression patterns of treated cells and control cells, both obtained from elderly adults, with those of untreated cells from younger people. They found that cells from elderly people exhibited signs of aging reversal after just four days of exposure to the reprogramming factors. Whereas untreated elderly cells expressed higher levels of genes associated with known aging pathways, treated elderly cells more closely resembled younger cells in their patterns of gene expression.

When the researchers studied the patterns of aging-associated chemical tags called methyl groups, which serve as an indicator of a cells chronological age, they found that the treated cells appeared to be about 1 to 3 years younger on average than untreated cells from elderly people, with peaks of 3 years (in skin cells) and 7 years (in cells that line blood vessels).

Next they compared several hallmarks of aging including how cells sense nutrients, metabolize compounds to create energy and dispose of cellular trash among cells from young people, treated cells from old people and untreated cells from old people.

We saw a dramatic rejuvenation across all hallmarks but one in all the cell types tested, Sebastiano said. But our last and most important experiment was done on muscle stem cells. Although they are naturally endowed with the ability to self-renew, this capacity wanes with age. We wondered, Can we also rejuvenate stem cells and have a long-term effect?

When the researchers transplanted old mouse muscle stem cells that had been treated back into elderly mice, the animals regained the muscle strength of younger mice, they found.

Finally, the researchers isolated cells from the cartilage of people with and without osteoarthritis. They found that the temporary exposure of the osteoarthritic cells to the reprogramming factors reduced the secretion of inflammatory molecules and improved the cells ability to divide and function.

The researchers are now optimizing the panel of reprogramming proteins needed to rejuvenate human cells and are exploring the possibility of treating cells or tissues without removing them from the body.

Although much more work needs to be done, we are hopeful that we may one day have the opportunity to reboot entire tissues, Sebastiano said. But first we want to make sure that this is rigorously tested in the lab and found to be safe.

Other Stanford co-authors are former postdoctoral scholar Marco Quarta, PhD; postdoctoral scholar Shravani Mukherjee, PhD; graduate student Alex Colville; research assistants Patrick Paine, Linda Doan and Christopher Tran; Constance Chu, MD, professor of orthopaedic surgery; Stanley Qi, PhD, assistant professor of bioengineering and of chemical and systems biology; and Nidhi Bhutani, PhD, associate professor of orthopaedic surgery.

Researchers from the Veterans Affairs Palo Alto Health Care System, the University of California-Los Angeles and the Molecular Medicine Research Institute in Sunnyvale, California, also contributed to the study.

The research was supported by the National Institutes of Health (grants R01 AR070865, R01 AR070864, P01 AG036695, R01 AG23806, R01 AG057433 and R01 AG047820), the Glenn Foundation for Medical Research, the American Federation for Aging Research and the Department of Veterans Affairs.

Sarkar, Quarta and Sebastiano are co-founders of the startup Turn Biotechnologies, a company that is applying the technology described in the paper to treat aging-associated conditions. Rando is a member of the scientific advisory board.

See the rest here:
Old human cells rejuvenated with stem cell technology - Stanford Medical Center Report

Early research published in Mayo Clinic Proceedings examines the first case at Mayo Clinic of stem cell therapy tested in humans for spinal cord injury. The case study found stem cell intervention, which took place after standard surgery, and physical and occupational therapy, restored some function in a patient with spinal cord injury. The report, "Celltop Clinical Trial: First Report From a Phase I Trial of Autologous Adipose-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury" is published in the Nov. 27, 2019 edition of Mayo Clinic Proceedings.

The research discusses the experience related to the first case in a phase I safety study of mesenchymal stem cell treatment for spinal cord injury. Mohamad Bydon, M.D., a Mayo Clinic neurologic surgeon and the lead author, cautions that each patient is different, so it's too early to consider stem cell therapies as a treatment or cure for paralysis from spinal cord injury. Dr. Bydon adds that much like early trials in general, the stem cell trials are going to show variable response rates.

"Whilein this case, the first subject was a superresponder, others may not respond inthe same manner. We do not yet understand all of the necessary biology neededto achieve neurological recovery in paralyzed individuals," says Dr.Bydon. "One of our objectives in this study and future studies is tobetter delineate who will be a responder and why patients respond differently."

The research

The research centers on a 53-year-old man who suffered a spinal cord injury in a surfing accident that left him paralyzed below the neck. The patient had immediate improvements with standard therapy, but plateaued at six months post-injury. Researchers enrolled the patient in the study at Mayo Clinic nine months after the accident and injected the patient with stem cells 11 months after injury. After the stem cell injection, the patient significantly improved motor and sensory function.

Thecase study focuses on feasibility, safety and dosing of stem cell therapy. Thestudy team derived mesenchymal stem cells from the patient's fat cells andinjected them into the lower back in a procedure known as lumbar puncture.

Dr.Bydon; Wenchun Qu,M.D., Ph.D.,a physical medicine and rehabilitation physician; and Allan Dietz,Ph.D.,a transfusion medicine physician, led the multidisciplinary research team atMayo Clinic.

"Severespinal cord injury is a devastating condition for which scientists andphysicians are trying to find a cure. For the first time, we are inspiring hopethat people may receive better recovery in their function and quality of life,"says Dr. Qu. "Mayo Clinic has been taking the lead in translating thefruits of decades of research and treating neurological conditions, among whichhave been very important clinical trials where we evaluate the safety,feasibility and efficacy of adult stem cells for severe spinal cord injuries."

"This work both demonstrates the ability of cells to initiate repair and capitalizes on more than 10 years of work in the Immune, Progenitor and Cell Therapeutics Lab at Mayo Clinic. While there is still much to learn about the amazing ability of cells to heal tissue, this trial is an important step in advancing cell-based therapies toward clinical practice," says Dr. Dietz.

Investigatorscollected cerebrospinal fluid to look for new biological markers that mightgive clues to healing. Biological markers are important because they can helpidentify the critical processes that lead to spinal cord injury at a cellularlevel and could lead to new regenerative therapies.

Furtherstudy is needed to understand the effectiveness of stem cell lumbar injectionsand why patients may respond differently.

Currently,there is no way to reverse the devastating life-changing effects of paralysisfrom spinal cord injuries. Today, the only treatment is supportive care, suchas surgery and physical and occupational therapy.

Dr.Bydon says his early findings give hope that new regenerative therapies are onthe horizon for spinal cord injuries.

"Thehope is that we will have novel treatments for spinal cord injuries in the comingyears that will be different from what we have today. These will be therapies thatdo not rely upon supportive care, but therapies that rely on science to createa regenerative process for the spinal cord," says Dr. Bydon.

This research was made possible by funding from Mayo Clinic Transform the Practice Initiative and Regenerative Medicine Minnesota with support from the Mayo Clinic Center for Regenerative Medicine and the Department of Laboratory Medicine and Pathology Immune, Progenitor and Cell Therapeutics lab. The Transform the Practice Initiative aims to foster multidisciplinary teams of clinicians and researchers who align discovery and translational science, create new capacities and achieve solutions that improve the practice and address the unmet needs of patients.

###

Read the news release

Tags: #Mayo Clinic Proceedings, #Spinal cord injury research, #stem cell lumbar puncture, #stem cell research, Dr. Allan Dietz, Dr. Mohamad Bydon, Dr. Wenchun Qu, Mayo Clinic Center for Regenerative Medicine, Regenerative Medicine Minnesota, Research, spinal cord injury

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Mayo Clinic research is a step toward hope for spinal cord ...

California: In a breakthrough study, researchers have found a potential treatment for life-threatening cardiac diseases by using gene therapy.

Danon disease is a very rare, life-threatening condition where the fundamental biological process of removing and recycling proteins does not work.

This impairment results in dysfunction of the heart, skeletal muscle, neurologic system, eyes, and liver. Most patients die or require heart transplants by the third decade of life.

In the study, which was published in Science Translational Medicine, researchers have identified a novel way to treat Danon disease using gene therapy.

Heart transplant is not always available for patients and does not treat the other organs affected in Danon disease. We knew we needed to find therapies specifically designed to address the underlying cause, said the lead researcher Eric Adler.

Danon disease is a result of mutations in the gene LAMP2. For nearly a decade, Adler and a team of researchers at UC San Diego Health have been working to determine whether gene therapy could provide a new treatment approach.

Gene therapy involves either replacing or repairing a gene that causes a medical problem or adding genes to help the body treat disease. In this case, Adler and the team focused on adding a specially designed gene that restores the LAMP2 function, resulting in improved cardiac and liver function.

We utilised mice that were a model for Danon disease and missing this specific LAMP gene. We applied gene therapy to a group of these mice and compared to mice that did not receive treatment, said Adler.

The mice that received gene therapy expressed positive results in heart, liver and muscle function. The hearts overall function of ejecting blood and relaxing improved, as did the bodys ability to degrade proteins and metabolism.

Danon disease is more common in males, and symptoms begin in early childhood or adolescence.

In many cases, the condition is inherited by a parent, typically the mother. We believe Danon disease is actually more common than we think, but it is often misdiagnosed, said Adler.

By utilising gene therapy, we were able to identify a possible new treatment approach other than a heart transplant. This study is a significant step for patients with Danon disease, Adler added.

Prior studies in Adlers lab have focused on using a patients skin cells to create stem cells. These stem cells were used to create a heart model, allowing researchers to study Danon disease at the cellular level.

The approach has provided new insight into the diseases pathology and led to the idea of using gene therapy. Our work is also proof that using stem cells to model diseases has great potential for helping develop new medicines, said Adler.

The next step, said Adler, is testing in patients with Danon disease. A Phase I clinical trial for safety and efficacy has begun.

This is the first trial using gene therapy to treat a genetic cardiac disorder and three patients are currently being treated, which means were that much closer to finding a cure for this terrible disease, and may be able to use similar methods to treat other diseases, said Adler.

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Study reveals gene therapy may help in treating cardiac disease - The Siasat Daily

In the recently published 3D bioprinting and its potential impact on cardiac failure treatment: An industry perspective, authors Ravi K. Birla and Stuart K. Williams explore the potential for tissue engineering in cardiac medicine, and the eventual assembly of a bioprinted heart.

While heart failure usually requires a transplant, it can be challenging to find a suitable donor. Once a transplant is completed, there is a long road ahead too via a permanent need for immune suppression therapytreatment that is hard on patients. The usual survival rate for patients is typically under 13 years.

There are currently more than 6.2 million patients in the US with heart failure, and heart failure accounted for 78,356 mortalities in 2016, stated the authors.

In this study, the researchers review the challenges of bioprinting for the creation of heart tissue, as well as the logical and systematic process to bioprint human heart.

While medical science is full of progressive tools, treatments, and devicesespecially for heart patientsno technology has been more promising for the eventual fabrication of organs than tissue engineering. With the potential to yield a biofabricated heart, made up of both biologic and artificial construct, a total heart could feasibly emerge with modular parts for easy replacing.

Definition of tissue engineeringthe building blocks of tissue engineering are cells, biomaterials, and bioreactors. Cells are the functional elements of all tissue and organs, while biomaterials are designed to simulate the mammalian extracellular matrix and provide structural support. Bioreactors are custom devices to deliver physiological cues for 3D tissue/organ development and maturation. Electrical stimulation is delivered by parallel electrodes, while uniaxial stretch, illustrated by the single arrow, is designed to apply cyclic movement of the bioengineered tissue.

Cardiac tissue engineering encompasses:

The ability to bioengineer components of the heart or the entire bioartificial heart, both have applications in changing the standard of care for patients with heart disorders, explained the authors. Depending on the severity of the patient, a cardiac patch may be sufficient to augment lost contractile function, while in cases of chronic heart failure, a total bioartificial heart may be required.

In addition to spatial regulation of the cells, bioprinting also allows accurate placement of the biomaterials. This is where 3D bioprinting provides a powerful tool that allows us to accurately position different cell types in a very specific pattern, thereby allowing tight control over the heart bioengineering process.

Overview of cardiac tissue engineeringthe field of cardiac tissue engineering includes methods to bioengineer contractile 3D heart muscle, biological pulsating pumps, bioengineered left ventricles, bioartificial valves and vascular grafts, and biofabricated hearts. Contractile 3D heart muscle is designed to replicate the properties of mammalian heart muscle tissue and can be used as a patch to augment left ventricle pressure after myocardial infarction. Pulsating pumps are designed to generate intra-luminal pressure and can be used as biological pumps. Left ventricles can be used as a component of the heart or to replace under-performing ventricles in pediatric cases of hypoplastic left heart syndrome. Valves and vascular grafts can be used to replaced mammalian valves and blood vessels or as components of the bioengineered heart.

Major components of the human heartthe human heart consists of four chambers, four valves, the cardiac conduction system, contractile cardiomyocytes, and a complex vasculature. The four chambers are the left and right ventricle and aorta, while the four valves are the aortic and mitral valves and pulmonary and tricuspid valves. The cardiac conduction system consists of the SAN, AVN, bundle of His, and the Purkinje fibers. Cardiac vasculature consists of the greater vessels as well as the smaller micro-circulation. Cardiomyocytes are the cells responsible for heart muscle contraction.

So far, most research involving bioprinting of cardiac tissue has shown the initial feasibility of bioprinting hearts. With the amount of research and tools available today, such progress is inevitable.

Based on the current state of the art in whole heart bioengineering, we can safely say that human hearts will be available for clinical transplantation though we cannot assign a specific timeframe for this fate to be accomplished, state the authors.

Bioprinting of the human heart has its beginnings in the initial history of tissue engineering in 2003, and then further in research a few years later.

The 3D bioprinting processisolated cells are suspended in a custom formulated bioink and loaded into a syringe. Examples of cells required to bioprint hearts include contractile cardiomyocytes, conducting pacemaker and Purkinje cells, structural fibroblast cells and vascular smooth muscle cells, and endothelial cells. Pneumatic pressure is used to extrude the cell-loaded bioink through the printing tip, and a layer by layer approach is used to build tissue and/or organ

Scientific breakthroughs for 3D bioprinting human hearts.

There has continued to be rapidly growing success in bioprinting and the subsequent fabrication of heart tissue, allowing scientists to realize less of fantasy in such exercisesand more of a reality.

Process for bioprinting human heartspatient MRI images are used to model the heart. Dermal fibroblasts are isolated from patient skin biopsies and converted to iPS cells and then to cardiomyocytes. Cardiomyocytes are combined with bioinks and used to bioprint patient-specific human hearts. Bioprinted hearts are conditioned in bioreactors and used for transplantation.

The roadmap for bioprinting a heart includes:

The single most important challenge that needs to be overcome in the field, and one that in general staggers the field of cardiac stem cell therapy, is the immaturity of reprogrammed cardiomyocytes, conclude the researchers. Conversion of iPS cells to cardiomyocytes is now standard and reproducible, the differentiated cells resemble an embryonic phenotype, and driving these cells to an adult phenotype remains a critical challenge in the field of cardiac stem cell therapy.

Once reproduced by independent research labs, coupled with the availability of commercial bioreactors for electromechanical stimulation, the availability of mature cardiomyocytes will provide a clear pathway to 3D bioprint human hearts for clinical transplantation.

Bioprinting is used in a wide variety of applications today, from cardiac patches and cellularized hearts to the creation of heart valves, and more, ultimately shaping an overall transformation of cell culture. What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

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The Progress & Ongoing Challenge of 3D Bioprinting Cardiac Tissue - 3DPrint.com

A team of University of California, Irvine researchers have published the first comprehensive overview of the major changes that occur in mammalian skin cells as they prepare to heal wounds. Results from the study provide a blueprint for future investigation into pathological conditions associated with poor wound healing, such as in diabetic patients.

"This study is the first comprehensive dissection of the major changes in cellular heterogeneity from a normal state to wound healing in skin," said Xing Dai, PhD, a professor of biological chemistry and dermatology in the UCI School of Medicine, and senior author. "This work also showcases the collaborative efforts between biologists, mathematician and physicists at UCI, with support from the National Institute of Arthritis & Musculoskeletal & Skin Diseases-funded UCI Skin Biology Resource-based Center and the NSF-Simons Center for Multiscale Cell Fate Research.

The study, titled, "Defining epidermal basal cell states during skin homeostasis and wound healing using single-cell transcriptomics," was published this week in Cell Reports.

"Our research uncovered at least four distinct transcriptional states in the epidermal basal layer as part of a 'hierarchical-lineage' model of the epidermal homeostasis, or stable state of the skin, clarifying a long-term debate in the skin stem cell field," said Dai.

Using single-cell RNA sequencing coupled with RNAScope and fluorescence lifetime imaging, the team identified three non-proliferative and one proliferative basal cell state in homeostatic skin that differ in metabolic preference and become spatially partitioned during wound re-epithelialization, which is the process by which the skin and mucous membranes replace superficial epithelial cells damaged or lost in a wound.

Epithelial tissue maintenance is driven by resident stem cells, the proliferation and differentiation dynamics of which need to be tailored to the tissue's homeostatic and regenerative needs. However, our understanding of tissue-specific cellular dynamics in vivo at single-cell and tissue scales is often very limited.

"Our study lays a foundation for future investigation into the adult epidermis, specifically how the skin is maintained and how it can robustly regenerate itself upon injury," said Dai.

Reference:Haensel, D., Jin, S., Sun, P., Cinco, R., Dragan, M., Nguyen, Q., Dai, X. (2020). Defining Epidermal Basal Cell States during Skin Homeostasis and Wound Healing Using Single-Cell Transcriptomics. Cell Reports, 30(11), 3932-3947.e6. https://doi.org/10.1016/j.celrep.2020.02.091

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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How Skin Cells Prepare To Heal Wounds - Technology Networks

A breakthrough study provides a blueprint for future investigation into pathological conditions associated with poor wound healing, such as in diabetic patients. A team of researchers from the University of California has published the first comprehensive overview of the major changes that occur in mammalian skin cells as they prepare to heal wounds.

The study, "Defining epidermal basal cell states during skin homeostasis and wound healing using single-cell transcriptomics", was published this week in Cell Reports. According to Xing Dai, Ph.D., a professor of biological chemistry and dermatology in the UCI School of Medicine, and senior author, "This study is the first comprehensive dissection of the major changes in cellular heterogeneity from a normal state to wound healing in the skin."

This work also showcases the collaborative efforts between biologists, mathematicians and physicists at UCI, with support from the National Institute of Arthritis & Musculoskeletal & Skin Diseases-funded UCI Skin Biology Resource-based Center and the NSF-Simons Center for Multiscale Cell Fate Research. "Our research uncovered at least four distinct transcriptional states in the epidermal basal layer as part of a 'hierarchical-lineage' model of the epidermal homeostasis, or stable state of the skin, clarifying a long-term debate in the skin stem cell field," said Dai.

Using single-cell RNA sequencing coupled with RNAScope and fluorescence lifetime imaging, the team identified three non-proliferative and one proliferative basal cell state in homeostatic skin that differ in metabolic preference and become spatially partitioned during wound re-epithelialization, which is the process by which the skin and mucous membranes replace superficial epithelial cells damaged or lost in a wound. Epithelial tissue maintenance is driven by resident stem cells, the proliferation and differentiation dynamics of which need to be tailored to the tissue's homeostatic and regenerative needs. However, our understanding of tissue-specific cellular dynamics in vivo at single-cell and tissue scales is often very limited.

"Our study lays a foundation for future investigation into the adult epidermis, specifically how the skin is maintained and how it can robustly regenerate itself upon injury," said Dai.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

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Study in mouse, human cells suggests unique anti-cancer properties of such a therapy

Pictured is a natural killer (NK) cell that researchers developed in the lab from human pluripotent stem cells. These NK cells mimic the properties of those found in the yolk sac during the earliest stages of development. Such NK cells may be more effective as immunotherapy for cancer treatment than adult NK cells that come from bone marrow, according to a new study from Washington University School of Medicine in St. Louis. White arrows point out granules that contain potent anti-cancer enzymes. Adult NK cells have very few of these granules.

Immunotherapy that involves treating cancer with the bodys own immune cells, or those of a matched donor, shows promise in clinical trials for some patients, but not all.

A new study from Washington University School of Medicine in St. Louis suggests that the age of certain immune cells used in such therapy plays a role in how effective the immunotherapy is. These cells natural killer (NK) cells appear to be more effective the earlier they are in development, opening the door to the possibility of an immunotherapy that would not utilize cells from the patient or a matched donor. Instead, they could be developed from existing supplies of what are called human pluripotent stem cells.

We are trying to improve the effectiveness of immunotherapy for more patients, said senior author Christopher M. Sturgeon, PhD, an assistant professor of medicine. This special source of natural killer cells has the potential to fill some of the gaps remaining with adult NK cell therapy. There is early evidence that they are more consistent in their effectiveness, and we would not need to process cells from a donor or the patient. They could be manufactured from existing cell supplies following the strict federal guidelines for good manufacturing practices. The characteristics of these cells let us envision a supply of them ready to pull off the shelf whenever a patient needs them.

Unlike the adult versions of NK cells used in most investigational therapies, earlier versions of such cells do not originate from bone marrow. Rather, these NK cells are a special type of short-lived immune cell that forms in the yolk sac of the early mammalian embryo. But for therapeutic purposes, such cells do not need to originate from embryos they can be developed from human pluripotent stem cells, which have the ability to give rise to many different cell types, including these specialized natural killer cells. Manufacturing such cells which many academic medical centers already have the ability to do would make them available quickly, eliminating the time needed to process the patients or donors cells, which can take weeks.

The study appears March 19 in the journal Developmental Cell.

Before a certain time point in early development, there is no such thing as bone marrow, but there is still blood being made in the embryo, Sturgeon said. Its a transient wave of blood that the yolk sac makes to keep the embryo going until bone marrow starts to form. And thats the blood cell generation thats making these unique natural killer cells. This early blood appears to be capable of things that adult blood simply cant do.

Studying mouse and human induced pluripotent stem cells that have been coaxed into forming these unique NK cells, the researchers showed that the NK cells are better at releasing specific anti-tumor chemicals a process called degranulation than their adult counterparts. Even NK cells derived from umbilical cord blood do not respond as robustly. NK cells of adult origin also release different chemicals that trigger harmful inflammation, but this response is not necessarily effective against cancer.

Past work by other groups suggested NK cells from earlier development might be more effective, but how and why this was the case remained unknown. The specific origin of these cells was also a mystery.

Now we know where these special natural killer cells come from and that we can never get them from an adult donor, only a pluripotent stem cell, Sturgeon said. Based on their unique behavior alone, there is one small clinical trial of these cells that is ongoing. Now that we know how to manufacture them and how they work, it opens the door for more trials and for improving upon their function.

According to Sturgeon, such cells could be produced from existing lines of pluripotent stem cells that would not need to come from a matched donor because, in general, NK cells do not heavily attack the bodys healthy tissues, as many T cell therapies can. T cells are another type of immune cell often used to treat blood cancer as part of a stem cell transplant, commonly called a bone marrow transplant. Even when NK cells do cause harm, they do not stay in the body for long periods of time.

From a basic science standpoint, Sturgeon also is interested in understanding why these cells are present in the early embryo in the first place and where they go in later development and after birth.

We can only speculate at this point, but its possible that during early embryonic development, when there is so much rapid cell division, these cells are there as a surveillance mechanism to protect against pediatric cancers or infection, he said.

This work was supported by the National Institutes of Health (NIH), grant numbers HL007088-41, R01DK09361, R01CA205239, P50CA171963, 5K12CA167540, and UL1TR002345; an American Society of Hematology Scholar Award; the University of Rochester; the American Cancer Society, grant number IRG-58-010-59-2; the Washington University Center of Regenerative Medicine; the technical expertise of Leah Vit; and the M. Napoleon Memorial Foundation. Electron microscopy was performed at the Washington University Center for Cellular Imaging (WUCCI). Transcriptome analyses were performed at the Genome Technology Access Center (GTAC).

Dege C, Fegan KH, Creamer JP, Berrien-Elliott MM, Luff SA, Kim D, Wagner JA, Kingsley PD, McGrath KE, Fehniger TA, Palis J, Sturgeon CM. Potently cytotoxic natural killer cells initially emerge from erythro-myeloid progenitors during mammalian development. Developmental Cell. March 19, 2020.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Immunotherapy using 'young cells' offers promising option against cancer - Washington University School of Medicine in St. Louis