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Researchers Manage to Create Pig-Monkey Chimeras for the First Time – Tdnews

By daniellenierenberg

Researchers in China are laying claim to the first ever pig-monkey chimeras to be born in what they hope will be a breakthrough for biomedicine, not just fuel for your nightmares.

The worlds first monkey-pig hybrids have been born in a Chinese lab amid scientific attempts to grow human organs inside animals. The incredible experiment saw two chimera piglets born with DNA from both pigs and cynomolgus monkeys. However, the experiment was short-lived as the two piglets both died within a week.

According to the researchers, the baby piglets had genetic material from cynomolgus monkeys in their heart, liver, spleen, lung and skin.

However, the success rate was significantly low as only 10 piglets were born from more than 4,000 implanted in sows.

From those, only two were chimeras in a result that has been deemed discouraging by other leading stem cell scientists.

Lead researcher Tang Hai at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing said: This is the first report of full-term pig-monkey chimeras.

Ms Hai confirmed that it was unclear why the piglets died, but the non-chimeric pigs died as well.

The Chinese research team suspect that the deaths could have been due to the IVF process instead than the chimerism

According to research study, stem cells from macaque monkeys were grown in a lab and then injected into pig embryos five days after fertilisation.

Ms Hai said that the next step in their research was to create healthy animals with a higher proportion of monkey cells before creating pigs in which one organ is composed almost entirely of primate cells.

The ultimate research goal is to grow human organs inside live animals as a way to resolve the crisis of organ transplantation.

University of California stem cell biologist Paul Knoepfler said: Given the extremely low chimeric efficiency and the deaths of all the animals, I see this as fairly discouraging.

Reaction to the study has prompted many social media users to question if this is a step too far.

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Cell Harvesting Market a compound annual growth rate (CAGR) of 11.3% for the period of 2018-2023 – Crypto News Byte

By daniellenierenberg

Theglobal market for cell harvestingshould grow from $885 million in 2018 to reach $1.5 billion by 2023 at a compound annual growth rate (CAGR) of 11.3% for the period of 2018-2023.

Report Scope:

The scope of the report encompasses the major types of cell harvesting that have been used and the cell harvesting technologies that are being developed by industry, government agencies and nonprofits. It analyzes current market status, examines drivers on future markets and presents forecasts of growth over the next five years.

The report provides a summary of the market, including a market snapshot and profiles of key players in the cell harvesting market. It provides an exhaustive segmentation analysis of the market with in-depth information about each segment. The overview section of the report provides a description of market trends and market dynamics, including drivers, restraints and opportunities. it provides information about market developments and future trends that can be useful for organizations, including wholesalers and exporters. It provides market positionings of key players using yardsticks of revenue, product portfolio, and recent activities. It further includes strategies adopted by emerging market players with strategic recommendations for new market entrants. Readers will also find historical and current market sizes and a discussion of the markets future potential. The report will help market players and new entrants make informed decisions about the production and exports of goods and services.

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Report Includes:

41 data tables and 22 additional tables Description of segments and dynamics of the cell harvesting market Analyses of global market trends with data from 2017, 2018, and projections of compound annual growth rates (CAGRs) through 2023 Characterization and quantification of market potential for cell harvesting by type of harvesting, procedure, end user, component/equipment and region A brief study and intact information about the market development, and future trends that can be useful for the organizations involved in Elaboration on the influence of government regulations, current technology, and the economic factors that will shape the future marketplace Key patents analysis and new product developments in cell harvesting market Detailed profiles of major companies of the industry, including Becton, Dickinson and Co., Corning, Inc., Fluidigm Corp., General Electric Co., Perkinelmer, Inc., and Thermo Fisher Scientific, Inc.

Summary

Stem cells are unspecialized cells that have the ability to divide indefinitely and produce specialized cells. The appropriate physiological and experimental conditions provided to the unspecialized cells give rise to certain specialized cells, including nerve cells, heart muscle cells and blood cells. Stem cells can divide and renew themselves over long periods of time. These cells are extensively found in multicellular organisms, wherein mammals, there are two types of stem cells embryonic stem cells and adult stemcells. Embryonic stem cells are derived from a human embryo four or five days old that is in the blastocyst phase of development. Adult stem cells grow after the development of the embryo and are found in tissues such as bone marrow, brain, blood vessels, blood, skin, skeletal muscles and liver. Stemcell culture is the process of harvesting the exosomes and molecules released by the stem cells for the development of therapeuticsfor chronic diseases such as cancer and diabetes. The process is widely used in biomedical applications such as therapy, diagnosis and biological drug production. The global cell harvesting market is likely to witness a growth rate of REDACTED during the forecast period of 2018-2023.The value of global cell harvesting market was REDACTED in 2017 and is projected to reach REDACTED by 2023. Market growth is attributed to factors such as increasing R&D spending in cell-based research,the introduction of 3D cell culture technology, increasing government funding, and the growing prevalence of chronic diseases such as cancer and diabetes.

The growing incidence and prevalence of cancer is seen as one of the major factors contributing to the growth of the global cell harvesting market. According to the World Health Organization (WHO), cancer is the second-leading cause of mortality globally and was responsible for an estimated 9.6 million deaths in 2018. Therefore, there is an increasing need for effective cancer treatment solutions globally. Cell harvesting is the preferred method used in cancer cell-related studies including cancer cell databases (cancer cell lines), and other analyses and drug discovery in a microenvironment. The rising prevalence of such chronic diseases has led governments to provide R&D funding to research institutes and biotechnology companies to develop advanced therapeutics. Various 3D cell culture technologies have been developed by researchers and biotechnology companies such as Lonza Group and Thermo Fischer Scientific for research applications such as cancer drug discovery. The application of cell culture in cancer research is leading to more predictive models for research, drug discovery and regenerative medicine applications.

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Platelet-rich plasma (PRP) therapy, a new biotechnology solution that has a heightened interest among researchers in tissue engineering and cell-based therapies, has various applications in the treatment of tissue healing in tendinopathy, osteoarthritis and muscle injury. It has been conventionally employed in orthopedics, maxillofacial surgery, periodontal therapy and sports medicines. PRP therapy can be used in the treatment of fat grafting, acne scars, and hair regrowth.

Major factors driving market growth include increasing healthcare costs and the high rate of adoption for modern medicines in emerging economies such as China and India. It has been estimated that India will witness a CAGR of REDACTED in the cell harvesting market during the forecast period. The active participation of foreign pharmaceutical companies has tapped the Indian healthcare sector with a series of partnerships and mergers and acquisitions, which in turn is positively impacting the growth of the market in this region. Consistent development and clinical trials for stem cell therapies, plus contribution from the government and private sectors through investments and cohesive reimbursement policies in the development of cancer biomarkers, is further fueling market growth. InSweden, a research team at Lund University has developed a device to collect fluid and harvest stem mesenchymal stem cells (MSCs). The device is developed with 3D-printed bio-inert plastics which, when used by doctors, can result in the safe extraction of fluids (medical waste) from the patients body. The liquid is then passed through a gauze filter for purifying thoroughly and MSCs are separated from the fluid by centrifugation and are grown in culture.

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Syndax Pharmaceuticals Announces Plans to Commence Phase 2 Expansion Cohort of SNDX-6352 for the Treatment of Chronic Graft Versus Host Disease -…

By daniellenierenberg

WALTHAM, Mass., Dec. 10, 2019 /PRNewswire/ --Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it plans to commence a Phase 2 expansion cohort based on encouraging clinical activity and a well-tolerated safety profile observed to date in the ongoing Phase 1 dose escalation trial of SNDX-6352 in patients with chronic graft versus host disease (cGVHD). SNDX-6352 is the Company's anti-CSF-1R monoclonal antibody.

The ongoing Phase 1, open-label, modified 3+3 dose escalation trial is designed to evaluate the safety and preliminary efficacy of SNDX-6352 in up to 30 patients with cGVHD who have received at least two prior lines of therapy. As of a November 25, 2019 data cutoff date, a total of five patients, all of whom received prior treatment with ibrutinib, steroids, and a calcineurin inhibitor, have been enrolled across three dose cohorts: one patient was treated at 0.15 mg/kg every two weeks (Q2W, Cohort 1), one is receiving a dose of 0.5 mg/kg Q2W (Cohort 2), and three patients are receiving 1.0 mg/kg Q2W (Cohort 3).

Responses have been observed in all evaluable patients as of the data cutoff date, with no dose limiting toxicities (DLTs) reported. Among the three patients dosed in Cohort 3 (1.0 mg/kg Q2W), one patient recently cleared the DLT period and has not yet been evaluated for efficacy, two patients experienced a partial response, and all three patients remain on therapy. The patient in Cohort 2 experienced a partial response and is currently in their ninth month of treatment with SNDX-6352 following prior treatment with ibrutinib and both Jakafi (ruxolitinib) and KD025, two agents currently being investigated for the treatment of cGVHD. The first patient (Cohort 1) achieved a partial response but discontinued in their third cycle due to elevated LFTs attributed to progression in their liver cGVHD. Cohort 4, which will explore a 3.0 mg/kg Q2W dose, is now open for enrollment.

"The initial results from our Phase 1 trial underscore the potential of SNDX-6352 to serve as an effective therapy for patients with cGVHD who are lacking alternative options," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We had not anticipated commenting on data from this initial trial until the second half of 2020, so it is quite encouraging to see the early signs of activity in patients with this difficult to treat disease. Based on these results, we have decided to advance into a Phase 2 expansion cohort to evaluate additional patients at the 1.0 mg/kg dose while we continue the dose escalation to 3.0 mg/kg. We continue to expect to present the Phase 1 trial results in the second half of 2020.

"Published preclinical data have demonstrated that CSF-1R blockade can prevent and treat disease in animal models of cGVHD1," said Peter Ordentlich, Ph.D., Chief Scientific Officer and Co-founder of Syndax."The initial data from our trial provide the first clinical evidence that targeting CSF-1R dependent macrophages may benefit patients with cGVHD."

To date, SNDX-6352 has been safe and well-tolerated, with no DLTs observed. Dose escalation is ongoing in the Phase 1 portion of the trial. The Phase 2 expansion cohort is expected to enroll up to 22 patients to further characterize the safety and efficacy at an initial dosing schedule of 1.0 mg/kg of SNDX-6352 administered every two weeks.

About Chronic Graft Versus Host Disease

Chronic graft versus host disease (cGVHD), an immune response of the donor-derived hematopoietic cells against recipient tissues, is a serious, potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HSCT) which can last for years. cGVHD is estimated to develop in approximately 40% of transplant recipients, and affect approximately 14,000 patients in the US. 2-4 cGVHD typically manifests across multiple organ systems, with the skin and mucosa being commonly involved, and is characterized by the development of fibrotic tissue.

About SNDX-6352

SNDX-6352 is an investigational monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages. In pre-clinical models, inhibition of signaling through the CSF-1 receptor has been shown to reduce the number of disease-mediating macrophages and the development of cutaneous and pulmonary chronic graft versus host disease (cGVHD), as well as to lead to the depletion of cells known as Tumor Associated Macrophages, or TAMS. SNDX-6352 is currently being evaluated in a Phase 1 multiple ascending dose clinical trial in cGVHD, and a Phase 1 multiple ascending dose clinical trial as monotherapy and in combination with Infinzi (durvalumab) in solid tumors. SNDX-6352 has the potential to treat a variety of solid tumor and immune-related diseases.

About Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticalsis a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, is being tested in a Phase 3 combination trial with exemestane for treatment of advanced HR+, HER2- breast cancer and has been evaluated in combination with several approved PD-1/PD-(L)1 antagonists. The Company's pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, and SNDX-5613, a highly selective inhibitor of the MeninMLL binding interaction. For more information, please visitwww.syndax.comor follow the Company on TwitterandLinkedIn.

Syndax's Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

References

1. Alexander, KA. et al. J Clin Invest. 2014;124(10):42664280.

2.Kantar GVHD Expert Interviews N=8 interviews

3. SmartAnalyst 2017 SmartImmunology Insights chronic GVHD report.

4. Bachier, CR. et al. ASH annual meeting 2019; abstract #2109 Epidemiology and Real-World Treatment of Chronic Graft-Versus-Host Disease Post Allogeneic Hematopoietic Cell Transplantation: A U.S. Claims Analysis.

Syndax Contacts

Investor ContactMelissa ForstArgot Partnersmelissa@argotpartners.com212.600.1902

Media ContactCraig HeitGCI Healthcraig.Heit@gcihealth.com347.451.4733

SNDX-G

SOURCE Syndax Pharmaceuticals, Inc.

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Syndax Pharmaceuticals Announces Plans to Commence Phase 2 Expansion Cohort of SNDX-6352 for the Treatment of Chronic Graft Versus Host Disease -...

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Pig-Monkey Chimeras Have Been Brought to Term For The First Time – ScienceAlert

By daniellenierenberg

Pigs engineered to have a small amount of monkey cells have been brought to full term and were even born alive, surviving for a few days after birth. Although the piglets died, it is claimed the experiment - performed in China - marks a major milestone for the future of lab-grown organs.

"This is the first report of full-term pig-monkey chimeras," Tang Hai of the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing told New Scientist.

The research is part of an ongoing effort to develop animals - whether they are sheep or pigs - that can grow human organs we could then harvest for transplants, a process called xenogeneic organogenesis.

Research has been done on both pig and sheep embryos with transplanted human stem cells; in both cases, the embryos continued to develop until the experiment was deliberately terminated.

That's because, due to ethical concerns, these chimeras - organisms that incorporate the genetic material of another species - cannot be cultivated or studied in the later stages of embryonic development. Some scientists worry that some of the human stem cellscould end upin other parts of the animal or even in its brain, with unintended consequences.

For that reason, in this experiment the team used stem cells from crab-eating macaques (Macaca fascicularis). These were imbued with fluorescent proteins so that they would glow under fluorescent light, and derived to produce fluorescing embryonic cells.

These cells were then injected into over 4,000 five-day-old pig embryos fertilised using IVF; the modified pig embryos were subsequently implanted into sows.

This fiddly and painstaking work produced just 10 piglets that made it to full term and were born alive. And only two of these were chimeric, with between one in 1,000 and one in 10,000 functional monkey cells to pig cells.

The monkey cells had migrated to the heart, liver, lungs, spleen and skin of the piglet hosts, but were not found in other organs, such as testes and ovaries, due to the low rate of chimerism, the researchers said.

Sadly, before a week was out, the piglets died - not just the two chimeras, but the other eight normal piglets, too. Because all the pigs died, Hai told New Scientist, the cause of death likely had less to do with chimerism, and more to do with IVF - a procedure that is notoriously tricky in pigs.

The low chimerism rate is also somewhat discouraging. However, the researchers remain optimistic. Although the birth rate was low, and the pigs didn't survive, the team now has a wealth of data they can apply to future experiments.

The scientists are planning to try again, increasing the chimeric cell ratio. And they believe their data may help other scientists working in the field.

"Here, we have used monkey cells to explore the potential of reconstructing chimeric human organs in a large animal model," they wrote in their paper.

"We believe this work will facilitate the development of xenogeneic organogenesis by providing a better understanding of the processes of xenogeneic recognition, fate determination, and the proliferation and differentiation of primate stem cells during porcine development.

"The findings could pave the way toward overcoming the obstacles in the re-engineering of heterogeneous organs and achieve the ultimate goal of human organ reconstruction in a large animal."

The research has been published in Protein & Cell.

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Top Florida Medical Spa, Amnion of Florida, Partners With Merakris Therapeutics to Advance Their Non-Surgical Treatment Options – Business Wire

By daniellenierenberg

ORLANDO, Fla.--(BUSINESS WIRE)--Amnion of Florida, a leading provider of alternative medicine utilizing cryopreserved placental cell allograft and advanced bioactive facial rejuvenation, is pleased to announce their vendor choice to round out regenerative anti-aging therapies.

Amnion announces a partnership with Merakris Therapeutics, LLC to advance the development of Merakris topical bioactive anti-aging hydrogel technology. Christopher Broderick, President, and Founder of Merakris Therapeutics stated, dedication to science-based outcomes is our primary focus, thus were delighted to be selected based upon our scientific approach to youth maintenance and rejuvenation technologies.

Amnion is focused on attracting women and men seeking affordable non-surgical options for youth maintenance via cell activated procedures, hair restoration, joint repair, dermal rejuvenation, and anti-aging treatments.

Our team of experienced medical professionals and aestheticians at Amnion are excited to utilize the Merakris Therapeutics product suite, including medical-grade, sterile filtered amniotic fluid serums and hydrogels at our newest Spa in Sanford, FL, said Eusebio Coterillo, President of Amnion.

In a constantly changing field, Amnion of Florida, under the guidance of the on-site medical staff, provides the highest level of quality products and procedures in cosmetic medicine. They offer cutting edge treatments that are proven by research, the use FDA cleared or registered products, and are widely published and peer endorsed.

More about Amnion of Florida

Amnion of Florida, based in Central Florida, is a leading provider of alternative medicine using cryopreserved placental cell transplants or allografts, processed from donated cellular birth tissue, which are natural alternatives to autologous regenerative medicine products. The primary function of our allogeneic regenerative treatments is to promote soft tissue joint/skin repair and regeneration mediated by growth factors and cells naturally found in placental tissue. These treatments have shown safety and efficacy in treating a variety of ailments including osteoarthritis, chronic ulcerative wounds, joint pain, skin rejuvenation, hair restoration, urinary incontinence, and ED. Learn more http://www.amnion.us.

More about Merakris Therapeutics, LLC

Merakris Therapeutics, based in Research Triangle Park, North Carolina, is focused on researching, developing, and marketing regenerative healthcare products. Merakris is pioneering commercially scalable biotherapeutic technologies derived from stem cells that have various clinical applications. Our vision is to improve global patient care and outcomes through the pioneering and innovation of acellular regenerative biotechnologies. Learn more at http://www.merakris.com.

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Meet the world’s first pig-monkey hybrid – Free Press Journal

By daniellenierenberg

Beijing: In a world first, researchers have been able to produce pig-monkey hybrids in a Chinese laboratory, a media report said. Two piglets - having monkey tissues in their hearts, liver and skin - were born in the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing but died within a week, the Mirror reported.

The announcement to this effect was made by Tang Hai. The experiment comes in the wake of Spanish scientist Juan Carlos Izpisua Belmonte's attempt to create pig-human hybrids two years ago. Tang and his team injected genetically modified monkey cells into more than 4,000 pig embryos before these were implanted into sows, the New Scientist magazine reported.

Only two of the 10 piglets thus born were hybrids - with tissues in the heart, liver, spleen, lung and skin, partly consisting of monkey cells. Experts suspected that the failure has to do with the IVF process.

Critics have now warned that the scientific development will create "disturbing" dilemmas over the ethics of human-animal hybrids. Doctor Angel Raya, director of the Barcelona Regenerative Medicine Centre, told the Spanish daily El Pais: "What happens if the stem cells escape and form human neurons in the brain of the animal? Would it have consciousness? And what happens if these stem cells turn into sperm cells?''

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Alpine Immune Sciences Presents ALPN-101 Phase 1 Healthy Volunteer Study Data and Details of Upcoming Phase I/II BALANCE GVHD Study at the 61st…

By daniellenierenberg

SEATTLE--(BUSINESS WIRE)--Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented Phase 1 data yesterday from the healthy volunteer study of ALPN-101, a first-in-class dual CD28/ICOS antagonist, and details on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute graft-versus-host disease (GVHD) at the 61st American Society of Hematology Annual Meeting (ASH) in Orlando, FL.

Jan Hillson, MD, Senior Vice President of Clinical Development at Alpine, presented An Open Label Study of ALPN-101, a First-in-Class Dual CD28/ICOS Antagonist, in Subjects with Steroid-Resistant or Steroid-Refractory Acute Graft Versus Host Disease (BALANCE) as part of the oral session, Chemical Biology and Experimental Therapeutics: Novel Compounds and Mechanisms of Action.

Highlights included:

Despite decades of intense research, GVHD remains a major cause of morbidity and mortality after hematopoietic stem cell transplantation, commented Sophie Paczesny, MD, PhD, Professor of Immunology and Pediatrics at Indiana University School of Medicine and lead of the Biomarkers Stem Cell Transplantation Program and one of Alpine's research collaborators. Current therapies are associated with significant toxicities or are simply insufficient to control the disease. CD28 and ICOS appear to be key pathways in the pathogenesis of GVHD, and the presented data with ALPN-101 appear uniquely strong. I look forward to the BALANCE study, which may demonstrate the therapeutic potential of ALPN-101.

About Graft Versus Host Disease (GVHD)

Graft versus host disease (GVHD) is the most common life-threatening complication of a hematopoietic cell transplant. It occurs when donor cells see recipient cells as foreign and attack them. Acute GVHD typically occurs within the early weeks and months after transplant, usually involving the skin, liver, and gastrointestinal tract. GVHD patients remain at risk of organ system damage and increased mortality due to the disease and to high dose glucocorticoids.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely-related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 CD80/86 or ICOS - ICOSL pathways alone.

About Alpine Immune Sciences, Inc.

Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit http://www.alpineimmunesciences.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the timing of our public presentations and potential publication of future clinical data, the efficacy of our clinical trial designs, expectations regarding our ongoing collaborations, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as may, will, should, would, expect, plan, intend, and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

Secreted Immunomodulatory Proteins, SIP, Transmembrane Immunomodulatory Protein, TIP, Variant Ig Domain, vIgD and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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Harvard geneticist George Church’s goal: to protect humans from viruses, genetic diseases, and aging – 60 Minutes – CBS News

By daniellenierenberg

Our lives have been transformed by the information age. But what's coming next is likely to be more profound, call it the genetic information age. We have mapped the human genome and in just the last few years we have learned to read and write dna like software. And you're about to see a few breakthroughs-in-waiting that would transform human health. For a preview of this revolution in evolution we met George Church, a world leading geneticist, whose own DNA harbors many eccentricities and a few genes for genius.

We found George Church in here.Cory Smith: Most of these are frozen George. Little bits of George that we have edited all in different tubes.

Church threw himself into his work, literally. His DNA is in many of the experiments in his lab at Harvard Medical School. The fully assembled George Church is 6'5" and 65. He helped pioneer mapping the human genome and editing DNA. Today, his lab is working to make humans immune to all viruses, eliminate genetic diseases, and reverse the effects of time.

Scott Pelley: One of the things your lab is working on is reversing aging.

George Church: That's right.

Scott Pelley: How is that possible?

George Church: Reversing aging is one of these things that is easy to dismiss to say either we don't need it or is impossible or both.

Scott Pelley: Oh, we need it.

George Church: Okay. We need it. That's good. We can agree on that. Well, aging reversal is something that's been proven about eight different ways in animals where you can get, you know, faster reaction times or, you know, cognitive or repair of damaged tissues.

Scott Pelley: Proven eight different ways. Why isn't this available?

George Church: It is available to mice.

In lucky mice, Church's lab added multiple genes that improved heart and kidney function and levels of blood sugar. Now he's trying it in spaniels.

Scott Pelley: So is this gene editing to achieve age reversal?

George Church: This is adding genes. So, it's not really editing genes. It's, the gene function is going down, and so we're boosting it back up by putting in extra copies of the genes.

Scott Pelley: What's the time horizon on age reversal in humans?

George Church: That's in clinical trials right now in dogs. And so, that veterinary product might be a couple years away and then that takes another ten years to get through the human clinical trials.

Human trials of a personal kind made George Church an unlikely candidate to alter human evolution. Growing up in Florida, Church was dyslexic, with attention deficit, and frequently knocked out by narcolepsy.

Scott Pelley: What was it that made you imagine that you could be a scientist?

George Church: The thing that got me hooked was probably the New York World's Fair in 1964. I thought this is the way we should all be living. When I went back to Florida, I said, "I've been robbed," you know? "Where is it all?" So, I said, "Well, if they're not going to provide it, then I'm gonna provide it for myself."

With work and repetition, he beat his disabilities and developed a genius for crystallography, a daunting technique that renders 3D images of molecules through X-rays and math. But in graduate school at Duke, at the age of 20, his mania for the basic structures of life didn't leave time for the basic structure of life.

Scott Pelley: You were homeless for a time.

George Church: Yeah. Briefly.

Scott Pelley: Six months.

George Church: Six months.

Scott Pelley: And where were you sleeping when you were homeless?

George Church: Well, yeah. I wasn't sleeping that much. I was mostly working. I'm narcoleptic. So, I fall asleep sitting up anyway.

His devotion to crystallography was his undoing at Duke.

George Church: I was extremely excited about the research I was doing. And so, I would put in 100-plus hours a week on research and then pretty much didn't do anything else.

Scott Pelley: Not go to class.

George Church: I wouldn't go to class. Yeah.

Duke kicked him out with this letter wishing him well in a field other than biology. But, it turned out, Harvard needed a crystallographer. George Church has been here nearly 40 years. He employs around 100 scientists, about half-and-half men and women.

Scott Pelley: Who do you hire?

George Church: I hire people that are self-selecting, they see our beacon from a distance away. There are a lot of people that are a little, you know, might be considered a little odd. "Neuroatypicals," some of us are called.

Scott Pelley: "Neuroatypical?"

George Church: Right.

Scott Pelley: Unusual brains?

George Church: Right, yeah.

Parastoo Khoshakhlagh: One thing about George that is very significant is that he sees what you can't even see in yourself.

Parastoo Khoshakhlagh and Alex Ng are among the "neuroatypicals." They're engineering human organ tissue.

Cory Smith: I think he tries to promote no fear of failure. The only fear is not to try at all.

Cory Smith's project sped up DNA editing from altering three genes at a time to 13,000 at a time. Eriona Hysolli went to Siberia with Church to extract DNA from the bones of wooly mammoths. She's editing the genes into elephant DNA to bring the mammoth back from extinction.

Eriona Hysolli: We are laying the foundations, perhaps, of de-extinction projects to come.

Scott Pelley: De-extinction.

Eriona Hysolli: Yes.

Scott Pelley: I'm not sure that's a word in the dictionary yet.

Eriona Hysolli: Well, if it isn't, it should be.

Scott Pelley: You know there are people watching this interview who think that is playing God.

George Church: Well, it's playing engineer. I mean, humans have been playing engineer since the dawn of time.

Scott Pelley: The point is, some people believe that you're mucking about in things that shouldn't be disturbed.

George Church: I completely agree that we need to be very cautious. And the more powerful, or the more rapidly-moving the technology, the more cautious we need to be, the bigger the conversation involving lots of different disciplines, religion, ethics, government, art, and so forth. And to see what it's unintended consequences might be.

Church anticipates consequences with a full time ethicist in the lab and he spends a good deal of time thinking about genetic equity. Believing that genetic technology must be available to all, not just those who can afford it.

We saw one of those technologies in the hands of Alex Ng and Parastoo Khoshakhlagh. They showed us what they call "mini-brains," tiny dots with millions of cells each. They've proven that cells from a patient can be grown into any organ tissue, in a matter of days, so drugs can be tested on that patient's unique genome.

Scott Pelley: You said that you got these cells from George's skin? How does that work?

Alex Ng: We have a way to reprogram essentially, skin cells, back into a stem cell state. And we have technologies where now we can differentiate them into tissue such as brain tissue

Scott Pelley: So you went from George's skin cells, turned those into stem cells, and turned those into brain cells.

Alex Ng: Exactly. Exactly.

Scott Pelley: Simple as that.

Organs grown from a patient's own cells would eliminate the problem of rejection. Their goal is to prove the concept by growing full sized organs from Church's DNA.

George Church: It's considered more ethical for students to do experiments on their boss than vice versa and it's good to do it on me rather than some stranger because I'm as up to speed as you can be on the on the risks and the benefits. I'm properly consented. And I'm unlikely to change my mind.

Alex Ng: We have a joke in the lab, I mean, at some point, soon probably, we're going to have more of his cells outside of his body than he has himself.

Church's DNA is also used in experiments designed to make humans immune to all viruses.

George Church: We have a strategy by which we can make any cell or any organism resistant to all viruses by changing the genetic code. So if you change that code enough you now get something that is resistant to all viruses including viruses you never characterized before.

Scott Pelley: Because the viruses don't recognize it anymore?

George Church: They expect a certain code provided by the host that they replicate in. the virus would have to change so many parts of its DNA or RNA so that it can't change them all at once. So, it's not only dead. But it can't mutate to a new place where it could survive in a new host.

Yes, he's talking about the cure for the common cold and the end of waiting for organ transplants. It's long been known that pig organs could function in humans. Pig heart valves are routinely transplanted already. But pig viruses have kept surgeons from transplanting whole organs. Church's lab altered pig DNA and knocked out 62 pig viruses.

Scott Pelley: What organs might be transplanted from a pig to a human?

George Church: Heart, lung, kidney, liver, intestines, various parts of the eye, skin. All these things

Scott Pelley: What's the time horizon on transplanting pig organs into human beings?

George Church: you know, two to five years to get into clinical trials. And then again it could take ten years to get through the clinical trials.

Church is a role model for the next generation. He has co-founded more than 35 startups. Recently, investors put $100 million into the pig organ work. Another Church startup is a dating app that compares DNA and screens out matches that would result in a child with an inherited disease.

George Church: You wouldn't find out who you're not compatible with. You'll just find out who you are compatible with.

Scott Pelley: You're suggesting that if everyone has their genome sequenced and the correct matches are made, that all of these diseases could be eliminated?

George Church: Right. It's 7,000 diseases. It's about 5% of the population. It's about a trillion dollars a year, worldwide.

Church sees one of his own genetic differences as an advantage. Narcolepsy lulls him several times a day. But he wakes, still in the conversation, often, discovering inspiration in his twilight zone.

Scott Pelley: If somebody had sequenced your genome some years ago, you might not have made the grade in some way.

George Church: I mean, that's true. I would hope that society sees the benefit of diversity not just ancestral diversity, but in our abilities. There's no perfect person.

Despite imperfection, Church has co-authored 527 scientific papers and holds more than 50 patents. Proof that great minds do not think alike.

The best science can tell, it was about 4 billion years ago that self-replicating molecules set off the spark of biology. Now, humans hold the tools of evolution, but George Church remains in awe of the original mystery: how chemistry became life.

Scott Pelley: Is the most amazing thing about life, then, that it happened at all?

George Church: It is amazing in our current state of ignorance. We don't even know if it ever happened ever in the rest of the universe. it's awe-inspiring to know that it either happened billions of times, or it never happened. Both of those are mind boggling. It's amazing that you can have such complex structures that make copies of themselves. But it's very hard to do that with machines that we've built. So, we're engineers. But we're rather poor engineers compared to the pseudo engineering that is biological evolution.

Produced by Henry Schuster. Associate producer, Rachael Morehouse. Broadcast associate, Ian Flickinger.

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Get The Gloss Beauty & Wellness Awards 2019: The winners & commended – Get The Gloss

By daniellenierenberg

Each day until Christmas we'll be announcing an award winner - think of it as a virtual advent calendar. Today its the turn of Best Hair Tool - brushes at the ready

Wednesday 27 November saw some of the biggest names in beauty and wellness gather at Get The Gloss' HQ with the sole purpose of whittling down the 450 awards entries we received.

Our judges blazed through the day swatching, spritzing and swirling, putting the products through their paces, and after hours spent poring over the latest and greatest beauty releases, our panel of esteemed judges narrowed down over 450 beauty products to a shortlist and a selection of worthy winners. From cult names to little-known brands, your beauty wish list is about to get a whole lot longer.

Check back here and on our Instagram @getthegloss each day to discover our very worthy winners...

Winner: Manta x Zoe Irwin, 25

More than just a hair brush, this ergonomically shaped tool feels like a mini head massage every time you use it - our judges loved the way it stimulated the scalp in ways that other handheld brushes dont.

Commended: Hair story Brush, 11

To be used in conjunction with our Best Health Hair Saviour winner New Wash, this helps rinse hair product thoroughly, and promotes blood circulation for less hair loss, as well as effectively removing dandruff and protecting the scalp from scratchy fingernails.

Winner: ZENii Stem Cell Renewal Day Cream SPF 30, 70

As opposed to a pure SPF product this is moisturiser combined with a high SPF; its comfortable enough to wear all day, with editorial director Victoria Woodhall saying: It feels lovely, quite amazing and very soft.

While it may be expensive, the hefty price tag comes backed up with powerful ingredients including citrus stem cells and hyaluronic acid.

Commended: Altruist Sunscreen SPF50, 7.50 for 2x100ml

For such a fabulous price point, you really cant go wrong with this. Its lightweight with founder Sarah Vine commenting: Thats very nice, I would actually wear that - big words!

We like the story behind it too - the price point is so reasonable as it was launched by a dermatologist who wanted to make sunscreen accessible to all to reduce skin cancer diagnoses.

Winner: Code8 Highlight HD Palette, 24

For a touch of summer in the chilliest months, you cant go wrong with this two-toned palette, that offers the perfect amount of shimmer.

Commended: Beuti Skincare Pomegranate Glow 3in1 Enzyme Cleanser flash mask, 55.00

We love a multi-purpose product, so this was an instant hit around the judging table. The gel-balm hybrid can be used as a cleanser or a mask for a mini-facial, depending on what youre after.

Winner: WooWoo Tame it! Hair Removal Cream, 6.75

A far cry from the hair removal creams of yesteryear, this has none of the unpleasant scent you might remember and leaves skin soft and smooth. It almost makes hair removal cool - no mean feat!

Highly commended: MegsMenopause Blossom Balm, 10

Targeting vaginal dryness, this intimate skin moisturiser makes menopause a whole lot more comfortable - plus, the bottle is made from 96% recyclable materials.

Winner: Votary Rose Geranium and Apricot Cleansing Oil, 45

When Ateh Jewel says she uses a product every night, you sit up and listen. Something of a cult item in beauty circles, this cleansing oil goes on like velvet and leaves your skin feeling like silk.

Highly commended: Jane Scrivner Nourishing Cleanser, 46

With a creamy and delicious texture, this removes every scrap of makeup without being harsh on the skin.

Highly commended: PAI Light Work Rosehip Cleansing Oil, 36

As the name says, this cleansing oil is light as air, with the rosehip leaving a pleasing glow on the skin.

Winner: 001 Cryopress Ice Facial Massager, 75

After a full-on day of judging, this ice-cold facial massager was a breath of fresh air. Kept between -8 and 2.5 degrees Celcius, rolling this over your face increases blood circulation, tightening, firming and lifting the skin. Get The Gloss founder Susannah Taylor commented how amazing it made her skin feel, and if it's good enough for her...

Highly commended: Hayou Beauty Restorer, 38

This jade facial massage tool might not look like much, but it sure packs a punch. Simply sweep it over your face for a massage that not only improves circulation but can also soothe headaches and release tension. Our editorial director Victoria Woodhall commented that she loves it because it transforms your skin from the inside out.

Winner: Hairstory New Wash, 44

When a product is loved by Jonathan Van Ness, you just know it's going to be good - and our judges were definitely in agreement on this one. Darren Fowler commented that he loved the idea of a biodegradable cleanser that does everything in one - a product to use in place of shampoo which strips excess oil, dirt and styling products, but leaves behind all the goodness your hair needs to be happy and healthy.

Highly commended: L'Oreal Professionnel Vitamino Colour Shampoo, 12.90

Expert judges Cher Webb and Susannah Taylor both already use this in their day-to-day lives, so we were excited to give it a whirl - and we weren't disappointed by this trusted and well-known shampoo. Designed for coloured hair, it leaves locks shiny and vibrant, without weighing it down.

Winner: IT Cosmetics Superhero Mascara, 20

A stalwart in makeup artists' bags, Superhero Mascara boasts serious staying power, with our judges impressed by how a little goes a long way - serious bang for your buck with this one. Judge Cher Webb said she always carried it in her kit.

Highly commended: Lottie London Power Foil, 5.20

Launched in 2014, Lottie London is a relatively new player in the game. This eyeshadow wowed the panel thanks to the highly pigmented formula that creates a three-dimensional illusion on the eyes - Christmas party makeup isn't complete without it. Judge and hairstylist Darren Fowler said he'd love to see this on a model when he's on a shoot.

Watch this space tomorrow for another winner's announcement and follow us on Instagram @getthegloss for updates.

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Stem Cells – The Hastings Center

By daniellenierenberg

By Insoo Hyun

Stem cells are undifferentiated cells that have the capacity to renew themselves and to specialize into various cell types, such as blood, muscle, and nerve cells. Embryonic stem cells, derived from five-day-old embryos, eventually give rise to all the different cells and organ systems of the embryo. Embryonic stem cells are pluripotent, because they are capable of differentiating along each of the three germ layers of cells in the embryo, as well as producing the germ line (sperm and eggs). The three germ layers are the ectoderm (skin, nerves, brain), the mesoderm (bone, muscle), and the endoderm (lungs, digestive system).

During later stages of human development, minute quantities of more mature stem cells can be found in most tissue and organ systems, such as bone marrow, the skin, and the gut. These are somatic stem cells, responsible for renewing and repairing the bodys specialized cells. Although the lay public often refers to them as adult stem cells, researchers prefer to call them multipotent because they are less versatile than pluripotent stem cells, and because they are present from the fetal stage of development and beyond. Multipotent stem cells can only differentiate into cells related to the tissue or organ systems from which they originated for instance, multipotent blood stem cells in bonemarrow can develop into different types of blood cells, but not into nerve cells or heart cells.

While multipotent stem cell research has been around for nearly 50 years and has led to clinical therapies for leukemia and other blood disorders, the field of human embryonic stem cell research is still relatively new, and basic discoveries have yet to be directly transitioned into clinical treatments. Human embryonic stem cells were first isolated and maintained in culture in 1998 by James Thomson and colleagues at the University of Wisconsin. Since then, more than a thousand different isolateslines of self-renewing embryonic stem cellshave been created and shared by researchers worldwide.

The main ethical and policy issues with stem cells concern the derivation and use of embryonic stem cells for research. A vocal minority of Americans objects to the destruction of embryos that occurs when stem cells are derived. Embryonic stem cell research is especially controversial for those who believe that five-day-old preimplantation human embryos should not be destroyed no matter how valuable the research may be for society.

To bypass this ethical controversy, the Presidents Council on Bioethics recommended in 2005 that alternative sources of pluripotent stem cells be pursued. Some alternatives have been developed, most notably, the induced pluripotent stem (iPS) cells human skin cells and other body cells reprogrammed to behave like embryonic cells. But embryonic stem cell research will remain needed because there are some questions only they have the potential to answer.

Embryonic stem cells are necessary for several aims of scientific and biomedical research. They include addressing fundamental questions in developmental biology, such as how primitive cells differentiate into more specialized cells and how different organ systems first come into being. By increasing our knowledge of human development, embryonic stem cells may also help us better understand the causes of fetal deformations.

Other important applications lie in the areas of disease research and targeted drug development. By deriving and studying embryonic or other pluripotent stem cells that are genetically-matched to diseases such as Parkinsons disease and juvenile diabetes, researchers are able to map out the developmental course of complex medical conditions to understand how, when, and why diseased specialized cells fail to function properly in patients. Such disease-in-a-dish model systems provide researchers with a powerful new way to study genetic diseases. Furthermore, researchers can aggressively test the safety and efficacy of new, targeted drug interventions on tissue cultures of living human cells derived from disease-specific embryonic stem cells. This method of testing can reduce the risks associated with human subjects research.

One possible way of deriving disease-specific stem cells is through a technique called somatic cell nuclear transfer (SCNT), otherwise known as research cloning. By replacing the DNA of an unfertilized egg with the DNA of a cell from a patients body, researchers are able to produce embryonic stem cells that are genetically-matched to the patient and his or her particular disease. SCNT, however, is technically challenging and requires the collection of high-quality human eggs from female research volunteers, who must be asked to undergo physically burdensome procedures to extract eggs.

A much more widespread and simpler technique for creating disease-specific stem cells was pioneered in 2006 by Shinya Yamanaka and colleagues in Kyoto, Japan. They took mouse skin cells and used retroviruses to insert four genes into them to to create iPS cells. In 2007, teams led by Yamanaka, James Thomson, and George Daley each used similar techniques to create human iPS cells. The iPS cell approach is promising because disease-specific stem cells could be created using skin or blood samples from patients and because, unlike SCNT, it does not require the procurement of human eggs for research.

However, despite these advances, scientists do not believe iPS cells can replace human embryonic stem cells in research. For one, embryonic stem cells must be used as controls to assess the behavior and full scientific potential of iPS cells. Furthermore, iPS cells may not be able to answer some important questions about early human development. And safety is a major issue for iPS cell research aimed at clinical applications, since the cell reprogramming process can cause harmful mutations in the stem cells, increasing the risk of cancer. In light of these and other concerns, iPS cells may perhaps prove to be most useful in their potential to expand our overall understanding of stem cell biology, the net effect of which will provide the best hope of discovering new therapies for patients.

Many who oppose embryonic stem cell research believe for religious or other personal reasons that all preimplantation embryos have a moral standing equal to living persons. On the other hand, those who support embryonic stem cell research point out that not all religious traditions grant full moral standing to early-stage human embryos.

According to Jewish, Islamic, Hindu, and Buddhist traditions, as well as many Western Christian views, moral standing arrives much later during the gestation process, with some views maintaining that the fetus must first reach a stage of viability where it would be capable of living outside the womb. Living in a pluralistic society such as ours, supporters argue, means having to tolerate differences in religious and personal convictions over such theoretical matters as when, during development, moral standing first appears.

Other critics of embryonic stem cell research believe that all preimplantation embryos have the potential to become full-fledged human beings and that they should never have this potential destroyed. In response, stem cell supporters argue that it is simply false that all early-stage embryos have the potential for complete human life many fertility clinic embryos are of poor quality and therefore not capable of producing a pregnancy (although they may yield stem cells). Similarly, as many as 75% to 80% of all embryos created through intercourse fail to implant. Furthermore, no embryos have the potential for full human life until they are implanted in a womans uterus, and until this essential step is taken an embryos potential exists only in the most abstract and hypothetical sense.

Despite the controversies, embryonic stem cell research continues to proceed rapidly around the world, with strong public funding in many countries. In the U.S., federal money for embryonic stem cell research is available only for stem cell lines that are on the National Institutes of Health stem cell registry. However, no federal funds may be used to derive human embryonic stem cell lines; NIH funds may only be used to study embryonic stem cells that were derived using other funding sources.

Despite the lack of full federal commitment to funding embryonic stem cell research in the U.S., there are wide-ranging national regulatory standards. The National Academy of Sciences established guidelines in 2005 for the conduct of human embryonic stem cell research. (See Resources.) According to these guidelines, all privately and publicly funded scientists working with embryonic stem cells should have their research proposals approved by local embryonic stem cell research oversight (ESCRO) committees. ESCRO committees are to include basic scientists, physicians, ethicists, legal experts, and community members to look at stem-cell-specific issues relating to the proposed research. These committees are also to work with local ethics review boards to ensure that the donors of embryos and other human materials are treated fairly and have given their voluntary informed consent to stem cell research teams. Although these guidelines are voluntarily, universities and other research centers have widely accepted them.

At the global level, in 2016 the International Society for Stem Cell Research (ISSCR) released a comprehensive set of professional guidelines for human stem cell research, spanning both bench and clinical stem cell research. (See Resources.) Unlike the NAS guidelines, the ISSCR guidelines go beyond American standards, adding, for example, the recommendation that stem cell lines be banked and freely distributed to researchers around the world to facilitate the fields progress on just and reasonable terms.The potential for over-commercialization and restrictive patenting practices is a major problem facing the stem cell field today, which may delay or reduce the broad public benefit of stem cell research. The promise of broad public benefit is one of thejustifying conditions for conducting stem cell research; without the real and substantial possibility for public benefit, stem cell research loses one of its most important moral foundations.

However, providing useful stem-cell-based therapies in the future is not a simple proposition, either. Developing a roadmap to bring stem cell research into the clinic will involve many complex steps, which the new ISSCR guidelines help address. They include:

These and other difficult issues must be sorted out if stem cell research in all its forms is to fulfill its promise.

STEM CELL GLOSSARY

Newer ethical issues in stem cell research go far beyond the embryo debate, since they encompass all stem cell types, not just human embryonic stem cells, and because they involve human subjects who, despite what one may think about the moral status of preimplantation embryos, are unequivocally moral persons. No other emerging issue better encapsulates the above concern than the growing phenomenon of stem cell tourism. At present, stem cell-based therapies are the clinical standard of care for only afew conditions, such as hematopoietic stem cell transplants for leukemia and epithelial stem cell-based treatments for burns and corneal disorders. Unfortunately, some unscrupulous clinicians around the world are exploiting patients hopes by purporting to provide for large sums of money effective stem cell therapies for many other conditions. These so-called stem cell clinics advance claims about their proffered stem cell therapies without credible scientific rationale, transparency, oversight, or patient protections.

The administration of unproven stem cell interventions outside of carefully regulated research protocols endangers patients and jeopardizes the legitimate progress of translational stem cell scientific research. Patients who travel for unproven stem cell therapies put themselves at risk of physical and financial harm.

The ISSCR guidelines are a good point for thinking about this important problem. The guidelines allow for exceptional circumstances in which clinicians might attempt medically innovative care in a very small number of seriously ill patients, subject to stringent oversight criteria. These criteria include: independent peer review of the proposed innovative procedure and its scientific rationale; institutional accountability; rigorous informed consent and close patient monitoring; transparency; timely adverse event reporting; and a commitment by clinician-scientists to move to a formal clinical trial in a timely manner after experience with at most a few patients. By juxtaposing some current stem cell clinics against the standards outlined in the ISSCR guidelines, one may easily identify some clinics shortcomings and call into question the legitimacy of their purported claims of providing innovative care to patients.

Moving beyond past debates about embryo status to issues concerning the uses of all varieties of stem cells, one can begin to focus the bioethical discourse on areas that have a much broader consensus base of shared values, such as patient and research subject protections and justice. Justice may also call on regulatory and oversight bodies to include a greater involvement of community and patient advocates in the oversight of research. Dealing with the bioethics of stem cell research demands that we wrestle with these and other tough questions.

Insoo Hyun, PhD, is an associate professor of bioethics at Case Western Reserve University.

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Antibiotic in human skin can beat superbugs. Now scientists have a way to put it to use – ThePrint

By daniellenierenberg

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New Delhi: A team of scientists in Bengaluru has claimed that it was able to stimulate skin cells to secrete naturally occurring antibiotics that can help treat superbugs or drug-resistant bacteria.

Antibiotic drugs used to treat infections are increasingly becoming ineffective globally, with bacteria having developed resistance to them over time.

According to the latest study published last monthin journal Cell Reports, scientists have discovered a way to stimulate skin cells to secrete antimicrobial peptides (AMPs).

AMPs target and kill bacteria in such variable ways that few bacteria ever become resistant to these molecules. This makes them uniquely suited to treating antibiotic-resistant bacteria, also called superbugs.

So far, artificially creating effective AMPs for use as antibiotic had not been possible.The new discovery has the potential to treat and prevent infections for post-surgery wounds, especially in diabetic patients and those with weakened immune systems, the researchers said in a statement Thursday.

The team comprises scientists from the National Centre for Biological Sciences, an affiliate of the Tata Institute of Fundamental Research, the Institute for Stem Cell Science and Regenerative Medicine (inStem) and the R&D department of Unilever, all based in Bengaluru.

Also read: Worlds most-isolated city catches NASAs attention as it hunts for innovative tech

To develop new strategies to deal with antimicrobial resistance, scientists from inStem and Unilever probed the cellular mechanisms that regulate the release of AMPs.

Apart from their role as natural antibiotics, AMPs are also known to be involved in wound healing.

Amitabha Majumdar, a researcher at Unilever, hypothesised that the same machinery used to release AMPs during wound-healing could be harnessed to control AMP release from skin cells for treating or preventing infections.

To test this, Majumdar worked with Colin Jamora, a researcher at inStems Centre for Inflammation and Tissue Homeostasis, whose group works extensively on the mechanisms of wound-healing in skin.

The team found a new signalling pathway for long-term release of AMPs from skin cells. Usually, AMPs are released to fight off bacterial infections when direct contact between skin epidermal cells and bacteria occurs. This process is triggered by a reduction in the levels of a protein called caspase-8.

The scientists found that using molecular techniques to reduce caspase-8 is enough to trigger the release of stored AMP from skin cells.

Their study showed that just by modulating caspase-8 levels in the skin, AMP release can be controlled to prevent a whole spectrum of infections.

This may be especially useful for diabetics and patients with weakened immune systems who are highly susceptible to bacterial, yeast, fungal, and viral infections in post-surgery wounds.

Over the last century, bacteria have evolved so much to protect themselves against antibiotics that the World Health Organisation (WHO) fears humankind may soon slip back into a situation similar to the pre-antibiotic era.

According to a WHO report, the death toll caused by antimicrobial resistance is estimated to rise to 10 million annually by 2050 with India carrying one of the largest burdens of drug-resistant pathogens worldwide.

Also read: Gene editing might alter our DNA, but at the cost of our humanity

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MaaT Pharma Announces the Presentation of Positive Data with Its Lead Microbiome Biotherapeutic in Intestinal-Predominant Acute…

By daniellenierenberg

LYON, France--(BUSINESS WIRE)--MaaT Pharma announced today that leading hemato-oncological experts presented clinical data on the compassionate use of MaaT Pharmas lead full-ecosystem microbiome restoration biotherapeutic, MaaT013. The data included eight patients that developed gastrointestinal-predominant, acute Graft-versus-Host-Disease (GI aGvHD) after receiving an allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) to treat their hematologic malignancies. All patients were positively impacted by the MaaT013 treatment, with three patients achieving complete response. GvHD, a condition where the transplant donors immune cells attack the patients tissues, is one of the most serious complications of allo-HSCT, and its acute GI form is fatal in most cases. MaaT013 features a consistently high diversity and richness of microbial species in their natural environment. It aims to restore the symbiotic relationship between microbes in the gut and the immune system of the patient to correct the responsiveness and tolerance (homeostasis) of immune functions and thereby contain GI GvHD. The results were presented in a poster presentation on December 7, 2019 during the 61st American Society of Hematology (ASH) Annual Meeting and Exposition held in Orlando, Florida.

The GI aGvHD patients who were treated with MaaT013 had a very poor prognosis with no other therapeutic options. The results following MaaT013 administration showed a positive impact on all patients, commented Professor Mohamad Mohty, MD, PhD, Head of the Hematology and Cellular Therapy Department at Sorbonne University, Saint Antoine Hospital in Paris. The most impressive results were seen in those patients who achieved a complete response and who were able to taper and stop using steroids and other immunosuppressants without relapse of gastrointestinal symptoms.

In the presented evaluation, eight patients with a median age of 67 were treated for classical aGvHD, late-onset aGvHD or aGvHD with overlap syndrome that were either steroid-resistant or steroid-dependent following stem cell transplantation. These patients had previously been treated with and failed up to five lines of systemic therapy for aGvHD. Each patient received at least one and up to three doses of MaaT013 and treatment response was evaluated seven days after each administration and on day 28 after the first dose. Based on the best response to the treatment, all eight patients experienced at least a partial response with three patients achieving complete response, two patients with very good partial response and three patients with partial response. Overall, the data demonstrated that reintroduction of a full-ecosystem microbiota provided therapeutic effect and was tolerated in a satisfactory manner in these patients.

Herv Affagard, Co-founder and CEO of MaaT Pharma added, We provided our cGMP-manufactured lead biologic drug, MaaT013, to hospitals as part of a compassionate use program to give GI GvHD patients a therapeutic option where there are no other available treatments after steroids and additional lines of treatment. These findings indicate that reestablishing the gut microbiome improved outcomes in these patients.

Moreover, MaaT Pharma is currently conducting the HERACLES Phase II clinical trial (NCT03359980) to evaluate the safety and efficacy of MaaT013 in steroid-refractory, GI aGvHD patients, with more than half of the patients enrolled.

To date, a total of 46 patients with GI GvHD have been treated with MaaT013, including patients under compassionate use and patients enrolled in the Phase II clinical trial. MaaT Pharma is actively developing an oral formulation of MaaT013 (a capsule, MaaT033) to provide easier administration for patients while delivering a similar effect of regenerating the microbial ecosystem with the goal of restoring immune homeostasis in the gut.

The poster can be viewed on the companys website under News.

About HERACLES

The HERACLES study is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the efficacy and safety of MaaT Pharmas lead microbiome restoration drug candidate, MaaT013, in steroid-resistant, gastrointestinal-predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction that is induced by the donor cells derived from the hematopoietic stem cell graft reacting against the host. These strategies have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics, and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition.

About MaaT013

MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using MaaT Pharmas integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the companys centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use.

About MaaT Pharma

MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and Graft-versus-Host-Disease, a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into improving outcomes of immunotherapy in solid tumors, we have built a powerful discovery and analysis platform, GutPrint, to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our biotherapeutics are produced under the strictest cGMP manufacturing and quality control process to safely deliver the full diversity and functionality of the microbiome. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spearhead microbiome treatment integration into clinical practice.

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If you have no idea where to start with your skin care, these new kits make it dummy-proof – Well+Good

By daniellenierenberg

Putting together a skin-care routine from scratch can be a daunting task. Usually, it involves a lot of scrolling through websites wondering where to begin. According to dermatologists, the basics of a good routine include a cleanser, an antioxidant serum, a retinol, a moisturizer, and a sunscreen. Even with that in mind, putting together a multi-step regimen can often feel overwhelming, especially if youre new to the game.

The good news? The holiday shopping season means skin-care kits that are filled with the products you need for a lot less. From cleansers to serums to moisturizers, these babies have got it alljust add some sunscreen into the mix and youll be good to go, all with the single click of the add to cart button. Shop the best skin-care sets below, and get ready to have your skin-care routine down pat.

Achieve the #topshelf of your dreams with this set, which puts mini versions of the brands cult faves into one place. Youll get a Milky Jelly Cleanser, Priming Rich Moisturizer, Future Dew and Super Bounce Serums, andtwo Balm Dotcoms. Your Instagram feed (and your skin) will look lit.

Every serum your skin could possibly need all in one place. Theres the cult-fave Good Genes for chemical exfoliation, C.E.O. Glow Vitamin C for brightening, and A+ High Dose Retinol for stimulating cell turnover. Its also got an eye cream and a moisturizer, so all you need to bring to a party is a cleanser (which derms say you can totally get at the drugstore) and youll be good to go.

This deal seems almost too good to be true. Its gotallof our favorite Fresh products, including the cleanser and lip balm that half of our editors swear by, plus a moisturizer, face mask, and eye cream. You skin will slurp nourishing ingredients like rose, lotus, and black tea right up, and your lips will feel kissable well past New Years Eve.

A great skin-care routine has both exfoliating and hydrating elements, which this kit offers in spades. Theres a cleanser to help prep your skin, AHA Facial Radiance Pads to slough away dead skin cells, and a hydrating hyaluronic acid serum and colloidal oatmeal cream to keep skin moisturized. To keep your lips from feeling left out, theres also a petroleum lip balm thatll soothe away any chapping.

Get your hands on Sephoras seven favorite skin-care products, all in one place. Its a great way to discover clean brands you may not have tried yet by way of their bestselling products, which do everything from exfoliate to hydrate to soothe your skin. A few of my personal favorite picks from this kit? Biossance Squalane + Vitamin C Rose Oil, Farmacy Honeymoon Glow AHA resurfacing night serum, and Youth to the People Superberry Hydrate + Glow Dream Mask.

The best part about The Ordinary? The products are as affordable as they are efficaciousall year round. The Daily Set has everything your dry skin needs, including a hydrating gentle cleanser, a 2 percent hyaluronic acid serum, and an ultra-hydrating moisturizer.

If youve heard everyone in your group chat raving about Drunk Elephant for the last few years and have yet to try it for yourself, consider this your best point of entry. This set includes travel-sized versions of the brands best sellers, including the C-Firma serum, T.L.C. Framboos Glycolic Night Serum, and Protini Polypeptide Cream (plus, my personal favorite sunscreen, Umbra Tinte Physical Daily Defense SPF 30). Its a great way to sample a huge selection of the line before deciding which products are investing in full sizes of. Or, if youre already a Drunk Elephant devotee, this is a great way to keep your routine with you everywhere you go.

Protecting your skin barrier is critical to healthy skin, and thats the priority of this full-service set. The gentle cleanser will get rid of makeup and grime, and the lotion and lip balm help seal in moisture. Theres also an antioxidant treatment that reduces redness and blotchiness, plus irritation-soothing creams for your body and hands.

This line is the K-beauty holy grail for hydration, and is perfect for combatting the effects that cold weather has on your skin during the early months of the year. Each of the productsfrom the cream cleanser to the essence to the moisture cream to the sleep maskare all formulated with ingredients to lock in moisture and keep your complexion from feeling parched. Plus, the Lip Sleeping Mask is a treat for chapped lips at all hours of the day and night.

Ask any derm the holy-grail serums that everyone should have in their routine, and theyll tell you Vitamin C, hyaluronic acid, and retinol. This kit has all three of them, plus a caffeine-infused eye cream that will make you look instantly more awake.

As far as skin care goes, you really cant go wrong with a dermatologist-developed line. Our editors are huge fans of all things from Dr. Dennis Gross, and this kit will allow you to try his cosmetically elegant products like a ferulic and retinol overnight serum and eye cream, a vitamin C and collagen serum, and a best-in-class AHA/BHA Peel. As a whole, the set is meant to target fine lines and wrinkles, all while hydrating and brightening in the process.

Hardly surprising, but a lot of Dermstores favorite products areour favorite products, too. In this kit, youll receive picks from Naturopathica, SkinMedica, Bioderma, Boscia, and First Aid Beauty, among others, that make up an entire multi-step regimen. If youre not quite sure about going all-in on a single brand, this is a great way to try a lot of different things all at the same time for aseriouslydiscounted price.

Finding the right routine for acne can be a lot of trial and error, but this medical-grade kit does a lot of the legwork for you. Its got all of the best acne-fighting ingredients like Benzoyl Peroxide and Retinol, plus a niacinamide-packed moisturizer to reduce any irritation from the treatments.

A fan-favorite brand among both French girls and beauty editors, this oh-so-simple three step routine is perfect for anyone looking to streamline what theyre doing to their skin. Theres a micellar water, which acts as a gentle cleanser, a sensitive-skin-friendly moisturizer, and a puffiness-reducing eye cream to top it all off.

This kit has everything you need for cleansing, hydrating and brightening your skin, the combination of which will leave it looking radiant. Theres a stem cell cleanser, three different serums that have hyaluronic acid and vitamins C, A, and E, plus a mask for nights when your face needs a little bit more love.

To help brighten skin, you first need to slough away the old, dead skin cells that have been accumulating on your complexion. Start with a lactic acid-spiked resurfacing treatment and then slather on the potent vitamin C-laced brightening serum. Top it all off with pure argan oil (the ingredient the brand is known for) to moisturize it.

Heres what a dermatologists skin-care routine looks like:

Looking to buy beauty gifts for someone else this holiday season? Consider this hi-def makeup mirror, or one of the products our readers swear by for bringing dry hair back to life.

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5 Innovations From the Science of Senses Now. Powered by – Now. Powered by Northrop Grumman.

By daniellenierenberg

Millions of people around the world have some form of sight or hearing loss, have no sense of smell or taste or have lost limbs, taking away their sense of touch. Fortunately, the science of senses is the most advanced its ever been. Biotech researchers are developing methods that merge humans and machines in ways that could restore human abilities to hear, see, taste, smell and touch. From neuro-prosthetic limbs that mimic touch to bionic eyes and smart glasses that restore sights, the innovations could drastically improve the quality of life of people around the world.

Some of the most advanced technology developed around the science of senses comes from the field of prosthetic limbs, where researchers are finding ways to connect tissue to metal. Systems called brain-machine interfaces literally wire robotic limbs to a persons nervous system. Two of the latest achievements were reported in July 2019 in the journal Science Robotics.

In the first, a team from the University of Utah connected a robotic hand and partial forearm to the remaining nerves in the mans arm. The man trained his brain to control the motion of the hand. At the same time, artificial zaps sent to the robotic hand were designed to mimic the skins natural response patterns to touch. Remarkably, the man could more easily discriminate between small and large objects as well as soft and hard items while blindfolded and wearing headphones. Another team, based at the National University of Singapore, engineered flexible, electronic skin that contains artificial nerves that transmit signals 1,000 times faster than nerves in human skin. The skin is able to sense temperature, pressure and humidity and is also durable enough to function even if it is scratched or damaged.

Since the mid-1980s, a tiny electronic device called a cochlear implant has been providing the sense of sound to hundreds of thousands of people worldwide, according to the National Institutes of Health. Part of the implant is surgically placed under the skin behind the ear, with another part attached in the same position externally. A third part is inserted inside the ear canal. Unlike a hearing aid that amplifies sound, a cochlear implant senses sounds and converts them into an electric signal that it uses to stimulate a persons auditory nerve. Even people who are profoundly deaf can learn to discern sounds as long as some fraction of their nerve still functions.

But cochlear implants are not perfect. They are only capable of sensing and transmitting part of a sound waves full audio spectrum, producing a sound that has a metallic quality. That can make it difficult to filter out background noise, such as a crowd conversations or traffic. In 2019, a team from the University of Greenwich in England reported on new research that improves upon this technology, reports MedicalXpress. It deconstructs sounds from the environment and then reconstructs them with 90% to 100% percent efficiency. This means patients will be able to better distinguish noises from background sounds.

Smell loss, called anosmia, affects about 5% of the general population, according to the Massachusetts Eye and Ear Infirmary. The condition may be the result of something temporary, such as a sinus infection or swelling or polyps in the nasal cavity or it could be the result of damage to the sensory nerves. Permanent loss of smell can impact daily enjoyment of life and even affect safety. The inability of smelling smoke or natural gas could put someone in harms way.

Although there is no proven therapy, researchers at the Massachusetts Eye and Ear have, for the first time, invented a device that stimulates different smells. Their technology, which they reported in 2018 in the International Forum of Allergy & Rhinology, uses an array of tiny electrodes to send an electrical signal to the olfactory bulb, a structure in the brain involved in smell. In a small experiment, the scientists created different electrical stimulation in five patients, producing smells similar to onions and antiseptic as well as sour and fruity aromas. Although the innovation is still in the early stage, it demonstrates a possible path forward for a cochlear implant for the nose, the scientists say.

Although smell is connected to taste, its the receptor cells on the taste buds of a persons tongue that discern sweet, salty, sour, bitter or savory flavors. Medical procedures inside the mouth or ear can alter a persons taste, as can head trauma or ear infections, according to MedicineNet. Scientists have made a couple of attempts to solve the problem with technology. Back in 2013, a team from the National University of Singapore developed a taste simulator that used a kind of electronic tongue depressor to simulate taste sensations, New Scientist reported. Later, another team at City University of London invented a similar device called Taste Buddy that also stimulated taste buds to alter the flavor of foods, reported Digital Trends.

Unfortunately, neither gadget went beyond the research lab. For now, solutions may lie within human DNA. Lynnette McCluskey, a neurobiologist at the Medical College of Georgia at Augusta University, and her team are investigating whether a protein called interleukin-1, or IL-1, secreted during an injury could help rebuild a persons sense of taste. The protein promotes inflammation and also helps regulate nerve growth. In 2018, she and her colleagues received grant money to study whether manipulating the proteins after an injury could help the nerves associated with taste recover faster, reports MedicalXpress. It could take a few more years to find out.

Worldwide, 36 million people are legally blind, according to Nature. Some biotechnological solutions, such as growing stem cells into those that can repair damage to the retina or using techniques from gene therapy to correct genetic defects, are showing promising results. But technology is also playing a big role.

A bionic eye, called the Argus II, is a retinal prosthesis system that, since its development in early 2000, has restored some vision capabilities to more than 300 people. Its reserved for people who have no vision or almost no vision due to a genetic condition called retinitis pigmentosa. Patients undergo surgery, in which a tiny electronic device is attached to the persons retina. Its connected wirelessly to a pair of smart glasses that have a portable video-processing unit that project images from the outside world onto the persons retina. Clinical trials done in 2015 showed that visual function improved in 90% of people wearing the prosthesis and that 80% of patients reported improved quality of life, according to the American Academy of Ophthalmology.

Advances in technology are allowing machines to merge with the human body. Coupled with our growing ability to correct genetic defects or repair cellular damage, the science of senses is moving into the future. One day all humans could move through the world with all five of their senses intact seeing the unseen, hearing the unheard and tasting, touching and smelling new wonders that evoke all of the pleasures of being alive.

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Exclusive: Two pigs engineered to have monkey cells born in China – New Scientist News

By daniellenierenberg

By Michael Le Page

Tang Hai

Pig-primate chimeras have been born live for the first time but died within a week. The two piglets, created by a team in China, looked normal although a small proportion of their cells were derived from cynomolgus monkeys.

This is the first report of full-term pig-monkey chimeras, says Tang Hai at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing.

The ultimate aim of the work is to grow human organs in animals for transplantation. But the results show there is still a long way to go to achieve this, the team says.

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Hai and his colleagues genetically modified cynomolgus monkey cells growing in culture so they produced a fluorescent protein called GFP. This enabled the researchers to track the cells and their descendents. They then derived embryonic stem cells from the modified cells and injected them into pig embryos five days after fertilisation.

More than 4000 embryos were implanted in sows. Ten piglets were born as a result, of which two were chimeras. All died within a week. In the chimeric piglets, multiple tissues including in the heart, liver, spleen, lung and skin partly consisted of monkey cells, but the proportion was low: between one in 1000 and one in 10,000.

It is unclear why the piglets died, says Hai, but because the non-chimeric pigs died as well, the team suspects it is to do with the IVF process rather than the chimerism. IVF doesnt work nearly as well in pigs as it does in humans and some other animals.

The team is now trying to create healthy animals with a higher proportion of monkey cells, says Hai. If that is successful, the next step would be to try to create pigs in which one organ is composed almost entirely of primate cells.

Something like this has already been achieved in rodents. In 2010, Hiromitsu Nakauchi, now at Stanford University in California, created mice with rat pancreases by genetically modifying the mice so their own cells couldnt develop into a pancreas.

In 2017, Juan Carlos Izpisua Belmontes team at the Salk Institute in California created pig-human chimeras, but only around one in 100,000 cells were human and, for ethical reasons, the embryos were only allowed to develop for a month. The concern is that a chimeras brain could be partly human.

This is why Hai and his team used monkey rather than human cells. But while the proportion of monkey cells in their chimeras is higher than the proportion of human cells in Belmontes chimeras, it is still very low.

Given the extremely low chimeric efficiency and the deaths of all the animals, I actually see this as fairly discouraging, says stem cell biologist Paul Knoepfler at the University of California, Davis.

He isnt convinced that it will ever be possible to grow organs suitable for transplantation by creating animal-human chimeras. However, it makes sense to continue researching this approach along with others such as tissue engineering, he says.

According to a July report in the Spanish newspaper El Pas, Belmontes team has now created human-monkey chimeras, in work carried out in China. The results have not yet been published.

While interspecies chimerism doesnt occur naturally, the bodies of animals including people can consist of a mix of cells. Mothers have cells from their children growing in many of their organs, for instance, a phenomenon called microchimerism.

Journal reference: Protein & Cell, DOI: 10.1007/s13238-019-00676-8

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A Genetic Network Sheds Light on the Evolution of the Modern Human Face – Technology Networks

By daniellenierenberg

The study, published inScience Advances, results from the collaboration between a UB team led by Cedric Boeckx, ICREA professor from the Section of General Linguistics at the Department of Catalan Philology and General Linguistics, and member of the Institute of Complex Systems of the UB (UBICS), and researchers from the team led by Giuseppe Testa, lecturer at the University of Milan and the European Institute of Oncology.

An evolutionary process similar to animal domestication

The idea of human self-domestication dates back to the 19th century. It is the claim that anatomical and cognitive-behavioral hallmarks of modern humans, such as docility or a gracile physiognomy, could result from an evolutionary process bearing significant similarities to the domestication of animals.

The key role of neural crest cells

Earlier research by the team of Cedric Boeckx had found genetic similarities between humans and domesticated animals in genes. The aim of the present study was to take a step further and deliver empirical evidence focusing on neural crest cells. This is a population of migratory and pluripotent cells - able to form all the cell types in a body - that form during the development of vertebrates with great importance in development. "A mild deficit of neural crest cells has already been hypothesized to be the factor underlying animal domestication. Could it be that humans got a more prosocial cognition and a retracted face relative to other extinct humans in the course of our evolution as a result of changes affecting neural crest cells?" asks Alejandro Andirk, PhD students at the Department of Catalan Philology and General Linguistics of the UB, who took part in the study.

To test this relationship, researchers focused on Williams Syndrome disorder, a specific human neurodevelopmental disorder characterized by both craniofacial and cognitive-behavioral traits relevant to domestication. The syndrome is a neurocristopathy: a deficit of a specific cell type during embryogenesis. In this case, neural crest cells.

In this study, researchers from the team led by Giuseppe Testa used in vitro models of Williams syndrome with stem cells derived from the skin. Results showed that the BAZ1B gene -which lies in the region of the genome causing Williams Syndrome- controls neural crest cell behavior: lower levels of BAZ1B resulted in reduced neural-crest migration, and higher levels produced greater neural-crest migration.

Comparing modern human and Neanderthal genomesResearchers examined this gene in archaic and modern human genomes. "We wanted to understand if neural crest cell genetic networks were affected in human evolution compared to the Neanderthal genomes", Cedric Boeckx said.

Results showed that that BAZ1B affects a significant number of genes accumulating mutations in high frequency in all living human populations that are not found in archaic genomes currently available. "We take this to mean that BAZ1B genetic network is an important reason our face is so different when compared with our extinct relatives, the Neanderthals," Boeckx said. "In the big picture, it provides for the first time experimental validation of the neural crest-based self-domestication hypothesis," continues.An empirical way to test evolutionary claims

These results open the road to studies tackling the role of neural crest cells in prosociality and other cognitive domains but is also one of the first examples of a potential subfield to test evolutionary claims. "This research constitutes one of the first studies that uses cutting-edge empirical technologies in a clinical setting to understand how humans have evolved since the split with Neanderthals, and establishes Williams Syndrome in particular as a unique atypical neurodevelopmental window onto the evolution of our species," Boeckx concludes.

Reference: Zanella et al. 2019.Dosage analysis of the 7q11.23 Williams region identifies BAZ1B as a major human gene patterning the modern human face and underlying self-domestication. Science Advances.DOI: 10.1126/sciadv.aaw7908.

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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Leafly’s Holiday Gifts: For the skin you’re in – Leafly

By daniellenierenberg

That dewy glow, like a cloudburst mist in the desert sky. Let your lit-from-within friends know they are seen. Theres even skincare for down there.

$50

Brought to you by MeCBD

Featuring Your Majesty CBD Cream, Pure Vitamin C Serum with CBD and CBD body butter, theMeCBD Holiday Beauty Faves package was made for the most glamorous person on your gift list. Whether theyve perfected the multi-step skincare routine, or simply aspire to CBD skin greatness, theyll enjoy the soothing, nourishing, and brightening ingredients of each organic product.

$49.99

If youve been keeping it cute and cuddly with someone, Heylos Loud Sensational Intimate Moisturizer might be the perfect gift to show them your appreciation. With lab-tested ingredients and a non-sticky formula, this lube is actually a great gift no matter what time of year. No bae in sight? Go ahead and treat yourself to this silky, CBD silicone-based delight.

$15.99

(Alex Manning/Leafly)

Amber has a wide range of CBD skin products that can be mixed and matched for a personalized holiday gift. Whatever you choose, dont miss the CBD face masque, infused with rosemary and black licorice to help keep skin aglow, even in the dreariest of winter months. Skincare lovers will squeal when they realize the mask comes in two convenient pieces so that it can hit every contour of their gorgeous faces.

$51

Brought to you by MeCBD

You cant always be sure that your faves can make it to the spa, but you can bring the spa to them with the MeCBD Holiday Spa Faves package. This package features CBD massage oil, CBD apple stem cell face cream formulated to reduce lines and wrinkles, and a Dead Sea mud mask infused with CBD to help revitalize worn-out, dull skin cells. Its the spa in a bag (or delivery box) that your hard-working loved ones deserve.

$48

Herbivores Emerald Deep Glow Oil contains CBD and adaptogens that leave faces looking dewy and rejuvenated. Its the perfect antidote for skin fighting the effects of dry winds and stale airplane air, so your faves can stay flawless no matter where they go. And remember, we wont tell if you get the full size for yourself, and the minis for your favorite jet-setters.

$80

Made with wild lavender, black currant seed oil, and frankincense, you dont have to be one of the Three Wise Men to know that this face serum is packed with heavy-hitting botanicals. Khus Khus Sen serum blends both Ayurvedic and Western ingredients to tap into the life cycle of cells and help with acne, inflammation, fine lines, and balance.

Leafly is the worlds largest cannabis information resource, empowering people in legal cannabis markets to learn about the right products for their lifestyle and wellness needs. Our team of cannabis professionals collectively share years of experience in all corners of the market, from growing and retail, to science and medicine, to data and technology.

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Novadip Biosciences to present data at 17th Annual Meeting of the International Federation for Adipose Therapeutics and Science – Financialbuzz.com

By daniellenierenberg

Novadip Biosciences to present data at 17th Annual Meeting of the International Federation for Adipose Therapeutics and Science

Mont-Saint Guibert, Belgium, 4 December, 2019: Novadip Biosciences (Novadip or the company), a clinical-stage biopharmaceutical company leveraging its unique tissue regeneration technology platform to generate multiple product candidates, announces that it is presenting data in a series of presentations at the 17th Annual Meeting of the International Federation for Adipose Therapeutics and Science (IFATS) taking place in Marseille, France, from 4-7 December 2019.

Dr Denis Dufrane, Chief Scientific Officer and co-founder, Novadip, commented: The findings that will be presented at IFATS highlight the capabilities of Novadips 3-dimensional, scaffold-free extracellular matrix (ECM) technology platform utilizing adipose-derived stem cells (ASCs) to generate product candidates to address critical size bone and skin reconstruction, as well as our manufacturing capabilities and expertise. We look forward to progressing our clinical programmes and generating further data in support of our unique platform as we look to address hard and soft tissue reconstruction for patients who have limited or no treatment options.

Novadip will deliver five oral presentations and one video presentation. Details of the presentations and short summaries are below.

Genetic stability assessment in bone tissue-engineered productsCline Pierard, oral presentation #8 (abstract 1395), 5 December 2019, 8:38 am CET

The presentation will discuss the different analytical approaches to predict the genetic behavior over the entirety of the manufacturing process for the companys product candidates for bone reconstruction.

A scaffold-free graft for large critical size bone defect: preclinical evidence to clinical proof of conceptSophie Veriter, video presentation #V5 (abstract 1363), 5 December 2019, 2:48 pm CET

The session will discuss how the scaffold-free 3D-graft (comprised of ASCs) plays a major role promoting ASCs engraftment and to induce osteogenesis in a fibrotic environment and promote bone fusion in a critical-sized bone defect.

The in vivo immunogenicity of a human 3D scaffold-free tissue engineered product for bone reconstruction: a xenogenic modelGatan Thirion, oral presentation #30 (abstract 1382), 5 December 2019, 4:30 pm CET

Detail will be provided on how the human scaffold-free 3D approach, in a xenogenic model, can elicit a specific anti-human immune response but can maintain the potential of in vivo osteogenicity.

An allogenic 3D scaffold-free tissue engineered product for deep thickness skin regeneration: in vitro development to in vivo proof of conceptSophie Veriter, oral presentation #88 (abstract 1317), 6 December 2019, 5:50 pm CET

The presentation will discuss how the scaffold-free approach with the allogenic 3D-graft (derived from ASCs) demonstrated safety and efficacy in a stringent xenogenic model of hyperglycemic and ischemic deep-thickness wound.

Allogenic 3D scaffold-free tissue engineered product for deep thickness skin regeneration: in vitro characterization and in vivo biocompatibilityValrie Lebrun, oral presentation #90 (abstract 1341), 6 December 2019, 6:06 pm CET

The presentation will provide an overview on how the allogenic scaffold-free 3D-graft improves ASC bioactivity for the angiogenesis and in vivo remodeling by the specific ECM-proteins of wound healing.

Monitoring of cell culture conditions and early prediction of the quality of an osteogenic cell-based medicinal productAnas Namur, oral presentation #136 (abstract 1392), 7 December 2019, 2:44 pm CET

The session will describe how cellular metabolism was studied throughout the companys manufacturing process to better understand the physiology of the proliferative and differentiated cells and subsequently develop predictive tests focused on critical attributes of the final product.

To view the full abstracts, please follow this link.

The full list of abstracts can be found here. Further information on IFATS is available here.

Ends

Notes to editors

Novadip Biosciences

Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its unique 3D tissue regeneration technology platform to generate multiple product candidates to address hard and soft tissue reconstruction for patients who have limited or no treatment options. The companys proprietary 3M3 platform is a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly-specific growth factors and miRNA to mimic the physiology of natural healing and creates a range of products that address specific challenges in tissue regeneration. Novadips initial focus is on critical size bone reconstruction and its lead program is in development for a rare pediatric orthopedic disease. The company is also applying its 3M3 platform to develop truly novel off-the-shelf/allogeneic therapies to address more prevalent tissue defects. For more information, visit http://www.novadip.com .

For further information, please contact:

Novadip Biosciences

Jeff Abbey

Chief Executive Officer

+32 (10) 779 220

info@novadip.com

For media enquiries:

Consilium Strategic Communications

Chris Gardner, Matthew Neal, Angela Gray

+44 (0) 20 3709 5700

novadip@consilium-comms.com

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We have the first genetic evidence of human self-domestication – ZME Science

By daniellenierenberg

New research at the University of Barcelona (UB) found the first genetic evidence that humanity has self-domesticated.

The team found a network of genes involved in the evolution of human face structure and prosociality in modern humans which is absent in the Neanderthal genome. This suggests that our ancestors preferred to hang out and mate with friendlier and more cooperative companions over less-cooperative, more aggressive ones. In effect, this amounted to selective pressure for prosocial behavior over time, meaning that we domesticated our own species.

Certain anatomical, cognitive, and behavioral traits of modern humans chief among them docility and a fragile facial structure are hallmarks of the domestication process. This led to the idea of human self-domestication being developed all the way back in the 19th century, the team explains. However, we lacked the tools to confirm that this process took place (i.e. that theres genetic evidence for it).

The study builds on the teams previous research that looked into genetic similarities between humans and domesticated animals. Now, the team went one step further and looked for genetic evidence for self-domestication in neural crest cells. This is a population of cells that have a major role to play in the early development of vertebrate embryos by differentiating into more specialized cells.

A mild deficit of neural crest cells has already been hypothesized to be the factor underlying animal domestication, explains co-author Alejandro Andirk, a Ph.D. student at the Department of Catalan Philology and General Linguistics of the UB.

Could it be that humans got a more prosocial cognition and a retracted face relative to other extinct humans in the course of our evolution as a result of changes affecting neural crest cells?

In order to test their hypothesis, the team focused on Williams syndrome disorder, a human-specific neurodevelopmental disorder caused by a deficit of neural crest cells as the embryo develops. It is characterized by mild to moderate intellectual disability or learning problems, unique personality characteristics, distinctive facial features, and cardiovascular problems.

The researchers used in vitro models of Williams syndrome (stem cells derived from the skin of patients with this syndrome). After poking around, they found that the BAZ1B gene, conveniently located in the region of the genome associated with Williams syndrome, is responsible for controlling the behavior of neural crest cells. If this gene was under-expressed, it led to reduced migration of these cells; higher expression levels led to greater neural crest migration. Then, they compared this gene to its equivalent in samples of archaic (i.e. extinct) and modern (i.e. our ancestors) human genomes.

We wanted to understand if neural crest cell genetic networks were affected in human evolution compared to the Neanderthal genomes, says Cedric Boeckx, ICREA professor at the Department of Catalan Philology and General Linguistics.

Differences in the BAZ1B gene between archaic and modern humans led to a high frequency of mutations in that accumulated over time in modern humans but not in any of the archaic genomes currently available. The team says this points to BAZ1B as being an important reason our face is so different when compared with our extinct relatives, the Neanderthals.

In the big picture, it provides for the first-time experimental validation of the neural crest-based self-domestication hypothesis, Boeckx adds.

The paper Dosage analysis of the 7q11.23 Williams region identifies BAZ1B as a major human gene patterning the modern human face and underlying self-domestication has been published in the journal Science Advances.

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Stromal Vascular FractionMarket Estimated to be Driven by Innovation and Industrialization – The Market Expedition

By daniellenierenberg

Stromal vascular fraction skin treatment is a type of stem cell therapy based on isolation of adipose tissue during liposuction or lipo-aspiration procedures of patients own body. In stromal vascular fraction treatment isolation of tissue contains fat cells, blood cells, and endothelial cells, as well as a large fraction of adipose-derived mesenchymal stem cells which provides regenerative properties and have positive anti-aging properties. A stromal vascular fraction is considered as a personalized stem cell therapy and effective tropical or injectable treatment.

With increasing age, regenerative and repair properties of skin are less effective due to decrease in stem cell count, and therefore, stromal vascular fraction treatment contains stem cell provides a boost in repair and maintenance mechanism of the skin leaving smooth, healthy, radiant skin. Stromal vascular fraction is a naturally occurring stem cell found in bundles of adipose tissues and are the primary source of growth factors along with macrophages and other cells. Due to the presence of growth factors, the stromal vascular fraction is utilized to decrease inflammation present in many diseases. A stromal vascular fraction is adopted in the treatment of rheumatoid arthritis, joint replacement, osteoarthritis, diabetes, Crohn's disease, and others.

Stromal Vascular Fraction Market: Overview

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Stromal vascular fraction is a combination of adipose-derived stromal cells (ADSCs), endothelial cells (ECs), endothelial precursor cells (EPCs), smooth muscle cells, macrophages, pericytes, and pre-adipocytes in the aqueous state. Stromal vascular fraction is advantageous over alternative medical treatments as SVF has the ability to regulate patients own system with the main focus on cell repair and regulation of defective cells. Stromal vascular fraction is a promising field for disease prophylaxis and currently are in clinical trials.

The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to categories such as market segments, geographies, types, technology and applications.

The report covers exhaustive analysis on: Market Segments Market Dynamics Market Size Supply & Demand Current Trends/Issues/Challenges Competition & Companies involved Technology Value Chain

Stromal Vascular Fraction Market: Segmentation

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The globalstromal vascular fraction marketcan be segmented on the basis of type of therapy, end-user, and region.

By Therapy Type SVF Isolation Products Enzymatic Isolation Non-enzymatic Isolation Automated POC Devices SVF Aspirate Purification Products SVF Transfer Products

By End-user Hospitals Specialty Clinics Stem Cell Banks/Laboratories Others

By Application Cosmetic Soft-tissue Orthopedic Others

By Region North America Latin America Europe Asia Pacific (APAC) South Korea Middle East and Africa (MEA)

In its last part, the report offers insights on the key players competing in the global market for stromal vascular fraction. With detailed profiling of each of the key companies active on the competitive landscape, the report provides information about their current financial scenario, revenue share at a global level, development strategies, and future plans for expansion. Strategic collaborations, mergers, and acquisitions have also been considered as a key strategy among a majority of leading companies in the market.

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