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Spinal Cord – Brain, Spinal Cord, and Nerve Disorders …

By daniellenierenberg

The spinal cord is a long, fragile tubelike structure that begins at the end of the brain stem and continues down almost to the bottom of the spine. The spinal cord consists of nerves that carry incoming and outgoing messages between the brain and the rest of the body. It is also the center for reflexes, such as the knee jerk reflex (see Figure: Reflex Arc: A No-Brainer).

Like the brain, the spinal cord is covered by three layers of tissue (meninges). The spinal cord and meninges are contained in the spinal canal, which runs through the center of the spine. In most adults, the spine is composed of 33 individual back bones (vertebrae). Just as the skull protects the brain, vertebrae protect the spinal cord. The vertebrae are separated by disks made of cartilage, which act as cushions, reducing the forces generated by movements such as walking and jumping. The vertebrae and disks of cartilage extend the length of the spine and together form the vertebral column, also called the spinal column.

A column of bones called vertebrae make up the spine (spinal column). The vertebrae protect the spinal cord, a long, fragile structure contained in the spinal canal, which runs through the center of the spine. Between the vertebrae are disks composed of cartilage, which help cushion the spine and give it some flexibility.

Like the brain, the spinal cord is covered by three layers of tissue (meninges).

Spinal nerves: Emerging from the spinal cord between the vertebrae are 31 pairs of spinal nerves. Each nerve emerges in two short branches (roots):

One at the front (motor or anterior root) of the spinal cord

One at the back (sensory or posterior root) of the spinal cord

The motor roots carry commands from the brain and spinal cord to other parts of the body, particularly to skeletal muscles.

The sensory roots carry information to the brain from other parts of the body.

Cauda equina: The spinal cord ends about three fourths of the way down the spine, but a bundle of nerves extends beyond the cord. This bundle is called the cauda equina because it resembles a horses tail. The cauda equina carries nerve impulses to and from the legs.

Like the brain, the spinal cord consists of gray and white matter. The butterfly-shaped center of the cord consists of gray matter. The front wings (also called horns) contain motor nerve cells (neurons), which transmit information from the brain or spinal cord to muscles, stimulating movement. The back horns contain sensory nerve cells, which transmit sensory information from other parts of the body through the spinal cord to the brain. The surrounding white matter contains columns of nerve fibers that carry sensory information to the brain from the rest of the body (ascending tracts) and columns that carry motor impulses from the brain to the muscles (descending tracts).

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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.


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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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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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.


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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With another $26M, Japan’s Heartseed aims to advance iPSC-derived regenerative medicine for heart failure – BioWorld Online

By daniellenierenberg

With another $26M, Japan's Heartseed aims to advance iPSC-derived regenerative medicine for heart failure  BioWorld Online

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Meditation increases blood flow in the heart, PET scans show – Health Imaging

By daniellenierenberg

Schneider noted that prior research has established psychosocial stress as a risk factor for coronary heart disease. However, stress reduction techniques arent typically included in cardiac rehabilitation.

In their study, the researchers randomly divided 56 patients into four groups: cardiac rehab, transcendental meditation, transcendental meditation plus cardiac rehabilitation or normal care.

According to the research, 37 patients completed the study. Of that group, patients who practiced transcendental meditation and cardiac rehabilitation increased their myocardial blood flow by 20.7%. PET scans also revealed a 12.8% increase in those who completed mediation alone. Cardiac rehab improved flow by 5.8%, while usual treatment decreased that metric by 10.3%.

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CALQUENCE Significantly Prolonged the Time Patients Lived Without Disease Progression or Death in Previously Untreated Chronic Lymphocytic Leukemia -…

By daniellenierenberg

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today presented results from the interim analysis of the Phase III ELEVATE TN trial, showing that CALQUENCE (acalabrutinib) combined with obinutuzumab or as monotherapy significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated chronic lymphocytic leukemia (CLL).

The Independent Review Committee (IRC)-assessed results were presented at the 2019 American Society of Hematology Annual Meeting and Exhibition in Orlando, US. At a median follow-up of 28.3 months, CALQUENCE in combination with obinutuzumab or as a monotherapy significantly reduced the risk of disease progression or death by 90% and 80%, respectively, vs. chlorambucil plus obinutuzumab.

In an exploratory analysis, CALQUENCE in combination or alone demonstrated consistent PFS improvements across most pre-specified subgroups of patients with high-risk disease characteristics, including the unmutated immunoglobulin heavy-chain variable gene (IGHV), del(11q) and complex karyotype. Overall, the safety and tolerability profile of CALQUENCE observed in the ELEVATE TN trial was consistent with its known profile.

Jos Baselga, Executive Vice President, Oncology R&D said: On the heels of approvals in the US, Australia and Canada, these full results provide further evidence that CALQUENCE, as a new treatment option for patients with chronic lymphocytic leukemia, demonstrates remarkable efficacy and a favorable tolerability profile. These results also provide, for the first time, post-hoc analysis data exploring the potential progression-free survival benefit of adding obinutuzumab to a BTK inhibitor versus BTK inhibitor monotherapy in a randomized trial.

Dr. Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE TN trial, said: In the detailed results from the ELEVATE TN trial comparing CALQUENCE to a commonly used chemo-immunotherapy treatment regimen, CALQUENCE demonstrated a clinically meaningful improvement in progression-free survival, while maintaining its known tolerability and safety profile. These are encouraging results for a patient population that is known to face multiple comorbidities, and where tolerability is a critical factor in their treatment.

Summary of key efficacy results as assessed by IRC from the ELEVATE TN trial at median follow-up of 28.3 months:

Efficacy measure

CALQUENCE plusobinutuzumab

N = 179

CALQUENCEmonotherapyN = 179

Chlorambucil plusobinutuzumabN = 177


Number of events (%)

14 (7.8)

26 (14.5)

93 (52.5)

Median (95% CI), months


NR(34.2, NE)

22.6(20.2, 27.6)

HR (95% CI)

0.10 (0.06, 0.17)

0.20 (0.13, 0.30)






Estimated PFS at 24 months, %





ORR, n (%)(95% CI)

168 (93.9)(89.3, 96.5)

153 (85.5)(79.6, 89.9)

139 (78.5)(71.9, 83.9)






Number of events (%)

9 (5.0)

11 (6.1)

17 (9.6)

Median (95% CI), months




HR (95% CI)

0.47 (0.21, 1.06)

0.60 (0.28, 1.27)






CI, Confidence Interval; NR, Not Reached; NE, Not Evaluable; HR, Hazard Ratio; ORR, Overall Response Rate, OS, Overall Survival

Adverse events (AEs) led to treatment discontinuation in 11.2% of patients treated with CALQUENCE in combination with obinutuzumab and 8.9% of patients treated with CALQUENCE monotherapy versus 14.1% of patients treated with chlorambucil plus obinutuzumab.

With over two years of follow-up, 79% of patients in both the CALQUENCE-containing arms remain on CALQUENCE as a monotherapy. In the CALQUENCE combination arm (n=178), the most common AEs of any grade (30%) included headache (39.9%), diarrhea (38.8%) and neutropenia (31.5%). In the CALQUENCE monotherapy arm (n=179), the most common AEs of any grade (30%) included headache (36.9%) and diarrhea (34.6%). In the chlorambucil plus obinutuzumab arm (n=169), the most common AEs of any grade (30%) included neutropenia (45.0%), infusion-related reaction (39.6%) and nausea (31.4%).

Other AEs of clinical interest (%)1

CALQUENCE plusobinutuzumabN = 178

CALQUENCEmonotherapyN = 179

Chlorambucil plusobinutuzumabN = 169


Grade 3


Grade 3


Grade 3

Atrial fibrillation







Major bleeding





















SPM excluding NMSC

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3-year-old needs bone marrow transplant to survive, says UAE-based father – Gulf News

By daniellenierenberg

mohammad hassan 3 years and two months Image Credit:

Dubai: The father of a three-year-old boy in Dubai, whose only hope for survival is a bone marrow transplant, is desperately appealing for help.

Hafeez Khan, father of Mohammad Hassan, said the boy who is suffering from acute myeloid leukaemia (AML), needs Rs4.8 million (Pakistani) or Dh114,000 for his treatment, which includes one-two cycles of chemotherapy and a bone marrow transplant, in Pakistan.

Hassan, who has not been able to attend school as he has been in and out of hospitals in Dubai and Pakistan, was first diagnosed with AML when he was only a year and a half. He remained under treatment at a Dubai hospital for nearly a year until October 2018.

After a brief remission, he developed high fever and body pain on October 17 this year. When he did not respond to any regular medications, we took him to a Dubai hospital where his AML relapse was confirmed, said the father.

He said investigations revealed that Hassan had a soft tissue mass in his sinus which was diagnosed as a chloroma, a solid collection of leukemic cells occurring outside the bone marrow.

Khan, who works as a site engineer for a Dubai-based company, said, Hassan is my first born and I will do everything I can to save him. I appeal for any support that I can get towards this effort.

He said the child was earlier scheduled to have a bone marrow transplant in Turkey but due to the prohibitive costs, they were nowconsidering Pakistan. Still, the estimates we have been given are beyond our reach,Khan said, adding that he was praying for a miracle to save his son.

AML is one of the commonest types of leukaemia or blood cancer in children. In AML, the body makes many immature white blood cells. These cells, called myeloid blasts, cant mature into normal white blood cells. Although AML is a serious disease, it can be cured with high intensity chemotherapy and a bone marrow / stem cell transplant at an early stage.

mohammad hassan 3 years and two months Image Credit:

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Jasper Therapeutics launches out of Stanford with new approach to stem cell treatment – Endpoints News

By daniellenierenberg

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didnt take. Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped.

She has normal T cells now, Judith Shizuru, the Stanford scientist who pioneered the antibody, told Endpoints News. Shes in school.

Its the kind of medical story to launch a biotech around, and thats what Shizuruis doing. Today, her company Jasper Therapeutics is emerging out of stealth-mode with $35 million in Series A funding led by Abingworth and Qiming, a molecule from Amgen, and a Phase I trial set for its first readout on Monday at ASH.

Jasper is broadly aimed at making stem cell transplants safer, more accessible and more effective by using antibodies as conditioning agents. Theseagents clear out bone marrow to make room for the new stem cells to graft onto the body.

Their Phase I uses a naked antibody called JSP191 to help patients with severe combined autoimmune deficiency receive stem cell transplants the only possible cure for the life-threatening disease but such transplants are used in a wide variety of conditions and Jasper has broader aims. Those include other autoimmune diseases, acute myeloid leukemia and cell-directed gene therapy.

Theres a significant amount of progress being made in gene therapy, interim CEO William Lis told Endpoints, but no progress being made in a conditioning agent that will help graft gene therapy.

Shizuru path to the new antibody was long and fortuitous. In 1987, Arl Arzst, the legendary ad executive and president of Proctor and Gamble international flew in on a recruiting trip for Stanford business students. There he visited Shizuru, a young biologyPhD candidate, because he knew her roommate. Arzsts daughter had diabetes and as Shizuru explained the work she was doing on pancreatic islet cell transplants, he told her to come to Europe.

Shizuru had never been to Europe, but there Arszt introduced her to Ken Farber and the other founders of the Juvenile Diabetes Foundation (now the JDRF). The founders struck a years-long correspondence and encouraged Shizuru to go to medical school, where she decided that if scientists were ever going to develop transplants that didnt trigger an immune response, it would be through stem cell work. She continued her work at the Irv Weissman Stanford regenerative lab, where eventually a graduate student made a discovery that piqued her interest.

To put new stem cells in, you have to get the old stem cells out. Thats not always easy. The cells sit inthese pockets in the bone marrow, and theyre pretty comfortable there. Doctors have to force them out, often using chemotherapy or radiation, which damage DNA and cause severe side effects. The costs sometimes outweigh the benefits.

There are diseases were not treating because its too dangerous, Shizuru said. And the kids were treating, theyre so, so fragile.

The grad student had shown in mice that antibodies could be used to deplete the stem cells and potentially eliminate the need for chemotherapy or radiation. Shizuru and her team began looking to see if anyone had developed a human version of the antibody, CD117. It turned out Amgen had already developed a version of this antibody for a different use. It also turned out she had a former postdoc and a former advisor who worked there. They began a collaboration.

We set out to cross the valley of death, Shizuru said, using an industry slang term for the jump from animal models to human uses.

After making a variety of tweaks to the treatment, they published a paper inScience Translational Medicine in 2016showing the antibodies created a 10,000 fold reduction in the number of stem cells in mice.

The same year, they began a clinical trial on 90 SCID patients. These patients had received stem cell transplants when they were very young but hadnt been given chemo or radiation for fear the side effects would be too severe. The original transplants boosted their numberof immune cells, but without chemo or radiation, the stem cells dont graft into those pockets and the body wont continue producing T cells. Without those, they are extraordinarily prone to infection. Many pass away before age 2.

The hope is that the antibodies allowed the stem cells to graft, and the preliminary answer to that question will be out on Monday. For the first girl in the trial, life has improved but questions about how long her body will make immune cells remain. Still, for that girl and others, Shizuru is confident.

We see there is stem cell engraftment, Shurizi said. They are actually making new T cells.

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Sickle Cell Anemia Patient Becomes First Person in the US to Have Her Genes Edited With CRISPR – Interesting Engineering

By daniellenierenberg

Last week, a woman namedVictoria Gray became the first person in the U.S. to have her cells edited with CRISPR. The41-year-old patient was sufferingfromsickle cell anemia.


The condition, caused by a genetic mutation that messes with the shape of red blood cells, causes havoc on patients, and to make things even worse, the options for treatment are very limited and ineffective. The only current treatment for sickle cell anemia patients is a donor transplant that works for just 10% of patients, but all that is about to change.

It was clear that analternative, much more effectivesolutionwas desperately needed. After much consideration, doctors believed that editing cells extracted from a patient's own bone marrow could restore effective red blood cell creation, and this is exactly the operation they attempted on Gray.

The doctors used CRISPR to tweak Gray's bone marrow DNA to turn on a specific protein that would allow proper red blood cell generation. The operation makes Gray the first person in the U.S. to undergo a CRISPR editing procedure and the second globally.

The treatment comes from observations made back in the 1940s.In 1941 a pediatrician named Jane Watson noticed that babies with sickle cell didnt have symptoms until 6 months to 1 year of age, Vivien Sheehan, a hematologist at Baylor University told Popular Science.

The pediatrician also discovered that these infants produced fetal hemoglobin for much longer periods than healthy babies.Following Watson's observations, the research since then has indicated that increasing fetal hemoglobin could provide an effective treatment for the disease.

Now, CRISPR may just make that treatment viable. But before we get too excited, it should be noted that the strategy comes with several risks.

In order for the edited cells to be inserted back into the patients bone marrow, other stem cells need to be deactivated. Otherwise, there is the chance the unedited stem cells may continue to produce sickled red blood cells very fast, outpacing the edited cells' production of healthy cells.

Now researchers say they need to follow Gray's progress for at least 15 years to rule out any other potential dangers of the procedure. Still, for those 90% suffering with sickle cell anemia that don't respond well to current treatment, the procedure, if successful, would offer the much-needed lifeline they've been hoping for.

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Mount Sinai Joins Progressive MS Trial of NurOwn Cell Therapy – Multiple Sclerosis News Today

By daniellenierenberg

Mount Sinai Medical Center has joined withBrainStorm Cell Therapeutics to explore the safety and efficacy of NurOwn as a potential treatment for progressive multiple sclerosis (MS) in an ongoing Phase 2 trial.

The New York center is the fourth clinical site participating in the trial, in addition to Keck School of Medicine of The University of Southern California (USC), Stanford University School of Medicine, and the Cleveland Clinic in Ohio.

Mount Sinai is ready to start enrolling patients under the supervision of neurologistFred Lublin, MD, and his clinical team at The Corinne Goldsmith Dickinson Center for Multiple Sclerosis.

We are happy to be a part of this exciting study to determine if neurally-directed stem cells can be a therapeutic approach to treating MS, Lublin said in a press release.

NurOwn is a cell-based therapy that uses the patients own bone marrow-derived mesenchymal stem cells (MSC) to promote and support the repair of nerve cells.

Patients MSCs are modified in the lab to secrete growth factors that are believed to protect nerve cells from damage, to promote the repair of the protective myelin sheath in nerve cells (which is destroyed in MS), and potentially slow or halt disease progression.

The open-label Phase 2 clinical trial (NCT03799718) will enroll and treat up to 20 adults with either primary progressive MS (PPMS) or secondary progressive MS (SPMS).

All participants will undergo a bone marrow biopsy to collect MSCs, which will later on be injected back to the patient through three intrathecal administrations injected directly into the cerebrospinal fluid over 16 weeks.

During this time, and for the following 12 weeks, researchers will evaluate the safety of the procedure, as well as the neuromodulatory effect of the modified MSCs.

To confirm that NurOwn cells are delivering neurotrophic factors and immunomodulatory signaling molecules as expected, the research team will look for an increase in the amount and type of these biomarkers in patients cerebrospinal fluid following the cell transplants.

BrainStorm looks forward to partnering with and supporting Dr. Lublin and the dedicated clinical trial team at the Mount Sinai Hospital to quickly advance the Phase 2 progressive MS clinical trial, said Ralph Kern, MD, MHSc, BrainStorms chief operating officer and chief medical officer.

For more information about the trial, including its sites and contacts, please visit this link.

NurOwn has been tested in animal models for various neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), where it showed a good safety profile and promising efficacy signs.

An ongoing Phase 3 trial (NCT03280056) testing NurOwn in people with ALS is expected to conclude in December 2020.

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Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Autolus Therapeutics Announces New Data Showcasing Clinical Progress of Programmed T Cell Therapy Pipeline in Blood Cancers – GlobeNewswire

By daniellenierenberg

AUTO1 shows 87% MRD negative complete response in adult patients with r/r ALL, with no severe cytokine release syndrome

Data presented at 61st American Society of Hematology Annual Meeting form basis for advancement of AUTO1 into pivotal clinical trial in adult ALL

Investor call to be held December 9 at 8:30 am ET / 1:30 pm GMT to review data

LONDON, Dec. 07, 2019 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL) announced today new data highlighting progress on its next-generation programmed T cell therapies to treat patients with acute lymphoblastic leukemia (ALL) and adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL). The data were presented in oral presentations at the 61stAmerican Society of Hematology(ASH) Annual Meeting and Exposition inOrlando, FL. Additional data on pediatric patients with ALL will be presented on December 8.

The data on AUTO1 presented at this years ASH meeting demonstrate the favorable safety profile and high level of clinical activity of AUTO1 in both adults and pediatric patients with ALL, and we look forward to initiation of the pivotal program in adult ALL in the first half of 2020, said Dr. Christian Itin, chairman and chief executive officer of Autolus.

Acute Lymphoblastic Leukemia Data Presented

Title: AUTO1 A novel fast off CD19CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL (Abstract # 226)

Updated results for ALLCAR19, the Phase 1 trial evaluating AUTO1 in adults with recurrent/refractory ALL, were presented by Dr. Claire Roddie MB, PhD, FRCPath, honorary senior lecturer,Cancer Institute, University College London (UCL), in an oral presentation. The trial is designed to assess the primary endpoints of safety ( Grade 3 toxicity) and feasibility of product generation, as well as other secondary endpoints, including efficacy. The trial enrolled patients with a high tumor burden (44% had 50% BM blasts), who were considered high-risk for experiencing cytokine release syndrome (CRS). Product was manufactured for 19 patients; product for 13 of those patients was manufactured using a semi-automated closed process, which will be used for commercial supply.

As of the data cut-off date of November 25, 16 patients had received at least one dose of AUTO1. AUTO1 was well tolerated, with no patients experiencing Grade 3 CRS, and 3 of 16 patients (19%), who had high leukemia burden, experiencing Grade 3 neurotoxicity that resolved swiftly with steroids.

Of 15 patients evaluable for efficacy, 13 (87%) achieved MRD negative CR at 1 month and all patients had ongoing CAR T cell persistence at last follow up. CD19-negative relapse occurred in 22% (2 of 15) patients. In the patients dosed with AUTO1 manufactured in the closed process, 9 of 9 (100%) achieved MRD negative CR at 1 month and 6 months event free survival, and overall survival in this cohort was 100%.

Adult ALL patients, who face a median survival of less than one year after their ALL recurs or relapses, have a significant need for a CAR T cell therapy that is highly active, safe and is a standalone therapy not requiring a stem cell transplant, said Dr. Hagop M. Kantarjian, Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center.

The novel CD 19 CAR-T therapy, AUTO1, is potentially transformative as a standalone curative option for patients with r/r ALL, especially in adults, given its favorable safety profile, said Dr. Max Topp associate professor of Internal Medicine, Hematology and Oncology at the University of Wuerzburg.

Title: Therapy of pediatric B-ALL with a lower affinity CD19 CAR leads to enhanced expansion and prolonged CAR T cell persistence in patients with low bone marrow tumor burden, and is associated with a favorable toxicity profile (Abstract # 225)

Dr. Sara Ghorashian, honorary senior lecturer, Great Ormond Street Institute of Child Health, University College London, presented updated data from the phase 1 CARPALL study of AUTO1 in pediatric ALL patients with low bone marrow tumor burden. The trial is intended to assess the primary endpoints of safety and proportion of patients in molecular complete remission at 1 month. The study recruited a total of 25 patients and stratified them into 2 cohorts. Fourteen patients were treated in cohort 1, which utilized a manual manufacturing process; product was unable to be generated in 3 patients. Median follow-up was 27 months in cohort 1. Seven patients were treated in cohort 2, which utilized the semi-automated closed manufacturing process, which will be used for commercial supply. The aim of cohort 2 was to demonstrate feasibility of manufacture at scale. Product was generated for 100% of patients. Median follow-up was 7 months in cohort 2.

AUTO1 was well-tolerated overall, with no patients experiencing Grade 3 CRS and 1 of 21 (5%) experiencing Grade 4 neurotoxicity, which was considered unrelated to CAR T therapy.

Nineteen of 21 treated patients (90%) achieved molecular complete remission at 1 month post infusion. Consistent with pre-clinical data, CAR T cell expansion was excellent and detectable by flow in a number of patients up to 36 months. Persistence was noted in 15 of 21 patients at last follow-up, up to 36 months. In cohort 2, 100% of patients achieved molecular complete remission at 1 month post infusion.

In the 14 patients in cohort 1, the overall survival at 6 months was 86% and at 12 months was 71%; event free survival (EFS) at 6 months was 71% and at 12 months was 54%. The patients in cohort 2 are not yet evaluable for these parameters. Overall, nine patients relapsed; 5 of 8 evaluable relapses were due to loss of CD19 antigen on the tumor cells.

Title: Clonal dynamics of early responder and long-term surviving CAR-T cells in humans (Abstract # 52)

Dr. Luca Biasco, senior research associate at University College London, presented a detailed analysis of CAR T products, and insertion site analysis from the CARPALL phase 1 patients. This analysis revealed highly polyclonal engraftment, even at very late time-points. Dr. Biasco hypothesized that the propensity for high level polyclonal long-term engraftment was due to favorable phenotype of the CAR T product and the binding kinetic of the receptor.

Diffuse Large B-cell Lymphoma Data Presented

Title: Phase 1/2 study of AUTO3, the first bicistronic chimeric antigen receptor (CAR) targeting CD19 and CD22 followed by an anti-PD1 in patients with relapsed/refractory (r/r) Diffuse Large B Cell Lymphoma (DLBCL): Results of cohort 1 and 2 of the ALEXANDER study (Abstract # 246)

Dr. Kirit Ardeshna, consultant hematologist, Department of Hematology, University College London Hospital NHS Foundation Trust, presented updated data from the ALEXANDER Phase 1/2 study of AUTO3, the first bicistronic CAR T targeting CD19 and CD22 followed by an anti-PD1, in diffuse large B cell lymphoma (DLBCL). 16 patients were treated, and fourteen patients were evaluable at one month. AUTO3 was well-tolerated, with no patients experiencing Grade 3 CRS with primary treatment, and 1 of 14 experiencing Grade 3 neurotoxicity that resolved swiftly with steroids. Five of 14 had a complete response, with 4 of 5 complete responses ongoing, the longest at 18 months.

DLBCL is an aggressive and rapidly progressing cancer, and early response is critical to ensuring positive outcomes for these patients. These early data show the promise of AUTO3 in DLBCL, and we expect to advance AUTO3 to a decision point in relapsed/refractory DLBCL by the middle of next year, said Dr. Christian Itin, chairman and chief executive officer of Autolus. In addition, we look forward to presenting the data from the AMELIA trial of AUTO3 in pediatric ALL during poster sessions on Sunday, December 8, 6:00 8:00 PM ET.

Investor call to review data on Monday, December 9

Autolus management will host an investor conference call on Monday, December 9, at 8:30 a.m. EDT/ 1:30pm GMT, to review the data presented at ASH.

To listen to the webcast and view the accompanying slide presentation, please go to:

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9796038. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9796038.

About AUTO1

AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells' abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights fromUCL Business plc(UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL.

About AUTO3

AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in pediatric ALL in the AMELIA clinical trial and in diffuse large B cell lymphoma in the ALEXANDER clinical trial.

AboutAutolus Therapeutics plc

Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus financial condition and results of operations, as well as statements regarding the anticipated development of Autolus product candidates, including its intentions regarding the timing for providing further updates on the development of its product candidates, and the sufficiency of its cash resources. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed on November 23, 2018 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' future filings with the Securities and Exchange Commission from time to time. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Investor and media contact: Silvia TaylorVice President, Corporate Affairs and Communications

UK:Julia Wilson+44 (0) 7818

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Buyer beware of this $1 million gene therapy for aging – MIT Technology Review

By daniellenierenberg

Its said that nothing is certain except death and taxes. But doubt has been cast over the former since the 1970s, when scientists picked at the seams of one of the fundamental mysteries of biology: the molecular reasons we get old and die.

The loose thread they pulled had to do with telomeresmolecular timepieces on the ends of chromosomes that shorten each time a cell divides, in effect giving it a fixed life span. Some tissues (such as the gut lining) renew almost constantly, and it was found that these have high levels of an enzyme called telomerase, which works to rebuild and extend the telomeres so cells can keep dividing.

That was enough to win Elizabeth Blackburn, Carol Greider, and Jack Szostak a Nobel Prize in 2009. The obvious question, then, was whether telomerase could protect any cell from agingand maybe extend the life of entire organisms, too.

While telomere-extending treatments in mice have yielded intriguing results, nobody has demonstrated that tweaking the molecular clocks has benefits for humans. That isnt stopping one US startup from advertising a telomere-boosting genetic therapyat a price.

Libella Gene Therapeutics, based in Manhattan, Kansas, claims it is now offering a gene therapy to repair telomeres at a clinic in Colombia for $1 million a dose. The company announced on November 21 that it was recruiting patients into what it termed a pay-to-play clinical trial.

Buyer beware, though: this trial is for an unproven, untested treatment that might even be harmful to your health.

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The company proposes to inject patients with viruses carrying the genetic instructions cells need to manufacture telomerase reverse transcriptase, a molecule involved in extending the length of telomeres.

The dangers are enormous, says Jerry Shay, a world expert on aging and cancer at the University of Texas Southwestern Medical Center. Theres a risk of activating a pre-cancerous cell thats got all the alterations except telomerase, especially in people 65 and over.

For years now, people involved in the company have made shifting claims about the study, raising uncertainty about who is involved, when it might start, and even where it would occur. Trial listings posted in October to currently show plans for three linked experiments, each with five patients, targeting critical limb ischemia, Alzheimers, and aging, respectively.

Jeff Mathis, president of Libella, told MIT Technology Review that two patients have already paid the enormous fee to take part in the study: a 90-year-old-woman and a 79-year-old man, both US citizens. He said they could receive the gene therapy by the second week of January 2020.

The decision to charge patients a fortune to participate in the study of an experimental treatment is a red flag, say ethics experts. Whats the moral justification for charging individuals with Alzheimers? asks Leigh Turner, at the University of Minnesotas Center for Bioethics. Why charge those bearing all the risk?

The telomere study is occurring outside the US because it has not been approved by the Food and Drug Administration. Details posted to indicate that the injections would be carried out at the IPS Arcasalud SAS medical clinic in Zipaquir, Colombia, 40 kilometers (25 miles) north of Bogot.

It takes a lot longer, is a lot more expensive, to get anything done in the US in a timely fashion, Mathis says of Libellas choice to go offshore.

To some promoters of anti-aging cures, urgency is justified. Heres the ethical dilemma: Do you run fast and run the risk of low credibility, or move slowly and have more credibility and global acceptancebut meanwhile people have died? says Mike Fossel, the president of Telocyte, a company planning to run a study of telomerase gene therapy in the US if it can win FDA signoff.

Our reporting revealed a number of unanswered questions about the trial. According to the listings, the principal investigatorwhich is to say the doctor in charge--is Jorge Ulloa, a vascular surgeon rather than an expert in gene transfer. I dont see someone with relevant scientific expertise, says Turner.

Furthermore, Bill Andrews, who is listed as Libellas chief scientific officer, says he does not know who Ulloa is, even though on Libellas website, the mens photos appear together on the list of team members. He said he believed that different doctors were leading the trial.

Turner also expressed concerns about the proposed 10-day observation period described in the posting for the overseas study: If someone pays, shows up, has treatment, and doesnt stick around very long, how are follow-up questions taking place? Where are they taking place?

Companies seeking to try the telomere approach often point to the work of Maria Blasco, a Spanish scientist who reported that telomere-lengthening gene therapy benefited mice and did not cause cancer. Blasco, director of the Spanish National Centre for Cancer Research, says she believes many more studies should be done before trying such a gene experiment on a person.

This isnt the first time Libella has announced that its trial would begin imminently. It claimed in late 2017 that human trials of the telomerase therapy would begin in the next few weeks. In 2016, Andrews (then partnered with biotech startup BioViva) claimed that construction of an age reversal clinic on the island nation of Fiji would be complete before the end of the year. Neither came to pass.

Similar questions surround Libellas most recent claims that it has two paying clients. Pedro Fabian Davalos Berdugo, manager of Arcasalud, said three patients were awaiting treatment in December. But Bioaccess, a Colombian contract research organization facilitating the Libella trial, said that no patients had yet been enrolled.

Also unclear is where Libella is obtaining the viruses needed for the treatment. Virovek, a California biotech company identified by several sources as Libellas manufacturer, did not answer questions about whether any treatment had been produced.

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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.


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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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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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.


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.


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.


(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.


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.


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.


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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The first step to getting lustrous healthy tresses this festive season? Try exfoliating your scalp – CNA

By daniellenierenberg

The first step to getting lustrous healthy tresses this festive season? Try exfoliating your scalp  CNA

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

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.


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 .

For further information, please contact:

Novadip Biosciences

Jeff Abbey

Chief Executive Officer

+32 (10) 779 220

For media enquiries:

Consilium Strategic Communications

Chris Gardner, Matthew Neal, Angela Gray

+44 (0) 20 3709 5700

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