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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 clinicaltrials.gov 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 clincaltrials.gov 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

By daniellenierenberg

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

$50

Brought to you by MeCBD

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

$49.99

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

$15.99

(Alex Manning/Leafly)

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

$51

Brought to you by MeCBD

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

$48

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

$80

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

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

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

By daniellenierenberg

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

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

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

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

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

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

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

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

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

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

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

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

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

By daniellenierenberg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

To view the full abstracts, please follow this link.

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

Ends

Notes to editors

Novadip Biosciences

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

For further information, please contact:

Novadip Biosciences

Jeff Abbey

Chief Executive Officer

+32 (10) 779 220

info@novadip.com

For media enquiries:

Consilium Strategic Communications

Chris Gardner, Matthew Neal, Angela Gray

+44 (0) 20 3709 5700

novadip@consilium-comms.com

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A #ReUp of 2019: The year when gene therapy, DNA modifications came of age & saved lives – Economic Times

By daniellenierenberg

In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering -- by editing her genome.

Victoria Gray's recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research -- gene therapy.

"I have hoped for a cure since I was about 11," the 34-year-old told AFP in an email.

"Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency."

Over several weeks, Gray's blood was drawn so doctors could get to the cause of her illness -- stem cells from her bone marrow that were making deformed red blood cells.

The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 -- pronounced "Crisper" -- a new tool informally known as molecular "scissors."

The genetically edited cells were transfused back into Gray's veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary but, theoretically, she has been cured.

"This is one patient. This is early results. We need to see how it works out in other patients," said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville.

"But these results are really exciting."

In Germany, a 19-year-old woman was treated with a similar method for a different blood disease, beta thalassemia. She had previously needed 16 blood transfusions per year.

Nine months later, she is completely free of that burden.

For decades, the DNA of living organisms such as corn and salmon has been modified.

But Crispr, invented in 2012, made gene editing more widely accessible. It is much simpler than preceding technology, cheaper and easy to use in small labs.

The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself.

"It's all developing very quickly," said French geneticist Emmanuelle Charpentier, one of Crispr's inventors and the cofounder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Crispr is the latest breakthrough in a year of great strides in gene therapy, a medical adventure started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy.

Scientists practising the technique insert a normal gene into cells containing a defective gene.

It does the work the original could not -- such as making normal red blood cells, in Victoria's case, or making tumor-killing super white blood cells for a cancer patient.

Crispr goes even further: instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the US and a blood disease in the European Union.

They join several other gene therapies -- bringing the total to eight -- approved in recent years to treat certain cancers and an inherited blindness.

Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution.

"Twenty-five, 30 years, that's the time it had to take," he told AFP from Paris.

"It took a generation for gene therapy to become a reality. Now, it's only going to go faster."

Just outside Washington, at the National Institutes of Health (NIH), researchers are also celebrating a "breakthrough period."

"We have hit an inflection point," said Carrie Wolinetz, NIH's associate director for science policy.

These therapies are exorbitantly expensive, however, costing up to $2 million -- meaning patients face grueling negotiations with their insurance companies.

They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion -- and fighting a general infection.

"You cannot do this in a community hospital close to home," said her doctor.

However, the number of approved gene therapies will increase to about 40 by 2022, according to MIT researchers.

They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who don't necessarily share the medical ethics of Western medicine.

Last year in China, scientist He Jiankui triggered an international scandal -- and his excommunication from the scientific community -- when he used Crispr to create what he called the first gene-edited humans.

The biophysicist said he had altered the DNA of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV, even though there was no specific reason to put them through the process.

"That technology is not safe," said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr "scissors" often cut next to the targeted gene, causing unexpected mutations.

"It's very easy to do if you don't care about the consequences," Musunuru added.

Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability.

There is also the temptation to genetically edit entire animal species -- malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the US.

The researchers in charge of those projects are advancing carefully, however, fully aware of the unpredictability of chain reactions on the ecosystem.

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Charpentier doesn't believe in the more dystopian scenarios predicted for gene therapy, including American "biohackers" injecting themselves with Crispr technology bought online.

"Not everyone is a biologist or scientist," she said.

And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies' crops?

Charpentier thinks that technology generally tends to be used for the better.

"I'm a bacteriologist -- we've been talking about bioterrorism for years," she said. "Nothing has ever happened."

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A #ReUp of 2019: The year when gene therapy, DNA modifications came of age & saved lives - Economic Times

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

By daniellenierenberg

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

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

Stromal Vascular Fraction Market: Overview

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

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

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

Stromal Vascular Fraction Market: Segmentation

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

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

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

By Application Cosmetic Soft-tissue Orthopedic Others

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

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

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

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PHATED to be: Yale researchers give shape to big data – Yale News

By daniellenierenberg

Scientists now have the ability to collect massive amounts of data on lifes most fundamental processes, such as the intricate choreography whereby a handful of embryonic stem cells give rise to trillions of specialized cells throughout the human body. But data doesnt always translate into knowledge unless the relationship of recorded data points can be presented in accurate, meaningful and visible ways.

The lab of Yales Smita Krishnaswamy, associate professor of genetics and computer science, has developed a new algorithm called PHATE that overcomes many of the shortcomings of existing data visualization tools, which are more susceptible to noise and distortion in the relationship of data points.

The panel above shows how PHATE visualizes the differentiation of human embryonic stem cells into neuronal cells, neural stem cells, cardiac cells, and endothelial cells, as compared to the visualizations created by three other technologies.A cleaner, more detailed representation is helpful, for example, for generating promising new hypotheses.

The researchers work is described Dec. 3 in the journal Nature Biotechnology.

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Spinning Disk Confocal Microscope Market Growth Fueled by Reviving Techniques to Treat Heart Failure with Cardiac Regenerative Medicine – MENAFN.COM

By daniellenierenberg

(MENAFN - iCrowdNewsWire) Dec 5, 2019

Cardiac failure is an insidious disease with the mortality rate as high as that of cancer around the globe. Heart failure affecting at least 26 million people worldwide in 2017 and is increasing in prevalence. The only medical treatment for heart failure is cardiac transplantation, although the shortage of donor poses a serious problem. Cell transplantation therapy with regenerative cardiomyocytes is the only solution to minimize the higher mortality rates, which requires detailed information at the level of individual cardiomyocytes. Spinning disk confocal microscopy has emerged as a new high-tech method in cardiovascular medicine for exploring the stem cells for regenerating damaged organs. This innovative microscopic technology can be used to create 3D images of the structures within living cells. Higher-efficiency imaging at lower laser powers includes less photobleaching and phototoxicity, yet cost-effective than other confocal microscopes which are the prominent features of the spinning disk confocal microscopes (SDCM). Furthermore, technological advancements in microscopy and increasing spending on the research & development are the key factors fueling the spinning disk confocal microscope market share.

The global spinning disk confocal microscope market size was valued at $245 million as of 2018 and is expected to grow with a CAGR of 3.6% throughout the forecast period 2019-2025.

Extensive Usage of Spinning Disk Confocal Microscope in the Evaluation of Various Eye Diseases

Spinning disk confocal microscope is an imaging technique which eliminates out-of-focus light efficiently and improves the image contrast, making it easier to resolve small and dim structures in the living cell. This technique is ideal for imaging poor signals at high magnification and provides prolonged life imaging with minimal photodamage. SDCM is widely used in the evaluation of various eye ailments and is predominantly useful for imaging, identification, and detailed analysis of cornea cells. Cataract accounts for the world's leading vision impairment cause, affecting approximately 12.6 million people and 52.6 million people who live with severe to mild blindness worldwide. The confocal microscope helps to provide valuable information about wound healing in the postsurgical cornea, especially after keratorefractive and transplant surgery, which in turn, creates a huge opportunity for the growth of the spinning disk confocal microscope market share. Besides, in the pharmaceutical industry, increasing usage of this confocal microscopy in the classification of systems such as tablets, film coatings and colloidal systems, which in turn, spur the growth of the spinning disk confocal microscope market size.

Application of Spinning Disk Confocal Microscopy in Bio-imaging

Confocal microscopy allows the analysis of specimens without physical sectioning when these specimens are fluorescently labeled, then more color differentiation is possible. Besides, it allows the 3D reconstruction of the live cells and organisms. For instance, researchers of the State University of New York Downstate Medical Center have found that hypoxia, the condition of lack of oxygen in the body or region of the body tissues to sustain bodily functions is because of abnormal blood flow. This, in turn, is responsible for half of the seizure-related neuronal degeneration cases in epilepsy. Consequently, the microscopic technique enables the researchers to detect abnormality in the vasodynamics of brain. Instances as such are increasing the demand for the spinning disk confocal microscope market in bio-imaging.

North America Holding Major Share of the Spinning Disk Confocal Microscope Market

North America generated 34.4% of the spinning disk confocal microscope market global revenue in 2018. Growing adoption of the confocal microscope in living cell imaging, increasing application in dentistry, and government funding and policies for medical research are key factors triggering the growth of the spinning disk confocal microscope market in this region. For instance, as part of the 2019 budget, Canadian government has decided to spend approximately $4 billion on basic medical research and this funding is given to The Stem Cell Network, a non-profit organization in Ottawa which is active into clinical applications research. Also, Genome Canada, a non-profit organization in Ottawa which supports genomic research, will get about $77 million from the government for medical research. Thus, these increasing investments in research activities is boosting the North American spinning disk confocal microscope market.

Life Sciences Observing Lucrative Opportunities in the Global Spinning Disk Confocal Microscope Market

The application segment that will be creating the most lucrative opportunities for the spinning disk confocal microscope market is life sciences. This application segment is projected to grow at a CAGR of 32.3% through to 2025. To observe the internal workings of cellular processes in the living cells, this procedure is widely used by researchers in life science. Spinning disk confocal microscope use lower light levels and provide accurate cell physiology through real-time image acquisition. Thus, the cell study is aiding the growth of the life sciences segment in the global spinning disk confocal microscope market.

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The Major Players in the Spinning Disk Confocal Microscope Market :

Prominent players in the spinning disk confocal microscope market include Bruker Corporation, Confocal.nl, Leica Microsystem, Nikon Corporation, Olympus Corporation, and ZEISS Group.

Bruker Corporation, an American-based scientific instruments manufacturer for molecular and materials research has launched its high-speed Atomic Force Microscopy (AFM) system for life science microscopic applications on Jan 29, 2019. AFM features advanced bio-imaging with high speed and high resolution. These properties of the AFM system can provide researchers to perform experiments on individual cells and allow Bruker to follow dynamic processes on cellular and molecular levels in real-time. Secondly, Confocal.nl, Dutch-based microscopes manufacturer has launched new Re-scan Confocal Microscopy (RCM) modules on April 10, 2019. This new module features integrated optimized de-convolution and high scan speed.

Mergers and acquisitions are the other key strategies adopted by the players to stay ahead of their competitors. Bruker Corporation, an American-based scientific instruments manufacturer for molecular and materials research has announced its acquisition with Hain Lifescience GmbH, German-based molecular diagnosis systems developer on Aug 24, 2018. With this acquisition, Bruker has expanded its capabilities in microbial and viral pathogen detection and offering solutions for human genetic diseases. Such mergers and acquisitions aid the market players to expand their geographical boundaries and accentuate their footprint into the global spinning disk confocal microscope market.

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Spinning Disk Confocal Microscope Market Growth Fueled by Reviving Techniques to Treat Heart Failure with Cardiac Regenerative Medicine - MENAFN.COM

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Stem Cell Therapy Market Robust pace of Industry during 2017-2025 – News Description

By daniellenierenberg

Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Year in Review: Respiratory Infection – MedPage Today

By daniellenierenberg

Continuing improvements in influenza prevention, including progress toward a "universal" flu vaccine, as well as newly approved treatment options for nosocomial pneumonia and new evidence about different methods to prevent or shorten the course of flu, dominated the headlines in infectious respiratory illnesses this year.

Inching Toward 'Universal' Flu Vaccine

An experimental candidate for a flu vaccine covering many strains, and that therefore wouldn't have to be reformulated every year, was announced by the NIH in April. The vaccine, developed at the National Institute of Allergy and Infectious Diseases, is designed to "display part of hemagglutinin (HA), an influenza protein, on the surface of a microscopic nanoparticle made of nonhuman ferritin," a protein found in all living cells, the agency said. HA comprises a head and a stem, but this candidate vaccine will contain a stem only. It's hoped to protect against influenza subtypes within "group 1," which includes both H1 and H5 influenza strains.

A universal flu vaccine is a major part of President Trump's initiative announced in September to overhaul flu vaccine development in the U.S. The order called for reduced reliance on current egg-based flu vaccines, and expanding capacity for alternative production methods such as cell-based vaccine technology, and also directed a search for more broadly protective vaccine candidates that can be used from year to year.

"What this [executive order] does is very useful, spells out the steps that can be taken and makes it a national priority," Andrew Pavia, MD, co-chair of the Infectious Diseases Society of America's Treatment Guidelines Panel, and chief of pediatric infectious diseases at the University of Utah, told MedPage Today. "But to make it happen, it's going to require money. That's the next step we need to hear about."

But for now, current flu shots are effective, according to research in February from Clinical Infectious Diseases, which estimated that vaccinations during the 2017-2018 flu season prevented 7 million infections and over 8,000 deaths. Despite this, the CDC found in October that only a little over half of pregnant women who were pregnant during flu season said they received the flu shot.

More Insights Into Flu Prevention

When it comes to preventing flu, choose antiseptic hand soap over alcohol-based hand sanitizers, according to research published in September in mSphere. The study examined samples of mucus from patients who tested positive for influenza A. While both the CDC and World Health Organization recommend hand hygiene practices with ethanol-based disinfectants for 15-30 seconds, the authors said this disinfection time is insufficient for not-yet-dried mucus, and current standard procedures calling for alcohol hand rubs to prevent flu outbreaks are not adequate.

For healthcare workers, ordinary medical masks were as effective in protecting against respiratory infections, including the flu as more expensive N95 respirators, according to a randomized trial published in JAMA in September, with researchers arguing that laboratory-confirmed respiratory infection was a "more relevant" endpoint compared to laboratory-confirmed influenza.

And once a patient has the flu, an earlier course of antiviral medication Tamiflu was found to cut the risk of death in some severe cases, according to research published in February in Clinical Infectious Diseases. While there was no decrease in overall influenza-associated mortality with an earlier course of oseltamivir versus a later course, there was an observed effect on patients with influenza A/H3N2.

New Treatment Options for Pneumonia

Several treatments showed promise for nosocomial pneumonia. Oral or intravenous Xenleta (lefamulin), a first-in-class, semi-synthetic pleuromutilin antibiotic, was approved for the treatment of community-acquired bacterial pneumonia in August. The FDA gave lefamulin its Qualified Infectious Disease Product Designation, speeding up the product's review.

A new indication for Zerbaxa (ceftolozane/tazobactam) for hospital-acquired and ventilator acquired pneumonia was approved in June. Zerbaxa was first approved in 2014 for complicated urinary tract and intra-abdominal infections.

In October, phase III data from cefiderocol, a new -lactam antibiotic, showed non-inferiority for 14-day all-cause mortality in hospitalized pneumonia patients compared to high-dose meropenem.

Cefiderocol was approved under the name Fetroja for complicated urinary tract infections in November, though it includes a warning about higher all-cause mortality in critically ill patients with multidrug-resistant Gram-negative bacterial infections, including among patients with nosocomial pneumonia -- an issue that an FDA advisory panel raised at an earlier meeting.

Earlier in the year, an FDA advisory panel voted that intramuscular bacitracin injections have no value for its recommended indication. Bacitracin injection once was a standard treatment for infants with pneumonia and collection of pus in the plural cavity, or empyema that are caused by staphylococci that are susceptible to the drug. But while clinicians largely abandoned it decades ago, the treatment technically remains approved. The committee didn't recommend that injectable bacitracin be pulled from the market entirely, though, because it still has use in some surgical applications.

Short Courses of Antibiotics and Pneumonia Outcomes

A study in the Annals of Internal Medicine in July provided some real world evidence behind the "shorter is better" theory for antibiotics when treating pneumonia. Researchers found that more than two-thirds of patients received antibiotics longer than the shortest duration consistent with recommended guidelines, and most of this was due to excess prescribing at discharge.

An accompanying editorial urged clinicians to "overcome inertia and tradition and change practice" in light of the evidence about short-course therapy. Specifically, they referenced the more than 45 randomized controlled trials and two meta-analyses that found "no difference in efficacy" between shorter and traditional therapy across a variety of infections, including pneumonia.

In November, a randomized trial in the New England Journal of Medicine found that adding a 2-day course of amoxicillin-clavulanate for patients who received targeted hypothermia resuscitation due to sudden cardiac arrest nearly halved the occurrence of ventilator-associated pneumonia during the first 7 days of hospitalization, compared to patients who received placebo. There was no significant difference between the two groups in other outcomes, however, including late ventilator-associated pneumonia, ICU length of stay, and mortality at day 28.

ACIP Updates Vaccine Guidance

In June, the CDC's Advisory Committee for Immunization practices voted to accept new guidance for the pneumococcal vaccine, 13-valent pneumococcal conjugate (PCV13, Prevnar) for older adults. The new policy said that PCV13 was recommended based on shared decision-making for this population who did not have an immunocompromising condition and had not received PCV13 before. These recommendations were formally added to the 2020 adult vaccination schedule in October.

Guidance for the flu vaccine, however, remained unchanged, other than the customary updating of its components. Confusion over the word "contraindication" with regard to the live attenuated influenza vaccine briefly derailed the panel's October meeting, with members ultimately agreeing to use the words "not recommended" for certain patient groups. The ACIP continues to recommend vaccination against flu for all people ages 6 months and older without such concerns.

Other research this year included:

HF Admissions Spike in Step with Flu

FluMist Flopped for Kids During Recent Flu Seasons

Whoopi Goldberg's Pneumonia Nightmare

Vaccinations, Flu Shots, and Multiple Sclerosis

Few CAP Patients Get Urinary Antigen Testing

Infection in Pregnancy Ups Child's Autism, Depression Risk

2019-12-06T13:30:00-0500

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MarketsandMarkets – 4th Annual Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine Congress – Hitz Dairies

By daniellenierenberg

In the 4th edition of MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine, we would be focusing on the pre-clinical, manufacturing, clinical and regulatory aspects of cell therapies and regenerative medicine. This Congress event will be held on 10th and 11th March 2020 in London -UK

Since the past three editions of Bioprocessing of Advanced Cellular Therapies and Regenerative Medicine, MarketsandMarkets aims to provide demonstrative approach to the latest developments in technologies of bioprocessing of cellular therapies.

What to expect:

The 4th edition of MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine would be concentrating on the pre-clinical, manufacturing, clinical and regulatory facets of cell therapies and regenerative medicine. The prime importance would be given on discussing topics such as tissue engineering, car-T cell-based immunotherapies, automated manufacturing, allogeneic therapies, from challenges in supply chain management and regulatory concern, point of view.

The conference will be useful for all the respective stakeholders of Advanced Cellular Therapies, majorly Pharma/Biotech delegates, Solution provider Delegates and Academic Delegates. The event will host VPs, directors, managers, leaders, engineers, scientists, academic heads, students which will boost the networking capacity of the attendees.

Download Agenda at https://www.reportsnreports.com/events/4th-annual-marketsandmarkets-bioprocessing-of-advanced-cellular-therapies-regenerative-medicine-congress/

Conference Agenda:

The two-day conference will have a list of agenda:

Key Pointers 4th Annual MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine Congress

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IFN-: The T cell’s license to kill stem cells in the inflamed intestine – Science

By daniellenierenberg

Abstract

IFN- produced by T cells directly induces intestinal stem cell death upon inflammation-induced intestinal injury (see the related Research Article by Takashima et al.).

Intestinal regeneration upon tissue damage is fueled by intestinal stem cells (ISCs) residing in the crypt bottom of the epithelium and marked by the gene Lgr5 (1, 2). There is growing evidence that tissue repair is at least partially mediated by a regenerative inflammatory response (3, 4). How inflammation-induced intestinal injury influences ISCs and their microenvironment (stem cell niche) remains poorly understood. In this issue of Science Immunology, Takashima et al. (5) explore the changes in the ISC niche in vivo upon T cellmediated injury as a model of graft-versus-host disease (GVHD) and in vitro using organoid T cell cocultures. Although earlier studies already implicated interferon- (IFN-) as a negative regulator of intestinal epithelial homeostasis (68), Takashima et al. now demonstrate that IFN- directly acts on ISCs by triggering apoptosis.

In an allogeneic bone marrow transplant (BMT) model, Takashima and colleagues found that ISC numbers per intestinal crypt were markedly reduced in mice receiving bone marrow alone or bone marrow and T cells when compared with normal control mice. While the ISCs in the mice receiving only bone marrow recovered 7 days later, the ISC numbers remained reduced in those mice also transplanted with donor T cells. Of note, Paneth cell numbers were also reduced after ISC depletion. The numbers of organoids established from the intestines of mice 10 days after BMT recovered back to that of control mice, whereas the organoid forming capacity from crypts of mice after combined transplantation of bone marrow and T cells remained significantly lower. Similar in vivo and in vitro results were obtained when autoreactive T cells were transplanted, pointing to a common feature of T cellmediated intestinal injury.

As seen by three-dimensional confocal microscopy, intraepithelial T cells (CD3+ IELs) preferentially localized to the villus region, whereas lamina propriaassociated T cells (CD3+ LPLs) were equally distributed along the crypt-villus axis of control mice (Fig. 1A). Conversely, mice receiving bone marrow and allogeneic T cells showed a progressive increase in the density of both CD3+ LPLs and CD3+ IELs in the crypt region.

To identify signaling molecules that cause the loss of ISCs in this model, Takashima and colleagues performed several elegant murine and human epithelial organoid coculture experiments. Murine nave allogeneic T cells did not impair murine intestinal organoid numbers, whereas alloreactive T cells effectively reduced organoid numbers. Likewise, human allogeneic cytotoxic T cells robustly inhibited human intestinal organoid forming efficiency. Even bead-activated autologous T cells suppressed human intestinal organoid growth. The authors then proceeded to screen for potential pathways mediating cytotoxicity. Organoids cocultured with T cells in the presence of antiIFN- neutralizing antibodies showed normal growth. Although IFN- receptor (IFN-R)depleted T cells were still able to affect organoid viability, IFN-Rdepleted organoids were resistant to T cellmediated killing. Organoid toxicity by IFN- was also observed in the absence of T cells. Live imaging confirmed the progressive ISC depletion upon organoid exposure to IFN-. Treatment of organoids with the immunosuppressive JAK1/2 inhibitor ruxolitinib robustly preserved numbers of both organoids and ISCs in the presence of IFN-, irrespective of whether the organoids were cultured alone or together with T cells. The authors additionally demonstrated that JAK1-depleted organoids are resistant to IFN- treatment. Further downstream, ruxolitinib prevented STAT1 phosphorylation by IFN- in intestinal crypts, and, in line, STAT1-depleted organoids were resistant to growth suppression in response to IFN- treatment.

IFN-treated organoids showed reduced expression of ISC marker genes. ISCs underwent apoptosis in vitro in a direct response to IFN-. Next, the authors confirmed in vivo that ISC numbers did not change upon transplanting allogeneic bone marrow and T cells when treating mice with IFN- neutralizing antibodies. Likewise, ruxolitinib treatment protected ISCs from T cellmediated killing in vivo. Donor T cells, particularly T helper 1 cells, were activated and IFN-+. Transplanting IFN-depleted allogeneic T cells robustly reduced the ISC loss and allowed epithelial cell proliferation to increase.

Takashima and colleagues lastly investigated whether IFN- directly induces ISC apoptosis. Using tissue-specific depletion of IFN-R1, the authors found that epithelial loss of the receptor protects from the immune-mediated GVHD phenotype. IFN-R1 is expressed by both ISCs and Paneth cells, the epithelial component of the ISC niche (9). However, Paneth celldeficient organoids remained sensitive to both IFN- and allogeneic T cellmediated cytotoxicity. Likewise, T cells were able to reduce the number of organoids containing IFN-R1deficient Paneth cells, whereas organoids containing IFN-R1deficient ISC were protected from cytotoxicity. The authors demonstrated in further experiments that IFN- directly induces ISC apoptosis independent of Paneth cells (Fig. 1, B and C).

The study by Takashima et al. extends our knowledge on signaling between ISCs and immune cells, identifying ISCs as direct targets of IFN- secreted by T cells in immune-mediated intestinal damage (as caused by GVHD). In the 2015 study by Lindemans et al., this group already identified that interleukin-22 (IL-22) secreted by group 3 innate lymphoid cells (ILC3s) directly stimulates ISCs to proliferate and regenerate the intestinal epithelium upon inflammation-induced intestinal injury (4). Modulating the effects of T cellderived IFN- on ISC, for instance, by suppressing JAK/STAT signaling via ruxolitinib treatment, may provide a new therapeutic avenue to reducing GVHD-induced damage of the intestinal epithelium (10).

(A) ISCs maintain adult homeostasis of the intestinal epithelium. T lymphocytes patrol the intestine. (B) Takashima et al. show that in GVHD as modeled by BMT and aberrant activation of T lymphocytes, T cellderived IFN- directly acts on ISCs and induces apoptosis via JAK/STAT signaling. (C) Disease progression results in marked intestinal damage due to loss of ISCs and their niche.

Acknowledgments: Funding: K.K. is a long-term fellow of the Human Frontier Science Program Organization (LT771/2015). Competing interests: H.C. and K.K. are named inventors on patents or patents pending on Lgr5 stem cellbased organoid technology.

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Cellex Opens New Plant to Manufacture Innovative Cell Therapy Products for Cancer – Yahoo Finance

By daniellenierenberg

COLOGNE, Germany, Dec. 5, 2019 /PRNewswire/ -- Cellex has opened a new Cell Manufacturing Plant in Cologne, Germany that will be the focal point for the production of innovative cell therapy products (e.g. CAR-T cells) as targeted treatments for different types of cancers and other diseases. The new facility has doubled the company's manufacturing capacity. Reasons for the expansion include the rising global demand and worldwide bottlenecks in production, as well as a considerable amount of promising research on new treatment approaches for various types of cancer. With this expansion, Cellex has laid the groundwork to provide comprehensive support to patients all over the world who are dependent on new therapies for the treatment of serious diseases. The facility offers more than 800 square meters of floor space and contains a clean room laboratory and other rooms for manufacturing and quality control.

At the new Cell Manufacturing Plant, advanced therapy medicinal products (ATMPs) such as CAR-T cells are produced using state-of-the-art methods including magnetic selection, cell purification, cryopreservation and cell-based efficacy tests. Other services include long-term cryo-storage for ATMPs. Through international partnerships, Cellex is already operating at a global level and is expecting to see growth in worldwide demand for its products. In addition to specialized expertise in manufacturing cell therapy products, the company also operates collection centers for stem cell and bone marrow donations as well as a CellCommunity for the donation of cells to science and research all over the world.

The Cellex Group was founded in 2001 with a primary focus on the collection of stem cells and bone marrow. Today, the Cellex Collection Center is the world's largest and most experienced collection center for allogeneic blood stem cell and bone marrow donations. Furthermore, Cellex has grown into an important full service provider for other companies in the production of innovative cellular therapy products (e.g. CAR-T cells). Since 2014, the company has been working on the development of its own innovative CAR-T cells and bispecific antibodies for the treatment of cancer in collaboration with its Dresden-based affiliate, GEMoaB.

During the opening ceremonies, Prof. Dr. Gerhard Ehninger, founder and owner of Cellex, pointed to the encouraging possibilities offered by CAR-T cell therapies being developed by Cellex. "Battling cancer with CAR-T cells specifically targeted against tumor cells is one of the most promising treatment approaches today. However, CAR-T cells developed so far harbor various risks, such as excessive cytokine release or the development of resistances. Therefore, we are now collaborating with our affiliate, GEMoaB, to develop new platforms that are easier to control such as bispecific antibodies or UniCAR cells, which are currently undergoing initial testing."

About Cellex

Cellex wants to help people suffering from serious diseases through stem cell donations, but also through innovative treatment options. Cellex develops, tests and establishes new therapy approaches for people with cancer. These new cutting-edge medicines are manufactured by Cellex at the company's Cell Manufacturing Plant.

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Rocket Pharmaceuticals Announces First Patient Treated in Global Registrational Phase 2 Study of RP-L102 Process B for Fanconi Anemia – BioSpace

By daniellenierenberg

NEW YORK--(BUSINESS WIRE)-- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the first patient in the global Phase 2 registration-enabling study of RP-L102 Process B received investigational therapy. RP-L102 is the Companys lentiviral vector (LVV)-based gene therapy for the treatment of Fanconi Anemia (FA).

The initiation of Rockets first Phase 2 trial is an important milestone for the company as well as patients throughout the world battling FA, said Kinnari Patel, Pharm.D., MBA, Chief Operating Officer and Head of Development of Rocket. With the recent feedback received from the FDA and EMA of MMC-resistance as the primary endpoint, we are optimistic about the prospect of benefiting patients and, if the data are positive, working towards BLA and MAA submissions.

The registrational package will include twelve patients from the U.S. and EU, two from the U.S. Phase 1 study and 10 additional patients from the global Phase 2 study (NCT04069533). Patients will receive a single intravenous infusion of RP-L102 that utilizes fresh cells and Process B which incorporates a modified stem cell enrichment process, transduction enhancers, as well as commercial-grade vector and final drug product. Improved mitomycin-C (MMC) resistance in bone marrow colony forming (progenitor) cells is the primary endpoint, and may also serve as a surrogate endpoint for accelerated approval. Additional outcome measures include stability or increase in blood counts with no significant worsening in anemia, neutropenia or thrombocytopenia and peripheral blood and bone marrow genetic correction, as demonstrated by progressive increases in vector copy number (VCN) over the months subsequent to infusion.

Lucile Packard Childrens Hospital Stanford and Hospital Infantil Universitario Nio Jess are serving as the lead clinical sites and University of Minnesota is conducting centralized evaluation of bone marrow MMC-resistance and engaging in advisory activities for the global trial of RP-L102. RP-L102 was in-licensed from the Centro de Investigaciones Energticas, Medioambientales y Tecnolgicas (CIEMAT), Centro de Investigacin Biomdica en Red de Enfermedades Raras (CIBERER), Instituto de Investigacin Sanitaria Fundacin Jimnez Daz (IIS-FJD) and Fundacion para la Investigacion Biomedica Hospital Infantil Universitario Nio Jesus (FIB-HIUNJ).

About Fanconi Anemia

Fanconi Anemia (FA) is a rare pediatric disease characterized by bone marrow failure, malformations and cancer predisposition. The primary cause of death among patients with FA is bone marrow failure, which typically occurs during the first decade of life. Allogeneic hematopoietic stem cell transplantation (HSCT), when available, corrects the hematologic component of FA, but requires myeloablative conditioning, which is highly toxic for the patient. HSCT is frequently complicated by graft versus host disease and also increases the risk of solid tumors, particularly upper aerodigestive tract squamous cell carcinomas. Approximately 60-70% of patients with FA have a FANCA gene mutation, which encodes for a protein essential for DNA repair. Mutations in the FANCA gene leads to chromosomal breakage and increased sensitivity to oxidative and environmental stress. Chromosome fragility induced by DNA-alkylating agents such as mitomycin-C (MMC) or diepoxybutane (DEB) is the gold standard test for FA diagnosis. These assays can further differentiate FA patients from mosaic patients. Somatic mosaicism occurs when there is a spontaneous reversion mutation that can lead to a mixed chimerism of corrected and uncorrected bone marrow cells leading to stabilization or correction of an FA patients blood counts in the absence of any administered therapy. Somatic mosaicism provides strong rationale for the development of FA gene therapy and demonstrates the selective advantage of gene-corrected hematopoietic cells in FA1.

1Soulier, J.,et al. (2005) Detection of somatic mosaicism and classification of Fanconi anemia patients by analysis of the FA/BRCA pathway. Blood 105: 1329-1336

About Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket) is advancing an integrated and sustainable pipeline of genetic therapies that correct the root cause of complex and rare childhood disorders. The companys platform-agnostic approach enables it to design the best therapy for each indication, creating potentially transformative options for patients contending with rare genetic diseases. Rocket's clinical programs using lentiviral vector (LVV)-based gene therapy are for the treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, and Pyruvate Kinase Deficiency (PKD) a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia. Rockets first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon disease, a devastating, pediatric heart failure condition. Rockets pre-clinical pipeline program is for Infantile Malignant Osteopetrosis (IMO), a bone marrow-derived disorder. For more information about Rocket, please visit http://www.rocketpharma.com.

Rocket Cautionary Statement Regarding Forward-Looking Statements

Various statements in this release concerning Rocket's future expectations, plans and prospects, including without limitation, Rocket's expectations regarding the safety, effectiveness and timing of product candidates that Rocket may develop, to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Infantile Malignant Osteopetrosis (IMO) and Danon disease, and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as "believe," "expect," "anticipate," "intend," "plan," "will give," "estimate," "seek," "will," "may," "suggest" or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket's ability to successfully demonstrate the efficacy and safety of such products and pre-clinical studies and clinical trials, its gene therapy programs, the pre-clinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Rocket's product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket's and its licensors ability to obtain, maintain and protect its and their respective intellectual property, the timing, cost or other aspects of a potential commercial launch of Rocket's product candidates, Rocket's ability to manage operating expenses, Rocket's ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Rocket's dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in Rocket's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed November 8, 2019. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191206005080/en/

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Gift of the Day: A Cream That Will Give You Rich Person Skin – The Cut

By daniellenierenberg

Photo: Courtesy of the Retailer

Some of the best things in life take a month before you can reap their full benefits. Like Advent calendars, or Augustinus Baders The Cream.

It takes between 30 and 40 days for skin cells to turn over, so using any new beauty product requires patience, not to mention compliance. It can be hard to wait that long, but for this cream, its worth it. Just ask Kate Bosworth, who says, It is truly the ONE product I cant live without. Or L.A. beauty expert Cassandra Gray, who puts it more succinctly: I look younger. Thats the easiest way to sell it. Or the Cuts own Kathleen Hou, who has called it the secret to rich-person skin.

The cream is fueled by a cocktail of active ingredients that includes vitamins, natural amino acids, and a bunch of allegedly miraculous synthesized molecules referred to as Trigger Factor Complex 8. The latter was formulated by a professor of applied stem cell biology at the University of Leipzig, who was looking for solutions to help burn survivors heal faster. Turned out, TFC8 kicks off the regeneration process within stem cells, enabling them to repair fine lines, dark spots, redness, and uneven tone and texture.

At $265, this product is not cheap. But it would be a great gift for someone you really love, who really loves skin care. Just make sure to check in with them 30 to 40 days later to hear what they think.

Augustinus Bader The Cream

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Gift of the Day: A Cream That Will Give You Rich Person Skin - The Cut

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

By daniellenierenberg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

To view the full abstracts, please follow this link.

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

- Ends -

Notes to editors

Novadip Biosciences

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

For further information, please contact:

Novadip Biosciences

Jeff Abbey

Chief Executive Officer

+32 (10) 779 220

info@novadip.com

For media enquiries:

Consilium Strategic Communications

Chris Gardner, Matthew Neal, Angela Gray

+44 (0) 20 3709 5700

novadip@consilium-comms.com

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

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