(The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.)

Christopher Tuggle, Iowa State University and Adeline Boettcher, Iowa State University

(THE CONVERSATION) The U.S. Food and Drug Administration requires all new medicines to be tested in animals before use in people. Pigs make better medical research subjects than mice, because they are closer to humans in size, physiology and genetic makeup.

In recent years, our team at Iowa State University has found a way to make pigs an even closer stand-in for humans. We have successfully transferred components of the human immune system into pigs that lack a functional immune system. This breakthrough has the potential to accelerate medical research in many areas, including virus and vaccine research, as well as cancer and stem cell therapeutics.

Existing biomedical models

Severe Combined Immunodeficiency, or SCID, is a genetic condition that causes impaired development of the immune system. People can develop SCID, as dramatized in the 1976 movie The Boy in the Plastic Bubble. Other animals can develop SCID, too, including mice.

Researchers in the 1980s recognized that SCID micecould be implanted with human immune cells for further study. Such mice are called humanized mice and have been optimized over the past 30 years to study many questions relevant to human health.

Mice are the most commonly used animal in biomedical research, but results from mice often do not translate well to human responses, thanks to differences in metabolism, size and divergent cell functions compared with people.

Nonhuman primates are also used for medical research and are certainly closer stand-ins for humans. But using them for this purpose raises numerous ethical considerations. With these concerns in mind, the National Institutes of Health retired most of its chimpanzees from biomedical research in 2013.

Alternative animal models are in demand.

Swine are a viable option for medical research because of their similarities to humans. And with their widespread commercial use, pigs are met with fewer ethical dilemmas than primates. Upwards of 100 million hogs are slaughtered each year for food in the U.S.

Humanizing pigs

In 2012, groups at Iowa State University and Kansas State University, including Jack Dekkers, an expert in animal breeding and genetics, and Raymond Rowland, a specialist in animal diseases, serendipitously discovered a naturally occurring genetic mutation in pigs that caused SCID. We wondered if we could develop these pigs to create a new biomedical model.

Our group has worked for nearly a decade developing and optimizing SCID pigs for applications in biomedical research. In 2018, we achieved a twofold milestone when working with animal physiologist Jason Ross and his lab. Together we developed a more immunocompromised pig than the original SCID pig and successfully humanized it, by transferring cultured human immune stem cells into the livers of developing piglets.

During early fetal development, immune cells develop within the liver, providing an opportunity to introduce human cells. We inject human immune stem cells into fetal pig livers using ultrasound imaging as a guide. As the pig fetus develops, the injected human immune stem cells begin to differentiate or change into other kinds of cells and spread through the pigs body. Once SCID piglets are born, we can detect human immune cells in their blood, liver, spleen and thymus gland. This humanization is what makes them so valuable for testing new medical treatments.

We have found that human ovarian tumors survive and grow in SCID pigs, giving us an opportunity to study ovarian cancer in a new way. Similarly, because human skin survives on SCID pigs, scientists may be able to develop new treatments for skin burns. Other research possibilities are numerous.

Pigs in a bubble

Since our pigs lack essential components of their immune system, they are extremely susceptible to infection and require special housing to help reduce exposure to pathogens.

SCID pigs are raised in bubble biocontainment facilities. Positive pressure rooms, which maintain a higher air pressure than the surrounding environment to keep pathogens out, are coupled with highly filtered air and water. All personnel are required to wear full personal protective equipment. We typically have anywhere from two to 15 SCID pigs and breeding animals at a given time. (Our breeding animals do not have SCID, but they are genetic carriers of the mutation, so their offspring may have SCID.)

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As with any animal research, ethical considerations are always front and center. All our protocols are approved by Iowa State Universitys Institutional Animal Care and Use Committee and are in accordance with The National Institutes of Healths Guide for the Care and Use of Laboratory Animals.

Every day, twice a day, our pigs are checked by expert caretakers who monitor their health status and provide engagement. We have veterinarians on call. If any pigs fall ill, and drug or antibiotic intervention does not improve their condition, the animals are humanely euthanized.

Our goal is to continue optimizing our humanized SCID pigs so they can be more readily available for stem cell therapy testing, as well as research in other areas, including cancer. We hope the development of the SCID pig model will pave the way for advancements in therapeutic testing, with the long-term goal of improving human patient outcomes.

Adeline Boettcher earned her research-based Ph.D. working on the SCID project in 2019.

This article is republished from The Conversation under a Creative Commons license. Read the original article here: https://theconversation.com/were-creating-humanized-pigs-in-our-ultraclean-lab-to-study-human-illnesses-and-treatments-156343.

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We're creating 'humanized pigs' in our ultraclean lab to study human illnesses and treatments - Alton Telegraph

Skin Stem Cells Comments Off on We’re creating ‘humanized pigs’ in our ultraclean lab to study human illnesses and treatments – Alton Telegraph | April 19th, 2021

Last year, something new was grafted to the tree of life.

Somewhere between a living organism and a robot, these tiny, living machines were created from clumps of stem cells from the African clawed frog. Stem cells from the heart gave them muscle, while skin stem cells provided structure.

Dubbed "Xenobots" (after the frog's scientific name not, alas, xenomorphs), their creators found that the living machines that could complete simple tasks in Petri dishes, as Freethink's Amanda Winkler explained last year.

Those same researchers, from Tufts and the University of Vermont, have now developed a second iteration, Xenobots 2.0, if you will, which can "self-assemble a body from single cells, do not require muscle cells to move, and even demonstrate the capability of recordable memory," as Tufts Now explains.

These Xenobots are also faster, can make their way through more complex environments, live longer than their predecessors, work in concert, and heal themselves.

Yeah, that sounds a lot like the T-1000 to me, too.

First generation Xenobots were constructed with a "top-down" approach, as Tufts put it. The researchers manually placed and surgically sculpted the heart and skin cells to form tiny biological robots in a variety of shapes.

Their shapes chosen with the help of a digital Xenobots simulator then impacted their various movements.

The original Xenobots were capable of "crawling, traveling in circles, moving small objects or even joining with other organic bots to collectively perform tasks," Winkler reported.

But to create Xenobots 2.0, the researchers utilized a "bottom up" approach, published in the journal Science Robotics.

Rather than crafting the frog heart and stem cells, the researchers simply scraped off some skin stem cells from frog embryos. Left to their own devices, the cells glommed together into spheroids on their own.

They could survive for 10 days without food and even grow if some sugar's in the mix.

"We've grown them for over four months in the lab," Tufts' Doug Blackiston, study coauthor, told Science News. "They do really interesting things if you grow them," including forming new, balloon-like shapes.

Some of the cells adapted to grow cilia a few days in. Usually used by cells to push away pathogens and ensure a nice coating of protective mucus, the Xenobots used their cilia to move around, eliminating the need for heart stem cells.

It's an example of life's remarkable plasticity, the researchers say.

"In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion," Michael Levin, professor of biology and director of Tufts' Allen Discovery Center and study corresponding author told Tufts Now.

"It is amazing that cells can spontaneously take on new roles and create new body plans and behaviors without long periods of evolutionary selection for those features."

Along with those new body plans came new abilities. Xenobots 2.0 can move around just like the first iteration did, but they are faster than what the researchers constructed. They're also better at sweeping up junk a swarm of them can round up iron oxide particles in a Petri dish and they can coat flat surfaces and shimmy through narrow capillaries.

Because they are biological, the Xenobots could also heal themselves, forming back together after injury even recovering from full-length lacerations halfway through their "bodies" in just 5 minutes.

"In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion."

Just like before, the Tufts team turned to computer simulations to tease out the best Xenobot layouts. Researchers at the University of Vermont did the data crunching, using the Vermont Advanced Computing Core's supercomputer cluster, called Deep Green.

Deep Green comes in because "it's not at all obvious for people what a successful design should look like," UVM computer scientist and robotics expert Josh Bongard told Tufts Now. "That's where the supercomputer comes in and searches over the space of all possible Xenobot swarms to find the swarm that does the job best."

The hope is that eventually Xenobots will be able to perform tasks like clearing microplastics from the ocean, or decontaminating soil.

Performing those jobs would be a hell of a lot easier with the ability to retain and access memory for guiding their actions something the original Xenobots lacked. This time around, the researchers gave them the ability to hold on to one piece of information.

The researchers injected the frog stem cells with mRNA carrying the instructions for a protein called EosFP. This protein normally glows green, but when exposed to a specific wavelength of light, it turns red instead.

Armed with their little running light, the Xenobots could now keep a record of being exposed to certain wavelengths of blue light in their environment. Further work could potentially allow them to keep track of multiple variables, or even alter their behaviors accordingly.

"When we bring in more capabilities to the bots, we can use the computer simulations to design them with more complex behaviors and the ability to carry out more elaborate tasks," Bongard said. "We could potentially design them not only to report conditions in their environment but also to modify and repair conditions in their environment."

The researchers' original work already opened questions of what, exactly, Xenobots are. Are they lifeforms? Robots, but made of biological material, in lieu of nuts and bolts?

As you can imagine, these improved iterations which organize on their own are provoking more of the same.

Tel Aviv University evolutionary biologist Eva Jablonka, who is unaffiliated with the work, told Quanta Magazine that she considers them a new form of life "defined by what it does rather than to what it belongs developmentally and evolutionarily."

Armed with a special protein that changes color from green to red, the next generation Xenobots could keep a simple record of their exposure to blue light. Credit: Doug Blackiston & Emma Lederer, Tufts University

University of Melbourne digital ethics researcher Kobi Leins believes new ethical issues arise with the creation of new forms of life. "Scientists like to make things, and don't necessarily think about what the repercussions are," she told Science News.

(For what it's worth, Levin agrees, telling Science News the questions raised by the Xenobots are like "finding a whole galaxy of weird new things.")

Levin hopes that within that galaxy, the Xenobots will do more than perform tasks: they may help us understand how biological life itself develops.

We'd love to hear from you! If you have a comment about this article or if you have a tip for a future Freethink story, please email us at [emailprotected]

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The Next Generation of Living Machines: Xenobots 2.0 - Freethink

Skin Stem Cells Comments Off on The Next Generation of Living Machines: Xenobots 2.0 – Freethink | April 4th, 2021

Using blobs of skin cells from frog embryos, scientists have grown creatures unlike anything else on Earth, a new study reports. These microscopic living machines can swim, sweep up debris and heal themselves after a gash.

Scientists often strive to understand the world as it exists, says Jacob Foster, a collective intelligence researcher at UCLA not involved with this research. But the new study, published March 31 in Science Robotics, is part of a liberating moment in the history of science, Foster says. A reorientation towards what is possible.

In a way, the bots were self-made. Scientists removed small clumps of skin stem cells from frog embryos, to see what these cells would do on their own. Separated from their usual spots in a growing frog embryo, the cells organized themselves into balls and grew. About three days later, the clusters, called xenobots, began to swim.

Normally, hairlike structures called cilia on frog skin repel pathogens and spread mucus around. But on the xenobots, cilia allowed them to motor around. That surprising development is a great example of life reusing whats at hand, says study coauthor Michael Levin, a biologist at Tufts University in Medford, Mass.

And that process happens fast. This isnt some sort of effect where evolution has found a new use over hundreds of thousands of years, Levin says. This happens in front of your eyes within two or three days.

Xenobots have no nerve cells and no brains. Yet xenobots each about half a millimeter wide can swim through very thin tubes and traverse curvy mazes. When put into an arena littered with small particles of iron oxide, the xenobots can sweep the debris into piles. Xenobots can even heal themselves; after being cut, the bots zipper themselves back into their spherical shapes.

Scientists are still working out the basics of xenobot life. The creatures can live for about 10 days without food. When fed sugar, xenobots can live longer (though they dont keep growing). Weve grown them for over four months in the lab, says study coauthor Doug Blackiston, also at Tufts. They do really interesting things if you grow them, including forming strange balloon-like shapes.

Its not yet clear what sorts of jobs these xenobots might do, if any. Cleaning up waterways, arteries or other small spaces comes to mind, the researchers say. More broadly, these organisms may hold lessons about how bodies are built, Levin says.

With the advent of new organisms comes ethical issues, cautions Kobi Leins, a digital ethics researcher at the University of Melbourne in Australia. Scientists like to make things, and dont necessarily think about what the repercussions are, she says. More conversations about unintended consequences are needed, she says.

Levin agrees. The small xenobots are fascinating in their own rights, he says, but they raise bigger questions, and bigger possibilities. Its finding a whole galaxy of weird new things.

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Frog skin cells turned themselves into living machines - Science News Magazine

Skin Stem Cells Comments Off on Frog skin cells turned themselves into living machines – Science News Magazine | April 4th, 2021

Newswise March 30, 2021 As cancer survival rates improve, more people are living with the aftereffects of cancer treatment. For some patients, these issues include chronic radiation-induced skin injury which can lead to potentially severe cosmetic and functional problems.

Recent studies suggest a promising new approach in these cases, using fat grafting procedures to unleash the healing and regenerative power of the body's natural adipose stem cells (ASCs). "Preliminary evidence suggests that fat grafting can make skin feel and look healthier, restore lost soft tissue volume, and help alleviate pain and fibrosis in patients with radiation-induced skin injury after cancer treatment," says J. Peter Rubin, MD, MBA, FACS, American Society of Plastic Surgeons (ASPS) President-Elect and Chair of the Department of Plastic Surgery at University of Pittsburgh Medical Center. He is one of the authors of a new review of the clinical evidence on fat grafting for radiation-induced skin and soft tissue injury.

"But while promising, available research has some key weaknesses that make it difficult for us to determine the true benefits of fat grafting right now," Dr. Rubin adds. The review appears in the April issue of Plastic and Reconstructive Surgery, the official medical journal of the ASPS.

More than half of patients diagnosed with cancer receive radiation therapy. Because skin cells turn over rapidly, they are exquisitely sensitive to the damaging effects of radiation. In the first few months after treatment, many patients develop acute radiation injury with skin inflammation, peeling, swelling, pain and itching. In most cases, symptoms resolve over time. However, if inflammation continues, radiation-induced skin injury can become a chronic problem leading to tight, stiff skin (fibrosis) with a risk of poor wound healing, ulcers, and tissue loss.

Fat grafting procedures transferring the patient's own fat cells from one part of the body to another have become widely used in many cosmetic and reconstructive plastic surgery procedures. In their review, Dr. Rubin and colleagues round up promising research on fat grafting for patients with radiation-induced skin injury.

In studies of breast cancer patients, fat grafting procedures have reduced pain and other symptoms of radiation-induced skin injury backed up by more-normal cellular appearance of skin cells under the microscope. In other studies, fat grafting has led to reduced risks and better outcomes of breast reconstruction after mastectomy.

For patients with radiation-induced skin injury after treatment for head and neck cancer, fat grafting has led to improvements in voice, breathing, swallowing, and movement. Good outcomes have also been reported in patients with radiation-induced skin injury in the area around the eye or in the limbs.

"The good news is fat grafting has the potential to really help patients with discomfort and disability caused by radiation-induced skin damage," according to Dr. Rubin. While research is ongoing, the benefits of fat grafting seem to result from the wide-ranging effects of ASCs including anti-scarring, antioxidant, immune-modulating, regenerative, and other actions.

"However," he adds, "the available evidence has a lot of shortcomings, including small sample sizes, lower-quality research designs, and a lack of comparison groups." Variations in fat cell collection and processing, as well as the timing and "dose" of fat grafting, make it difficult to compare results between studies. There are also unanswered questions regarding potential risks related to ASC injection and concerns that fat grafting might affect cancer follow-up.

The reviewers outline some steps for further research to clarify the benefits of fat grafting for radiation-induced skin and soft issue injury, including approaches to clinical assessment and imaging studies, testing of skin biomechanics and circulation, and cellular-level analyses. For all of these outcomes, standardized measures are needed to achieve more comparable results between studies.

"We hope our review will inform efforts to establish the benefits of specific types of fat grafting procedures in specific groups of patients," says Dr. Rubin. "To do that, we'll need studies including larger numbers of patients, adequate control groups, and consistent use of objective outcome measures."

Click here to read Fat Grafting in Radiation-Induced Soft-Tissue Injury: A Narrative Review of the Clinical Evidence and Implications for Future Studies.

DOI: 10.1097/PRS.0000000000007705

###

Plastic and Reconstructive Surgery is published in the Lippincott portfolio by Wolters Kluwer.

About Plastic and Reconstructive Surgery

For more than 70 years, Plastic and Reconstructive Surgery (http://www.prsjournal.com/) has been the one consistently excellent reference for every specialist who uses plastic surgery techniques or works in conjunction with a plastic surgeon. The official journal of the American Society of Plastic Surgeons, Plastic and Reconstructive Surgery brings subscribers up-to-the-minute reports on the latest techniques and follow-up for all areas of plastic and reconstructive surgery, including breast reconstruction, experimental studies, maxillofacial reconstruction, hand and microsurgery, burn repair and cosmetic surgery, as well as news on medico-legal issues.

About ASPS

The American Society of Plastic Surgeons is the largest organization of board-certified plastic surgeons in the world. Representing more than 7,000 physician members, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 94 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.

About Wolters Kluwer

Wolters Kluwer (WKL) is a global leader in professional information, software solutions, and services for the clinicians, nurses, accountants, lawyers, and tax, finance, audit, risk, compliance, and regulatory sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with advanced technology and services.

Wolters Kluwer reported 2019 annual revenues of 4.6 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 19,000 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.

Wolters Kluwer provides trusted clinical technology and evidence-based solutions that engage clinicians, patients, researchers and students with advanced clinical decision support, learning and research and clinical intelligence. For more information about our solutions, visit https://www.wolterskluwer.com/en/healthand follow us onLinkedInand Twitter@WKHealth.

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Fat grafting shows promise for cancer patients with radiation-induced skin injury - Newswise

Skin Stem Cells Comments Off on Fat grafting shows promise for cancer patients with radiation-induced skin injury – Newswise | April 4th, 2021

The Augustinus Bader story hasbecome a beauty legend. Professor Bader, one of the worlds leading stem-cell experts, makes a groundbreaking wound gel that rehabilitates the skin of burns victims,without the need for grafts or scarring. At a dinner hosted by Robert Friedland, the self-made billionaire and long-time mentor to Steve Jobs, Bader meets Charles Rosier, a young French financier. They are kicking around ideas forfunding the necessary clinical trials forthe product, which would likely run intothetens of millions. Pharmaceutical companies arent interested because most burns victims are in emerging countries, where the market for sophisticated healing products is negligible.

Rosier has a flash of inspiration: couldBader use what he knows about wound healing to make an anti-ageing cream? Yes, answers Bader unhesitatingly. Two years and much cajoling later, the professor makes a prototype skincare cream, and pretty soon anyone who has ever had more than a passing interest in face cream is talking about it.

According to Deloitte, as many as 90per cent of beauty launches fail within ayear. By contrast, the Augustinus Bader skincare brand has grown from a turnover of $7m in 2018 to $70m in 2020. It has also shattered traditional conventions of luxury skincare along the way. For a start, the company launched with just two face products, The Cream (fornormal/oily skin) and The Rich Cream (dry skin) and insisted that apart from cleanser andSPF theyre all you need to use. No eye cream, no neck cream, no serum underneath, no primer ontop just one cream, and a very specific two pumps at that. This was intriguing. Most luxury-skincare brands (the creams retail at205 each) dont just sell you a dream they sell you a regime.

Charles Rosier believes that their inexperience in the beauty industry helpedat first. If Id known how complex and competitive the industry is, maybe Iwouldnt have had so much passion for it. But because I had seen what Augustinuss science could do, I was truly convinced thathe could create a product that was new, disruptive and of higher quality than whatever else was in the market.

As it turned out, it was. Celebrities normally paid handsomely to endorse beauty brands were not only recommending the Augustinus Bader cream unprompted butinvesting in the company too (Courteney Cox, Melanie Griffith and Carla Bruni to note). Usually cynical beauty editors discussed it with the fervour of addicts (myself included). And in February, a panel of more than 300 industry experts voted The Cream and The Rich Cream as Womens Wear Dailys Greatest Skincare Product ofAll Time (Crme de la Mer, launched in 1965, took second place and Este Lauder Advanced Night Repair, from 1982, took third), neatly capping off a pleasing statistic of 36 awards in 36 months.

Bader a softly spoken, bow tie-wearing 61-year-old German is both asthrilled and bemused by the brands success as youd hope. Before making the face cream, he says, he had never used a skincare product in his life. But he likes the fact that now, when he uses the cream before shaving, he no longer cuts himself. It would never have occurred to him to have created a cleanse/tone/moisturise-type regime. Beauty is always from inside, he says. You dont need a routine, as many people have been used to. The idea is that just after washing your face, you use The Cream or The Rich Cream. Everything is in that one product.

Before making the face cream, Bader had never used a skincare product inhis life

It would be tempting to paint Bader asthe sneery scientist, dabbling with the beauty world as a means to an end(close to10per cent of the brands profits in 201920 went to wound-healing research and other charities). The opposite is true: what finally convinced him to embark onthe project was his patients reaction tohisearly prototype: When I gave theproduct to patients with diabetic wounds, their skin became healthier-looking and stronger, and I could see how happy it made them...so for me, even though it was just a skincare product, it developed a kind of medical meaning.

Also subversive is the brandsconspicuous lack ofmiracle ingredients. Baderswork is guided by theprinciple that your skin contains all it needs already its the communication between thecells thats important, notapplying endlessnew ingredients that your skin doesnt recognise. Conventional medicine very often tries to helpby treating symptoms, but what the patientreally wants is a healing process, he says. The creams themselves contain a complex called TCF8, which hesays is mainly made out of vitamins, amino acids and lipid structures.

$70mThe brands turnoverin2020

10%The profits in 20192020 thatwent towards wound-healing research and other charities

11The number of products in the Augustinus Bader line

50%The acceleration in healing time experienced by patientsusing Baders wound-healing gel

According to Charles Rosier, Bader isprobably the person in the team who is strictest about only using gentle ingredients which means the brand is able to satisfy the current appetite for clean skincare too. Thats why theres no SPF; because Bader is vehemently opposed to chemical sun filters and has so far found it hard to make sufficiently premium-feeling sun protection without them. And, says Bader, a little bit of sun is good for your skin as is a little bit of stress (and carrot juice: he says that people who eat a lot of carrots generally have good skin).

Last month the brand also launched avegan version of The Rich Cream, with original ingredients such as beeswax and lanolin removed and a slightly upgraded formulation. It has the same rich texture and the same uncanny ability which fans can eulogise about for hours to hug your skin within seconds of applying.

But is it getting harder to avoid the pull of the beauty mainstream? Some devotees have taken a recent spate of new launches to mean that the brand is moving away from its original one cream is all you need philosophy, and that as a result has lost some of its outsider charm. In the second half of 2020, launches came thick and fast: theres now anEssence, Face Oil, Cleansing Balm, Cleansing Gel and Lip Balm, plus body oils and lotions.

Rosier points outthat most of their competitors have around 200 products and that last years bottleneck of launches was largely due to hold-ups in the lab, as well as Covid-19. Perhaps our philosophy has switched a little from Well give you one cream to Wellgive you the essential basics of a skincare routine, he concedes. Well never do 20 serums, but well do products where we feel they can be better than otherthings that exist in the market, and allow you to have an Augustinus Bader routine and not have to mix our products with other brands.

Given how feverish the current Baderobsession is, it seems unlikely thatcustomers would need much convincingnot to mix other brands products into their routines. What isdebatable is how long this brand can remain a disrupter. Ever the renegade, Bader is less interested in being a beauty outsider than encouraging the rest of the field toraise its game.

This new beauty side of mywork is interesting because, ultimately, healthy skin contributes to beauty and for me, thats notsomething superficial, its something absolutely relevant to all the work that I do, including the medical research. In a way, Ihope that perhaps what we can do is be a little bit game-changing about what a skincare product may want to achieve. And that, to me, sounds like real hope in a jar.

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Augustinus Bader and the making of a $70m phenomenon - Financial Times

Skin Stem Cells Comments Off on Augustinus Bader and the making of a $70m phenomenon – Financial Times | April 4th, 2021

Advances in the treatment of patients with leukemias and lymphomas have led to a significant improvement in survival, which has increased the need for bone marrow transplant as a later-line therapy, said Mehrdad Abedi, MD, who added that Orca-T, a high precision cell therapy, confers significant antitumor activity, minimizes the incidence of acute and chronic graft-vs-host disease (GVHD), and causes less adverse effects (AEs) compared with standard bone marrow transplant among these patients.

There is a lot of research [ongoing]; the holy grail of research is trying to figure out whether we can separate the graft-vs-leukemia or graft-vs-lymphoma effect from GVHD, said Abedi. [The Orca-T trial] is basically looking at the past 10 years of research in this area to try to identify the cells that are good from those that are bad.

During the 2021 Transplantation and Cellular Therapy (TCT) Meetings, findings from an analysis of 2 studies demonstrated a significant reduction in cases of GVHD, a higher GVHD relapse-free survival rate, and a lack of treatment-related mortalities with Orca-T when historically compared with hematopoietic stem cell transplant (HSCT).

Additionally, the median time to neutrophil engraftment, median time to platelet engraftment, and median time from day 0 to hospital discharge was shortened with Orca-T compared with HSCT.

In an interview with OncLive during the 2021 TCT Meetings, Abedi, a professor of cancer, hematology/oncology, and internal medicine in the Department of Internal Medicine, Division of Hematology and Oncology at the UC Davis Comprehensive Cancer Center, discussed the challenges of standard transplant, how Orca-T could overcome some of those limitations, and the potential future of transplant in hematologic malignancies.

Abedi: HSCT has been around for more than 50 years in one form or another. It has been used mostly for patients with blood cancers, [such as] leukemia and lymphoma. Allogeneic bone marrow transplants, where we use cells from a donor, are very effective. [They are associated with] a very high response rate for patients who have no other options and whose disease is going to [recur] without transplant.

The problem [with allogeneic bone marrow transplant] is that it [is associated with] AEs. When we give donor cells to patients after high-dose chemotherapy, [which is given] so that the patients body doesnt reject [the cells], even though the cells are a match for the patient, they can still [develop] severe GVHD.

The acute form of GVHD can be life threatening, whereas the chronic form can become a nuisance for the rest of a patients life. A lot of patients suffer [from GVHD] to the point where they regret going through transplant. Fortunately, that is not everybody, but it is still a problem that needs to be solved and an unmet need for the field.

This research has been focused on [the question of]: Are there specific cells in the graft we give to the patients immune cells that can cause GVHD? Can we separate those cells from those that are responsible for causing graft-vs-leukemia effects?

Basically, Orca Bio approached UC Davis a few years ago to [start] collaborative research with our Good Manufacturing Practice [GMP] facility and to produce these products.

Each graft of [the Orca-T] product has stem cells and immune cells in it. The stem cells are what we need to maintain the graft and [allow the product to] stay in the patient for a long time. The immune cells are the ones that can cause graft-vs-leukemia [effects], which is what we want.

From the work that Robert Negrin, [MD] at Stanford University and many other investigators [did], it is very clear that there is a population of T cells called T-regulatory cells that can prevent GVHD. There are other populations, such as the nave T cells or conventional T cells that can cause GVHD. It looks like a smaller number of [those cells] may actually be helpful; they can cause graft-vs-leukemia, but not GVHD.

The graft is basically designed so that we can give stem cells, but they get rid of a lot of conventional T cells that can cause rapid GVHD. [The graft provides] a small amount of conventional T cells that can cause graft-vs-leukemia effects, as well as the regulatory T cells that can prevent GVHD. UC Davis got involved [with this work] because we have a very robust GMP facility. We helped Orca Bio design these protocols and manufacture the cells. Now, [Orca Bio] has moved on to their own facility. I have been involved [with this research] for the past few years.

[We] havent looked at the QOL data, but there have been several short-term and long-term benefits so far that we have seen.

We give high-dose chemotherapy that can get rid of all [the patients] stem cells and leukemia or lymphoma cells. Then, we give the graft; however, after the graft is given, it takes a couple of weeks usually to engraft [before] new cells [develop]. In between, the patients are sick because of the effects of the chemotherapy; patients also have low blood counts.

[With Orca-T] we have seen that the engrafting [occurs] a little bit earlier. For everyday [sooner] the engraftment [occurs], there is less risk of complication and suffering for the patient. That has been a major difference [with Orca-T].

Also, we have noticed that patients in general are doing better [with Orca-T compared with traditional transplant]. When we give high-dose chemotherapy, it is the same whether the patient is on a clinical trial or not. They may still get sick [with Orca-T] because of the effects of chemotherapy.

However, there is also inflammation [that can occur] as the donor cells are trying to establish themselves in the body because some of them attack the body. That inflammation also adds to the problems with chemotherapy. We havent seen that inflammation [with Orca-T]. We have seen some effects from the chemotherapy, but because we dont have the inflammation, other AEs that we see with the standard of care arent seen with Orca-T.

In general, patients do better [with Orca-T vs standard of care], and that has been a universal experience with all of our patients who have gone through the trial so far.

[Patients] just look and feel better. When they are discharged, they are not as sick compared with patients [receiving] the standard of care.

With the standard of care, after we give the graft, we have to give patients a new medication to prevent GVHD because it is such a lethal problem. If we dont put patients on immunosuppressive medications to prevent GVHD, there is a very high chance that they get and die from GVHD. Those immunosuppressive medications are critical.

The way the Orca-T graft is designed is that we dont need as many of those [immunosuppressive] medications. For example, there is a medication called methotrexate that we give on days 1, 3, 6, and 11 after [standard] transplant. That medication can cause a lot of other AEs, such as mouth sores, delayed engraftment, and kidney [problems], that can make the patient miserable. With Orca-T, we dont have to [give methotrexate], which by itself is a huge improvement.

We do give immunosuppressive medications, such as tacrolimus [Envarsus XR] or sirolimus [Rapamune] to these patients, but we dont give 2 or 3 medications as we usually do with the standard of care. Less immunosuppressive medications mean probably less infection, but more importantly, less AEs. Thats [a factor that has made] a big difference in patient experience.

That is a very loaded question. There are a lot of new drugs coming, some of which are very targeted to treat leukemia or lymphoma. Thus far, we havent seen any curative [benefit] with those drugs, so in most situations, we will still need an allogeneic stem cell transplant for patients.

The exceptions [to that] were rare diseases, such as chronic myeloid leukemia [CML], where [an oral medication was approved] and we dont need to transplant patients. That is an example of a targeted treatment that may exclude [the need to] transplant patients. That would be great because transplant is not a trivial procedure and it has a lot of AEs.

However, [CML] is a very specific disease with 1 gene that causes the disease. In most leukemias and lymphomas, multiple genes are involved, so we dont think single-target treatments will get rid of the disease. We still think that allogeneic transplant will be around for a long time.

In fact, if you look at any center in the country, the volume of transplant has substantially increased over time because patients are living longer. Patients end up being able to go to a transplant vs before when many were dying in the middle of their treatment and not getting to transplant.

That being said, there are 2 directions [we can go in]. One is to try to decrease the AEs associated with transplant. This [Orca-T cell therapy] is very effective [in doing this] by targeting the graft-vs-leukemia effect and preventing GVHD. The second direction is to use these allogeneic cells to specifically target the tumor cells. That is why gene modifications, CAR T-cell therapies, and other approaches are coming. They still use allogeneic cells from a donor, but now they are directing them to specifically go after tumor cells.

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Orca-T Offers an Alternative to HSCT With Improved Patient Experience - OncLive

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Published on April 2, 2021

Recently, a 43-year-old man was presented at Fortis Hospital, Noida, complaining of severe back pain. Upon investigation, it was found that he was suffering from a rare disease, multiple myeloma which is a type of cancer that forms in the white blood cells or plasma cells. Here cancerous plasma cells accumulate in the bone marrow and crowd around the healthy blood cell that help in fighting infections by building antibodies, this puts the patients life at high risk. He therefore urgently required a Bone Marrow Transplant (BMT). Dr Rahul Bhargava, Director and Head, Hematology and Bone Marrow Transplant, Fortis Hospital, Noida and his team took a timely decision to go ahead with BMT to save his life.

A bone marrow transplant is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells. Bone marrow is the soft, fatty tissue inside your bones. The bone marrow produces blood cells. Stem cells are immature cells in the bone marrow that give rise to different blood cells. Bone marrow transplant has now revolutionised. It is like a peripheral blood stem cell transplant, meaning, it is just like a blood transfusion (like platelet apheresis) which does not require any anesthesia.

Upon further investigation it was revealed that chemotherapy was required before BMT. Following the chemotherapy, on the 10thday of admission the team of doctors engulfed stem cells in the patients body which provided the body with a new source of healthy cells. Safe hospital environment and the doctors expertise in the area ensured that the BMT was done smoothly, without any complications and within 15 days the patient had been discharged. Usually, a patient takes 25-30 days to recover but here, due to patients will to recover and the facilities provided to him in the hospital he recovered at a faster pace.

Dr Rahul Bhargava, Director and Head, Hematology and Bone Marrow Transplant, Fortis Hospital, Noida, said,The case was complicated as the patient was suffering from high-risk multiple myeloma, which is a rare form of cancer. We took the necessary precautions and performed chemotherapy first to which he responded well and post that a Bone Marrow Transplant (BMT) was performed successfully. The process was smooth, and no complications arose during the same. We request patients to not fear BMT and undergo the process when required.

Talking about the clinical excellence at Fortis Hospital, NOIDA,Mr Hardeep Singh, Zonal Director, Fortis Hospital, Noidasaid, The team at Fortis Hospital, Noida try their best to save lives and do not give up even if there is 1% chance of survival. The patient was suffering from high-risk multiple myeloma for which immediate bone marrow transplant was required. The case was managed extremely well and with a lot of patience by Dr Rahul Bhargava and his team. I applaud the team of doctors for their continued commitment towards clinical expertise and patient care.

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Timely Bone Marrow Transplant by Fortis gives new lease of life to a patient with Multiple Myeloma - APN News

Bone Marrow Stem Cells Comments Off on Timely Bone Marrow Transplant by Fortis gives new lease of life to a patient with Multiple Myeloma – APN News | April 4th, 2021

Large granular lymphocytic (LGL) leukemia is a kind of cancer that affects blood cells. The disease is rare: Only about 1,000 people per year are diagnosed with it. It affects men and women in roughly equal numbers, and most of those diagnosed are over 60 years old.

Heres what we know about this form of leukemia.

Your blood is made up of four different parts:

Some of your white blood cells are larger than the rest. These cells contain tiny granules that can be seen under a microscope.

In people with LGL leukemia, these large, granular white blood cells copy themselves until there are too many. The fact that the white blood cells (also called lymphocytes) replicate themselves is what makes this disorder a type of cancer.

Your blood contains two different types of lymphocytes: T-cells (T-LGL) and B-cells, which are also known as natural killer cells (NK-LGL). B-cells fight off invading bacteria and viruses. T-cells attack other cells in your body that have become harmful, like cancer cells.

When your T-cells are copying themselves too much, you have T-LGL leukemia. If your natural killer cells are replicating too much, you have NK-LGL leukemia.

Most cases of LGL leukemia are chronic and slow-growing, whether theyre NK-LGL or T-LGL. Only around 10 percent of all LGL cases are aggressive, fast-growing cells.

Researchers dont yet know what causes LGL leukemia. The disorder is associated with a genetic change or mutation, usually to the STAT3 and STAT5b genes.

Between 10 and 40 percent of people with LGL leukemia also have a history of autoimmune disorders. The immune disorder most often associated with LGL leukemia is rheumatoid arthritis (RA).

About 20 percent of those with LGL leukemia also have RA. So far, researchers have been unable to determine which disorder began first.

Most people who are diagnosed with LGL leukemia will experience some of these symptoms:

A healthcare professional may look for other symptoms, too, including:

You should contact your doctor and seek treatment if youre having recurring infections, especially if you have a fever that doesnt go away or you have other infection symptoms, such as swelling or sores, that arent getting better.

To find out if you have LGL leukemia, a healthcare professional will analyze a sample of your blood. Your doctor may also take a sample of your bone marrow, often from your hip area, to look for abnormal cells.

To determine which type of LGL leukemia you have, your doctor could use a laser technology called flow cytometry to identify whether T-cells or NK-cells are replicating too much.

Most cases of LGL leukemia are slow growing. Doctors sometimes take a wait-and-watch approach to treatment.

You may not start treatment until tests or symptoms show that the condition has reached a certain level.

If tests show that your neutrophil levels have dropped too much, your doctor may start treatment at that time. Around 45 percent of people with this condition needed immediate treatment.

When treatment for LGL leukemia begins, it may or may not follow the same intensive course as other cancer treatments.

Most people will eventually need some combination of chemotherapy and immune-suppressing drug therapy. Your medications could include:

In some cases, treatment for LGL leukemia involves a bone marrow or stem cell transplant. Its also possible that your treatment could include removing your spleen, an organ in your abdomen that filters your blood and helps maintain your immune system.

Two to three times a year, you may need to visit a healthcare professional to have bloodwork done to monitor your health and the activity of your white blood cells.

While theres no cure for LGL leukemia, most cases progress very slowly, unlike other forms of leukemia. One study that followed 1,150 people with the disease found that they lived an average of 9 years after their diagnosis.

The more aggressive form of LGL leukemia doesnt respond well to treatment. Life expectancy is likely much shorter for those with this very rare subtype of LGL leukemia.

LGL leukemia is a rare type of cancer where large white blood cells copy themselves too much, making your body prone to frequent infections.

Most cases of LGL leukemia are slow-growing, so treatment might not be necessary at first.

Eventually, people with this condition might need a combination of chemotherapy and immunosuppressing medications to slow the growth of cancer cells. Theres no cure yet for LGL leukemia.

A small percentage of cases are a faster-growing type of leukemia that doesnt respond well to treatments. Life expectancy for this subtype is shorter than the slow-growing type.

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LGL Leukemia: Overview, Symptoms, and Treatment - Healthline

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One of the common research approaches to treating brain diseases such as Parkinsons disease (PD) and Alzheimers disease (AD) is using antibodies designed to clear the accumulated misfolded proteins implicated in the diseases. To date, these drug trials have not been particularly successful at improving the disease, even when they are effective at removing the proteins. A new theory hypothesizes that the antibodies are actually increasing the neuroinflammation associated with PD and AD, basically making the disease worse while removing the proteins.

Stuart Lipton, a researcher at Scripps Research Institute, recently published research suggesting that this may be exactly what is happening. They ran a series of in vitro assays and experiments in mice that had brain grafts of human-induced pluripotent stem cell (hiPSC)-derived microglia (hiMG). They found that the antibodies that target the misfolded proteins found in PD and AD trigger the NLRP3 inflammasome, which can lead to cell death.

Our findings provide a possible explanation for why antibody treatments have not yet succeeded against neurodegenerative diseases, said co-senior author Lipton, Step Family Foundation endowed chair in the department of molecular medicine and founding co-director of the Neurodegeneration New Medicines Center at Scripps Research.

The results were published in Proceedings of the National Academy of Sciences (PNAS).

The research started when Dorit Trudler, a postdoctorate researcher in Liptons lab, attempted to make microglia in the lab. Microglia are the innate immune cells in the brain, and it is a notoriously difficult task because the cells dont originate from the same type of stem cells in the bone marrow that generates the rest of the immune system.

Instead of coming from the bone marrow like B and T cells and macrophages, microglia are created from the yolk sac that embryos swim in during early development, then migrate from the sac to the brain. Trudler was able to turn human-derived stem cells to turn into a yolk sac-like structure, and from there, developed cells that were identical to microglia removed from humans based on the mRNA they expressed.

Lipton indicated, They match as closely as possible.

They then exposed these microglia to either alpha-synuclein, the misfolded protein identified in Parkinsons patients, and the microglia shot off inflammatory signals. And when they exposed the microglia to amyloid-beta, the hallmark of Alzheimers, the inflammation grew worse.

They then worked with biopharma companies to obtain antibodies that bind to either alpha-synuclein or amyloid-beta. Although Lipton is not saying which companies, it did say one of them was not Biogens aducanumab, which is up for approval or rejection for Alzheimers by June 7 by the U.S. Food and Drug Administration (FDA).

The surprising and potentially extremely important result was that although the antibodies successfully attached to their protein targets, it didnt help with inflammation. Rather than make things better, it actually made things worse, Lipton said.

And they further found in humanized mice with both human and mice microglia, that the pro-inflammatory response was unique to the human cells. This means that biopharma companies, in working with laboratory animals on therapeutic antibodies for these diseases, would not have seen this reaction. Although unclear yet why its causing inflammation, they are convinced the NLRP3 pathway is involved, although they dont have the exact mechanism worked out. Potentially, however, it might be possible to treat patients with a combination of the protein-clearing drugs and anti-inflammatories that block the NLRP3 pathway.

In an unrelated study, researchers at Massachusetts General Hospital utilized whole-genome sequencing (WGS) to identify rare genomic variants associated with AD. In doing so, they found 13 mutations, which establish new genetic links between AD and synaptic function. They believe it could help guide the development of new drugs for AD.

The first group of genes identified that were associated with AD involve the accumulation of amyloid-beta. The next 30 AD gene mutations identified were linked to chronic inflammation in the brain. Loss of synapses is the neurological change most closely linked with the severity of dementia in AD, but until now clear genetic association had not been identified.

Rudolph Tanzi, vice chair of Neurology and director of the hospitals Genetics and Aging Research Unit, said, It was always kind of surprising that whole-genome screens had not identified Alzheimers genes that are directly involved with synapses and neuroplasticity.

Tanzi went on to note that identifying less-common mutations that increase the risk for AD may provide critical information about the disease. Rare gene variants are the dark matter of the human genome, he said.

There are many of them, as it turns out. Of the three billion pairs of nucleotide bases in the human genome, about 5o to 60 million are gene variants and 77% are rare.

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Do Therapies for Alzheimer's & Parkinson's that Clear Abnormal Brain Proteins Make the Diseases Worse? - BioSpace

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MELVILLE, N.Y., March 31, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, today announced that the United States Patent Office has issued a notice of allowance for a patent application related to the Companys metabolic ThermoStem Program. The notice of allowance was issued on March 22, 2021 and is related to a new patent application not previously announced.

Claims granted under the new patent cover methodologies related to generating exosomes and brown adipocytes from human brown adipose-derived stem cells. Exosomes are small extracellular vesicles produced by cells that contain lipids, messenger-RNA, micro-RNA, cytokines and proteins. Therapeutic benefits of using exosomes have been demonstrated in various disease models and may provide a valuable therapeutic tool for treating disease.

We are pleased to see that we have been granted an additional patent by the USPTO for our ThermoStem Program, said Lance Alstodt, the Companys CEO. Our comprehensive portfolio of patents under our ThermoStem Program continues to expand as we develop and protect intellectual property related to large and growing markets where brown adipocyte therapeutics can be applied. Im very proud of our team, driving towards the achievement of our stated goals. The advancement of our technology is a core, fundamental value driver of our Company. Our family of intellectual property coupled with our financial reporting progress are critical factors contributing to our growth strategy.

It is expected that the exosome diagnostic and therapeutic market will reach $368 million by 2022 as the development of research, clinical tools and therapeutics continues to grow in this emerging technology.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: ir@biorestorative.com

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BioRestorative Therapies Announces Notice of Allowance for a New Patent Application Related to its Off-the-Shelf ThermoStem Program - GlobeNewswire

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What would happen if you stuck your body inside a particle accelerator? The scenario seems like the start of a bad Marvel comic, but it happens to shed light on our intuitions about radiation, the vulnerability of the human body, and the very nature of matter.

Particle accelerators allow physicists to study subatomic particles by speeding them up in powerful magnetic fields and then tracing the interactions that result from collisions. By delving into the mysteries of the Universe, colliders have entered the Zeitgeist and tapped the wonders and fears of our age.

As far back as 2008, the Large Hadron Collider (LHC), operated by the European Organization for Nuclear Research (CERN), was charged with creating microscopic black holes that would allow physicists to detect extra dimensions. To many, this sounds like the plot of a disastrous science-fiction movie.

It came as no surprise when two people filed a lawsuit to stop the LHC from operating, lest it produce a black hole powerful enough to destroy the world. But physicists argued that the idea was absurd and the lawsuit was rejected.

Then, in 2012, the LHC detected the long-sought Higgs boson, a particle needed to explain how particles acquire mass. With that major accomplishment, the LHC entered popular culture; it was featured on the album cover of Super Collider (2013) by the heavy metal band Megadeth, and was a plot point in the US television series The Flash (2014-).

Yet, despite its accomplishments and glamour, the world of particle physics is so abstract that few understand its implications, meaning, or use. Unlike a NASA probe sent to Mars, CERNs research doesnt produce stunning, tangible images.

Instead, the study of particle physics is best described by chalkboard equations and squiggly lines called Feynman diagrams. Aage Bohr, the Nobel laureate whose father Niels invented the Bohr model of the atom, and his colleague Ole Ulfbeck have even gone as far as to deny the physical existence of subatomic particles as anything more than mathematical models.

Which returns us to our original question: what happens when a beam of subatomic particles traveling at nearly the speed of light meets the flesh of the human body? Perhaps because the realms of particle physics and biology are conceptually so far removed, its not only laypeople who lack the intuition to answer this question, but also some professional physicists.

In a 2010 YouTube interview with members of the physics and astronomy faculty at the University of Nottingham, several academic experts admitted that they had little idea what would happen if one were to stick a hand inside the proton beam at the LHC. Professor Michael Merrifield put it succinctly: Thats a good question. I dont know is the answer. Probably be very bad for you.

Professor Laurence Eaves was also cautious about drawing conclusions. [B]y the scales of energy we notice, it wouldnt be that noticeable, he said, likely with a bit of British understatement. Would I put my hand in the beam? Im not sure about that.

Such thought experiments can be useful tools for exploring situations that cant be studied in the laboratory. Occasionally, however, unfortunate accidents yield case studies: opportunities for researchers to study scenarios that cant be experimentally induced for ethical reasons. Case studies have a sample size of one and no control group.

But, as the neuroscientist V S Ramachandran has pointed out in Phantoms in the Brain (1998), it takes only one talking pig to prove that pigs can talk. On 13 September 1848, for example, an iron rod pierced through the head of the US railway worker Phineas Gage and profoundly changed his personality, offering early evidence of a biological basis for personality.

And on 13 July 1978, a Soviet scientist named Anatoli Bugorski stuck his head in a particle accelerator. On that fateful day, Bugorski was checking malfunctioning equipment on the U-70 synchrotron the largest particle accelerator in the Soviet Union when a safety mechanism failed and a beam of protons traveling at nearly the speed of light passed straight through his head, Phineas Gage-style.

Its possible that, at that point in history, no other human being had ever experienced a focused beam of radiation at such high energy. Although proton therapy a cancer treatment that uses proton beams to destroy tumors was pioneered before Bugorskis accident, the energy of these beams is generally not above 250 million electron volts (a unit of energy used for small particles). Bugorski might have experienced the full wrath of a beam with more than 300 times this much energy, 76 billion electron volts.

Proton radiation is a rare beast indeed. Protons from the solar wind and cosmic rays are stopped by Earths atmosphere, and proton radiation is so rare in radioactive decay that it was not observed until 1970. More familiar threats, such as ultraviolet photons and alpha particles, do not penetrate the body past skin unless a radioactive source is ingested.

Russian dissident Alexander Litvinenko, for instance, was killed by alpha particles that do not so much as penetrate paper when he unknowingly ingested radioactive polonium-210 delivered by an assassin. But when Apollo astronauts protected by spacesuits were exposed to cosmic rays containing protons and even more exotic forms of radiation, they reported flashes of visual light, a harbinger of what would welcome Bugorski on the fateful day of his accident.

According to an interview in Wired magazine in 1997, Bugorski immediately saw an intense flash of light but felt no pain. The young scientist was taken to a clinic in Moscow with half his face swollen, and doctors expected the worst.

Ionizing radiation particles such as protons wreak havoc on the body by breaking chemical bonds in DNA. This assault on a cells genetic programming can kill the cell, stop it from dividing or induce a cancerous mutation. Cells that divide quickly, such as stem cells in bone marrow, suffer the most. Because blood cells are produced in bone marrow, for instance, many cases of radiation poisoning result in infection and anemia from losses of white blood cells and red blood cells, respectively.

But unique to Bugorskis case, radiation was concentrated along a narrow beam through the head, rather than being broadly distributed from nuclear fallout, as was the case for many victims of the Chernobyl disaster or the bombing of Hiroshima.

For Bugorski, particularly vulnerable tissues, such as bone marrow and the gastrointestinal track, might have been largely spared. But where the beam shot through Bugorskis head, it deposited an obscene amount of radiation energy, hundreds of times greater than a lethal dose by some estimates.

And yet, Bugorski is still alive today. Half his face is paralyzed, giving one hemisphere of his head a strangely young appearance. He is reported to be deaf in one ear. He suffered at least six generalized tonic-clonic seizures. Commonly known as grand mal seizures, these are the seizures most frequently depicted in film and television, involving convulsions and loss of consciousness.

Bugorskis epilepsy is likely a result of brain tissue-scarring left by the proton beam. It has also left him with petit mal or absence seizures, far less dramatic staring spells during which consciousness is briefly interrupted. There are no reports that Bugorski has ever been diagnosed with cancer, though that is often a long-term consequence of radiation exposure.

Despite having nothing less than a particle accelerator beam pass through his brain, Bugorskis intellect remained intact, and he successfully completed his doctorate after the accident. Bugorski survived his accident. And as frightening and awesome as the inside of a particle accelerator might be, humanity has thus far survived the nuclear age.

This article by Joel Frohlich was originally published at Aeon and has been republished under Creative Commons.

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Heres what happens when a beam of subatomic particles hits you in the face - The Next Web

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New Delhi: People woke up to terrible news of actor-politician Kirron Kher suffering from multiple myeloma, a type of blood cancer. She is currently undergoing treatment in Mumbai. Chandigarh BJP President and Kirrons colleague, Arun Sood revealed this at a press conference on Wednesday after which Anupam Kher also confirmed the same in a long note on Thursday morning. Also Read - Confirmed: Kirron Kher Diagnosed With Blood Cancer, Anupam Kher Calls Her a 'Fighter'

She had suffered a broken left arm at her Chandigarh house on November 11 last year. After her medical tests at Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh, she was diagnosed with multiple myeloma. The disease had spread to her left arm and right shoulder. For treatment she had to go to Mumbai on December 4, Sood said at the press conference. Also Read - Anupam Kher And Kirron Kher Wish Each Other on 35th Wedding Anniversary With This Romantic Picture

Fans and well-wishers of Kirron are devastated by the news with many fans not being able to comprehend the shocking news. Here are a few things to know about the disease Multiple Myeloma that Kirron has been diagnosed with: Also Read - Kirron Kher-Anupam Kher's Mushiness in THESE Throwback Pictures on 34th Anniversary is All Hearts

It is a type of cancer that forms in a type of white blood cells known as a plasma cell. Your healthy plasma cells will fight infections and make antibodies that will attack germs, as per Mayoclinic. The cancerous plasma cells accumulate in the bone marrow. In this case, the cancer cells start producing an abnormal protein which further leads to complications. In simpler words, Multiple Myeloma happens when plasma cells become cancerous and grow out of control.

The symptoms can vary depending on an individual. Few reports suggest that initial symptoms may not be noticeable. But after a while, when it starts getting aggressive, as per Healthline, 4 major symptoms are noticeable which are referred to by the acronym CRAB which means:

Body gets a high level of calcium which can cause:

The cause is still unknown. It initiates with abnormal plasma cells which multiply in the bone marrow. Myeloma cells do not multiple and die, they divide indefinitely, as per Healthline.

Till now there is no cure for multiple myeloma. There are multiple treatments available including chemotherapy, interventional radiology, radiation therapy, stem cell transplantation, targeted therapy. Treatments are used when the disease starts getting worse.

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All About Multiple Myeloma, Type of Blood Cancer Kirron Kher is Suffering From - India.com

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Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell therapy, and the increasing government spend related to these novel techniques, have now caught the eye of federal regulators and prosecutors. In this client alert, we profile some brief context of stem cell therapy, the governments regulations governing these techniques, and some of the best practices for those interested in this emerging space.

Stem cells are cells from which all other cells with specialized functions are generated (i.e., the bodys raw materials). Stem cells may duplicate themselves to create more stem cells or they may generate cells with a specific function like blood or brain cells.

Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions and diseases from multiple sclerosis to vision loss to traumatic spinal cord injuries to Lou Gehrigs disease just to name a few.

The Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. While the FDA has acknowledged that stem cell therapy has the potential to treat diseases or conditions for which few treatments exist, there are still only a few treatments that have actually been approved by the FDA. Many treatments are still only in early investigatory stages.

The FDA has recognized the massive potential that stem cell therapy has in allowing patients treatments for various conditions. Consequently, in 2017, the FDA issued guidance indicating its intent to exercise enforcement discretion as a means to support and expedite the development of regenerative medicine products. This enforcement discretion period was to allow innovators time to determine whether to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application as appropriate. The FDA, however, has made clear its enforcement discretion policy only applies to products that do not raise potential significant safety concerns. What the FDA considers significant is debatable, creating uncertainty and ambiguity for those who might be relying on the FDAs enforcement discretion period.

Initially, the FDA stated that its enforcement discretion period would last through November 2020. But in July 2020, the FDA extended its enforcement discretion period through May 2021 a fast-arriving date. It remains unclear whether the FDA intends to extend the time period of its enforcement discretion any further, but either way, stem cell therapy providers would be well-served by planning for and expecting enforcement efforts to ramp up in the near future.

In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy hype, and encouraged consumers to make sure any stem cell therapy treatments were either approved or being studied as an IND. The FDAs concerns have led to multiple enforcement actions, including one just last month. On February 1, 2021, for example, the government announced the indictment of Ashton Derges, a healthcare provider in Missouri, who marketed stem cell shots as a successful treatment for various conditions, including COVID-19. According to the indictment, Derges was paid nearly $200,000 by patients for the stem cell shots, none of which actually contained stem cells at all. While this alleged fraud was not particularly sophisticated, it nonetheless marked a significant development: the governments first criminal prosecution of those touting stem cell therapies.

But blatant fraud is not the only type of stem cell therapy case the government has expressed interest in investigating. A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. A good case study of the risks associated with aggressive marketing of stem cell therapy is a case out of Florida involving US Stem Cell Clinic Inc. The clinic was marketing stem cell therapy to treat conditions and diseases such as Parkinsons disease, stroke, and brain injuries none of which were approved by the FDA. And, much of the marketing that US Stem Cell Clinic used promised almost miraculous results. As a result, last year, the FDA successfully permanently enjoined the US Stem Cell Clinic from selling or providing those stem cell therapy treatments. Notably, this case was pursued by the FDA despite the FDA explicitly stating its intent to be lenient with emerging stem cell therapy treatments.

Stem cell therapy is a groundbreaking medical tool with great possibilities to treat a plethora of diseases and conditions. As the industry continues to expand, so will the governments interest. Our firm continues to see an uptick in cases involving stem cell therapy treatments. And we have successfully assisted clients in avoiding unnecessary scrutiny by the FDA and other government regulators.

If you are in the stem cell therapy industry or are considering offering stem cell therapy treatments, we recommend that you:

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The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra

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Multiple sclerosis (MS) causes a wide range of symptoms involving the brain, optic nerves, and spinal cord. Research is only just beginning to reveal who is at risk and what causes the condition.

MS is a chronic condition affecting 2.8 million people worldwide. While treatment options are currently limited, trials of several new approaches are underway.

Researchers believe that MS is an autoimmune disorder. This type of illness involves the immune system attacking healthy cells, much as it would attack viruses or bacteria.

In the case of MS, the immune system attacks the myelin sheath that surrounds nerve cells. The attack causes lesions to form, and over time, these cause scarring, which leads to nerve damage and reduced function.

As a result of this damage, a person with MS may experience numbness and tingling sensations, fatigue, muscle weakness, dizziness and vertigo, memory issues, and vision problems, among other symptoms.

There are four types of MS: clinically isolated syndrome (CIS), relapsing-remitting MS, primary progressive MS, and secondary progressive MS.

CIS is a single episode of MS-like symptoms that lasts for at least 24 hours. People with CIS do not necessarily have MS, but experiencing an episode can be the first sign of the condition.

Treating MS involves interdisciplinary care, including rehabilitation, disease-modifying drugs (DMARDs), and complementary and alternative therapies.

Scientists do not fully understand the risk factors for MS and the mechanisms of the condition. However, they are making new headway in the search for answers and improvements in treatment.

What does the latest research show about the risk factors, mechanisms, and treatments of MS? In this Special Feature, Medical News Today takes a closer look.

French neurologist Jean-Martin Charcot first described the features of MS in 1868. He noted the differences between this condition and the tremor of paralysis agitans, a symptom of the neurological condition later named Parkinsons disease.

The three symptoms associated with MS at the time were called Charcots triad. They included a characteristic tremor, involuntary eye movements, also known as nystagmus, and scanning speech, which some call staccato or explosive speech.

Decades later, the invention of MRI scans helped doctors diagnose MS. Treatment with steroids became commonplace, and doctors then began to use medications in a class of drugs called interferons. The Food and Drug Administration (FDA) first approved interferons for use in people with MS in 1993.

Article highlights:

Although scientists and healthcare professionals understand the defining features of MS, several aspects of the condition remain a mystery.

While researchers recognize that MS is an autoimmune condition, they do not understand why immune cells attack myelin.

Also, diagnosing MS is still an ambiguous process because its symptoms are similar to those of many other health conditions.

In addition, experts do not know why women are 23 times more likely to be diagnosed with MS than men.

Research suggests that risk factors of MS include a lack of vitamin D or sunlight, smoking, obesity, a history of infection with the Epstein-Barr virus, being female, and possibly having inherited specific genes, as well as environmental factors.

More recently, the gut microbiota has emerged as a possible risk modulator.

A recent overview of clinical research found that people with MS had larger populations of Pedobacteria, Flavobacterium, Pseudomonas, Mycoplana, Acinetobacter, Eggerthella, Dorea, Blautia, Streptococcus, and Akkermansia bacteria in their intestines than people without MS.

People with MS also had reduced populations of Prevotella, Bacteroides, Parabacteroides, Haemophilus, Sutterella, Adlercreutzia, Coprobacillus, Lactobacillus, Clostridium, Anaerostipes, and Faecalibacterium bacteria.

Researchers speculate that balancing out the populations of gut bacteria in people with MS may reduce inflammation and the overactivation of the immune system.

Research from the MS Society Edinburgh Centre for MS Research found that people with MS had reduced numbers of inhibitory neurons, compared with people who did not have the condition.

However, people with MS had as many stimulating neurons as those without the condition. This was true even for people who had received their MS diagnoses many years earlier.

These findings help reveal the types of neurons affected by MS, shedding more light on how the condition evolves within the body. The research may also offer insight into treatments that could protect the targeted neurons.

DMARDs that health authorities have recently approved as MS treatments include cladribine (Mavenclad) and siponimod (Mayzent) for relapsing-remitting and active secondary progressive forms of the condition.

Cladribine targets lymphocytes, white blood cells responsible for attacks on myelin. Siponimod harnesses specific white blood cells that attack myelin and prevents them from circulating in the body.

However, due to their interactions with the immune system, these drugs may lead to a reduction in lymphocytes, making a person vulnerable to infections.

The medicines actions may also contribute to reduced responses to vaccines in people who receive routine vaccinations. With the introduction of COVID-19 vaccines, scientists have investigated whether people with MS who take medications such as cladribine can have adequate responses to vaccines.

The latest research indicates that people taking cladribine do produce protective antibodies to other common vaccines, despite having decreased lymphocyte levels induced by the medication.

This result gives scientists and others in the medical community hope that people who take these drugs for MS will have similarly adequate responses to COVID-19 vaccines.

Some scientists are currently investigating the potential for stem cell therapy for MS. In a phase 1 study conducted at the Karolinska Institute, in Stockholm, Sweden, seven people with progressive MS received infusions of stem cells derived from each participants own bone marrow.

As early as 7 days after administration of the stem cell therapy, researchers found evidence of positive changes in the participants immune systems. At 12 weeks, five out of six participants had no new characteristic lesions on follow-up MRI brain scans.

As their understanding of the condition evolves, many scientists are investigating the root cause of MS.

An analysis of the current data has revealed a possible connection between gut health and the condition. Data revealing relationships between the gut microbiota and the brain continually emerge, and scientists are hopeful that diet modifications, probiotics, and certain drugs that balance the gut microbiome will play a role in MS treatment.

Also in development are remyelination and neuroprotection therapies. The latter aim to protect the axons and myelin from further damage, while the former could restore lost function for people with MS.

Meanwhile, immunotherapy drugs would protect the nerves from destruction and rebuild neurons that have already sustained damage.

Another potential treatment in phase 1 trials is a tumor necrosis factor-alpha (TNF-alpha) inhibitor called MYMD-1. TNF-alpha is a type of cytokine produced by white blood cells that regulates some aspects of the immune system.

Overproduction of this cytokine is associated with several autoimmune conditions, including MS. MYMD-1 is a new type of TNF-alpha blocker that shows promise as a treatment for MS and other conditions.

Trials for therapies involving the gut microbiome, stem cells, neuroprotective treatments, remyelination, and MYMD-1 are still in the earliest stages. However, the possibilities provide hope that ongoing research will lead to effective ways to prevent MS and better methods of treatment.

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Multiple sclerosis: Recent research on causes and treatments - Medical News Today

Spinal Cord Stem Cells Comments Off on Multiple sclerosis: Recent research on causes and treatments – Medical News Today | April 4th, 2021

The same team of biologists and computer scientists from Tufts University and the University of Vermont that created the Xenobots last year have now developed Xenobots 2.0. Last years version were novel, tiny self-healing biological machines created from frog cells, and they could navigate, push payloads, and act as a collective unit in some cases.

The new Xenobots 2.0 are life forms that can self-assemble a body from single cells. They do not require muscles to move, and they have even demonstrated recordable memory. Compared to their previous counterparts, the new bots move faster, navigate even more environments, and have longer lifespans. At the same time, they can still work together and heal themselves when damaged.

The new research was published in Science Robotics.

With the Xenobots 1.0, the millimeter-sized automations were constructed top down, with the manual placement of tissue and surgical shaping of frog skin and cardiac cells, which produces motion. With the new version of the technology, they were constructed bottom up.

Stem cells were taken from the embryos of the African frog called Xenopus laevis, and this enabled them to self-assemble and grow into spheroids. After a few days, the cells differentiated and produced cilia that moved back and forth or rotated in a specific way.

These cilia provide the new bots with a type of legs that enables them to rapidly travel across surfaces. In the biological world, cilia, or tiny hair-like projections, are often found on mucous surfaces like the lungs. They help by pushing out foreign material and pathogens, but in the Xenobots, they offer rapid locomotion.

Michael Levin is a Distinguished Professor of Biology and director of the Allen Discovery Center at Tufts University. He is the corresponding author of the study.

We are witnessing the remarkable plasticity of cellular collectives, which build a rudimentary new body that is quite distinct from their default in this case, a frog despite having a completely normal genome, said Levin. In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion. It is amazing that cells can spontaneously take on new roles and create new body plans and behaviors without long periods of evolutionary selection for those features.

Senior scientist Doug Blackiston was co-first author of the study along with research technician Emma Lederer.

In a way, the Xenobots are constructed much like a traditional robot. Only we use cells and tissues rather than artificial components to build the shape and create predictable behavior. said Blackiston On the biology end, this approach is helping us understand how cells communicate as they interact with one another during development, and how we might better control those interactions.

Over at UVM, the scientists were developing computer simulations that modeled different shapes of the Xenobots, which helped identify any different behaviors that were exhibited in both individuals and groups. The team relied on the Deep Green supercomputer cluster at UVMs Vermont Advanced Computing Core.

Led by computer scientists and robotics expert Josh Bongard, the team came up with hundreds of thousands of environmental conditions through the use of an evolutionary algorithm. The simulations were then used to identify Xenobots that could work together in swarms to gather debris in a field of particles.

We know the task, but its not at all obvious for people what a successful design should look like. Thats where the supercomputer comes in and searches over the space of all possible Xenobot swarms to find the swarm that does the job best, says Bongard. We want Xenobots to do useful work. Right now were giving them simple tasks, but ultimately were aiming for a new kind of living tool that could, for example, clean up microplastics in the ocean or contaminants in soil.

The new version of the bots are faster and more efficient at tasks like garbage collection, and they can now cover large flat surfaces. The new upgrade also includes the ability for the Xenobot to record information.

The most impressive new feature of the technology is the ability for the bots to record memory, which can then be used to modify its actions and behaviors. The newly developed memory function was tested and the proof of concept demonstrated that it could be extended in the future to detect and record light, the presence of radioactive contamination, chemical pollutants, and more.

When we bring in more capabilities to the bots, we can use the computer simulations to design them with more complex behaviors and the ability to carry out more elaborate tasks, said Bongard. We could potentially design them not only to report conditions in their environment but also to modify and repair conditions in their environment.

The new version of the robots are also able to self-heal very efficiently, demonstrating that they are capable of closing the majority of a severe full-length laceration half their thickness within just five minutes.

The new Xenobots carry over the ability to survive up to ten days on embryonic energy stores, and their tasks can be carried out with no additional energy sources. If they are kept in various different nutrients, they can continue at full speed for months.

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Xenobots 2.0 are Here and Still Developed With Frog Stem Cells - Unite.AI

Cardiac Stem Cells Comments Off on Xenobots 2.0 are Here and Still Developed With Frog Stem Cells – Unite.AI | April 4th, 2021

Scientists have created small, synthetic living machines that self-organize from single cells, move quickly through different environments without the need for muscle cells, can remember their experiences, heal themselves when damaged, and exhibit herd behaviors.

Earlier, scientists have developed swarms of robots from synthetic materials and moving biological systems from muscle cells grown on precisely shaped scaffolds. But until now the creation of a self-directed living machine has remained beyond reach.

Biologists and computer scientists from Tufts University and the University of Vermont have created novel, tiny self-healing living machines from frog cells (Xenopus laevis) that they call Xenobots. These can move around, push a payload, and even exhibit collective behavior in a swarm.

In an article titled A cellular platform for the development of synthetic living machinespublished in the journal Science Robotics, the researchers report a method for creating these of Xenobots from frog cells. This cellular platform can be used to study self-organization, collective behavior, and bioengineering and provide versatile, soft-body, living machines for applications in biomedicine and environmental biology.

The next version of Xenobots have been createdtheyre faster, live longer, and can now record information [Doug Blackiston, Tufts University]

We are witnessing the remarkable plasticity of cellular collectives, which build a rudimentary new body that is quite distinct from their defaultin this case, a frog despite having a completely normal genome, says Michael Levin, Distinguished Professor of Biology and director of the Allen Discovery Center at Tufts University, and corresponding author of the study. In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion. It is amazing that cells can spontaneously take on new roles and create new body plans and behaviors without long periods of evolutionary selection for those features.

Xenobots can move around in a coordinated manner with the help of cilia present on their surface. These cilia grow through normal tissue patterning and do not require complicated architectural procedures such as scaffolding or microprinting, making the high-throughput production of Xenobots possible. And while the frog cells are organizing themselves into Xenobots, they are amenable to surgical, genetic, chemical, and optical stimulation. The researchers show that the Xenobots can maneuver through water, heal after damage and exhibit predictable collective behaviors.

The scientists also provide a proof of principle for a programmable molecular memory using a light-controlled protein that can record exposure to a specific wavelength of light.

Compared to their first edition, Xenobots 1.0, that were millimeter-sized automatons constructed in a top down approach by manual placement of tissue and surgical shaping of frog skin and cardiac cells to produce motion, this updated version of Xenobots 2.0 takes a bottom up approach. The biologists took stem cells from frog embryos and allowed them to self-assemble and grow into spheroids, where some of the cells after a few days differentiated to produce ciliatiny hair-like projections that move back and forth or rotate in a specific way. Cilia act like legs to help the new spheroidal Xenobots move rapidly across a surface.

In a way, the Xenobots are constructed much like a traditional robot. Only we use cells and tissues rather than artificial components to build the shape and create predictable behavior. Says Doug Blackiston, PhD, senior scientist and co-first author on the study with research technician, Emma Lederer. On the biology end, this approach is helping us understand how cells communicate as they interact with one another during development, and how we might better control those interactions.

Scientists at UVM ran computer simulations that modeled different shapes of the Xenobots and analyzed its effects on individual and collective behavior. Robotics expert, Joshua Bongard, PhD, and a team of computer scientists used an evolutionary algorithm on the Deep Green supercomputer cluster at UVMs Vermont Advanced Computing Core to simulate the behavior of the xenobots under numerous random environmental conditions. These simulations identified Xenobots that excelled at working together in swarms to gather large piles of debris in a field of particles.

We know the task, but its not at all obviousfor peoplewhat a successful design should look like. That is where the supercomputer comes in and searches over the space of all possible Xenobot swarms to find the swarm that does the job best, says Bongard. We want Xenobots to do useful work. Right now, were giving them simple tasks, but ultimately were aiming for a new kind of living tool that could, for example, clean up microplastics in the ocean or contaminants in soil.

Xenobots can quickly collect garbage working together in a swarm to sweep through a petri dish and gather larger piles of iron oxide particles. They can also cover large flat surfaces and travel through narrow capillaries.

The Tufts scientists engineered the Xenobots with a memory capability to record one bit of information, using a fluorescent reporter protein called EosFP that glows green but when exposed to blue light at 390nm wavelength, the protein emits red light instead.

The researchers injected the cells of the frog embryos with messenger RNA coding for the EosFP protein before the stem cells were excised to create the Xenobots so that the mature Xenobots have a built-in fluorescent switch which can record exposure to blue light.

To test the memory capacity, the investigators, allowed 10 Xenobots to swim around a surface on which one spot is illuminated with a beam of blue light. After two hours, they found that three bots emitted red light. The rest remained their original green, effectively recording the travel experience of the bots. This molecular memory in Xenobots could be harnessed to detect the presence of radioactive contamination, chemical pollutants, drugs, or a disease condition.

When we bring in more capabilities to the bots, we can use the computer simulations to design them with more complex behaviors and the ability to carry out more elaborate tasks, said Bongard. We could potentially design them not only to report conditions in their environment but also to modify and repair conditions in their environment.

The biological materials we are using have many features we would like to someday implement in the botscells can act like sensors, motors for movement, communication and computation networks, and recording devices to store information, says Levin. One thing the Xenobots and future versions of biological bots can do that their metal and plastic counterparts have difficulty doing is constructing their own body plan as the cells grow and mature, and then repairing and restoring themselves if they become damaged. Healing is a natural feature of living organisms, and it is preserved in Xenobot biology.

Cells in a biological robot can also absorb and break down chemicals and work like tiny factories, synthesizing and excreting chemicals and proteins.

Xenobots were designed to exhibit swarm activity, moving about on cilia legs. [Doug Blackiston, Tufts University]

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Scientists Create Living Machines That Move, Heal, Remember and Work in Groups - Genetic Engineering & Biotechnology News

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ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics, Inc. (AgeX; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported its financial and operating results for the fourth quarter and the full year ended December 31, 2020.

Recent Highlights

Liquidity and Capital Resources

Amendment to 2019 Loan Agreement

On February 10, 2021, AgeX entered into an amendment to its 2019 Loan Facility Agreement with Juvenescence Limited (Juvenescence). The Amendment extends the maturity date of loans under the agreement to February 14, 2022 and increases the amount of the loan facility by $4.0 million. All loans in excess of the initial $2.0 million that AgeX previously borrowed are subject to Juvenescences discretion.

At-the-market Offering Facility

During January 2021 AgeX entered into a sales agreement with Chardan Capital Markets LLC (Chardan) for the sale of shares of AgeX common stock in at-the-market (ATM) transactions. In accordance with the terms of the sales agreement, AgeX may offer and sell shares of common stock having an aggregate offering price of up to $12.6 million through Chardan acting as the sales agent. Through March 26, 2021, AgeX raised approximately $496,000 in gross proceeds through the sale of shares of common stock.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, AgeX believes that its cash and cash equivalents and available sources of debt and equity capital would not be sufficient to satisfy AgeXs anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Annual Report on Form 10-K for the year ended December 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

Balance Sheet Information

Cash, and cash equivalents, and restricted cash totaled $0.6 million as of December 31, 2020, as compared with $2.5 million as of December 31, 2019. Since January 1, 2021, AgeX had cash proceeds of approximately $3.2 million through loans from Juvenescence, sales of shares of AgeX common stock, and the disposition of its subsidiary LifeMap Sciences, Inc. (LifeMap Sciences) through a cash-out merger.

Fourth Quarter and Annual 2020 Operating Results

Revenues: Total Revenues for the fourth quarter of 2020 were $0.5 million. Total revenues for the year ended December 31, 2020 were $1.9 million, as compared with $1.7 million in the same period in 2019. AgeX revenue was primarily generated by its subsidiary LifeMap Sciences, Inc. which AgeX disposed of on March 15, 2021 through a cash-out merger. Revenues for the year ended December 31, 2020 also included approximately $0.3 million of allowable expenses under a research grant from the NIH as compared with $0.2 million in the same period in 2019.

Operating expenses: Operating expenses for the three months ended December 31, 2020, were $2.9 million, as reported, which was comprised of $2.5 million for AgeX and $0.4 million for LifeMap Sciences, and were $2.3 million, as adjusted, comprised of $2.0 million for AgeX and $0.3 million for LifeMap Sciences.

Operating expenses for the full year 2020 were $12.4 million, as reported, which was comprised of $10.4 million for AgeX and $2.0 million for LifeMap Sciences, and were $10.2 million, as adjusted, comprised of $8.7 million for AgeX and $1.5 million for LifeMap Sciences.

Research and development expenses for the year ended December 31, 2020 decreased by $0.9 million to $5.0 million from $5.9 million in 2019. The decrease was primarily attributable to the layoff of research and development personnel in May 2020.

General and administrative expenses for the year ended December 31, 2020 decreased by $0.7 million to $7.4 million from $8.1 million in 2019. Increases in personnel costs related to an increase in administrative staffing were offset to some extent by a decrease in noncash stock-based compensation expense, general office expense and supplies and travel related expenses with the shelter in place mandates since March 15, 2020 resulting from the COVID-19 pandemic, and the elimination of shared facilities and services fees from AgeXs former parent Lineage Cell Therapeutics, Inc. following the termination of a Shared Facilities and Services Agreement on September 30, 2019.

The reconciliation between operating expenses determined in accordance with accounting principles generally accepted in the United States (GAAP) and operating expenses, as adjusted, a non-GAAP measure, is provided in the financial tables included at the end of this press release.

Other expense, net: Net other expense for the year ended December 31, 2020 was $0.5 million, as compared with net other income of $0.3 million in the same period in 2019. The change is primarily attributable to increased amortization of deferred debt costs to interest expense following the consummation of loan agreements.

Net loss attributable to AgeX: The net loss attributable to AgeX for the year ended December 31, 2020 was $10.9 million, or ($0.29) per share (basic and diluted) compared to $12.2 million, or ($0.33) per share (basic and diluted), for the same period in 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeXs PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem is AgeXs delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amounts)

December 31,

2020

2019

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

527

$

2,352

Accounts and grants receivable, net

326

363

Prepaid expenses and other current assets

1,430

1,339

Total current assets

2,283

4,054

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AgeX Therapeutics Reports Fourth Quarter and Annual 2020 Financial Results and Provides Business Update - Business Wire

Cardiac Stem Cells Comments Off on AgeX Therapeutics Reports Fourth Quarter and Annual 2020 Financial Results and Provides Business Update – Business Wire | April 4th, 2021

The pancreas, saysGary Lewis, an endocrinologist at Toronto General Hospital and director of the Banting & Best Diabetes Centre at the University of Torontos Temerty Faculty of Medicine, is like an exquisitely sensitive and perfectly networked computer.

Second by second,he notes,the pancreassecretesjust the right amount ofinsulinor glucagontolower or raiseblood sugarintotheportal veinthat leadsdirectlyto the liver, the site of key metabolic processes. Insulingis then distributedto every tissue in the body via general circulation.

Thats one reason a cure for diabetes has proven elusive 100 years after the discovery of insulin.

Another big reason is the complexity of how the disease arises. In type 1 diabetes, the immune system destroys the insulin-producing beta cells of the pancreas, creating a life-threatening spike in blood sugar. Type 2 diabetes usually comes on more slowly, as the body becomes resistant to insulin or the pancreas cant produce enough of it.

Genetics play a role in both types. Exposure to viruses and other environmental effects may be a factor in type 1. Lifestyle factors, including weight gain and physical inactivity, are strongly linked to type 2.

The bottom line, says Lewis, is that diabetes is a multifactoral disease, and were not close to a cure.

Ask about treatments, though, and Lewis gets excited.

The last two decades have brought a plethora of clinical and research advances, from new drugs to boost and sensitize the body to insulin and promote weight loss, to lifestyle interventions that improve diet, continuous monitoring of blood sugar, long- and short-lasting insulin, better insulin pumps, pancreatic transplantsand pre-clinical stem cell and immunosuppressive therapies.

Progress on treatments has been fantastic, especially for type 2, Lewis says. Im very, very hopeful.

The distinction between treatment and cure in medicine is often unclear. And for the 3.6 million Canadians living with diabetes, the distinction matters less and lessif the goal is a full and healthy life.

Type 2 diabetes accounts for about 90 per cent of diabetes cases in Canada. Prevalence is rising, but Canadians with type 2 diabetes are living longer and have fewer diabetes-related complications.

The clinic doesnt look like it did 30 years ago, says Lewis, who mainly treats patients with type 2. We see fewer amputees, less blindness. Patients are generally healthier, and their prognosis is often excellent if they maintain their blood sugar target and other key parameters.

Weight loss is a cornerstone of treatments to lower blood sugar, and recent research has strengthened the link between weight reduction and type 2 diabetes management. Some people with type 2 can lose weight and control blood sugar through dietary changes and exercise alone.

Bariatric surgery is very effective for weight loss and often results in diabetes remission, although it comes with surgical risks and is expensive.

If we could prevent obesity, we could greatly reduce the incidence of type 2, Lewis says. And experiments have shown wecan get a remission withlifestyle changes, so we know what works.

The problem is broad implementation.

Ive tried to lose weight and I know how difficult it can be, especially in an environment of convenient and inexpensive calories, Lewis says. Moreover, factors such as income, education, ethnicity, access to healthy food and living conditions can make lifestyle changes that curb obesity nearly impossible.

Social determinants of health are overwhelmingly the most important influence on who gets type 2 diabetes, and how well or poorly they do with it, Lewis says.

Fortunately, dozens of new drugs for diabetes have hit the market in the last two decades.

Medications for weight loss round out the armamentarium, and some also protect against kidney damage and lower cardiac risk. Current therapies can reduce body weight up to 10 per cent, although a loss of 20 per cent or more would have a greater effect on outcomes for patients with type 2 diabetes, saysJacqueline Beaudry, an assistant professor of nutritional sciences at U of T who studies links between obesity, hormones and diet.

Beaudry is probing the biology that underpins these medications, including the gut hormones GLP-1 and GIP. They control blood glucose and reduce appetite, but scientists are unsure how.

If we could understand their mechanisms of action, we could design better drugs, Beaudry says.

For people with type 1 diabetes, continuous glucose monitors, insulin pumps and even automated closed-loopsystems that run on mobile apps to deliver insulin as-needed have radically changed the patient experience.

Sara Vasconcelos left),an assistant professor at U of Ts Institute of Biomedical Engineering, has worked withCristina Nostro (right), an associate professor in the department of physiology,and her team in the McEwen Stem Cell Institute at UHNto extend the survival and functionality of pancreatic precursor cells generatedfrom human stem cells.

Cell therapy could prove more liberating still.

University labs and biotechs are working on implantable devices that house insulin-producing cells derived from stem cells.

To that end,Cristina Nostro, an associate professor in the department of physiology in the Temerty Faculty of Medicine,and her team in the McEwen Stem Cell Institute at University Health Network recently discovered a more efficient way to generate and purify pancreatic precursor cells from human stem cells in the lab.

They have also found a way to vascularize those cells by working withSara Vasconcelos, an assistant professor at U of Ts Institute of Biomedical Engineering. Together, they have extended the survival and functionality of the cells in animal models of diabetes.

The biggest problem with these therapies is that the immune system rejects them. The same challenge currently hinders pancreas and islet transplants.

The immune system is an amazing machine, were luckyits so good, says Nostro. But its very difficult to control when it goes awry, as in autoimmune conditions.

Nostro is working with immunologists at the university on a method to protect insulin-producing beta cells from immune rejection, and she says many researchers in the field are now focused on immune-protective approaches.

Another strategy for type 1 diabetes is to tamp down the autoimmune response before the disease progresses. The idea is to prevent immune cells that damage the pancreas while the body still produces beta cells.

Groups around the world are bringing different ideas and creative approaches to treat type 1 diabetes, thats the beauty of science, says Nostro. I am very hopeful about what the future holds. Who knows? Maybe we will see hybrid technologies combining a pump and cells. We have to keep an open mind.

This story was originally published in U of T Med Magazines Insulin Issue.

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While The Rich Cream is not the first vegan Augustinus Bader product (The Lip Balm, The Face Oil, The Essence, The Cleansing Balm, and The Body Oil have that designation as well), the upgrade features what cofounder Augustinus Bader (a famed stem-cell scientist) describes as "an advanced and smart formula resulting in deeper nourishment and hydration and, overall, a more immaculate complexion."

As a fan of both original and upgraded The Rich Cream versions, I can attest to that statement. The rich, buttery formula sinks in quickly and keeps my dry, stressed skin intensely hydrated overnight and well into the next day. "We merge a deep respect for nature and biology with knowledge-fueled targeting of skin repair needs," Bader tells Allure. "Now that our Rich Cream is vegan, it's an added bonus it is the ultimate sign of respect for nature." Another piece of exciting news: The brand says it's working on becoming entirely vegan.

The non-vegan ingredients cut from the formula include lanolin and beeswax. King (who is not affiliated with the brand) explains that lanolin is derived from wool grease and can cause long-term sensitivity and allergic reactions for some people. You also won't find lactic acid (a type of alpha hydroxy acid or AHA) in the upgraded formula, which King says is most likely created from fermented milk, and, therefore, not vegan.

On the flip side, the brand added moisture-binding hyaluronic acid, irritation-soothing hydrolyzed rice protein, and sisymbrium irio seed oil which, according to King, promotes cell turnover, firms the appearance of skin, and even helps reduce eczema. And despite the upgrades, this version keeps the essence of the original, fan-favorite The Rich Cream intact and for good reason; it works. Associate clinical professor of dermatology at Yale School of Medicine, Mona Gohara, counts herself among the legion of The Rich Cream's fans. "It's packed with peptides, a Trigger Factor Complex (which helps skin cells regenerate), vitamins [like panthenol, aka, vitamin B5], shea butter, and squalane," she praises, likening it to the cake and icing of skin care.

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I find it hard to stay in the loop these days. When it comes to new consumer productsespecially in beauty, it seems like there is a new brand coming out daily. As a natural skeptic, I can be leery of new things.But, I rounded up seven innovative skincare brands that deliver clinical results that are definitely worth exploring.

Eskafil

Eskafil

Due to recent buzz, particularly in the K-Beauty space, snail slime as a hero ingredient may have popped up on your radar. But like so many trends, they are rooted in something much older. In fact,Hippocrates used to prescribe the mucusto clear up skin inflammation while small, rural communities used it to hydrate skin and to alleviate acnes and calluses.

In the spirit of its traditional use in skincare,Eskafilwas created in fall 2020. Founded by Jeffrey Lee and Marius Ronnov, Eskafil is a dermatologist-crafted beauty line of highly effective skincare products packed with ingredients found in nature. We are brand that revolves around the power of natural ingredients, in our case snail slime, Ronnov tells me. We believe ourselves to be gatekeepers of natures secrets and stewards of self-care. To us, skincare is self-care and we work to inspire our customers to commit to themselves everyday, with something as simple as a skincare routine.

Ancient Greeks coined snail mucin as the fountain of youth due to its ability to stimulate new cell repair and increase collagen production, the protein responsible for young healthy skin. What makes snail mucin so effective is one of its active ingredients, allatonin. It is this substance that repairs the snails shell when it accidentally becomes chipped or split. So just imagine what it can do for your skin, especially if you suffer from scarring caused by acne or from eczema, states Lee. The extract's healing properties are also known to heal cuts, soften scar tissue, fight infections, repair sun damage, regenerate skin cells and make skin look younger, tighter and brighter. Recognizing its hydrating properties and skin healing abilities, we wanted to introduce this miracle ingredient to users in the Western world.

Eskafil

Eskafils three-step skincare rangeis easy to use, packaged beautifully, and effective. After a few weeks of use, my skin definitely looks brighter. I would imagine this is due to the high levels of snail mucin concentrate in the products, which is 98%. I havent used eye creams in years since many of them felt heavy and often congested my eye area. But I love the way this light formula instantly cools and hydrates my eye area. It feels like you have nothing on your skin. We pride ourselves on using dermatologist-approved formulas that take supporting ingredients such as macadamia oil, shea butter and golden seaweed to enhance the healing nature of snail slime, explains Ronnov. This combination of ingredients across our products drives hydration, acne scar repair, reduction of fine lines and protection against signs of aging.

If you are wondering if any snails got injured in the whole process, the pair tells me that what makes their brand stand apart from the other snail slime products is there ethical sourcing. We obtain the snail slime through a system that places snails in an environment that makes them extremely pleasured and happy, Lee tells me. This environment is a room thats at the exact temperature and darkness for ultimate snail happiness. The snails then excrete their slime over a mesh covering then the slime is removed and placed into Eskafils skincare products.

Heraux

Heraux

Launched this past spring byAmir Nobakht MD, MBA, and Ben Van Handel, PhD,two of the top leading researchers on the topic of inflammaging,Herauxoffers a paradigm shift in skincare.

Inflammaging is the aging process that is attributable to chronic, low-grade inflammation in our bodies, explains Van Handel, PhD, who is a stem cell biologist at the University of Southern California. Inflammaging is actually caused by things like oxidative stress and environmental damage. These stressors cause our body to release inflammatory molecules, which harm the cellular environment and result in the visible signs of aging. Inflammaging specifically is what happens when this inflammatory process stays active on our body over a long period of time due to stressors like the environment, sun, and even our diets.

It is important to reduce chronic inflammation because once you have it Van Handel, PhD tells me your body just creates more inflammation. Thats how our cells work; by releasing some inflammatory molecules into our systems other cells respond by releasing more as well and the cycle, if left unchecked, continues. When we treat the inflammatory component of these conditions, we stop that cycle and allow the cellular environment to improve so our cells, including stem cells, can regenerate and function at an optimal level, continues Van Handel, PhD.

Heraux is the worlds first anti-inflammaging skin care product.It is the only skin care product to address inflammaging, Nobakht MD, MBA tells me. We are a science forward skincare brand that uses proprietary molecular technologies to improve our skin by combating the negative effects of inflammaging which is the aging caused by everyday chronic inflammation. Unlike most skin care products that only treat the symptoms of medical issues like acne, rosacea and the visible signs of aging,Heraux Molecular Anti-inflammaging Serumgets to the root of the problem by modulating the inflammatory pathway in the skin.

Heraux

The serum is the brands first product release and is based on HX-1, a proprietary biomimetic lipid the pair discovered while researching arthritis for over a decade. Van Handel, PhD explains to me that the lipid is a major breakthrough in the fight against chronic inflammation and skin aging. This revolutionary one-of-a-kind molecule shields stem cells from the effects of stress and promotes their overall youthful function by modulating the protein that regulates regeneration versus inflammation. The lightweight formula also hashyaluronic acid, peptides, vitamins C + E, and red maple bark extract included to make it a well rounded face serum.

The formulation itself is patented, continuesVan Handel, PhD. Themain benefits includea reduction in wrinkles and fine lines, improved skin texture, increased brightness, reduction in hyperpigmentation and increased skin elasticity, all of which have been verified by an independent clinical trial. Results are seen in as little as 1 week with continued improvement with extended use. When I ask if there will be any other products to follow Nobakht MD, MBA responds, We are looking to launch a spot treatment version for acne and hyperpigmentation as well as a sunscreen very soon.I really like the way my skin feels and looks from using this product for the last few weeks. My vascular rosacea has definitely calmed down. A sunscreen would be a welcome new addition.

Pour Moi Skincare

Pour Moi Skincare

Skincare brandPour Moiwas created based on the premise that regardless of age, ethnicity, or gender that our skins appearance is affected by our exposure to daily, local weather. Founded by Ulli Haslacher, the company officially launched in 2020 (after a soft launch in 2017), shortly after receiving its first patent, with a second one issued a few months later, and several more on the way.

Climate-Smart Pour Moi is the worlds first climate-based skincare brand, changing everything you think you know about skincare, Haslacher tells me. Our brand offer products that are specifically formulated for six global and seasonal climates considering how each climates distinctive range of humidity, temperature, air pressure and light profoundly impacts the look and feel of skin. They are not created in the traditional way to only manage visible symptoms of aging skin. But rather scientifically designed to counteract the major cause of an aging complexionthe climate that you are in!

Not only did Haslacher change the approach to skincare based onclimate research, she even changed the way her products were tested. During R&D our formulas were not just tested in a controlled lab environment but tested on actual people in climate chambers, mimicking different climatic conditions and sudden changes to these conditions, explains Haslacher.

While each formula is based on one of six climate types, Haslacher tells me that there is one consistent principle across the entire ranges, the brands Geo-hydraDynamic Complex. Its the vital operating system of Climate-Smart skincare.It is the only complex in the world that intuitively aligns the upper layers of the skin with the various local atmospheric humidity conditions to achieve optimal hydration in each distinctive climate.Due to the adaptive nature of our complex, it has the unique ability to self-adjust to meet skins ever-changing hydration needs within the millions of nuances of specific climate.

Pour Moi Skincare

Customized for each specific climate, our patented complex is comprised ofingredientswith skin-identical properties including multi-size molecular hydra-actives and a French fungi, high in amino acids and valuable sugars, continues Haslacher. Together, they act as a biomimetic supramolecular network to uniquely boost the hydrating potential of the climate-specific creams and increase the efficiency of the entrapped actives. These include climate-specific antioxidants (for example the Red Snow Algae for Mountain climate and the ocean micro-algaeThermus Thermophilus Fermentfor Marine climate) as well as encapsulatedvitamins including A, C and E and anti-wrinkle peptidesfor an optimal release within the skin and a long lasting effect in each climate.

Haslacher tells me that the reason she has received both global and domestic patents is her three-step system of quenching, drenching, and geo-moisturizing. Step 1 is our Hydrating Balancer. It is an anti-aging liquefier that instantly hydrates, softens and preps skin for the next steps. Step 2 is our quenching serum that intelligently supports skins natural defense system against geo-climatic stressors in specific locations such as the mountains, beaches, plains and deserts. Step 3 is the geo-moisturizing game changer. Select the Day Cream that matches your daily weather to adapt, repair and protect skin in the climate you are in. This allows the customer tocustomize the systemfor their exact location. Think of it as anti-aging skincare for your zip code!

When I asked Haslacher if there is any sunscreen in her products, she tells me, We are working on an innovative sunscreen line which will launch in 2022. However, our formulas do account for how light impacts skin differently in different locations and seasons. While the formulas do not include SPF, they include climate-specific antioxidant strategies.I really like the concept of the brand. I just started using it, so I am excited to see what kind of changes my skin sees.

Reflekt

Reflekt

If you were under the impression that exfoliation means stripping your skin of moisture,Reflektis on a mission to change that with their 3-step hyaluronic acid-based products. Launched in 2017 and founded by Nancy Schnoll, Reflekt is a luxury skincare brand (for any skin type) thats rooted in pharmaceutical and medical principles and centered around simplifying your skincare routine, while delivering clinical results.

Reflekt is a skincare company that believes gentle daily exfoliation is the key to healthy balanced skin. We realize daily exfoliation is a novel concept, but it is the cornerstone of our brand, states Schnoll. The brands hero product,Reflekt 1is an exfoliating cleaner designed for all skin types and is gentle enough to use morning and night. Reflekt 1 was intentionally launched by itself to educate people about the benefits of a skincare regimen that consists of deliberate light exfoliation coupled with the infusion of hydrating actives.

This May, the brand will launch Reflekt 2 Brightening & Hydrating Serum, a silky serum that seals in moisture, brightens and gently exfoliates the skin, and Reflekt 3 Renewing & Hydrating Face Cream that gently exfoliates while moisturizing the skin to promote cell renewal and a firmer and even skin tone.

Reflekt

The entire Reflekt range is vegan, clean, and non-toxic and both exfoliates and hydrates the skin while not disturbing the skin barrier. Each product has unique characteristics. The exfoliating component in Reflekt 1 is the biodegradable jojoba esters that melt from the warmth of the water and your body as you cleanse, explains Schnoll. For Reflekt 2 and 3 the exfoliator is our unique fruit enzyme blend consisting of 9 different fruits (like pomegranate, passion fruit, and pineapple) and varies in percentage depending on the product. The hydrating aspect varies, but whether hyaluronic acid, aquaxyl, or squalene, each product packs a one-two punch of exfoliation and hydration.

I love the Reflekt collection. After using the 3-step system my skin looks dewy, brighter, smoother, and it feels hydrated. I also enjoy the light fragrance.

Saro de Re

Saro de Re

By now, most of us have heard about the benefits of hyaluronic acid for the skin. ButSaro de Retakes the experience to a whole new level. Founded by Mimi Kim, the brand launched last fall with their first product, the freeze-dried hyaluronic acid experience.

Saro de Re is a K-Beauty luxury brand rooted from the medical and pharmaceutical field for the professional results at the comfort of our own home and it is designed for any age, gender, any skin types, and skin conditions, Kim tells me. I have been sourcing ingredients and inventing beauty products for nearly three decades, and I have seen some very impressive technologies, products and unique ingredients that are not available to consumers. My goal over the years has been to make these discoveries available to the masses. When I partnered with a Korean Pharmaceutical R&D team and found something this ground-breaking, I knew we had something very unique.

Not all hyaluronic acids are made equal. Ourhyaluronic acid is 99.9% pure. Nowater, preservatives, fillers, additives, or chemicals. Each tablet is made up of 98.5% highly concentrated hyaluronic acid with a small amount of two additional ingredients for moisturizing: Squalene and Vitamin E.Clean beauty at its core, states Kim when I ask her what makes her formula unique.

Saro de Re

Other hyaluronic acid serums on the market contain primarily water as the number one top ingredient, which means the hyaluronic acid is not in its purest form. Our product has the patent on the method of preparing low molecular weight range that is small enough to permeate, but large enough to attract and retain the most abundant water, continues Kim. In fact, 1000 times its weight in water and the ability to release it for an immediate plumping and hydrating effect on skin with long-lasting results. No other brand has the capability to create HA in this molecular weight, which requires it to be in its purest form.

The ingredients are then freeze-dried and preserved until they are activated by the Saro de Re Pure Activator, which includes adenosine for wrinkle reduction, Niacinamide for skin brightening, and Allantoin and Hyaluronic Acid for hydration.Once activated and applied, it adds instant hydration that lasts up to 72 hours on skin with just one application. No competitive products can make this claim or be used once every other day or every three days, states Kim. Additionally, there are three botanicals included in the activator that synergistically work with the main active ingredients to achieve superior anti-aging benefits including purslane, pomegranate, and White Mulberry. Users can expect instant and accumulativeresultsincluding plumper skin, a brighter, tighter complexion, and improved tone and texture.

I have seen a huge difference in my skin with the addition of this product. I also like the alchemic process of activating the hyaluronic acid. I definitely feel like I am getting a lab-grade product when compared to other hyaluronic acid serums that I have used. It also works great with Reflekt skincare range. As for any follow up products, Kim tells me that the brand will be launching some new products soon.

The Nue Co

The Nue Co

Discussion about the gut microbiome and overall health have become mainstream and correlations between immunity and the gut have been supported clinically. But, the bodys skin is its largest first line of defense when it comes to immunity so it makes sense to treat it similarly. EnterThe Nue Co, a wellness brand launched in 2017 by founder and CEO, Jules Miller that approaches health holistically, as an entire ecosystem.

For too long health issues have been viewed as siloed issues. For example, breakouts are an issue with your skin, so the solution should be focused only on your skin. But actually, your skin is usually the mirror to our gut. Stress plays out on your skin and sleep affects your skin. To get to the root of an issue and drive real results, you have to view health as an ecosystem, states Miller. We definitely take that approach with our skincare - which we view as topical supplements. Whilst many brands focus on what we call, cosmetic ingredients, the kind which deliver on the instant glow and lovely scent but are proven to increase inflammation and erode the skin-barrier over time, every ingredient in our formulas delivers benefits to your skin health-long term.

The Nue Cosskincare formulations are grounded in clinical science and as such provides users with clinical results. They are a blend of natural ingredients, with the best of clinical research, which enables them to drive real, fast results, without compromising the health of your skin or the environment long-term, Miller tells me. There seems to be so much misinformation about skin health, with one of the biggest myths being that elaborate skincare regimes are the secret to healthy skin.Restoring the health of your skin and removing the complication of multiple products from your routine was part of a bigger shift we were noticing towards ending a culture of overconsumption, what some are calling skip-care or skin fasting. The impact of our beauty addiction has been profound, not only on our skin, but on our planet.

The Nue Co

This cycle of pollution, Miller tells me, is also a contributing factor to our skins barrier health. Our skin barrier, or the outermost layer of the skin, is responsible for defending against pollution, UV light, infection, and locking in hydration. The erosion of the skin barrier is identified as the number one cause of skin issues by dermatologists, causing premature ageing, breakouts, hyperpigmentation, sensitivity and dryness, explains Miller. And just like the gut, our skin is home to an ecosystem of microorganisms that help to keep the skin balanced. Our topical microbiome is just as important as our internal microbiome. In fact, its estimated that 21% of our microbiome lives on our skin whereas 26% lives in our gut. Like any ecosystem, it can be disrupted by outside forces and pollutants.

To support the skins barrier health and the skins microbiome, the brand is launching two newskincare products, BARRIER CULTURE Cleanser and BARRIER CULTURE Moisturizer on March 22ndon their website. Using patented, first to market technology, BARRIER CULTURE contains prebiotics, probiotics, and postbiotics to rebuild the skins microbiome. BARRIER CULTURE is the most comprehensive delivery of skin-barrier building ingredients in a two-step routine. In addition to its microbiome technology, BARRIER CULTURE uses anti-pollution ingredients to protect from external aggressors and boost the skins natural immune system; and hydrating actives to replenish and lock in moisture, states Miller.

The cleanser is designedto replace your double-cleanse, by removing dirt, pollution, and makeup without stripping or disrupting the skins PH. Almost immediately, we have found people have noticed a difference to the feel of their skin with a focus on deep-cleaning, rather than stripping. The application of pre, pro and postbiotics works to replenish the topical microbiome, whilst actively calming and conditioning the skin, Miller tells me.

The new moisturizer leaves skin instantly plumped and hydrated. The formula rebuilds and restores your skin barrier, containing ceramides and probiotics that rebuild and restore the skins natural defenses. Niacinamide activates the skins immune system, helping to repair dark marks, scarring and support natural healing and regeneration, whilst squalane protects against pollution and everyday stressors on the skin barrier. BARRIER CULTUREs microbiome technology also delivers an instant soothing effect to the skin, calming irritation and redness.

I just started using the products so I wont see all of the results for at least a month. But, I am already hopeful. I do love the way my skin feels squeaky clean, yet moisturized when I use the cleanser.

U Beauty

U Beauty

U Beauty launched in 2019 byTina Craig(aka. The Bag Snob) with the philosophy of less is more. U Beautyis tech-driven, science-backed, high-performance skincare, Craig tells me. Our strategic and singular products replace excess with essence and provide real results, without the risk of irritation. We're about amplifying your skin with a select, strategic edit of multifunctional products that streamline your routine and simplify your life.

What makes the brands three products, the Resurfacing Compound,The SUPER Hydrator, and the newest productThe SCULPT Arm Compound,is the brands proprietary technology called SIREN Capsule. Unlike most skincare that release actives all over the skin, SIRENS lures damage-causing free radicals to it like a magnet, explains Craig. By attracting only the compromised cells, healthy cells are preserved, while the Capsule releases age-reversing actives on free radicals (generated after exposure to pollution, secondhand smoke and sunshine), which materialize as vulnerable, damaged areas, instead of all over your skins surface. So your skin gets nothing but benefit.

While theResurfacing Compoundcontains the original SIREN Capsules, The Super and The Sculpt feature dual SIRENS. The SUPERs HYDRA-SIREN produces immediate hydration and with five unique types of hyaluronic acid, it continues to hydrate for up to 48 hours. Specifically designed for the arm area, the SCULPT-SIREN contains a targeted blend of marine extracts, probiotics and select ferments. It delivers oxygen and nutrients to the skin, increasing anti-aging ATP levels and boosting hydration, Craig tells me.

U Beauty

U Beautys latest formulation, The SCULPT Arm Compound, is a product of years of dreaming on behalf of Craig. No matter how often I work out, I was never able to change the fragile texture of the skin on my arms. Its not about being thin. Its about a healthy, bouncy skin consistency, says Craig. I can honestly say The SCULPT is unlike anything youve ever used. Thanks to a genius blend of peptides, marine extract, our signatureSIREN Capsule technologyand now the new SCULPT-SIREN, it visibly tightens, tones and sculpts the skin on the arms. Overall, skin is less subject to the effects of gravity and more resilient in its ability to address the visible signs of damage.

I just received The SCULPT so I cant say for certain what the accumulative results will be just yet. But, I can say that my arm skin feels much tighter immediately after applying the formulaso I am very hopeful. When I ask Craig if she will be creating any other body specific products she tells me, Were about taking a 360-degree approach to skincare, which means treating the whole body, not just the face. I will never create a product if theres not a white space in the industry and a personal need for it first. With that in mind, we have some exciting and revolutionary things coming out in the near future, so look out!

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Seven Innovative Skincare Brands That Deliver Clinical Results - Forbes

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