Stem cell treatment corrects skull shape and restores brain function in mouse model of childhood disorder – National Institutes of Health

News Release

Thursday, January 7, 2021

Scientists regenerate parts of the skull affected by craniosynostosis, a common birth defect.

Using stem cells to regenerate parts of the skull, scientists corrected skull shape and reversed learning and memory deficits in young mice with craniosynostosis, a condition estimated to affect 1 in every 2,500 infants born in the United States, according to the Centers for Disease Control and Prevention. The only current therapy is complex surgery within the first year of life, but skull defects often return afterward. The study, supported by the National Institute of Dental and Craniofacial Research (NIDCR), could pave the way for more effective and less invasive therapies for children with craniosynostosis. The findings were published Jan. 7, 2021 in Cell. NIDCR is part of the National Institutes of Health.

This is a pivotal study demonstrating both structural regeneration and functional restoration in an animal model of craniosynostosis, said Lillian Shum, Ph.D., director of NIDCRs Division of Extramural Research. It holds great potential for translation to treatment of the human condition.

Healthy infants are born with sutures flexible tissue that fills the space between the skull bones that allow the skull to expand as the brain grows rapidly in the first few years of life. In craniosynostosis, one or more sutures turn into bone too early, closing the gap between skull plates and leading to abnormal growth. The resulting increase in pressure inside the skull may cause physical changes in the brain that lead to thinking and learning problems.

The connection between changes in the skull and the development of cognitive deficits had not been fully explored, said Yang Chai, D.D.S., Ph.D., director of the Center for Craniofacial Molecular Biology and associate dean of research at the Herman Ostrow School of Dentistry at the University of Southern California, Los Angeles, who led the study. We wanted to know if restoring sutures could improve neurocognitive function in mice with mutations in a gene that causes craniosynostosis in both mice and humans.

That gene, called TWIST1, is thought to be important for suture formation during development. In humans, mutations in this gene can lead to Saethre-Chotzen syndrome, a genetic condition characterized by craniosynostosis and other skeletal abnormalities.

To see if flexible sutures could be restored in mice with craniosynostosis due to Twist1 mutations, the scientists focused on a group of stem cells normally found in healthy sutures. Previous studies by the group indicated that these stem cellscalled Gli1+ cellsare key to keeping skull sutures of young mice intact. The team had also found that Gli1+ cells are depleted from the sutures of mice that develop craniosynostosis due to Twist1 mutations. Chai and his colleagues reasoned that replenishing the cells might help regenerate the flexible sutures in affected animals.

To test this idea, the researchers added Gli1+ cells from healthy mice to a biodegradable gel. They deposited the mixture into grooves meant to re-create the space where skull sutures had been in mice with craniosynostosis.

Skull imaging and tissue analysis revealed that after six months, new fibrous sutures had formed in treated areas and that the new tissue remained intact even after a year. In contrast, the same grooves closed in mice that received a gel that lacked Gli1+ cells.

Closer analysis showed that Gli1+ cells in the regrown sutures had different origins: some were descended from the cells that had been implanted, while others were the animals own, having migrated from nearby areas. The findings suggest that Gli1+ cell implantation leads to suture regeneration in part by recruiting native Gli1+ stem cells to help in the process.

Further experiments showed that untreated mice with craniosynostosis had increased pressure inside their skulls and poor performance on tests of social and spatial memory and motor learning. After treatment, these measures all returned to levels typical of healthy mice. The skull shapes of treated mice were also partially corrected.

The treatment also reversed the loss of brain volume and nerve cells in areas involved in learning and memory. According to the scientists, this finding sheds light on the mechanisms underlying impaired brain function and its improvement after suture regeneration.

We have discovered that Gli1+ stem-cell-based suture regeneration restores not only skull shape but also neurocognitive functions in a mouse model of craniosynostosis, said Chai.

The scientists note that more work remains before such an intervention can be tested in humans, including studies to determine the optimal timing of surgery and the ideal source and amount of stem cells.

This study provides a foundation for efforts to develop a less-invasive, stem cell-based therapeutic strategy that can benefit patients who suffer from this devastating disorder, Chai said.

This research was supported by NIDCR grants R01-DE026339, R01-DE012711, R01-DE022503, and U24-DE026914.

About the National Institute of Dental and Craniofacial Research: NIDCRis the nations leading funder of research on oral, dental, and craniofacial health.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Yu M, Ma L1, Yuan Y, Ye X, Montagne A, He J, Ho T-V, Wu Y, Zhao Z, Sta Maria N, Jacobs R, Urata M, Wang H, Zlokovic BV, Chen J-F, and Chai Y. Cranial suture regeneration mitigates skull and neurocognitive defects in craniosynostosis.CellJan 7 2021. DOI: 10.1016/j.cell.2020.11.037

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Stem cell treatment corrects skull shape and restores brain function in mouse model of childhood disorder - National Institutes of Health

Doctors Make Medical Breakthrough In Treating Severe Cases Of COVID – CBS New York

MIAMI (CBSMiami) Doctors in South Florida say an experimental treatment involving stem cells has been incredibly successful in treating severe cases of COVID.

The study involved patients at Jackson Memorial Hospital and at the University Miami Tower. Many of them had acute respiratory distress syndrome (ARDS).

I think this could be a turning point, said Dr. Camillo Ricordi, director of the Cell Transplant Center at the University of Miami Miller School of Medicine.

According to Ricordi, the groundbreaking treatment uses stem cells from a babys umbilical cord.

The treatment has shown to safely reduce the risk of death and has made recovery time faster for some of the most ill patients.

We just published the study that using stem cells derived from the umbilical cord of a healthy newborn baby. We generally throw away the placenta that is discarded after birth. But we are using cells that are extracted and expand from that umbilical cord. That can generate and provide therapeutic doses for over 10,000 patients from a single umbilical cord. It is an amazing result, he said.

Ricordi, one of the lead researchers of the study, said treating coronavirus patients with these mesenchymal stem cells just made sense.

When the COVID pandemic exploded, I called our collaborators in China, saying, Why dont we try to use these cells in COVID? Because they have the same properties that help us fight autoimmune conditions, he explained.

The FDA approved to go forward with the trial.

In a double blind study, involving 24 patients with acute respiratory distress syndrome, each received two infusions given days apart of either the stem cells or placebo.

The physician nor the patient knew if someone received a cell or just an infusion of the solution of the cells, Ricordi said.

Researchers found the patient survival rate treated with the stem cells was 91%.

Ricordi said these stem cells have potential to restore normal immune response and also promote tissue regeneration.

When a person develops ARDS, their lungs develop severe inflammation and buildup fluid in their lungs.

Ricordi said ARDS patients usually undergo invasive procedures, but thats not the case with these stem cells.

These cells injected in the IV naturally go with a very simple procedure that does not require any invasive procedure. You can just direct the transfusion to the lung, he explained. The cells go to the lungs and it has just been an amazing kind of result and we are very excited to move to the next step.

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Doctors Make Medical Breakthrough In Treating Severe Cases Of COVID - CBS New York

Global Stem Cell Therapy Market Report 2020: Market to Recover and Reach $14.76 Billion in 2023 at a CAGR of 19.62% – Forecast to 2030 – Yahoo Finance

Dublin, Jan. 05, 2021 (GLOBE NEWSWIRE) -- The "Stem Cell Therapy Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.

Stem Cell Therapy Global Market Report 2020-30: COVID-19 Growth and Change provides the strategists, marketers and senior management with the critical information they need to assess the global stem cell therapy market.

Major players in the stem cell therapy market are Anterogen, JCR Pharmaceuticals, Medipost, Osiris Therapeutics, Pharmicell, Astellas Pharma, Cellectis, Celyad, Novadip Biosciences and Gamida Cell.

The global stem cell therapy market is expected to decline from $8.73 billion in 2019 to $8.62 billion in 2020 at a compound annual growth rate (CAGR) of -1.24%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The market is then expected to recover and reach $14.76 billion in 2023 at a CAGR of 19.62%.

The stem cell therapy market consists of the sales of stem cell therapy and related services by entities (organizations, sole traders, and partnerships) that provide stem cell therapy. Stem cell therapy, also known as regenerative medicine, promotes the repair response of diseased patient, dysfunctional or injured tissue using stem cells or their derivatives. Only goods and services traded between entities or sold to end consumers are included.

The stem cell therapy market covered in this report is segmented by type into allogeneic stem cell therapy; autologous stem cell therapy. It is also segmented by cell source into adult stem cells; induced pluripotent stem cells; embryonic stem cells, by application into musculoskeletal disorders; wounds and injuries; cancer; autoimmune disorders; others, and by end-user into hospitals; clinics.

In September 2019, Vertex Pharmaceuticals Inc, a US-based biopharmaceutical company, announced its decision to acquire Semma Therapeutics, a private biotechnology company, for $950 million. The acquisition is expected to align with Vertex's strategy of investing in scientific innovation that creates transformative medicine for patients with serious diseases. Semma Therapeutics is a US-based company that is involved in using stem cell therapy for diabetes treatment.

The high cost of stem cell therapy is expected to limit the growth of the stem cell therapy market. The pressure to contain costs and demonstrate value is widespread. Political uncertainty and persistent economic stress in numerous countries are calling into question the sustainability of public health care funding. In less wealthy countries, the lack of cost-effective therapies for chronic diseases has impacted the health conditions of the population and has led to a low average life expectancy. According to the DVCSTEM, the average cost of stem cell therapy in the USA is between $20,000 to $25,000, in Mexico, it is $33,000, in Central America, it is $30,000, and in Asia, it is $50,000, thus restraining the growth of the market.

The companies in the stem cell therapy market are increasingly investing in strategic partnerships. The strategic partnership is a mutually beneficial agreement between two companies that do not compete directly with each other. For instance, in September 2018, CRISPR Therapeutics, a biotechnology company that develops transformative medicine using the gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated for the development and commercialization of allogeneic stem cell therapies for diabetes treatment.

The rising prevalence of chronic diseases contributed to the growth of the stem cell therapy market. Long working hours, limited physical activity, and unhealthy eating and drinking habits contribute to the prevalence of chronic diseases among people, thus driving the need for stem cell therapy. According to a United Nations article, by 2030, the proportion of global deaths due to chronic diseases is expected to increase to 70% of total deaths. The global burden of chronic diseases is expected to reach about 60%. The rising prevalence of chronic diseases is expected to drive the stem cell therapy market.

Key Topics Covered:

1. Executive Summary

2. Stem Cell Therapy Market Characteristics

3. Stem Cell Therapy Market Size And Growth 3.1. Global Stem Cell Therapy Historic Market, 2015 - 2019, $ Billion 3.1.1. Drivers Of The Market 3.1.2. Restraints On The Market 3.2. Global Stem Cell Therapy Forecast Market, 2019 - 2023F, 2025F, 2030F, $ Billion 3.2.1. Drivers Of The Market 3.2.2. Restraints On the Market

4. Stem Cell Therapy Market Segmentation 4.1. Global Stem Cell Therapy Market, Segmentation By Type, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

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4.2. Global Stem Cell Therapy Market, Segmentation By Cell Source, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.3. Global Stem Cell Therapy Market, Segmentation By Application, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.4. Global Stem Cell Therapy Market, Segmentation By End-User, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. Stem Cell Therapy Market Regional And Country Analysis

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/zaisiw

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Stem Cell Therapy Market Report 2020: Market to Recover and Reach $14.76 Billion in 2023 at a CAGR of 19.62% - Forecast to 2030 - Yahoo Finance

Engineered stem cells that evade immune detection could boost cell therapy and I-O – FierceBiotech

Sana Biotechnology was founded in 2018 with a mission of solving some of the most difficult challenges in gene and cell therapy. Toward that end, the company is engineering hypoimmune stem cells that can evade detection and destruction by the immune system.

Now, some of Sanas founders, who are scientists at the University of California, San Francisco (UCSF), are describing how these engineered stem cells are able to shut down the immune systems natural killer (NK) cells. They believe their findings could enhance the development of implantable cell therapies, as well as cancer immunotherapies, they reported in the Journal of Experimental Medicine.

The ability to evade NK cells could enhance a range of experimental treatments, including implants of insulin-producing cells for patients with diabetes and cardiac cells to repair heart damage. These cells are typically rejected by the immune systema problem hypoimmune stem cells were designed to circumvent.

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.

The UCSF team used gene modification technology to design the cells so they avoid the immune responses that are either built into the bodys defense system or learned. The researchers achieved that feat by engineering the cells to express the protein CD47, which shuts down innate immune cells by activating signal regulatory protein alpha, or SIRP-alpha.

The researchers were surprised to discover that the hypoimmune stem cells were able to escape NK cells, even though NK cells were not previously known to express SIRP-alpha. Rather than studying lab-grown cell lines, they took cells directly from patients. Thats where they found SIRP-alpha.

Whats more, the UCSF team discovered that NK cells begin to express SIRP-alpha after they are activated by cytokines that are typically abundant in inflammatory states.

RELATED: Fierce Biotech's 2020 Fierce 15 | Sana Biotechnology

To further prove out the utility of engineered stem cells, the UCSF researchers implanted cells with rhesus macaque CD47 into monkeys. They documented the activation of SIRP-alpha in NK cells. Those NK cells did not kill the transplanted cells.

A similar technique could be used, but in reverse, to implant pig cardiac cells into people, the UCSF team argued. If human CD47 were engineered into pig heart cells, they could be implanted into people without risking rejection by NK cells, they suggested.

Sana made waves in 2018 when it raised a whopping $700 million in a single venture round from the likes of Arch Venture Partners, Flagship Pioneering and Bezos Expeditions. We believe that one of, if not the most, important thing happening in medicine over the next several decades is the ability to modulate genes, use cells as medicines, and engineer cells, said Steve Harr, president and CEO of Sana, at the time.

Sana did not provide materials or funding for the new study, but it is now developing the hypoimmune stem cell technology for clinical testing.

The UCSF team believes their findings could also boost cancer immunotherapy. The engineered cells could help combat checkpoints that allow tumors to evade immune detection, they said.

"Many tumors have low levels of self-identifying MHC-I protein and some compensate by overexpressing CD47 to keep immune cells at bay," said Lewis Lanier, Ph.D., director of the Parker Institute for Cancer Immunotherapy at the UCSF Helen Diller Family Comprehensive Cancer Center, in a statement. "This might be the sweet spot for antibody therapies that target CD47."

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Engineered stem cells that evade immune detection could boost cell therapy and I-O - FierceBiotech

BENEV Announces Investigative Report on Combination Treatment with Human Adipose Tissue Stem Cell- derived Exosomes and Fractional CO2 Laser for Acne…

This report outlines the investigative study that was conducted by a team of world renowned scientists, doctors including Hyuck Hoon KWON, Steven Hoseong YANG, Joon LEE, Byung Chul PARK, Kui Young PARK, Jae Yoon JUNG, Youin BAE,and Gyeong-Hun at Oaro Dermatology Institute (Seoul, South Korea), Guam Dermatology Institute (Guam, USA), Department of Dermatology, Dankook University, College of Medicine (Cheonan, South Korea), Department of Dermatology, Chung-Ang University, College of Medicine (Seoul, South Korea), and Department of Dermatology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine (Hwaseong, South Korea). Researchers involved in this study evaluated the clinical efficacy and safety of adipose tissue stem cell-derived exosomes as an adjuvant therapy after application of fractional CO2laser for acne scars. 25 patients consisting of 18 men and 7 women, between ages 19 and 54, 12 with Fitzpatrick Skin Type 3 and 13 with Fitzpatrick skin type 4 and atrophic acne scars, underwent the 12-week prospective, double-blind, randomized, split-face trial. Each received three consecutive treatment sessions of fractional CO2laser to the whole face, with a follow-up evaluation, and a post- laser split face regimen, where one side of each patient's face was treated with an adipose tissue stem cell-derived exosome gel. Exosomes in this study were acquired from human ASC-CM by ExoSCRT technology developed by ExoCoBio Inc., and the other side of the face was treated with control gel. Findings revealed that the adipose tissue stem cell-derived exosome-treated sides of the face had achieved a significantly greater improvement than the control sides at the final follow-up visit (percentage reduction in echelle d'evaluation clinique des cicatrices d'acne scores: 32.5 vs 19.9%, p<0.01). Treatment-related erythema was milder, and post-treatment downtime was shorter on the applications of human adipose tissue stem cell-derived exosome-treated side.

The investigative study proved that a variety of applications of human adipose tissue stem cell-derived exosomes can serve as a novel cell-free therapeutic strategy in the regenerative and aesthetic medical fields and demonstrated the suitability of adipose tissue stem cell derived exosomes as an adjuvant treatment modality in combination with fractional carbon dioxide laser for the treatment of acne scars.

This reportis an open access article under the CC BY-NC license Society for Publication of Acta Dermato-Venereologica.

"The science is clearly demonstrating that exosomes are the wave of the future not just for aesthetics but for many other areas of medicine, and the richest source of this material, by far, is adipose tissue," says Dr. Randy Miller, M.D., F.A.C.S.

Facial atrophic acne scarring is a psychologically damaging condition that can cause emotional, mental, and social disability. "With a huge percentage of the world population struggling with this condition, the need for widening of therapeutic options was astoundingly clear," says Dr. Diane Duncan, M.D., F.A.C.S. who added, "While ablative fractional carbon dioxide laser resurfacing has demonstrated clinical efficacy in acne scar treatments, patients have sustained side-effects during post-procedural wound healing and had demanded improvement. The adjuvant application of adipose-derived stem cell conditioned medium with synergistic effects in augmenting treatment responses and reducing adverse effects through its potential to accelerate tissue rejuvenation is a victory for those suffering."

The sentiments have been echoed by so many other medical professionals, including, Dr. JD McCoy, NMP, whose patient roster includes professional athletes who do not have time for extended downtime and need to recover fast. "Since implementing the addition of Exosome Regenerative Complex powered by ExoSCRT into my protocol, I've observed a significant improvement in the speed of healing, skin quality and comfort during recovery," said Dr. Richard Jin, M.D., PhD. "Patients suffering from acne scarring range in all ages, and the pain that they feel is very real. Ensuring that my patients receive the best treatment results with the least amount of downtime and discomfort is non-negotiable, and that's why I choose to integrate Exosome Regenerative Complex powered by ExoSCRT, into all of my treatments."

Exosomes are lipid bilayer-enclosed extracellular vesicles, 30200 nm in diameter, produced by almost all cells and present in all body fluids (810). They are regarded as an essential mediator of intercellular communication by transferring proteins and genetic material between cells. Several studies have shown that mesenchymal stem cell-derived exosomes carry the essential properties of mesenchymal stem cells suggesting that exosomes may be a compelling alternative in regenerative and aesthetic medicine, as they would avoid most of the problems associated with live mesenchymal stem cell-based therapy. Interestingly, recent studies have shown that human adipose tissue stem cell-derived exosomes possess the critical properties of stem cells and are as potent as mesenchymal stem cells in the repair of various organ injuries.

BENEV's Exosome Regenerative Complex powered by ExoSCRT was developed and designed in tandem with the 4th largest exosome research company in the world, ExoCoBio. The intensive dual action complex is quickly absorbed into the skin, delivering the concentrated power of over 2.5 billion lyophilized exosomes, potent growth factors, peptides, co-enzymes, minerals, amino acids and vitamins. The paraben-free, steroid-free, and hypoallergenic patented technologies and ingredients are clinically proven to rejuvenate and regenerate the skin. "Lyophilizing exosomes maximize topical therapeutic potential. Making them ideal for treatments," says Dr. Richard Goldfarb, M.D., F.A.C.S.

ExoCoBio's ExoSCRT, is an innovative patented purification method of separating and refining 0.1 pure exosomes from stem cell conditioned media. The concentration of materials is significantly greater than what can be achieved with a product such as PRP. Studies have shown that this product increases fibroblast production by 180% and collagen production by 300%.

BENEV Company Inc. Medical Advisory Board Members:

Richard Jin, MD, PhD, BENEV's Chief Medical Director, studied at the Boston University School of Medicine, Harvard Medical School and the University of California Irvine. He completed research in the areas of cardiovascular disease, pulmonary hypertension, antioxidant enzyme properties, cell signaling, cellular redox mechanisms, free radical-induced oxidant stress, platelet biology, growth factors, and wound healing. For more information visitwww.rjclinicalinstitute.com

Richard M. Goldfarb, M.D, F.A.C.S., graduated from the University of Health Sciences /Finch University, The Chicago Medical School with top honors in Surgery. He completed his surgical training atNortheastern Ohio College of Medicine. He did additional training in cosmetic surgery at theUniversity of Pennsylvania, Department of Plastic Surgery andYale University. Dr. Goldfarb's 30 years of combined experience in General, Vascular, and Cosmetic Surgery provides his patients with the surgical expertise they are seeking. Dr. Goldfarb established the Center for SmartLipo & Plastic Surgery in 2007. For more information visitwww.centerforsmartlipo.com

Diane I. Duncan, M.D., F.A.C.S., obtained her medical degree from the Tulane University School of Medicine. She is certified by the American Board of Plastic Surgery and is a member of several plastic surgery professional societies, including the American Society of Plastic Surgeons (ASPS), the American Society of Aesthetic Plastic Surgeons (ASAPS) and the International Society of Aesthetic Plastic Surgeons (ISAPS). In addition to these affiliations, Dr. Duncan is a fellow of the American College of Surgeons (ACS). Dr. Duncan joined our Medical Advisory Board with over 30 years of experience in private practice as a plastic surgeon. She is an internationally recognized speaker and educator in plastic surgery and has delivered presentations at industry conferences around the world. She has also authored medical journal articles on a variety of subjects in plastic surgery and currently serves as a member of the editorial review board for theAesthetic Surgery Journal. For more information visit http://www.drdianeduncan.com

Randy B. Miller, M.D., is a board certified cosmetic and reconstructive plastic surgeon practicing in Miami, Florida. Dr. Miller earned his Bachelor of Arts in psychology and a Master's degree in clinical immunology and completed medical school at Jefferson Medical College where he graduated at the top of his class. He completed his training in general surgery and otolaryngology - head and neck surgery at Thomas Jefferson University Hospital in Philadelphia. Dr. Miller performed his plastic surgery training at Baylor College of Medicine located within the Texas Medical Center in Houston, which is the largest medical center in the world. Dr. Miller is a former president of the Miami Society of Plastic Surgeons, the Florida Society of Plastic Surgeons, and the Plastic Surgeons Patient Safety Foundation. Having served five consecutive terms on the Board of Directors of the Dade County Medical Association and as a delegate to the Florida Medical Association, Dr. Miller is a member of, and has received presidential appointments from, the American Society of Plastic Surgeons. In addition to his role as a clinical professor in the Division of Plastic Surgery at the University of Miami, Dr. Miller serves as a plastic surgery resident mentor. For many years he has served as the liaison between the University of Miami, Division of Plastic Surgery, and the Miami Society of Plastic Surgeons. Based on his research, publications and 25 years of clinical experience, Dr. Miller has become an internationally recognized expert in the fields of stem cell research and therapy, including human and veterinary tissue regeneration. Dr. Miller provides a uniquely comprehensive approach to aesthetics and age management. For more information visit http://www.millerplasticsurgery.com

Dr. J.D. McCoy, NMP, received his doctorate in Naturopathic Medicine at the Canadian College of Naturopathic Medicine. He is one of the most accomplished naturopathic physicians practicing aesthetic medicine in the country. He completed an internship in internal medicine in Hawaii, and began specialized training, certification, and externship in cosmetic medicine and light-based therapies. Dr. McCoy has devoted his specialization, passion and his entire practice to the art of less-invasive cosmetic rejuvenation, weight-management, and natural bio-identical hormone therapy since 2003. Dr. McCoy's principles in the practice of aesthetic medicine include prevention, the use of natural substances (light/energy, nutrients and other natural substances), and the use of the least invasive treatments possible. Dr. McCoy finds innovative solutions that reduce or eliminate the need for more invasive surgery- beautiful results naturally. He is recognized as an innovator and physician trainer for multiple technologies and techniques in cosmetic medicine including but most certainly not limited to a Physician Member: American Academy of Cosmetic Surgery, American Academy of Aesthetic Medicine, American Society of Aesthetic Mesotherapy, International Federation for Adipose Therapeutics and Science. For more information visitwww.contourmedical.com

BENEV Company Inc.1-949-457-2222 http://www.BENEV.com

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BENEV Announces Investigative Report on Combination Treatment with Human Adipose Tissue Stem Cell- derived Exosomes and Fractional CO2 Laser for Acne...

Four promising COVID-19 therapies being tested at nearby UVA – Rappahannock News

Over the past nine months, clinical trials conducted at the University of Virginia have led to new treatments for patients fighting COVID-19 and new tools for health care workers saving lives around the commonwealth and world.

We have been able to learn very quickly, and try new things that have changed the way we approach treatment for this virus, said Dr. Kyle Enfield, a professor and physician in pulmonary and critical care medicine who has helped to coordinate clinical trials at UVA Health.

We are seeing clinical research happen at a speed that has never been seen before, both for drug therapies and vaccine development, Dr. Linda Duska, associate dean for clinical research in the School of Medicine, added. Weve also seen funding and the regulatory apparatus really adapt to this pandemic, while maintaining rigorous standards.

Four clinical trials of COVID-19 drug therapies either underway or completed at UVA, and their implications for patients and for the ongoing pandemic, are summarized below.

A single-site trial based at UVA, the study examines the use of convalescent plasma derived from blood donated by recovered COVID-19 patients to treat patients hospitalized with the virus, but not yet in intensive care. In theory, the antibodies in the plasma will bind to virus cells, blocking them from harming healthy cells.

Convalescent plasma therapy has been around for more than 100 years, and there has been a lot of interest in it since COVID-19 appeared, said Dr. Jeff Sturek, who specializes in pulmonary and critical care medicine and is the principal investigator for the trial. We wanted to bring this therapy to UVA, to contribute to the development of the field and to offer our patients as many options as possible.

The trial was approved in April and patients were enrolled at UVA from May to August. Researchers are now in the process of analyzing results, which look promising.

UVA is part of a multisite Adaptive COVID-19 Treatment Trial, or ACTT, testing the antiviral drug remdesivir in adults hospitalized with COVID-19.

Results from the first part of the trial found that the drug sped recovery time in patients with advanced cases of COVID-19, prompting the U.S. Food and Drug Administration to issue an emergency use authorization for remdesivir. It was the first drug authorized to treat COVID-19.

The trial is now in its third phase; it began with comparing remdesivir to a placebo drug, and then progressed to pairing different drugs with remdesivir, to see which combination was most effective.

The trial was designed to be iterative, to allow us to continue to adapt the study as we learn more about the drug, Duska said. That lets us continually improve treatment without having to go through a complete restart.

Another multisite trial that includes UVA is investigating if infusion of the mesenchymal stromal cell remestemcel-L, a type of stem cell derived from bone marrow, can increase survival rates among COVID-19 patients experiencing acute respiratory distress syndrome.

The cells have been shown to migrate to the lungs when inflammation occurs and release anti-inflammatory factors that can reduce cytokines secreted by the immune systems. High levels of cytokine production have been associated with severe illness and death among COVID-19 patients.

These adult bone marrow stem cells have been used to treat a variety of inflammatory diseases, which means they have already been through early safety trials and we could move more quickly into a larger trial, said Sturek, also the principal investigator for this trial. We hope that the cells can turn down inflammation in the lungs and help the lungs repair themselves, especially for critical ill patients on ventilators.

The trial is halfway through its enrollment process, with a target of enrolling 300 patients. It has already passed initial safety checks with the National Institutes of Healths Data Safety Monitoring Board.

In this multisite trial, researchers are working to determine if monoclonal antibodies made by the drug company Regeneron Pharmaceuticals can prevent COVID-19 infection among people who have been exposed by someone in their household, but have not yet developed the disease. The trial is testing the same antibody cocktail given to President Trump when he was hospitalized with COVID-19, though with a different use.

In this case, the antibodies are intended to prevent people from getting sick if they have a household member with COVID, Enfield said. So far, UVA has done a good job with recruitment, which is particularly tricky in this case as you have to find people who have been exposed to COVID in their household, but who do not yet have COVID.

UVA is recruiting 40 participants for the study, each of whom will receive four injections of either the antibodies or a placebo. Participants must have been exposed to COVID-19 by someone in their household within the previous 96 hours and continue to live with that person for a month.

Its been a rapid process, and a testament to the multidisciplinary team involved, from infectious disease clinicians and researchers to cell therapy, pulmonary critical care and several other departments, Sturek said. Its been all-hands-on-deck.

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Four promising COVID-19 therapies being tested at nearby UVA - Rappahannock News

MCL Landscape Adapts to Changes After CAR T-Cell Therapy Approval – OncLive

Despite the introduction of CAR T-cell therapy to the mantle cell lymphoma (MCL) armamentarium, induction therapy followed by stem cell transplant has maintained a role, said James Gerson, MD, who added that he continues to recommend transplant for patients, since they are still eligible for CAR T-cell therapy upon relapse on transplant.

I tell patients that we have very long-term data that a consolidative transplant for those who are eligible leads to a prolonged remission, Gerson explained. If a patient can be in remission for 10 years, maybe 10 years from now we will have something that is even better and more tolerable than CAR T-cell therapy.

In July 2020, the FDA approved brexucabtagene autoleucel (Tecartus) for the treatment of adult patients with relapsed/refractory MCL. The indication was based on findings from the phase 2 ZUMA-2 trial where brexucabtagene autoleucel, given as a single infusion, induced an 87% objective response rate and a 62% complete response rate in this patient population.

Unlike in diffuse large B-cell lymphoma where more restrictions [with CAR T-cell therapy] exist, any patient with MCL who had 1 prior therapy and relapsed can go straight to CAR T-cell therapy, Gerson said. We can use BTK inhibitors to bridge them, but we dont have to. There are a lot of possibilities.

Though not yet planned, further studies evaluating CAR T-cell therapy in the frontline setting for patients with high-risk MCL may be worth exploring, said Gerson.

In an interview with OncLive during a 2020 Institutional Perspectives in Cancer webinar on hematologic malignancies, Gerson, an assistant professor of clinical medicine at Penn Medicine, discussed navigating treatment selection amid the approval of CAR T-cell therapy in MCL and the role of transplant after induction therapy.

OncLive:What induction regimens do you consider for your patients with MCL and how do you select between possible options?

Gerson: For young, fit patients, there is really no right answer for induction therapy because [treatment selection] is based on phase 2, nonrandomized data. Typically, induction therapy involves high-dose chemotherapy. Im actually very intrigued by a recent publication from the French group that looked at obinutuzumab [Gazyva] with DHAP [dexamethasone, cytarabine, and cisplatin; O-DHAP] as frontline therapy for young patients prior to consolidative transplant.

Ive used a lot of R-DHAP [rituximab (Rituxan) plus DHAP], but I havent used this O-DHAP. I think there is rationale to be excited about that option. Even though it is a phase 2 trial, it should [yield] reasonable data to take to insurance and get approval for. Again, it is not something Ive given, but Im very compelled by it and it is something I will try in the coming months.

Then, [we] usually follow [induction therapy] with a stem cell transplant for patients who are eligible.

In the relapsed setting, second-line BTK inhibition is pretty much the standard of care now. There is no right answer between [ibrutinib (Imbruvica) and acalabrutinib (Calquence)]. Anecdotally and by some limited published data, ibrutinib seems to have a higher occurrence of adverse effects [AEs]. Acalabrutinib is a little bit different but seems to be more tolerable in the long run. I tend to tell patients that and then they tend to want the medication that probably has fewer AEs. A lot of us end up choosing acalabrutinib, but from an efficacy standpoint, we have no comparative data. The curves are pretty similar when we look between the 2 trials.

In the era of cellular therapy, what is the role of transplant in MCL?

The challenge, of course, is that with the FDA approval of brexucabtagene autoleucel and CAR T-cell therapy coming into MCL, it is hard to know if we should still be transplanting patients. No one knows the answer because it is obviously not something that has been explored. The only thing that is known is that patients who have been transplanted can still go forward with [CAR T-cell] therapy and respond quite well. Therefore, it is not that getting a transplant means a patient cannot get CAR T-cell therapy in the future.

[With that], I usually tell my patients not to skip transplant because of the approval of brexucabtagene autoleucel in the relapsed/refractory setting. That said, it is an individualized choice. Certainly, some patients might make that choice not to undergo a transplant now that CAR T-cell therapy is available to them should they relapse. Still, in my practice, I will still offer transplant to a patient who is young and fit as a consolidative measure after induction therapy.

Do you see CAR T-cell therapy gaining a more significant role in MCL? Will it eventually moveinto the frontline setting?

Right now, the label given to brexucabtagene autoleucel was very open, [encompassing] any relapsed/refractory patient [with MCL]. That is great not only for patients but for practicing physicians.

[Bringing CAR T-cell therapy to] the frontline setting will likely be investigated in the future, especially for high-risk patients with high MIPI [Mantle Cell Lymphoma International Prognostic Index] scores,TP53mutations, blastoid variant MCL, or pleomorphic variant MCL. [These features] tend to [confer] worse outcomes. There are areas where using [CAR T-cell therapy] in the frontline setting is worth looking into.

It is completely up to the company whether they want to pursue it. Otherwise, it is going to be left to investigator-initiated trials, which are going to be difficult because of the cost associated with CAR T-cell therapy. Some centers may pursue using homegrown CAR T-cell therapy where the cost is much lower for some of these high-risk patients, but I hope the company will pursue such trials in the frontline setting.

What other regimens are potentially on the horizon in MCL and how could they best fit into the paradigm?

There are a lot of similarities between chronic lymphocytic leukemia [CLL] and MCL. A similar triplet strategy to ibrutinib, obinutuzumab, and venetoclax [(Venclexta) in CLL] is being looked at in frontline and relapsed/refractory MCL. That is incredibly exciting and could very well supplant typical [cytarabine]-based induction and transplant. We will need long-term follow-up, so we probably wont know for many years.

Thankfully, with minimal residual disease [MRD], we will possibly be able to know much sooner, because if we can get a large percentage of patients into an MRD-negative state, that is a proxy for outcome. Again, we wont know for probably about 10 years before we get that long-term follow-up, but we will have a good enough idea if we [should] use MRD as a surrogate end point.

Reference

Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N Eng J Med. 2020;382(14):1331-1342. doi:10.1056/NEJMoa1914347

Read more:
MCL Landscape Adapts to Changes After CAR T-Cell Therapy Approval - OncLive