Andre Terzic, M.D., Ph.D.

Center for Regenerative Medicine, Mayo Clinic

Andre Terzic, M.D., Ph.D.: Regenerative medicine is an exciting component of modern health care. It harnesses breakthroughs in technologies to address major unmet needs of the population, both nationally but also globally. With the successes of traditional medicine, we'll live longer. And aging has been viewed as a major triumph of humanity. At the same time, unfortunately, with aging, we are facing with a growing pandemic of so-called chronic diseases diseases that live with us throughout our lifespan, heart disease, cancer, diabetes and so on.

So regenerative medicine comes with this new ability to understand how our body can heal and to harness its innate ability, that self-ability to heal, to actually provide new solutions to these patients in need. So the Center for Regenerative Medicine at Mayo Clinic has been built to address the unmet needs of patients. It builds on our new knowledge, bringing new ways to promote the self-repair ability of our body.

There have been magic moments during these few decades that we have built the regenerative medicine field. One such moment was when we saw, for the first time, how out of a stem cell, we can create new beating heart tissue. It was a revolution for us.

We would like to bring now this knowledge that may have started in one field to build it across fields as the new science allows, essentially, for learning between fields. We need true, radical innovation to move the current knowledge into new solutions. That is where regenerative medicine has a unique role. It changes the way we treat patients.

Excerpt from:
About Regenerative Medicine - Center for Regenerative Medicine - Mayo ...

The Alliance for Regenerative Medicine Announces the Appointment of Timothy D. Hunt as Chief Executive Officer

WASHINGTON, D.C. August 10, 2022

The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization representing the cell and gene therapy sector, today formally announced that its Board of Directors has appointed Timothy D. Hunt as the organizations next Chief Executive Officer. Hunt will succeed Janet Lynch Lambert, who announced in April her plan to step down as CEO and who served on the Boards Search Committee. Hunt will start at ARM on September 6.

We are excited to welcome Tim to the ARM team at such a pivotal moment for our sector, said Emile Nuwaysir, Chair of the ARM Board and Search Committee,and President and Chief Executive Officer of Ensoma, an in vivo genomic medicines company. Tims two decades of experience advocating for biotechnology companies, knowledge of the key issues facing the cell and gene therapy field, and expertise in leading teams make him the ideal choice to guide ARM in building the future of medicine. Tim has a deep philosophy of engagement with major stakeholders that will support ARM members and help bring cell and gene therapies into mainstream medical practice.

Hunt was most recently the Chief Culture and Corporate Affairs Officer at Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer. Prior to that, he was the Chief Corporate Affairs Officer at CRISPR gene-editing pioneer Editas Medicine, where he led the companys global policy and government affairs, bioethics, communications, market development and human resources initiatives. He also served in executive public affairs roles at Cubist Pharmaceuticals and Biogen.

Hunt was an Advisory Group member of the Value-Based Payments for Medical Products consortium at the Duke-Margolis Center for Health Policy. He also has been a member of the Board of Directors of the non-profit organization Life Science Cares and has chaired the Ethics Committee of the American Society of Gene and Cell Therapy (ASGCT). Hunt previously served as a member of ARMs Gene Editing Task Force and on the Biotechnology Innovation Organizations Gene Editing Working Group. He received a B.A. in history and philosophy from Boston College and a J.D. from the Columbus School of Law at the Catholic University of America.

I am honored to succeed Janet as Chief Executive Officer of the Alliance for Regenerative Medicine and for the tremendous opportunity to build upon her legacy of developing ARM into the leading sector advocate and resource for the industry, said Hunt. Cell and gene therapies are already transforming patients lives, and we are on the cusp of even more breakthroughs in both rare and prevalent diseases. Our mission is both urgent and clear: to engage all our major stakeholders to ensure the patients we serve have access to the durable and potentially curative therapies of the present and future.

Tim is an excellent choice to continue to grow and strengthen this amazing organization and help realize the potential of regenerative medicine, said Lambert, whose tenure includes doubling ARMs global membership to 425 members, strengthening the organizations advocacy in the US and Europe, and building the ARM team.

Cell and gene therapies to treat blood cancers, spinal muscular atrophy, and an inherited form of blindness are approved in the US and Europe. 2022 could be a record year for new gene therapy approvals for rare disease, and regulators in the US and Europe could approve the first such therapies for hemophilia and sickle cell disease in late 2022 and 2023. More than 2,400 regenerative medicine clinical trials 60% of which targeted prevalent diseases including diabetes and cardiovascular disease were active globally at the end of 2021. ARM is committed to working with stakeholders to ensure that patients benefit from this rapidly advancing pipeline of transformative therapies.

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs).ARMpromotes legislative, regulatory, reimbursement and manufacturing initiativesin Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-engineered therapies.Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing ATMPs.In its 12-year history,ARMhas become the global voice of the sector, representing the interests of 425+ members worldwide and 80+ members across 15 Europeancountries, including small and large companies, academic research institutions, major medical centres and patient groups.To learn more aboutARMor to become a member, visithttp://www.alliancerm.org.

Media inquiries

For more information or for media requests, please contact Stephen Majors, Senior Director of Public Affairs for ARM, atsmajors@alliancerm.org.

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The Alliance for Regenerative Medicine Announces the Appointment of Timothy D. Hunt as Chief Executive Officer - GlobeNewswire

The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) updated its Guidance Agenda in June 2022,1which provides that the agency plans to issue 18 guidance documents in 2022, including eight guidance documents on tissues and advanced therapies. In this alert, we highlight some key considerations from three draft guidance documents on human gene therapy products that incorporate gene editing (GE) components, chimeric antigen receptor (CAR) T cell products, and regenerative medicine therapies that can benefit biopharmaceutical developers and sponsors. Recognizing the challenges of developing such complex, multi-component biologic drug products, including unanticipated risks associated with on-target and off-target activities, these draft guidance documents describe the FDA's recommendations for preclinical and clinical testing, chemistry, manufacturing, and controls (CMC), as well as information that should be included in investigational new drug (IND) applications to ensure proper identity, potency/strength, quality, and purity of the investigational drug products. FDA recommends sponsors of such complex products to communicate with the Office of Tissues and Advanced Therapies (OTAT) in CBER early in product development before submission of an IND, to discuss the product-specific considerations in preparation for transitioning to the clinical phase.

FDA expects detailed information and data IND applications before sponsors can transition to clinical testing. We recommend biopharmaceutical developers and sponsors review the applicable FDA draft guidance documents early in their product development process to identify these needs. Work closely with both FDA regulatory counsel and intellectual property/patent counsel to ensure there is sufficient data to support an IND application, including adequate testing and quality control measures, and that CMC, preclinical, and clinical development plans are coordinated with intellectual property and patent strategies to ensure robust protection of their intellectual property and to maximize the benefits of their patents and FDA regulatory exclusivities. We also encourage interested persons to submit comments to shape the policies proposed in FDA's draft guidance documents prior to finalization.

Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing2

Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products3

Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies4

Stakeholders have until September 14, 2022, to submit comments to this draft guidance to ensure they are considered by FDA before finalization of the guidance.

For More Information

For questions regarding FDA strategy, approval, and regulatory compliance, please contact any member of Wilson Sonsini'sFDA regulatory, healthcare, and consumer productspractice. For questions regarding intellectual property and patent counseling, please contact any member of Wilson Sonsini'spatents and innovationspractice.

Andrea Chamblee,Paul Gadiock, andEva Yincontributed to the preparation of this Wilson Sonsini Alert.

[1] FDA, Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022 (Updated June 2022), available at https://www.fda.gov/media/120341/download.

[2] FDA, Draft Guidance for Industry: Human Gene Therapy Products Incorporating Genome Editing (March 2022), available at https://www.fda.gov/media/156894/download.

[3] FDA, Draft Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, available at https://www.fda.gov/media/156896/download.

[4] FDA, Draft Guidance for Industry: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (June 2022), available at https://www.fda.gov/media/159237/download.

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FDA Issues Draft Guidance to Facilitate Development of Human Gene Therapy, CAR T Cell, and Regenerative Medicine Products - Wilson Sonsini Goodrich...

The Business Research Company's induced pluripotent stem cell (IPSC) market research report expands on key drivers, trends, and growth opportunities in the market.

LONDON, Aug. 9, 2022 /PRNewswire/ --The increasing prevalence of genetic diseases is expected to drive the induced pluripotent stem cell market in the forecast period. To reveal the pathogenesis of genetic diseases, various patient-derived iPSCs were developed. These genetic abnormality-harboring iPSCs can be repaired, and the genetically repaired iPSC can be differentiated into normal-functioning cells. In the future, these patient-derived normal cells can be used in a patient-tailored therapy to replace the damaged cells due to the disease. iPSCs for various genetic diseases have been developed, such as for certain types of Parkinson's disease, spinal muscular atrophy, lentigines, electrocardiographic abnormalities, and other genetic disorders.For instance, in the case of albinism, which is a genetic disorder, an estimated 1 in 20,000 people worldwide are born with oculocutaneous albinism. Also, nearly one million people were living with Parkinson's disease (PD) in the U.S. by 2020.

The global induced pluripotent stem cell (iPSC) market size is expected to grow from $ 2.43 billion in 2021 to $ 2.64 billion in 2022 at a compound annual growth rate (CAGR) of 8.6%. The induced pluripotent stem cell (iPSC) technology market is expected to reach $ 3.57 billion in 2026 at a CAGR of 7.8%.

Request a free sample of the Induced Pluripotent Stem Cell (IPSC) Market Report

Induced Pluripotent Stem Cells Market Overview

The induced pluripotent stem cell (iPSC) market consists of sales of induced pluripotent stem cells and related services. Induced pluripotent stem cells are the regenerated form of stem cells, which are produced from an existing adult cell, such as hepatocytes, fibroblasts, keratinocytes, and neurons. The various applications include academic research, drug development and discovery, toxicity screening, and regenerative medicine and are used in several sectors such as hospitals and research laboratories.

Induced Pluripotent Stem Cells Are Increasingly Being Used To Treat Type 1 Diabetes

As per the induced pluripotent stem cell (iPSC) market report, players in the industry are extensively developing pluripotent cells to treat type 1 diabetes. Cellular therapy has recently been started for type 1 diabetes (T1D) to replace islet cells, which are insulin-producing cells that are lost in T1D patients. These problems could be at least partially resolved by producing pancreatic islet cells from PSCs, and significant advancements have been made by imitating how the human pancreas naturally develops. Recently, two biotech companies, Semma Therapeutics and Viacyte, produced cells that were found to be capable of functional insulin secretion upon exposure to high-glucose or high-potassium stimuli.

In 2021, Fujifilm Holdings Corporation Held The Largest Market Share

Fujifilm Holdings Corporation was the largest competitor in the induced pluripotent stem cell market in 2021, with a 10.46% share of the market. FUJIFILM Cellular Dynamics's growth strategy focuses on strengthening its cell therapy business through expanding its operational capabilities. For instance, in March 2020, the company began the operation of its new cGMP-compliant-1 iPSC production at the Innovation Facility for Advanced Cell Therapy (i-FACT). The new facility is involved in manufacturing and developing induced pluripotent stem cells for therapeutic applications.

See more on the Induced Pluripotent Stem Cell (IPSC) Market Report

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Regenerative Medicine For Cartilage Global Market Report 2022 By Treatment Modality (Cell-Based, Non-Cell-Based), By Treatment Type (Palliative, Intrinsic Repair Stimulus), By Site ( Knee Cartilage Repair, Ribs), By Application (Hyaline Cartilage Repair And Regeneration, Elastic Cartilage Repair And Regeneration, Fibrous Cartilage Repair And Regeneration), By End-Use (Ambulatory Surgical Centers, Hospitals & Clinics, Surgical Centers ) Market Size, Trends, And Global Forecast 2022-2026

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Phase III Clinical Stage Company Demonstrates Superior Efficacy of Proprietary Stem Cell Apoptotic Body Based Drug

ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International announced today new data demonstrating superior effects of the Companys ApoptoCyte procedure treated JadiCell product compared to other stem cells in treating an animal model of Chronic Obstructive Pulmonary Disease (COPD).

In a series of experiments, mice were administered the enzyme elastase to mimic COPD. It was shown that untreated JadiCell stem cells, as well as stem cells from sources conventionally utilized, specifically fat and bone marrow, had some therapeutic activity including reduction of inflammation, stimulation of regenerative growth factors, and preservation of alveoli structure1. All cell types had improved therapeutic activity when processed using the ApoptoCyte procedure, with JadiCell possessing the highest activity.

In May of this year we announced and filed a patent on the ApoptoCyte procedure which involves the induction of cellular suicide in the stem cell, extraction of small vesicles called apoptotic bodies and co-administration with specific drugs such as certain histone deacetylase (HDAC) inhibitors. Leveraging this technology, we have filed a new patent on COPD which contains the data disclosed today, said Dr. James Veltmeyer, Chief Medical Officer of the Company, and co-inventor of both patents. The demonstration that the ApoptoCyte Procedure is applicable to COPD, which is one of the major causes of death in the world, is extremely exciting.

The Company possesses IND #28508 for using non-modified JadiCells for COPD, however the clinical trial is expected to initiate following further discussions between the Company and the FDA. Additionally, the Company currently is running a Phase III clinical trial using JadiCells for treatment of advanced COVID-19 infection.

COPD represents a significant unmet medical need for which no curative approaches exist, said Timothy Dixon, President, and CEO of the Company and co-inventor of the patents. We are grateful to have a team of cellular and COPD experts who have assisted us in creating what we believe is a first in class approach to treating COPD. We hope to continue exploring the applicability of the ApoptoCyte Procedure in other therapeutics in the regenerative medicine space.

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com.

1 Therapeutic Solutions International Announces ApoptoCyte Procedure for Enhancing Stem Cell Activity | BioSpace

View source version on businesswire.com: https://www.businesswire.com/news/home/20220812005201/en/

Timothy G. Dixon[emailprotected]

Source: Therapeutic Solutions International, Inc.

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Therapeutic Solutions International Reports Superior Efficacy of ApoptoCyte on Chronic Obstructive Pulmonary Disease Model Compared to Conventional...

Israeli scientists have created the worlds first synthetic embryos. They used mouse stem cells to create embryos, nurtured them in an artificial womb, and grew them for 8 days roughly the equivalent of three weeks of a human pregnancy.

Their research, which was published in the journal Cell last week, is being acclaimed by scientists as a ground-breaking development. Inside the tiny mouse embryos, the researchers can see organs developing. We view the embryo as the best 3D bio printer, says Jacob Hanna, a biologist at the Weizmann Institute of Science, told MIT Technology Review. Its the best entity to make organs and proper tissue.

The mouse embryos developed beating hearts, flowing blood, intestinal tracts and cranial folds in the brain even though they were created from scratch in a Petri dish.

This experiment has huge implications, says Bernard Siegel, of the World Stem Cell Summit, a group which lobbies for regenerative medicine. One wonders what mammal could be next in line.

All going well, the next mammal is going to be homo sapiens.

Dr Hannas ambitions are immense. The ultimate goal of his start-up company, Renewal Bio, is to make humanity younger and healthier by leveraging the power of the new stem cell technology to solve ailments such as infertility, genetic diseases, and longevity.

He believes that there will be a huge market for products derived from synthetic human embryos.

Since the turn of the century, developed nations have seen a clear trend: declining birth rates and fast aging populations. With significant socioeconomic implications, this trend threatens to upend health systems, retirement programs, and workforces across the globe. At the beginning of life, this is shown by a 5-10% increase in infertility treatments by U.S. couples each year. Towards the end of life, these issues are manifesting in fast-aging populations that balloon healthcare costs. In the U.S., the aging population is driving national health expenditures to increase at a rate of 5.5% per year, and are expected to reach more than $6 trillion annually by 2027.

The vision of the company is Can we use these organized embryo entities that have early organs to get cells that can be used for transplantation? We view it as perhaps a universal starting point, Dr Hanna says.

What he has in mind is projects like rebooting the immune system for the elderly by creating blood from an embryo. Or growing a female embryo until the gonads form and the eggs can be harvested. In other words, Dr Hanna and his colleagues want to strip-mine human embryos which have been custom-made for their clients.

They also claim that their method of producing synthetic embryos creates the placenta and yolk sac surrounding the embryo. This suggests that perhaps a baby could reach full term in an artificial womb with no need for a mother at all.

But would these synthetic embryos really be human? Hanna dismisses the idea. We are not trying to make human beings. That is not what we are trying to do, he told MIT Technology Review. To call a day-40 embryo a mini-me is just not true.

However, Dr Hanna is not a philosopher. He is just a talented technician tinkering with biological structures. Whether or not it is human is not his to decide. Even though the embryo has not been conceived naturally, it might grow into a human being if it were transferred into a womb.

At the moment scientists quoted in the media are insisting that synthetic embryos are definitely not embryos. As Australian stem cell scientist Megan Munsie wrote in The Conversation: They replicate only some aspects of development, but not fully reproduce the cellular architecture and developmental potential of embryos derived after fertilisation of eggs by sperm so-called natural embryos.

But even if this is true, Dr Hannas ultimate goal seems to be to create synthetic embryos which are as close as possible to natural embryos. If they are not human initially, might they become human later on, as the field advances?

With so many unknowns, the need for regulation of this new technology is urgent. And the ones writing the law should not be the same entrepreneurs who stand to become billionaires if their dreams come true. If the brief history of stem cell science has taught us anything, it is that scientists lust for power always outruns their interest in ethics.

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Ethical perils lie ahead after the creation of 'synthetic embryos' - MercatorNet

This latest, additional patent for preserving biologics marks a paradigm shift for skincare and adds additional protection to Aesthetics Biomedicals product portfolio, Shaun Wootten, Director of Innovation and Design.

PHOENIX (PRWEB) August 10, 2022

Aesthetics Biomedical Inc (ABM), a leader in regenerative medicine and advanced aesthetics committed to the development and distribution of breakthrough, novel, and personalized aesthetic devices and products announces the issuance of its third US patent for Biological Preserving Composition and Methods of Use from the United States Patent Trademark Office. The newly issued [third] patent continues the protection of its innovation in the proprietary topical compositions of its SoME Skincare product which combines with physician infused biologics and presents the future of personalized skincare.

Founder & Chief Executive Officer, MaryAnn Guerra says of the issuance Once again, I am excited to see that Aesthetics Biomedicals innovations have been validated by the issuance of a new patent, further strengthening our SoME Skincare brand and patent portfolio. Our SoME Skincare product line will be expanded to fully utilize the broader patent coverage, under the leadership of our Director of Innovation & Design, Shaun Wootten.

SoME Skincare, medically dispensed through professional offices, with its unique technology platform combines the bodys own regenerative cytokines within skincare. Proven in skin renewal and regeneration, SoME Skincare is clinically shown to improve both visual and cellular facial aging. This latest, additional patent for preserving biologics marks a paradigm shift for skincare and adds additional protection to Aesthetics Biomedicals product portfolio, said Shaun Wootten, Director of Innovation and Design. This is Aesthetics Biomedicals broadest patent yet on the matter and cements the ingenuity of our Center of Aesthetic Innovation.

The growth factors, derived from Platelet Rich Plasma [PRP] infused within its advanced formula signals the biochemical receptors on the cell surface to stimulate new collagen and new elastin critical for regeneration and repair of photodamaged skin to produce a personalized, autologous skincare treatment. Aesthetics Biomedical Inc. is continuing to build its pipeline of regenerative products with a focus on skin, hair, and nail personalized products. The patents cover multiple delivery systems including, gel, cream, ointment, and spray. This is coupled with the PRP serving as a rich source of exosomes that provide a natural comprehensive means for regeneration. According to Lawrence A Rheins PhD, Chief Scientific Officer, The additional patent protection offered for SoME Skincare, will continue to provide Aesthetics Biomedical with a unique technology platform consisting of stabilized platelet rich plasma, permitting Aesthetics Biomedical to develop a multitude of topical products for various skin conditions including facial anti-aging.

ABOUT AESTHETICS BIOMEDICAL: Aesthetics Biomedical Inc., headquartered in Phoenix, Ariz., is committed to the development and distribution of novel aesthetic devices, products, and services in the global market. Aesthetics Biomedicals innovation center is a leader in breakthrough technologies and combination therapies for its clients, physician network, and the aesthetic arena, creating novel and unique patient experiences that benefit from ongoing research, approved clinical indications for use, as well as a personalized approach designed for consumer benefit. For more information, please visit [AestheticsBiomedical.com.

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SEOUL, South Korea, Aug. 10, 2022 /PRNewswire/ --Panacell Biotech Co., Ltd. said that NK cells, exosomes, and brown adipose-derived stem cells are effective to treat patients with long COVID conditions, or post COVID-19 conditions, as well as those with terminal illness.

Seung-Ho Choi, CEO of Panacell Biotech

Panacell Biotech is South Korea's research institute specializing in advanced regenerative medical cell therapy using adipose-derived stem cells (ADSC).

The company announced on August 10 that it will soon conduct those cells' toxicity tests through clinical trials and laboratory animals.

Currently, in South Korea, there are guidelines for plasma treatment that administers plasma from patients who have recovered from COVID-19 to other patients. Although there already exist COVID-19 treatments, such as Paxrovid, a clear therapeutic effect has not been confirmed yet.

There are over 60 long COVID conditions, including decreased libido and hair loss.

According to the Mayo Clinic, a nonprofit American academic medical center, "A whopping one in four people aged 65 or above suffer from aftereffects of COVID-19"

The Guardian also reported that people with long COVID often experience and an "extremely broad" variety of symptoms, including less well-known side effects such as amnesia, and an inability to perform familiar movements or commands."

According to the TIME magazine said about four million people or 2.4% of the U.S. employed population have reduced ability to work because of Long COVID.

Associate Professor Gwenalle Douaud at the Nuffield Department of Clinical Neurosciences (NDCN), University of Oxford, and her team observed a "greater reduction in grey matter thickness and tissue contract in the orbitofrontal cortex and parahippocampal gyrus" and "greater changes in markers of tissue damage in regions that are functionally connected to primary olfactory cortex." While the long-term effects of COVID-19 on smell remain inconclusive, the study suggests a possible connection between brain changes by COVID-19 and memory.

However, there have been many clinical results in which the coronavirus causes inflammation in various organs, including the respiratory system, and chronic symptoms persist.

While research on a treatment for COVID-19 is underway around the world, Chinese researchers said they are researching ways to treat COVID-19 patients using stem cells.

Sun Yanrong, Deputy Director of China Biotechnology Development Center, asserted, "We are continuing to monitor the treatment using stem cells. In Wuhan, over 200 patients have already been treated with stem cells."

He continued explaining, "The clinical treatment results show that the stem cell therapy has good safety and has also been confirmed to have a therapeutic effect. It was also effective in recovering the lungs."

Seung-Ho Choi, CEO of Panacell Biotech, affirmed, "We expect that this clinical trial will reveal therapeutic effects of stem cell therapy along with these treatments."

Panacell Biotech is a leading bio institute in advanced regenerative medicine and cell therapy, widely recognized for its contributions to the development of biotechnology by researching stem cell culture and cell banking, focusing on the development of treatments for various cancers and incurable diseases.

The Ministry of Food and Drug Safety of South Korea approved Panacell Biotech on April 1 this year as one of the 21 licensed cell treatment facilities.

It received the K-ESG Management Innovation Award in June 2022, and is scheduled to receive the 2022 Global Clean Environment Award in the healthcare category in this upcoming October 18.

View original content to download multimedia:https://www.prnewswire.com/news-releases/panacell-biotech-to-conduct-toxicity-tests-for-nk-cells-exosomes-and-brown-adipose-derived-stem-cells-to-treat-patients-with-long-covid-301603403.html

Source: Panacell Biotech Co., Ltd.

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Panacell Biotech to conduct toxicity tests for NK cells, exosomes, and brown adipose-derived stem cells to treat patients with long COVID - PR...

The PAINWeek National Conference, September 6-9

MONTCLAIR, N.J. (PRWEB) August 11, 2022

The statistics are alarming: At least a fifth of the US population has chronic pain.[1] Costs to society, ranging from direct costs to lost work, is over $630 billion a year.[2] Something needs to change, and education will help. At the PAINWeek National Conference, September 6-9 at The Cosmopolitan of Las Vegas, attendees will experience stellar pain management education, including the ASIPPAmerican Society of Interventional Pain Physiciansand the Interventional Pain Management Tracks.

The ASIPP Track will include Nick Knezevic, MD, PhD, presenting Atomic Secrets: Regenerative Medicine in Managing Chronic Pain. He commented, ASIPP has a long-standing relationship with PAINWeek. Together, theyve organized a series of lectures with ASIPP key leaders as speakers to help explain the importance of interventional pain management procedures in managing pain conditions.

The ASIPP Track will also feature the following courses and presenters:

Sean Li, MD, who will present during the Interventional Pain Management Track, stated, PAINWeek has always been one of my favorite meetings because of its diversity and inclusion: it is the only meeting where I can join clinicians from all specialties who treat pain patients. Dr. Li's sessions: The Petrified Forest: Sacroiliac Joint Dysfunction and Treatment Update; and When Stars Align: The New Era of Peripheral Nerve Stimulation. He continued, Attendees will experience an emersion of emotional and intellectual experiences into the world of pain management. Dont miss out!

Johnathan Goree, MD, who will co-present East v. West: Who Should Hold the Needle First?, commented, I am excited to again take part in PAINWeek, this time discussing back pain and Whats next? I will debate Carrie Hyde, MD, a physician medical acupuncturist, and discuss our approaches to the low back pain patient, treatment philosophies, cost benefit analysis. Wholl win the debate? Both attendees and patients!

The Interventional Pain Management Track will also feature:

PAINWeek will present over 75 CME/CE credit hours in tracks such as Behavioral Pain Management, Chronic Pain Syndromes, Health Coaching, Integrative Pain Management, Medical/Legal, Neurology, Physical Therapy, Pharmacotherapy, and Psychedelics. Master Classes, Special Interest Sessions, and sponsored courses complement the agenda, along with tracks presented by the International Pelvic Pain Society.

For more information, click PAINWeek or go to painweek.org.

Dr. Goree: Associate Professor and Director of Chronic Pain Division, University of Arkansas for Medical Sciences, Little Rock. Dr. Knezevic: Clinical Professor of Anesthesiology & Surgery, College of Medicine, University of Illinois, Chicago. Dr. Li: Regional Medical Director, National Spine and Pain Centers, Lincroft, New Jersey.

PAINWeek accreditation provided by Global Education Group:

Global Education Group focuses on producing partnership-based CME for healthcare practitioners. The Global team works with a select group of medical education companies, associations, academic institutions, and healthcare facilities to develop and accredit live healthcare conferences and workshops as well as online activities. With each partnership or joint providership, Global brings accreditation expertise, project management excellence and grant funding intelligence. Based in Littleton, Colo., Global has accreditation with commendation from the ACCME and accredited with distinction from the ANCC. Global also holds accreditations to offer continuing education for nurse practitioners, pharmacists, dietitians, dentists, and psychologists. Global is a division of Ultimate Medical Academy.

1. National Center for Health Statistics, National Health Interview Survey, 2019.2. https://nationalpain.org/fast-facts-about-pain

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VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced the appointment of Dr. Gail K. Naughton to its Board of Directors.

Dr. Naughton has been a pioneer in the field of regenerative medicine for over 35 years. She was the founder of Advanced Tissue Sciences (NASDAQ:ATIS) where she oversaw the design and development of the worlds first up-scaled manufacturing facility for cell-based products, established corporate development and marketing partnerships with companies including Smith & Nephew, Medtronic, and Inamed Corporation, was pivotal in raising over $350 million from the public market and corporate partnerships, and brought four human cell-based products from concept through FDA approval and market launch. She founded Histogen (NASDAQ:HSTO) in 2007 and holds more than 125 U.S. and foreign patents and has been extensively published in the field. Dr. Naughton served as Dean of the College of Business Administration at San Diego State University from 2002 until 2011 where she helped to make SDSU the first US campus to establish a Ph.D./MBA in life sciences. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering and regenerative medicine. Dr. Naughton received her Ph.D. and M.S. from NYU Medical Center and an MBA from UCLA. She currently sits on the Board of directors of Therapeutics MD (NASDAQ: TXMD) and is the Chair of the Board of the La Jolla Institute for Immunology.

A highly accomplished visionary in biotechnology, Dr. Naughton has brought several FDA approved products to market, and we are very pleased to welcome her to our board. Her unparalleled expertise will be very helpful to CEL-SCI, stated CEL-SCI CEO Geert Kersten.

Dr. Naughton commented, Based on the results of the largest study of its kind, Multikine can significantly improve outcomes for patients with newly diagnosed head and neck cancer. CEL-SCIs management team and board have been tenacious in advancing an immune therapy that can have the greatest beneficial impact on patientswhen they are first diagnosed with cancer. I look forward to contributing my guidance as the company transitions through regulatory approval and into delivering treatments that can help extend patient lives.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patients immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiochemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of advanced primary head and neck cancer.

Multikine is designed to help the immune system see the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups. The study results announced in June 2021 showed excellent survival benefit for those patients who received Multikine treatment regimen plus surgery and radiation. When chemotherapy was added to radiotherapy following surgery the survival benefit was negated.

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. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2021. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

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CEL-SCI Appoints Dr. Gail Naughton to Its Board of Directors - Business Wire