FOSTER CITY, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the initiation of patient dosing in the AVIATION Trial, a Phase 1b clinical trial evaluating TERN-201, an orally-administered, highly selective inhibitor of vascular adhesion protein-1 (VAP-1) in patients with NASH.

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Terns Announces Initiation of Patient Dosing in AVIATION Phase 1b NASH Clinical Trial of VAP-1 Inhibitor TERN-201

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Findings Published in Nature Chemical Biology Support Clinical Development of RMC-5552, the Company’s First-in-Class, Phase 1/1b Bi-steric mTORC1-Selective Inhibitor Findings Published in Nature Chemical Biology Support Clinical Development of RMC-5552, the Company’s First-in-Class, Phase 1/1b Bi-steric mTORC1-Selective Inhibitor

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Revolution Medicines Announces Publication of Scientific Paper Describing Novel Class of Anti-Tumor Compounds Targeting mTORC1

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Ultrasonic Technology to Heal Diabetic Foot Ulcers Ultrasonic Technology to Heal Diabetic Foot Ulcers

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Bioventus Invests in Vaporox

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Avicanna Announces Results of Annual General Meeting and Provides Corporate Update

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Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

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Sanofi: Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with...

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Timeline Guidance for Both Programs Confirmed

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Oxurion NV to Focus Resources on Clinical Assets THR-687 and THR-149

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Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma

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Sanofi: Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell...

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Nicox’s Licensee Bausch + Lomb Receives Approval for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in the United Arab Emirates

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Sanofi: Availability of the Q2 2021 Memorandum for modelling purposes

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Cases of mucormycosis or "black fungus," a rare but serious fungal infection, are climbing in India among some coronavirus patients, per news reports.

Infections have risen to over 30,000 in three weeks, with at least 2,100 deaths, the New York Times reported, compounding the need to protect the country's population, a large percentage of which remain unvaccinated against COVID-19 ahead of a feared third wave this fall.

The infection is caused by a group of molds called mucormycetes which live throughout the environment and typically do not agitate otherwise healthy people, according to the Centers for Disease Control and Prevention (CDC).

However, in those who have health problems, or take medications that lower the bodys ability to fight off germs and sickness, it could infect the sinuses or lungs when inhaled through the air or on injured skin. Diabetes, cancer, organ transplants, stem cell transplants, low white blood cells, long-term corticosteroid use, injection drug use, too much iron, skin injury and premature or low birth weight are all considered to be risk factors.

INDIA'S CORONAVIRUS DOCTORS REPORT BLACK FUNGUS INFECTIONS AMONG SOME PATIENTS

Doctors in India suspect the countrys overwhelmed hospitals and shortage of medical oxygen left patients vulnerable to the fungal infection. Dr. Bela Prajapati, in charge of treatment for hundreds of mucormycosis patients, told the Times that doctors excessive use of steroids to fight inflammation in coronavirus patients, to help them breathe easier, in turn spiked blood sugar levels and left diabetes patients at risk of infection.

Researcher and microbiologist Dr. Arunaloke Chakrabarti noted many doctors didnt have time to question patients over underlying conditions before turning to the steroids.

"Doctors hardly had any time to do patient management," Chakrabarti told the newspaper. "They were all looking at how to take care of the respiratory tract."

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'Black fungus' infections on the rise in India: report - Yahoo News

Skin Stem Cells Comments Off on ‘Black fungus’ infections on the rise in India: report – Yahoo News | June 25th, 2021

Continued, heavy thunderstorms along the Gulf Coast will further flash flooding concerns left by the tropical storm. Accuweather

Planning a hike or a nature walk? You probably know to avoid poison ivy by its distinguishable three leaves on a single stem or stinging nettle by its tiny hair-like projections. But there may be one seemingly innocuous plant not on your radar, as one Facebook post claims.

"(It's) about that time of the year again and we are terrified of the kidscoming into contact with Wild Parsnip. Please, please be aware of how dangerous this plant really is!" claims the May 31, 2019, post,since shared over 142,000 times on the social media platform.

The poster says the yellow flowering plant, resembling an upturned umbrella in accompanying pictures, produces a sapthat reacts violently with skin after exposure to sunlight, causing blisters, burns and potentially blindness.

Large, fluid-filled blisters on the chest, hands and arms of an unidentified child, purportedly the poster's son, are included, emphasizing the need for awareness and caution.

Fact check: Brood X cicadas are infected with a sexually transmitted fungus

"I have heard about Wild Parsnip but never knew it was this bad. Poor little guy," commented one Facebook user.

"Oh my gosh, (I) had this in the field behind my house last year, wonder if it comes back every year," said another.

Wild parsnip, an invasive plant species from Europe and Asia likely brought by European settlers to North America for its edible root, is a widespread problem in Canada and in states like Ohio, New Yorkand Minnesota. USA TODAY cannot verify the images shared in the post, but its word of warning about the plant is indeed scientifically true.

Standing at almost 5-feet tall with a single, deeply ridged stem about 2- to 5-centimetersthick, wild parsnip is found throughout southern Canada and the northern U.S. All parts of the plant from the stems, leaves and flowers contain phytochemicals called psoralens, which kill skin cells by inserting themselves into our DNA.

Normally, our skin shields us from a type of radiation emitted by the sun called long-wave ultraviolet radiation, or LWUVR. But with psoralens essentially hijacking our genetic code, they boost the amount of LWUVR our skin absorbsand stop cellular growth.

This may sound bad, and does result in a condition called phytophotodermatitis characterized by angry-looking blisters and burn-like symptoms, but psoralens in combination with ultraviolet light therapy havebeen usedto safely treat skin diseases like psoriasis and vitiligo since the 1970s.

Fact check: Image of human-elephant hybrid is art, doesn't show real baby

Other conditions resulting from coming into contact with wild parsnipcan include blindness if the sap gets into your eyes.

The plant can also inflict injury in animals; livestock that eat it tend to lose weight and may have fertility issues.

Wild parsnip grows in a whole range of environments butis commonly foundalong roadsides, pastures, abandoned fields and any place where soil has been disturbed and native vegetation has yet to be established, according tothe New York Invasive Species Information Clearinghouse.

It's advised if you do come into contact with the yellow-flowered planttoget out of the sun as soon as possible or immediately cover the affected areas before washing with warm water and soap. While photosensitivity and discoloration typically last up to eight hours, these symptoms can linger for up to two years.

Based on our research, we rate TRUE the claim wild parsnip sap can cause skin blisters. A phytochemical secreted by wild parsnip, called psoralens, reacts when exposed to sunlight, affecting cell growth, which results in blisters, other burn-like symptoms and even blindness if the sap gets in the eyes.

Thank you for supporting our journalism. You can subscribe to our print edition, ad-free app or electronic newspaper replica here.

Our fact check work is supported in part by a grant from Facebook.

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Fact check: Contact with wild parsnip harmful to humans and animals - USA TODAY

Skin Stem Cells Comments Off on Fact check: Contact with wild parsnip harmful to humans and animals – USA TODAY | June 25th, 2021

Express News Service

Both internal and external factors cause the skin to age. As we age, collagen and other supportive tissues in the deeper layers of the skin decrease, causing the skin to lose its elasticity. Excessive sun exposure, air pollution, stress and chronic ill-health can hasten the process. Aesthetic and surgical treatments for men are now coming into prominence. Here are some:

Laser treatments: New technology is giving laser treatments an impetus, which are good to treat pigmentation and other skin problems. Carbon dioxide and erbium lasers are good options. Botulinum toxin and dermal filler injections: Fat is a very good, popular and natural filler. Botox is a protein that paralyses muscles and prevents them from contracting, thus smoothening fine lines and wrinkles.

Platelet Rich Plasma (PRP) therapy: This is a simple, quick and effective therapy that restores radiance. A small amount of blood is drawn from the patient, centrifuged (spun at fast speed) to separate the platelet-rich plasma and is then injected into the facial skin using a fine needle.

Autologous fat grafting: Fat is harvested from one part of the body, purified and injected into the facial area. With new techniques, the fat can be treated to extract fat stem cells, which have better rejuvenating and repairing potential. This technique is called Nano fat grafting and can be combined with micro-needling.

Thermage: Also known as the lunchtime facelift, it is a quick, non-invasive facial rejuvenation technique. A handpiece delivers radiofrequency heat energy into the collagen-containing layers of the skin, stimulating the collagen to renew and repair itself, and thus adding volume and improving the texture of the facial skin.

HIFU skin tightening: It is a new cosmetic treatment that is a non-invasive and painless replacement for facelifts. Surgical facelift: This is useful when the degree of sagging and wrinkles is unlikely to be corrected by non-surgical techniques. It is done under general anaesthesia.

The author is a SeniorConsultant and Cosmetic Surgeon, Apollo Hospital, New Delhi

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Mens Guide to Cosmetic Beauty - The New Indian Express

Skin Stem Cells Comments Off on Mens Guide to Cosmetic Beauty – The New Indian Express | June 25th, 2021

ABU DHABI, 22nd June, 2021 (WAM) -- The Ministry of Health and Prevention (MoHAP) and the Emirates Health Services (EHS) recently revealed innovative immunotherapy for cancer and viral infections in cooperation with Japans Kyoto University.

This came during the participation of the ministry and the EHS at the Arab Health 2021 which began in Dubai on 21st June and concludes on 24th June.

The treatment is based on the clinical application of the therapy using T cell preparation after it was discovered that such cells can fight cancer and viral infections. The T cell medicine will be produced using the iPS cell technology.

T Cell makes up a group of lymphocytes present in the blood and plays a major role in cellular immunity. It is possible to produce T cells in large numbers and store them in appropriate conditions to be administered to patients when needed.

Thus, by the success of this project, patients with cancer or viral infection may have great merit in which they can make very easy access to T cell therapy.

Strategic partnerships Dr. Youssef Mohamed Al Serkal, Director-General of the Emirates Health Services, spoke about the commitment of the ministry and the EHS to having strategic partnerships with the most prestigious medical research centres while keeping an eye on the sustainable investment in future healthcare services.

"Although the prevalence of cancer in the UAE is considered lower than in other parts of the world, we work hard to make a qualitative shift in cancer and viral infection healthcare," Al Serkal stated, adding, "This is part of our strategy to provide healthcare services in innovative and sustainable ways and implement the national strategy to reduce cancer mortality rates."

Al Serkal pointed out that the ministry and EHS support the National Cancer Control Programme and prepare a road map to achieve the target indicator. They also analyse the current status of cancer diseases and their diagnostic and therapeutic pathways, support research and studies on the control of cancer diseases and viral infections, and back workshops and educational and training activities. awareness campaigns, and innovative initiatives.

Dr. Kalthum Al Balushi, Director of Hospitals Department, said, "The ground-breaking treatment technology for cancer and viral infections, in cooperation with the Kyoto University, represents a paradigm shift in health services provided by the Ministry and the EHS."

The treatment is based on stimulating immune cells to fight cancer cells using pluripotent stem cells, which is a recent global trend that has begun to open great prospects for improving the quality of life of patients, Al Balushi added.

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MoHAP, EHS reveal immunotherapy for cancer, viral infections at Arab Health 2021 - WAM EN

IPS Cell Therapy Comments Off on MoHAP, EHS reveal immunotherapy for cancer, viral infections at Arab Health 2021 – WAM EN | June 25th, 2021

BOSTON--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the results of a Phase 3 clinical study of omidubicel have been published in Blood, the official journal of the American Society of Hematology. Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies.

The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery compared to a standard umbilical cord blood graft, and results in fewer early bacterial and viral infections and less time in the hospital.

We are pleased that the data from this well-conducted international Phase 3 trial have been published in Blood, the highly respected, peer-reviewed journal of the American Society of Hematology, said Ronit Simantov, M.D., chief medical officer of Gamida Cell. The robust results of this clinical trial have demonstrated that omidubicel could provide an important new option for patients with hematologic malignancies in need of a bone marrow transplant.

Data from this study were previously presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research, and most recently during the Presidential Symposium at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation. The pivotal study was an international, multi-center, randomized Phase 3 trial designed to compare the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant.

Previous studies have shown that engraftment with omidubicel is durable, with some patients in the Phase 1/2 study now a decade past their transplant. The Phase 3 data reinforce omidubicels potential to be a new standard of care for patients who are in need of stem cell transplantation but do not have access to an appropriate matched donor, said Mitchell Horwitz, M.D., lead author of the paper and a professor of medicine at the Duke Cancer Institute.

The full Blood manuscript is available here: https://ashpublications.org/blood/article/doi/10.1182/blood.2021011719/476235/Omidubicel-Versus-Standard-Myeloablative-Umbilical.

Details of Phase 3 Efficacy and Safety Results Shared in Blood

The intent-to-treat analysis included 125 patients aged 1365 years with a median age of 41. Forty-four percent of the patients treated on study were non-Caucasian, a population known to be underrepresented in adult bone marrow donor registries. Patient demographics and baseline characteristics were well-balanced across the two study groups. Patients with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America.

Gamida Cell previously reported in May 2020 that the study achieved its primary endpoint, showing that omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment, a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells and a key milestone in a patients recovery from a bone marrow transplant. The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001).

All three secondary endpoints, details of which were first reported in December 2020, demonstrated a statistically significant improvement among patients who were randomized to omidubicel compared to patients randomized to standard cord blood graft. Platelet engraftment was significantly accelerated with omidubicel, with 55 percent of patients randomized to omidubicel achieving platelet engraftment at day 42, compared to 35 percent for the comparator (p = 0.028). Hospitalization in the first 100 days after transplant was also reduced in patients randomized to omidubicel, with a median number of days alive and out of hospital for patients randomized to omidubicel of 61 days, compared to 48 days for the comparator (p=0.005). The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p=0.027). Additional data reported in the manuscript included a comparison of infection density, or the number of infections during the first year following transplantation, which showed that the risk for grade 2 and grade 3 infections was significantly lower among recipients of omidubicel compared to control (risk ratio 0.5, p<0.001).

Data from the study relating to exploratory endpoints also support the clinical benefit demonstrated by the studys primary and secondary endpoints. There was no statistically significant difference between the two patient groups in incidence of grade 3/4 acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Non-relapse mortality was shown to be 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09).

These clinical data results form the basis of a Biologics License Application (BLA) that Gamida Cell plans to submit to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplants for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit http://www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potential for omidubicel to become a new standard of care and the anticipated submission of a BLA for omidubicel, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to Gamida Cells ability to prepare regulatory filings and the review process therefor; complications in Gamida Cells plans to manufacture its products for commercial distribution; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended on March 22, 2021, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

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Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to Evaluate a Cell Therapy...

Bone Marrow Stem Cells Comments Off on Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to Evaluate a Cell Therapy… | June 25th, 2021

Imagine being able to reverse blindness, cure multiple sclerosis (MS), or rebuild your heart muscles after a heart attack. For the past few decades, research into stem cells, the building blocks of tissues and organs, has raised the prospect of medical advances of this kind yet it has produced relatively few approved treatments. But that could be about to change, says Robin Ali, professor of human molecular genetics of Kings College London. Just as gene therapy went from being a fantasy with little practical value to becoming a major area of treatment, stem cells are within a few years of reaching the medical mainstream. Whats more, developments in synthetic biology, the process of engineering and re-engineering cells, could make stem cells even more effective.

Stem cells are essentially the bodys raw material: basic cells from which all other cells with particular functions are generated. They are found in various organs and tissues, including the brain, blood, bone marrow and skin. The primary promise of adult stem cells lies in regenerative medicine, says Professor Ali.

Stem cells go through several rounds of division in order to produce specialist cells; a blood stem cell can be used to produce blood cells and skin stem cells can be used to produce skin cells. So in theory you can take adult stem cells from one person and transplant them into another person in order to promote the growth of new cells and tissue.

In practice, however, things have proved more complicated, since the number of stem cells in a persons body is relatively limited and they are hard to access. Scientists were also previously restricted by the fact that adult stem cells could only produce one specific type of cell (so blood stem cells couldnt produce skin cells, for instance).

In their quest for a universal stem cell, some scientists initially focused on stem cells from human embryos, but that remains a controversial method, not only because harvesting stem cells involves destroying the embryo, but also because there is a much higher risk of rejection of embryonic stem cells by the recipients immune system.

The good news is that in 2006 Japanese scientist Shinya Yamanaka of Kyoto University and his team discovered a technique for creating what they call induced pluripotent stem cells (iPSC). The research, for which they won a Nobel Prize in 2012, showed that you can rewind adult stem cells development process so that they became embryo-like stem cells. These cells can then be repurposed into any type of stem cells. So you could turn skin stem cells into iPSCs, which could in turn be turned into blood stem cells.

This major breakthrough has two main benefits. Firstly, because iPSCs are derived from adults, they dont come with the ethical problems associated with embryonic stem cells. Whats more, the risk of the body rejecting the cells is much lower as they come from another adult or are produced by the patient. In recent years scientists have refined this technique to the extent that we now have a recipe for making all types of cells, as well as a growing ability to multiply the number of stem cells, says Professor Ali.

Having the blueprint for manufacturing stem cells isnt quite enough on its own and several barriers remain, admits Professor Ali. For example, we still need to be able to manufacture large numbers of stem cells at a reasonable cost. Ensuring that the stem cells, once they are in the recipient, carry out their function of making new cells and tissue remains a work in progress. Finally, regulators are currently taking a hard line towards the technology, insisting on exhaustive testing and slowing research down.

The good news, Professor Ali believes, is that all these problems are not insurmountable as scientists get better at re-engineering adult cells (a process known as synthetic biology). The costs of manufacturing large numbers of stem cells are falling and this can only speed up as more companies invest in the area. There are also a finite number of different human antigens (the parts of the immune system that lead a body to reject a cell), so it should be possible to produce a bank of iPSC cells for the most popular antigen types.

While the attitude of regulators is harder to predict, Professor Ali is confident that it needs only one major breakthrough for the entire sector to secure a large amount of research from the top drug and biotech firms. Indeed, he believes that effective applications are likely in the next few years in areas where there are already established transplant procedures, such as blood transfusion, cartilage and corneas. The breakthrough may come in ophthalmology (the treatment of eye disorders) as you only need to stimulate the development of a relatively small number of cells to restore someones eyesight.

In addition to helping the body repair its own tissues and organs by creating new cells, adult stem cells can also indirectly aid regeneration by delivering other molecules and proteins to parts of the body where they are needed, says Ralph Kern, president and chief medical officer of biotechnology company BrainStorm Cell Therapeutics.

For example, BrainStorm has developed NurOwn, a cellular technology using peoples own cells to deliver neurotrophic factors (NTFs), proteins that can promote the repair of tissue in the nervous system. NurOwn works by modifying so-called Mesenchymal stem cells (MSCs) from a persons bone marrow. The re-transplanted mesenchymal stem cells can then deliver higher quantities of NTFs and other repair molecules.

At present BrainStorm is using its stem-cell therapy to focus on diseases of the brain and nervous system, such as amyotrophic lateral sclerosis (ALS, also known as Lou Gehrigs disease), MS and Huntingtons disease. The data from a recent final-stage trial suggests that the treatment may be able to halt the progression of ALS in those who have the early stage of the disease. Phase-two trial (the second of three stages of clinical trials) of the technique in MS patients also showed that those who underwent the treatment experienced an improvement in the functioning of their body.

Kern notes that MSCs are a particularly promising area of research. They are considered relatively safe, with few side effects, and can be frozen, which improves efficiency and drastically cuts down the amount of bone marrow that needs to be extracted from each patient.

Because the manufacture of MSC cells has become so efficient, NurOwn can be used to get years of therapy in one blood draw. Whats more, the cells can be reintroduced into patients bodies via a simple lumbar puncture into the spine, which can be done as an outpatient procedure, with no need for an overnight stay in hospital.

Kern emphasises that the rapid progress in our ability to modify cells is opening up new opportunities for using stem cells as a molecular delivery platform. Through taking advantage of the latest advances in the science of cellular therapies, BrainStorm is developing a technique to vary the molecules that its stem cells deliver so they can be more closely targeted to the particular condition being treated. BrainStorm is also trying to use smaller fragments of the modified cells, known as exosomes, in the hope that these can be more easily delivered and absorbed by the body and further improve its ability to avoid immune-system reactions to unrelated donors. One of BrainStorms most interesting projects is to use exosomes to repair the long-term lung damage from Covid-19, a particular problem for those with long Covid-19. Early preclinical trials show that modified exosomes delivered into the lungs of animals led to remarkable improvements in their condition. This included increasing the lungs oxygen capacity, reducing inflammation, and decreasing clotting.

Overall, while Kern admits that you cant say that stem cells are a cure for every condition, there is a lot of evidence that in many specific cases they have the potential to be the best option, with fewer side effects. With Americas Food and Drug Administration recently deciding to approve Biogens Alzheimers drug, Kern thinks that they have become much more open to approving products in diseases that are currently considered untreatable. As a result, he thinks that a significant number of adult stem-cell treatments will be approved within the next five to ten years.

Adult stem cells and synthetic biology arent just useful in treatments, says Dr Mark Kotter, CEO and founder of Bit Bio, a company spun out of Cambridge University. They are also set to revolutionise drug discovery. At present, companies start out by testing large numbers of different drug combinations in animals, before finding one that seems to be most effective. They then start a process of clinical trials with humans to test whether the drug is safe, followed by an analysis to see whether it has any effects.

Not only is this process extremely lengthy, but it is also inefficient, because human and animal biology, while similar in many respects, can differ greatly for many conditions. Many drugs that seem promising in animals end up being rejected when they are used on humans. This leads to a high failure rate. Indeed, when you take the failures into account, it has been estimated that it may cost as much to around $2bn to develop the typical drug.

As a result, pharma companies are now realising that you have to insert the human element at a pre-clinical stage by at least using human tissues, says Kotter. The problem is that until recently such tissues were scarce, since they were only available from biopsies or surgery. However, by using synthetic biology to transform adult stem cells from the skin or other parts of the body into other types of stem cells, researchers can potentially grow their own cells, or even whole tissues, in the laboratory, allowing them to integrate the human element at a much earlier stage.

Kotter has direct experience of this himself. He originally spent several decades studying the brain. However, because he had to rely on animal tissue for much of his research he became frustrated that he was turning into a rat doctor.

And when it came to the brain, the differences between human and rat biology were particularly stark. In fact, some human conditions, such as Alzheimers, dont even naturally appear in rodents, so researchers typically use mice and rats engineered to develop something that looks like Alzheimers. But even this isnt a completely accurate representation of what happens in humans.

As a result of his frustration, Kotter sought a way to create human tissues. It initially took six months. However, his company, Bit Bio, managed to cut costs and greatly accelerate the process. The companys technology now allows it to grow tissues in the laboratory in a matter of days, on an industrial scale. Whats more, the tissues can also be designed not just for particular conditions, such as dementia and Huntingdons disease, but also for particular sub-types of diseases.

Kotter and Bit Bio are currently working with Charles River Laboratories, a global company that has been involved in around 80% of drugs approved by the US Food and Drug Administration over the last three years, to commercialise this product. They have already attracted interest from some of the ten largest drug companies in the world, who believe that it will not only reduce the chances of failure, but also speed up development. Early estimates suggest that the process could double the chance of a successful trial, effectively cutting the cost of each approved drug by around 50% from $2bn to just $1bn. This in turn could increase the number of successful drugs on the market.

Two years ago my colleague Dr Mike Tubbs tipped Fate Therapeutics (Nasdaq: FATE). Since then, the share price has soared by 280%, thanks to growing interest from other drug companies (such as Janssen Biotech and ONO Pharmaceutical) in its cancer treatments involving genetically modified iPSCs.

Fate has no fewer than seven iPSC-derived treatments undergoing trials, with several more in the pre-clinical stage. While it is still losing money, it has over $790m cash on hand, which should be more than enough to support it while it develops its drugs.

As mentioned in the main story, the American-Israeli biotechnology company BrainStorm Cell Therapeutics (Nasdaq: BCLI) is developing treatments that aim to use stem cells as a delivery mechanism for proteins. While the phase-three trial (the final stage of clinical trials) of its proprietary NurOwn system for treatment of Amyotrophic lateral sclerosis (ALS, or Lou Gehrigs disease) did not fully succeed, promising results for those in the early stages of the disease mean that the company is thinking about running a new trial aimed at those patients. It also has an ongoing phase-two trial for those with MS, a phase-one trial in Alzheimers patients, as well as various preclinical programmes aimed at Parkinsons, Huntingtons, autistic spectrum disorder and peripheral nerve injury. Like Fate Therapeutics, BrainStorm is currently unprofitable.

Australian biotechnology company Mesoblast (Nasdaq: MESO) takes mesenchymal stem cells from the patient and modifies them so that they can absorb proteins that promote tissue repair and regeneration. At present Mesoblast is working with larger drug and biotech companies, including Novartis, to develop this technique for conditions ranging from heart disease to Covid-19. Several of these projects are close to being completed.

While the US Food and Drug Administration (FDA) controversially rejected Mesoblasts treatment remestemcel-L for use in children who have suffered from reactions to bone-marrow transplants against the advice of the Food and Drug Administrations own advisory committee the firm is confident that the FDA will eventually change its mind.

One stem-cell company that has already reached profitability is Vericel (Nasdaq: VCEL). Vericels flagship MACI products use adult stem cells taken from the patient to grow replacement cartilage, which can then be re-transplanted into the patient, speeding up their recovery from knee injuries. It has also developed a skin replacement based on skin stem cells.

While earnings remain relatively small, Vericel expects profitability to soar fivefold over the next year alone as the company starts to benefit from economies of scale and runs further trials to expand the range of patients who can benefit.

British micro-cap biotech ReNeuron (Aim: RENE) is developing adult stem-cell treatments for several conditions. It is currently carrying out clinical trials for patients with retinal degeneration and those recovering from the effects of having a stroke. ReNeuron has also developed its own induced pluripotent stem cell (iPSC) platform for research purposes and is seeking collaborations with other drug and biotech companies.

Like other small biotech firms in this area, it is not making any money, so it is an extremely risky investment although the rewards could be huge if any of its treatments show positive results from their clinical trials.

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Investing in stem cells, the building blocks of the body - MoneyWeek

Bone Marrow Stem Cells Comments Off on Investing in stem cells, the building blocks of the body – MoneyWeek | June 25th, 2021

FRIDAY, June 18, 2021 (HealthDay News) -- It's been more than six months since Brandy Compton last landed in a hospital emergency room.

That's an amazing medical achievement, brought about by scientific breakthroughs that have been unfortunately overshadowed by the coronavirus pandemic, experts say.

Compton, 31, was born with sickle cell disease, a genetic condition that primarily affects people of African descent.

The disease causes episodes of pain so bad that in the past, Compton had to be hospitalized frequently for full blood transfusions.

"In grade school, I was in the hospital for a week, I'd get out of the hospital for maybe a good week and a half, two weeks, and then I'd be back in the hospital for another week," recalls Compton, who lives in Hartford, Conn. "It was constant."

But last year Compton started on a once-monthly IV drug called Adakveo (crizanlizumab), one of a handful of new sickle cell drugs approved by the U.S. Food and Drug Administration just before the pandemic hit.

The drug has cut in half the amount of blood Compton requires during a transfusion, and has prevented the sort of pain crisis that would send her to an ER, she said.

As the pandemic subsides, sickle cell disease experts are now trying to spread the word about these handful of treatments that could improve and potentially extend the lives of patients.

"In the last three years or so, three new medicines got approved by the FDA with different ways of working that could actually be used together and give more preventive, disease-modifying types of approaches rather than just waiting for the bad complications to occur," said Dr. Lewis Hsu, chief medical officer of the Sickle Cell Disease Association of America.

Progress also is being made on cures that would fix the genetic error that causes sickle cell, either through a donor bone marrow transplant or gene therapy that would fix the patient's own stem cells, Hsu added.

'Jagged rocks shredding your veins'

Sickle cell disease affects the shape of a person's red blood cells, which are normally disc-shaped and flexible enough to move easily through blood vessels.

The red blood cells of a person with sickle cell are crescent-shaped, resembling a sickle. The cells are stiff and sticky, and cause pain episodes and other health problems when they clump together in different parts of the body. They also are less capable of carrying oxygen to a person's tissues, causing chronic fatigue.

"Sickle cell feels like jagged rocks shredding the inside of your veins, and your bones being crushed," Compton says.

Sickle cell disproportionately affects Black people in the United States. About 1 in 13 Black babies is born with the genetic trait for sickle cell, and about 1 in every 365 Black babies is born with sickle cell disease, according to the U.S. National Institutes of Health.

For a long time, there was no treatment at all for sickle cell, Hsu said, outside of regular blood transfusions.

"At the age of 13, I started getting blood transfusions," Compton recalls. "After that, it started getting under control. I would be able to go about a month without having to be hospitalized. That time got longer as I got older."

In 1998, the FDA approved hydroxyurea, an oral medicine that can reduce or prevent sickle cell complications in people with specific subtypes of the disease. But following that, there was a "long gap" in new treatments, Hsu said.

That ended in 2017 with the approval of L-glutamine powder, sold under the brand name Endari. Patients sprinkle a packet of this purified amino acid powder on their food or drink twice a day, Hsu said.

"Particularly, it help the red cells be healthier and have better energy stores," Hsu said.

But the two real breakthroughs occurred in November 2019, on the cusp of the pandemic, with FDA approval of two new drugs -- Adaveko and Oxbryta (voxelotor).

Adaveko essentially creates an "oil slick" in the bloodstream that keeps sickled red blood cells from clumping, explained Genice Nelson, program director of the New England Sickle Cell Institute at the University of Connecticut. She also leads Compton's care.

"It helps to improve blood flow by having the cells move along better, gliding instead of sticking to each other," Hsu said.

Showing promise at a high price

Thanks to Adaveko, Compton now only needs four units of blood every four weeks, down from seven, and does not suffer frequent pain episodes.

The other drug, Oxbryta, improves the ability of deformed red blood cells to hold onto oxygen, Nelson said.

"It inhibits the deformation of the red blood cell, so it's able to hold onto oxygen," Nelson said. "Because the red blood cell is able to hold onto oxygen, it's able to give that oxygen to the tissues within the body."

Because these drugs act in different ways, the hope is that a sickle cell patient taking two or more would receive added benefits, Hsu said.

Unfortunately, the new drugs are expensive and insurance companies have balked at paying for them, Hsu said.

For example, Adakveo costs about $10,000 a month for a patient, Nelson said. It seems like a great expense, but is likely cheaper than regular ER visits.

"If someone is in the hospital several days out of the month every month, dollar for dollar you'd rather invest it in preventing them from being in the hospital rather than trying to treat them once they're in the hospital," Nelson said.

Despite this, insurance companies have dragged their feet accepting the new drugs.

"We have great, great difficulty prescribing them and getting them authorized," Hsu said. "It's a case-by-case issue for every single prescription. It takes two months or so to get the authorizations, and then we go for refills or another prescription and they have to go through the same process again."

Experts hope that the track record of these drugs will lead insurance companies to relent.

"The data is clear there is benefit to patients being on disease-modifying therapies," said Dr. Alexis Thompson, head of hematology for the Ann & Robert Lurie Children's Hospital in Chicago. "The natural history of sickle cell disease is devastating. To not think about where the opportunities are to intervene early, to modify the natural history of the disease and really reduce suffering, is something we all need to be committed to."

Great progress also has been made in cures for sickle cell, Hsu added.

Transplants tricky, but improvements underway

For a long time, the only potential cure was a full bone marrow transplant from a genetically matched donor, usually a sibling, Hsu said. Only children could handle the stress of this cure, because their existing bone marrow had to be killed off through chemotherapy prior to the transplant.

But improved medications that inhibit immune system rejection now have made transplants also available to children who have a half-matched relative. These drugs selectively inhibit immune attack cells without harming the healthy stem cells being transplanted, Hsu said.

Over the past decade, even adult sickle cell patients have been receiving transplants, through a method that replaces most but not all of the person's bone marrow.

"This is a mixture that's enough to allow the donor to supply most of the red cells that are floating around, so they're not sickle red cells, and the tiny portion of host red cells are diluted heavily," Hsu said. "This has found to be successful and stable."

Five to seven research groups also are working on what could be the ultimate cure for sickle cell, a gene therapy that would take the person's own bone marrow and fix it to remove the genetic anomaly that causes the disease.

"You'd no longer have to find a donor for the stem cells," Hsu said. "You basically do your own donation of stem cells."

Research efforts are focused on fixing the stem cells by treating them with a genetically modified virus, or by using newly discovered methods of gene editing, Hsu said. In both cases, the person's bone marrow is removed, treated in a lab, and then put back inside them.

These efforts have met with some hurdles, with the gene therapy causing leukemia in something like 2 of every 47 cases in some instances, Hsu said.

"We do need to keep working on ways to limit the side effects or toxicity of those approaches, but one cannot argue that the early data is quite remarkable," Thompson said.

Compton, now the mother of a healthy 9-year-old boy, is hopeful that these efforts will lead to a cure, even though she doesn't expect to benefit from one at her age.

"I know about gene therapy and things like that," Compton said. "I do hope there would be a cure available."

More information

The Mayo Clinic has more about sickle cell disease.

SOURCES: Brandy Compton, Hartford, Conn.; Lewis Hsu, MD, PhD, chief medical officer, Sickle Cell Disease Association of America; Alexis Thompson, MD, MPH, head, hematology, Ann & Robert Lurie Children's Hospital, Chicago; Genice Nelson, DNP, program director, New England Sickle Cell Institute, University of Connecticut, Farmington

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Sickle Cell Plagues Many Black Americans, But There's Hope for Better Treatments - HealthDay News

Bone Marrow Stem Cells Comments Off on Sickle Cell Plagues Many Black Americans, But There’s Hope for Better Treatments – HealthDay News | June 25th, 2021

REDWOOD CITY, Calif. and NEW YORK and BASEL, Switzerland, June 21, 2021 /PRNewswire/ --Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, andAruvant Sciences, a private company focused on developing gene therapies for rare diseases, today announced that they have entered a non-exclusive research collaboration to evaluate the use of JSP191, Jasper's anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning agent with ARU-1801, Aruvant's investigational lentiviral gene therapy for sickle cell disease (SCD). The objective of the collaboration is to evaluate the use of JSP191 as an effective and more tolerable conditioning agent that can expand the number of patients who can receive ARU-1801, a potentially curative treatment for SCD.

"This research collaboration with Aruvant is the first to use a clinical-stage antibody-based conditioning agent and a novel clinical-stage gene therapy, giving this combination a clear advantage by moving beyond the harsh conditioning agents currently used for gene therapy and establishing this next-generation potentially curative treatment as a leader in sickle cell disease," said Kevin N. Heller, M.D., executive vice president, research and development of Jasper. "Our goal is to establish JSP191 as a potential new standard of care conditioning agent, broadly in autologous gene therapy and allogeneic hematopoietic stem cell transplantation."

Gene therapies and gene editing technologies generally require that a patient's own hematopoietic stem cells first be depleted from the bone marrow to facilitate the engraftment of the new, gene-modified stem cells through a process called conditioning. Other investigational gene therapies and gene editing approaches in SCD use a high-dose chemotherapy such as busulfan for the conditioning regimen, which can place patients at prolonged risk for infection and bleeding, secondary malignancy and infertility. ARU-1801 is currently the only gene therapy that has demonstrated durable efficacy using both a lower dose of chemotherapy and a different agent than busulfan with a more limited side effect profile. The Aruvant-Jasper partnership is focused on evaluating the potential of using JSP191, a highly targeted anti-CD117 (stem cell factor receptor) monoclonal antibody agent, as the foundationof a novel conditioning regimen for use in combination with ARU-1801 to further reduce the negative side effects while maintaining efficacy.

"The unique attributes of ARU-1801 enable us to bring a potentially curative one-time therapy to individuals with sickle cell disease that can be delivered in the safest way possible," said Will Chou, M.D., Aruvant chief executive officer. "By partnering with Jasper to evaluate the use of JSP191 with ARU-1801, we are one step closer to developing a next-generation definitive therapy with an even more patient-friendly conditioning regimen. We believe that this combination may be able to further expand the number of patients who can benefit from ARU-1801 in the future, including potentially those with more moderate disease."

About JSP191 JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. While hematopoietic cell transplantation can be curative for patients, its use is limited because standard high dose myeloablative conditioning is associated with severe toxicities and standard low dose conditioning has limited efficacy. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. It is currently enrolling in two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) and expects to begin enrollment in four additional studies in 2021 for severe autoimmune disease, sickle cell disease, chronic granulomatous disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.

About ARU-1801 ARU-1801 is designed to address the limitations of current curative treatment options, such as low donor availability and the risk of graft-versus-host disease (GvHD) seen with allogeneic stem cell transplants. Unlike investigational gene therapies and gene editing approaches which require fully myeloablative conditioning, the unique characteristics of ARU-1801 allow it to be given with reduced intensity conditioning ("RIC"). Compared to myeloablative approaches, the lower dose chemotherapy regimen underlying RIC has the potential to reduce not only hospital length of stay, but also the risk of short- and long-term adverse events such as infection and infertility. Preliminary clinical data from the MOMENTUMstudy, an ongoing Phase 1/2 trial of ARU-1801 in patients with severe sickle cell disease, demonstrate continuing durable reductions in disease burden.

The MOMENTUM Study Aruvant is conducting the MOMENTUM study, which is evaluating ARU-1801, a one-time potentially curative investigational gene therapy for patients with SCD. This Phase 1/2 study is currently enrolling participants, and information may be found at momentumtrials.comwhich includes a patient brochure, an eligibility questionnaireand information for healthcare providers.

About Jasper Therapeutics Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, a first-in-class anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic and autologous hematopoietic cell transplants and gene therapies. In parallel, Jasper Therapeutics is advancing its preclinical engineered hematopoietic stem cell (eHSC) platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

About Aruvant Sciences Aruvant Sciences, part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talented team with extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an active research program with a lead product candidate, ARU-1801, in development for individuals suffering from sickle cell disease (SCD). ARU-1801, an investigational lentiviral gene therapy, is being studied in a Phase 1/2 clinical trial, the MOMENTUM study, as a one-time potentially curative treatment for SCD. Preliminary clinical data demonstrate engraftment of ARU-1801 and amelioration of SCD is possible with one dose of reduced intensity chemotherapy. The company's second product candidate, ARU-2801, is in development to cure hypophosphatasia, a devastating, ultra-orphan disorder that affects multiple organ systems and leads to high mortality when not treated. Data from pre-clinical studies with ARU-2801 shows durable improvement in disease biomarkers and increased survival. For more information on the ongoing ARU-1801 clinical study, please visit http://www.momentumtrials.comand for more on the company, please visit http://www.aruvant.com. Follow Aruvant on Facebook, Twitter @AruvantSciencesand on Instagram @Aruvant_Sciences.

About Roivant Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants nimble and focused biopharmaceutical and health technology companies. For more information, please visit http://www.roivant.com.

SOURCE Aruvant Sciences andJasper Therapeutics

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Jasper Therapeutics and Aruvant Announce Research Collaboration to Study JSP191, an Antibody-Based Conditioning Agent, with ARU-1801, a Novel Gene...

Bone Marrow Stem Cells Comments Off on Jasper Therapeutics and Aruvant Announce Research Collaboration to Study JSP191, an Antibody-Based Conditioning Agent, with ARU-1801, a Novel Gene… | June 25th, 2021

Heart muscle regeneration researchers (left to right) Naoto Muraoka, Elaheh Karbassi, and Chuck Murry. (University of Washington Photo)

Human stem cell scientists have long dreamed of repairing damaged hearts, but have been stymied by researchshowing that the cells yield irregular heartbeats in laboratory animals. A new genetic engineering approach overcomes this barrier, according to a report at the annual meeting of the International Society for Stem Cell Research by scientists at the University of Washington and Sana Biotechnology, a Seattle-based company.

A heart attack typically kills about one billion cells, said Charles Murry, director of the Institute for Stem Cell and Regenerative Medicine at the UW, who presented the data Monday. Such massive cell death can lead to downstream effects such as heart failure, an often-debilitating condition that affects about 6.2 million people in the U.S. Using stem cells to repair the damage after a heart attack has long been a goal in his lab.

One major challenge in the field is that implanting cells into the hearts of laboratory animals can nudge the whole heart into beating rapidly, a condition called engraftment arrhythmia, said Murry, who is also a senior vice president and head of cardiometabolic cell therapy at Sana, which went public earlier this year.

This engraftment arrhythmia, where the heart races too quickly, has been one of the major hurdles weve been trying to overcome en route to clinical trials, said Murry in a press release.

In their study, Murry and his colleagues quelled engraftment arrhythmia using a genetic engineering strategy in cells implanted into pig hearts. Their next step is to see if the cells can repair heart damage in macaques if those studies work, the researchers will initiate clinical trials in people, he said.

To quell the arrhythmia, Murry and his colleagues turned to CRISPR, the Nobel Prize-winning technique to knock out genes. They knocked out three genes in stem cells encoding different ion channels, molecules embedded in the cell membrane that mediate impulses that propagate heart beats. They also added DNA for another ion channel, KCNJ2, which mediates the movement of potassium across the membrane, Its a chill out channel, Murry told GeekWire, It tells the heart cell not to be so excitable.

The engineered stem cells, derived from human embryonic stem cells, were coaxed in a petri dish to produce heart muscle cells, which were then implanted into pigs via open heart surgery or a catheter. The result was an even heartbeat the genetically altered cells did not cause engraftment arrhythmia.

The researchers landed on this strategy after years of effort, assessing which channels were present in the cells during arrhythmia, and knocking out multiple types of channels until they hit the right combination.

In their next set of experiments in macaques, We want to make sure these cells are still effective, said Murry, They look good beating in culture, so I think they are going to be OK. Moving forward, the researchers will also use induced human pluripotent stem cells, obtainable from adults and more amenable longer-term for clinical use.

In another recent study, published in Cell Systems, scientists at the Allen Institute for Cell Science took a close look at cardiac muscle cells derived from stem cells. They found that they could classify the state of the cells, such as how mature they were, by assessing both cell structure and which genes were turned on.

This paints a broader picture of our cells. If someone wants to really understand and characterize a cells state, we found that having both of these types of information can be complementary, said Kaytlyn Gerbin, a scientist at the Allen Institute for Cell Science in a statement. The findings provide a fine-tooth analysis of cell state, which may guide future experiments on cardiac muscle and other cell types.

Murrys research was conducted primarily at the UW, with financial support from Sana. In addition to its cardiac program, Sana has cell and gene therapy programs in diabetes, blood disorders, immunotherapy and other areas.

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Univ. of Washington and Sana researchers use gene editing to prep stem cells for heart repair - GeekWire

Cardiac Stem Cells Comments Off on Univ. of Washington and Sana researchers use gene editing to prep stem cells for heart repair – GeekWire | June 25th, 2021

This Autologous Stem Cell Based Therapies market report provides vital info on survey data and the present market place situation of each sector. The purview of this Autologous Stem Cell Based Therapies market report is also expected to involve detailed pricing, profits, main market players, and trading price for a specific business district, along with the market constraints. This anticipated market research will benefit enterprises in making better judgments.

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Key global participants in the Autologous Stem Cell Based Therapies market include:Med cell Europe US STEM CELL, INC. Tigenix Mesoblast Pluristem Therapeutics Inc Brainstorm Cell Therapeutics Regeneus

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Segmentation on the Basis of Application:Neurodegenerative Disorders Autoimmune Diseases Cardiovascular Diseases

Market Segments by TypeEmbryonic Stem Cell Resident Cardiac Stem Cells Umbilical Cord Blood Stem Cells

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Autologous Stem Cell Based Therapies Market2 Market Trends and Competitive Landscape3 Segmentation of Autologous Stem Cell Based Therapies Market by Types4 Segmentation of Autologous Stem Cell Based Therapies Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Autologous Stem Cell Based Therapies Market in Major Countries7 North America Autologous Stem Cell Based Therapies Landscape Analysis8 Europe Autologous Stem Cell Based Therapies Landscape Analysis9 Asia Pacific Autologous Stem Cell Based Therapies Landscape Analysis10 Latin America, Middle East & Africa Autologous Stem Cell Based Therapies Landscape Analysis 11 Major Players Profile

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Autologous Stem Cell Based Therapies Market to Eyewitness Huge Growth by 2027 with Covid-19 Impact The Manomet Current - The Manomet Current

Cardiac Stem Cells Comments Off on Autologous Stem Cell Based Therapies Market to Eyewitness Huge Growth by 2027 with Covid-19 Impact The Manomet Current – The Manomet Current | June 25th, 2021

Its not the fountain of youth, but a fast-emerging class of drugs could bring us closer to achieving the age-old quest for longer life, better health, and greater vitality.

The drugs, called senolytics, carry out search-and-destroy missions against senescent cells, which are linked to aging. Early in life, senescent cells support crucial functions such as embryonic tissue development and later wound repair. They also send signals that cause women to go into labor and initiate live birth.

But senescent cells stop dividing over timethat is how they function. They accumulate in the body and release harmful molecules that contribute to arthritis, osteoporosis, glaucoma, Parkinsons disease, Alzheimers disease, and many other age-related conditions and afflictions. They were recently shown to be a major mediator of fatalities in coronavirus-infected mice, possibly explaining the increased susceptibility of older people to COVID-19.

To find out more about senolytics and their potential to prolong both the quality and length of life, Tufts Now talked with Christopher Wiley, a researcher on the Basic Biology of Aging Team at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts.

Tufts Now: What is cellular agingor senescenceand how does it contribute to aging?

Chris Wiley: Senescent cells are those that have been dividing, but stop doing so and go into permanent lockdown. If the cells are stem cells or other forms of progenitor cells, they are not able to contribute in a meaningful, positive way to that tissue ever again. If you have too many of these cells, you can easily imagine a situation in which your body is unable to regenerate after illness or injury.

The more problematic part of senescence is that these cells dont just sit there after their positive contributions are over. Instead, they release a blend of factors called the senescence-associated secretory phenotype, or SASP. This is a combination of molecules that can cause disease by promoting inflammation and disrupting the environment around the cell.

Senescent cells show up in virtually every vertebrate, from fish to humans. If you live long enough, they appear in nearly every tissue in the body. We cant keep up with the number of diseases that they seem to drive. Its almost as if theres a new one discovered every other month.

Can you provide some examples of senolytics?

One of the first that was discovered is fisetin, a flavonoid found in strawberries, apples, onions, and cucumbers. Flavonoids are compounds, often found in plants, that have many properties. For example, vitamin B2, or riboflavin, is a well-known dietary flavonoid.

Fisetin is one of the most prolific senolytics tested on mice so far, and has even entered clinical trials in humans. But this is not something where you eat a couple of strawberries every day and get a dose that would kill senescent cells. Youd have to consume an extremely large number, which no one should try. It is currently being sold to the public as a dietary supplement.

Another senolytic, quercetin, is the most abundant flavonoid in food. It is found in green tea, coffee, various berries, apples, onions, broccoli, grapes, citrus fruits, and red wine. Like fisetin, it is available as a dietary supplement.

What have studies shown about the effects of senolytics?

Studies in mice suggest that by destroying senescent cells, senolytics extended life by as much as 27 percent, which is pretty considerable. I want to be careful about extrapolating, but for illustrative purposes, life expectancy in the US before COVID was almost 79 years. If the mouse results were to apply in humans, that would boost life expectancy to 100 years.

Its not just that the mice lived longer, since if they were unhealthy, that wouldnt be good. Encouragingly, results from senolytic studies include better cardiac function, less dementia, fewer cataracts, and reduced muscle loss.

Early studies with human volunteers, which are designed to first test for safety, offer grounds for optimism. In one three-week trial, 14 patients with pulmonary fibrosis walked further, faster, and rose more quickly from their chairs after receiving a handful of doses of senolytics. I want to be cautious and note that there was not a control group for this early-stage study, the participants took additional medications, and many aspects of the disease did not improve.

The field is undergoing explosive growth, with as many as 100 companies exploring senolytics. Academic researchers are just as active. For example, theres a clinical trial for senolytics with diabetic kidney disease and another for addressing frailty. There are many others. The FDA process emphasizes drugs for specific diseases, so researchers are testing senolytics for individual conditions, even if they might have broader implications for aging.

I presume we shouldnt leap to the conclusion that these are miracle drugs. What caution would you offer about their efficacy and possible side effects?

Senolytics are only now being tested on humans, and while their effect on mice is often dramatic, we know that results from mice dont always translate to humans. Were also at the earliest stages of understanding efficacy, which will likely take years. There are at least 20 clinical trials taking place right now.

To date, side effects of senolytics have been things such as cough, shortness of breath, and gastrointestinal discomfort or heartburn. As we develop new senolytics, we should be able to improve both the efficiency of senescent cell elimination and the incidence of side effects.

Should people be taking these supplements based on these early findings?

Im a researcher, not a health-care provider, and people should consult their health-care provider before taking supplements.

Heres what I think: People should not look at early positive test results from studies in mice and start taking senolytic supplements. First, supplements are poorly regulated. At the basic level, there is no guarantee that youre going to get what it says on the bottle.

Second, you dont know what else has been added to the supplement.

Third, even if something works in mice, it is far from certain that it will work in humans.

Fourth, taking supplements may be harmful in some cases. If you take a senolytic supplement and have surgery, or a wound, senolytics could weaken the capacity of the body to respond properly.

And in light of the importance of senescent cells in embryo formulation, most definitely dont take them if you are or could be pregnant. This field is in its infancy; we have so much more work to do with safety and efficacy.

What does your senolytic research focus on?

There is a specific fatty acid made in small amounts in the body called dihomo-gamma-linoleic acid or DGLA. Its also present in tiny amounts in the diet. When I gave aged mice larger amounts of DGLA, they went from having quite a few senescent cells to having significantly fewer.

This presents a new therapeutic target. I identified a candidate compound using the DGLA metabolic pathway that works at a dose that is over 1,000 times lower than fisetin, so you can imagine were quite excited by these results.

Like many biomedical discoveries, it was accidental. DGLA makes anti-inflammatory lipids, which help alleviate conditions such as rheumatoid arthritis. I was studying this aspect of DGLA when I was surprised to discover that it killed senescent cells.

My work is in its very early stages, and weve only studied a small number of mice, so its too early for even tentative conclusions, although Im obviously pleased that weve seen the elimination of a meaningful number of senescent cells in old mice. Well be closely monitoring DGLAs positive effects as well as any negative effects on the mice.

How would DGLA be given to people?

We are several years away from that, because everything has to be perfect with mice before we even think about trials with people.

First, we have to figure out how DGLA is killing senescent cells in mice. Again, not all studies with mice yield similar results in humans, so we are very careful about how we convey our findings and possible future actions.

But being at the HNRCA, I have met USDA researchers and nutrition scientists, and discovered that some of those folks were developing DGLA-enriched soybeans. In one scenario, you might go out for sushi and get a little bowl of DGLA-enriched edamame as a side. By the time youre done eating, youve helped reduce the odds of getting some age-related pathology.

I dont know if it will play out that way, but its an idea were working toward. I also am working on therapies that elevate the amount of naturally occurring DGLA in senescent cells that I am very excited about, so this would be an alternative approach.

You are also studying ways to test senolytic therapies beyond such measures as improvement in distance walked, right?

Yes, I am developing a quick and easy test to tell if senolytic therapy is working. Testing for senolytic effectiveness is not really being done nowyou just look for improvement in symptoms or functioning and essentially conclude that its due to the therapy.

But we cant say that with full confidence. Currently, researchers obtain skin or fat samples from patients in these trials before and after senolytic treatment to look for senescent cells. But this is an invasive procedure and its especially challenging for older people to undergo this testing.

One way to solve this dilemma is to identify a biomarker, a measurable compound that consistently and reliably can confirm an interventions effectiveness. For example, we know that a certain lipid, dihomo-15d-PGJ2, accumulates in large amounts inside of senescent cells.

When we give a senolytic therapy that kills these cells in mice or human cells, this lipid is liberated. Detecting it in blood and urine is far less invasive, so thats what Im working on now. Our aim is to be able to test people receiving senolytic therapy for the presence of dihomo-15d-PGJ2 in their blood and urine by the end of the summer.

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Taking on Harmful Cells That Contribute to Age-Related Diseases - Tufts Now

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