Stem Cell Clinic

Week In Review: Nanjing Legend Files To Stage IPO In The U.S. – Seeking Alpha

By Stem Cell Treatment

Deals and Financings

Nanjing Legend Biotech, a subsidiary of GenScript (HK: 1548) (OTC:GNNSF), has filed for an IPO on a US exchange. In 2017, Legend surprised the world when its CAR-T therapy produced a 94% response rate in pretreated multiple myeloma patients. Six months later, Johnson & Johnson (NYSE:JNJ) partnered the treatment in a deal that paid Legend $350 million upfront, plus unspecified milestones and royalties. The CAR-T candidate, JNJ-4528, is now in Phase II trials in the US.

Harbour BioMed (HBM) raised $75 million in a Series B+ round to advance its clinical-stage compounds and portfolio of next-gen biotherapies for cancer and immunological diseases. The company builds its portfolio by in-licensings and via its proprietary Harbour Mice program. Harbour develops drugs for China and US markets, while it has entered partnerships to discover candidates for China companies Innovent (OTCPK:IVBIY) and BeiGene (NASDAQ:BGNE), along with other prominent global biopharmas. The company previously completed an $85 million Series B financing in August 2018. HBM is headquartered in Cambridge, MA, and it conducts R&D in Suzhou and Shanghai.

GenFleet Therapeutics (Shanghai) closed a $57 million Series B financing, co-led by CDH Investments and Shenzhen Capital Group. Founded in 2017, GenFleet is developing novel large and small therapeutic molecules for oncology and immunology targets. The company says its projects are potential first-in-class therapeutics with technical advantages and large markets. It will use the capital for ex-China development and clinical trials of its existing pipelines, plus expanding its immunology platform, working on new projects and building an industrial base.

Arctic Vision of Shanghai in-licensed greater China rights to Xipere, a treatment for macular edema associated with uveitis, from Clearside Bio (NASDAQ:CLSD) in a $35.5 million agreement. Founded last year, Arctic in-licenses breakthrough ophthalmology products for China. Xipere is its first deal. Arctic plans to acquire China rights to 3-5 products and then expand to a combination of global rights and internal discovery for additional drugs. Clearside, which is located in Alpharetta, Georgia, said Xipere is a proprietary suspension of the corticosteroid triamcinolone acetonide.

Exuma Biotech (formerly F1 Oncology), a Florida-Shanghai company developing CAR-T products for solid tumors, closed a $19 million Series B round. The financing included investments from MSD Partners and F1 BioVentures, plus conversion of notes held by individual investors. Exuma's Logic Gated CAR-T products become activated only when the target antigen and the tumor microenvironment are both present, reducing off-tumor side effects. The company has started clinical trials of two candidates. Exuma's Shanghai subsidiary oversees the company's development, manufacturing, and commercial units in Shanghai and Shenzhen.

OBiO Technology (Shanghai) completed a B+ Round of more than $15 million for its viral-based gene therapy CRO services and genetic drug CDMO/CMO services. Founded in 2013, OBiO collaborated with GE Healthcare (NYSE:GE) to establish the first domestic GMP viral production workshop in China and supply CRO/CDMO/CMO services for viral drugs. At the same time, OBiO is incubating gene therapy drugs for cancer therapy with three ADC candidates for oncotherapy that have proprietary IP. The B+ Round investors included GP Capital, Sinowisdom and Efung Capital.

Shanghai OPM Biosciences raised $14 million from China Life Medical Fund to support its CDMO service platform. The company offers serum-free media for cell cultures based on animal cells, as well as a full-range of cell culture development services. It customizes high-quality personalized animal cell culture media to optimize the cell culture process and reduce production costs. OPM has developed a variety of chemically defined CHO/HEK293 cell culture media and nutritional products. The company claims its media improve cell growth and expression.

China Immunotech Biotech of Beijing completed a $6.5 million Series A financing, led by Jianxin Capital with Grower Venture Capital and Huacheng Group participating. Founded in March 2018, China Immunotech is developing TCR-T and CAR-T products that target hematological tumors, solid tumors and virus-related diseases. It has two unique technology platforms, STAR-T and TCR-T. The STAR-T platform uses a proprietary structure of antigen receptor complexes. The company believes the platform provides multi-targeted molecules with better efficacy, fewer side effects and easier development than traditional CAR-T products.

Chengdu's HitGen has signed a licensing agreement to develop a novel class of drugs for Kaken, a Japanese (TK: 4521) specialty pharma. HitGen has already used its large library of small molecule and macrocyclic compounds to identify potential candidates. Few details were released, but Kaken is known to be concentrating its R&D on inflammation/immunology (dermatitis, rheumatoid arthritis and osteoarthritis), pain relief and fungal infections. One year ago, the two companies formed a similar collaboration, presumably for other targets. HitGen will receive an upfront payment and be eligible to receive preclinical and clinical milestones.

Suzhou Ascentage Pharma (HK: 6855) announced approvals for three clinical studies of APG-2575, a novel Bcl-2 inhibitor, two in the US and one in China. APG-2575 is an oral drug designed to treat several hematologic malignancies by blocking Bcl-2 to restore the normal apoptosis process in cancer cells. According to Ascentage, the candidate is the first China-made Bcl-2 inhibitor to start clinical trials. In its Phase I clinical studies, APG-2575 did not exhibit any dose-limiting toxicity or tumor lysis syndrome (which is commonly associated with other Bcl-2 inhibitors).

Denovo Biopharma, a San Diego-Beijing precision medicine company, has discovered a novel genetic biomarker for depression that it intends to use with DB104, a triple dopamine, serotonin and norepinephrine reuptake inhibitor. The company made the discovery using its proprietary biomarker discovery platform. Denovo licensed DB104 from Albany Molecular Research. Bristol-Myers Squibb (NYSE:BMY) returned the candidate to Albany after two Phase IIb clinical trials in treatment-resistant depression. The biomarker is one of four DeNovo biomarkers aimed at psychiatric use.

I-Mab (NASDAQ:IMAB), a Shanghai clinical-stage biopharma, has started to develop TJM2 (TJ003234) to treat cytokine release syndrome in severe cases of COVID-19. TJM2 is an I-Mab-discovered neutralizing antibody that binds human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic inflammation. By binding GM-CSF, TJM2 prevents downstream signaling and target cell activation, inhibiting other inflammatory responses. I-Mab intends to start clinical trials in the US and expand to countries especially hard-hit by COVID-19.

Mesoblast (NSDQ: MESO; ASX: MSB), an Australia-based regenerative medicine company, announced plans to start trials of remestemcel-L, its allogeneic mesenchymal stem cell (MSC) product candidate, in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19. The trial will be conducted in the US, Australia, China and Europe. ARDS is the principal cause of death in COVID-19 patients. In a small China trial, allogeneic MSCs cured or significantly improved all seven patients with severe COVID-19 pneumonia.

Ascletis (HK: 1672), a Hangzhou biopharma, reported that an initial group of 11 COVID-19 patients all recovered after being treated with a combination Ganovo and Ritonavir therapy. Ascletis's Ganovo, the first approved direct-acting anti-viral agent developed by a China company, was launched in 2018 to treat hepatitis C. Ritonavir is a generic anti-retroviral that is used in AIDS/HIV combination therapies. The small clinical trial was led by Dr. Hongyi Chen, the director of the Ninth Hospital of Nanchang.

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Week In Review: Nanjing Legend Files To Stage IPO In The U.S. - Seeking Alpha

Why soap works – even on coronavirus – and how its discovery altered human history – Chattanooga Times Free Press

By Gene Therapy Clinics

It probably began with an accident thousands of years ago. According to one legend, rain washed the fat and ash from frequent animal sacrifices into a nearby river, where they formed a lather with a remarkable ability to clean skin and clothes. Perhaps the inspiration had a vegetal origin in the frothy solutions produced by boiling or mashing certain plants. However it happened, the ancient discovery of soap altered human history. Although our ancestors could not have foreseen it, soap would ultimately become one of our most effective defenses against invisible pathogens.

People typically think of soap as gentle and soothing, but from the perspective of microorganisms, it is often extremely destructive. A drop of ordinary soap diluted in water is sufficient to rupture and kill many types of bacteria and viruses, including the new coronavirus that is currently circling the globe. The secret to soap's impressive might is its hybrid structure.

Soap is made of pin-shaped molecules, each of which has a hydrophilic head -- it readily bonds with water -- and a hydrophobic tail, which shuns water and prefers to link up with oils and fats. These molecules, when suspended in water, alternately float about as solitary units, interact with other molecules in the solution and assemble themselves into little bubbles called micelles, with heads pointing outward and tails tucked inside.

Some bacteria and viruses have lipid membranes that resemble double-layered micelles with two bands of hydrophobic tails sandwiched between two rings of hydrophilic heads. These membranes are studded with important proteins that allow viruses to infect cells and perform vital tasks that keep bacteria alive. Pathogens wrapped in lipid membranes include coronaviruses, HIV, the viruses that cause hepatitis B and C, herpes, Ebola, Zika, dengue, and numerous bacteria that attack the intestines and respiratory tract.

When you wash your hands with soap and water, you surround any microorganisms on your skin with soap molecules. The hydrophobic tails of the free-floating soap molecules attempt to evade water; in the process, they wedge themselves into the lipid envelopes of certain microbes and viruses, prying them apart.

"They act like crowbars and destabilize the whole system," said professor Pall Thordarson, acting head of chemistry at the University of New South Wales. Essential proteins spill from the ruptured membranes into the surrounding water, killing the bacteria and rendering the viruses useless.

In tandem, some soap molecules disrupt the chemical bonds that allow bacteria, viruses and grime to stick to surfaces, lifting them off the skin. Micelles can also form around particles of dirt and fragments of viruses and bacteria, suspending them in floating cages. When you rinse your hands, all the microorganisms that have been damaged, trapped and killed by soap molecules are washed away.

On the whole, hand sanitizers are not as reliable as soap. Sanitizers with at least 60% ethanol do act similarly, defeating bacteria and viruses by destabilizing their lipid membranes. But they cannot easily remove microorganisms from the skin. There are also viruses that do not depend on lipid membranes to infect cells, as well as bacteria that protect their delicate membranes with sturdy shields of protein and sugar. Examples include bacteria that can cause meningitis, pneumonia, diarrhea and skin infections, as well as the hepatitis A virus, poliovirus, rhinoviruses and adenoviruses (frequent causes of the common cold).

These more resilient microbes are generally less susceptible to the chemical onslaught of ethanol and soap. But vigorous scrubbing with soap and water can still expunge these microbes from the skin, which is partly why hand-washing is more effective than sanitizer. Alcohol-based sanitizer is a good backup when soap and water are not accessible.

In an age of robotic surgery and gene therapy, it is all the more wondrous that a bit of soap in water, an ancient and fundamentally unaltered recipe, remains one of our most valuable medical interventions. Throughout the course of a day, we pick up all sorts of viruses and microorganisms from the objects and people in the environment. When we absentmindedly touch our eyes, nose and mouth -- a habit, one study suggests, that recurs as often as every 2 1/2 minutes -- we offer potentially dangerous microbes a portal to our internal organs.

Washing with soap and water is one of the key public health practices that can significantly slow the rate of a pandemic and limit the number of infections, preventing a disastrous overburdening of hospitals and clinics. But the technique works only if everyone washes their hands frequently and thoroughly: Work up a good lather, scrub your palms and the back of your hands, interlace your fingers, rub your fingertips against your palms, and twist a soapy fist around your thumbs.

Or as the Canadian health officer Bonnie Henry said recently, "Wash your hands like you've been chopping jalapeos and you need to change your contacts." Even people who are relatively young and healthy should regularly wash their hands, especially during a pandemic, because they can spread the disease to those who are more vulnerable.

Soap is more than a personal protectant; when used properly, it becomes part of a communal safety net. At the molecular level, soap works by breaking things apart, but at the level of society, it helps hold everything together. Remember this the next time you have the impulse to bypass the sink: Other people's lives are in your hands.

The New York Times

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Why soap works - even on coronavirus - and how its discovery altered human history - Chattanooga Times Free Press

Stem cells can reverse damage caused by heart attack; repair mechanism discovered: Study – International Business Times, Singapore Edition

By Stem Cell Clinic

Revolutionary Gene-Editing Tool

Cardiovascular or heart disease (CVDs) is the leading cause of death across the world. Heart attacks resulting due to CVDs can cause death, and severe damage to cardiac muscle a muscle that forms the wall of the heart in survivors. However, researchers claim that they have discovered stem-cell activated mechanisms that promote healing after a heart attack.

According to the study by researchers from Mayo Clinic, stem cells were found to reverse the damage and restore cardiac muscle back to its condition before a heart attack. Human cardiopoietic cells obtained from stem cells within the bone marrow were found to hone in on damaged proteins and reverse intricate changes that a heart attack caused.

"The response of the diseased heart to cardiopoietic stem cell treatment revealed development and growth of new blood vessels, along with new heart tissue," said Dr. Kent Arrell, first author of the study, in a statement.

For the study, the researchers examined the diseased hearts of mice. The hearts of mice that received human cardiopoietic stem cell therapy were compared with those of that did not. Nearly 4,000 cardiac proteins were identified using a data science technique to map proteins found in the cardiac muscle. Over 10 per cent of the discovered proteins were found to suffer damage as a result of a heart attack.

"While we anticipated that the stem cell treatment would produce a beneficial outcome, we were surprised how far it shifted the state of diseased hearts away from disease and back toward a healthy, pre-disease state," said Dr. Arrell.

While the organs in the human body have the ability to repair their damaged cells, they may be unable to restore the loss entirely, and this holds good for cardiac cells as well. Dr. Andre Terzic, senior author of the study, said: "The extent of change caused by a heart attack is too great for the heart to repair itself or to prevent further damage from occurring."

He explained that upon the administration of cardiopoietic stem cell therapy to mice, a partial or complete reversal of nearly two-thirds of the damage caused by a heart attack was noted. Around 85 per cent of all cellular functional categories struck by the disease responded favorably to the treatment.

According to the World Health Organisation (WHO), CVDs claim nearly 18 million lives every year, which translates to 31 per cent of all deaths. The findings of the study provide an improved understanding of the restoration of heart health using stem cells and provide a framework for wider utilization of stem cell therapy for the treatment of various conditions.

Stressing that the actual mechanism behind the repair of diseased organs by stem cells is poorly understood, Dr. Terzic added: "This study sheds light on the most intimate, yet comprehensive, regenerative mechanisms paving a road map for responsible and increasingly informed stem cell application."

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Stem cells can reverse damage caused by heart attack; repair mechanism discovered: Study - International Business Times, Singapore Edition

Newly Discovered Memory in Our Bones: Keeping a Record of Previous Infections to Boost Immunity – SciTechDaily

By Stem Cell Clinic

Immune cells by fluorescence microscopy: Blood stem cells remember a previous attack and produce more immune cells like these macrophages to fight a new infection. Credit: Sieweke lab/CIML

These findings should have a significant impact on future vaccination strategies and pave the way for new treatments of an underperforming or over-reacting immune system. The results of this research are published in Cell Stem Cell on March 12, 2020.

Stem cells in our bodies act as reservoirs of cells that divide to produce new stem cells, as well as a myriad of different types of specialized cells, required to secure tissue renewal and function. Commonly called blood stem cells, the hematopoietic stem cells (HSC) are nestled in the bone marrow, the soft tissue that is in the center of large bones such as the hips or thighs. Their role is to renew the repertoire of blood cells, including cells of the immune system which are crucial to fight infections and other diseases.

Until a decade ago, the dogma was that HSCs were unspecialized cells, blind to external signals such as infections. Only their specialized daughter cells would sense these signals and activate an immune response. But work from Prof. Michael Siewekes laboratory and others over the past years has proven this dogma wrong and shown that HSCs can actually sense external factors to specifically produce subtypes of immune cells on demand to fight an infection. Beyond their role in an emergency immune response, the question remained as to the function of HSCs in responding to repeated infectious episodes. The immune system is known to have a memory that allows it to better respond to returning infectious agents. The present study now establishes a central role for blood stem cells in this memory.

We discovered that HSCs could drive a more rapid and efficient immune response if they had previously been exposed to LPS, a bacterial molecule that mimics infection, said Dr. Sandrine Sarrazin, Inserm researcher and senior-author of the publication. Prof. Michael Sieweke, Humboldt Professor at TU Dresden, CNRS Research Director and last author of the publication, explained how they found the memory was stored within the cells: The first exposure to LPS causes marks to be deposited on the DNA of the stem cells, right around genes that are important for an immune response. Much like bookmarks, the marks on the DNA ensure that these genes are easily found, accessible and activated for a rapid response if a second infection by a similar agent was to come.

The authors further explored how the memory was inscribed on the DNA, and found C/EBP? to be the major actor, describing a new function for this factor, which is also important for emergency immune responses. Together, these findings should lead to improvements in tuning the immune system or better vaccination strategies.

The ability of the immune system to keep track of previous infections and respond more efficiently the second time they are encountered is the founding principle of vaccines. Now that we understand how blood stem cells bookmark immune response circuits, we should be able to optimize immunization strategies to broaden the protection to infectious agents. It could also more generally lead to new ways to boost the immune response when it underperforms or turn it off when it overreacts, concluded Prof. Michael Sieweke.

The research group of Prof. Michael Sieweke works at the interface of immunology and stem cell research. The scientists focus on the study of hematopoietic stem cells and macrophages, long-lived mature cells of the immune system that fulfil an important role in tissue regeneration. In 2018, Prof. Michael Sieweke received the most valuable research award in Germany: the Alexander von Humboldt Professorship, which brings top international researchers to German universities. In addition to his position as Research Director at the Centre for Immunology at the University of Marseille Luminy, he now acts as Deputy Director at the Center for Regenerative Therapies at TU Dresden (CRTD). CRTD is academic home for scientists from more than 30 nations. Their mission is to discover the principles of cell and tissue regeneration and leveraging this for recognition, treatment and reversal of diseases. The CRTD links the bench to the clinic, scientists to clinicians to pool expertise in stem cells, developmental biology, gene-editing and regeneration towards innovative therapies for neurodegenerative diseases such as Alzheimers and Parkinsons disease, hematological diseases such as leukaemia, metabolic diseases such as diabetes, retina and bone diseases.

Reference: C/EBP-Dependent Epigenetic Memory Induces Trained Immunity in Hematopoietic Stem Cells by Brengre de Laval, Julien Maurizio, Prashanth K. Kandalla, Gabriel Brisou, Louise Simonnet, Caroline Huber, Gregory Gimenez, Orit Matcovitch-Natan, Susanne Reinhardt, Eyal David, Alexander Mildner, Achim Leutz, Bertrand Nadel, Christophe Bordi, Ido Amit, Sandrine Sarrazin and Michael H.Sieweke, 12 March 2020, Cell Stem Cell.DOI: 10.1016/j.stem.2020.01.017

This study was funded by TU Dresden / CRTD through the German Excellence Initiative, the German Research Foundation as well as through an ERC Advanced Grant from the European Research Council and the Alexander von Humboldt Foundation. The study was further supported by funding from the Institut National de la Sante et de la Recherche Medicale, the Centre National de la Recherche Scientifique, Aix-Marseille University, the Agence Nationale de la Recherche, the Foundation ARC pour la Recherche sur le Cancer, an INSERM-Helmholtz cooperation programme and the Einstein Foundation.

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Newly Discovered Memory in Our Bones: Keeping a Record of Previous Infections to Boost Immunity - SciTechDaily

The race to find a coronavirus treatment: One strategy might be just weeks away, scientists say – USA TODAY

By Stem Cell Clinic

As flu season comes to an end and allergy season starts to heat up, there may be concerns about symptoms that mimic the new coronavirus COVID-19. Wochit

MILWAUKEE, Wis. In a week whenthe coronavirus closures and quarantines hitlikefalling dominoes the lockdown in Italy,the emptyworkplaces and college campusesin the U.S., suspended sports seasons, canceled festivals far less attention fell on theglobal scientific community's driveto find treatments forthe new virus.

But researchers are already suggesting strategies tohelp patientssuffering from the virus, which is marked by fever, coughing and difficulty breathing. One treatment could be just weeks away.

With no vaccine expected anytime soon, treatmentsarecrucialtosaving the lives of thousands of the infected, especiallyhigh-riskpatients the elderly, those with compromised immune systems and those with chronic illnesses, such as diabetes, heart disease and lung disease.

"I'm very hopeful and very positive. We'll get through this,"said Robert Kruse, a doctor in the Department of Pathology at Johns Hopkins Hospitalin Baltimore. "I've been shocked this week at the measures that have been taken (to alter daily life). They were probably the correct ones, given that they have worked in other countries."

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Kruse has been pursuing two different treatmentstrategies, one of which has a long history andcould be availablewithinweeks rather than months. The quickest option is likely to be the use ofantibodies from recovered COVID-19 patients. As of Saturday, there were almost 72,000 such patients worldwide. Thevirus has infected about 150,000, killing more than 5,500.

The use of survivor antibodies, serum therapy,dates back to 1891 when it was used successfully to treat a child with diphtheria. Since then, serum from recovered patients has been used "to stem outbreaks of viral diseases such as poliomyelitis, measles, mumps and influenza," according to a paperFriday in The Journal of Clinical Investigation.

"As we are in the midst of a worldwide pandemic, we recommend that institutions consider the emergency use (of serum from recovered patients) and begin preparations as soon as possible. Time is of the essence," wrote the paper's two authors, Arturo Casadevall of Johns Hopkins School of Public Health, and Liise-anne Pirofski of the Albert Einstein College of Medicine in New York.

All of the strategies, including the use of serum from recovered patients, have drawbacks. Transfusion of serum carries potential side effects, including fever, allergic reactions, and a very small risk of infectious disease transmission.

Collecting large amounts of serum from recovered patients could be a sizable task. It could turn outthat serum from one recovered patient is only enough to save a singlesick one, explainedKruse at Johns Hopkins. "It's a logistical challenge to put it together, but at the very least there are no hurdles (from the U.S. Food and Drug Administration)to producing the therapy."

Kruse advanced anothertechnique in a paper published in late Januaryin the journal F1000 Research.

His method seeks to take advantage of the new coronavirus' ability to latch onto and enter cells.

Scientists often talk about "cell receptors," which are essentially doors that allow a virus to enter the cell.

The "door" the new coronavirus is entering through is known as the ACE-2 protein. Kruse's technique involves detaching the externalportionof ACE-2, which would act as a decoy for the virus. Thevirus would bind tothe decoy, leaving it unable to reachtheactual door into the cell, and thus, unable tocause infection.

"It won't realize, 'Oh gosh, this isn't a cell,'" Kruse explained in an interview. "The virus can't mutate away from this."

Kruse'sdecoy therapy would not be available until fall at the earliest. However, a similar version of the strategy is currently being tested in trials in China.

Afaster optioninvolves what's called "repurposing" a drug.

This is when a drug that has already been found safe and approved fortreatment of one disease also is foundusefulin treating another. One example is thedrug Sildenafil, which is sold as Viagra andused to treat both erectile dysfunction andpulmonary hypertension.

There are three ways in which scientists try to findan existing drug that can treat a new condition.

The rational method involves using drugs that have characteristics and targets that suggestthey might be used to treatthe new condition.

The computational method involves examining protein structures and using them to predict an existing drug that might work.

The final method takes advantage of the vast drug libraries possessed by companies and academic institutions. High-speed technology allows researchers to screen thousands of drugs very quickly to determine whether they will act against a specific target.

Considerable hope,interest and money have been invested in one drug not previously approved, remdesivir. The drug was previously tested against Ebola, but failed in trials.

Gilead Sciences, a Foster City, California-based biopharmaceutical company,announced that two clinical studies of the drugare beginning thismonth. Two more clinical trials of the drug are already underway in China.

In the U.S., the clinical trials process is slow and painstaking, takingseveral years andsometimes much longer.

Another approach to the new virus championed by numerous researchers isthe use oflab-made proteinscalled monoclonal antibodies.

These confer what's called "passive immunity" and have been used previously to treat cancer, multiple sclerosis,cardiovascular disease and many other conditions.

"The use of monoclonal antibodies is a new era in infectious disease prevention which overcomes many drawbacks associated with serum therapy ... in terms of specificity, purity, low risk of blood-borne pathogen contamination and safety," wrote the authors of a recent paper in the Asian Pacific Journal of Allergy and Immunology.

The biotechnology company Regeneron, based in Tarrytown, New York, started work searching for a monoclonal antibody "for this particular virus in early/mid-January," said Christos Kyratsous, the company's vice president for infectious diseases and viral vector technologies. "But really we started working on it decades ago when we began building our unique end-to-end drug discovery and development technologies."

Gregory Poland, director of Mayo Clinic's Vaccine Research Group, said the use of monoclonal antibodies "needs to be designed and tested in this specific disease, but I wouldn't see any reason it wouldn't work. The idea is right."

Like other scientists, Poland was less hopeful that a vaccine would be developed anytime soon.

"We won't have a vaccine for this outbreak," he said. "It will be before thenext (outbreak)."

Monoclonal antibodies do havepitfalls. They require extensive testing. Also, viruses can mutate and escape from the antibodies. Companies sometimestarget two different parts of the virus to make it harder for the virusto mutate and elude the antibodies.

Ajay K. Sethi,associate professor of population health sciences at the University of Wisconsin-Madison, expressed support for the development of monoclonal antibodies.

"In my opinion, trying a strategy like monoclonal antibodies to provide passive immunity is a good idea," Sethi said.He added that given the technique's past successes, "it is hopeful, but not surprising."

Strategies forcombating the new coronavirus will likely requirereaching patients early before they get too sick. Toward that end, Kruse said he believes the U.S. should pursue the much broader coronavirus testing policythat South Koreaadopted.

"Maybe in the next few weeks we will get to the point where we are testing everyone," he said.

Take a break from coronavirus news: The 12 adorable baby animal photos you need right now

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The race to find a coronavirus treatment: One strategy might be just weeks away, scientists say - USA TODAY

Worldwide Cell Therapy Market Projections to 2028 – The Largest Expansion Will Be in Diseases of the Central Nervous System, Cancer and Cardiovascular…

By Embryonic Stem Cells

DUBLIN, March 12, 2020 /PRNewswire/ -- The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The cell-based markets was analyzed for 2018, and projected to 2028. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 309 of these are profiled in part II of the report along with tabulation of 302 alliances. Of these companies, 170 are involved in stem cells.

Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 25 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

This report contains information on the following:

The report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

Key Topics Covered

Part I: Technologies, Ethics & RegulationsExecutive Summary 1. Introduction to Cell Therapy2. Cell Therapy Technologies3. Stem Cells4. Clinical Applications of Cell Therapy5. Cell Therapy for Cardiovascular Disorders6. Cell Therapy for Cancer7. Cell Therapy for Neurological Disorders8. Ethical, Legal and Political Aspects of Cell therapy9. Safety and Regulatory Aspects of Cell Therapy

Part II: Markets, Companies & Academic Institutions10. Markets and Future Prospects for Cell Therapy11. Companies Involved in Cell Therapy12. Academic Institutions13. References

For more information about this report visit https://www.researchandmarkets.com/r/sy4g72

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

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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22.5% Growth Rate for Synthetic Stem Cells Market by 2028 | Overview, Top Technologies, Key Insights and Company Profiles – News Times

By Embryonic Stem Cells

Get Instant Free Sample Report at https://www.reportsnreports.com/contacts/requestsample.aspx?name=1799811

According to Market Study Report, Synthetic Stem Cells Market provides a comprehensive analysis of the Synthetic Stem Cells Market segments, including their dynamics, size, growth, regulatory requirements, competitive landscape, and emerging opportunities of global industry. This report also provides market landscape and market share information in the Synthetic Stem Cells Market. An exclusive data offered in this report is collected by research and industry experts team.

Top Key Players Profiled in the Synthetic Stem Cells Market include are North Carolina State University (NCSU) (US) and Zhengzhou University (China).

Synthetic Stem Cells Market is expected to grow from US$ 14 Million in 2023 to US$ 37 Million by 2028, at a CAGR of 22.5% during the forecast period. The synthetic stem cells market is driven by various factors such as ethical concerns regarding embryonic stem cells and the risk of tumor formation and immune rejection of natural stem cells.This report spread across 55 Pages, profiling 02 companies and supported with tables and figures are now available in this research.

The neurological disorders segment is expected to witness the highest CAGR during the forecast period.

The neurological disorders application is the faster-growing segment in the overall synthetic stem cells market. Based on application, the synthetic stem cells market is segmented into cardiovascular diseases, neurological disorders, and other diseases that include various cancers, wounds and injuries, musculoskeletal disorders, and blood disorders that require regenerative therapies.

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North America is expected to record the highest growth rate during the forecast period.

Countries in North America are constantly modernizing their healthcare infrastructure by investing in advanced therapies. The increasing prevalence of target diseases, focus on development of for regenerative medicines, fast adoption of advanced therapies, and regulatory support for stem cell therapies will result in the high rate of adoption of synthetic stem cell therapies in this region by 2023.

The Study Objectives of this report are:

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Reason to access this report:

The report will provide the market leaders/new entrants in this market with information on the closest approximations of the revenue of the overall synthetic stem cells market and its sub segments. This report will help stakeholders understand the competitive landscape and gain insights to better position their businesses and plan suitable go-to-market strategies. The report will also help stakeholders to understand the pulse of the market and provide them with information on key market drivers, restraints, challenges, and opportunities.

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22.5% Growth Rate for Synthetic Stem Cells Market by 2028 | Overview, Top Technologies, Key Insights and Company Profiles - News Times

Stem Cell Injections: What Are They & Does Stem Cell Therapy Work

By Stem Cell Treatment

The headlines sound almost too good to be true: Researchers Stunned by Stem Cell Experiment That Helped Stroke Patient Walk; Wife Recovered From Cancer After Pioneering Stem Cell Treatment; Stem Cell Transplant Trial Has Miraculous Effect on Multiple Sclerosis Sufferers.

Indeed, even experts are excited about these miracle cells, which are abundant in the body and can repair and replace all kinds of tissue. Theres no doubt in my mind that stem cells are going to revolutionize the way medicine is practicedwith the same kind of impact that antibiotics and vaccinations hadgetting at the root causes of disease rather than dancing around the periphery, says Charles Murry, M.D., Ph.D., director of the Institute for Stem Cell and Regenerative Medicine at the University of Washington in Seattle.

But when it comes to medical research, Dr. Murry cautions, stem cells are barely at the starting gate. Despite their hitting the petri dish more than 20 years ago, many big questions remain: Which people, with which diseases, might benefit from their use? What types of stem cells should be used? How can the cells be manipulated and administered for lasting effect? And how does the treatment work? Exciting as the clinical trials are, most of those that have been completed so far are just at the phase one stage, in which researchers test a small number of people to see if an intervention is safe, not yet whether its effective.

What actually is too good to be true, then, are the claims being made by many of the for-profit stem cell clinics that have proliferated in the U.S. (more than 700 and counting). Using nothing more than very early study results and testimonials, these clinics promise thatfor thousands or tens of thousands of dollarsthey can use your own stem cells to treat everything from MS and rheumatoid arthritis to heart disease, diabetes, damaged joints, and cancer. Some offer cosmetic stem cell face-lifts or cellular breast and buttock jobs; others promise to boost athletic prowess.

Theres a striking gap between the claims these centers are making and the research thats been done for most of these diseases, says Leigh Turner, Ph.D., an associate professor in bioethics at the University of Minnesota who studies these clinics. People need to be very cautious about this treatment right now.

Most of the cells in our bodies are specific types of cellsheart, lung, muscle, nerve, blood, and more. But stem cells are undifferentiated, which means they have the potential to turn into more stem cells or other types of cells. Stem cells also can divide indefinitely and replace worn-out tissue, giving them the ability to become other cells and the potential to act as a ready repair system for the body.

What it's like to have stem cells injected into your face for younger-looking skin:

Stem cells generate so much buzz because they have the unique ability to turn into different types of cells. This means they have the potential to rebuild organs that are diseased, which in the medical field is known as regenerative medicine. Early on, scientists focused on stem cells taken from embryos because those cells naturally transform into the myriad ones that develop into the babys tissues and organs. But ethical issues and federal regulations related to these cells sent researchers scrambling to find alternatives.

Today, cutting-edge scientists are working to coax adult blood cells to become nascent cells akin to the embryonic kind by adding certain DNA molecules. These induced pluripotent stem cells, which have shown early promise, generally require months of careful manipulation in a lab and thus are mainly limited to top medical centers. Most of the for-profit clinics have settled on using cells taken from fully developed tissue, known as adult stem cells. By using cells from a persons own body, these clinics can complete a treatment in a day or a few weeks. Doctors typically liposuction a little fat or remove some bone marrow (which is an especially rich source of stem cells), put it through a few steps to remove other tissue, then inject the stem cells where they want them to proliferate. Someone whos coming in with arthritic hip pain, for example, might have cells removed from her belly and inserted into her hip.

Critics say the for-profit clinics that currently claim they can treat all manner of disease with adult stem cells are not being honest. Much more study is needed before any of these claims can be substantiated, says Kapil Bharti, Ph.D., a research scientist at the National Eye Institute of the National Institutes of Health who is at the leading edge of research on using pluripotent cells to treat macular degeneration. The problem with the cells is what we dont know. Those clinics inject the cells and hope they will secrete something beneficial, but every time they do the injections, theyre rolling the dice, he says.

The scientific consensus is that stem cells taken from fat or bone marrow are not as malleable as embryonic cells, meaning that rather than turn into completely different cells, they mostly create more of the same tissue. There is zero evidence, for example, that bone marrow tissue can make eye tissue, even though many of these clinics say it can. The cells dont integrate, so they die off, Bharti saysand the injections may cause significant damage in the process.

At the moment, stem cell treatments are medically recommended only for a small number of blood disorders. To treat leukemia, for example, patients typically have their bone marrow harvested before their bodies are blasted with high-dose chemotherapy. The stem cells from the marrow are then reinserted into the bloodstream to restore damaged cells there.

Early-stage research involving other conditions reveals why physicians are so excited about the methods future prospects. A very small industry-funded clinical trial in Australia found that in people who had the anterior cruciate ligament (ACL) in the knee reconstructed, those who subsequently had stem cells injected into their knees had less pain and better physical results on their MRIs than did a control group. An ongoing multiyear study of 110 patients with relapsing-remitting MS is finding that those treated with stem cells from their own bone marrow (along with some chemotherapy and/or radiation) are much less likely to have their disability worsen than those on standard disease-modifying drugsan incredible 6% versus 60%.

The potential to help her severe MS was what drove SammyJo Wilkinson of Edmonds, WA, to seek out stem cell treatment from a for-profit clinic in 2012. Wilkinson was desperate for something that might improve a disease that had forced her to shutter her thriving technology company and go on disability a decade earlier. After researching clinics, she settled on one in Texas (later relocated to Mexico). She liked that the clinic was up-front that the procedure was experimental and that her stem cells were banked for future rounds.

Six years and five treatments later, Wilkinson is happy with the results, even though major symptoms, including blindness in her right eye and the inability to walk without a wheelchair, remain. But of the 28 symptoms she said had decimated her life, 17 have disappeared, from fatigue and brain fog to numbness in her hands. My quality of life is so much better. No current medication can do what this treatment did, she says. Still, when other women with MS call her for advice, she lets them know that she is not curedand that the cost of her treatments ($90,000 plus travel expenses, none of it covered by insurance) was staggering.

While Wilkinson was lucky that she had positive results, this isnt true for many others. Thats one reason stem cell scientists are angry that the Food and Drug Administration hasnt come down harder on for-profit clinics. Between 2011 and 2017, the FDA issued some warning letters, and the Department of Justice filed for injunctions against only two clinics (one with multiple locations) this past May. In December 2018, the FDA issued yet another warning after 12 patients fell seriously ill after receiving stem cell injections. Litigation is ongoing, although the clinics can still see patients.

For-profit clinics point out that the FDA differentiates between drugs that need to go through the multiyear, multimillion-dollar approval process and those that use minimally manipulated substances taken from a persons own body, which dont. The clinics claim their treatments fall into the latter category, though critics say theyre manipulated much more heavily than the FDA intended for nondrug treatments. This has come to be a really important line, and many for-profit businesses claim theyre on the right side of it when realistically they arent, says Paul S. Knoepfler, Ph.D., a professor at the UC Davis School of Medicine who runs The Niche (ipscell.com), a blog that sheds light on the industry.

It might seem that theres no danger in receiving a treatment using your own cells, but that isnt the case. People have suffered very serious complications, Turner says. An article in Nature counts nine lawsuits in which people alleged that their treatmentsfor diabetes, lupus, lung disease, cosmetic surgery, and morecaused them harm. A report in the New England Journal of Medicine described three women with macular degeneration whose vision significantly worsened (two are now legally blind) when stem cells harvested from belly fat were injected into their eyes. Several stem cell clinic patients have died.

And those are just the people we know aboutside effects and serious complications dont have to be reported by the clinics, Turner says. Whats more, once-promising treatments have been shown to be potentially dangerous. Doctors were initially excited to think stem cells might repair diseased hearts, but a 2017 study on mice found that when the cells were injected, they turned inflammatory and worsened heart disease. (More research is being done.)

Another big issue is money. The fees Wilkinson paid are typical, and even cheaper therapies can feel like a rip-off. Although one injection of stem cells several years ago helped Olympic track and field hurdler LaVonne Idlette heal tendinitis in her knee, when she went back to treat a pulled hamstring muscle, another injection did nothing. At $1,200 a shot, it was ridiculously expensive, says the 32-year-old Miami resident, now an attorney.

If you want to look into stem cell treatment, experts say the best way is to ask your doctor whether any reputable medical centers are conducting clinical trials focused on your disease. You can find trials at the National Institutes of Healths website clinicaltrials.gov, but theres another caveat: Some clinics say theyre doing a patient-funded study, and theyll even list it on the government website, but when you look at the details, there are a lot of red flags, Turner says. One of those is being asked to pay thousands of dollars to participate (reputable studies typically ask only that you pay your own travel fees). Turner also doubts that data from these so-called trials are being tabulated; he and others say some clinics are simply trying to legitimize risky treatments.

Beyond entering a trial youre sure is being done properly, experts say that for now you should steer clear. Mayo Clinic has started a regenerative medicine consult service and tells patients this: The current standard of care for nearly all medical conditions is still the best. If you have arthritis in your knees, for example, physical therapy, medication, or even knee replacement surgery will give you much better odds than experimental stem cell treatments, says Shane Shapiro, M.D., program director at Mayo Center Regenerative Medicine Therapeutic Suites.

Of course, clinics point to success stories as reasons to try their stem cell therapies. Seven years ago, Amy Klein, a freelance writer in New York City, received a stem cell face-lift to get rid of a tired complexion and dark bags under her eyes. Stem cells were taken from her stomach fat and injected into her face. So many years later, my skin still looks really good. Not only are my bags gone, but the quality of my skin is back to the dewy tightness of my youth, she says.

But when small numbers of patients claim good results, scientists call it anecdotal medicine and stress that its not strong enough evidence to base treatment advice on. Before you can call something a success, you have to repeat your findings with a large number of patients over a long period of time, Dr. Shapiro says. Until those major studies are done and its proven that stem cells are safe and effective for the conditions for which theyre being advertised, patients are simply rolling the dice.

Despite warnings, some patients with serious degenerative diseases who have tried all the conventional treatments choose for-profit stem cell clinics. If someone thinks its better to take a low-percentage shot as opposed to waiting for a degenerative disease to progress, that may not be an entirely irrational way to view things, says Dr. Murry. The problem is, its nearly impossible for the average patient to evaluate whether an unproven treatment has evidence for safety or efficacy. This is why the clinics need regulatory oversight.

How to protect yourself if you do decide to proceed:

See what the evidence shows. The federal database pubmed.gov lists results of most published studies. If you read reputable journals to see what the evidence reveals, youll be less likely to fall prey to a clinics overselling. If theres zero research on the use of stem cells for your condition, be especially concerned.

Know that some treatments are riskier than others. Procedures that inject cells into vital organs, like the brain, nervous system, heart, or eyes, have the potential to do more serious damage if the treatment goes awry than those aiming to fix joints or appearance.

Choose a clinic with care. If they tell you a treatment theyre selling has no risks, thats a big red flag: Theyre either woefully lacking in knowledge or not being honest, and I would walk away, says Paul S. Knoepfler, Ph.D. Keep your doctor informed. Youll want to let your physician know youre planning to do this, then see him or her soon after your treatment, Dr. Murry advises.

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Stem Cell Injections: What Are They & Does Stem Cell Therapy Work

Stem Cell Therapy | Stanford Initiative to Cure Hearing Loss

By Stem Cell Treatment

What if doctors could grow a new working inner ear from a persons own skin cells? Or repair the damaged inner ear from within?

Solving this profound mystery is the driving force behind stem cell research and the promise of tissue engineering in otolaryngology. While hearing aids and cochlear implants can provide good recovery of hearing function, the development of a biological method to repair the damaged cochlea has the potential to restore normal hearing without any type of prosthesis.

One approach to restore hearing might be to surgically place stem cells within the cochlea in such a way that they would fuse with the remaining cochlear structures and develop and function as hair cells. Scientists believe this is a viable approach because, unlike most organs that are destroyed by disease, the inner ear remains structurally intactonly the hair cells are lost. By mimicking the steps involved in the formation of embryonic mouse ears, Stanford scientists have produced stem cells in the laboratory that look and act very much like hair cells, the sensory cells that normally reside in the inner ear. If they can generate hair cells in the millions, it could lead to significant scientific and clinical advances along the path to curing deafness in the future.

A promising source of creating hair cells comes from induced pluripotent stem cells (iPS)adult cells, taken for example from a patients own skin that have been genetically reprogrammed to revert back to stem cells. This breakthrough process represents a major opportunity to eventually treat a patient with his or her own cells.

Currently, our research team is working toward producing human hair cells for the first time in a culture dish. This work could lead, in the long run, to novel therapies based on cell transplantation.

Equally exciting is an ongoing approach to use embryonic stem cell-based approaches for discovery of novel drugs that could be used for treatment for deafness. More about this exciting new direction can be found under Molecular Therapy.

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Stem Cell Therapy | Stanford Initiative to Cure Hearing Loss

Does Medicare Cover Stem Cell Therapy in 2020? Find Out Here

By Stem Cell Treatment

Stem cell therapy has revolutionized the healthcare system. It has provided hopes for patients who suffer from diseases that were considered incurable and even some other acute and chronic diseases that had a lesser chance of recovery.

It can relieve the symptoms the patients are experiencing and also enhance the quality of their life. Here is a brief discussion about whether stem cell theory is covered by Medicare.

Medicare Plan A and B cover the costs of stem cell therapies when certain criteria are fulfilled. However, even in these cases, Medicare does not reimburse the full costs.

Stem cell therapies that involve blood-forming stem cells are approved by the FDA. And hence, only these therapies would be covered by Medicare. There are certain limits to the coverage of stem cells therapies depending on the types of stem cells used as discussed beneath:

Stem cells are the cells that are formed in the body at birth. The uniqueness of these cells is they can change into any type of cell found in any organ or tissue of the body. These cells have the ability to regenerate and form more cells of a similar type to heal the damaged tissues and organ. These cells play an important role in producing organs, ligaments, bones, muscles, tendons, joints and skin.

There are basically 4 main types of stem cells that the body can produce during its life.

HSCT or Hematopoietic Stem Cells are also a type of stem cell. Stem cell therapies using these cells would be covered by Medicare only when it is performed for conditions such as:

Autologous Stem Cell Transplantation is covered by Medicare Plan A and B when it is recommended for the management of the following conditions:

Stem Cell Therapy is not covered by Medicare to treat the following conditions:

When stem cell therapy is performed for the management of these conditions, it would not be covered by Medicare Plan A or B. For example; though Stem cell therapy is considered effective for the management of osteoarthritis of the knee joint, it is not covered by Medicare as it is not approved by the FDA,

Medicare beneficiaries who experience chronic pain due to osteoarthritis can check whether any other insurance plan covers the expenses of stem cell therapy.

They can check the coverage offered by Medicare Advantage Plans and sign up for one if they anticipate they might need to undergo the procedure in the future. They should also check the specific criteria that must be fulfilled in order to be eligible for the coverage.

Link:
Does Medicare Cover Stem Cell Therapy in 2020? Find Out Here

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