Stemson Therapeutics Secures $7.5M Seed Financing for the Development of Breakthrough Hair Regeneration Therapy to Cure Hair Loss – Business Wire

SAN DIEGO--(BUSINESS WIRE)--Stemson Therapeutics announced today a $7.5 million seed financing led by Allergan Aesthetics, an AbbVie Company, and impact investor Fortunis Capital to advance development of Stemsons therapeutic solution to cure hair loss. Stemson aims to restore human hair growth with a novel approach using the patients own cells to generate new hair follicles. Allergan Aesthetics is a world-leading medical aesthetics company. Fortunis Capital, a London-based venture capital firm, is committed to continuing support of Stemsons regenerative cell therapy to treat hair loss. Fortunis Capitals new Impact Fund intends to invest in companies, such as Stemson, who offer significant social or environmental benefit.

Stemsons novel cell therapy approach to treat hair loss has game-changing potential. Their experienced management team is poised to elevate its proprietary regenerative cell therapy method as it begins the next phase of its preclinical program, stated Sir Andrew Ross, Director of Investments at Fortunis Capital. Fortunis Capital is committed to supporting companies that are creating innovative solutions with worldwide social or environmental benefit, and we believe that Stemson has the team, technology and the tools in place to develop a therapy capable of solving the hair loss problem for millions of people in need.

The seed funding supports the preclinical development of Stemsons Induced Pluripotent Stem Cell (iPSC) based technology, which is capable of producing the cell types required to initiate hair follicle growth. Globally, hundreds of millions of men and women suffer from various forms of hair loss, and no solution today is capable of generating a new supply of follicles for patients in need.

Allergan Aesthetics research and development efforts are focused on products and technologies that drive the advancement of aesthetics medicine. Hair loss is a significant unmet medical need for millions of men and women, and Stemson Therapeutics efforts to develop novel methods to regrow hair is an opportunity to make a difference in this area, said Yehia Hashad, M.D. Senior Vice President, Research and Development, Allergan Aesthetics.

The initial seed financing allows Stemson to expand its management team and R&D resources, while recent approval of a foundational patent provides stability surrounding the Companys efforts to develop its radical solution for hair growth. The additions of Meghan Samberg, Ph.D. as Vice President of R&D and Preclinical Development, and Cenk Sumen, Ph.D. as Chief Technology Officer, complement the work of Stemsons cofounder and Chief Scientific Officer, Dr. Alexey Terskikh and the R&D team. Stemson received approval in the United States of its cornerstone Human Induced Pluripotent Stem Cell (iPSC) method patent licensed exclusively from the Sanford Burnham Prebys Medical Discovery Institute. The patent covers a novel process developed by Dr. Terskikh to differentiate iPSC into dermal papilla cells, the cell type primarily responsible for controlling hair follicle generation and hair cycling. The patent secures foundational methods using iPSC cell therapy to grow hair.

Stemson has established the biological and technical building blocks which are needed to solve the problem of hair loss. A truly curative solution is now feasible, and we have built a world-class team to deliver a therapy for the millions of hair loss sufferers across the world, said Geoff Hamilton, cofounder and chief executive officer of Stemson Therapeutics. We are grateful for support from Allergan Aesthetics and Fortunis Capital, and we look forward to expanding our base of investors as we move toward our first human clinical trial.

About Cell Regeneration Technology

Human Induced Pluripotent Stem Cell (iPSC) have the unique capability to replicate indefinitely and give rise to all cell types of the human body, including the cell types required for repair. iPSC-based technology is capable of producing the cell types required to initiate hair follicle growth. As a new therapeutic platform, iPSCs represent an emerging area of regenerative cell therapy. Stemson is one of a growing number of companies at the forefront in developing iPSC-based treatments.

About Fortunis Capital

Fortunis Capital is a London-based impact investment venture capital firm, whose vision is to support the positive evolution of society through sound and intelligent investment. The Company is the 101st signatory to the IFC led impact principles scheme under the auspices of the World Bank and a UK Home Office endorsing body that seek out and supports global innovation. Fortunis Capital invests in concepts that support the positive evolution of society by providing solutions to problems worth solving. Fortunis Capital seeks ground-breaking and innovative concepts and drives these companies forward to success. For more information about Fortunis Capital and their impact venture capital investing, please visit http://www.fortuniscapital.co.uk.

About Stemson Therapeutics

Stemson Therapeutics is driven by a vision where anyone battling the emotional trauma or social stigma of hair loss has an opportunity to truly cure their condition and safely restore their natural hair. Stemson was founded in 2018 based on a novel cell engineering process capable of producing the cell types required to regenerate hair follicles. Our engineered cells are combined with a unique tissue engineering solution and are capable of generating a net new supply of hair follicles for patients in need. Stemson Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.stemsontx.com.

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Treatment, Access to Caregivers Among Factors Affecting QoL in MM – AJMC.com Managed Markets Network

Investigators from the First Affiliated Hospital of Sun-Yat Sen, including corresponding author Juan Li, PhD, noted that while QoL has been studied extensively in patients with MM, most of the research has been conducted on western populations, and such studies tend to be based on clinical trial data, which they said is not representative of the wider population of patients with MM.

In the current study, the authors sent out a questionnaire to people with MM in all 27 provinces of China. A total of 430 people responded, and they had an average age of 55.7 years.

The results of the survey showed a number of factors can affect HRQoL. Among them, patients who underwent autologous stem cell transplantation (ASCT) had higher HRQoL than those who did not have the transplant. However, toxicities were a major concern. A vast majority (91.5%) of patients on maintenance therapy said they intended to stop the treatment, mostly due to adverse events and the high cost of treatment.

The application of ASCT has significantly improved the prognosis of patients with MM and prolonged the OS of patients, Li and colleagues wrote. However, as patient survival is prolonged, patients experience different levels of pain due to treatment-related toxicities.

Patient HRQoL scores were improved when patients were diagnosed quickly, though the study found only 16.7% of patients were diagnosed within a month of the onset of symptoms. The reasons for the delayed diagnosis included lack of awareness of the severity of the condition, failure by the hospital to confirm the diagnosis quickly, and inability to pay for care.

Access to a caregiver benefited patients HRQoL, but more than one-third (38.4%) did not have a caregiver. More than half of the patients (56.3%) said they had to travel to another city to receive care, another factor that negatively impacted their scores on functional and symptom measures, though it did not impact overall HRQoL, the authors said.

Four in 10 patients in the study reported psychosocial challenges, such as anxiety and depression.

Patients live with the uncertainty of a treatable but incurable cancer; they worry about how their illness will progress and are concerned about death and dying, the authors said. Overall, these findings suggest that patients need more psychological support during all phases of treatment.

Basic demographic factors, like age and sex, yielded mixed results. In a univariate analysis, both factors appeared to be associated with HRQoL. However, when investigators performed a multiple linear regression analysis, neither factor emerged as an independent predictor of HRQOL.

The authors said these data should provide clinicians with tools to identify patients who are at risk of diminished HRQoL.

Efforts should be made to identify persons at risk of low HRQOL earlier and improve the overall quality of life of these patients in China, they concluded.

Reference

Li X, Liu J, Chen M, et al. Health-related quality of life of patients with multiple myeloma: A real-world study in China. Cancer Med. Published online September 2, 2020. doi:10.1002/cam4.3391

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Stemson Therapeutics Secures GBP6m in seed financing – Private Equity Wire

Stemson Therapeutics announced today 6 million seed financing from impact investor Fortunis Capital and Allergan Aesthetics, an AbbVie Company, to advance development of Stemsons therapeutic solution to cure hair loss.

Stemson aims to restore human hair growth with a novel approach using the patients own cells to generate new hair follicles. Allergan Aesthetics is a world leading medical aesthetics company. Fortunis Capital, a London-based venture capital firm is committed to continuing support of Stemsons regenerative cell therapy to treat hair loss. Fortunis Capitals new Impact Fund intends to invest in companies, such as Stemson, which offer significant social or environmental benefit.

Stemsons novel cell therapy approach to treat hair loss has game-changing potential. Their experienced management team is poised to elevate its proprietary regenerative cell therapy method as it begins the next phase of its preclinical programme, says Sir Andrew Ross, Director of Investments at Fortunis Capital. Fortunis Capital is committed to supporting companies that are creating innovative solutions with worldwide social or environmental benefit and we believe that Stemson has the team, technology and the tools in place to develop a therapy capable of solving the hair loss problem for millions of people in need.

The seed funding supports the preclinical development of Stemsons Induced Pluripotent Stem Cell (iPSC) based technology which is capable of producing the cell types required to initiate hair follicle growth. Globally, hundreds of millions of men and women suffer from various forms of hair loss, and no solution today is capable of generating a new supply of follicles for patients in need.

Allergan Aesthetics research and development efforts are focused on products and technologies that drive the advancement of aesthetics medicine. Hair loss is a significant unmet medical need for millions of men and women, and Stemson Therapeutics efforts to develop novel methods to regrow hair is an opportunity to make a difference in this area, says Yehia Hashad, MD Senior Vice President, Research and Development, Allergan Aesthetics.

The initial seed financing allows Stemson to expand its management team and R&D resources, while recent approval of a foundational patent provides stability surrounding the Companys efforts to develop its radical solution for hair growth. The additions of Meghan Samberg, PhD as Vice President of R&D and Preclinical Development and Cenk Sumen, PhD as Chief Technology Officer complement the work of Stemsons cofounder and Chief Scientific Officer, Dr Alexey Terskikh and the R&D team. Stemson received approval in the United States of its cornerstone Human Induced Pluripotent Stem Cell (iPSC) method patent licensed exclusively from the Sanford Burnham Prebys Medical Discovery Institute. The patent covers a novel process developed by Dr Terskikh to differentiate iPSC into dermal papilla cells, the cell type primarily responsible for controlling hair follicle generation and hair cycling. The patent secures foundational methods using iPSC cell therapy to grow hair.

Stemson has established the biological and technical building blocks which are needed to solve the problem of hair loss. A truly curative solution is now feasible, and we have built a world class team to deliver a therapy for the millions of hair loss sufferers across the world, says Geoff Hamilton, cofounder and chief executive officer of Stemson Therapeutics. We are grateful for support from Allergan Aesthetics and Fortunis Capital, and we look forward to expanding our base of investors as we move toward our first human clinical trial.

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LabRoots Announces Speakers to Present Cutting-Edge Research Findings at its 4th Annual Cell Biology Virtual Conference – PR Web

Cell Biology Virtual Event, September 23, 2020

YORBA LINDA, Calif. (PRWEB) September 17, 2020

LabRoots, the leading scientific social networking website offering premier, interactive virtual events and webinars, will be hosting its Cell Biology Virtual Event, scheduled on September 23, 2020. This day-long forum marks the fourth annual event that will attract innovative researchers, top scientists, biologists, and leading academia and industry from across the globe.

Emphasizing the principals and fundamentals of biology, the one-day program features four sessions encompassing Organelle Dynamics, Cell Biology of Cancer, Extra Cellular Matrices, and Exosomes convening global leaders to present their latest progress in cell research. Discussions on transformative new technologies and applications in the field will be unveiled via over 15 scientific presentations on topics such as the role of Nox-derived Reactive Oxygen Species in Axonal Growth and Guidance, the journey into discovery oncology at the crossroad of cell biology, Extracellular Matrix in Renal Development and Cancer, GeoMx Digital Spatial Profiling read-out for Next-Generation Sequencers with the Cancer Transcriptome Atlas (CTA), Extracellular Vesicles and Chronic Kidney Disease, and Beyond the Culture Flask: How Membrane- and Microfluidic-based Platforms can create more Physiologically Relevant Tissue Culture Systems, naming a few.

This years first keynote address will be given by internationally recognized Muller Fabbri, MD, PhD, Associate Professor, Co-Leader Cancer Biology Program, University of Hawaii Cancer Center, explaining how MicroRNAs in Extracellular Vesicles orchestrate the biology of the Tumor Microenvironment. The programs second keynote will be delivered by Steve Caplan, PhD, Professor and Vice Chair for Administration, Dept. of Biochemistry and Molecular Biology, Director, UNMC Advanced Microscopy Core Facility on sorting out the mechanisms of endocytic recycling. Following, Benedetta Bussolati, Associate Professor of Nephrology, University of Torino, President of the Italian Society for Extracellular Vesicles, and internationally known for her studies of stem cell biology and regenerative medicine, will explore Extracellular vesicles in Regenerative Medicine during her keynote presentation. Lastly, the final keynote talk presented by Kenneth W. Witwer, PhD, Associate Professor, Molecular and Comparative Pathobiology, John Hopkins University of School of Medicine will explore starting at the source: tissue extracellular vesicles and Alzheimers disease.

This Cell Biology event produced by Labroots includes different tracks on the most exciting approaches to understand Cell Biology, ranging from exosome/extracellular vesicles to proteomics and cancer biology, said Dr. Laura Perin, Assistant Professor at the Keck School of Medicine, University of Southern California, and Planning Committee Member. The Committee is grateful to the high caliber leaders and experts that will share insights and novel research which are fundamental in advancing the field of medicine bringing innovative avenues for the discovery of new treatments for our patient populations.

Cell Biology 2020 is committed to continuing our unique tradition of bringing the scientific community together providing the discovery, innovation, and medical advances that drive biomedical research forward, said Greg Cruikshank, Chief Executive Officer of LabRoots. For the 4th consecutive year, were delighted to showcase some of the brightest minds in cell science on the agenda, while offering cutting-edge educational content for our attendees on a global front.

The online event produced on LabRoots signature platform allows participants to learn and connect seamlessly across all desktop and mobile devices. Featuring up-to-date emerging findings from the field in the auditorium, poster and exhibit halls, and a networking lounge to foster collaborations, Cell Biology 2020 delivers an all-inclusive interactive environment. By attending this event, you can earn 1 Continuing Education credit per presentation for a maximum of 30 credits.

To register for the event and for more information, click here. Participants can follow the conversation online by using #LRcellbio.

About LabRoots LabRoots is the leading scientific social networking website, and primary source for scientific trending news and premier educational virtual events and webinars and more. Contributing to the advancement of science through content sharing capabilities, LabRoots is a powerful advocate in amplifying global networks and communities. Founded in 2008, LabRoots emphasizes digital innovation in scientific collaboration and learning. Offering more than articles and webcasts that go beyond the mundane and explore the latest discoveries in the world of science, LabRoots users can stay atop their field by gaining continuing education credits from a wide range of topics through their participation in the webinars and virtual events.

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Stem Cells May Help COVID-19 and ARDS Patients Breathe Easier – BioSpace

ARDS makes you feel like you cant breathe, like youre suffocating, said Eileen Rubin, J.D., ARDS survivor and Founder of the ARDS Foundation.

Acute respiratory distress syndrome (ARDS) is as scary as it sounds. A person is usually sick with something else, such as the flu, COVID-19, or sepsis (a serious bloodstream bacterial infection), before they develop ARDS. Suddenly, the person has trouble breathing, is short of breath, and feels like they are suffocating. ARDS patients quickly go into respiratory distress and usually need to be put on a ventilator (and are typically put into a medically induced coma) to get them the oxygen they so desperately need.

Within about two days in the hospital, I went into respiratory arrest and was diagnosed with ARDS at age 33, Rubin explained. I spent nine weeks in the hospital, eight weeks on a ventilator, and four weeks in a medically induced coma.

Despite the seriousness of ARDS, Rubin wants those affected by the disease and their families to know there is hope. Over 50% of the almost 200,000 Americans diagnosed with ARDS each year recover and it is not a terminal illness.

ARDS patients are given the grim statistics about what is going to happen to them and how dire it is, she added. Where there is life, there is hope families should talk to their ARDS loved one if theyre in a coma, tell them the reasons they need to have hope and focus on the things they need to survive for.

This year, more people will be diagnosed with ARDS due to COVID-19. ARDS tends to develop in severely ill COVID-19 patients and is a common cause of death in these critical patients.

Rubin told BioSpace how her ARDS experience prompted her to help others by creating the ARDS Foundation. We also spoke to Gil Van Bokkelen, Ph.D., CEO of Athersys, a company developing stem cell therapy to treat ARDS, which is currently being tested in COVID-19 patients who develop ARDS.

Eileen Rubin, J.D., ARDS survivor and founder of the ARDS Foundation (left) and Gil Van Bokkelen, Ph.D., Chairman and CEO of Athersys (right). Source: Eileen Rubin and Athersys.

Eileens story: I cant breathe. I think Im dying.

It all started with lower back pain not something you think would land you in the hospital on a ventilator, fighting for your life days later.

I was suffering from excruciating lower back pain for eight days before going to my doctor, Rubin explained. They said I likely pulled a muscle, prescribed me a muscle relaxant, and sent me home.

A week later, she still felt horrible and was having difficulty breathing. She saw another doctor, who basically said the same thing and didnt order any tests, sending her home with the same muscle relaxer.

The next morning, she awoke around 5:00 a.m. with labored breathing and difficulty walking. After calling her doctor, they said they wouldnt see her again because they had just seen her yesterday. Frustrated and scared, she found another doctor who saw her later that afternoon. By then, her blood pressure was dangerously low (70/50), she had blood in her urine and she became delirious. This third doctor finally ordered bloodwork and a chest x-ray but sent her home to await the results.

She awoke very early the next morning to a phone call from the doctor telling her to go to the emergency room immediately her white blood cell count was 3.5 times higher than normal. Once in the emergency room, she saw a pulmonologist who said she would need to be ventilated if her breathing got any worse. That night, her kidneys failed. Luckily, she was stabilized, but during her second day in the hospital, she became extremely short of breath.

I said to my mother, I cant breathe. I think Im dying. And my mother ran out of the room, Rubin recounted. My mother rushed to find my internist and repeated what I had said. My internist said, Shes okay, I just saw her. Shes just anxious. My mother replied, Listen, she just said this, and I need you to come see her now. So, the doctor came in and saw me.

Upon realizing how badly Rubin was doing, her doctor cleared the room, called a code and declared that she was in respiratory arrest. Almost three hours later, her family was let back into her room, only to find her ventilated in a medically induced coma.

Unfortunately, this pain denial isnt uncommon pain that women experience is far too often downplayed, not taken seriously, or outright dismissed in healthcare.

A woman in her 30s says she has pain in her chest and is having difficulty breathing is seen totally differently than a man with the same symptoms, Rubin noted. My doctors didnt even consider doing an EKG.

After receiving many units of blood, having her lungs collapse multiple times, developing some hospital-acquired infections and having five chest tubes placed, she was sent home to slowly recover after nine weeks in the hospital. Read her entire battle with ARDS, From Trial Attorney to Life Support in Only Days, on the ARDS Foundation website.

ARDS Foundation

A few years after recovering from her battle with ARDS, Rubin wanted to help other ARDS patients and their families, providing the information and support that she and her family didnt have.

When my sister went on the internet, all she got were medical articles filled with jargon and autopsy photos, Rubin commented. There was nothing positive written about ARDS, nothing that offered any support.

Rubin wanted to change that, so she created the ARDS Foundation in 2000. The foundation initially started to create a simple, easy to understand brochure for families explaining what ARDS is. Today, it is a nonprofit organization offering support, information, and awareness of ARDS to patients and families.

After ARDS, a lot of people become less outgoing, more reserved, Rubin noted. They dont feel like doing certain things and their personality changes they may suffer from anxiety, depression, or PTSD because their life is completely altered.

The foundation is also facilitating medical research to improve ARDS care and treatment.

My ARDS was treated much like it is today, with supportive therapy and ventilation there is no specific treatment for ARDS, Rubin explained. My doctors were just trying to put out all the fires that were going on while I was critically ill.

A stem cell therapy for ARDS

One company working towards an ARDS treatment is Athersys, a biotech company focusing on regenerative medicine therapies for diseases with significant unmet need. Their product, called MultiStem, is a certain type of off-the-shelf human stem cell being studied to treat a wide array of conditions, including neurological, cardiovascular, inflammatory, and immune diseases.

A vial of MultiStem cells. Source: Athersys

To make this therapy, stem cells are isolated from the bone marrow of healthy donors and separated to collect a certain population of cells called multipotent adult progenitor cells (MAPC). These specific stem cells are expanded in the lab to become MultiStem; they can be frozen for extended periods of time, ready for use when a patient needs them.

These cells have a robust and highly distinctive expansion potential material from a single donor can be used to produce millions of doses, which is well beyond the limits of other donor-derived cell types, explained Van Bokkelen.

MultiStem cells dont express molecules that would elicit a rejection response, meaning they dont require donor-recipient matching or immune suppression when being given to the patient. The cells can be used like a universal donor Type O blood product, Van Bokkelen added.

Because of the time sensitive nature of the conditions MultiStem is being used to treat (ARDS, stroke, trauma), timing is everything; being able to simply thaw ready-to-use cells and administer them to the recipient rapidly is key. Once the cells are delivered into the patient, they express a range of proteins and immune factors, giving the cells a unique drug-like profile.

Were administering living cells that are dynamically responsive to the signals and cues produced by the human body, unlike traditional pharmaceuticals or biologics that are designed to do one very specific thing, said Van Bokkelen. MultiStem is a living multifactor delivery system the cells home to sites of tissue damage and inflammation where they perform a whole series of actions.

When a virus like COVID-19 or another pathogen enters the body, the immune system becomes activated to destroy the pathogen. Sometimes, a hyperactive, over inflammatory state is triggered, which can actually be counterproductive and harmful. In fact, this cytokine storm is thought to cause ARDS in severe COVID-19 patients, resulting in the need for ventilation and frequently leading to death among seriously and critically ill individuals.

If we administer MultiStem cells to patients in this hyperinflammatory state, the cells will home to the spleen, the warehouse of activated immune cells, and calm everything down, restoring immunological homeostasis, Van Bokkelen explained. MultiStem cells dont just regulate one type of cell, they regulate a whole series of pathways that is what makes them so powerful.

Once the overactive immune response has been reigned in, the body is able to recover and heal faster, rather than spiraling out of control.

You might be thinking, If we have these stem cells inside us already, why wouldnt they do the same thing and tamp down the overactive immune response in the first place? While a person in the throws of a hyperactive immune response may have some of these specific stem cells (usually there is a very small amount in the bone marrow), they are slow to mobilize and there may not be enough to balance out the storm of activated immune cells.

If someone sustains a serious injury and theyre losing lots of blood, we give those patients a blood transfusion, Van Bokkelen posed. Its not that the body cant make red blood cells, its just that it cant do it fast enough to deal with the rapid blood loss. Similarly, we can administer MultiStem to a patient much faster than the body would be able to respond on its own, helping to get things back to where we want them to be.

A similar situation happens during a hyperactive immune response administering MultiStem to provide the body with more calming stem cells helps balance the immune response quickly to avoid damage to the patient.

Another bonus of these cells is that they have a finite half-life in the body; unlike a bone marrow transplant that replaces the bone marrow permanently, MultiStem cells are cleared over time just like other normal cells in the body.

MultiStem cells to treat COVID-19-induced ARDS

When COVID-19 appeared, the Athersys team thought MultiStem may be helpful for ARDS in COVID-19 patients because it had already been tested in ARDS animal models and clinical studies. Previously, MultiStem, delivered either intravenously or directly to the lungs (endobronchially), effectively treated ARDS in sheep alone and in conjunction with extracorporeal membrane oxygen (ECMO).

Athersys concluded a randomized, double-blind, placebo-controlled Phase I/II study (MUST-ARDS) last year in 36 ARDS patients. Patients treated with MultiStem had:

Overall, the cells were well-tolerated with no serious adverse reactions within 24 hours of administration.

We saw a dramatic difference one year after patients received a single dose of MultiStem, Van Bokkelen said. We were really helping patients get on the path to recovery and get back to where they wanted to be in terms of functional independence and quality of life.

The company currently has two ongoing studies of MultiStem in ARDS patients: ONE-BRIDGE, a Phase II study in non-infection induced (pneumonitis) ARDS patients; and MACoVIA, a Fast Track designated Phase 2/3 study in COVID-19 induced ARDS patients.

ONE-BRIDGE, sponsored by HEALIOS K.K., is a randomized study aiming to enroll 35 adult participants to assess MultiStems safety and effects on ventilator-free days and various biomarkers. Enrollment is expected to be completed by the end of 2020.

MACoVIA is a randomized, placebo-controlled study designed to enroll up to approximately 400 adult participants to assess MultiStems safety and tolerability in COVID-19 ARDS patients, as well as evaluate its effect on ventilator-free days and all-cause mortality. We worked with the FDA to get study approval in an accelerated timeframe of a few months we started enrolling patients in early May, added Van Bokkelen. Were hoping to complete the study sometime next year.

We welcome the progress being made by Athersys to find a solution to the huge unmet need of ARDS treatment, Rubin commented. We hope that their Phase 3 trials are completely successful because this treatment is much needed. We support all companies engaging in research on treatment options for ARDS.

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California’s $7.8 Billion Proposition 14 Could Expand Conflicts of Interest in Stem Cell Research | K. Lloyd Billingsley – The Beacon

K. Lloyd Billingsley Tuesday September 15, 2020 1:15 PM PDT

Proposition 14, according to Californias legislative analyst, Authorizes Bonds to Continue Funding Stem Cell and Other Medical Research. A yes vote means the state could sell $5.5 billion in general obligation bonds primarily for stem cell research. As David Jensen notes at Capitol Weekly, theres a bit more to it.

The $5.5 billion would extend the California Institute for Regenerative Medicine (CIRM), created by the $3 billion Proposition 71 in 2004. This measure, authored by real estate developer Robert Klein, promised life-saving cures for Parkinsons Alzheimers and other diseases. A ballpark figure for the number of certified life-saving cures and therapies CIRM produced in 16 years is zero. Proposition 71 also promised more than $1 billion for state coffers, but as Jensen notes, royalties to date have totaled only $462,433. CIRM failed to accomplish its stated goal, and now it wants to conduct research on therapy delivery and aging as a pathology along with vital research opportunities, not related to stem cells.

Proposition 14 would enlarge the CIRM board from 29 to 35 members. As Jensen explains, that creates more possibilities for conflicts of interest, a long-standing issue for the agency.

In 2012, for example, the prestigious Institute of Medicine found that more than 90 percent of CIRM funding went to institutions with representatives on the CIRM governing board. Proposition 14 enlarges that board and also increases the costs to Californians.

According to the legislative analyst, we estimate the total cost to pay off the bonds would be $7.8 billion$5.5 billion for the principal and $2.3 billion for the interest. State costs would average about $260 million per year for about 30 years.

The analyst also explains a way voters can prevent this spending. A no vote means the state could not sell $5.5 billion in general obligation bonds. If voters reject Proposition 14, David Jensen explains, CIRM will begin shutting its doors this winter.

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Study focuses on new discovery in regenerative medicine – ANI News

ANI | Updated: Sep 16, 2020 23:39 IST

Washington [US], September 16 (ANI): An international collaboration involving Monash University and Duke-NUS researchers have made an unexpected world-first stem cell discovery that may lead to new treatments for placenta complications during pregnancy.While it is widely known that adult skin cells can be reprogrammed into cells similar to human embryonic stem cells that can then be used to develop tissue from human organs -- known as induced pluripotent stem cells (iPSCs) -- the same process could not create placenta tissue.iPSCs opened up the potential for personalised cell therapies and new opportunities for regenerative medicine, safe drug testing, and toxicity assessments, however little was known about exactly how they were made.An international team led by ARC Future Fellow Professor Jose Polo from Monash University's Biomedicine Discovery Institute and the Australian Research Medicine Institute, together with Assistant Professor Owen Rackham from Duke-NUS in Singapore, examined the molecular changes the adult skin cells went through to become iPSCs. It was during the study of this process that they discovered a new way to create induced trophoblast stem cells (iTSCs) that can be used to make placenta cells.This exciting discovery, also involving the expertise of three first authors, Dr Xiaodong Liu, Dr John Ouyang and Dr Fernando Rossello, will enable further research into new treatments for placenta complications and the measurement of drug toxicity to placenta cells, which has implications during pregnancy.

"This is really important because iPSCs cannot give rise to placenta, thus all the advances in disease modelling and cell therapy that iPSCs have brought about did not translate to the placenta," Professor Polo said."When I started my PhD five years ago our goal was to understand the nuts and bolts of how iPSCs are made, however along the way we also discovered how to make iTSCs," said Dr Liu."This discovery will provide the capacity to model human placenta in vitro and enable a pathway to future cell therapies," commented Dr Ouyang."This study demonstrates how by successfully combining both cutting edge experimental and computational tools, basic science leads to unexpected discoveries that can be transformative," Professor Rackham said.Professors Polo and Rackham said many other groups from Australian and international universities contributed to the study over the years, making it a truly international endeavour. (ANI)

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New research connects the hormones we’re born with to lifetime risk for immunological diseases – MSUToday

Differences in biological sex can dictate lifelong disease patterns, says a new study by Michigan State University researchers that links connections between specific hormones present before and after birth with immune response and lifelong immunological disease development.

Published in the most recent edition of the Proceedings of the National Academy of Sciences, the study answers questions about why females are at increased risk for common diseases that involve or target the immune system like asthma, allergies, migraines and irritable bowel syndrome. The findings by Adam Moeser, Emily Mackey and Cynthia Jordan also open the door for new therapies and preventatives

This research shows that its our perinatal hormones, not our adult sex hormones, that have a greater influence on our risk of developing mast cell-associated disorders throughout the lifespan, says Moeser, Matilda R. Wilson Endowed Chair, professor in the Department of Large Animal Clinical Sciences and the studys principle investigator. A better understanding of how perinatal sex hormones shape lifelong mast cell activity could lead to sex-specific preventatives and therapies for mast cell-associated diseases.

Mast cells are white blood cells that play beneficial roles in the body. They orchestrate the first line of defense against infections and toxin exposure and play an important role in wound healing, according to the study, Perinatal Androgens Organize Sex Differences in Mast Cells and Attenuate Anaphylaxis Severity into Adulthood.

However, when mast cells become overreactive, they can initiate chronic inflammatory diseases and, in certain cases, death. Moesers prior research linked psychological stress to a specific mast cell receptor and overreactive immune responses.

Moeser also previously discovered sex differences in mast cells. Female mast cells store and release more inflammatory substances like proteases, histamine and serotonin, compared with males. Thus, female mast cells are more likely than male mast cells to kick-start aggressive immune responses. While this may offer females the upper hand in surviving infections, it also can put females at higher risk for inflammatory and autoimmune diseases.

IBS is an example of this, says Mackey, whose doctoral research is part of this new publication.

While approximately 25% of the U.S. population is affected by IBS, women are up to four times more likely to develop this disease than men.

Moeser, Mackey and Jordans latest research explains why these sex-biased disease patterns are observed in both adults and prepubertal children. They found that lower levels of serum histamine and less-severe anaphylactic responses occur in males because of their naturally higher levels of perinatal androgens, which are specific sex hormones present shortly before and after birth.

Mast cells are created from stem cells in our bone marrow, Moeser said. High levels of perinatal androgens program the mast cell stem cells to house and release lower levels of inflammatory substances, resulting in a significantly reduced severity of anaphylactic responses in male newborns and adults.

We then confirmed that the androgens played a role by studying males who lack functional androgen receptors, says Jordan, professor of Neuroscience and an expert in the biology of sex differences.

While high perinatal androgen levels are specific to males, the researchers found that while in utero, females exposed to male levels of perinatal androgens develop mast cells that behave more like those of males.

For these females, exposure to the perinatal androgens reduced their histamine levels and they also exhibited less-severe anaphylactic responses as adults, says Mackey, who is currently a veterinary medical student at North Carolina State University.

In addition to paving the way for improved and potentially novel therapies for sex-biased immunological and other diseases, future research based will help researchers understand how physiological and environmental factors that occur early in life can shape lifetime disease risk, particularly mast cell-mediated disease patterns.

While biological sex and adult sex hormones are known to have a major influence on immunological diseases between the sexes, were learning that the hormones that we are exposed to in utero may play a larger role in determining sex differences in mast cell-associated disease risk, both as adults and as children, Moeser said.

For more information on Moesers research, go to the Gastrointestinal Stress Biology Laboratory. Also, visit the MSU College of Veterinary Medicines website for more about its research efforts.

(Note for media: Please include the following link to the study in all online media coverage: https://www.pnas.org/content/early/2020/09/10/1915075117)

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FDA Approves Study to Investigate the Use of Cell Therapy to Treat COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C) – PRNewswire

NEW YORK, Sept. 16, 2020 /PRNewswire/ --The Cura Foundation in collaboration with The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now, is supporting a clinical trial of human cord tissue mesenchymal stromal cells (hCT-MSC) to treat children with Multisystem Inflammatory Syndrome in Children (MIS-C). The trial is being led by Dr. Joanne Kurtzberg at Duke University to determine if infusions of hCT-MSCs are safe and can suppress the hyper-inflammatory response and positively impact the symptom course and duration, as well as the long-term effects of this life-threatening syndrome. The hCT-MSCs are manufactured in the Robertson GMP Cell Manufacturing Laboratory at Duke. The U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) Application, and Dr. Kurtzberg will proceed with a multi-site pilot study later this month.

As the school year is underway more children are being diagnosed with the SARS-CoV-2 virus. According to the American Academy of Pediatrics (AAP), the cumulative number of coronavirus cases diagnosed in children has more than tripled between July 2 and September 3 from 165,845 to 513,415. As of September 3rd, children represent at least 9.8% of diagnosed cases in the U.S. and in states such as Alaska, Minnesota, Tennessee, South Carolina, New Mexico and Wyoming, children account for more than 15 percent of total cases. Some of these children have developed very serious disease. The Centers for Disease Control and Prevention reported that as of September 3rd at least 792 children in 42 states have been diagnosed with Multisystem Inflammatory Syndrome in Children (MIS-C) and 16 have died.

The Principal Investigator of the study, Joanne Kurtzberg, MD, is the Jerome Harris Distinguished Professor of Pediatrics; Professor of Pathology; Director, Marcus Center for Cellular Cures; Director, Pediatric Blood and Marrow Transplant Program; Director, Carolinas Cord Blood Bank; Co-Director, Stem Cell Transplant Laboratory at Duke University School of Medicine/Duke Health and a leader in transplantation, cell therapy, and regenerative medicine in children. Clinical sites include Duke University (Durham, NC), Children's Healthcare of Atlanta (Atlanta, GA), New York Medical College (Valhalla, NY), and others as cases occur.

"We hope this is just the beginning of our ability to support the development of cell therapies to treat COVID-19 Related Multisystem Inflammatory Syndrome in Children," said Dr. Robin Smith,president of the Cura Foundation. "As students across the country return to in-class instruction, it is more important now than ever to ensure we are equipped with potential treatment options to care for children who develop this serious disease."

About the Sponsors

The Cura Foundationleads a global health movement with the goal to improve human health. Cura unites public and private sectors, partnering with doctors, patients, business leaders, philanthropists and thought leaders to create a collaborative network that tackles major health issues and accelerates funding to advance innovations in medicine. Cura believes that by encouraging interdisciplinary approaches to medicine, promoting preventative measures and advancing the development of breakthrough medical technologies you can improve access to care, streamline health care delivery and eliminate social disparities in health care. The Cura Foundation is a nonsectarian, nonpartisan, public and tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code. For more information, please visit: https://thecurafoundation.org/

The Marcus Foundationwas founded in 1989 by Bernie Marcus, co-founder and former CEO of The Home Depot, to support programs in Children and Youth Development, Community, Free Enterprise, National Security, Veterans, Jewish Causes, Healthcare and Medical Research.

Sanford Health, one of the largest health systems in the United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered in Sioux Falls, South Dakota, the organization includes 46 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and 10 countries. Learn more about Sanford Health's transformative work to improve the human condition at sanfordhealth.orgor Sanford Health News.

Duke Healthconceptually integrates the Duke University School of Medicine, Duke-NUS Medical School, Duke University School of Nursing, Duke University Health System, Private Diagnostic Clinic (Duke physicians practice), and incorporates the health and health research programs within the Duke Global Health Institute as well as those in schools and centers across Duke University, including the Duke-Robert J. Margolis Center for Health Policy.

Duke Health is committed to conducting innovative basic and clinical research, rapidly translating breakthrough discoveries to patient care and population health, providing a unique educational experience to future clinical and scientific leaders, improving the health of populations, and actively seeking policy and intervention-based solutions to complex global health challenges. Underlying these ambitions is a belief that Duke Health is a destination for outstanding people and a dedication to continually explore new ways to help our people grow, collaborate and succeed.

Alliance for Cell Therapy Now(ACT Now) is an independent, non-profit organization devoted to advancing the availability of and access to safe and effective cell therapies for patients in need. ACT Now convenes experts and stakeholders to develop and advance sound policies that will improve the development, manufacturing, delivery, and improvement of regenerative cell therapies. Seehttp://allianceforcelltherapynow.org/

Contact

The Cura FoundationRobin Smith, MD, +1-212-584-4176[emailprotected]

SOURCE Alliance for Cell Therapy Now

allianceforcelltherapynow.org

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FDA Approves Study to Investigate the Use of Cell Therapy to Treat COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C) - PRNewswire

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Global Regenerative Medicine Market Analysis & Forecast to 2025 – ResearchAndMarkets.com – Business Wire

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Market Analysis & Forecast to 2025; Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries" report has been added to ResearchAndMarkets.com's offering.

This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials. The analysis indicates that the global regenerative medicine market was worth $35 billion in 2019 and will grow to over $124 billion by 2025, with a CAGR of 23.3% between this time frame. This report describes the evolution of such a huge market in 15 chapters supported by over 350 tables and figures in 700 pages.

Key Questions Answered

Key Topics Covered:

1.0 Report Synopsis

2.0 Introduction

3.0 Stem Cells and Clinical Trials

4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing

5.0 Stem Cell Biomarkers

6.0 Manufacturing Stem Cell Products

7.0 Investment & Funding

8.0 Regenerative Medicine Market Analysis & Forecast to 2025

9.0 Stem Cell Market Analysis & Forecast to 2025

10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2025

11.0 Biobanking Market Analysis

12.0 Global Access & Challenges of the Regenerative Medicine Market

13.0 Cell and CAR T Therapy

14.0 Company Profiles

15.0 SWOT Industry Analysis

Companies Mentioned

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

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