Ad hoc announcement pursuant to Art. 53 LR

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FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

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- Successful nomination of lead SAFEbody candidates triggers milestone payment -

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Adagene Achieves Key Milestone in Collaboration with Exelixis for SAFEbody® Novel Masked Antibody-Drug Conjugate Candidates

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MONMOUTH JUNCTION, N.J., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that the Company has satisfied the requirements for trading of the Company’s common stock on the OTCQX® Best Market (“OTCQX”) and will begin trading on OTCQX at the open of the market on December 23, 2021 under the symbol ADXS. The Company previously traded on Nasdaq.

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Advaxis Announces Acceptance for Trading on the OTCQX

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FORT WORTH, TX , Dec. 22, 2021 (GLOBE NEWSWIRE) -- Sanara MedTech Inc. (“Sanara” or the “Company”) (NASDAQ: SMTI), a provider of products and technologies for surgical and chronic wound care dedicated to improving patient outcomes, announced today that J. Michael (“Mike”) Carmena will step down from the Company’s Board of Directors (the “Board”) and resign as the Company’s Principal Executive Officer, effective December 31, 2021 and Eric Tanzberger has been appointed to the Company’s Board effective January 1, 2022. Concurrently with his appointment to the Board, Mr. Tanzberger was appointed Chair of the Audit Committee.

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Sanara MedTech Inc. Announces the Retirement of J. Michael Carmena and Appointment of Eric Tanzberger to its Board of Directors

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PORTLAND, Ore., Dec. 22, 2021 (GLOBE NEWSWIRE) -- Chalice Brands Ltd. (CSE: CHAL) (OTCQB: CHALF) (“Chalice” or the “Company”), a premier consumer-driven cannabis company specializing in retail, production, processing, wholesale, and distribution, today announces the Company received all required regulatory approvals from the Oregon Liquor Control Commission (“OLCC”) and Clackamas County to complete its previously announced acquisition of the assets of Tozmoz, LLC (“Tozmoz”), an Oregon limited liability company, and it has reached an agreement (“Agreement”) on final terms.

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Chalice Brands Ltd. Announces Final Closing and Amended Terms of Acquisition of Tozmoz Assets, A Premier Cannabis Extractor In Oregon

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Basel, December 22, 2021 — Novartis, a leader in rheumatology and immuno-dermatology, today announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older1. Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the US. These are the second and third approvals for Cosentyx in a pediatric population in the US, and Cosentyx now has a total of five indications across rheumatology and dermatology1.

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Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis

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American Hospital Dubai launches the first and only autologous stem cell transplant department in Dubai. It is the first private hospital in the UAE to offer in-housestem cell transplant of patients stem cells, without the need for a donor. The services include laboratory diagnostics, chemotherapy, stem cell mobilisation, collection, storage and re-infusion with individualised care in specialised rooms.

stem cell transplant of patients stem cells, without the need for a donor. The services include laboratory diagnostics, chemotherapy, stem cell mobilisation, collection, storage and re-infusion with individualised care in specialised rooms.

The DHA-licensed stem cell unit is another step forward for American Hospital Dubais comprehensive cancer care programme, established more than 12 years ago.

The unit has a team of European- and US-qualified medical consultants, subspecialists and allied staff, with an international affiliation for multidisciplinary case review and discussions.

The units nurses are highly skilled in Bone Marrow Transplant (BMT) procedures, with experience in apheresis (separating blood components), cellular therapy, and post-transplant care.

The non-surgical transplant procedure is akin to a blood transfusion. It involves stimulating the stem cells, present mainly in bone marrow, by medication to travel out into the blood. This process, called Peripheral Blood Stem Cell collection, is more common in stem cell transplants for cancer treatment than harvesting stem cells directly from the bone marrow for a BMT.

Welcoming the launch, Dr Tarek Dufan, Chief Medical Officer, American Hospital Dubai, said, The stem cell transplant unit is another milestone in American Hospital Dubais commitment to delivering the most advanced healthcare to UAE and the region. Our cutting-edge Cancer Care Department has been a leader in oncology, and the stem cell unit expands our expertise in offering the latest cancer treatments and management.

Dr Maroun El Khoury, Director of Cancer Centre, said, American Hospital Dubais autologous stem cell transplant unit is the only one of its kind in the UAE. We have highly trained staff specialised in stem cell transplant and care management, excellent in-house laboratory services, radiation facilities, and psychological support systems to deliver a complete and compassionate care experience for patients.

The unit, led by Dr Shabeeha K. Rana, Consultant Haematologist and Director of Stem Cell Transplantation and Cellular Therapy at American Hospital Dubai, includes Dr Maroun El Khoury, Director of Cancer Centre; Dr Faraz Khan, Consultant Haematologist/Oncologist; Dr Julieta Zuluaga, Specialist Haematology and Stem Cell Transplantation; Dr Mona Tareen, Pain Management/Palliative Care Consultant; and Dr Melanie Schlatter, Clinical Psychologist.

The unit will treat haematological cancers such as multiple myeloma, lymphoma, certain types of leukaemia and amyloidosis (build-up of a rare protein called amyloid in the body). In addition, it will treat non-haematological conditions such as germ cell tumours and autoimmune diseases such as multiple sclerosis, Crohns, and ulcerative colitis.

The unit provides patients with support groups who have undergone stem cell transplants as an invaluable psychological tool. Every opportunity is made available to patients to provide feedback, ask questions, and inform and educate themselves with written material resources and emotional support for pre-and post-treatment phases.

American Hospital Dubais stem cell transplant unit follows strict selection criteria before accepting patients to ensure the highest adherence to care quality, safety and efficacy.

This content comes from Reach by Gulf News, which is the branded content team of GN Media.

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American Hospital Dubai launches first and only autologous stem cell transplant centre in the UAE - Gulf News

Bone Marrow Stem Cells Comments Off on American Hospital Dubai launches first and only autologous stem cell transplant centre in the UAE – Gulf News | December 10th, 2021

JSP191 is well tolerated with no treatment-related adverse events in dose-escalation study

Single-agent conditioning with JSP191 is associated with engraftment, immune reconstitution, and clinical benefit

REDWOOD CITY, Calif., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (NASDAQ: JSPR), a biotechnology company focused on hematopoietic cell transplant therapies, today announced that data on JSP191 showing long-term benefits of hematopoietic stem cells (HSC) engraftment following targeted single-agent JSP191 conditioning in the treatment of severe combined immunodeficiency (SCID) will be presented at the 2021 American Society of Hematology (ASH) Annual Meeting.

The accepted abstract is published and available on the ASH website here.

Title: JSP191 As a Single-Agent Conditioning Regimen Results in Successful Engraftment, Donor Myeloid Chimerism, and Production of Donor Derived Nave Lymphocytes in Patients with Severe Combined Immunodeficiency (SCID)Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities; Novel Conditioning Approaches. Hematology Disease Topics & Pathways:Abstract: 554Date and Time: Sunday, December 12, 2021, 4.45 p.m. ET

Our ongoing study shows JSP191 to be well tolerated with no treatment-related adverse events across multiple patients ranging from 3 months to 38 years old, said Kevin N. Heller, M.D., Executive Vice President, Research and Development. In this study six of nine non-IL2RG patients with prior hematopoietic cell transplant (HCT), dosed in the initial JSP191 dose escalation (0.1, 0.3, 0.6 and 1.0 mg/kg), achieved HSC engraftment, nave donor T lymphocyte production, and demonstrated clinical improvement. As this trial continues to enroll, the 0.6 mg/kg dose will continue to be evaluated as the potential recommended Phase 2 dose (RP2D) based on HSC engraftment, clinical outcomes and an optimal half-life allowing for integration within existing transplant protocols. We believe that with these initial successful clinical findings, we are one step closer, and uniquely positioned to deliver a targeted non-genotoxic conditioning agent to patients with SCID.

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About Jasper Therapeutics

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

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements the proposed business combination between AMHC and Jasper Therapeutics, the estimated or anticipated future results and benefits of the combined company following the business combination, including Jasper Therapeutics business strategy, expected cash resources of the combined company and the expected uses thereof, current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the respective management teams of Jasper Therapeutics and AMHC and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper Therapeutics and AMHC. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions the outcome of any legal proceedings that may be instituted against the parties regarding the Business Combination; the risk that the potential product candidates that Jasper Therapeutics develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jasper Therapeutics product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper Therapeutics will be unable to successfully market or gain market acceptance of its product candidates; the risk that Jasper Therapeutics product candidates may not be beneficial to patients or successfully commercialized; the risk that Jasper Therapeutics has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper Therapeutics business; the risk that third parties on which Jasper Therapeutics depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper Therapeutics business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper Therapeutics will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; the potential inability of the parties to successfully or timely consummate the proposed transaction; the risk of failure to realize the anticipated benefits of the proposed transaction and other risks and uncertainties indicated from time to time in AMHCs public filings, including its most recent Annual Report on Form 10-K for the year ended December 31, 2020 and the proxy statement/prospectus relating to the proposed transaction, including those under Risk Factors therein, and in AMHCs other filings with the SEC. If any of these risks materialize or AMHCs and Jasper Therapeutics assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that neither AMHC nor Jasper Therapeutics presently know, or that AMHC or Jasper Therapeutics currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect AMHCs and Jasper Therapeutics expectations, plans or forecasts of future events and views as of the date of this press release. AMHC and Jasper Therapeutics anticipate that subsequent events and developments will cause AMHCs and Jasper Therapeutics assessments to change. However, while AMHC and Jasper Therapeutics may elect to update these forward-looking statements at some point in the future, AMHC and Jasper Therapeutics specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing AMHCs and Jasper Therapeutics assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com

Lily Eng (media)Real Chemistry206-661-8627leng@realchemistry.com

Jeet Mahal (investors)Jasper Therapeutics650-549-1403jmahal@jaspertherapeutics.com

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Jasper Therapeutics to Present Data on JSP191 Conditioning in SCID patients at the 2021 American Society of Hematology Annual Meeting - Yahoo Finance

Bone Marrow Stem Cells Comments Off on Jasper Therapeutics to Present Data on JSP191 Conditioning in SCID patients at the 2021 American Society of Hematology Annual Meeting – Yahoo Finance | December 10th, 2021

Fifty years ago a boy was born whose brief life would bring hope for thousands of people diagnosed with blood disease.

Anthony Nolans struggle with deadly Wiskott Aldrich Syndrome and his mum Shirleys tireless campaign to save him by finding a suitable bone marrow donor moved the world.

Shirley established the worlds first register of volunteer donors here in the UK.

Tragically, she never did find a suitable match for Anthony and he died when he was seven years old.

But the register became his legacy, recruiting donors around the world. Their bone marrow and stem cells have saved more than 20,000 patients with leukaemia and other blood disorders.

Alan Corby spent six months in the next isolation room to Anthony at Westminster Childrens Hospital. Neither were expected to survive.

Alan said: Much of the time he was the only person I could see. We would talk and play card games like Twist through the glass.

When I was well enough I moved to my local hospital. I went back to see Anthony a few months later, but he had passed away.

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His life may have been short, but it had an incredible impact. Thousands have been given a second chance of life thanks to him and his mum.

On what would have been Anthonys 50th birthday, the Mirror meets three boys given hope of beating deadly blood diseases by his legacy.

Visit anthonynolan.org for more information or to join the donor register.

Georgie McAvoy knows the heartache Shirley Nolan endured searching for a donor to save her son.

Because her little boy Daniel was born with the same rare disease that killed Anthony.

Daniel, two, has Wiskott Aldrich Syndrome which prevents his blood cells from fighting infection and clotting properly. His only hope is a bone marrow transplant to reset his immune system.

A first transplant in June last year failed as Daniel body rejected his donor cells and relapsed.

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He is now preparing to undergo another gruelling course of chemotherapy, followed by a second transplant and will spend Christmas recovering in hospital.

Georgie, 31, said: We have been through so much, but Daniel is still fighting. He has coped with everything that has been thrown at him and he keeps smiling.

We are so grateful for the donor register and everything that Shirley Nolan did it is the reason that Daniel is still alive.

Daniels parents realised something was wrong when he began suffering nosebleeds and they found blood in his nappy when he was three weeks old.

He then developed sepsis and spent 11 days fighting for his life in intensive care.

Georgie and dad Andrew, 38, even asked the hospital chaplain to christen Daniel is his cot as they feared he might not survive.

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Georgie, from Huntingdon in Cambridge, said: The doctors told us he needed a bone marrow transplant to save his life, but that some children didnt make it to transplant.

It was devastating. We didnt know if he would start to walk or go to school. I remember thinking, I need him to be christened in case something happens.

It was emotional. Daniels big sister Holly wore a christening gown made from my wedding dress and Id planned for Daniel to wear it too, but that obviously wasnt possible.

Daniel was eventually diagnosed with Wiskott-Aldrich syndrome, a rare genetic disorder that affects one in every one million boys, in May last year after an unrelated hernia operation.

Neither his parents nor Holly, four, were a suitable match, so their only hope was to find a donor through the stem cell register, which the charity Anthony Nolan managed within two months.

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Daniel was due to undergo the transplant in March last year, but his procedure was postponed after the Covid pandemic began for fear there would be a shortage of doctors, nurses, or beds.

Georgie said: That was really scary. Daniel had been through all his preparation and we were ready to go, then everything blew up before our eyes. We didnt know what would happen.

Daniel continued to deteriorate, picking up more infections until his transplant finally went ahead at Great Ormond Street Hospital at the end of June as doctors could not risk waiting any longer.

He was only allowed one parent with him as he underwent chemotherapy to remove his immune system ahead of the transplant.

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Daniel returned home in August but suffered a drug relating seizure, then graft versus host disease as his body tried to reject the donor cells and spent last Christmas in hospital.

Georgie said: The last two relapses have been particularly difficult. During the last one he began vomiting digested blood. His stomach had to be drained constantly.

At that point they said there were no more options, we had to do another transplant and we needed a different donor as his body had rejected the first.

It will be hard spending another Christmas in hospital, but we feel so lucky to have found another donor to give Daniel a second chance. That wouldnt have happened without Anthony Nolan.

Time is running out for Alife Pinckney to find a lifesaving stem cell donor.

The eight year-old from Exeter relies on weekly blood transfusions to top up his critically low levels of platelets. That has bought Alfie more time, but his condition is getting worse.

His desperate family know his only hope is a transplant, but his mixed British and Chinese heritage makes it harder to find a matching tissue type to prevent his body rejecting the donor cells.

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Alfies mum Lily, said: Its so hard to watch your child in pain and be incapable of helping. Its tearing me apart. Our only hope is to encourage as many people as possible to join the register.

Alfie developed Aplastic Anaemia when he was five years-old. It means his body cannot produce the platelets he needs for his blood to clot properly and he cannot fight infection.

At the time his British-born parents Lily and Charles were living and working in Hong Kong. They returned to the UK just before lockdown last year to be near family and step up Alfies treatment just like Shirley Nolan moved home from Australia to search for a donor for Anthony.

They hoped they had found a donor earlier this year when a woman in Brazil was confirmed as a matching tissue type, but that fell through.

Image:

Since then, Alfie has continued to deteriorate as his body burns through the weekly platelet transfusions and he suffered a terrifying haemorrhage.

Dad Charles said: He had a huge, uncontrollable nosebleed and bleeding from the gums. He was clutching the kitchen bin, vomiting blood, screaming Daddy, help me.

We rushed him into the high dependency unit and I was mopping blood of his arms, face, and torso as several doctors and nurses tried to keep him alive. It was harrowing.

Its so easy to join the register. It only takes three minutes to swab your checks, then you can get on with your life. But that could help to save Mason or another childs life.

Katie Jordan got the devastating news that little Mason had blood cancer on Christmas Eve last year.

Image:

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The only cure for his Juvenile Myelomonocytic Leukaemia was a bone marrow transplant but mum Katie was not a good match, nor was anyone on the donor register.

Most children with the disease only survive for 12 months after diagnosis. So Katie, a single mum like Shirley, launched her own campaign to save her son.

Masons Mission raised nearly 54,000 for Anthony Nolan, helping the charity to test the backlog of 25,000 swab samples that built up during the pandemic and add them to the donor register.

Katie, from Stockton-on-Tees said: I was living my worst nightmare. It was heartbreaking to think that Christmas could have been our last together.

I would give my life for Mason, but I wasnt a match. So I did everything I could to find a donor.

Image:

Thankfully Anthony Nolan did find a suitable donor two months later and Mason had a successful stem cell transplant in March this year.

He was rushed back to hospital over the summer after developing blisters all over his body and spent a week fighting for his life in intensive care before they subsided.

But the two year-old made a full recovery and is now looking forward to a happy, healthy Christmas.

Katie said: We were lucky that we found a donor so quickly. When they told us, I couldnt stop crying. I would love to meet his donor one day and thank them."

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The Anthony Nolan legacy: Three boys given hope of beating deadly blood diseases - The Mirror

Bone Marrow Stem Cells Comments Off on The Anthony Nolan legacy: Three boys given hope of beating deadly blood diseases – The Mirror | December 10th, 2021

Report Ocean presents a new report on Mesenchymal Stem Cells Market size, share, growth, industry trends, and forecast 2026, covering various industry elements and growth trends helpful for predicting the markets future. The global mesenchymal stem cells market size to reach USD 2,518.5 Million by 2026, growing at a CAGR of 7.0% during forecast period, according to a new research report published . The report Mesenchymal Stem Cells Market, [By Source (Bone Marrow, Umbilical Cord Blood, Peripheral Blood, Lung Tissue, Synovial Tissues, Amniotic Fluids, Adipose Tissues); By Application (Injuries, Drug Discovery, Cardiovascular Infraction, Others); By Region]: Market Size & Forecast, 2018 2026 provides an extensive analysis of present market dynamics and predicted future trends. The market was valued at USD 1,335.1 million in 2017. In 2017, the drug discovery application dominated the market, in terms of revenue. North America region is observed to be the leading contributor in the global market revenue in 2017.

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In order to produce a holistic assessment of the market, a variety of factors is considered, including demographics, business cycles, and microeconomic factors specific to the market under study. Mesenchymal Stem Cells Market report 2021 also contains a comprehensive business analysis of the state of the business, which analyzes innovative ways for business growth and describes critical factors such as prime manufacturers, production value, key regions, and growth rate.

The Centers for Medicare and Medicaid Services report that US healthcare expenditures grew by 4.6% to US$ 3.8 trillion in 2019, or US$ 11,582 per person, and accounted for 17.7% of GDP. Also, the federal government accounted for 29.0% of the total health expenditures, followed by households (28.4%). State and local governments accounted for 16.1% of total health care expenditures, while other private revenues accounted for 7.5%.

This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the markets future growth.

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These stem cells mainly function for the replacement of damaged cell and tissues. The potential of these cell is to heal the damaged tissue with no pain to the individual. Scientists are majorly focusing on developing new and innovative treatment options for the various chronic diseases like cancer. Additionally, the local governments have also taken various steps for promoting the use of these stem cells.

The significant aspects that are increasing the development in market for mesenchymal stem cells consist of enhancing need for these stem cells as an efficient therapy option for knee replacement. Raising senior populace throughout the world, as well as increasing frequency of numerous persistent conditions consisting of cancer cells, autoimmune illness, bone and cartilage diseases are elements anticipated to enhance the market development throughout the forecast period. The mesenchymal stem cells market is obtaining favorable assistance by the reliable federal government policies, as well as funding for R&D activities which is anticipated to influence the market growth over coming years. According to the reports released by world health organization (WHO), by 2050 individuals aged over 60 will certainly make up greater than 20% of the globes population. Of that 20%, a traditional quote of 15% is estimated to have symptomatic OA, as well as one-third of these individuals are expected to be influenced by extreme specials needs. Taking into consideration all these aspects, the market for mesenchymal stem cells will certainly witness a substantial development in the future.

Increasing demand for better healthcare facilities, rising geriatric population across the globe, and continuous research and development activities in this area by the key players is expected to have a positive impact on the growth of Mesenchymal Stem Cells market. North America generated the highest revenue in 2017, and is expected to be the leading region globally during the forecast period. The Asia Pacific market is also expected to witness significant market growth in coming years. Developing healthcare infrastructure among countries such as China, India in this region is observed to be the major factor promoting the growth of this market during the forecast period.

The major key players operating in the industry are Cell Applications, Inc., Cyagen Biosciences Inc. Axol Bioscience Ltd., Cytori Therapeutics Inc., Stem cell technologies Inc., Celprogen, Inc. BrainStorm Cell Therapeutics, Stemedica Cell Technologies, Inc. These companies launch new products and undertake strategic collaboration and partnerships with other companies in this market to expand presence and to meet the increasing needs and requirements of consumers.

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Polaris Market Research has segmented the global mesenchymal stem cells market on the basis of source type, application and region:

Mesenchymal Stem Cells Source Type Outlook (Revenue, USD Million, 2015 2026)

Bone Marrow

Umbilical Cord Blood

Peripheral Blood

Lung Tissue

Synovial Tissues

Amniotic Fluids

Adipose Tissues

Mesenchymal Stem Cells Application Outlook (Revenue, USD Million, 2015 2026)

Injuries

Drug Discovery

Cardiovascular Infraction

Others

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Mesenchymal Stem Cells Regional Outlook (Revenue, USD Million, 2015 2026)

North America

U.S.

Canada

Europe

Germany

UK

France

Italy

Spain

Russia

Rest of Europe

Asia-Pacific

China

India

Japan

Singapore

Malaysia

Australia

Rest of Asia-Pacific

Latin America

Mexico

Brazil

Argentina

Rest of LATAM

Middle East & Africa

What are the aspects of this report that relate to regional analysis?

The reports geographical regions include North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa.

The report provides a comprehensive analysis of market trends, including information on usage and consumption at the regional level.

Reports on the market include the growth rates of each region, which includes their countries, over the coming years.

How are the key players in the market assessed?

This report provides a comprehensive analysis of leading competitors in the market.

The report includes information about the key vendors in the market.

The report provides a complete overview of each company, including its profile, revenue generation, cost of goods, and products manufactured.

The report presents the facts and figures about market competitors, alongside the viewpoints of leading market players.

A market report includes details on recent market developments, mergers, and acquisitions involving the key players mentioned.

What is the key information extracted from the report?

Extensive information on factors estimated to affect the Market growth and market share during the forecast period is presented in the report.The report offers the present scenario and future growth prospects Market in various geographical regions.The competitive landscape analysis on the market as well as the qualitative and quantitative information is delivered.The SWOT analysis is conducted along with Porters Five Force analysis.The in-depth analysis provides an insight into the Market, underlining the growth rate and opportunities offered in the business.

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Mesenchymal Stem Cells Market Growth Drivers 2021, Industry Share-Size, Global Demand, Emerging Trends, Opportunities in Grooming Regions, Key Players...

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Sanford Health is continuing to explore the potential of orthobiologics and regenerative medicine with a study that may advance treatment for those living with osteoarthritis.

This trial known as ENDURE, which is run in full compliance with the FDA, will examine the safety and effectiveness of adult, adipose (fat)-derived stem cells.

Im really excited to get the trial started, said Donella Herman, M.D., a specialist in sports medicine at Sanford Health. Im even more excited about a year from now because I feel like were just going to learn so much about how effective this treatment is and what it is effective for.

Learn more: Orthopedics regenerative medicine at Sanford Health

Essentially, orthobiologics and regenerative medicine tap into the bodys natural healing ability.

Orthobiologics, a part of regenerative medicine, refers to the use of biological substances found in the body to help treat muscle and bone issues.

This may include injuries to muscles, tendons, and ligaments and as the focus of this trial more chronic conditions such as osteoarthritis.

When used properly by qualified providers, cell therapies are proving to be effective treatment options.

Our goals are to collect data for the different branches of orthobiologics, Dr. Herman said. Do people with knee osteoarthritis respond better with PRP (platelet rich plasma) or bone-marrow derived cells or fat-derived stem cells? Which works best? Which works for the longest time? Thats the kind of information were looking for. Its that kind of ratio that we just dont have right now.

One of the obstacles in regenerative medicine at this point, Dr. Herman said, is that its often being marketed by people with dubious clinical qualifications. They use underdeveloped research and make unfounded claims.

Its become a little bit of a wild, wild west with stem cells and PRP, Dr. Herman said. There are pop-up shops all over the place. Its one thing to have access to these things and allow access to people, but if youre not doing that in a responsible way and using that opportunity to build on a knowledge base, its kind of smoke and mirrors.

In sharp contrast to that scenario, this trial aims to add to the bank of knowledge in regenerative medicine.

We know we can tell people what were putting in their knee or their hip or their shoulder because were testing, Dr. Herman said. A lot of other places theyre just injecting it. They dont know if the stem cells are viable or not.

A typical candidate for the study, as described by Dr. Herman, might have osteoarthritis in their wrist and would not want to sacrifice a loss of motion that could come with surgery. They also would likely have exhausted the steroid injections treatment options that offer temporary relief.

We think of regenerative medicine as a possible alternative therapy that may help people put off surgery, Dr. Herman said. I dont ever tell people it means you will never need surgery but what it does is hopefully buy a little time until youre ready for that. There are lots of times where well do steroid injections until those fail and then they have to get a new joint. Were hoping for this to give us a bridge.

Once a patient is approved to be part of the ENDURE study, the procedure includes:

Follow-ups are then completed in person and over the phone.

Qualified candidates must be 18 or older and:

The cost associated with the study is not currently covered by insurance. By enrolling in the ENDURE study, however, participants may be playing a role in advancing regenerative cell research that could have the potential to improve care for future generations.

Those interested in hearing more about possible eligibility in the study can call (605) 328-3700.

Posted In Innovations, Orthopedics, Research, Specialty Care, Sports Medicine

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Sanford Health opens study of cell injections for arthritis - Sanford Health News

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What happened

Shares of Longeveron (NASDAQ:LGVN), a clinical-stage biotechnology company headquartered in Miami, are soaring in response to good news from the U.S. Food and Drug Administration (FDA). Investors excited about an orphan drug designation for the company's stem cell treatment pushed the stock 36.7% higher as of 10:37 a.m. ET on Friday.

Longeveron is developing bone marrow-derived mesenchymal stromal cells for the treatment of a variety of age-related disorders including Alzheimer's disease. Today, the FDA granted the company's lead candidate, Lomecel-B, an orphan designation for the treatment of a rare condition called hypoplastic left heart syndrome.

Image source: Getty Images.

Generally, orphan drug designations aren't something to get excited about. The FDA hands them out like candy to just about anyone that intends to develop a drug for underserved patients with a rare condition.

If approved to treat hypoplastic left heart syndrome, this orphan drug designation can begin assisting Longeveron with a handful of useful benefits. The most important one is seven years of market exclusivity.

There isn't much of a difference between the bone marrow-derived stem cells in Lomecel-B and the stem cells biomedical scientists have been researching for decades. They've been renamed medical signaling cells in recent years, but evidence of a significant benefit for specific indications remains elusive.

Longeveron is now a good stock to buy, and betting against it could prove disastrous, too. In the first quarter of 2022, Longeveron intends to begin clinical trials with Lomecel-B as a treatment for Alzheimer's disease.

This article represents the opinion of the writer, who may disagree with the official recommendation position of a Motley Fool premium advisory service. Were motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

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Here's Why Longeveron Is Surging Today - Motley Fool

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Significance

The recently introduced RNA velocity methods, by leveraging the intrinsic RNA splicing process, have shown their unique capability of identifying the directionality of the cell differentiation trajectory. However, due to the minimal amount of unspliced RNA contents, the estimation of RNA velocity suffers from high noise and may result in less reliable trajectories. Here, we present Velocity Autoencoder (VeloAE), a tailored autoencoder to denoise RNA velocity for more accurate quantification of cell transitions. Through various biological systems, we demonstrate its effectiveness for correcting the inferred trajectory and its interpretability for linking the learned dimensions to underlying biological processes.

RNA velocity is a promising technique for quantifying cellular transitions from single-cell transcriptome experiments and revealing transient cellular dynamics among a heterogeneous cell population. However, the cell transitions estimated from high-dimensional RNA velocity are often unstable or inaccurate, partly due to the high technical noise and less informative projection. Here, we present Velocity Autoencoder (VeloAE), a tailored representation learning method, to learn a low-dimensional representation of RNA velocity on which cellular transitions can be robustly estimated. On various experimental datasets, we show that VeloAE can both accurately identify stimulation dynamics in time-series designs and effectively capture expected cellular differentiation in different biological systems. VeloAE, therefore, enhances the usefulness of RNA velocity for studying a wide range of biological processes.

Author contributions: C.Q. and Y.H. designed research; C.Q. performed research; C.Q. contributed new reagents/analytic tools; C.Q. analyzed data; and C.Q. and Y.H. wrote the paper.

The authors declare no competing interest.

This article is a PNAS Direct Submission.

This article contains supporting information online at https://www.pnas.org/lookup/suppl/doi:10.1073/pnas.2105859118/-/DCSupplemental.

VeloAE is an open-source Python package available at GitHub, https://github.com/qiaochen/VeloAE. All the analysis notebooks for reproducing the results are also available in this repository. Previously published data were used for this work (8, 10, 1925).

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Representation learning of RNA velocity reveals robust cell transitions - pnas.org

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In the summer of 2015, a 7-year-old named Hassan was admitted to the burn unit of the Ruhr University Childrens Hospital in Bochum, Germany, with red, oozing wounds from head to toe.

It wasnt a fire that took his skin. It was a bacterial infection, resulting from an incurable genetic disorder. Called junctional epidermolysis bullosa, the condition deprives the skin of a protein needed to hold its layers together and leads to large, painful lesions. For kids, its often fatal. And indeed, Hassans doctors told his parents, Syrian refugees who had fled to Germany, the young boy was dying.

The doctors tried one last thing to save him. They cut out a tiny, unblistered patch of skin from the childs groin and sent it to the laboratory of Michele de Luca, an Italian stem cell expert who heads the Center for Regenerative Medicine at the University of Modena and Reggio Emilia. De Lucas team used a viral vector to ferry into Hassans skin cells a functional version of the gene LAMB3, which codes for laminin, the protein that anchors the surface of the skin to the layers below.

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Then the scientists grew the modified cells into sheets big enough for Ruhr University plastic surgeons Tobias Hirsch and Maximilian Kueckelhaus to graft onto Hassans raw, bedridden body, which they did over the course of that October, November, and the following January.

It worked better than the boys doctors could have imagined. In 2017, de Luca, Hirsch, Kueckelhaus, and their colleagues reported that Hassan was doing well, living like a normal boy in his lab-grown skin. At the time though, there was still a big question on all their minds: How long would it last? Would the transgenic stem cells keep replenishing the skin or would they sputter out? Or worse could they trigger a cascade of cancer-causing reactions?

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Today, the same team is out with an update. Five years and five months after the initial intervention, Hassan is still, for the most part, thriving in fully functional skin that has grown with the now-teenager. He is attending school, and playing sports with his friends and siblings, though he avoids swimming due to blistering in the areas that werent replaced by the lab-grown skin. One of his favorite activities is a pedal-powered go kart. There are no signs his modified stem cells have lost their steam, and no traces of tumors to be found.

The encouraging follow-up data has been instrumental in moving forward a larger clinical trial of the approach, offering hope to the 500,000 epidermolysis bullosa patients worldwide currently living without treatment options.

We were astonished by the speedy recovery, Kueckelhaus, now at University Hospital Muenster, told STAT via email. But experience from skin transplantation in other settings made him and his colleagues wary of the grafts failing as the months and years wore on. Thankfully, wrote Kueckelhaus, those fears never materialized. We are very happy to be able to prove that none of these complications appeared and the genetically modified skin remains 100% stable. The chances are good that he will be able to live a relatively normal life.

Over the last five years, Hassans team of doctors and researchers has put his new skin through a battery of tests checking it for sensitivity to hot and cold, water retention, pigmentation and hemoglobin levels, and if it had developed all the structures youd expect healthy skin to have, including sweat glands and hair follicles. Across the board, the engineered skin appeared normal, without the need for moisturizers or medical ointments. The only flaw they found was that Hassans skin wasnt as sensitive to fine touch, especially in his lower right leg. This mild neuropathy they attributed not to the graft itself, but to how that limb was prepared doctors used a more aggressive technique that might have damaged the nerves there.

The team also used molecular techniques to trace the cells theyd grown in the lab as they divided and expanded over Hassans body. They found that all the different kinds of cells composing the boys new skin were being generated by a small pool of self-renewing stem cells called holoclone-forming cells, carrying the Italian teams genetic correction.

This was quite an insight into the biology of the epidermis, said de Luca. Its an insight he expects will have huge consequences for any efforts to advance similar gene therapies for treating other diseases affecting the skin. You have to have the holoclone-forming cells in your culture if you want to have long-lasting epidermis, he said.

The approach pioneered by de Lucas team will soon be headed for its biggest clinical test yet, after nearly a decade of fits and starts. They expect to begin recruiting for a multi-center Phase 2/3 trial sometime next year.

De Luca first successfully treated a junctional EB patient in 2005. But then a change to European Union laws governing cell and gene therapies forced his team to stop work while they found ways to comply with the new rules. It took years of paperwork, building a manufacturing facility, and spinning out a small biotech company called Holostem to be ready to begin clinical research again. Hassan came along right as they were gearing up for a Phase 1 trial, but data from the boys case, which was granted approval under a compassionate use provision, convinced regulators that the cell grafts could move to larger, more pivotal trials, according to de Luca.

We didnt cure the disease, he told STAT. But the skin has been restored, basically permanently. We did not observe a single blister in five years. The wound healing is normal, the skin is robust. From this point of view, the quality of life is not even comparable to what it was before.

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Syrian refugee is thriving five years after last-gasp gene therapy - STAT - STAT

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Stem cell therapy, sometimes called regenerative medicine, is one of the most exciting areas of the life sciences sector right now.

Since the pandemic, the sector has emerged into the publics spotlight with new developments in mRNA-based vaccines and therapies.

Nasdaq is the obvious breeding ground for world-class stem cell companies with the likes of Moderna and BioNTech, and lesser known names like Anavex and Enochian.

In Australia, Mesoblast (ASX:MSB) has long been the local poster child for the regenerative medicine industry.

Mesoblast has developed a platform of innovative cellular medicines, but the company has struggled since the FDA rejected its drug in October last year.

Now, other ASX companies like Cynata Therapeutics (ASX:CYP)are making rapid progress to take over the mantle from MSB in this hot field.

Cynata is developing a mesenchymal stem cells (or MSC) technology, which it says has huge therapeutic potential for numerous unmet medical needs.

This includes asthma, heart attack, sepsis, and acute respiratory distress syndrome (ARDS), which all add up to a market opportunity worth $46bn, says the company.

According to CEO Dr Ross Macdonald, who spoke to Stockhead today, MSC is the hottest segment of stem cell therapy at the moment, and has gained a lot of attention recently.

There is a huge interest, and theres been more than 1000 clinical trials conducted around the world using MSC, Dr Macdonald told Stockhead.

He explains that the humans immune system controls many of the bodys functions responsible for repairing tissue after injury or disease, and defending against invading germs like viruses or bacteria.

And just like an orchestral conductor, MSC seems to be playing a central role in that coordination within our immune system.

We now have a firm understanding of how those cells coordinate the bodys responses, and can use that knowledge to enhance those processes that they control, Dr Macdonald explained.

In short, MSC therapies work by expressing a variety of chemokines and cytokines that aid in repair of degraded tissue, restoration of normal tissue metabolism and, most importantly, counteracting inflammation.

And because MSCs play that co-ordination role within the immune system, they can be used to treat different diseases.

However theres one big problem with cell-based therapies, and its not to do with the safety and efficacy.

Its how to manufacture these products on a mass scale, that is the greatest challenge right now, says Dr Macdonald.

Unlike aspirin where it can be synthesised in a chemical lab and produced in bulk, manufacturing a living drug like a cell is a whole lot more complicated.

But that big challenge is the exact area of strength and competitive advantage that Cynata has, Dr Macdonald told Stockhead.

He says Cynata has a technology platform which allows it to manufacture essentially limitless quantities of MSCs, consistently and economically.

Dr Macdonald explains there are two approaches to using cell therapy, the autologous and the allogeneic approach.

The autologous approach is where the patient themselves serves as their own donor.

This is obviously bespoke and inefficient, because the drug can only be manufactured for that one patient, and is obviously not an industrialised process, he said.

But by taking an allogeneic approach, Cynata has the ability to start with a one time donation of cells from one single donor.

Well never have to go back to that human donor ever again, so our process of producing cells has become a very much more typical industrialised process.

The company has a patent for this, with two clinical trials underway and two more under preparation.

A Phase 3 clinical trial for osteoarthritis which is funded by a NHMRC grant has progressed the furthest, while a Phase 2 trial in COVID-19 is ongoing.

Meanwhile a Phase 1 study in GvHD, which was published in prestigious journal Nature Medicine, is probably the closest to commercialisation according to Dr Macdonald.

GvHD is a challenging disease which occurs in patients who have had a bone marrow transplant as part of their chemotherapy treatment for cancer.

Chemo is still very much a sledgehammer therapy where you use very toxic drugs that do kill the cancer cells, but they also kill the surrounding healthy cells that grow hair and bone marrow.

Unfortunately for many patients, the bone marrow transplant reacts against their body and starts to attack all of the tissues in the body, and its ultimately fatal.

Its a horrible death, destroying the lungs, liver, intestines and the skin, Macdonald explains.

Cynatas MSC therapy has been shown to reset that reaction, so the patient can recover from the GvHD, and also recover from their underlying cancer.

With all these clinical trials concurrently under way, Macdonald believes there is a clear significant upside potential for Cynata, particularly given its small market cap of $70m compared to other similar plays like Mesoblast ($1 billion market cap).

Osteopore (ASX:OSX) focuses in bones and specialises in the production of 3D printed bioresorbable implants that are used in surgical procedures to assist with the natural stages of bone healing.

The 3D bio-printer makes a scaffold that mimics bone, with a patented micro-architecture which traps the patients own stem cells.

Orthocell (ASX:OCC) develops collagen medical devices and cellular therapies for the repair and regeneration of human tendons, bone, nerve and cartilage defects.

Its flagship product, the CelGro, is a naturally derived collagen medical device for tissue repair.

Aroa Biosurgery (ASX:ARX) develops FDA-approved medical devices for wounds and tissue repair using its extracellular matrix (ECM) technology, mainly in the United States.

Recent study shows 100% success rates from the use of its Myriad product when patients underwent surgical reconstruction of exposed vital structures such as bone and tendon.

Regeneus (ASX:RGS) Progenza is a cellular therapy targeting pain and inflammation which uses Secretome to improve not only the resident tissue, but the MSCs themselves.

It fills a gap in the current treatment market for osteoarthritis, by providing disease modification and pain relief to address patient symptoms.

Anteris Technologies (ASX:AVR) claims that its Adapt Technology is the first and only bio-scaffold technology that completely re-engineers xenograft tissue into a pure collagen scaffold.

A recent study indicated that Adapt-treated tissue has superior anti-calcification attributes compared with tissues used in competitor valves.

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Mesoblast has long been the one poster child for stem cell therapy. Now Cynata and other ASX stocks have e ... - Stockhead

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Inbreeding and wild tigers at risk of extinction

As habitat fragmentation increases worldwide, wild animal populations are shrinking and becoming more isolated, thus facing a heightened risk of inbreeding and extinction. The extent to which the viability of small, isolated populations could be improved by purging deleterious alleles through natural selection is unclear. Anubhab Khan et al. analyzed whole-genome sequences from 57 wild Bengal tigers from either a small, isolated population or large, connected populations in India. The results revealed evidence of partial purging of highly detrimental variants across populations. However, the small, isolated population showed genomic signs of greater inbreeding and a higher overall frequency of deleterious alleles, compared with two large populations. On average, pairs of individuals from the small, isolated population shared approximately 40% of their genomes in tracts at least 1 megabase long, whereas pairs from the large, connected populations shared approximately 1525% of their genomes. Together, the findings suggest that purging may not eliminate all detrimental alleles and inbreeding-associated fitness costs in small, isolated populations. According to the authors, the findings highlight the need for genetic rescue strategies that enhance the fitness of inbred populations by decreasing the frequency of harmful mutations and increasing genetic variation. J.W.

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In This Issue - pnas.org

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All articles published by MDPI are made immediately available worldwide under an open access license. No specialpermission is required to reuse all or part of the article published by MDPI, including figures and tables. Forarticles published under an open access Creative Common CC BY license, any part of the article may be reused withoutpermission provided that the original article is clearly cited.

Feature Papers represent the most advanced research with significant potential for high impact in the field. FeaturePapers are submitted upon individual invitation or recommendation by the scientific editors and undergo peer reviewprior to publication.

The Feature Paper can be either an original research article, a substantial novel research study that often involvesseveral techniques or approaches, or a comprehensive review paper with concise and precise updates on the latestprogress in the field that systematically reviews the most exciting advances in scientific literature. This type ofpaper provides an outlook on future directions of research or possible applications.

Editors Choice articles are based on recommendations by the scientific editors of MDPI journals from around the world.Editors select a small number of articles recently published in the journal that they believe will be particularlyinteresting to authors, or important in this field. The aim is to provide a snapshot of some of the most exciting workpublished in the various research areas of the journal.

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Cells | Free Full-Text | Improving Cardiac Reprogramming ...

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Event summary produced by The Globe and Mail Events team. The Globes editorial department was not involved.

Canada was a pioneer of stem cell research and today, innovators are developing clinical trials to test regenerative treatments for a range of illnesses including cardiac disease and Parkinsons. At the same time, theyre navigating risks and considerations that often surround medical innovations.

The Globe and Mail hosted a webcast on November 30 to explore the promise and potential of stem cells. Speakers also discussed ethical issues, misinformation and the importance of rigorous evaluation in bringing new treatments to market.

Missed the live event or would like to view it again? Scroll down to the video player, below.

Andr Picard, health reporter and columnist with The Globe and Mail moderated the event and hosted the following speakers:

Read a summary of the event here

View the full webcast, below:

The Globe and Mail presented the webcast with sponsor support from Bayer.

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Stem cells and the future of health care - The Globe and Mail

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LAWRENCE The human body contains trillions of cells at any given moment, each doing highly specialized work to help us function but they dont operate in isolation. Imagine a sophisticated FedEx or UPS delivery network empowering communication between our cells. The nano-sized delivery vehicles in this scenario are called exosomes, and a company born from technology developed at the University of Kansas is harnessing the power of these tiny vessels to enable tomorrows medical breakthroughs.

Clara Biotech, founded by KU engineering alumnus Jim West and former KU professor of chemical & petroleum engineering and chemistry Mei He, has spent the last three years refining a novel technology to isolate and purify exosomes, which can be used for early disease diagnosis, targeted drug delivery, cancer immunotherapy and other forms of regenerative medicine.

Now, the company is poised to commercialize its first product after recently finalizing $1.5 million in seed funding and being recognized in a national competition. Clara Biotech was the only Midwest company singled out in MedTech Innovators Biotools Innovator program, which recognizes the 10 best life science tools startups. The company received $10,000 for securing a spot in the 2021 cohort and a $5,000 best-video award for a one-minute spot introducing the company and detailing what sets it apart.

Clara Biotech was founded to help move exosomes from the bench to the bedside, said West, who serves as Claras CEO. Our company is about building a platform that everybody can leverage to bring their products to market and help solve challenges around isolation and purification, which today is one of the number one issues in the field.

Exosomes deliver genetic information to cells throughout the body. Exosomes from regenerative cells, such as stem cells, can help the body heal and repair itself. Exosomes released from diseased cells might be used for early detection and diagnosis of cancer and other conditions.

But at 100 nanometers in diameter less than the wavelength of visible light exosomes are difficult to handle.

Clara Biotechs patented ExoRelease platform is unique in the industry. Current processes rely on bulk isolation, whereas Claras capture and release technology isolates pure exosomes. This allows researchers to easily isolate and target specific exosomes including cardiac, neurological, cancer and others and use them for therapeutic treatments and drug delivery platforms.

Im very excited about the work that Clara Biotech is doing to improve exosome purification, said Kathryn Zavala, managing director of BioTools Innovator. Their technology has the potential to significantly impact how we diagnose and treat diseases by advancing the field of exosome research and development.

Clara Biotech launched in 2018 with a Small Business Innovation Research grant from the National Cancer Institute and received training through the National Science Foundations Innovation Corps (I-Corps) program on how to transfer knowledge into products and processes that benefit society. It has seven full-time employees, and its lab is housed in the KU Innovation Park.

Clara Biotech is an example of how KU innovation provides the foundation to form a company that addresses societal needs and creates Kansas jobs, said Tricia Bergman, KUs director of strategic partnerships. It also illustrates how technology developed in KU labs can transition into the KU Innovation Park, where the company can continue to develop through ongoing partnerships with the university.

Until now, Clara Biotech has provided lab services to its customers. Now, its moving toward packaging its technology so other companies, labs and researchers can leverage it to complete the isolation process themselves.

Were trying to democratize access to these exosomes, West said.

Clara Biotech is beta-testing kits containing its isolation technology with promising results from early adopters and hopes to launch its first product by the end of the year.

Building a company is probably the hardest thing Ive ever done in my life, but its also super rewarding, West said. The work were doing is really important.

Photo: Jim West, CEO of Clara Biotech, holds the two checks his company won at MedTech Innovators Biotools Innovator program in San Diego in October.

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Biotech company with KU roots wins national competition, secures funding to help move research 'from bench to bedside' | The University of Kansas - KU...

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Findings Continue to Change the Treatment of Blood Cancers

HACKENSACK, N.J., Dec. 9, 2021 /PRNewswire/ -- Researchers from Hackensack Meridian Health John Theurer Cancer Center (JTCC), a part of the Georgetown Lombardi Comprehensive Cancer Center, will present updates on treatment advances in multiple myeloma, lymphoma, leukemia, and bone marrow transplantation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, to be held virtually and live at the Georgia World Congress Center in Atlanta from December 11-14, 2021.

"John Theurer Cancer Center is a world leader in the care of people with hematologic malignancies and a pioneer in clinical research related to blood cancers. The acceptance of 47 studies from our investigators demonstrates our expertise in this area and our commitment to improving outcomes not only for our own patients, but people affected by these diseases everywhere," said Andre Goy, MD, MS, chairman and executive director of the John Theurer Cancer Center.

This year's presentations will include a plenary session as the #2 ranked abstract for the entire conference with data that will change the paradigm in the treatment of relapsed aggressive lymphoma for the FIRST TIME in 40 years. Dr. Lori Leslie, MD, director of the Indolent Lymphoma and Chronic Lymphocytic Leukemia Research Programs at JTCC will be co-presenter of the phase III international ZUMA-7 clinical trial (abstract #2), which compared axicabtagene ciloleucel (axi-cel) CAR T-cell therapy with standard of care (SOC) in patients with relapsed / refractory diffuse large B-cell lymphoma (DLBCL) after initial therapy. For decades the SOC has been high dose therapy followed by autologous stem cell transplant (ASCT) but patients with high risk disease and / or early relapse still do very poorly. Axi-cel is now used to treat DLBCL that have failed two prior regimens of treatment, including standard salvage chemoimmunotherapy (CIT) followed by ASCT.

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Bringing axi-cel earlier as second line therapy resulted in a 2.5-fold increase in median event-free survival (defined as the time without any cancer progression or any related complications) and doubled the complete response rate (65% vs 32%).

"This study is the first to change the paradigm for relapsed and refractory DLBCL that was established decades ago, demonstrating significant and clinically meaningful improvements in outcome," said Dr. Leslie. "Axi-cel may replace chemoimmunotherapy and autologous stem cell transplantation as the standard of care for people with DLBCL that relapses or persists after initial treatment. It is a game-changer."

The JTCC presentations address new developments in the treatment of multiple myeloma, lymphoma, leukemia, and bone marrow transplantation, as well as a study assessing gene therapy for sickle cell disease in pediatric patients.

Multiple Myeloma Research

Adding a PI3K inhibitor improved duration of CAR T-cell response. (Abstract #548, David S. Siegel, MD, PhD) In this phase I clinical trial, researchers showed that adding a PI3 kinase inhibitor called bb007 to bb2121 CAR T-cell therapy (forming a combined therapy called bb21217) in relapsed/refractory multiple myeloma (MM) patients who had three or more regimens of treatment resulted in a duration of response of 17 months (compared with 10 months for bb2121 alone in a prior study), and CAR T cells were detectable longer.

Study shows feasibility of "off the shelf" donated CAR T cells. (Abstract #651, David S. Siegel, MD, PhD). Current CAR T-cell therapies involve expensive modification of a patient's own T cells. Allogeneic (donated) CAR T cells represent a potentially more accessible, less expensive option but carry the risk of rejection and complications such as graft-vs-host disease. The phase I UNIVERSAL study demonstrated the safety of donated anti-BCMA CAR T cells in heavily pretreated MM patients, with mild to moderate side effects as expected for this type of immunotherapy.

Novel targeted MM therapies. Three abstracts provided additional data on novel targeted agents for relapsed/refractory MM. Selinexor was FDA approved in December 2020 and is being assessed in combination with other agents. A study of once-weekly oral selinexor with pomalidomide and dexamethasone (abstract #2748, Noa Biran, MD) showed an overall response rate of more than 60% in relapsed/refractory MM, including patients whose disease persisted after CAR T-cell therapy or after anti-CD38 antibody treatment. This is important because patients with MM after CAR T-cell therapy usually do not respond to additional treatment.

Study shows patients fare better if treated in high-volume academic medical centers. (Abstract #2996, David Vesole, MD, PhD, with Lombardi Comprehensive Cancer Center researchers) An analysis of data from the National Cancer Database of nearly 175,000 patients with MM treated at all types of facilities showed that the median overall survival was 75.5 months at high-volume centers versus 50.2 months at low-volume centers. Academic/research cancer programs with high volumes have the best outcomes in MM and are more likely to use chemotherapy, immunotherapy, and autologous stem cell transplantation than low-volume centers, particularly community cancer centers.

Lymphoma Research

Long-term data confirm durability of CAR T-cell benefit in indolent lymphoma. (Abstract #93, Lori Leslie, MD) An update of the pivotal ZUMA-5 clinical trial, which led to the approval of axi-cel CAR T-cell therapy for relapsed/refractory follicular lymphoma, confirmed continued benefit in patients with indolent lymphoma. In follicular lymphoma (most common subtype of indolent lymphoma), high response rates translated to durable responses, with a median duration of response of 38.6 months and 57% of patients free of cancer progression at last follow-up.

Study confirms benefit of CAR T-cell therapy for mantle cell lymphoma (MCL). (Abstract #744, Andre Goy, MD) ZUMA-2 led to the first approval of CAR T-cell therapy for MCL. An analysis of real-world data of MCL patients who received this treatment, 73% of whom would not have been eligible for ZUMA-2, demonstrated similar effectiveness, with an overall response rate of 86% and 64% achieving a complete response. The results support the paradigm-shifting benefit of this therapy in a heavily pretreated patient population where the median overall survival would have otherwise been very poor.

Molecular biomarkers predictive of CAR T-cell response. (Abstract #165, Andrew Ip, MD, Andre Goy, MD) Researchers performed whole exome and transcriptome sequencing to show that patients with DLBCL who had genetic signatures of high-risk disease with standard initial therapy do well with CAR T-cell therapy. Some mutations predicted good versus poor outcomes after CAR T-cell therapyreflecting differences in the tumor or its microenvironmentand may provide the rationale for choosing the most appropriate treatment for each patient and augmenting the response to CAR T-cell therapy.

Value of adding brentuximab to standard chemotherapy for peripheral T-cell lymphoma (Abstract #133, Tatyana Feldman, MD, Lori Leslie, MD) Non-anaplastic subtypes of T-cell lymphoma have poor outcomes and require new options. This study showed that adding brentuximab to conventional combination chemotherapy was tolerable and effective in patients with non-anaplastic CD30-positive peripheral T-cell lymphoma.

Machine learning useful for stratifying lymphoma patients. (Abstract #2395, Andre Goy, MD) Using machine learning and data on 380 patients with DLBCL with expression levels of 180 genes, researchers used machine learning to develop a model to reliably stratify patients with DLBCL treated with R-CHOP combination therapy into four survival subgroups. The model can be used to identify which patients may not respond well to R-CHOPa standard DLBCL treatmentand instead be considered for other therapies or clinical trials.

Lymphoma/CLL adversely affects COVID-19 outcomes. (Abstract #184, Lori Leslie, MD) A study of electronic medical record data on 500 patients with lymphoma, chronic lymphocytic leukemia (CLL), or other lymphoid cancers who tested positive for SARS-CoV-2 showed that those with aggressive non-Hodgkin lymphoma and CLL and patients who had received recent cytotoxic chemotherapy or anti-CD20 antibody treatment (such as rituximab) may be at risk for poor COVID-19 outcomes. JTCC researchers are now working with investigators in the Center for Discovery and Innovation to study T-cell immunity in people with cancer.

Other studies focused on adding ublituximab and umbralisib to ibrutinib in people with CLL (Abstract #395, Lori Leslie, MD) and assessing cerdulatinib as monotherapy for patients with relapsed/refractory peripheral T-cell lymphoma (Abstract #622, Tatayana Feldman, MD).

Leukemia Research

Oral therapy for low-risk myelodysplastic syndrome (MDS) (Abstract #66, James McCloskey, MD) People with MDS are at risk for developing acute leukemia. Those with low-risk MDS may receive supportive care for low blood counts. Patients with high-risk MDS have received inconvenient injections with drugs such as azacitidine and decitabine. This study showed that oral decitabine and cedazuridine was pharmacokinetically equivalent to intravenous decitabine; in patients with low-risk MDS, the oral treatment was well tolerated with prolonged treatment and may be useful for preventing the progression of this disease to leukemia.

Effectiveness of adding venetoclax to gilteritinib effective for FLT3-mutated acute leukemia (Abstract #691, James McCloskey, MD) Acute myeloid leukemia (AML) with FLT3 mutations initially responds to FLT3 inhibitors but frequently becomes resistant to these drugs. This study showed that giving venetoclax (a BCL2 inhibitor) with the FLT3 inhibitor gilteritinib was very effective, clearing the FLT3 mutation in most patients, and was associated with longer overall survivaleven in patients with high-risk subtypes.

Liquid biopsy for detecting molecular abnormalities in AML (Abstract #3463, Jamie Koprivnikar, MD, James McCloskey, MD, and others) This study assessed next-generation sequencing (NGS) to detect molecular abnormalities in AML using liquid biopsies. The data show that this approach is reliable for detecting structural chromosomal abnormalities in myeloid neoplasms. It could potentially replace the need for conventional cytogenetic testing, be much more convenient (replacing bone marrow biopsies for materials), and be more cost-effective.

Bone Marrow Transplantation Research

Next-generation sequencing and liquid biopsy valuable for detecting early relapse after stem cell transplantation. (Abstract #1828, Scott Rowley, MD, Michele Donato, MD, Maher Albitar, MD, and others) Cell-free DNA was isolated from the peripheral blood post-allogeneic transplant in patients treated for AML, acute lymphocytic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, MDS, MM, and lymphoma. Researchers showed that NGS and liquid biopsy are useful for detecting residual disease. The data suggest that this approach, which examines cancer DNA in peripheral blood rather than a sample from a bone marrow biopsy, may be effective for detecting and managing minimal residual disease (MRD)the next frontier in oncologyenabling doctors to modify therapy to achieve MRD negative status or, during transplantation, to adjust immunosuppressors or use additional T cells to prevent relapse.

Use of NGS and machine learning after transplant to predict graft-vs-host disease (GVHD) (Abstract #2892, Scott Rowley, MD, Michele Donato, MD, Maher Albitar, MD, and others) Using NGS RNA sequencing plus a machine learning approach, researchers looked at over 1,400 genes in 46 patients who had an allogeneic bone marrow transplant and developed a model based on 7 genes to predict acute GVHD, one of the most significant complications of receiving a transplant from a bone marrow donor. There are currently no valid ways to predict acute GVHD and intervene early until patients become symptomatic. The ability to identify molecular markers of this complication while patients are asymptomatic may allow for early intervention to prevent GVHD.

Sickle Cell Disease Research

Sustained quality of life in patients receiving gene therapy for sickle cell disease (Abstract #7, Stacey Rifkin-Zenenberg, DO, Hackensack University Medical Center) LentiGlobin gene therapy (bb1111) has been under study in a clinical trial as a one-time treatment and cure for sickle cell disease. This study presented long-term quality of life data for one group in the study, demonstrating an improvement in hematologic parameters and complete resolution of veno-occlusive events and related pain as well as sustained and clinically meaningful improvement in quality of life 6 and 24 months post-treatment. Even patients with the worst baseline quality of life scores experienced a benefit. LentiGlobin is the first gene therapy for sickle cell disease and the results of this study are very promising, with the potential to change patient outcomes for this chronic debilitating disease.

The full set of ASH data presentations by JTCC researchers is as follows:

Abstract #

Type

Title

Authors

Presenting (PST)

2

Plenary Scientific Session

Primary Analysis of ZUMA-7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma

Lori A. Leslie

Sunday, December 12, 2021: 2:00 PM-4:00 PM

7

Oral

Sustained Improvements in Patient-Reported Quality of Life up to 24 Months Post-Treatment with LentiGlobin for Sickle Cell Disease (bb1111) Gene Therapy

Stacey Rifkin

Saturday, December 11, 2021: 9:30 AM-11:00 AM

50

Oral

A Large Multicenter Real-World Evidence (RWE) Analysis of Autoimmune (AI) Diseases and Lymphoma: Histologic Associations, Disease Characteristics, Survival, and Prognostication

Tatyana A. Feldman, Jason Lofters

Saturday, December 11, 2021: 9:45 AM

66

Oral

Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study

James K McCloskey

Saturday, December 11, 2021: 10:45 AM

93

Oral

Long-Term Follow-up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL)

Pashna N. Munshi, Lori A. Leslie,

Saturday, December 11, 2021: 10:00 AM

133

Oral

Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed By BV Consolidation in Patients with CD30-Expressing Peripheral T-Cell Lymphomas

Tatyana A. Feldman, Lori A. Leslie

Saturday, December 11, 2021: 12:00 PM-1:30 PM

165

Oral

Impact of Molecular Features of Diffuse Large B-Cell Lymphoma on Treatment Outcomes with Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy

Andrew Ip, MD, Andre Goy

Saturday, December 11, 2021: 12:30 PM

184

Oral

A Multi-Center Retrospective Review of COVID-19 Outcomes in Patients with Lymphoid Malignancy

Lori A. Leslie

Saturday, December 11, 2021: 12:00 PM-1:30 PM

307

Oral

Post Hoc Analysis of Responses to Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) By Baseline BCR-ABL1 Level and Baseline Mutation Status in the Optic Trial

James K McCloskey

Saturday, December 11, 2021: 4:00 PM-5:30 PM

395

Oral

A Phase 2 Study Evaluating the Addition of Ublituximab and Umbralisib (U2) to Ibrutinib in Patients with Chronic Lymphocytic Leukemia (CLL): A Minimal Residual Disease (MRD)-Driven, Time-Limited Approach

Lori A. Leslie

Sunday, December 12, 2021: 10:30 AM

548

Oral

Updated Clinical and Correlative Results from the Phase I CRB-402 Study of the BCMA-Targeted CAR T Cell Therapy bb21217 in Patients with Relapsed and Refractory Multiple Myeloma

David S. Siegel

Sunday, December 12, 2021: 4:30 PM-6:00 PM

561

Oral

Polyclonality Strongly Correlates with Biological Outcomes and Is Significantly Increased Following Improvements to the Phase 1/2 HGB-206 Protocol and Manufacturing of LentiGlobin for Sickle Cell Disease (SCD; bb1111) Gene Therapy (GT)

Stacey Rifkin-Zenenberg

Sunday, December 12, 2021: 4:30 PM-6:00 PM

622

Oral

Phase 2a Study of the Dual SYK/JAK Inhibitor Cerdulatinib (ALXN2075) As Monotherapy in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma

Feldman

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