COVID- 19 Third Dose Approved for Certain Immunocompromised Individuals – the City of Cambridge

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The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recently approved an additional third dose of the COVID-19 vaccine for certain people who are immunocompromised due to a medical condition or because they are receiving medications or treatments that weaken their immune response.

The specific conditions and treatments include but are not limited to:

People who are immunocompromised are especially vulnerable to COVID-19 because they are more at risk of serious, prolonged illness, and may benefit from an additional dose to make sure they have enough protection against COVID-19. The CDC recommendation applies to immunocompromised people who received one of the mRNA vaccines (Pfizer or Moderna) and not the one-shot Johnson & Johnson vaccine (J&J).

Cambridge residents who have questions about whether a third dose of vaccine is recommended should contact their medical provider to discuss these recommendations.

Additional information may be found on the CDCs website here.

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COVID- 19 Third Dose Approved for Certain Immunocompromised Individuals - the City of Cambridge

Acute Myeloid Leukemia Treatment: What You Need to Know – Healthline

The umbrella term of leukemia encompasses several distinct types of leukemia, including acute myeloid leukemia (AML).

In 2021, its estimated that over 20,000 new cases of AML will be diagnosed, according to the National Cancer Institute (NCI). Since treatment varies depending on the specific kind of leukemia present, an accurate diagnosis is crucial.

There are a variety of treatments for AML. Your doctor will explain them and help choose a treatment plan based on the type of cancer you have and your individual situation.

Read on to learn more about the various treatment options for AML.

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. It affects white blood cells (WBCs), making them abnormal. In some forms of AML, they may also multiply very quickly.

Other names for AML include:

Read this for more information about AML.

Once the diagnosis is confirmed, your healthcare team will develop a plan to treat AML. Depending on the specific type and stage of AML, you may receive one or more of these treatments:

Chemotherapy is the main form of treatment for AML. Its divided into two phases:

Since AML can progress quickly, treatment is usually started as soon as possible after diagnosis. Other treatments may be used as well.

Chemotherapy, also called chemo, is the use of anti-cancer drugs to treat cancer. This is the main treatment for AML.

These drugs can be injected into a vein or under the skin, allowing the chemotherapy to travel through the bloodstream to attack cancer cells throughout the body. If leukemia has been found in the brain or spinal cord, chemo medication may be injected into the cerebrospinal fluid (CSF).

Chemo medications most often used to treat AML include:

Other chemo medications may include:

Side effects of chemotherapy can vary depending on the drug, dosage, and duration. They can include:

While chemotherapy is the main treatment for AML, for a subtype of AML called acute promyelocytic leukemia (APL), other non-chemotherapy drugs are more effective.

APL is caused by a specific gene mutation that affects WBCs. Some medications work better than chemo to help those cells develop normally. Two of these medications are:

ATRA can be given with chemotherapy or with ATO for the initial treatment of APL. Both drugs can also be given during consolidation.

Side effects of ATRA include:

Side effects of ATO can include:

Radiation therapy uses high-energy radiation to kill cancer cells. While its not the main treatment for those with AML, it can be used in treating AML. In AML, the radiation used is external beam radiation, which is similar to an X-ray.

Radiation can be used in AML to treat:

Side effects of radiation can include:

Surgery is rarely used in AML treatment. Leukemia cells are spread through the bone marrow and blood, making the condition impossible to improve with surgery. On rare occasions, a tumor or mass related to leukemia may form that may be treated with surgery.

Prior to chemotherapy, a small surgery to place a central venous catheter (CVC) or a central line, is often done. During this procedure, a small flexible tube is placed into a large vein in the chest. The end of it is either right under the skin or sticks out in the chest or upper arm.

Having a central line installed allows the treatment team to give intravenous medication and chemotherapy through the CVC, and to draw blood from it, reducing the number of needle sticks an individual has to have.

While chemotherapy is the main treatment for AML, it has its limits. Since high doses of these medications are toxic, the dosage must be limited. A stem cell transplant allows for higher doses of chemotherapy medications.

In a stem cell transplant, very high doses of chemotherapy medications, sometimes combined with radiation, are given. All of the individuals original bone marrow is destroyed on purpose.

Once this stage of therapy is over, blood-forming stem cells are given. These stem cells will grow, rebuilding the bone marrow. Healthy, cancer-free stem cells replace the destroyed bone marrow.

Read this article for more information about a stem cell transplant.

Targeted therapy drugs are medications that target only certain parts of cancer cells. They can be very effective for some people with AML. Most targeted therapy drugs are taken orally, except for gemtuzumab ozogamicin (Mylotarg), which is given as an intravenous infusion.

Talk with your treatment team about the potential side effects of each drug and what you should watch for when taking it. Some targeted therapy medications include:

One type of targeted therapy medication called FLT3 inhibitors targets the FLT3 gene. In some people with AML, a mutation in the FLT3 gene causes the creation of a protein, also called FLT3, that enables cancer cells to grow. Drugs in this category include:

Side effects of these drugs may include:

In some people with AML, there is a mutation in the IDH2 gene. These mutations stop bone marrow cells from maturing in a normal way. Medications called IDH inhibitors block IDH proteins produced by these mutated genes, allowing these bone marrow cells to grow normally and remain healthy.

Drugs in this category include:

Side effects can include:

AML cells contain a protein called CD33. A medication called gemtuzumab ozogamicin (Mylotarg) attaches to this CD33 protein and helps deliver chemotherapy medications directly to cancer cells so that these drugs are more effective.

Common side effects include:

There are less common but serious side effects like:

Venetoclax (Venclexta) is a BCL-2 inhibitor. This drug targets BCL-2, which is a protein that helps cancer cells live longer. The drug stops the BCL-2 protein from helping cancer cells survive so that these cancer cells die sooner. This medication can be used along with other chemotherapy drugs.

Side effects include:

AML can cause cellular mutations that prevent cells like bone marrow cells from developing and functioning normally. These mutations may affect the pathway cells use to send necessary signals. This pathway is called hedgehog. For some people with AML, especially those over age 75, strong chemo medications may be so harmful that chemo is not an option. For these individuals, a medication called, Glasdegib (Daurismo), may help them live longer. This medication helps stop the mutations and allows bone marrow cells to function normally.

Side effects of this medication may include:

Refractory AML happens when an individual is not in remission even after one to two cycles of induction chemotherapy, which means they have a blast count of 5 percent or more. Ten to 40 percent of people with AML have refractory AML.

If treatment isnt successful with one course of chemo, another one may be done. If a person is still not in remission after the second course of chemo, they may be given other medications or an increased dose of their current chemotherapy medications.

Other treatment options include stem cell transplant or a clinical trial of new therapies.

When an individual has no evidence of disease after treatment, its called remission or complete remission. Remission means these three criteria are met:

If there is no evidence at all of leukemia cells in the bone marrow, using highly sensitive tests, its called complete molecular remission. Minimal residual disease (MRD) occurs when, after treatment, leukemia cells cannot be seen in the bone marrow with standard tests but more sensitive tests like PCR tests do find leukemia cells.

Even after an individual has entered remission, they will likely need follow-up care and will need to be monitored by their doctor and healthcare team. This may mean additional tests, more frequent physical exams, and other care.

Although chemotherapy is the main treatment for AML, there are a variety of treatment options, depending on the AML subtype or whether you have a specific mutation. Treatment also depends on your response to initial treatment and whether or not remission is sustained.

Your treatment team will explain all of your treatment options and help you choose the treatment plan that is best for you and your individual situation.

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Acute Myeloid Leukemia Treatment: What You Need to Know - Healthline

3D Bioprinting Market Size to Reach USD 2,687.8 Million in 2027 | Increasing Use of 3D Bioprinters in Medical Procedures, Training and Testing Along…

VANCOUVER, BC, Aug. 17, 2021 /PRNewswire/ -- The global 3D bioprinting market size is expected to reach USD 2,687.8 Million in 2027 at a CAGR of 20.7% during the forecast period, according to the recent report by Emergen Research. Rapid technological advancements in 3D bioprinters, increasing investment to accelerate research and development activities of bioprinters, and rising use of 3D bioprinters to develop biomaterials for drug research and regeneration of joints and ligaments are key factors expected to drive market revenue growth over the forecast period. In addition, numerous advantages of 3D bioprinting in organ reconstruction to treat various end-stage disorders is another key factor contributing to the revenue growth of the market.

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3D bioprinting leverages techniques similar to additive manufacturing to mix up growth factors, cells, and biomaterials to create biomedical parts that can mimic natural tissue attributes. 3D bioprinting leverages layer-by-layer technique to add materials called as bioinks to create tissue-like structures that can be used in medical and tissue engineering procedures. Recent advancements in the technique has expanded its scope in drug design and development by creating target tissues and cells for drug research and testing. In addition, 3D bioprinters can be used to reconstruct tissues from any body part and this has further increased its applications for treating various severe and chronic disorders. Significant progress in tissue engineering and production of biomaterials have contributed considerably to the 3D bioprinting market growth.

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3D bioprinters have been extensively used in vaccine research during the COVID-19 pandemic. Bioprinting is widely being used in the development of regenerative medicines, stem cell therapies, drug research and therapies, and tissue and organ reconstruction. Increasing application of 3D bioprinting in cosmetic and pharmaceutical sector is also a key factor contributing to the revenue growth of the market going ahead. However, lack of skilled professionals and technical knowledge, high costs of 3D bioprinting, and limited access to advanced technologies in developing and underdeveloped countries are some key factors expected to restrain market growth to a significant extent over the forecast period.

Story continues

Some Key Highlights in the Report:

Inkjet-based printing segment is expected to account for largest revenue share over the forecast period owing to increasing adoption of ink-jet-based printing in healthcare industry for biofabrication of tissues and cells and in drug delivery approaches owing to its cost-effectiveness, higher reliability, and increased efficiency.

Living cells segmented accounted for a significantly large revenue share in the global market in 2019 and is expected to register considerable revenue growth going ahead owing to increasing use of living cells in stem cell research and regenerative medicine.

Research application dominated other segments in terms of revenue in 2019 and is expected to register robust revenue CAGR over the forecast period owing to increasing investment to accelerate R&D activities, rapid progress in stem cell research, and growing demand for regenerative medicine owing to increasing incidence of chronic diseases.

North America market revenue is expected to expand significantly over the forecast period owing to establishment of state-of-the-art healthcare facilities, increasing R&D activities in stem cell and regenerative medicine, rising investment by public and private organizations, and presence of key players in the region.

Asia Pacific is expected to register robust revenue CAGR over the forecast period owing to increasing demand for tissue and organ transplants, growing preference for cosmetic surgeries, and increasing investment to boost drug research and development.

Key companies in the market include Allevi Inc., Organovo Holdings, Inc., CELLINK, Aspect Biosystems Ltd., Cyfuse Biomedical K.K., EnvisionTEC GmbH, TeVido BioDevices, Poietis, Digilab, Inc., and Nano3D Biosciences, Inc, among others.

In July 2021, T&R Biofab, which is a Korean 3D printer manufacturer, announced successful fabrication of liver tissues and translation into an animal test subject for the first time ever in a groundbreaking research step. Leveraging the firm's 3DX bioprinter, researchers have been able to develop spherical microtissues into structures that can replicate the "lobules" found in human liver.

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For the purpose of this report, Emergen Research has segmented the global 3D bioprinting market on the basis of technology, material, application, and region:

Technology Outlook (Revenue, USD Million; 2017-2027)

Laser-based

Inkjet-based

Syringe-based

Magnetic Levitation

Others

Material Outlook (Revenue, USD Million; 2017-2027)

Hydrogels

Living Cells

Extracellular Matrices

Others

Application Outlook (Revenue, USD Million; 2017-2027)

Clinical Application

Research Application

Have a look at Report Description and Table of Contents of Market Research Report@ https://www.emergenresearch.com/industry-report/3d-bioprinting-market

Regional Outlook (Revenue, USD Million; 2017-2027)

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

Explore more reports offered by Emergen Research:

The Global Oncology Informatics Market size was valued at USD 4.62 Billion in 2019 and is anticipated to reach USD 8.01 Billion by 2027 at a CAGR of 7.1%. An increase in the awareness of the different types of treatment options for oncology will drive the demand for the oncology informatics market. The major driving factor is the rise in the prevalence of cancer and heavy investment by the government institutes and research organizations.

The Global Nerve Repair and Regeneration Market size was valued at USD 6.05 Billion in 2019 and is forecasted to reach USD 11.62 Billion by 2027 at a CAGR of 9.0%. The market is mainly driven by the rising geriatric population and the increasing prevalence of nerve injuries. The high incidence of neurological disorders among the growing population is expected to drive the Nerve Repair and Regeneration Market growth.

The Global Spinal Fusion Devices Market size was valued at USD 6.88 Billion in 2019 and is forecasted to reach USD 8.90 Billion by 2027 at a CAGR of 3.5%. The market is mainly driven by the increasing aging population and their growing need for spine care. Advancements in surgical technology is a key contributing factor behind the increasing demand for spinal fusion devices over the forecast period.

The Global Interventional Oncology Devices Market size was valued at USD 1.92 Billion in 2019 and is expected to reach USD 3.11 Billion by 2027 at a CAGR of 6.6%. The global Interventional Oncology Devices market is forecasted to expand exponentially owing to the rising preference for minimally invasive surgical procedures. The increasing government initiatives to support Interventional Oncology is anticipated to further propel the market growth over the forecasted timeframe.

The global spinal implants and surgery devices market size was valued at USD 10.22 Billion in 2019 and is forecasted to reach USD 14.70 Billion by 2027 at a CAGR of 4.6%. The spinal implants and surgery devices market is observing high demand owing to factors including the rising occurrence of spinal disorders, a rise in the elderly population, growing inclination for less invasive surgery, and growing research activities for developing technologically updated in spinal devices.

About Emergen Research

Emergen Research is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target, and analyze consumer behavior shifts across demographics, across industries, and help clients make smarter business decisions. We offer market intelligence studies ensuring relevant and fact-based research across multiple industries, including Healthcare, Touch Points, Chemicals, Types, and Energy. We consistently update our research offerings to ensure our clients are aware of the latest trends existent in the market. Emergen Research has a strong base of experienced analysts from varied areas of expertise. Our industry experience and ability to develop a concrete solution to any research problems provides our clients with the ability to secure an edge over their respective competitors.

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Some Residents Should Consider Third COVID-19 Vaccine Dose – Wyoming Department of Health

August 17, 2021

A third vaccine dose is now being recommended for a limited group of Wyoming residents with certain medical conditions, according to the Wyoming Department of Health (WDH).

Dr. Alexia Harrist, state health officer and state epidemiologist with WDH, said the Centers for Disease Control and Prevention (CDC) recommends people with moderately to severely compromised immune systems should receive an additional dose of Pfizer or Moderna COVID-19 vaccines.

National experts are seeing that people who are moderately to severely immunocompromised are especially vulnerable to COVID-19 because they are more at risk of serious, prolonged illness, Harrist said. An additional dose of the Pfizer or Moderna vaccines can help these people make sure they have enough protection against COVID-19.

Harrist said those who should consider an additional vaccine dose at this time include people who have:

Added doses have NOT yet been authorized or recommended and are not available at this time for people without compromised immune systems or who may have received the one-dose Johnson and Johnson vaccine.

The additional dose for people with compromised immune systems should be administered at least 28 days after the original vaccination series is completed. Residents with questions on whether they should consider the additional dose are encouraged to discuss the recommendation with their regular medical professional.

More important details about the current third-dose recommendation from the CDC can be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.

The authorized vaccines each continue to offer solid protection from infection for Wyoming residents, including against the Delta variant, Harrist said.

An updated WDH review of more than 7,000 lab-confirmed and probable cases identified among Wyoming residents age 18 and older between May 1 and August 10 shows just over 95 percent of the individuals did not report being fully vaccinated against COVID-19. During the same period, of the nearly 350 persons infected by COVID-19 who were hospitalized at the time they were interviewed by public health representatives, just under 95 percent did not report being fully vaccinated against COVID-19.

Harrist continues to encourage residents to seek out free, safe and effective COVID-19 vaccines, which remain readily available across Wyoming. As always, we will continue sharing information about future vaccine-related recommendations, she said.

Convenient ways to find where to get COVID-19 vaccines include:

A person is considered fully vaccinated two weeks after two doses of either the Pfizer or Moderna vaccine or two weeks after one dose of the Johnson and Johnson (Janssen) vaccine.

More information from WDH about vaccination in Wyoming can be found at https://health.wyo.gov/publichealth/immunization/wyoming-covid-19-vaccine-information/.

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Some Residents Should Consider Third COVID-19 Vaccine Dose - Wyoming Department of Health

Stem Cell Alopecia Treatment Market Size, Demand, Growth, Trends, Segmentation and Forecasts to 2028 – The Market Writeuo – The Market Writeuo

New Jersey, United States,-Verified Market Research recently released a new report titled Stem Cell Alopecia Treatment MarketSize Report, Growth and Forecast 2021-2028, Breakdown Data by Company, Key Regions, Types and Applications. The report has been compiled using primary and secondary research methodology that will provide a precise and precise understanding of the Stem Cell Alopecia Treatment market. Analysts used a top-down and bottom-up approach to assess the segments and properly assess their impact on the Stem Cell Alopecia Treatment market. The report offers a market overview which briefly describes the market situation and major segments. It also mentions the best players represented in the Stem Cell Alopecia Treatment market.

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APEX Biologix, Belgravia Center, RepliCel, Riken Research Institute, Kerastem, Sanford Burnham Prebys Medical Discovery Institute.

Stem Cell Alopecia Treatment Market Segmentation

Stem Cell Alopecia Treatment Market, By Indication

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Head-To-Head Phase 3 Trial To Evaluate BTK Inhibitors in MCL – Targeted Oncology

The open-label, randomized BRUIN trial will compare LOXO-305 to investigators choice of either ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa). Approximately 500 patients will be enrolled in the study.

"MCL patients who have been treated with a covalent BTK inhibitor have very few therapeutic options, and outcomes are extremely poor. LOXO-305 has demonstrated a promising efficacy profile in these patients, a setting where we urgently need new therapies," said Michael Wang, MD, Puddin Clarke Endowed professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, in a press release.

The primary end point of BRUIN is progression-free survival (PFS), and the secondary end points include event-free survival, time to treatment failure, time to worsening of MCL-related symptoms, comparative tolerability, overall response rate (ORR), duration of response, and overall survival.

A confirmed diagnosis of MCL is required for inclusion in the study as well as being previously treated with at least 1 prior line of systemic therapy for MCL, having measurable disease per Lugano criteria, having an ECOG performance status of 0 to 2, and having adequate laboratory values at baseline.

In the case of prior treatment with an FDA-approved or investigational BTK inhibitor, patients are ineligible to enroll in the study. According to the criteria, patients are also excluded if they have a history of bleeding diathesis, stroke, or intracranial hemorrhage within 6 months of randomization, and prior allogeneic stem cell transplant (ASCT) or chimeric antigen receptor (CAR) T-cell therapy within 60 days of randomization. In addition, patients with significant cardiovascular disease, and other comorbidities that may interfere with study treatment are not eligible to enroll.

Treatment with LOXO-305 has already shown promise for the treatment of 323 patients with previously treated B-cell malignancies. In the phase 1/2 BRUIN study, the use of the agent was investigated in patients with MCL, chronic lymphocytic leukemia/small lymphocytic leukemia, Waldenstroms macroglobulinemia (WM), and other B-cell malignancies. The patients were pretreated with a BTK inhibitor (95%), anti-CD20 antibody (98%), chemotherapy (92%), lenalidomide (Revlimid; 20%), autologous transplant (25%), CAR T-cell therapy (5%), and ASCT.3

According to data presented during the 2020 American Society of Hematology Annual Meeting, the ORR observed with LOXO-305 in 59 efficacy-evaluable patients from the MCL cohort was 52% (95% CI, 38%-65%), which included 14 complete and 15 partial responses. The median time to the first response in these patients was 1.8 months.

In the WM cohort of 19 efficacy-evaluable patients, the ORR observed was 68% (95% CI, 44%-87)%, which notably was similar in patients who were previously treated with a BTK inhibitor (69%; 95% CI, 39%-91%). Further, 4 out of 8 patients with follicular lymphoma had a response to LOXO-305, in addition to 75% of the evaluable Richter's transformation cohort, and 8 out of 35 patients with other B-cell malignancies, including diffuse large B-cell lymphoma and marginal zone lymphoma.

The most commonly reported adverse events (AEs) with LOXO-305 in the phase 1/2 BRUIN study were fatigue (20%), diarrhea (17%), and contusion (13%). Eight percent of patients had dose interruptions due to AEs, while 2.2% had dose reduction, and 1.5% permanently discontinued treatment with LOXO-305.

LOXO-305 was designed to overcome some of the limitations seen with current BTK therapies and we believe the promising efficacy and tolerability data demonstrate its potential to be an important new treatment option for MCL patients, said David Hyman, MD, chief medical officer of Loxo Oncology at Lilly, in a press release.

References:

1. Mato AR, Pagel JM, Coombs CC, et al. 542LOXO-305, a next generation, highly selective, non-covalent BTK inhibitor in previously treated CLL/SLL: results from the phase 1/2 bruin study. . Presented at: 2020 ASH Annual Meeting and Exposition. December 4-8, 2020; Virtual. Abstract 542.

2. Study of BTK inhibitor LOXO-305 versus approved BTK inhibitor drugs in patients withmantle cell lymphoma(MCL) (BRUIN-MCL-321). Clnicaltrials.gov. Accessed August 17, 2021. https://bit.ly/3CXTgu4

3. Loxo Oncology at Lilly announces updated data from the phase 1/2 BRUIN Clinical Trial for LOXO-305 in mantle cell lymphoma and non-Hodgkin lymphomas at the American Society of Hematology (ASH) Annual Meeting. News release. Loxo Oncology at Lilly. December 5, 2020. accessed August 17, 2021. https://prn.to/37QNw7a

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Head-To-Head Phase 3 Trial To Evaluate BTK Inhibitors in MCL - Targeted Oncology

Safety of Stem Cell Therapy for Chronic Knee Pain Confirmed in New Study – SciTechDaily

A study released inSTEM CELLS Translational Medicinehas confirmed the safety of a novel type of cellular therapy for knee pain caused by osteoarthritis. Conducted by a multi-institutional team of researchers in Japan who had developed the new therapy, the study was designed to confirm that their treatment which involves transplanting the patients own mesenchymal stem cells (MSCs) into the affected knee did not cause tumors.

The results showed that five years after transplantation, osteoarthritis-related tears to the knee meniscus had healed and, just as importantly, none of the patients experienced any serious side effects from the treatment. The meniscus is a crescent-shaped cartilage in the knee joint that plays a role in shock absorption. Age-related damage to the meniscus often leads to the progression of osteoarthritis of the knee.

Chronic knee pain is a major issue for the aging, affecting approximately 25 percent of all adults, according to the Centers for Disease Control and Prevention (CDC). Osteoarthritis is the most common cause of this condition in people aged 50 and older. Along with pain, which can be debilitating, knee problems can significantly affect the persons mobility and quality of life.

Knee replacement surgery is the gold standard of treatment, with the majority of people experiencing a dramatic reduction in pain and, thus, improvement in their ability to live a normal life. However, though rare, such surgery does come with risks such as the possibility of infection.

Lead investigator Mitsuru Mizuno, DVM, Ph.D. and corresponding author Ichiro Sekiya, M.D., Ph.D. Credit: AlphaMed Press

Cellular therapies are showing great potential as a less invasive way to treat difficult-to-heal knee injuries. The team behind the current study, which included researchers from Tokyo Medical and Dental University, Kyoto University and Kazusa DNA Research Institute, recently developed a therapy involving the transplantation of MSCs derived from the knees soft tissue (the synovium) into the injured meniscus. MSCs are multipotent adult stem cells present in the umbilical cord, bone marrow, fat, dental and other body tissues. Their ability to secrete biologically active molecules that exert beneficial effects on injured tissues makes them a promising target in regenerative medicine.

But some stem cell treatments have been known to cause tumors, which is why the team wanted to ensure that their therapy was free of any negative side effects. In particular, they wanted to investigate the safety of any MSCs that might show a type of chromosomal disorder called trisomy 7.

Trisomy 7 occurs frequently in patients with severe knee disease such as osteoarthritis. The detection of trisomy 7 in epithelial cells has been associated with tumor formation. However, the safety of these cells after transplantation has not been investigated. Thats what we wanted to learn from this study, said corresponding author Ichiro Sekiya, M.D., Ph. D., director and professor of the Center for Stem Cell and Regenerative Medicine (CSCRM) at Tokyo Medical and Dental University.

Mitsuru Mizuno, DVM, Ph.D., assistant professor with CSCRM, served as the studys lead investigator. He reported on the results. We recruited 10 patients for the study and transplanted their own stem cells into the affected knee joints, then followed up with MRIs over the next five years. The images revealed that tears in the patients knee meniscus were obscured three years after transplantation. We also identified trisomy 7 in three of the patients, yet no serious adverse events including tumor formation were observed in any of them.

Dr. Sekiya added, Keep in mind that these were autologous MSCs used in our study, which means that the transplanted MSCs came from the patients themselves. Any problems that might arise in the case of allogeneic cells, which are donated by someone other than the patient, still need to be determined.

Nevertheless, we believe that these data suggest that MSCs with trisomy 7 are safe for transplantation into human knees and show much promise in treating osteoarthritis.

This study highlights the ability of a patients own stem cells to potentially heal torn cartilage in the knee, said Anthony Atala, M.D., Editor-in-Chief ofSTEM CELLS Translational Medicineand director of the Wake Forest Institute for Regenerative Medicine. These outcomes suggest a potential approach that could change the overall physical health of patients who suffer from osteoarthritis and experience debilitating joint pain. We look forward to the continuation of this research to further document clinical efficacy.

Reference: Transplantation of human autologous synovial mesenchymal stem cells with trisomy 7 into the knee joint and 5 years of follow-up by Mitsuru Mizuno, Kentaro Endo, Hisako Katano, Naoki Amano, Masaki Nomura, Yoshinori Hasegawa, Nobutake Ozeki, Hideyuki Koga, Naoko Takasu, Osamu Ohara, Tomohiro Morio and Ichiro Sekiya, 3 August 2021, STEM CELLS Translational Medicine. DOI: 10.1002/sctm.20-0491

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Safety of Stem Cell Therapy for Chronic Knee Pain Confirmed in New Study - SciTechDaily

Asia-Pacific Cell Therapy Market8 – Opportunities in the Approval of Kymriah and Yescarta – Markets Insider

DUBLIN, Aug. 4, 2021 /PRNewswire/ -- The "Asia Pacific Cell Therapy Market Size, Share & Trends Analysis Report by Use-type (Clinical-use, Research-use), by Therapy Type (Autologous, Allogeneic) and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

The Asia Pacific cell therapy market size is expected to reach USD 2.9 billion by 2028. The market is expected to expand at a CAGR of 14.9% from 2021 to 2028.

Rapid advancements in regenerative medicine are anticipated to provide effective solutions for chronic conditions. A substantial number of companies in the growing markets, such as India and South Korea, are striving to capitalize on the untapped opportunities in the market, thereby driving the market.

The growth is greatly benefitted by the fund and regulatory support from government bodies and regulatory agencies. For instance, in August 2020, the government of South Korea passed an Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine to establish a regulatory system for patient safety during quality control and clinical trials and to strengthen the regulatory support for regenerative medicine development.

The implementation of the act is expected to enhance clinical studies and approvals of regenerative medicine in South Korea. Furthermore, CAR-T and TCR T-cell therapies have already revolutionized hematologic cancer treatment. With the onset of the COVID-19 pandemic, scientists are deciphering its potential against the novel coronavirus. The concept of using T cells against chronic viral infections, such as HIV and hepatitis B, has already been proposed.

Based on the previous research insights, Singapore-based Duke-NUS medical school's emerging infectious diseases research program demonstrated the utility of these immunotherapies in treating patients with COVID-19 infection.

Thus, an increase in research for use of cell therapies for COVID-19 treatment is expected to drive the market in Asian countries. In April 2021, a team of researchers from Japan used induced pluripotent stem cells (iPS) to find drugs that can effectively inhibit the coronavirus and other RNA viruses.

Key Topics Covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary 2.1 Market Snapshot

Chapter 3 Cell Therapy Market Variables, Trends, and Scope 3.1 Market Trends and Outlook 3.2 Market Segmentation and Scope 3.3 Market Dynamics 3.3.1 Market driver analysis 3.3.1.1 Rise in number of clinical studies for cellular therapies in Asia Pacific 3.3.1.2 Expanding regenerative medicine landscape in Asian countries 3.3.1.3 Introduction of novel platforms and technologies 3.3.2 Market restraint analysis 3.3.2.1 Ethical concerns 3.3.2.2 Clinical issues pertaining to development & implementation of cell therapy 3.3.2.2.1 Manufacturing issues 3.3.2.2.2 Genetic instability 3.3.2.2.3 Condition of stem cell culture 3.3.2.2.4 Stem cell distribution after transplant 3.3.2.2.5 Immunological rejection 3.3.2.2.6 Challenges associated with allogeneic mode of transplantation 3.3.3 Market opportunity analysis 3.3.3.1 Approval of Kymriah and Yescarta across various Asian countries 3.3.3.2 Developments in CAR T-cell therapy for solid tumors 3.3.4 Market challenge analysis 3.3.4.1 Operational challenges associated with cell therapy development & usage 3.3.4.1.1 Volume of clinical trials for cell and gene therapy vs accessible qualified centers 3.3.4.1.2 Complex patient referral pathway 3.3.4.1.3 Patient treatment, selection, and evaluation 3.3.4.1.4 Availability of staff vs volume of cell therapy treatments 3.4 Penetration and Growth Prospect Mapping for Therapy Type, 2020 3.5 Business Environment Analysis 3.5.1 SWOT Analysis; By factor (Political & Legal, Economic and Technological) 3.5.2 Porter's Five Forces Analysis 3.6 Regulatory Framework 3.6.1 China 3.6.1.1 Regulatory challenges & risk of selling unapproved cell therapies 3.6.2 Japan

Chapter 4 Cell Therapy Market: COVID-19 Impact analysis 4.1 Challenge's analysis 4.1.1 Manufacturing & supply challenges 4.1.2 Troubleshooting the manufacturing & supply challenges associated to COVID-19 4.2 Opportunities analysis 4.2.1 Need for development of new therapies against SARS-CoV-2 4.2.1.1 Role of T-cell based therapeutics in COVID-19 management 4.2.1.2 Role of mesenchymal cell-based therapeutics in COVID-19 management 4.2.2 Rise in demand for supply chain management solutions 4.3 Challenges in manufacturing cell therapies against COVID-19 4.4 Clinical Trial Analysis 4.5 Key Market Initiatives

Chapter 5 Asia Pacific Cell Therapy CDMOs/CMOs Landscape 5.1 Role of Cell Therapy CDMOs 5.2 Key Trends Impacting Asia Cell Therapy CDMO Market 5.2.1 Regulatory reforms 5.2.2 Expansion strategies 5.2.3 Rising investments 5.3 Manufacturing Volume Analysis 5.3.1 Wuxi Biologics 5.3.2 Samsung Biologics 5.3.3 GenScript 5.3.4 Boehringer Ingelheim 5.3.5 Seneca Biopharma, Inc. 5.3.6 Wuxi AppTech 5.4 Competitive Milieu 5.4.1 Regional network map for major players

Chapter 6 Asia Pacific Cell Therapy Market: Use Type Business Analysis 6.1 Market (Stem & non-stem cells): Use type movement analysis 6.2 Clinical Use 6.2.1 Market (stem & non-stem cells) for clinical use, 2017 - 2028 (USD Million) 6.2.2 Market (stem & non-stem cells) for clinical use, by therapeutic area 6.2.2.1 Malignancies 6.2.2.1.1 Market (stem & non-stem cells) for malignancies, 2017 - 2028 (USD Million) 6.2.2.2 Musculoskeletal disorders 6.2.2.3 Autoimmune disorders 6.2.2.4 Dermatology 6.2.3 Market (stem & non-stem cells) for clinical use, by cell type 6.2.3.1 Stem cell therapies 6.2.3.1.1 Market, 2017 - 2028 (USD Million) 6.2.3.1.2 BM, blood, & umbilical cord-derived stem cells/mesenchymal stem cells 6.2.3.1.3 Adipose-derived stem cell therapies 6.2.3.1.4 Other stem cell therapies 6.2.3.2 Non-stem cell therapies 6.3 Research Use

Chapter 7 Asia Pacific Cell Therapy Market: Therapy Type Business Analysis 7.1 Market (Stem & Non-stem Cells): Therapy type movement analysis 7.2 Allogeneic Therapies 7.3 Autologous Therapies

Chapter 8 Asia Pacific Cell Therapy Market: Country Business Analysis 8.1 Market (Stem & Non-stem Cells) Share by Country, 2020 & 2028

Chapter 9 Asia Pacific Cell Therapy Market: Competitive Landscape

For more information about this report visit https://www.researchandmarkets.com/r/3hdt1c

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

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Asia-Pacific Cell Therapy Market8 - Opportunities in the Approval of Kymriah and Yescarta - Markets Insider

Background should not be a barrier to access stem cell transplant treatment and care – PoliticsHome

4 min read30 July

Taking account of a patients background, the circumstances of their lives and the particular challenges they might face is crucial to delivering complex treatments like stem cell transplantation.

In May, the APPG on Stem Cell Transplantation published a report following its inquiry looking at how a patients background and circumstances, including a patients geographical location, socioeconomic background and ethnicity, can lead to barriers when accessing treatment and care.

Health Inequalities, as defined by NHS England, are unfair and avoidable differences in health across the population, and between different groups within society.

Rik Basra discovered the difficulties faced by patients of an Asian background when his Acute Myeloid Leukaemia (AML) returned after a two-year remission. The only hope for Rik was a stem cell transplant but he discovered his would be an uphill battle because its less likely for patients of an ethnic minority background to have someone already on the stem cell donor register who is a genetic match to donate their stem cells for this lifesaving treatment. Unfortunately for a variety of reasons, ethnic minority patients have only a 37% chance of finding an unrelated stem cell donor, compared to 72% for white patients.

This is just one of the experiences we heard about as part of this important Inquiry. A patient shouldnt experience disparity when it comes to the best treatment and care or chance of survival and future quality of life because of their background. The inquiry has explored how ethnicity, as well as other factors such as age, where you live and your socio-economic status can impact different parts of a patients treatment and care journey when receiving a stem cell transplant. The focus has been on understanding where the barriers lie, and what can be done to remove these barriers.

We were fortunate that we were able to find a donor for Max, others were not so lucky, particularly those from mixed race and ethnic minority backgrounds

My interest in this area stems from personal experience when some 13 years ago my elder son Max was diagnosed with Leukaemia. This was devastating for my son and my family. The whole world turns upside down as you embark on a programme of treatment and the subsequent decision to go down the transplant path.

We were fortunate that we were able to find a donor for Max. We were acutely aware that others were not so lucky, particularly those from mixed race and ethnic minority backgrounds. We were again fortunate that we had a supportive family network and a job that paid well. For many the financial impact of supporting a family member through this journey is huge and rarely talked about. I have long argued that we need to look at a treatment and support plan that looks at all these factors rather than just the physical treatment itself.

We received rich and insightful responses in our inquiry from over 40 patients, family members, clinicians, charities, and researchers through written and oral evidence. What became clear was that taking account of a patients background, the circumstances of their lives and the particular challenges they might face is crucial to delivering complex treatments like stem cell transplantation.

Our report explores recommendations to address these challenges, calling on government and the NHS, amongst others, to make changes such as investing in research and making sure care is culturally appropriate, meaning healthcare professionals have the ability to understand, communicate with and effectively interact with people across cultures. We were joined by Lord Bethell, a Health Minister with responsibility for stem cell transplantation, at the report launch. He commented on timeliness of this report and welcomed the recommendations made, citing a commitment for the Department to work with APPG on the recommendations.

We hope the findings from this report will act as a springboard to encourage more research and a renewed focus on understanding and overcoming barriers to accessing treatment and care for a stem cell transplant.

Our findings and our recommendations will be relevant far beyond stem cell transplantation. Its vital we use the lessons from the pandemic to make a real step-change in health inequalities. We have a once in a lifetime opportunity to ensure patients get the treatment, care and support they need whatever their background. Find out more about the inquiry here.

Mark Tamiis the Labour MP for Alyn and Deeside and chair of theAPPG on Stem Cell Transplantation.

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Background should not be a barrier to access stem cell transplant treatment and care - PoliticsHome

Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-Cell Therapy |…

Details Category: DNA RNA and Cells Published on Tuesday, 03 August 2021 10:03 Hits: 755

Off-the-Shelf CAR T-cell Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

Phase 1 Clinical Study will Evaluate Three Dosing Regimens of FT819 for Patients with Advanced B-cell Leukemias and Lymphomas

SAN DIEGO, CA, USA I August 02, 2021 I Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today that the first patient has been treated with FT819, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies. FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, a renewable cell source that enables mass production of high quality, allogeneic CAR T cells with greater product consistency, off-the-shelf availability, and broader patient accessibility. FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy.

Remarkable clinical outcomes have been achieved through treatment with patient-derived CAR T-cell therapy, however, next-generation approaches are necessary to reach more patients who are in need of these highly-effective therapies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Treatment of the first-ever patient with FT819 ushers in a new era for off-the-shelf CAR T-cell therapy, with the potential to overcome the real-world limitations of existing patient- and donor-derived therapeutic approaches and unlock the full potential of CAR T-cell therapy. We would like to thank our collaborators at Memorial Sloan Kettering Cancer Center, whose partnership over the past five years has profoundly contributed to this landmark achievement.

FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies. Under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering and Head, Gene Expression and Gene Transfer Laboratory, the Company incorporated several first-of-kind features into FT819 including:

The multi-center Phase 1 clinical trial of FT819 is designed to determine the recommended Phase 2 dose and schedule of FT819 and assess its safety and clinical activity in adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-cell lymphomas (BCL). Three treatment regimens will be independently evaluated for each type of malignancy in dose escalation: Regimen A as a single dose of FT819; Regimen B as a single dose of FT819 with IL-2 cytokine support; and Regimen C as three fractionated doses of FT819. For each indication and regimen, dose-expansion cohorts may be enrolled to further evaluate the clinical activity of FT819. The first patient with relapsed / refractory ALL was enrolled in Regimen A and received a dose of 90 million cells.

At the 24th American Society of Gene & Cell Therapy Annual Meeting held in May 2021, the Company presented preclinical data demonstrating that FT819 exhibits uniform 1XX CAR expression with complete elimination of endogenous TCR expression. The product candidate was shown to contain a stem- and central-memory T-cell phenotype, and had high-level expression of the activation marker CD25 and the trafficking marker CXCR4 and very low-level expression of the checkpoint proteins PD1, TIM3, CTLA4 and LAG3. Additionally, data from functional assessments showed that FT819 had potent antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of healthy donor-derived CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia.

Pursuant to a license agreement with MSK, Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452, which covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

Fate Therapeutics haslicensedintellectual propertyfrom MSK on which Dr. Sadelain is aninventor.As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics iPSC Product Platform The Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT819 FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease (GvHD). FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia (Valamehr et al. 2020). FT819 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

SOURCE: Fate Therapeutics

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Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-Cell Therapy |...