Stem Cell Clinic

Editing Reproduction: CRISPR and preventing heritable diseases, With Dr. Dietrich Egli and Dr. Sam Sternberg – Columbia University Irving Medical…

By Stem Cell Medical Center

PhD, Molecular Biology, University of Zurich, Maimonides Assistant Professor of Developmental Cell Biology, Columbia University BA, Biochemistry, Columbia University; PhD, Chemistry, University of California, Berkeley Assistant Professor of Biochemistry and Molecular Biophysics, Columbia University Host: Dr. Frances Onyimba, PS '12 Assistant Professor at University of Maryland School of Medicine

The genome we are endowed with at conception determines much of our health as an adult. Most human diseases have a heritable component and thus it may be possible to prevent them through heritable genome editing.Preventing disease from the beginning of life, and before irreversible damage occurs is just one of the many transformative opportunities of CRISPR/Cas systems.The ability to target an enzymatic activity to a precise location of the genome is already transforming science and is also poised to change medicine in many ways.

Please join us as our special panel explores the state of the field and distinguish science from science fiction.Dr. Sternberg will explain CRISPR and its origins, its ability to recruit enzymatic activities to the genome in a targeted manner, and how it has evolved into a powerful precision gene-editing tool. Then Dr. Egli Dieter will present pioneering research at Columbia and elsewhere on CRISPR's application in Reproduction, and its therapeutic potential in the adult population.

Time will be allocated for Q&A.

Dr. Dietrich Egli,grew up in Switzerland, and received his Ph.D. in molecular biology in 2003 from the University of Zurich with the mentorship of Prof. Walter Schaffner. He then joined the laboratory of Prof. Kevin Eggan at Harvard University as a postdoctoral fellow where he studied somatic cell reprogramming. Joining the New York Stem Cell Foundation Research Institute as one of the founding members in 2008, first as a postdoctoral fellow and from 2011 as an independent group leader, his group made numerous advances in somatic cell nuclear transfer and mitochondrial replacement. He is both a NYSCF Druckenmiller Alumn as well as a NYSCF Robertson Fellow Alumn, and is now the Maimonides Assistant Professor of Developmental Cell Biology at Columbia University Irving Medical Center. Areas of research in his group include human embryonic development, somatic cell reprogramming, modeling of metabolic disease using pluripotent stem cells, cell cycle regulation and double strand break repair, and preventing the transmission of disease-causing mutations in human reproduction.

Samuel H. Sternberg, PhD, runs a research laboratory at Columbia University, where he is an assistant professor in the Department of Biochemistry and Molecular Biophysics. He received his B.A. in Biochemistry from Columbia University in 2007, graduating summa cum laude, and his Ph.D. in Chemistry from the University of California, Berkeley in 2014, under the mentorship of Dr. Jennifer Doudna. He earned graduate student fellowships from the National Science Foundation and the Department of Defense, and received the Scaringe Award and the Harold Weintraub Graduate Student Award. Sam's research focuses on the mechanism of DNA targeting by RNA-guided bacterial immune systems (CRISPR-Cas) and on the development of these systems for genome engineering applications. He is the recent recipient of the NIH Directors New Innovator Award, and is a Sloan Fellow and Pew Biomedical Scholar. In addition to publishing his work in leading scientific journals, he co-authored a popular science book with Jennifer Doudna, entitled A Crack in Creation, about the discovery, development, and applications of CRISPR gene-editing technology.

Frances OnyimbaMD is a gastroenterologist at the University of Maryland Medical Center with a focus in esophageal diseases and GI motility disorders. She completed medical school at Columbia University College of Physicians and Surgeons prior to completing her internal medicine residency and a fellowship in GI motility and Neurogastroenterology at The Johns Hopkins Hospital. She subsequently completed her general GI fellowship at University of California San Diego, where she served as a chief fellow. In 2019, she was selected into the Young Physician Leadership Scholars Program by the American College of Gastroenterology for leadership development and physician advocacy. Her interests include health communications and innovative programs and practices within healthcare.

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Editing Reproduction: CRISPR and preventing heritable diseases, With Dr. Dietrich Egli and Dr. Sam Sternberg - Columbia University Irving Medical...

U. Cancer Center pilot projects: investigating cancer connections – The Brown Daily Herald

By Stem Cell Medical Center

Eight labs who were recipients of the University Cancer Centers funding in December for projects advancing cancer research will use the funds to delve into cancer biology, cancer therapeutics and population science.

Four of the eight projects are investigating immunotherapy for gastrointestinal cancers, the tumor environments impact on cancer cell growth, the potential application of an FDA-approved Parkinsons drug to treat glioma brain tumors and the ability of a novel drug to target cancer cells that exhibit heightened aggressiveness following immunotherapy, The Herald previously reported.

The Herald spoke with three of the four other principal investigators that received grants.

Assistant Professor of Medicine Hina Khans pilot project will study the effects of blocking the antibody for chitinase 3-like-1, or CHI3L1, in advanced non-small cell lung cancer. CHI3L1 is a protein that plays an important role in tissue repair, and elevated levels of the protein indicate poor outcomes in advanced stage cancer patients. The researchers will test whether blocking the antibody a molecule that binds CHI3L1 will prevent cell resistance to immune checkpoint inhibitors in this type of lung cancer.

Assistant Professor of Medicine Olin Liang is interested in exploring womens ability to fight off leukemia and other blood diseases later in life relative to men. While the effect of aging on blood cancer development has been well-studied, not much research has gone into studying sex differences, Liang said.

Past work from the Liang lab has shown that the bone marrow environment remains healthier longer in women, leading to better blood cell production and immune response. By transplanting bone marrow stem cells from young male mice into middle-aged male and female mice, the researchers were able to compare the expression of these cells amongst the two sexes. They found higher expression in female middle-aged mice, which is indicative of a healthier bone marrow environment. This observation was due to receptors molecules that can interact with hormones to produce a response in a cell on the surface of bone marrow stem cells that were uniquely responsive to sex hormones predominantly found in women.

We have narrowed it down to two sex hormone receptors that may play a role, Liang said, referring to the receptors for follicle-timulating hormone and androgen hormone. The lab plans to use the Cancer Center pilot project funds to further study the importance of these receptors.

Using gene editing technology, the researchers plan on removing genes that code for these hormone receptors from model organisms. This step will allow them to test the effect that the loss of one or both of the receptors has on female stem cell expression levels. If the elimination of the sex hormone receptor diminishes stem cell expression, that may indicate that the receptor plays a regulatory role.

The Liang lab believes that results from these experiments will not only offer greater insight to the development of blood cancers, but also help in the formulation of sex-specific treatments. Liang hopes this research leads to treatments that enhance the male (blood cell producing) system to reduce risk of age-related blood cancer, or even other diseases.

Assistant Professor of Molecular Biology, Cell Biology and Biochemistry Mamiko Yajima studies the expression of germline molecules, which are normally only expressed during development, and how they contribute to plasticity, or the cells adaptability. Her pilot project will focus on the specific germline factor DEAD-Box Helicase 4 (DDX4), which has been found to be abnormally expressed in the tumors of certain cancers, such as small cell lung cancer and melanoma.

Yajimas lab has previously studied the expression of DDX4 in cells and organisms like sea urchins and mice. She plans to test if (DDX4) actually contributes to plasticity in the context of cancer. Yajima believes that as a germline factor, DDX4 may increase cancer cells adaptability, allowing them to develop drug resistance and migrate throughout the body more frequently.

The Yajima lab plans on using the Cancer Center funding to partner with Director of Thoracic Oncology at Rhode Island Hospital Christopher G. Azzoli and Associate Professor of Pathology and Laboratory Medicine Maria L. Garcia-Moliner to analyze DDX4 expression in cancer patient samples.

I applied for this funding with the specific goal to have access to clinical samples, Yajima said. This next stage of the project will facilitate collaboration between me, a basic biologist, and physician scientists that have the expertise to help me answer the question I want to study in a clinical setting.

To identify whether DDX4 expression correlates with patient survival, the lab will also use the funds to conduct clinical data mining of patient gene expression using the Universitys supercomputer.

Associate Professor of Dermatology and Epidemiology Eunyoung Cho studies the role of dietary factors in the development of chronic diseases. Previous work from Chos lab found that eating foods containing high levels of citrus, such as grapefruits, oranges and figs, is associated with an increased risk of skin cancer. The Cho lab plans to use the Cancer Center pilot project funds to determine the component of citrus fruit responsible for the increased risk of melanoma, the most fatal type of skin cancer.

Cho believes that furanocoumarins, a class of compounds present in high levels in citrus fruits, are what lead to the higher rates of skin cancer. These compounds can absorb ultraviolet radiation from sunlight and become activated, damaging DNA and causing mutations that can result in cancer.

To test this hypothesis, Cho has partnered with Associate Professor of Medical Science Elena Oancea, who specializes in melanoma research at the molecular level. They plan on measuring whether melanin-forming skin cells show increased levels of DNA damage when exposed to furanocoumarins and UV light.

If their data supports that furanocoumarins increase risk of cancer, this could open the door to population-based studies. Cho described one potential future direction as assessing whether furanocoumarin levels in human urine samples are indicative of melanoma risk.

Its very interesting to think about citrus fruit is something you eat all the time, Cho said. People dont understand that when you eat grapefruit (and) then go into the sunlight, you may actually increase your chance of (getting) skin cancer.

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U. Cancer Center pilot projects: investigating cancer connections - The Brown Daily Herald

COVID-19 can kill heart muscle cells, interfere with contraction Washington University School of Medicine in St. Louis – Washington University School…

By Stem Cell Medical Center

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Study reveals details of how coronavirus infects heart; models of tissue damage may help develop potential therapies

A study from Washington University School of Medicine in St. Louis provides evidence that the coronavirus that causes COVID-19 can invade and replicate inside heart muscle cells, causing cell death and interfering with heart muscle contraction. The image of engineered heart tissue shows human heart muscle cells (red) infected with SARS-CoV-2 (green).

Since early in the pandemic, COVID-19 has been associated with heart problems, including reduced ability to pump blood and abnormal heart rhythms. But its been an open question whether these problems are caused by the virus infecting the heart, or an inflammatory response to viral infection elsewhere in the body. Such details have implications for understanding how best to treat coronavirus infections that affect the heart.

A new study from Washington University School of Medicine in St. Louis provides evidence that COVID-19 patients heart damage is caused by the virus invading and replicating inside heart muscle cells, leading to cell death and interfering with heart muscle contraction. The researchers used stem cells to engineer heart tissue that models the human infection and could help in studying the disease and developing possible therapies.

The study is published Feb. 26 in the Journal of the American College of Cardiology: Basic to Translational Science.

Early on in the pandemic, we had evidence that this coronavirus can cause heart failure or cardiac injury in generally healthy people, which was alarming to the cardiology community, said senior author Kory J. Lavine, MD, PhD, an associate professor of medicine. Even some college athletes who had been cleared to go back to competitive athletics after COVID-19 infection later showed scarring in the heart. There has been debate over whether this is due to direct infection of the heart or due to a systemic inflammatory response that occurs because of the lung infection.

Our study is unique because it definitively shows that, in patients with COVID-19 who developed heart failure, the virus infects the heart, specifically heart muscle cells.

Lavine and his colleagues including collaborators Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine, and Michael J. Greenberg, PhD, an assistant professor of biochemistry and molecular biophysics also used stem cells to engineer tissue that models how human heart tissue contracts. Studying these heart tissue models, they determined that viral infection not only kills heart muscle cells but destroys the muscle fiber units responsible for heart muscle contraction.

They also showed that this cell death and loss of heart muscle fibers can happen even in the absence of inflammation.

Inflammation can be a second hit on top of damage caused by the virus, but the inflammation itself is not the initial cause of the heart injury, Lavine said.

Other viral infections have long been associated with heart damage, but Lavine said SARS-CoV-2, the virus that causes COVID-19, is unique in the effect it has on the heart, especially in the immune cells that respond to the infection. In COVID-19, immune cells called macrophages, monocytes and dendritic cells dominate the immune response. For most other viruses that affect the heart, the immune systems T cells and B cells are on the scene.

COVID-19 is causing a different immune response in the heart compared with other viruses, and we dont know what that means yet, Lavine said. In general, the immune cells seen responding to other viruses tend to be associated with a relatively short disease that resolves with supportive care. But the immune cells we see in COVID-19 heart patients tend to be associated with a chronic condition that can have long-term consequences. These are associations, so we will need more research to understand what is happening.

Part of the reason these questions of causation in heart damage have been hard to answer is the difficulty in studying heart tissue from COVID-19 patients. The researchers were able to validate their findings by studying tissue from four COVID-19 patients who had heart injury associated with the infection, but more research is needed.

To that end, Lavine and Diamond, are working to develop a mouse model of the heart injury. To emphasize the urgency of the work, Lavine pointed to the insidious nature of the heart damage COVID-19 can cause.

Even young people who had very mild symptoms can develop heart problems later on that limit their exercise capacity, Lavine said. We want to understand whats happening so we can prevent it or treat it. In the meantime, we want everyone to take this virus seriously and do their best to take precautions and stop the spread, so we dont have an even larger epidemic of preventable heart disease in the future.

This work was supported by funding from the National Institutes of Health (NIH), grant numbers R01HL141086, R01 HL138466, R01 HL139714, 75N93019C00062 and R01 AI127828; the Burroughs Welcome Fund, grant number 1014782; the Defense Advanced Research Project Agency, grant number HR001117S0019; the March of Dimes Foundation, grant number FY18-BOC-430198; The Foundation for Barnes-Jewish Hospital, grant number 8038-88; and the Childrens Discovery Institute of Washington University and St. Louis Childrens Hospital, grant numbers CH-II-2017628 and PM-LI-2019-829. Imaging was performed in the Washington University Center for Cellular Imaging (WUCCI), which is funded in part by the Childrens Discovery Institute of Washington University and St. Louis Childrens Hospital, grant numbers CDI-CORE-2015-505 and CDI-CORE-2019-813; and The Foundation for Barnes-Jewish Hospital, grant number 3770. The authors thank Dr. Cynthia Goldsmith for help interpreting electron microscopy micrographs and the McDonnell Genome Institute (MGI) at Washington University School of Medicine for assistance in performing sequencing and analysis.

Bailey AL, et al. SARS-CoV-2 infects human engineered heart tissues and models COVID-19 myocarditis. Journal of the American College of Cardiology: Basic to Translational Science. Feb. 26, 2021.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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COVID-19 can kill heart muscle cells, interfere with contraction Washington University School of Medicine in St. Louis - Washington University School...

Vaccinating by age groups is unfair, particularly to minorities, advisory panel tells CDC – USA TODAY

By Stem Cell Medical Center

Four million doses will be released on March 2 with a total of 20 million to be released by the end of March. USA TODAY

Many states prioritized COVID-19 vaccines for people over 75, then moved to thoseover 65, but they shouldn't keep stepping down by age, an advisory committee to the Centers for Disease Control and Prevention said Monday.

The approachis inherently unfair to minorities, committee members said, because they have a lower life-expectancyand because people of color are dying of COVID-19 at younger ages than white Americans even in their 30s, 40s and 50s.

"I'm not in favor of any part of an age eligibility bracket under 65," saidDr. Jos Romero, a pediatric infectious disease specialist at the University of Arkansas for Medical Sciences inLittle Rock and chairman of theAdvisory Committee on Immunization Practices.

The committee disagreed with plans in some states to require people to show proof that they have two medical conditions on a pre-specified list before being allowed to be vaccinated.

As of Feb. 25, CVS will offer the COVID vaccine in 17 states by appointment.(Photo: Scott Eisen/CVS Health via AP Images)

People with two medical conditions that are well-controlled might be at lower risk of serious COVID-19 than those with one out-of-control condition or with a less common disease that wasn't frequent enough make the list.

For example, although Type 2 diabetes is considered a highest-risk condition,Type 1 isn't always, even though people with thisless common, autoimmune version are at the same risk, notedDr. Katherine Poehling, a professor of pediatrics at Wake Forest School of Medicine inWinston-Salem, North Carolina.

Yes, there will be some people who lie about their medical conditions, admitted Dr. Helen Talbot, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tennessee. "There's always someone who finds a way to cheat."

But it's better to let in a few cheaters than to deny vaccine to people who really need it, she said.

The other category of people who should be prioritized, committee members said, are those who care for others who may not be able to be vaccinated.

Dr. Grace Lee, a professor of pediatric infectious diseases atthe Lucile Packard Childrens Hospital and Stanford University School of Medicine inStanford, California, cited the parents of children who received stem cell transplants.

"Being able to protect those individuals in the absence of any high-risk medical condition, I think in and of itself, is important, in part because we can't vaccinate young kids at this time," she said.

Every state makes its own vaccination allotment plan, so there's a lot of mixed messages about who should be prioritized in the next few monthsas vaccine supply remains tight, committee members said.

For that reason, committee members said the Johnson & Johnson vaccine, authorized over the weekend, should be added to the general pool of available vaccines, rather than targeted to any particular group or population.

The Director at the Centers for Disease Control and Prevention is warning Americans to remain vigilant against the coronavirus as the 3rd vaccine is rolled out. (March 1) AP Domestic

Theyreemphasized their commitment to equitable distribution of vaccines, even as they are distributed to as many people as possible.

"I feel very challenged by ensuring that we continue to keep equity as a focus for implementation of the COVID-19 vaccination program," Lee said.

Many vaccine distribution facilities are so worried about getting precisely the right people vaccinated that they're turning too many away, she continued.

"Since our intent is to vaccinate everyone anyway, other than the most egregious of situations, whether or not I get high-risk condition A versus Bcorrect, I think, is less important than just making sure that we are providing access," she said.

About50 million Americans have received at least one dose of a COVID-19 vaccine. Bythe end of this month, Pfizer-BioNTech will have provided a total of 120 million doses of its vaccine, enough to vaccinate 60 million people; Moderna will have provided 100 million doses to vaccinate 50 million people; and J&J will provide 20 million doses of its single-shot vaccine.That's enough to cover more than half of the 210 million adults in the USA.

In its second four-hour meeting in two days, the committeeconsidered whether to extend the recommended period between the two doses of the Pfizer-BioNTech or Modernavaccines.

Some suggested a delay would allow more vaccine to be distributed, but committee members said they did not feel there was enough data to justify delaying the second dose of either vaccine.

There were more mixed opinions on whether people who had symptomatic COVID-19 would need both doses of the two-dose vaccines.

Basic immunology suggests that the illness would act as a primary dose and the first shot as a booster, Talbot said. "I don't need any more data. We've all taken immunology," she said.

Others raised questions about whether the risks of vaccination for people who have had COVID-19 would outweigh the benefits, particularly of a second shot.CDC officials said there is not enough information to answer that question.

Implementing such a policy would be challenging, because it's not clear how long protection lasts and how sick someone has to be to develop adequate natural protection.

Contact Karen Weintraub at kweintraub@usatoday.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it. USA TODAY

Read or Share this story: https://www.usatoday.com/story/news/health/2021/03/01/should-states-prioritize-vaccine-age-some-experts-say-no/6872711002/

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Vaccinating by age groups is unfair, particularly to minorities, advisory panel tells CDC - USA TODAY

Stem Cell Banking Market Report 2021 | Growth and Opportunities Analysis – BioSpace

By Stem Cell Medicine

The demand within the global stem cell banking market is growing on account of advancements in the field of regenerative medicine. The medical fraternity has become extremely focused towards the development of artificial tissues that can infuse with the human body. Furthermore, medical analysis and testing has gathered momentum across biological laboratories and research institutes. Henceforth, it is integral to develop stem cell samples and repositories that hold relevance in modern-day research. The need for regenerative medicine emerges from the growing incidence of internal tissue rupture. Certain types of tissues do not recover for several years, and may even be damaged permanently. Therefore, the need for stem cell banking is expected to grow at a significant pace.

In a custom report, TMR Research digs into the factors that have aided the growth of the global stem cell banking market. The global stem cell banking market can be segmented on the basis of bank size, application, and region. The commendable developments that have incepted across the US healthcare industry has given a thrust to the growth of the North America stem cell banking market.

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Global Stem Cell Banking Market: Notable Developments

The need for improved regenerative medication and anatomy has played an integral role in driving fresh developments within the stem cell banking market.

Gallant has emerged as a notable market entity that has remained as the torchbearer of innovation within the global stem cell banking market. The company has recently launched stem cell banking for dogs, and has attracted the attention of the masses. As people become increasingly concerned about their pets, the new move by Gallant shall help the company in earning the trust of the consumers. Moreover, it can move several notches higher on the innovation index.

Cells4Life has also remained at the forefront of developments within the global stem cell banking market. After suffering backlash for its error in cord blood stem cell promotion, the company is expected to use effective public relation strategies to regain its value in the market.

Global Stem Cell Banking Market: Growth Drivers

Development of improved facilities for storage of stem cells has played an integral role in driving market demand. Furthermore, the unprecedented demand for improved analysis of regenerative medications has also created new opportunities within the global stem cell banking market. Medical research has attracted investments from global investors and stakeholders. The tremendous level of resilience shown by biological researchers to develop stem cell samples has aided market growth. Henceforth, the total volume of revenues within the global stem cell banking market is slated to multiply.

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Commercialization of stem cell banks has emerged as matter of concern for the healthcare industry. However, this trend has also helped in easy storage and procurement of cells stored during the yester years of children. Presence of sound procedures to register at stem cell banks, and the safety offered by these entities, has generated fresh demand within the global market. New regional territories are opening to the idea of stem cell banking. Several factors are responsible for the growth of this trend. Primarily, improvements in stem cell banking can have favourable impact on the growth of the healthcare industry. Moreover, the opportunities for revenue generation associated with the development of functional stem cell banks has aided regional market growth.

The global stem cell banking market is segmented on the basis of:

Source

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Banking Market Report 2021 | Growth and Opportunities Analysis - BioSpace

Global Cell Therapy Biomanufacturing Market (2020 to 2025) – Featuring Lonza Group, Merck & Novartis Among Others – ResearchAndMarkets.com -…

By Stem Cell Medicine

DUBLIN--(BUSINESS WIRE)--The "Cell Therapy Biomanufacturing: Global Markets" report has been added to ResearchAndMarkets.com's offering.

This research report presents an in-depth analysis of the global cell therapy biomanufacturing market by product type, application and region. The report discusses the key inhibitors to the growth of cell therapy biomanufacturing. The report discusses the role of participants in the supply chain from manufacturers to researchers. The report analyzes key companies operating in the global cell therapy biomanufacturing market. In-depth patent analysis in the report will provide a look at the existing and coming technological trends.

In this report, the cell therapy biomanufacturing market is segmented by product type, application and region. Based on product type, the market is segmented into source of cells (T-cells, Dendritic cells, tumor cells and stem cells), and type of therapy (autologous cell therapies, allogeneic cell therapies). The market by application is categorized into cardiovascular diseases, bone repair, neurological disorders, skeletal muscle repair, cancer and others. The market by region is segmented into North America, Europe, Asia-Pacific and ROW.

An increase in the incidence of cardiovascular diseases, rise in the demand for chimeric antigen receptor (CAR) T cell therapy, and further development of stem cell therapy approaches are driving the market's growth. However, market restraints include the bottlenecks experienced by manufacturers during commercialization of cell therapies and the high costs associated with cell therapies. The rise in the development of allogeneic cell therapy is expected to drive the market's growth. Allogeneic cell therapy involves chemo radiotherapeutic conditioning therapy that is followed by transplantation of hematopoietic stem cells as well as lymphocytes isolated from allogeneic healthy donors for treatment of various chronic diseases. (Allogeneic means from "one person to another," vs. autologous, which means from "one person back to the same person after processing.")

Companies Mentioned

Report Includes:

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background

Chapter 4 Market Trends and Challenges

Chapter 5 Market Breakdown by Product Type

Chapter 6 Market Breakdown by Application

Chapter 7 Market Breakdown by Region

Chapter 8 Regulatory Structure

Chapter 9 Company Profiles

Chapter 10 Appendix: References

For more information about this report visit https://www.researchandmarkets.com/r/747t6w

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Global Cell Therapy Biomanufacturing Market (2020 to 2025) - Featuring Lonza Group, Merck & Novartis Among Others - ResearchAndMarkets.com -...

Mouth Sores from Chemo: Symptoms, Causes, and Treatments – Healthline

By Stem Cell Treatment

While youre receiving treatment for cancer, some of the drugs you take can cause painful sores to develop inside your mouth. You can also get them if youve had a bone marrow (stem cell) transplant as part of your cancer care.

Although they often heal on their own, these mouth sores can make it uncomfortable to eat and talk. Well discuss what you can do to relieve the pain and prevent them from getting worse.

Mouth sores can be a common side effect of cancer treatment. The condition, known as stomatitis or mucositis, is an inflammation of the tissues inside your mouth.

Whitish, ulcer-like sores can form on your cheeks, gums, lips, tongue, or on the roof or floor of your mouth. Even if you dont develop mouth ulcers, you may have patches that feel inflamed and painful, as if theyve been burned.

Anyone who is receiving chemotherapy, radiation therapy, or a bone marrow (stem cell) transplant can develop mouth sores as a side effect of these treatments.

If you have dry mouth or gum disease, or if your teeth and gums are not well taken care of, you may be at a higher risk of getting mouth sores during your treatment. Women and people who smoke or drink alcohol are also at a higher risk, according to the Oral Cancer Foundation.

If youre receiving chemotherapy, the sores could begin forming anywhere from 5 days to 2 weeks after your treatment. Depending on the specific cause, the sores could go away on their own in a few weeks, or they could last longer.

Its important to find ways to manage your pain and to watch for signs of an infection. Cancer-related mouth sores can lead to weight loss, dehydration, and other serious complications.

Cancer cells can grow very quickly. The aim of cancer treatment is to stop or slow down that growth. The cells in the mucous membranes lining your mouth are also fast-growing cells, so cancer treatments affect them, too.

Cancer treatments also keep the cells in your mouth from being able to repair themselves efficiently when theyre damaged.

Radiation therapy can also damage the glands in your mouth that make saliva. A dry mouth is more susceptible to infections that cause mouth sores.

Chemotherapy and radiation can both change the microbiome in your mouth, upsetting the balance between good and bad bacteria. The growth of harmful bacteria in your mouth can also lead to mouth sores.

Sometimes cancer treatments suppress your immune system, which may make it more likely that youll get a bacterial, viral, or fungal infection that causes mouth sores. An older infection (such as the herpes simplex virus) can also suddenly flare up again.

If youve had a bone marrow (stem cell) transplant, sores may be a sign that youve developed a condition known as graft-versus-host disease (GVHD).

When this happens, the cells in your body are attacking the transplanted cells as though they were an unhealthy invader. According to research published in Journal of Clinical and Experimental Dentistry, short-term (acute) GVHD occurs in 50 to 70 percent of stem cell transplant cases and longer-term (chronic) GVHD is seen in 30 to 50 percent of cases.

The form of GVHD that causes mouth sores is usually mild, and doctors often treat it with corticosteroid medications.

Its important to talk with your doctor if you develop mouth sores after a stem cell transplant, as some kinds of GVHD can turn serious if left untreated.

There is a good chance that youll experience mouth sores at some point during your cancer treatment. Researchers estimate that 20 to 40 percent of those who have chemotherapy and 80 percent of those who have high-dose chemotherapy will develop mucositis afterward.

Still, there are steps you and your cancer care team can take to lower your risk, reduce the severity of the sores, and promote faster healing.

About a month before your cancer treatment begins, schedule an appointment with your dentist to make sure your teeth and gums are healthy. If you have cavities, broken teeth, or gum disease, its important to come up with a dental treatment plan to take care of these conditions so they dont lead to infections later, when your immune system may be vulnerable.

If you wear braces or dentures, ask your dentist to check the fit and remove any part of the device you dont need during your treatment.

Its very important to maintain good oral hygiene practices throughout your treatment to lower your risk of infection. Brush and floss gently but regularly, avoiding any painful areas. You can also ask your dentist whether a mouth rinse with fluoride is advisable in your case.

For certain kinds of chemotherapy (bolus 5fluorouracil chemotherapy and some high-dose therapies), your healthcare team may give you ice chips to chew for 30 minutes before your treatment. This type of cold therapy can lower your risk of getting mouth sores later.

During treatment of some blood cancers, doctors may give you injections of palifermin, also known as human keratinocyte growth factor-1 (KGF-1), to prevent mouth sores.

If youre scheduled to receive high-dose chemotherapy or radiotherapy, your cancer care team may prepare your mouth using low-level laser therapy beforehand to keep you from getting mouth sores.

For people who have radiation therapy for head and neck cancers, doctors may prescribe this medicated mouthwash to minimize mouth sores.

The length of time your mouth sores may last depends on the specific cancer treatment youve had. Here are some estimates broken down by treatment:

You may notice symptoms anywhere between a few days and a few weeks after your cancer treatment. Heres what you may see and feel as mucositis develops:

You may notice that the sores become slightly crusty as they heal. Its important to keep track of your symptoms and let your oncologist know if the sores arent healing on their own.

Contact your doctor right away if you:

Untreated mouth sores can lead to malnutrition, dehydration, and life-threatening infections.

There are a few different ways that you can help mouth sores heal and avoid prolonger pain or an infection.

While the sores are healing, its very important to keep the inside of your mouth clean to prevent an infection from developing.

The National Cancer Institute recommends that you gently clean your teeth every 4 hours and just before you go to sleep at night. Here are a few tips to consider:

If the pain from mouth sores is interfering with your ability to eat and drink, your doctor may treat the condition with a opioid mouthwash or one containing doxepin or lidocaine.

To ease discomfort and keep your mouth from feeling dry, you may want to try rinsing with a mild saltwater or baking soda solution. Heres how to make each of them:

Your cancer care team may recommend that you use a lubricating liquid (artificial saliva) to moisten the inside of your mouth if dryness is a problem. These liquids are usually gel-like. They coat your mouth with a thin film to help ease discomfort and promote healing.

Some people have found it useful to rinse with a blend of medications called the magic mouthwash. Formulas for this mouthwash vary, but most of them include a combination of medications to treat different symptoms, including:

Magic or miracle mouthwash solutions usually have to be prescribed by a doctor and prepared by a pharmacist, although some people mix up an over-the-counter version at home.

There isnt enough research to say for sure whether magic mouthwash works. If you think youd like to try it, talk with your oncologist or a healthcare professional about whether its a good idea for you.

Here are a few more things you can try at home that may help ease pain from mouth sores:

Mouth sores are one of the most common side effects of cancer treatment. Shortly after chemotherapy, radiation, or transplant treatments, painful, ulcer-like sores can form on the inside of your mouth.

These sores may go away on their own. If they dont, its important to seek medical treatment for them because they can lead to very serious complications.

Before you start cancer treatments, visit a dentist to make sure your teeth and gums are healthy. Keeping up good dental hygiene practices during and after cancer treatment will help limit mouth sores.

If the sores are keeping you from eating and drinking, talk with your oncologist about medications could relieve the pain and speed up the healing process, so you can enjoy a better quality of life during treatment.

Its really important to keep track of any sores in your mouth so you can reach out to your healthcare team if they dont improve. Sores that deepen or worsen can lead to serious even life-threatening complications.

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Mouth Sores from Chemo: Symptoms, Causes, and Treatments - Healthline

ThermoGenesis Holdings Begins a Year of Celebration of its 35th Anniversary in the Cell Banking and Cell Therapy Industry – PRNewswire

By Stem Cell Treatment

RANCHO CORDOVA, Calif., Feb. 17, 2021 /PRNewswire/ -- ThermoGenesis Holdings, Inc.("ThermoGenesis" or the "Company") (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, announced today that the Company will kick off a year of celebration of its 35th anniversary by aligning its future corporate strategy in offering cell processing systems and services to meet the large-scale cellular manufacturing needs of the increasing number of therapies to be developed over the next decade.

ThermoGenesis has built a solid reputation in the cell banking and cell therapy field. The Company was originally founded in 1986 during a pivotal time, when the stem cell and gene therapy industry was in its infancy. In the early-1990s, ThermoGenesis' original founder, Phil Coelho, formed a long-term collaboration with Dr. Pablo Rubinstein of the New York Blood Center, the father of all cord blood stem cell banking. Together, they invented, patented, and obtained FDA clearance for the first "functionally closed" system for concentrating and isolating stem cells from fresh cord blood samples as well as the protocol for long term cryopreservation of those stem cells to insure retrieval decades later. These breakthrough methods were widely adopted and enabled the cord blood banking industry to grow, expand, and become commercially viable today.

These earliest inventions and protocols were followed by the launch of ThermoGenesis' fully automated BioArchive smart cryopreservation system in 1999 and later its AXP automated cell harvesting system in 2005. These fully automated systems have been adopted by over 130+ leading cord blood transplant centers and other stem cell institutes such as MD Anderson, Cleveland Clinic, Duke University, New York Blood Center in 40+ countries. These systems remain "state-of-the-art" almost 20 years later.

"In the past 20 years, ThermoGenesis and its affiliated companies have helped to advance and shape the landscape of the cell banking industry," said Chris Xu, PhD, Chief Executive Officer of ThermoGenesis. "Cell based therapies have become one of the fastest growing sectors in medicine with over 1,000 clinical trials underway in CAR-T cell therapy alone. As we enter the Company's 35th anniversary, we remain committed to staying as the world's leading technology provider for the cell and gene therapy field."

About ThermoGenesis Holdings, Inc.

ThermoGenesis Holdings, Inc. develops, commercializes, and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automated processing for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpressplatform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit:www.ThermoGenesis.com.

Company Contact:Wendy Samford 916-858-5191 [emailprotected]

Investor Contact:Paula Schwartz,Rx Communications 917-322-2216 [emailprotected]

SOURCE ThermoGenesis Holdings, Inc.

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ThermoGenesis Holdings Begins a Year of Celebration of its 35th Anniversary in the Cell Banking and Cell Therapy Industry - PRNewswire

Meet the women hoping to recruit more stem cells donors from Black communities – CTV News

By Stem Cell Treatment

SASKATOON -- An effort to increase stem cell donors within Black communities across Canada is being driven by a group of women whove had difficulty finding full genetic matches themselves.

Genetic matches are crucial for patients in need of stem cell transplants, such as those with leukemia and lymphoma, and matches are more commonly found within their own racial, ethnic and ancestral groups.

But the new Black Donors Save Lives campaign notes that fewer than two per cent of those in the Canadian Blood Services stem cell donor registry are Black.

And that decreases their chance of finding a match, campaign lead Sylvia Okonofua told CTVNews.ca in a phone interview. It becomes a numbers game for Black people on the stem cell waiting list, where its like finding a needle in a hay stack for them.

The recent University of Regina biochemistry graduate, with sights on becoming a hematologist, timed the virtual campaign to kick off during Black History Month.

It was overall frustrating to know that a patient from my community is so much less likely than other patients to be helped, she told CTVNews.ca. When you see that your people have a really, really low chance of being helped out, it takes you aback.

Okonofua noted part of the campaign uses TikToks, shareable infographics, and even an original song to get the message out and reach a wide audience.

And she said part of the outreach involves having Black stem cell recipients talk about their experiences with the health-care system and speak to the historical mistrust the Black community has towards the medical community.

She founded her campus chapter of Stem Cell Club, a non-profit organization with chapters across Canada which recruits Canadians as potential stem cell donors.

Registration for Black Donors Save Lives can be done online, where participants between the ages of 17 to 35 can fill out a questionnaire and have a swab kit mailed to their address. After they swab the inside of their cheeks and send the sample back, if there is a person in need, 90 per cent of donors will be asked to donate stem cells very similar to the way a person would be giving blood.

But a big difference is the donor is given a growth hormone a week before donation in order to increase the number of stem cells, as well as the process taking four to six hours.

Alternatively, one out of 10 donors will be asked if theyd like to donate stem cells via bone marrow surgery, which can take place over a day.

In 2017, Reve Agyepong experienced firsthand the lack of Black stem cell donors, to treat her sickle cell disease, which involve red blood cells becoming misshapen, which can block blood vessels and lead to damage to bones, brain, kidneys, and lungs, and can ultimately be fatal.

But Agyepong, who was born in Edmonton to Ghanaian parents, was fortunate to receive a stem cell transplant from her sister.

It is such a blessing to have a match within your own family because the percentages are just so low, she told CTVNews.ca by email. I am so fortunate to have found a match in my family or else transplant would have been off the table for me.

In fact, only one in four patients who need a stem cell transplant are able to find a matched donor within their family, with Black patients being less than half as likely as white patients to find a unrelated person they match with on a donor registry, according to the campaign.

For Jamaican-Canadian Dorothy Vernon-Brown, who helped inspire this months campaign, the current efforts are deeply personal. In 2013, she was diagnosed with acute myeloid leukaemia and was heartbroken to discover there were no stem cell matches in Canada's registry or internationally.

She ultimately received stem cells from her sister, who was a half-match, and has been spreading information to Black Canadians ever since, through her own advocacy group, Donor Drive for Dorothy.

Stem cell transplantation is a miracle for patients, and I wish people knew how easy it is to be a stem donor, she recounted on a Twitter thread for another stem cell awareness campaign. You could give someone an opportunity like my sister gave me, to be around and live the life I want. People want to live, so if that gift is in your hands, I appeal to you to see it as something significant to do in your life.

Okonofua and Vernon-Browns efforts are being aided by Dr. Warren Fingrut, a hematologist whos the director of the aforementioned Stem Cell Club.

He told CTVNews.ca in an email hes seen firsthand far too many patients from ethnic and racial minority groups in situations where they dont have fully-matched donors and are forced to seek other treatments.

I find this heart wrenching and I am very motivated to work to address this, Fingrut said.

That led to him founding his non-profit a decade ago, which has gone on to recruit more than 20,000 Canadians as stem cell donors, with more than 55 per cent being non-white. But in cases such as Vernon-Brown and others, those figures need to be much higher.

We started running national campaigns last year, focused on the recruitment of diverse peoples as donors, as well as males who are also preferred by transplant physicians (all else being equal) as they are associated with better outcomes for patients, Fingrut explained.

The campaign is also being done in partnership with several other groups, including the Katelyn Bedard Bone Marrow Association, Black Physicians of Canada, Black Medical Students Association of Canada and the National Black Law Students Association of Canada.

This campaign is one example of an initiative in the health-care sector, which seeks to address racial disparity impacting the care of Black patients, he wrote, noting Black people face many such disparities in access to care, and we want to see others in the health-care sector working with Black Canadians to tackle these issues and address them, in collaboration with Black communities.

Okonofua hopes next Black History Month, theyll be able to have in-person swabbing events in places of worship, community hubs, and cultural gatherings to show how easy it is.

Fingrut said this the first time his group has specifically engaged with one racial group and hopes to expand it to other ethnic and racial communities including South Asians, Indigenous peoples, and those of mixed ancestry in the near future.

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Meet the women hoping to recruit more stem cells donors from Black communities - CTV News

CAR T-Cell Therapy Carves Out a Role in Multiple Myeloma – OncLive

By Stem Cell Treatment

Autologous and allogeneic BCMA-directed CAR T-cell therapies are leading to deep and durable responses in patients with heavily pretreated multiple myeloma, with a low incidence of severe cytokine release syndrome (CRS) and neurotoxicity, explained Yi Lin, MD, PhD, who added that with a pending biologics license application (BLA), the field should start to consider which patients, who dont fit the typical clinical trial eligibility criteria, might be a candidate for the treatment in real-world practice.

On September 22, 2020, the FDA granted a priority review designation to a BLA for idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adult patients with multiple myeloma who have received at least 3 previous therapies, based on data from the pivotal phase 2 KarMMa trial (NCT03361748).

When [these approaches are] available in practice, well have to look at the FDA label, said Lin. Putting that in context with the trial experience and also with what were learning in standard-of-care practice in lymphoma and leukemia, what we will need to understand beyond the approved indication [in a certain] line of therapy is really patient characteristics, such as comorbidities and so on, because we would likely not be restricted by trial criteria anymore. Understanding what a safe condition to use CAR T-cell therapy in while still preserving the efficacy of the product [is something well have to determine].

In an interview withOncLiveduring the 2020 Institutional Perspectives in Cancer webinar on multiple myeloma,Lin, consultant, Division of Hematology, Department of Internal Medicine, consultant, Division of Experimental Pathology and Laboratory Medicine, Department of Laboratory Medicine and Pathology, assistant professor of medicine and oncology, Mayo Clinic, discussed promising data with CAR T-cell therapy in multiple myeloma.

Lin: Cilta-cel [ciltacabtagene autoleucel; JNJ-68284528]and ide-cel are already in pivotal trials. With ide-cel, the BLA has been submitted to the FDA, so were anticipating review in early 2021. Cilta-cel is also getting ready for BLA submission to the FDA as well. Potentially in 2021, we may have these BCMA-targeted CAR T-cell therapies available in standard-of-care practice.

In these trials of heavily pretreated patients with poor-risk cytogenetics and penta-refractory disease, a single infusion of the CAR T [cells is leading to] very high overall response rates. A high percentage of these patients are having deep responses and reaching complete remission [CR] or stringent CR. A good proportion of those patients are also experiencing MRD [minimal residual disease]negative disease. In myeloma, those are relevant metrics in terms of having more durable responses, and were seeing that [thats true with] CAR T-cell therapy as well.

The median PFS [progression-free survival] is around 8.8 months for ide-cel, and the 12-month PFS rate for cilta-cel is close to 77%. Thats very exciting for a patient who has had continuous treatment. We have heard anecdotal reports from these patients on the CAR T-cell therapy trials that when theyre in remission, when theyre recovering post CAR T-cell therapy, its the best they have felt. Its almost like before they had myeloma. Some of these metrics are being formally measured as quality-of-life outcomes in the pivotal trial. Weve seen some of that reported as well in poster format at the 2020 ASH Annual Meeting and Exposition. Those data are very important to consider.

bb21217 is very interesting, because its one of these next-generation approaches were looking at to improve upon CAR T-cell therapy. There are a lot of emerging data regarding the phenotype of CAR T cells in myeloma, including other hematologic malignancies, [in that] the T cell that has more of a nave with memory potential phenotype may contribute to better persistence and more active T cells. Thats one of the ways that bb21217 is trying to approach that.

During manufacturing, theyre exposing the T cells to a PI3K inhibitor to drive the phenotype functions of B cells. Were seeing that with the CAR T cell thats generated from patients on the study, the profiles of the CAR T-cell product do have more presence of these cells [compared with other products]. Its still a little too early to say how the long-term clinical response will look, but initial results, in terms of response rates, are very encouraging.

Thats certainly a possibility. Weve seen the data with ALLO-715; its very early yet. That study only has about 3 months of follow-up, but what weve seen has been very encouraging. The potential advantage of allogeneic CAR T-cell therapy [is that because] youre generating [the allogeneic product] from a healthy donor, the T-cell function or the T-cell health or fitness might be better [than that of an autologous product from a patient with myeloma].

You can also make [the product] ahead of time, so it would be more ready off-the-shelf, but that comes with challenges. You are infusing T cells from somebody else, so there could be a risk for graft-versus-host-disease [GVHD], which we have seen with allogeneic stem cell transplant. This particular product comes with a lot of additional gene editing approaches to try to address that, and so far of about 31 patients who have been dosed, we havent seen any alarming signals for GVHD. These CAR T cells persist and are measurable in patients, which is also very encouraging, and were seeing early signals for response. Were not seeing any concerns yet for the high incidence of more severe CRS, neurotoxicity, or infections.

It will be interesting to see how it is adopted in the market. Ive certainly heard concerns from others in the field that were not quite seeing a plateau in terms of PFS as we have seen in lymphoma. We have to keep in mind that these are very heavily pretreated patients that are studied on trials. I suspect, based on how the trials are designed, that the potential position of where it would be with the final FDA-approved indication would be after 3 lines of prior therapy and exposure to a proteasome inhibitor, IMiD [immunomodulatory drug], and a monoclonal antibody. If it is truly adopted for patients who would be eligible and have access to treatment centers, it could potentially buy them at least a period of time where they dont need any therapies.

Though, we still have patients on these studies that are 2 years out or more in continued remission. I suspect because of how BCMA CAR T-cell therapy worksits really targeting a surface antigen, its not targeting particular cell signaling pathways, and we are seeing responses across other cytogenetic risksthat it wouldnt necessarily impact how well it could function in real-world practice, but thats something that well need to learn as it becomes available.

Its certainly very encouraging to see that, across the CAR T-cell therapy studies, we have not generally seen a very high signal in terms of grade 3 or more severe CRS or neurotoxicity that would require ICU level monitoring. [Such scenarios have] generally [occurred] in single-digit percentages in less than 10% of cases.

There may be some component of how these CARs are designed. There may be some elements of the nature of the myeloma disease that contributes to this, but were also evolving in our understanding of when interventions like tocilizumab (Actemra) and steroids could be safely used to walk that balance between not losing response but preventing more severe toxicities. Within each protocol, the threshold for using tocilizumab and steroids do vary. Generally, there is a move towards using these drugs earlier in the onset of those symptoms, so patients dont have to suffer through the more severe late effects. Theres a variable percentage of patients who get [these interventions], but its a higher percentage than in the earlier studies.

I was most excited to see Allogenes allogeneic product. Whats reassuring is that generally we are seeing response signals, but its a little too early to tell whether that will translate into an advantage in clinical response compared with the current generation CAR T cells. There are lots of products to keep an eye on, but its hard to pick a lead yet.

With the bispecific antibodies, were now seeing some reports from non-BCMA approaches. With a number of BCMA-targeted CAR T-cell therapies and bispecific antibody-drug conjugates, we do need to move into the non-BCMA space fairly quickly. Its very exciting to see pretty high early response rate signals from those approaches as well. CAR T-cell therapies targeting those same antigens are also starting [to be developed], so probably by the 2021 ASH Annual Meeting and Exposition, well hear some results from those studies as well. Immunotherapy approaches are moving very quickly in myeloma, and its always exciting to have those options for our patients.

Its never too early to think about patient selection. Its quite common that patients with myeloma need to get bridging therapy or continue some type of therapy while their autologous CAR T cells are being made. How that may impact or potentially be used to optimize the response of CAR T-cell therapy is not formally studied in a trial. Well learn from real-world practice. In terms of patient access to this product, is there a potentially broader range of conditions and comorbidities where CAR T-cell therapy can still be safely given with a reasonable expectation of response?

GPRC5D and FcRH are the ones that are currently [being developed for] bispecific approaches. CAR T-cell therapy trials will be starting or have recently started [with those targets] as well. Thus far, based on the expression of these targets, they seem to have very limited off-target toxicities. Fingers crossed. Well continue to truly see that profile in the clinical trial settings. Those are the [targets] to really watch out for.

The very first report of CAR T activity in myeloma was with a CD19-directed approach. Theres still some continued effort to see if a combination of CD19 and BCMA have a role in myeloma. To that end, there are some combinations of BCMA-directed CAR T-cell therapy approaches with and CD38 or CS1. Ultimately, the novel targets are the ones to watch out for and likely will have a role, if we do see a desirable response, very quickly after BCMA-directed approaches.

US Food and Drug Administration (FDA) accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel; bb2121). News release. Bristol Myers Squibb and bluebird bio, Inc. September 22, 2020. Accessed February 8, 2021.https://bit.ly/2G0K3Iq.

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CAR T-Cell Therapy Carves Out a Role in Multiple Myeloma - OncLive

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