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Advisory Body Backs MesoBlast Therapy for Transplant Complication – Xconomy

By daniellenierenberg

XconomyNew York

An FDA advisory committee Thursday voted 9-1 to recommend that the agency approve a stem cell therapy developed by MesoBlast as a treatment for acute graft-versus-host disease (aGVHD) in children. The panel weighed the need for a new way to address the potentially fatal condition against shortcomings of the clinical trial the Australian biotech conducted to evaluate the investigational cell therapy.

Shares in (NASDAQ: MESO), which fell more than 30 percent earlier in the week after the FDA released briefing documents ahead of the committees meeting, closed up 51 percent Friday at $17.88 apiece compared to $11.81 at market close Wednesday. (Trading was halted on Thursday.)

The MesoBlast cell therapy, remestemcel-L (Ryoncil), is made from mesenchymal cells taken from healthy donors. The properties of these cells, which dont prompt an immune reaction, allow them to be used as an off-the-shelf treatment without accompanying immunosuppressants that put patients at greater risk for infection, among other side effects.

Some patients with blood cancer are treated with a stem cell transplant, in which cells from a healthy donor are infused into their bloodstream with the intent that those cells will travel to the bone marrow and form new healthy blood cells. Frequently, however, when donors are unrelated, their cells identify the recipients as foreign, prompting them to attack organs and tissues. Treatment with systemic corticosteroids can help control the severity of the condition. But in up to 90 percent of aGVHD patients who dont respond to steroid treatment, the condition can prove fatal.

MesoBlasts submission was based on a clinical trial that enrolled 55 children age 2 months to 17 years who had received a transplant of bone marrow, peripheral blood stem cells, or cord blood, were diagnosed with aGVDH and werent responding to steroid therapy. The study tracked their responses to remestemcel on day 28. Overall, 70 percent of the patients responded, including 76 percent of the 25 patients whose condition was graded as most severe. On day 100, 74 percent of patients remained alive; on day 180, 69 percent.

However, the trial was neither randomized nor controlled, raising concerns of confounding factors and potential bias. MesoBlast said investigators werent willing to enroll children in such a trial. But the company said randomization and controlled design would be incorporated into a planned post-marketing study in adults.

In previous clinical trials in wider patient populations, the treatment missed the primary goal. Analyses of results from those earlier trials prompted MesoBlasts decision to focus the drugs further development to steroid-refractory pediatric patients. In its presentation to the advisory panel the company said the remestemcel manufacturing process has been improved since those trials in ways that have made the treatment more potent.

The panel voted on whether MesoBlast provided enough clinical data to show that its therapy was effective in treating aGVHD in this narrower group. Panelist Christian Hinrichs, a clinical researcher at the National Cancer Institute and physician by training, was the sole no vote. Nine panelists felt the available data did indicate efficacy. (The committee recorded the tally as 8-2, but a MesoBlast representative said one no vote was made in error.)

I do think that the two prior randomized trials convincingly show that the [earlier version of remestemcel], at least in the population that was being studied, which is similar but not the same, clearly did not have meaningful activity, Hinrichs said. So, you know, do we think that these tweaks to the manufacturing have suddenly made it highly effective, and the change in patient population has suddenly made it highly effective?

Jorge Garcia, division chief of solid tumor oncology at University Hospitals Seidman Cancer Center in Cleveland, however, said while it isnt clear how the treatment compares to other drugs used to treat patients with the condition, the data indicate it is safe and has shown some efficacy.

In May 2019 an Incyte (NASDAQ: INCY) treatment, ruxolitinib (Jakafi), became the first FDA-approved treatment for patients with aGVHD who didnt responded to steroid therapy. Ruxolitinib was OKd for patients starting at age 12. But no treatment is approved for those younger.

Although the FDA considers advisory panel recommendations during drug reviews, committee recommendations are not binding, and the agency doesnt always follow them. Its decision on remestemcel is anticipated by Septembers end.

Image: iStock/Yarygin

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Stem Cell Therapy Market Size By Product Analysis, By Application, By End-Users, By Regional Outlook, By Top Companies and Forecast to 2027 – Bulletin…

By daniellenierenberg

New Jersey, United States,- The Stem Cell Therapy Market is predicted by Verified Market Researchs report to find players focusing on new product development to secure a strong position in terms of revenue sharing. Strategic collaboration can be a powerful way to bring new products to the market. The level of competition observed in the market may increase.

This research report categorizes the global market by players/brands, regions, types, and applications. The report also analyzes the global market status, competitive landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels, five forces of distributors, and porters.

The latest 2020 edition of this report reserves the right to provide further comments on the latest scenarios, recession, and impact of COVID-19 on the entire industry. It also provides qualitative information on when the industry can rethink the goals the industry is taking to address the situation and possible actions.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Stem Cell Therapy Market Segment Analysis-

The research report includes specific segments by Type and Application. Each type provides information about the production during the forecast period of 2015 to 2027. The application segment also provides consumption during the forecast period of 2015 to 2027. Understanding the segments helps in identifying the importance of different factors that aid market growth.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

The study analyses the following key business aspects:

Analysis of Strategies of Leading Players: Market players can use this analysis to gain a competitive advantage over their competitors in the Stem Cell Therapy market.

Study on Key Market Trends: This section of the report offers a deeper analysis of the latest and future trends of the Stem Cell Therapy market.

Market Forecasts:Buyers of the report will have access to accurate and validated estimates of the total market size in terms of value and volume. The report also provides consumption, production, sales, and other forecasts for the Stem Cell Therapy market.

Regional Growth Analysis:All major regions and countries have been covered in the report. The regional analysis will help market players to tap into unexplored regional markets, prepare specific strategies for target regions, and compare the growth of all regional markets.

Segmental Analysis:The report provides accurate and reliable forecasts of the market share of important segments of the Stem Cell Therapy market. Market participants can use this analysis to make strategic investments in key growth pockets of the Stem Cell Therapy market.

Business Opportunities in Following Regions and Countries:

North America (United States, Canada, and Mexico)

Europe (Germany, UK, France, Italy, Russia, Spain, and Benelux)

Asia Pacific (China, Japan, India, Southeast Asia, and Australia)

Latin America (Brazil, Argentina, and Colombia)

How will the report assist your business to grow?

The document offers statistical data about the value (US $) and size (units) for the Stem Cell Therapy industry between 2020 to 2027.

The report also traces the leading market rivals that will create and influence the Stem Cell Therapy business to a greater extent.

Extensive understanding of the fundamental trends impacting each sector, although greatest threat, latest technologies, and opportunities that could build the global Stem Cell Therapy market both supply and offer.

The report helps the customer to determine the substantial results of major market players or rulers of the Stem Cell Therapy sector.

Reason to Buy this Report:

Save and reduce time carrying out entry-level research by identifying the growth, size, leading players, and segments in the global Stem Cell Therapy Market. Highlights key business priorities in order to assist companies to realign their business strategies. The key findings and recommendations highlight crucial progressive industry trends in Stem Cell Therapy Market, thereby allowing players to develop effective long term strategies.

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

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Umbilical cord blood banking: Is it worth it? – mtltimes.ca

By daniellenierenberg

Expectant parents have so many decisions to make before and after their childs birth. Until recently, decisions related to the Umbilical cord blood banking werent one of those.

Back then, the umbilical cord was merely discarded after the birth of the child. Lately, expectant parents are increasingly considering new ways of handling the umbilical cord and the cord blood since new research is beginning to reveal the usefulness of these items.

Cord Blood Explained

The term Cord Blood refers to the type of blood found within the placenta as well as the umbilical cord of a baby. It is usually acquired from the babys umbilical cord after being birthed. The cord blood, as well as its tissues, has an ample amount of stem cells and other important cells. Due to its biological and chemical properties, it is now considered a life-saving treatment for various health conditions.

For instance, some medical experts now say that cord blood is useful for treating over 80 health conditions and disorders. Another game-changing element to it is its usefulness for conditions that require bone marrow transplant. Also, stem cells from the cord blood rarely carry infectious diseases, unlike those found in the bone marrow. This means that stem cells from the cord blood are less likely to be rejected when used for treatment.

Some of the health conditions that the cord blood can help in treating include tumors, cancer, immune deficiencies and disorders, genetic diseases, and blood disorders. Particularly, the stem cells in cord blood can help treat anemia, lymphoma, leukemia, diabetes, cerebral palsy, autism, and the like. With these numerous health benefits, it is no wonder that expectant parents now want to store their newborns cord blood. This means that storing the cord blood for future use might be worth it.

Handling Cord Blood

In todays medical setup, parents have the option of discarding, donating, or storing their newborns cord blood. Whatever the decision made, there is no right or wrong one. On the one hand, if the parents agree to discard their childs umbilical cord and everything that accompanies it, then thats fine. On the other hand, they can also decide to store the childs cord blood in a private cord blood bank.

Storage involves fees, of course. But the advantage of storing it is that the parents can request access to it later if needed. The parents can also decide to donate their childs cord blood to public cord blood banks for future patients or medical research.

There are two methods of cord blood banking. They are:

You can decide to store your childs cord blood in a commercial cord blood bank for later use by your child or other family members. Storing in private cord blood banks can be expensive, especially at the initial stage. Whether youre storing just the cord blood or the cord blood and tissues, expect nothing less than between USD$500 and USD$2,500 for the initial processing charges. In addition, youd still have to pay an annual storage renewal fee of somewhere between USD$100 and USD$300.

Some specialists believe that spending thousands of dollars to store cord blood in a private bank isnt worth it. This is because theres a slim probability that the child who owns the cord blood will need it. First, the child might not have a condition that warrants the use of the blood. Besides, if the child has a health condition that requires stem cell treatment, its most likely that the stem cells in the cord blood would contain the same genetic defects that are now causing the health problem. This means that the child cant make use of the cord blood.

However, it doesnt necessarily mean that it becomes useless. In case other siblings had their cord blood stored as well, the afflicted child can use theirs instead because theres a higher chance that their blood would match. Also, other complications that accompany having a third-party blood donor would be out of the way.

Unlike private cord banks, you wont be charged any fee for storage in a public cord blood bank. Theres no need for any payment because instead of the blood being stored for your personal use, the cord blood is being donated to the bank.

The beauty of this choice is that the cord blood is made available to individuals who need it. Most people prefer this option than storing for personal use since no financial commitment is involved. Moreover, if you or your family members later need cord blood, you could get cord blood donations as well.

Conclusion

Just like there are two sides to a coin, the decision whether storing your childs cord blood is worth it or not is dependent on diverse factors, most of which are beyond your control. Before choosing to discard, store, or donate your childs cord blood, try to consult your doctor first. Your doctor will guide you on how to handle the cord blood. Otherwise, if you dont have any problem with the financial commitments, then having umbilical cord blood when it is needed is definitely worth it!

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G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer – GlobeNewswire

By daniellenierenberg

- PDUFA action date of February 15, 2021 assigned by U.S. Food and Drug Administration- Priority Review for trilaciclib is based on positive data from three randomized clinical trials showing robust myelopreservation benefits- G1 launching expanded access program (EAP) for patients with small cell lung cancer in the U.S.

RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021. Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes.

There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur, said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.

The FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.The trilaciclib NDA was supported by compelling myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with SCLC. Trilaciclibhas been granted Breakthrough Therapy Designation by the FDA.In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting to discuss this application.

While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations, said Jared Weiss, M.D., Lineberger Comprehensive Cancer Center,University of North Carolina Chapel Hill, NC. Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.

Myelosuppression is the result of damage to bone marrow stem cells and is one of the most common side effects of chemotherapy. Myelosuppression can lead to serious conditions such as anemia, neutropenia or thrombocytopenia, which have broad ranging clinical, patient experience and economic impacts on ongoing cancer treatment and overall outcomes. In clinical trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression, and patients receiving trilaciclib experienced fewer dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared to patients receiving chemotherapy alone.

Expanded Access ProgramG1 is making trilaciclib available to SCLC patients in the U.S., who are unable to enter clinical trials and for whom there are no appropriate alternative treatments while the trilaciclib NDA is under regulatory review, pursuant to FDAs expanded access program (EAP). To facilitate needed access through the EAP, G1 is collaborating with Bionical Emas, a global specialist clinical research organization (CRO). For more information about the EAP access to trilaciclib, email patient.access.us@Bionical-emas.com.

Complications from myelosuppression have been a long-standing challenge when treating patients with SCLC, said Dr. Malik. Establishing an expanded access program provides qualified patients in serious need with access to trilaciclib while the NDA is under review.

Trilaciclib in Small Cell Lung CancerTrilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. In 2019, trilaciclib received FDA Breakthrough Therapy Designation, and, in June 2020, G1 submitted the NDA based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy in patients with small cell lung cancer (SCLC). In August 2020, G1 received FDA Priority Review with the Prescription Drug User Fee Act (PDUFA) date of February 15, 2021.

In June 2020, G1 announced a co-promotion agreement with Boehringer Ingelheim for trilaciclib in small cell lung cancer in the U.S. and Puerto Rico. If approved, G1 will lead marketing, market access and medical engagement initiatives for trilaciclib. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives.G1 will book revenue and retain development and commercialization rights to trilaciclib and pay Boehringer Ingelheim a promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/ Boehringer Ingelheim agreement can be found here.

Evaluating Trilaciclib in Other CancersIn a randomized trial of women with metastatic triple-negative breast cancer, preliminary data showed that trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to present final overall survival data from this trial in the fourth quarter of 2020. Trilaciclib is being evaluated in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL, and the company expects to initiate a Phase 3 trial in patients treated with chemotherapy for colorectal cancer in the fourth quarter of 2020.

About G1 TherapeuticsG1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies: trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy; rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. In 2020, the company out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.

G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclibs possibility to improve patient outcomes across multiple indications, rintodestrants potential to be best-in-class oral SERD, lerociclibs differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), are based on the companys expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the companys actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the companys filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the companys ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the companys initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:Investors:Jeff MacdonaldG1 Therapeutics, Inc.Senior Director, Investor Relations & Corporate Communications919-907-1944jmacdonald@g1therapeutics.comMedia:Christine RogersG1 Therapeutics, Inc.Associate Director, Corporate Communications984-365-2819crogers@g1therapeutics.com

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Increasing Number of iPS Cell Therapies Tested in Clinical …

By daniellenierenberg

In a surgical procedure last month, neurosurgeons from Kyoto University implanted 2.4 million cells into the brain of a patient with Parkinsons disease. The cellsderived from peripheral blood cells of an anonymous donorhad been reprogrammed into induced pluripotent stem cells (iPSCs) and then into dopaminergic precursor cells, which researchers hope will boost dopamine levels and ameliorate the patients symptoms.

The procedure is the most recent attempt by clinicians to test whether iPSCs can treat disease. In recent years, Japanese scientists have launched several clinical studies to examine their efficacy in heart disease and macular degeneration of the eye. And other researchers around the globe are exploring ways to turn the cells into treatments for everything from endometriosis to spinal cord injury. The initial foray into clinical trials raises hopes that the technology will bear fruit 12 years after its Nobel Prizewinning discovery.

Im excited that theyre trying to move it to the clinical level, because the iPS field does at some point need to start demonstrating that [these cells] have regenerative potential, says Jalees Rehman of the University of Illinois at Chicago. But the move towards clinical work is also revealing the difficulties of developing therapies. Its a learning curve, he adds.

So far, only a handful of patients have undergone iPSC-based treatments. In 2014, a woman with macular degeneration of the eye received a transplant of iPSC-based retinal cells derived from her own cells. The woman treated showed no apparent improvement in her vision, but the safety of the iPSC-derived cells was confirmed, writes Jun Takahashi, a stem cell biologist at Kyoto University who helped derive the dopaminergic precursor cells implanted into the Parkinsons disease patient. It was his wife, Masayo Takahashi of the RIKEN Center for Developmental Biology, who created the retinal cells used in that trial.

Last year, five patients were treated for the same eye condition with iPSC-derived retinal cells, which were taken from different donors. One of them patients developed a serious, but non-lifethreatening, reaction to the transplant, forcing doctors to remove it, according to the Japan Times.

More clinical studies are underway: Next year, heart surgeons plan to implant sheets of iPSC-derived cardiomyocytes into the hearts of three patients with heart disease, and Takahashi hopes to treat six more patients with Parkinsons disease by 2022. These are all in the earliest phases of testing. It is too early to say something [about the cells efficacy] in our trial, he adds.

While some researchers are waiting for the results of clinical studies to determine whether iPSCs have regenerative potential, others are racing ahead with preclinical studies presenting ever more ways on how to use them therapeutically. For instance, April Pyle, a stem cell biologist at the University of California, Los Angeles, recently developed an approach she believes is promising in treating Duchenne muscular dystrophy, a devastating disease caused by a mutation in the gene encoding the muscle-strengthening protein dystrophin. She and her colleagues used CRISPR-Cas9 to repair the gene in human iPSCs, turned them into skeletal muscle cells, and injected them into the muscle of dystrophin-deficient mice. We [could] actually see that weve restored dystrophin in pockets of the muscle, she explains.

I think its really just the beginning, she says. I think that were finally seeing the payoff for all of the hard work . . . and there will be many more trials to follow from these initial studies.

By now, researchers have figured out how to coax iPSCs to grow into most known cell types, Rehman says. But to get these cells to take on the roles of mature cells in a new tissue environment is another issue. In the heart, for instance, researchers have found that new stem cells have to be electrically aligned with the other cells. Experiments on human iPSC-derived heart muscle cells in culture show that by subjecting them to electrically induced contractions as they develop, the cells mature faster, suggesting that they become more able to handle the adult workload in vivo. How to integrate the new cells so they will survive in injured or diseased tissue is another question. Do you need a special matrix, a gel, a patch, an organoid, to ensure the success of these cells long term? Rehman asks. These challenges are faced in all the organs.

Researchers have been relying on monkey models to evaluate the efficacy of engraftment procedures before testing them in human patients, explains Takahashi. Last year, his team demonstrated on monkeys that human iPSCderived dopaminergic neurons stably integrated into existing brain tissue, where they produced dopamine and ultimately improved Parkinsonian symptoms.

The closer we get to [clinical] applications, the more we obviously realize the challenges that lie ahead.

Jalees Rehman, University of Illinois at Chicago

Another challenge with the implantation of iPSC-derived tissue is the ever-present risk that the cells might trigger cancer, because they stem from a cell type that is by nature highly proliferative. To avoid this, Takahashi and his colleagues filter the implanted cells to eliminate undifferentiated ones that are most prone to overgrowth, and also test the cell lines for tumorgenicity by implanting a sample into mice.

Still, we cannot completely eliminate the possibility of tumor formation, notes Tetsuo Maruyama, an associate professor of obstetrics and gynecology from Keio University School of Medicine. He thinks that such procedures should focus on non-essential organs, such as the eye or the uterus, for instance. He recently succeeded in deriving healthy uterine cells from iPSCs and plans to use these to study how endometriosis occurs, and also to generate human endometrium that could eventually be used clinically.

Another concern researchers have frequently raised are the immunosuppressive drugs that patients require if the iPSCs are derived from cells other than the patients own. Takahashis patient with Parkinsons, for instance, will be on immunosuppressants for a year, possibly making the patient less able to fight off infections and cancer. But despite the risks, many researchers have opted to use allogeneic stem cellsthose from a donorforemost because the approach will save time, cost, and labor when the time comes to scale up such treatments for commercialization. It is important when you think about industrialization, Takahashi writes in an email.

The possibility to create off the shelf iPSC therapies has also attracted industry, not just academics. For instance, Australia-based biotech company Cynata Therapeutics recently concluded a Phase I trial using iPSC-derived mesenchymal stem cells to treat graft-versus-host disease (GVHD). The condition occurs after bone marrow transplants when immune cells of the donor recognize cells in the recipients body as foreign and attack them, often resulting in death. But mesenchymal stem cells, which can mature into a variety of cell types, suppress the proliferation and activation of the donors T cells, explains Kilian Kelly, the companys vice president for product development. The company produced these cells by starting from iPSCs, reprogramming them in to an intermediary cell called a mesenchymoangioblast, and then directing them to become mesenchymal cells.

The trial, which the company claims is the worlds first to use iPSCs, administered the cells intravenously to 15 patients with GVHD who had previously failed to respond to steroid treatment and as such faced a grim prognosis. Although its too soon to evaluate efficacy, Kelly says, he sees it as a positive sign that 14 of them showed a notable improvement in their condition. And conveniently, immune rejection isnt an issue with mesenchymal stem cells because they dont express the donor-specific antigens that trigger rejection. So that means that we can use cells from a single iPS [cell] bank to treat essentially anybody, says Kelly.

Developing off-the-shelf treatments is also vastly more cost effective than maturing iPSC-derived cells for individual patients, adds Ross McDonald, the companys CEO. He points to personalized T-cell immunotherapiestwo of which have been recently FDA-approvedwhich can nearly$500,000 per patient. Its too soon to predict how much his product might cost, he adds.

This is one reason why several groups are developing banks of iPSCs that can be used to develop regenerative therapies at scale. For instance, the Japanese government decided to put around $250 million towards developing an iPSC stock for biomedical research. The donors from whom these cells are derived were carefully selected with immune compatibility in mind: the bank is designed to encompass a diverse set of commonly present human leukocyte antigen (HLA) types, so that they are broadly representative of the majority of the population. Then, implantation will require only a minimum amount of immune suppression. This is kind of a middle ground between using patient-specific cells and cells chosen at random, explains Amanda Mack, director of iPSC reprogramming at Fujifilm Cellular Dynamics, a Wisconsin-based company that grows human cells for biomedical research.

Together, the cells will be immunocompatible with almost 70 percent of the Japanese population, says Maruyama. This might be more difficult for countries such as the US, where the genetic makeup is more diverse, but similar efforts are also underway there. For instance, Macks company aims to develop a bank of iPSCs that are matched to a majority of the US population.

While efforts like these continue, researchers around the world are still figuring out the nuts and bolts of applying these cells therapeutically. The closer we get to [clinical] applications, the more we obviously realize the challenges that lie ahead, says Rehman. I think thats a very normal process for scientific discovery.

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Researchers find method to regrow cartilage in the joints – Stanford Medical Center Report

By daniellenierenberg

Damaged cartilage can be treated through a technique called microfracture, in which tiny holes are drilled in the surface of a joint. The microfracture technique prompts the body to create new tissue in the joint, but the new tissue is not much like cartilage.

Microfracture results in what is called fibrocartilage, which is really more like scar tissue than natural cartilage, said Chan. It covers the bone and is better than nothing, but it doesnt have the bounce and elasticity of natural cartilage, and it tends to degrade relatively quickly.

The most recent research arose, in part, through the work of surgeon Matthew Murphy, PhD, a visiting researcher at Stanford who is now at the University of Manchester. I never felt anyone really understood how microfracture really worked, Murphy said. I realized the only way to understand the process was to look at what stem cells are doing after microfracture. Murphy is the lead author on the paper. Chan and Longaker are co-senior authors.

For a long time, Chan said, people assumed that adult cartilage did not regenerate after injury because the tissue did not have many skeletal stem cells that could be activated. Working in a mouse model, the team documented that microfracture did activate skeletal stem cells. Left to their own devices, however, those activated skeletal stem cells regenerated fibrocartilage in the joint.

But what if the healing process after microfracture could be steered toward development of cartilage and away from fibrocartilage? The researchers knew that as bone develops, cells must first go through a cartilage stage before turning into bone. They had the idea that they might encourage the skeletal stem cells in the joint to start along a path toward becoming bone, but stop the process at the cartilage stage.

The researchers used a powerful molecule called bone morphogenetic protein 2 (BMP2) to initiate bone formation after microfracture, but then stopped the process midway with a molecule that blocked another signaling molecule important in bone formation, called vascular endothelial growth factor (VEGF).

What we ended up with was cartilage that is made of the same sort of cells as natural cartilage with comparable mechanical properties, unlike the fibrocartilage that we usually get, Chan said. It also restored mobility to osteoarthritic mice and significantly reduced their pain.

As a proof of principle that this might also work in humans, the researchers transferred human tissue into mice that were bred to not reject the tissue, and were able to show that human skeletal stem cells could be steered toward bone development but stopped at the cartilage stage.

The next stage of research is to conduct similar experiments in larger animals before starting human clinical trials. Murphy points out that because of the difficulty in working with very small mouse joints, there might be some improvements to the system they could make as they move into relatively larger joints.

The first human clinical trials might be for people who have arthritis in their fingers and toes. We might start with small joints, and if that works we would move up to larger joints like knees, Murphy says. Right now, one of the most common surgeries for arthritis in the fingers is to have the bone at the base of the thumb taken out. In such cases we might try this to save the joint, and if it doesnt work we just take out the bone as we would have anyway. Theres a big potential for improvement, and the downside is that we would be back to where we were before.

Longaker points out that one advantage of their discovery is that the main components of a potential therapy are approved as safe and effective by the FDA. BMP2 has already been approved for helping bone heal, and VEGF inhibitors are already used as anti-cancer therapies, Longaker said. This would help speed the approval of any therapy we develop.

Joint replacement surgery has revolutionized how doctors treat arthritis and is very common: By age 80, 1 in 10 people will have a hip replacement and 1 in 20 will have a knee replaced. But such joint replacement is extremely invasive, has a limited lifespan and is performed only after arthritis hits and patients endure lasting pain. The researchers say they can envision a time when people are able to avoid getting arthritis in the first place by rejuvenating their cartilage in their joints before it is badly degraded.

One idea is to follow a Jiffy Lube model of cartilage replenishment, Longaker said. You dont wait for damage to accumulate you go in periodically and use this technique to boost your articular cartilage before you have a problem.

Longaker is the Deane P. and Louise Mitchell Professor in the School of Medicine and co-director of the Institute for Stem Cell Biology and Regenerative Medicine. Chan is a member of the Institute for Stem Cell Biology and Regenerative Medicine and Stanford Immunology.

Other Stanford scientist taking part in the research were professor of pathology Irving Weissman, MD, the Virginia and D. K. Ludwig Professor in Clinical Investigation in Cancer Research; professor of surgery Stuart B. Goodman, MD, the Robert L. and Mary Ellenburg Professor in Surgery; associate professor of orthopaedic surgery Fan Yang, PhD; professor of surgery Derrick C. Wan, MD; instructor in orthopaedic surgery Xinming Tong, PhD; postdoctoral research fellow Thomas H. Ambrosi, PhD; visiting postdoctoral scholar Liming Zhao, MD; life science research professionals Lauren S. Koepke and Holly Steininger; MD/PhD student Gunsagar S. Gulati, PhD; graduate student Malachia Y. Hoover; former student Owen Marecic; former medical student Yuting Wang, MD; and scanning probe microscopy laboratory manager Marcin P. Walkiewicz, PhD.

The research was supported by the National Institutes of Health (grants R00AG049958, R01 DE027323, R56 DE025597, R01 DE026730, R01 DE021683, R21 DE024230, U01HL099776, U24DE026914, R21 DE019274, NIGMS K08GM109105, NIH R01GM123069 and NIH1R01AR071379), the California Institute for Regenerative Medicine, the Oak Foundation, the Pitch Johnson Fund, the Gunn/Olivier Research Fund, the Stinehart/Reed Foundation, The Siebel Foundation, the Howard Hughes Medical Institute, the German Research Foundation, the PSRF National Endowment, National Center for Research Resources, the Prostate Cancer Research Foundation, the American Federation of Aging Research and the Arthritis National Research Foundation.

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CytoDyn Will Attempt to Duplicate Berlin and London Patients’ HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also…

By daniellenierenberg

HIV monotherapy trials update: 215 patients completed almost one year of monotherapy. Only some were allowed to continue in extension arm; five patients reached almost 6 years. Twenty-five reached 2 to 4 years and 20 patients are 1 to 2 years

VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company gives full update on all of its HIV programs.

HIV CureThe HIV co-receptor CCR5 has proven to be a key molecule in mediating HIV remission. The only two individuals functionally cured of HIV, one from London and the other from Berlin, received allogeneic stem cell transplantations from CCR5-deficient donors. However, because it is extremely rare to find a stem cell donor who lacks CCR5 and meets stringent MHC matching criteria, such an approach is unfeasible to cure HIV on a larger scale. CytoDyn believes its CCR5 blocking antibody, leronlimab, could be used in the setting of allogeneic stem cell transplantation to functionally convert a stem cell graft from a wildtype CCR5 stem cell donor into one from a CCR5 deficient donor, and thereby functionally cure the recipient of HIV.

CytoDyn plans to test this theory in a pilot clinical trial of five HIV patients with cancer who require bone marrow transplantation. Leronlimab will be used during the peri-transplant period to mimic a CCR5 deficient donor in order to achieve HIV cure.

HIV PrEPAs presented at the AIDS 2020 Virtual Conference, a pre-clinical study in the macaque model of HIV sexual transmission demonstrated leronlimab can prevent infection by blocking HIVs access to the CCR5 co-receptor. This protection is similar to that seen in individuals naturally CCR5 deficient and forms the rationale for use in HIV cure. CytoDyn believes leronlimab could be a once-a-month self-injectable, subcutaneous treatment for HIV PrEP and is in discussions with potential organizations to fund its next trial in HIV PrEP.

MonotherapySignificantly, for the first time documented, of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trial for two to four years and five patients for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg. The number of participants in the extension groups was limited due to costs.

The Company will submit manuscripts for two publications in regards to its findings.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We now have four paths forward for use of leronlimab in the HIV indication for different populations. The first path is a combination therapy where we successfully completed a Phase 3 trial with statistically significant p value for our primary endpoint. CytoDyn is awaiting a Type A meeting with the FDA for this treatment. Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting. Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients HIV functional cure.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.

The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The Company has requested a Type A meeting with the FDA to discuss the FDAs request for additional information in order to resubmit its Biologics License Application for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors:Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

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Global Autologous Cell Therapy Market Outlook to 2025 by Therapy, Application, Source, End User and Geography – Yahoo Finance

By daniellenierenberg

DUBLIN, Aug. 17, 2020 /PRNewswire/ -- The "Global Autologous Cell Therapy Market: Growth, Trends and Forecasts (2020-2025)" report has been added to ResearchAndMarkets.com's offering.

The Global Autologous Cell Therapy market is anticipated to grow at a CAGR of 15.9% during the forecast period.

The major factors attributing to the growth of the autologous cell therapy market are the rising incidence of chronic diseases such as autoimmune diseases, cancer, blood disorder, and others.

A rise in the population suffering from chronic diseases is also propelling the demand for market growth. In 2018, as per the AARDA (American Autoimmune Related Diseases Association) statistics, around 50 million Americans have an autoimmune disease, and this number is expected to rise in the future.

As per the CDC (Centers for Disease Control and Prevention) estimates Sickel Cell Disease (SCD) affects around 100,000 Americans annually - and there are few more factors which are playing crucial roles in taking the autologous cell therapy market to the next level, among them one is on-going drug developments for new applications which are expected to further propel the growth of the autologous cell therapy market.

Key Market Trends

Bone Marrow Segment Expected to Hold the Largest Market ShareBone marrow transplant is a technique for replacing damaged and destroyed cells with new stem cells in the bone marrow. Bone marrow is the most commonly used for autologous cell therapy as it can benefit individuals with a range of cancer (malignant) and non-cancer (benign) diseases and will drive the market during the forecast period.

As per the statistics from Globocan 2018, worldwide 18,078,957 individuals have cancer. Asia remains the leading contributor in the rising incidence of cancer with a reported share of 48.4% followed by Europe, North and Latin America, Africa, and Oceania with a share of 23.4%, 13.2% and 7.8%, 5.8%, and 1.4% respectively.

North America Dominates the Market and is Expected to do Same Over the Forecast Period

North America is expected to dominate the overall autologous cell therapy market, throughout the forecast period. This is owing to factors such as the rising incidence of chronic diseases such as cancer, blood disorder, autoimmune diseases, and other diseases and the availability of advanced healthcare infrastructure among the major factors.

In North America, the United States holds the largest market share owing to the factors such as increasing number of population suffering from cancer and other chronic diseases, along with the rising geriatric population and developments related to stem cell therapy and rising demand for biotechnological practices in the country, is anticipated to further drive the demand in this region.

Competitive Landscape

The autologous cell therapy market is moderately competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. And some prominent players are vigorously making acquisitions and joint ventures with the other companies to consolidate their market positions across the globe.

Some of the companies which are currently dominating the market are Vericel Corporation, Pharmicell Co. Inc., Holostem Terapie Avanzate S.r.l., Lineage Cell Therapeutics Inc., and Opexa Therapeutics.

Key Topics Covered

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Rising Incidence of Chronic Diseases4.2.2 Emphasis Increasingly on Drug Development for New Applications4.3 Market Restraints4.3.1 Systemic Immunological Reactions Possibility4.3.2 Expensive Practise, Product and High Capital Investment4.4 Porter's Five Force Analysis

5 MARKET SEGMENTATION5.1 By Therapy5.1.1 Autologous Stem Cell Therapy5.1.2 Autologous Cellular Immunotherapies5.2 By Application5.2.1 Oncology5.2.2 Musculoskeletal Disorder5.2.3 Blood Disorder5.2.4 Autoimmune Disease5.2.5 Others5.3 By Source5.3.1 Bone Marrow5.3.2 Epidermis5.3.3 Others5.4 By End User5.4.1 Hospitals5.4.2 Research Centers5.4.3 Others5.5 Geography5.5.1 North America5.5.2 Europe5.5.3 Asia-Pacific5.5.4 Middle-East and Africa5.5.5 South America

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Vericel Corporation6.1.2 Pharmicell Co. Inc.6.1.3 Holostem Terapie Avanzate S.r.l.6.1.4 Lineage Cell Therapeutics, Inc.6.1.5 Opexa Therapeutics6.1.6 BrainStorm Cell Therapeutics6.1.7 Sangamo Therapeutics

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

For more information about this report visit https://www.researchandmarkets.com/r/22argo

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Uncles incredible tribute to niece who died from the good cancer’ – Yahoo News Australia

By daniellenierenberg

An uncles poignant and loving tribute to his niece after she died following a seven-year battle with Hodgkin Lymphoma has led to life-saving stem cell and bone marrow donations.

Dr Melissa Baker, a single mum of two and forensic pathologist from Melbourne, died on January 16 - just two days after her 45th birthday.

In her memory, Melissas beloved uncle Max Tomlinson placed her photo and information about how to become a stem cell donor on his rear window in the hope of carrying on her hard work.

In memory of my beautiful niece Dr Melissa Baker. You can save a life, dont let Melissas be in vain. Order your swab kit now. Ideally men aged 18 to 45 with diverse backgrounds needed urgently. Order your kit now urthecure.com.au, it reads in white marker pen.

Melissas beloved uncle, Max Tomlinson, placed her photo and information about how to become a stem cell donor on his car's rear window. Source: Facebook

Melissas sister, Jenni Baker, recently posted a picture of Mr Tomlinsons car on Facebook while thanking a member of the public who tucked a yellow flower under his windshield wiper.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work, Jenni, a Melbourne police officer, told Yahoo News Australia on Friday.

She underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection, her sister said.

Doctors told the 45-year-old, who had since developed cancer of the bone marrow as a result of the chemotherapy, she desperately needed a donor and so she began advocating for UR The Cure.

The volunteer-run charity works with the Australian Bone Marrow Donor Registry (ABMDR) to increase the number of donors especially middle-aged people of diverse backgrounds.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work. Source: Facebook

Reluctantly, in November 2019, she underwent a more risky half-match stem cell transplant where I was her donor, Jenni said.

The odds werent great but she had no choice.

Tragically, after 58 days in the hospital, most of which she spent on a ventilator, Melissa died on January 16.

Jennis Facebook post about her uncles tribute has garnered more than 2,500 likes and hundreds of comments, many of which are people who said they had since signed up to be a stem cell donor.

I was a bone marrow donor for my dad. Unfortunately he passed just four months after the donation. I would do it again in a heartbeat for anyone who needed it, one woman wrote.

Beautiful! Tell your uncle I just ordered my kit! another said.

A woman named Amanda also commented, revealing she had been one of Melissas nurses.

I dont know if you remember me. I am one of the nurses who took care of your sister in the ICU. I always admired how much support Melissa had from you and your sister. Her life is definitely not in vain and the love she had from you all was so strong, she wrote.

Melissa Baker underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection. Source: Facebook

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Jenni said Melissa never thought in her wildest dreams this would happen and had at one point thought the cancer would be a battle she would have to fight throughout her life.

The 47-year-old police officer told Yahoo News Australia Melissa became upset when she was often told she had the good cancer because of Hodgkins higher success rate.

She was so mad about it she even made a blog called I Got the Good Cancer documenting her struggles and treatments.

And then everything bad that could have happened, happened, Jenni said.

Jenni (right) and Melissa (left) are pictured together in front of Parliament House. Source: Facebook

The mum-of-two spent last Christmas intubated and sedated in hospital but was able to squeeze her childrens hands when they came to visit.

When the tubes came out on Boxing Day, Melissa mumbled to Jenni, Im scared. This is really scary.

They were the last words Melissa said.

Just two days later Melissa was ventilated again until the tubes were removed on January 14 - her birthday - after deciding it was too cruel.

Fifty-two hours later she passed surrounded by her parents, siblings and children.

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Stem Cell Therapy Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line

By daniellenierenberg

New Jersey, United States,- This detailed market research covers the growth potential of the Stem Cell Therapy Market, which can help stakeholders understand the key trends and prospects of the Stem Cell Therapy market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Stem Cell Therapy market.

The report was touted as the most recent event hitting the market due to the COVID-19 outbreak. This outbreak brought about a dynamic change in the industry and the overall economic scenario. This report covers the analysis of the impact of the COVID-19 pandemic on market growth and revenue. The report also provides an in-depth analysis of the current and future impacts of the pandemic and post-COVID-19 scenario analysis.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.

Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.

The research report offered by Verified Market Research provides an updated insight into the global Stem Cell Therapy market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Stem Cell Therapy Report:

Overview of the Global Stem Cell Therapy Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Stem Cell Therapy market forecast estimation

This Stem Cell Therapy report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Stem Cell Therapy market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Stem Cell Therapy market?

What is the expected growth rate of the Stem Cell Therapy market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Stem Cell Therapy market?

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

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Hackensack University Medical Center Has the Best Cancer Center in New Jersey John Theurer Cancer Center recognized by U.S. News & World Report -…

By daniellenierenberg

Newswise HACKENSACK, N.J.,AUGUST 17, 2020 U.S. News & World Report has recognized John Theurer Cancer Center at Hackensack University Medical Center as the best cancer center in New Jersey. The recognition reflects the extraordinary strength of its comprehensive patient care, research and education programs.

In 2019, John Theurer Cancer Center became a member of the National Cancer Institute-approved Georgetown Lombardi Comprehensive Cancer Center Consortium, making the Cancer Center a member of one of just 16 cancer consortia based at the nation's most prestigious institutions. The NCI endorses such consortia to bring together accomplished institutionswith independently proven records of excellence to join forces in pursuit of the NCI's original mission: improving cancer outcomes through scientific discovery, reducing the impact of cancer on individuals and communities and diminishing cancer disparities, and developing the next generation of cancer scientists, clinicians and educators.

John Theurer Cancer Center is organized into 16 specialized divisions, each led by a recognized expert in the field. With a strong focus on clinical science and innovation, John Theurer Cancer Center investigators were directly involved in the development of more than 40 new anticancer agents approved by the U.S. Food and Drug Administration over the last three yearsparticularly for blood cancers such as leukemia, lymphoma, and multiple myeloma, as well as solid tumors through Phase I first-in-human clinical trials.

"Our multidisciplinary team cares for patients with cancers of every type and stage in a highly subspecialized environment," said Robert C. Garrett, FACHE, CEO, Hackensack Meridian Health. "Our commitment to cancer is reflective of our approach to everything we do: to provide the most advanced health care services based on the latest findings of medical research in a compassionate, culturally sensitive setting. It is an honor for us to be recognized as the top cancer center in our state."

"Our exceptional team is proud to be recognized as the top cancer program in New Jersey. The scope and depth of expertise, together with our focus on clinical science and innovation, are what make our Cancer Center a destination program, explained Andre Goy, M.D., M.S., chair and chief physician of John Theurer Cancer Center, Lymphoma Division chief, physician-in-chief of the Hackensack Meridian Health Oncology Care Transformation Service, and a renowned lymphoma expert who led the Cancer Center's participation in the pioneering ZUMA-2 study. "Understandably, every person who receives a diagnosis of cancer seeks the center with the most experience and the best innovation. This is why patients come to John Theurer Cancer Center. We take care of each patient in a compassionate and friendly environment, and that's what makes our patients smile.

A number of metrics support that successful track record:

This recognition as the state's best cancer center reflects the strength of our research, the dedication of our multidisciplinary team, and the expertise of our physicians," said Ihor Sawczuk, MD, FACS, Hackensack Meridian Health regional president, Northern Market and chief research officer. We are grateful to our patients who have trusted us with their care and who continually inspire us to provide the best possible experience.

For more information, please contact Katherine Emmanouilidis, Director, Communications & Public Relations, 551-996-3764.

About Hackensack Meridian Health Hackensack University Medical Center

Hackensack Meridian Health Hackensack University Medical Center, a 781-bed nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the countys first hospital, it is now part of the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care, which is comprised of 35,000 team members and more than 7,000 physicians. Hackensack University Medical Center is ranked #2 in New Jersey and #59 in the country in U.S. News & World Reports 2019-20 Best Hospital rankings and is ranked high-performing in the U.S. in colon cancer surgery,lung cancersurgery,COPD, heart failure, heart bypass surgery, aortic valve surgery,abdominal aortic aneurysm repair, knee replacement and hip replacement. Out of 4,500 hospitals evaluated, Hackensack is one of only 57 that received a top rating in all nine procedures and conditions. Hackensack University Medical Center is one of only five major academic medical centers in the nation to receive Healthgrades Americas 50 Best Hospitals Award for five or more years in a row. Beckers Hospital Review recognized Hackensack University Medical Center as one of the 100 Great Hospitals in America 2018. The medical center is one of the top 25 green hospitals in the country according to Practice Greenhealth, and received 28 Gold Seals of Approval by The Joint Commission more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet recognized hospital for nursing excellence; receiving its sixth consecutive designation in 2019. Hackensack University Medical Center has created an entire campus of award-winning care, including: John Theurer Cancer Center, a consortium member of the NCI-designated Georgetown Lombardi Comprehensive Cancer Center; the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Womens and Childrens Pavilion, which houses the Joseph M. Sanzari Childrens Hospital and Donna A. Sanzari Womens Hospital, which was designed with The Deirdre Imus Environmental Health Center and listed on the Green Guides list of Top 10 Green Hospitals in the U.S. Hackensack University Medical Center is the Hometown Hospital of the New York Giants and the New York Red Bulls and is Official Medical Services Provider to THE NORTHERN TRUST PGA Golf Tournament. It remains committed to its community through fundraising and community events especially the Tackle Kids Cancer Campaign providing much needed research at the Childrens Cancer Institute housed at the Joseph M. Sanzari Childrens Hospital. To learn more, visit http://www.HackensackUMC.org.

About John Theurer Cancer Center atHackensack University Medical Center

John Theurer Cancer Center at Hackensack University Medical Center is New Jerseys largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 16 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey.John Theurer Cancer Center is amember of the Georgetown Lombardi Comprehensive Cancer Center Consortium,one of just 16 NCI-approved cancer research consortiabased at the nations most prestigious institutions. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities.For additional information, please visitwww.jtcancercenter.org

ABOUTHACKENSACKMERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two childrens hospitals - Joseph M. Sanzari Childrens Hospital in Hackensack, K. Hovnanian Childrens Hospital in Neptune; nine community hospitals Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital Carrier Clinic in Belle Mead; and two rehabilitation hospitals - JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 36,000 team members, and 7,000 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The networks notable distinctions include having four of its hospitals are among the top hospitals in New Jersey for 2020-21, according toU.S. News & World Report. Additionally, the health system has more top-ranked hospitals than any system in New Jersey. Childrens Health is again ranked a top provider of pediatric health care in the United States and earned top 50 rankings in the annual U.S. News 2020-21 Best Childrens Hospitals report. Other honors include consistently achieving Magnet recognition for nursing excellence from the American Nurses Credentialing Center and being named to Beckers Healthcares 150 Top Places to Work in Healthcare/2019 list.

The Hackensack Meridian School of Medicine, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its On3 campus in Nutley and Clifton. The Hackensack Meridian Center for Discovery and Innovation (CDI), housed in a fully renovated state-of-the-art facility, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions.

Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

To learn more, visit http://www.hackensackmeridianhealth.org.

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Scientists See Signs of Lasting Immunity to Covid-19, Even After Mild Infections – The New York Times

By daniellenierenberg

Notably, several of the new studies are finding these powerful responses in people who did not develop severe cases of Covid-19, Dr. Iyer added. Some researchers have worried that infections that take a smaller toll on the body are less memorable to the immune systems studious cells, which may prefer to invest their resources in more serious assaults. In some cases, the body could even jettison the viruses so quickly that it fails to catalog them. This paper suggests this is not true, Dr. Iyer said. You can still get durable immunity without suffering the consequences of infection.

Updated August 17, 2020

What has been observed in people who fought off mild cases of Covid-19 might not hold true for hospitalized patients, whose bodies struggle to marshal a balanced immune response to the virus, or those who were infected but had no symptoms at all. Research groups around the world are continuing to study the entire range of responses. But the vast majority of the cases are these mild infections, said Jason Netland, an immunologist at the University of Washington and an author on the paper under review at Nature. If those people are going to be protected, thats still good.

This new spate of studies could also further assuage fears about how and when the pandemic will end. On Friday, updated guidance released by the Centers for Disease Control and Prevention was misinterpreted by several news reports that suggested immunity against the coronavirus might last only a few months. Experts quickly responded, noting the dangers of propagating such statements and pointing to the wealth of evidence that people who previously had the virus are probably at least partly protected from reinfection for at least three months, if not much longer.

Considered with other recent reports, the new data reinforce the idea that, Yes, you do develop immunity to this virus, and good immunity to this virus, said Dr. Eun-Hyung Lee, an immunologist at Emory University who was not involved in the studies. Thats the message we want to get out there.

Some illnesses, like the flu, can plague populations repeatedly. But that is at least partly attributable to the high mutation rates of influenza viruses, which can quickly make the pathogens unrecognizable to the immune system. Coronaviruses, in contrast, tend to change their appearance less readily from year to year.

Still, much remains unknown. Although these studies hint at the potential for protectiveness, they do not demonstrate protection in action, said Cheong-Hee Chang, an immunologist at the University of Michigan who was not involved in the new studies. Its hard to predict whats going to happen, Dr. Chang said. Humans are so heterogeneous. There are so many factors coming into play.

Research in animals could help fill a few gaps. Small studies have shown that one bout of the coronavirus seems to protect rhesus macaques from contracting it again.

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Wave of New Therapies Improve Outcomes for Patients with Multiple Myeloma – Cancer Health Treatment News

By daniellenierenberg

For many patients with multiple myeloma, a new generation of drugs and drug combinations is producing better outcomes and fewer side effects. In recent months, several novel therapies studied and tested by Dana-Farber scientists have gained approval from the U.S. Food and Drug Administration (FDA) or taken a step toward approval after posting solid results in clinical trials.

The drugs are the fruit of years of research into improving treatment for multiple myeloma, a cancer of white blood cells known as plasma cells in the bone marrow. Many of the new agents are biologically derived made from substances such as proteins and antibodies found in living things and target biological mechanisms in a very specific, targeted fashion. Dana-Farber researchers have played a key role in these efforts.

These are each powerful examples of how next-generation novel therapies translated here at Dana-Farber from bench to bedside are further improving outcomes for our patients, and at a remarkable pace, says Paul G. Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber.

Option for relapsed or refractory (non-responsive) myeloma

Following a Dana-Farber-led clinical trial, the FDA recently approved the novel drug isatuximab in combination with pomalidomide and dexamethasone for adults with relapsed or refractory (non-responsive) myeloma who have received at least two prior therapies, including lenalidomide and drugs known as proteasome inhibitors. The drug went into trials after laboratory work by Dana-Farbers Yu-Tzu Tai, PhD, and Kenneth Anderson, MD, showed it was active against myeloma cells. In the clinical trial, the three-drug combination lowered the risk that the disease would progress by 40%, compared to pomalidome and dexamethasone alone.

A drug that doesnt cause hair loss

Dana-Farber investigators conducted laboratory research and led the first clinical trial of the drug melflufen plus dexamethasone in patients with relapsed or refractory myeloma. Melflufen is a peptide conjugate drug made of a stub of protein, or peptide, joined to a chemotherapy agent and delivers a toxic payload directly to myeloma cells in a selective, time-sparing approach.

Results from an early-phase clinical trial published in Lancet Oncology showed the drug is active in patients with myeloma and is safe at recommended doses. Unlike the previously used standard drug melphalan, it doesnt cause mucositis inflammation of membranes within the digestive tract or hair loss. The results prompted investigators to launch two larger trials, some of whose results are being processed and are due to be published soon.

Drug for patients eligible for stem cell transplant

In a major study published in Blood, Dana-Farber researchers and their associates found that in patients newly diagnosed with myeloma who are eligible for a stem cell transplant, adding the drug daratumumab to the standard three-drug regimen produced more responses, and deeper responses, than in patients receiving the three-drug therapy alone.

Targeting myeloma cells and cell division

Dana-Farber researchers were involved in the development and initial testing of the drug belantamab mafodotin, which has shown considerable promise in clinical trials and has been granted priority review for approval by the FDA.

An antibody conjugate drug consisting of an antibody that specifically targets myeloma cells and an agent that disrupts cell division, its use was informed by a preclinical trial at Dana-Farber involving Yu-Tzu Tai, PhD, and Kenneth Anderson, MD. Balantamab mafodotin was tested in studies led by Paul Richardson, MD, in patients with relapsed or refractory multiple myeloma whose disease continued to worsen after a stem cell transplant, chemotherapy, or other treatment. In the DREAMM-1 and -2 trials, the drug showed strong anti-myeloma activity with manageable side effects.

This article was originally published on August 4, 2020, by Dana-Farber Cancer Institute. It is republished with permission.

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What do we need to know about our bone health during this pandemic – Times of India

By daniellenierenberg

As the on-going COVID-19 pandemic continues we are facing a huge healthcare crisis. Globally the pandemic has accelerated or rather decelerated the entire human population into the confines. Work from home, social shielding and discreet outdoor ventures has not only disrupted our emotional well-being but has also drastically affected our physical health. As people are confined to their homes with reduced physical activity there is rapid bone resorption (loss) as muscles and bones are not getting adequate stimulation. Also lack of exposure to sun during the pandemic has critically affected vitamin D levels in our body. People are frequently feeling tired with lack of energy and strength. Everyone needs to be cautious about the health of their bones as much as their other needs. Bones support us and allow us to be mobile. Bone health is always a priority and we always tend to overlook it. Bone density problem is a silent manifestation and could lead to a major medical issue over a period of time. While osteoporosis onsets with age among men & women, women face the brunt a little earlier, like from their 30s. Well-versed with the situation and to avoid unnecessary bones issues, let us now take a look at some measures that can take care of your bones during the pandemic.Eat a well-balanced diet rich in calcium and vitamin DGood sources of calcium include low-fat dairy products, green leafy veggies and dry fruits. Good sources of vitamin D include fortified cereals, egg yolks, saltwater fish, liver and milk. Calcium and vitamin D work together to protect your bones - calcium helps to build and maintain bones; while vitamin D helps your body to effectively absorb calcium.

Get exposure to sunlight to make enough vitamin DRegular sun exposure is the most natural way to get enough vitamin D. The sun's ultraviolet B (UVB) rays hit cholesterol in the skin cells, providing the energy for vitamin D synthesis. Vitamin D has a significant role in calcium homeostasis and metabolism.

As per pan-India study the best time to get exposed to the sun is between 11 am and 1 pm since the wavelength of ultraviolet B (UVB) rays is 290-320nm during this period which is essential for skin to make vitamin D.

Get plenty of physical activityLike muscles, bones become stronger with exercise. The best exercises for healthy bones are strength-building and weight-bearing exercise like walking, climbing stairs, lifting weights and dancing. Try to get 30 minutes of exercise each day.

Strength-building and weight-bearing exercise provides stimulation to bone cells and helps to increased bone mineral density and bone size thus reduced the risk of osteoporosis.

Live a healthy lifestyle

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Reflections on My ‘Re-birthday’ and the Past Year of Recovery – Lymphoma News Today

By daniellenierenberg

By the time this column is published, the one-year anniversary of my lifesaving stem cell transplant will have come and gone. But as I sit here sweating away in the thick humidity of a rare August heat wave, and as the sun sets upon my little garden in the boroughs of North London, I cant help but bask in this moment of reflection and humble appreciation.

An entire year has come and gone, just like that. Time is such a strange, bizarre phenomenon. It feels as if it has passed by in a blur a simple snap of my fingers and yet so much has transpired. So much has unfurled and unfolded, fallen apart and come together, all in just 12 tiny months.

One year ago today, I was lying in a sterile hospital bed with a drip attached to my veins. I was puffy, exhausted, and frail from the chemicals seeping into my blood. I had no immune system and was days away from having my sisters stem cells infused into my bloodstream, where they would collectively begin to regenerate an entirely new immune system.

A year ago, I could barely walk because I was so weak. I had no connection to my body other than distrust. I was small, sad, tired, and full of grief and heartache. A year ago, the world was painfully heavy and dark. Now, as I sit here staring at the trees in my backyard and watching the sun pour through the gaps in the branches, painting the leaves a brilliant verdant green, I see so much light in the world its almost blinding.

I just returned from a weekend in the English countryside with some of my best friends. We stayed in a house beside the sea on the coast of Cornwall. The sun was warm, and the world felt like it was washed in a soft, tangerine glow. I cant remember the last time I have laughed so much. I felt wonderfully alive, radiating with joy at the sheer beauty of all the small, simple things. The tiny white and yellow daisies we picked from the bushes on the side of the road, the perfect flapping of a butterflys delicate wings, the sound of my friends laughter, the lightness of being, the magnificence of loving, and being loved in return.

This anniversary is deeply significant to me because it symbolizes just how far I have come. If only a year ago, lying in that hospital bed, Id had a crystal ball and could have seen into the future and understood that everything really would be OK. If only I could have seen my strong, able body, my mop of unruly blond curls, my happy, overflowing heart. Back then, it felt like my life was falling apart. Now, despite all the unexpected twists and turns and challenges of this tumultuous year, the disparity between where I was then and where I am now is not lost on me.

I think thats the greatest gift Ive gained from the long periods of sickness and convalescence Ive endured understanding the true value of being healthy.

Nothing can take that lesson from me now, and for that, Im deeply grateful. Ill always be able to look back and recall exactly what it felt like to lie in that ward, watching the clock, wishing time would pass, desperately longing to feel better, to just feel like myself again.

Health and time are the two things we take for granted the most, yet they are the greatest gifts we will ever have.

Despite how quickly this year has passed, it also has been filled with nothing but time. Time to sit and reflect. Time inside. Time alone. Time apart from loved ones. Its been tough, painful, and full of missing. But its also been deeply healing. I have watched as my body has transformed from a weak, thin, pale, depleted shell of skin and bones to a strong, tanned, healthy, muscular machine. I have watched the pigment return to my skin, the smile return to my cheeks, the sparkle return to my eyes. I never could have imagined the progress I would make in a year, and Im so deeply proud of myself for persevering through those dark, drawn-out days.

For anyone facing the eye of the storm now, or fresh off the boat of treatment, I want you to know that it does get better. If only I could whisper in the ear of that scared and sick girl and tell her that everything will be OK. That things wont stay dark forever. To hold on, theres so much more to come.

What a year, what a life.

***

Note: Lymphoma News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Lymphoma News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to lymphoma.

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bluebird bio to Present New Data from Clinical Studies of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral Adrenoleukodystrophy…

By daniellenierenberg

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that new data from the clinical development program for its investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including data from the Phase 2/3 Starbeam study (ALD-102) and available data from the Phase 3 ALD-104 study, will be presented at the 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2020), taking place virtually from August 29 - September 1, 2020.

New Cerebral Adrenoleukodystrophy (CALD) Data at EBMT 2020

Lenti-D hematopoietic stem cell gene therapy stabilizes neurologic function in boys with cerebral adrenoleukodystrophy (ALD-102 and ALD-104)Presenting Author: Dr. Jrn-Sven Khl, Department of Pediatric Oncology, Hematology and Hemostaseology, Center for Womens and Childrens Medicine, University Hospital LeipzigPoster Session & Number: Gene Therapy; ePoster O077

Additional bluebird bio data at EBMT 2020 includes encore presentations from the companys CALD, sickle cell disease (SCD), transfusion-dependent -thalassemia (TDT) and multiple myeloma programs.

Cerebral Adrenoleukodystrophy (CALD) Encore Data at EBMT 2020

Outcomes of allogeneic hematopoietic stem cell transplant in patients with cerebral adrenoleukodystrophy vary by donor cell source, conditioning regimen, and stage of cerebral disease status (ALD-103)Presenting Author: Dr. Jaap Jan Boelens, Chief, Pediatric Stem Cell Transplantation and Cellular Therapies Service, Memorial Sloan Kettering Cancer CenterPoster Session & Number: Haemoglobinopathy and inborn errors; ePoster O106

Multiple Myeloma Correlative Encore Data at EBMT 2020

Markers of initial and long-term responses to idecabtagene vicleucel (ide-cel; bb2121) in the CRB-401 study in relapsed/refractory multiple myelomaPresenting Author: Dr. Ethan G. Thompson, Bristol Myers SquibbPoster Session & Number: CAR-based Cellular Therapy clinical; ePoster A089

Sickle Cell Disease (SCD) Encore Data at EBMT 2020

LentiGlobin for sickle cell disease (SCD) gene therapy (GT): updated results in Group C patients from the Phase 1/2 HGB-206 studyPresenting Author: Dr. Markus Y. Mapara, Director, Adult Blood and Marrow Transplantation Program, Columbia University Medical CenterOral Session & Number: Inborn Errors; O080Date & Time: September 1, 2020; 4:35 4:42 PM CET/10:35 10:42 AM ET

Transfusion-Dependent -Thalassemia (TDT) Encore Data at EBMT 2020

Clinical outcomes following autologous hematopoietic stem cell transplantation with LentiGlobin gene therapy in the Phase 3 Northstar-2 and Northstar-3 studies for transfusion-dependent -thalassemiaPresenting Author: Professor Franco Locatelli, Director, Department of Pediatric Hematology and Oncology, Ospedale Pediatrico Bambino GesPoster Session & Number: Gene Therapy; ePoster O074

LentiGlobin gene therapy treatment of two patients with transfusion-dependent -thalassemia (case report)Presenting Author: Dr. Mattia Algeri, Department of Pediatric Oncohematology - Transplantation Unit and Cell Therapies, Ospedale Pediatrico Bambino GesPoster Session & Number: Haemoglobinopathy and inborn errors; ePoster A328

Cross Indication Encore Data at EBMT 2020

Safety of autologous hematopoietic stem cell transplantation with gene addition therapy for transfusion-dependent -thalassemia, sickle cell disease, and cerebral adrenoleukodystrophyPresenting Author: Dr. Evangelia Yannaki, Director, Gene and Cell Therapy Center, Hematology Department, George Papanicolaou HospitalPoster Session & Number: Gene Therapy; ePoster O078

Abstracts outlining bluebird bios accepted data at EBMT 2020 are available on the Annual Meeting website. On August 29, 2020, at 12:30 PM CET/6:30 AM ET, the embargo will lift for ePosters and oral presentations accepted for EBMT 2020. Presentations will be available for virtual viewing throughout the duration of the live meeting and content will be accessible online following the close of the meeting until November 1, 2020.

About elivaldogene autotemcel (eli-cel, Lenti-D gene therapy)In July 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an accelerated assessment to eli-cel gene therapy for cerebral adrenoleukodystrophy (CALD). bluebird bio is currently on track to submit the Marketing Authorization Application (MAA) in the EU for eli-cel for CALD by year-end 2020, and the Biologics License Application (BLA) in the U.S. in mid-2021.

bluebird bio is currently enrolling patients for a Phase 3 study (ALD-104) designed to assess the efficacy and safety of eli-cel after myeloablative conditioning using busulfan and fludarabine in patients with CALD. Contact clinicaltrials@bluebirdbio.com for more information and a list of study sites.

Additionally, bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-304) for patients who have been treated with eli-cel for CALD and completed two years of follow-up in bluebird bio-sponsored studies.

The Phase 2/3 Starbeam study (ALD-102) has completed enrollment. For more information about the ALD-102 study visit: http://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT01896102.

Adrenoleukodystrophy (ALD) is a rare, X-linked metabolic disorder that is estimated to affect one in 21,000 male newborns worldwide. Approximately 40 percent of boys with ALD will develop CALD, the most severe form of ALD. CALD is a progressive neurogenerative disease that involves breakdown of myelin, the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control. Symptoms of CALD usually occur in early childhood and progress rapidly, if untreated, leading to severe loss of neurologic function, and eventual death, in most patients.

The European Medicines Agency (EMA) accepted eli-cel gene therapy for the treatment of CALD into its Priorities Medicines scheme (PRIME) in July 2018, and previously granted Orphan Medicinal Product designation to eli-cel.

The U.S. Food and Drug Administration (FDA) granted eli-cel Orphan Drug status, Rare Pediatric Disease designation, and Breakthrough Therapy designation for the treatment of CALD.

Eli-cel is not approved for any indication in any geography.

About idecabtagene vicleucel (ide-cel; bb2121)Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3- chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

In addition to the pivotal KarMMa trial evaluating ide-cel in patients with relapsed and refractory multiple myeloma, bluebird bio and Bristol Myers Squibbs broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

In July 2020, Bristol Myers Squibb (BMS) and bluebird bio submitted the Biologics License Application for ide-cel to the U.S. Food and Drug Administration for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Ide-cel is the first CAR T cell therapy submitted for regulatory review to target BCMA and for multiple myeloma.

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority Medicines (PRIME) designation, as well as Accelerated Assessment status, by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between BMS and bluebird bio.

Ide-cel is not approved for any indication in any geography.

About LentiGlobin for Sickle Cell DiseaseLentiGlobin for sickle cell disease (SCD) is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel and LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS). HbS causes red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive crises (VOCs). For adults and children living with SCD, this means painful crises and other life-altering or life-threatening acute complicationssuch as acute chest syndrome (ACS), stroke and infections. If patients survive the acute complications, vasculopathy and end-organ damage, resulting complications can lead to pulmonary hypertension, renal failure and early death; in the U.S. the median age of death for someone with sickle cell disease is 43 - 46 years.

LentiGlobin for SCD received Orphan Medicinal Product designation from the European Commission for the treatment of SCD.

The U.S. Food and Drug Administration (FDA) granted Orphan Drug status and Regenerative Medicine Advanced Therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for the treatment of SCD.

bluebird bio reached general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a Biologics Licensing Application (BLA) submission for LentiGlobin for SCD will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint with at least 18 months of follow-up post-treatment with LentiGlobin for SCD. Globin response will be used as a key secondary endpoint.

bluebird bio anticipates additional guidance from the FDA regarding the commercial manufacturing process, including suspension lentiviral vector. bluebird bio announced in a May 11, 2020 press release it plans to seek an accelerated approval and expects to submit the U.S. BLA for SCD in the second half of 2021.

LentiGlobin for SCD is investigational and has not been approved in any geography.

About betibeglogene autotemcel (beti-cel; formerly LentiGlobin gene therapy for -thalassemia)The European Commission granted conditional marketing authorization (CMA) for betibeglogene autotemcel, marketed as ZYNTEGLO gene therapy, for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for ZYNTEGLO, supported by data from 32 patients treated with ZYNTEGLO, including three patients with up to five years of follow-up.

In the HGB-207 clinical study supporting the conditional marketing approval of ZYNTEGLO, the primary endpoint was transfusion independence (TI) by Month 24, defined as a weighted average Hb 9 g/Dl without any RBC transfusions for a continuous period of 12 months at any time during the study after infusion of ZYNTEGLO. Ten patients were evaluable for assessment of TI. Of these, 9/10 (90.0%, 95% CI 55.5-99.7%) achieved TI at last follow-up. Among these nine patients, the median (min, max) weighted average Hb during TI was 12.22 (11.4, 12.8) g/dLl.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Beti-cel adds functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

Non-serious adverse events (AEs) observed during the clinical studies that were attributed to betibeglogene autotemcel included abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnoea, pain in extremity, and non-cardiac chest pain. Two serious adverse events (SAE) of thrombocytopenia were considered possibly related to beti-cel.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

The CMA for beti-cel is valid in the 27 member states of the EU as well as UK, Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration granted beti-cel Orphan Drug status and Breakthrough Therapy designation for the treatment of TDT. Beti-cel is not approved in the United States.

Beti-cel continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit http://www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207), NCT03207009 for Northstar-3 (HGB-212).

About bluebird bio, Inc.bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

Lenti-D and bluebird bio are trademarks of bluebird bio, Inc.

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys financial condition, results of operations, as well as statements regarding the plans for regulatory submissions for beti-cel (marketed as ZYTENGLO in the European Union), eli-cel, ide-cel, and LentiGlobin for SCD, including anticipated endpoints to support regulatory submissions and timing expectations; the companys expectations regarding the potential for the suspension manufacturing process for lentiviral vector; its expectations for commercialization efforts for ZYNTEGLO in Europe; as well as the companys intentions regarding the timing for providing further updates on the development and commercialization of ZYNTEGLO and the companys product candidates. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the COVID-19 pandemic and resulting economic conditions will have a greater impact on the companys operations and plans than anticipated; that our amended collaboration with BMS will not continue or be successful; that preliminary positive efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in our ongoing or future clinical trials; the risk that our plans for submitting a BLA for LentiGlobin for SCD may be delayed if the FDA does not accept our comparability plans for the use of the suspension manufacturing process for lentiviral vector; the risk that the submission of BLA for ide-cel is not accepted for filing by the FDA or approved in the timeline we expect, or at all; the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates, including due to delays from the COVID-19 pandemics impact on healthcare systems; the risk that the current or planned clinical trials of our product candidates will be insufficient to support regulatory submissions or marketing approval in the United States and European Union; the risk that regulatory authorities will require additional information regarding our product candidates, resulting in delay to our anticipated timelines for regulatory submissions, including our applications for marketing approval; the risk that we will encounter challenges in the commercial launch of ZYNTEGLO in the European Union, including in managing our complex supply chain for the delivery of drug product, in the adoption of value-based payment models, or in obtaining sufficient coverage or reimbursement for our products; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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bluebird bio to Present New Data from Clinical Studies of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral Adrenoleukodystrophy...

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Stem Cell Therapy Market Landscape Assessment By Type and Analysis Current Trends by Forecast To 2025 – The Daily Chronicle

By daniellenierenberg

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

Know the Growth Opportunities in Emerging Markets

Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

Order this Report TOC for Detailed Statistics

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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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 Therapy Market Landscape Assessment By Type and Analysis Current Trends by Forecast To 2025 - The Daily Chronicle

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Re: Management of post-acute covid-19 in primary care – The BMJ

By daniellenierenberg

Dear EditorExcellent review and so needed and well-timedThe only issue that did not get the attention it needs are the neuropsychiatric symptoms of mild COVID-19. This is important for medical professionals to know, to avoid labeling the patients' problems as psychiatric and even hysterical as some recently did in a major newspaper here in Belgium.There are two sides to the mental sequelae of mild COVID.a) the consequences of the impact of going through a global pandemic, of lockdown, of COVID patients in their immediate environment, of the fear of infection or infecting others, of losing their job, and finally of their own infection.b) the mental symptoms of an organic disorder.In the subject literature about COIVD-19 (and MERS, SARS and other infections) several mechanisms are mentioned.-A direct neurotropic impact of the virus, especially, but not only via ACE2, both in neurons and glial cells, especially targeting the brain stem which plays a role in emotions. and brought there, among other things, via the direct connection of the olfactory bulb.-Inflammatory and immune reactions that result in cognitive and psychiatric symptoms:(the "misty brain" cited by many patients)-Reactions of the autonomic nervous system, eg cardiac arrhythmias can also be very scary.-Alteration of the gas exchange -oxygen nd carbon dioxide- due to damage to the alveoli resulting in a suboptimal pH.These results in mental symptoms of an organic disorder: memory problems, word finding disorders, confusion, major sleeping problems, insecure motor skills, anorexia, etc. and of course very often chronic fatigue, muscle weakness and anxiety.Of course, fear or anger of the patient are amplified when the doctor labels this as purely psychological, while the patient who has never been ill before, clearly experiences its not.

Because we have only known the disease for six months and we still know so little about it, it is therefore better to take the experiences of the patients seriously, instead of brushing them off as purely psychological or psychiatric.

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Re: Management of post-acute covid-19 in primary care - The BMJ

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RT-PCR is the most reliable test in the covid diagnosis: Dr A. Velumani, CEO, Thyrocare Technologies Ltd. – ETHealthworld.com

By daniellenierenberg

Shahid Akhter, editor, ETHealthworld, spoke to. Dr A. Velumani, Promoter, Chairman, Managing Director and Chief Executive Officer, Thyrocare Technologies, to know more about the challenges and opportunities associated with Covid diagnostics business.

Covid-19 : ChallengesBecause of the lockdown, the existing non-covid healthcare and diagnostics business collapsed. It collapsed to 2% suddenly within a week and it didn't allow it to resume for three months.Multiple advisory's multiple tests, whom to test and whom not to, along with plenty of show cause notice because a lot of administrators wanted to under-report positivity and some probably wanted the professional gains, so a lot of time they took in the review. These were the challenges but there were a lot of opportunities as well.

Covid-19: LearningsIn my opinion, Lockdown is not the solution, repeating lockdowns, having every different strict guideline for every different state is not the solution. It won't help to reduce. Secondly, Rapid antigen kits are useless, it doesn't solve anything so we've learned the RT-PCR is the most reliable one in the covid diagnosis.Covid-19: Government's InitiativeAlso, the government labs have contributed significantly which wasn't expected, we were all thinking it is just the private labs who are truly scaling up but government labs too scaled up and contributed more in more than 50% of the testing.

Covid-19: Immunity and antibodyImmunity matters, I don't think lockdown can stop Covid. It is the antibodies that can stop the Covid and India is blessed as only 30% tests are there per million whereas in the US there are 600 tests per million. The antibody power is important to be seen as well if not then there is a problem.

Covid-19: Towards a new normalWork from home will continue, even in healthcare, it is just 17% which is working from home. Also, there will be two different religions in healthcare that will be Covid and Non-Covid so that infection will not pass on to one covid patient to another and non-covid will not move to covid hospitals. The spending on hygiene needs to be high because the general population is scared, medical doctors are scared and the patients are scared.

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RT-PCR is the most reliable test in the covid diagnosis: Dr A. Velumani, CEO, Thyrocare Technologies Ltd. - ETHealthworld.com

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 2029 – Owned

By daniellenierenberg

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Stem Cell-Derived Cells market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Stem Cell-Derived Cells market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Stem Cell-Derived Cells market to assist our clients arrive at beneficial business decisions.

The Stem Cell-Derived Cells market study is a well-researched report encompassing a detailed analysis of this industry with respect to certain parameters such as the product capacity as well as the overall market remuneration. The report enumerates details about production and consumption patterns in the business as well, in addition to the current scenario of the Stem Cell-Derived Cells market and the trends that will prevail in this industry.

Request Sample Report @ https://www.persistencemarketresearch.co/samples/28780

What pointers are covered in the Stem Cell-Derived Cells market research study?

The Stem Cell-Derived Cells market report Elucidated with regards to the regional landscape of the industry:

The geographical reach of the Stem Cell-Derived Cells market has been meticulously segmented into United States, China, Europe, Japan, Southeast Asia & India, according to the report.

The research enumerates the consumption market share of every region in minute detail, in conjunction with the production market share and revenue.

Also, the report is inclusive of the growth rate that each region is projected to register over the estimated period.

The Stem Cell-Derived Cells market report Elucidated with regards to the competitive landscape of the industry:

The competitive expanse of this business has been flawlessly categorized into companies such as

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

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Exclusive details pertaining to the contribution that every firm has made to the industry have been outlined in the study. Not to mention, a brief gist of the company description has been provided as well.

Substantial information subject to the production patterns of each firm and the area that is catered to, has been elucidated.

The valuation that each company holds, in tandem with the description as well as substantial specifications of the manufactured products have been enumerated in the study as well.

The Stem Cell-Derived Cells market research study conscientiously mentions a separate section that enumerates details with regards to major parameters like the price fads of key raw material and industrial chain analysis, not to mention, details about the suppliers of the raw material. That said, it is pivotal to mention that the Stem Cell-Derived Cells market report also expounds an analysis of the industry distribution chain, further advancing on aspects such as important distributors and the customer pool.

The Stem Cell-Derived Cells market report enumerates information about the industry in terms of market share, market size, revenue forecasts, and regional outlook. The report further illustrates competitive insights of key players in the business vertical followed by an overview of their diverse portfolios and growth strategies.

For any queries get in touch with Industry Expert @ https://www.persistencemarketresearch.co/ask-an-expert/28780

Some of the Major Highlights of TOC covers:

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 2029 - Owned

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