Category Archives: Cell Therapy

Researchers report that a patient who underwent stem-cell transplantation and a chemotherapy drug regimen has been cured of HIV.

An HIV patient to undergo stem cell transplantation from donors with a HIV-resistant gene no longer suffers from the condition, according to a new study. Researchers reveal that there was no active viral infection in the patients blood 30 months after they stopped anti-retroviral therapy, making him the second person cured of HIV.

However, they report that although there was no active viral infection in the patients body, remnants of integrated HIV-1 DNA remained in tissue samples, which were also found in the first patient to be cured of HIV. The authors suggest that these can be regarded as so-called fossils, as they are unlikely to be capable of reproducing the virus.

We propose that these results represent the second ever case of a patient to be cured of HIV. Our findings show that the success of stem cell transplantation as a cure for HIV, first reported nine years ago in the Berlin patient, can be replicated, said lead author on the study, Professor Ravindra Kumar Gupta at the University of Cambridge, UK.

The London and Berlin patient are examples of using the CCR5 gene in curative therapies outside of gene editing

He emphasised that as a high-risk treatment, this therapy is unlikely to be offered widely to patients with HIV who are on successful antiretroviral treatment.

In 2011, a patient based in Berlin (the Berlin patient) was the first HIV patient to be reportedly cured of the virus three and half years after undergoing similar treatment. This therapy included total body irradiation, two rounds of stem cell transplant from a donor who carried a CCR532/32 gene, which is resistant to HIV and finally a chemotherapy drug regimen. The transplant aimed to make the virus unable to replicate in the patients body, whilst the body irradiation and chemotherapy targeted any residual HIV virus.

The patient reported in this study (the London patient), underwent one stem-cell transplantation and a reduced-intensity chemotherapy drug regimen, without whole body irradiation. In 2019, it was reported that his HIV was in remission and the new study provides follow-up viral load blood test results at 30-months, as well as a modelling analysis to predict the chances of viral re-emergence.

Ultrasensitive viral load sampling from the London patients cerebrospinal fluid, intestinal tissue or lymphoid tissue was taken at 29 months after interruption of antiretroviral therapy (ART) and viral load sampling of his blood at 30 months. At 29 months, CD4 cell count (indicators of immune system health and stem cell transplantation success) was measured and analysed to identify the extent to which the patients immune cells have been replaced by those derived from the transplant.

The results showed no active viral infection was detected in samples of the patients blood at 30 months or in his cerebrospinal fluid, semen, intestinal tissue and lymphoid tissue 29 months after stopping ART.The patient also had a healthy CD4 cell count, suggesting he recovered well from the transplant, with his CD4 cells replaced by cells derived from the HIV-resistant transplanted stem cells. Furthermore, 99 percent of his immune cells were derived from the donors stem cells, indicating the stem-cell transplant had been successful.

The authors highlight that their case study of the London patient represents a step towards a less intensive treatment approach. They suggest that the long-term remission of HIV can be achieved using reduced intensity drug regimens, with one stem cell transplant (rather than two) and without total body irradiation.

However, being only the second reported patient to undergo this experimental treatment successfully, the authors note that that the London patient will need continued, but much less frequent, monitoring for re-emergence of the virus.

Speculating on what their results might mean for future developments of HIV cures that utilise the CCR5 gene, co-author on the study, Dr Dimitra Peppa at the University of Oxford, UK, said: Gene editing using the CCR5 has received a lot of attention recently. The London and Berlin patient are examples of using the CCR5 gene in curative therapies outside of gene editing. There are still many ethical and technical barriers eg, gene editing, efficiency and robust safety data to overcome before any approach using CCR5 gene editing can be considered as a scalable cure strategy for HIV.

The study was published in The Lancet HIV.

HIV

Here is the original post:
Second patient cured of HIV using stem cell therapy - European Pharmaceutical Review

In this report, the global Cancer Stem Cell Therapy market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.

For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2019 to 2025.

The Cancer Stem Cell Therapy market report firstly introduced the basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the Cancer Stem Cell Therapy market report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

Request Sample Report @ https://www.marketresearchhub.com/enquiry.php?type=S&repid=2542097&source=atm

The major players profiled in this Cancer Stem Cell Therapy market report include:

The following manufacturers are covered:AVIVA BioSciencesAdnaGenAdvanced Cell DiagnosticsSilicon Biosystems

Segment by RegionsNorth AmericaEuropeChinaJapanSoutheast AsiaIndia

Segment by TypeAutologous Stem Cell TransplantsAllogeneic Stem Cell TransplantsSyngeneic Stem Cell TransplantsOther

Segment by ApplicationHospitalClinicMedical Research InstitutionOther

You can Buy This Report from Here @ https://www.marketresearchhub.com/checkout?rep_id=2542097&licType=S&source=atm

The study objectives of Cancer Stem Cell Therapy Market Report are:

To analyze and research the Cancer Stem Cell Therapy market status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.

To present the Cancer Stem Cell Therapy manufacturers, presenting the sales, revenue, market share, and recent development for key players.

To split the breakdown data by regions, type, companies and applications

To analyze the global and key regions Cancer Stem Cell Therapy market potential and advantage, opportunity and challenge, restraints and risks.

To identify significant trends, drivers, influence factors in global and regions

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the keyword market.

Make An EnquiryAbout This Report @ https://www.marketresearchhub.com/enquiry.php?type=E&repid=2542097&source=atm

See the original post:
Cancer Stem Cell Therapy Market Global Size, Demand-sales, Suppliers by Key Applications 2019 Detailed Analysis and Growth Aspects on Manufacturing...

Canine Stem Cell Therapy Market size will reach xx million US$ by 2029, from xx million US$ in 2018, at a CAGR of xx% during the forecast period. In this study, 2018 has been considered as the base year and2029 as the forecast period to estimate the market size for Canine Stem Cell Therapy.

This industry study presents the Canine Stem Cell Therapy Market size, historical breakdown data 2014-2019 and forecast 2029. The Private Plane production, revenue and market share by manufacturers, key regions and type; The consumption of Canine Stem Cell Therapy Market in volume terms are also provided for major countries (or regions), and for each application and product at the global level.

ThisPress Release will help you to understand the Volume, growth with Impacting Trends. Click HERE To get SAMPLE PDF (Including Full TOC, Table & Figures) at https://www.xploremr.com/connectus/sample/2360

Canine Stem Cell Therapy Market report coverage:

The Canine Stem Cell Therapy Market report covers extensive analysis of the market scope, structure, potential, fluctuations, and financial impacts. The report also enfolds the precise evaluation of market size, share, product & sales volume, revenue, and growth rate. It also includes authentic and trustworthy estimations considering these terms.

The Canine Stem Cell Therapy Market has been reporting substantial growth rates with considerable CAGR for the last couple of decades. According to the report, the market is expected to grow more vigorously during the forecast period and it can also influence the global economic structure with a higher revenue share. The market also holds the potential to impact its peers and parent market as the growth rate of the market is being accelerated by increasing disposable incomes, growing product demand, changing consumption technologies, innovative products, and raw material affluence.

The study objectives are Canine Stem Cell TherapyMarket Report:

In this study, the years considered to estimate the market size of Canine Stem Cell TherapyMarket:

History Year: 2014 2018

Base Year: 2018

Estimated Year: 2019

Forecast Year:2029

This report includes the estimation of market size for value (million USD) and volume (K Units). Both top-down and bottom-up approaches have been used to estimate and validate the market size of Canine Stem Cell Therapy Market, to estimate the size of various other dependent submarkets in the overall market. Key players in the market have been identified through secondary research, and their market shares have been determined through primary and secondary research. All percentage shares, splits, and breakdowns have been determined using secondary sources and verified primary sources.

For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Get Your Copy at a Discounted Rate!!! Limited Time Offer!!! https://www.xploremr.com/connectus/check-discount/2360

The report covers exhaustive analysis on:

Regional analysis includes

Get Full Report Access athttps://www.xploremr.com/cart/2360/SL

Benefits of Purchasing from XMR:

About Us

XploreMR is one of the worlds leading resellers of high-quality market research reports. We feature in-depth reports from some of the worlds most reputed market research companies and international organizations. We serve across a broad spectrum from Fortune 500 to small and medium businesses. Our clients trust us for our unwavering focus onquality and affordability. We believe high price should not be a bottleneck for organizations looking to gain access to quality information.

Contact us:

XploreMR111 North Market Street, Suite 300,San Jose, CA 95113, United StatesPh.No: +16692840108E-mail id-[emailprotected]Web-https://www.xploremr.com

Read the rest here:
Canine Stem Cell Therapy Market to Witness Growth Acceleration During 2029 - Monroe Scoop

Revolutionary Gene-Editing Tool

Cardiovascular or heart disease (CVDs) is the leading cause of death across the world. Heart attacks resulting due to CVDs can cause death, and severe damage to cardiac muscle a muscle that forms the wall of the heart in survivors. However, researchers claim that they have discovered stem-cell activated mechanisms that promote healing after a heart attack.

According to the study by researchers from Mayo Clinic, stem cells were found to reverse the damage and restore cardiac muscle back to its condition before a heart attack. Human cardiopoietic cells obtained from stem cells within the bone marrow were found to hone in on damaged proteins and reverse intricate changes that a heart attack caused.

"The response of the diseased heart to cardiopoietic stem cell treatment revealed development and growth of new blood vessels, along with new heart tissue," said Dr. Kent Arrell, first author of the study, in a statement.

For the study, the researchers examined the diseased hearts of mice. The hearts of mice that received human cardiopoietic stem cell therapy were compared with those of that did not. Nearly 4,000 cardiac proteins were identified using a data science technique to map proteins found in the cardiac muscle. Over 10 per cent of the discovered proteins were found to suffer damage as a result of a heart attack.

"While we anticipated that the stem cell treatment would produce a beneficial outcome, we were surprised how far it shifted the state of diseased hearts away from disease and back toward a healthy, pre-disease state," said Dr. Arrell.

While the organs in the human body have the ability to repair their damaged cells, they may be unable to restore the loss entirely, and this holds good for cardiac cells as well. Dr. Andre Terzic, senior author of the study, said: "The extent of change caused by a heart attack is too great for the heart to repair itself or to prevent further damage from occurring."

He explained that upon the administration of cardiopoietic stem cell therapy to mice, a partial or complete reversal of nearly two-thirds of the damage caused by a heart attack was noted. Around 85 per cent of all cellular functional categories struck by the disease responded favorably to the treatment.

According to the World Health Organisation (WHO), CVDs claim nearly 18 million lives every year, which translates to 31 per cent of all deaths. The findings of the study provide an improved understanding of the restoration of heart health using stem cells and provide a framework for wider utilization of stem cell therapy for the treatment of various conditions.

Stressing that the actual mechanism behind the repair of diseased organs by stem cells is poorly understood, Dr. Terzic added: "This study sheds light on the most intimate, yet comprehensive, regenerative mechanisms paving a road map for responsible and increasingly informed stem cell application."

See the original post here:
Stem cells can reverse damage caused by heart attack; repair mechanism discovered: Study - International Business Times, Singapore Edition

Two words that haven't been on investors' minds in more than a decade now are the reality: bear market. Escalating global fears about the coronavirus disease COVID-19 have wreaked havoc on stocks. Travel to Europe has been largely halted. Professional sports leagues are suspending their seasons. There won't be any March Madness for college basketball fans.

Should investors wring their hands in worry and panic? Not at all. A far better reaction is to take Warren Buffett's advice to "be greedy when others are fearful." That means you should buy quality stocks that are now available at more attractive prices than in the past.

But which stocks are smart choices? If you've got $5,000 to invest right now, here are three stocks I think are great ones to buy during the coronavirus-caused bear market.

Image source: Getty Images.

Bristol Myers Squibb' (NYSE:BMY) stock hasn't fallen quite as much as the S&P 500 during the market meltdown but isn't too far behind. But the outlook for the drugmaker is just as good now as it was earlier this year when the pharmaceutical stock was at a 52-week high.

Thanks to its acquisition of Celgene last year, BMS now claims a pipeline that's chock-full of potential blockbuster drugs. It should win Food and Drug Administration approval for ozanimod in treating relapsed multiple sclerosis within the next couple of weeks. FDA approval of cancer cell therapy liso-cel could be on the way by Aug. 17. The company should also soon file for U.S. approval of another cell therapy, ide-cel, in treating multiple myeloma, a type of blood cancer.

Then there's BMS' current lineup. Market researcher EvaluatePharma projects that two of the big pharma company's drugs -- cancer immunotherapy Opdivo and blood thinner Eliquis -- will rank among the top five biggest blockbuster drugs of 2024. Sales for arthritis drug Orencia and multiple myeloma drug Empliciti are soaring. So are sales for several drugs gained with the Celgene buyout, including blood cancer juggernaut Revlimid and solid tumor drug Abraxane.

Because of coronavirus concerns weighing on the overall stock market, BMS stock is now dirt cheap. Its shares trade at only 9.6 times expected earnings. With multiple pipeline candidates likely to win approval in the next year or so, the company's growth prospects make its valuation even more attractive. And BMS' growth potential shouldn't be impacted in the slightest by COVID-19.

Guardant Health (NASDAQ:GH), on the other hand, isn't such an obvious bargain. But the stock is less expensive than it was just a few weeks ago thanks to a certain pesky virus.

As is the case with Bristol Myers Squibb, Guardant Health's business shouldn't be affected by the COVID-19 pandemic. Sales are going through the roof for the company's two liquid biopsy products, Guardant360 and GuardantOMNI. The former product helps identify the best treatment for patients with advanced-stage cancer. The latter is used by drugmakers to screen patients for clinical trials of cancer drugs. The coronavirus pandemic won't put even a dent in the demand for the two products.

Actually, there are a couple of catalysts likely on the way that will boost sales for Guardant360. Guardant Health could receive FDA approval for the liquid biopsy later this year. The company also hopes to win a Medicare national coverage determination (NCD) for Guardant360 that wouldestablish a standard reimbursement for the liquid biopsy in treating multiple types of cancer for all Medicare beneficiaries.

Guardant Health estimates that the U.S. market potential for Guardant360 by itself is close to $6 billion annually. But there's an even greater opportunity for the company's Lunar assays that are currently available for research use only. These liquid biopsies hold the promise to detect cancer at early stages as well as monitor for recurrence. The potential market for the products could top $45 billion. With Guardant Health's market cap now below $8 billion, the stock looks like an attractive pick for long-term investors.

I'd put MongoDB (NASDAQ:MDB) in the same boat as Guardant Health. The stock isn't exactly cheap based on conventional valuation metrics, but the coronavirus-fueled market sell-off has caused it to trade at a discount from earlier this year. And I have no doubt that MongoDB will bounce back in a big way.

Regardless of what happens with COVID-19, businesses will keep on churning out ginormous quantities of data. Unlike in the past, though, all of this data won't be the kind that can fit nicely into rows and columns. Instead, today's world uses a lot of unstructured data such as audio, videos, and text.

Major databases sold by Oracleand IBMwere designed decades ago and weren't built to support unstructured data. MongoDB's database was. It was also created from scratch to be run anywhere, from an onsite data center to the cloud. That's a big plus with organizations across the world moving their apps and data to the cloud.

It's not surprising that MongoDB's Atlas cloud-based database service is the company's biggest growth driver. I expect continued strong growth from Atlas for years to come.

Continue reading here:
Coronavirus Bear Market: Where to Invest $5000 Right Now - Motley Fool

In 2020, the National Eye Institute is launching a clinical trial to test the safety of a patient-specific stem cell therapy to treat geographic atrophy, the advanced dry form of age-related macular degeneration (AMD). The protocol is the first of its kind in the United States to replace a patients eye tissue with tissue derived from induced pluripotent stem (iPS) cells engineered from a patients own blood.

If successful, this new approach to AMD treatment could prevent millions of Americans from going blind. AMD is a leading cause of vision loss in people age 65 and older. By 2050, the estimated number of people with AMD is expected to more than double from 2.07 million to 5.44 million.

The first symptoms of age-related macular degeneration are dark spots in ones central vision, which is used for daily activities such as reading, seeing faces and driving. But as the disease progresses, the spots grow larger and increase in number, which can lead to significant loss of the central vision.

There are two kinds of AMD: the neovascular, or wet, form and the geographic atrophy, or dry form. Remarkable progress has been made in the ability to prevent vision loss from the neovascular form. In particular, anti-VEGF therapy has been shown to preserve vision required for driving among about half of patients who take it for five years.

By contrast, no therapies exist for treating geographic atrophy. Should this NEI-led study, and future studies, confirm the safety and efficacy of iPS cell-derived RPE-replacement therapy, it would likely be the first therapy approved for the treatment of geographic atrophy.

To produce the therapy, we isolate cells from a patients blood and, in a lab, convert them into iPS cells. These iPS cells are theoretically capable of becoming any cell type of the body.

The iPS cells are then programmed to become retinal pigment epithelium (RPE). RPE cells are crucial for eye health because they nourish and support photoreceptors, the light-sensing cells in the retina. In geographic atrophy, RPE cells die, leading to the death of photoreceptors and blindness. The goal of the iPS cell-based therapy is to protect the health of the remaining photoreceptors by replacing dying RPE tissue with healthy iPS cell-derived RPE tissue.

We grow a single-cell layer of iPS cell-derived RPE on a biodegradable scaffold. That patch is then surgically placed next to the photoreceptors where, as we have seen in animal models, it integrates with cells of the retina and protects the photoreceptors from dying.

This years clinical trial is a phase I/IIa study, which means it will focus solely on assessing the safety and feasibility of this RPE replacement therapy. The dozen participants will have one eye treated. Importantly, everyone will already have substantial vision loss from very advanced disease, such that the therapy is not expected to be capable of significant vision restoration. Once safety is established, later study phases will involve individuals with earlier stage disease, for which we are hopeful that therapy will restore vision.

A safety concern with any stem cell-based therapy is its oncogenic potential: the ability for cells to multiply uncontrollably and form tumours. On this point, animal model studies are reassuring. When we genetically analysed the iPSC-derived RPE cells, we found no mutations linked to potential tumour growth.

Likewise, the risk of implant rejection is minimised by the fact that the therapy is derived from patient blood.

Several noteworthy innovations have occurred along the way to launching the trial. Artificial intelligence has been applied to ensure that iPS cell-derived RPE cells function similar to native RPE cells. In addition, Good Manufacturing Practices, have been developed to ensure quality control, which will be crucial for scaling up production of the therapy should it receive approval from the U.S. Food and Drug Administration. Furthermore, the iPS cell-derived RPE patch is being leveraged to develop more complex RPE/photoreceptor replacement therapies.

Potential breakthroughs in treatment cannot move forward without the support of patients willing to participate in clinical trial research. Patients who volunteer for trials such as this are the real heroes of this work because theyre doing it for altruistic reasons. The patients in this first trial are not likely to benefit, so they are doing it to help move the field forward for future patients.

Editor's Recommended Articles

Read the original post:
Eye health: Testing the safety of stem cell therapy for age-related macular degeneration - Open Access Government

Your immune system works by keeping track of all the substances normally found in your body. Any new substance the immune system doesn't recognize raises an alarm, causing the immune system to attack it. Chimeric antigen receptor (CAR) T-cell therapy is a promising new way to get immune cells called T cells (a type of white blood cell) to fight cancer by changing them in the lab so they can find and destroy cancer cells.CAR T-cell therapies are sometimes talked about as a type of gene or cell therapy, or immune effect cell therapy.

The immune system recognizes foreign substances in the body by finding proteins called antigens on the surface of those cells. Immune cells called T cells have their own proteins called receptors that attach to foreign antigens and help trigger other parts of the immune system to destroy the foreign substance.

The relationship between antigens and immune receptors is like a lock and key. Just as every lock can only be opened with the right key, each foreign antigen has a unique immune receptor that is able to bind to it. Cancer cells also have antigens, but if your immune cells do not have the right receptors, they cannot attach to the antigens and help destroy the cancer cells.

The T cells used in CAR T-cell therapies get changed in the lab to spot specific cancer cells by adding a man-made receptor (called a chimeric antigen receptor or CAR). This helps them better identify specific cancer cell antigens. Since different cancers have different antigens, each CAR is made for a specific cancer's antigen. For example, certain kinds of leukemia or lymphoma will have an antigen on the outside of the cancer cells called CD19. The CAR T-cell therapies to treat those cancers are made to connect to the CD-19 antigen and will not work for a cancer that does not have the CD19 antigen. The patient's own T cells are used to make the CAR T cells.

The process for CAR T-cell therapy can take a few weeks.

First, white blood cells (which include T cells) are removed from the patients blood using a procedure called leukapheresis. During this procedure, patients usually lie in bed or sit in a reclining chair. Two IV lines are needed because blood is removed through one line, and then put back into the bloodstream through the other line, after the white blood cells have been removed. Sometimes a special type of IV line is used called a central venous catheter, that has both IV lines built in. The patient will need to stay still for 2 to 3 hours during the procedure. Sometimes calcium levels can drop during leukapheresis, which can cause numbness and tingling or muscle spasms. This can be easily treated with calcium, which may be given by mouth or through an IV .

After the white cells are removed, the T-cells are separated, sent to the lab, and genetically altered by adding the specific chimeric antigen receptor (CAR). This makes them CAR T cells. It can take a few weeks to finish making the large number of CAR T cells needed for this therapy.

Once enough CAR T cells have been made, they will be given back to the patient to launch a precise attack against the cancer cells. A few days before a CAR T-cell infusion, the patient might be given chemotherapy to help lower the number of other immune cells. This gives the CAR T cells a better chance to get activated to fight the cancer.This chemotherapy is usually not very strong because CAR T cells work best when there are some cancer cells to attack. Once the CAR T cells start binding with cancer cells, they start to increase in number and can destroy even more cancer cells.

CAR T cell therapy is FDA approved for some kinds oflymphomas, and for certain patients with relapsed or hard to treat leukemia. Many clinical trials are underway with the hope of treating even more patients. One problem with some types of cancer is that they dont have the same antigens for the CAR T cell to work with because the proteins are inside the cells, not on the cell surface. This may mean that the CAR T cell needs a special armor to be able to get into the cell to work. More research is needed to study this.

The CAR T-cell therapies currently approved are:

Some people have had serious side effects from this treatment, especially as the CAR T cells multiply in the body to fight the cancer. As CAR T cells multiply, they cause massive amounts of chemicals called cytokines to be released into the blood. Serious side effects of this release can include very high fevers and dangerously low blood pressure in the days after treatment is given. This is called cytokine release syndrome, or CRS. Even though it can be a scary side effect, it's important to remember that it means the CAR T cells are working and doctors have learned how to expect it and treat it.

Other serious side effects include neurotoxicity or changes in the brain that cause swelling, confusion, seizures, or severe headaches.

One other problem is that the CAR T cells can kill off some of the good B cells that help fight germs, so the patient may be at risk for infection.

Read more from the original source:
CAR T-cell Therapy and Its Side Effects

Cell Therapy Market Size, Share & Trends Analysis Report By Use-type (Research, Commercialized, Musculoskeletal Disorders), By Therapy Type (Autologous, Allogeneic), By Region, And Segment Forecasts, 2020 - 2027

New York, March 05, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell Therapy Market Size, Share & Trends Analysis Report By Use-type, By Therapy Type, By Region And Segment Forecasts, 2020 - 2027" - https://www.reportlinker.com/p05868803/?utm_source=GNW

The global cell therapy market size is expected to reach USD 8.8 billion by 2027 at a CAGR of 5.4% over the forecast period. Cellular therapies hold a great therapeutic promise across various clinical applications. This has resulted in substantial global investments in research and clinical translation. Moreover, rapid advances in stem cell research hold the potential to fulfill the unmet demand of pharmaceutical entities, biotech entities, and doctors in disease management. These factors have boosted revenue growth for the market.

Currently, there are a limited number of FDA-approved commercial stem and non-stem cell therapies in the market.Furthermore, LAVIV (Azficel-T), manufactured and commercialized by Fibrocell Technologies, witnessed revenue wind-down in the past years.

Key developers are making substantial investments in the adoption of advanced technologies to address the aforementioned challenges.

The introduction of proprietary cell lines is recognized as the primary means by which a single cell can be exploited for the production of a robust portfolio of candidates. Companies are leveraging new technologies not only for the expansion of their product portfolio but also for establishing out-licensing or co-development agreements with other entities to support their product development programs.

For instance, MaxCyte has more than 40 high-value cellular therapy partnership programs within immune-oncology, regenerative medicine, and gene editing, including fifteen clinical-stage programs. Increase in the number of collaborations between entities for product commercialization is anticipated to accelerate market revenue to a major extent in the coming years.

In Asia Pacific, the market is anticipated to witness significant growth over the forecast period.This is attributed to rising awareness cellular therapies among patients and healthcare entities in chronic disease management.

In addition, availability of therapeutic treatment at lower prices is also driving the regional market. Japan is likely to witness fast growth over the forecast period attributed to increasing research activities on regenerative medicine.

Further key findings from the report suggest: The clinical-use segment accounted for low revenue share due to stringent regulations and non- commercial viability of some products However, the expanding knowledge over the commercial potential of cellular therapies is anticipated to result in the commercialization of a large number of products in the coming years On the contrary, the research-use segment accounted for the largest revenue share in 2019 owing to increase in research activities to explore the potential of the therapy in substantially improving disease management Furthermore, an increase in funding to explore the potential of these therapies has contributed to the large share of the research segment Allogenic therapies dominated the revenue share in 2019 owing to relatively lower relapse rates and growth in stem cell banking activities This is due to the high price and a large number of companies involved in the development of allogenic therapies Moreover, several companies are preparing to shift their business towards allogeneic therapy product development, resulting in significant revenue growth in this segment Autologous therapies are estimated to grow at the fastest pace during the forecast period Lack of donors and low affordability of allogeneic therapies are two key factors contributing to the increase in adoption of autologous therapies Considering the growing share of the cell therapy market in the biopharma industry, the companies are striving to gain a competitive advantage Vericel Corporation, JCR Pharmaceuticals Co. Ltd., MEDIPOST, and Osiris Therapeutics, Inc. are some key players operating in the market These companies are engaged in the expansion of their product portfolio, either through product development or acquisition of other players operating in the space.Read the full report: https://www.reportlinker.com/p05868803/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

__________________________

Story continues

Clare: clare@reportlinker.comUS: (339)-368-6001Intl: +1 339-368-6001

Continue reading here:
Cell Therapy Market Size, Share & Trends Analysis Report By Use-type, By Therapy Type, By Region And Segment Forecasts, 2020 - 2027 - Yahoo...

For years, the foundations of cancer treatment were surgery,chemotherapy, andradiation therapy. Over the last two decades, targeted therapies likeimatinib(Gleevec) andtrastuzumab(Herceptin)drugs that target cancer cells by homing in on specific molecular changes seen primarily in those cellshave also cemented themselves as standard treatments for many cancers.

But over the past several years, immunotherapytherapies that enlist and strengthen the power of a patient's immune system to attack tumorshas emerged as what many in the cancer community now call the "fifth pillar" of cancer treatment.

A rapidly emerging immunotherapy approach is called adoptive cell transfer (ACT): collecting and using patients' own immune cells to treat their cancer. There are several types of ACT (see the boxbelow, titled"ACT: TILs, TCRs, and CARs"), but, thus far,the one that has advanced the furthest in clinical development is called CAR T-cell therapy.

Until recently, the use of CAR T-cell therapy has been restricted to small clinical trials, largely in patients with advanced blood cancers. But these treatments have nevertheless captured the attention of researchers and the public alike because of the remarkable responses they have produced in some patientsboth children and adultsfor whom all other treatments had stopped working.

In 2017, two CAR T-cell therapies were approved by the Food and Drug Administration (FDA), onefor the treatment of children with acute lymphoblastic leukemia (ALL) andthe otherfor adults with advanced lymphomas. Nevertheless, researchers caution that, in many respects, its still early days for CAR T cells and other forms of ACT, including questions about whether they will ever be effective against solid tumors like breast and colorectal cancer.

The different forms of ACT "are still being developed," said Steven Rosenberg, M.D., Ph.D., chief of the Surgery Branch in NCI's Center for Cancer Research (CCR), an immunotherapy pioneer whose lab was the first to report successful cancer treatment with CAR T cells.

But after several decades of painstaking research, the field has reached a tipping point, Dr. Rosenberg continued. In just the last few years, progress with CAR T cells and other ACT approaches has greatly accelerated, with researchers developing a better understanding of how these therapies work in patients and translating that knowledge into improvements in how they are developed and tested.

"In the next few years," he said, "I think we're going to see dramatic progress and push the boundaries of what many people thought was possible with these adoptive cell transferbased treatments."

CAR T cells are the equivalent of "giving patients a living drug," explained Renier J. Brentjens, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center in New York, another early leader in the CAR T-cell field.

As its name implies, the backbone of CAR T-cell therapy is T cells, which are often called the workhorses of the immune system because of their critical role in orchestrating the immune response and killing cells infected by pathogens. The therapy requires drawing blood from patients and separating out the T cells. Next, using a disarmed virus, the T cells are genetically engineered to produce receptors on their surface called chimeric antigen receptors, or CARs.

These receptors are "synthetic molecules, they don't exist naturally," explained Carl June, M.D., of the University of Pennsylvania Abramson Cancer Center, during a recent presentation on CAR T cells at the National Institutes of Health campus. Dr. June has led a series of CAR T cell clinical trials, largely in patients with leukemia.

These special receptors allow the T cells to recognize and attach to a specific protein, or antigen, on tumor cells. The CAR T cell therapies furthest along in development target an antigen found on B cells called CD19 (see the box below, titled "The Making of a CAR T Cell").

Once the collected T cells have been engineered to express the antigen-specific CAR, they are "expanded" in the laboratory into the hundreds of millions.

The final step is the infusion of the CAR T cells into the patient (which is preceded by a "lymphodepleting" chemotherapy regimen). If all goes as planned, the engineered cells further multiply in the patient's body and, with guidance from their engineered receptor, recognize and kill cancer cells that harbor the antigen on their surfaces.

The Making of a CAR T Cell

A growing number of CAR T-cell therapies are being developed and tested in clinical studies.

Although there are important differences between these therapies, they all share similar components. The CAR on the cells surface is composed of fragments, or domains, of synthetic antibodies. The domains that are used can affect how well the receptor recognizes or binds to the antigen on the tumor cell.

The receptors rely on stimulation signals from inside the cell to do their job. So each CAR T cell has signaling and "co-stimulatory" domains inside the cell that signal the cell from the surface receptor. The different domains that are used can affect the cells' overall function.

Over time, advances in the intracellular engineering of CAR T cells have improved the engineered T cells' ability to produce more T cells after infusion into the patient (expansion) and survive longer in the circulation (persistence).

Advances have also been made in how long it takes to produce a batch of CAR T cells. Although it initially took several weeks, many labs have now reduced the time to less than 7 days.

The initial development of CAR T-cell therapies has focused largely on ALL, the most common cancer in children.

More than 80% of children diagnosed with ALL that arises in B cellsthe predominant type of pediatric ALLwill be cured by intensive chemotherapy. But for patients whose cancers return after chemotherapy or a stem cell transplant, the treatment options are "close to none," said Stephan Grupp, M.D., Ph.D., of the Children's Hospital of Philadelphia (CHOP).

Relapsed ALL, in fact, is a leading cause of death from childhood cancer.

Dr. Grupp has led several trials of CAR T cells in children and young adults with ALL that had recurred or was not responding to existing therapies. In one of these earlier trials, which used CD19-targeted CAR T cells, all signs of cancer disappeared (a complete response) in 27 of the 30 patients treated in the study, with many of these patients continuing to show no signs of recurrence long after the treatment.

These early successes laid the foundation for a larger trial of a CD19-targeted CAR T-cell therapy, called tisagenlecleucel (Kymriah), for children and adolescents with ALL. Many of the patients who participated in the trial, funded by Novartis, had complete and long-lasting remissions. Based on the trial results, FDA approved tisagenlecleucel in August 2017.

Similar results have been seen in trials of CD19-targeted CAR T cells led by researchers in CCR's Pediatric Oncology Branch (POB).

The progress made with CAR T-cell therapy in children with ALL "has been fantastic," said Terry Fry, M.D., a lead investigator on several POB trials of CAR T cellswho is now at Children's Hospital Colorado. CD19-targeted CAR T cells were initially tested in adults. But the fact that the first approval is for a therapy for children and adolescents with ALL is a watershed moment, Dr. Fry continued.

The agency approving a new therapy in children before adults "is almost unheard of in cancer," he said.

However, there is no shortage of promising data on CAR T cells used to treat adult patients with blood cancers. CD19-targeted CAR T cells have produced strong results not only in patients with ALL but also in patients with lymphomas. For example, in a small NCI-led trial of CAR T cells primarily in patients with advanced diffuse large B-cell lymphoma, more than half had complete responses to the treatment.

"Our data provide the first true glimpse of the potential of this approach in patients with aggressive lymphomas, who, until this point, were virtually untreatable," said the trial's lead investigator, James Kochenderfer, M.D., of the NCI Experimental Transplantation and Immunology Branch.

Since that time, findings from a larger trial funded by Kite Pharmaceuticals (which has a research agreement with NCI to develop ACT-based therapies) have confirmed these earlier results and formed the basis for FDA's approval of Kite's CAR T-cell product, axicabtagene ciloleucel (Yescarta),for some patients with lymphoma.

The results in lymphoma to date "have been incredibly successful," Dr. Kochenderfer said, "and CAR T cells are almost certain to become a frequently-used therapy for several types of lymphoma."

The rapid advances in and growth of CAR T-cell therapy has exceeded the expectations of even those who were early believers in its potential.

"Did I think it could work? Yes," Dr. Brentjens said. But he initially thought it would be a "boutique therapy" limited to a very small, defined patient group. The experience over the past 5 years, including the entry of the biopharmaceutical industry into the field, has altered his outlook.

"We have cohorts of patients who would have been considered terminal who are now in durable and meaningful remissions with good quality of life for up to 5 years," he continued. "So the enthusiasm for this technology is now quite high."

Like all cancer therapies, CAR T-cell therapy can cause several worrisome, and sometimes fatal, side effects. One of the most frequent is cytokine release syndrome (CRS).

As part of their immune-related duties, T cells release cytokines, chemical messengers that help to stimulate and direct the immune response. In the case of CRS, there is a rapid and massive release of cytokines into the bloodstream, which can lead to dangerously high fevers and precipitous drops in blood pressure.

Ironically, CRS is considered an "on-target" effect of CAR T-cell therapythat is, its presence demonstrates that active T cells are at work in the body. Generally, patients with the most extensive disease prior to receiving CAR T cells are more likely to experience severe CRS, Dr. Kochenderfer explained.

In many patients, both children and adults, CRS can be managed with standard supportive therapies, including steroids. And as researchers have gained more experience with CAR T-cell therapy, theyve learned how to better manage the more serious cases of CRS.

Several years ago, for instance, the research team at CHOP noticed that patients experiencing severe CRS all had particularly high levels of IL-6, a cytokine that is secreted by T cells and macrophages in response to inflammation. So they turned to therapies that are approved to treat inflammatory conditions like juvenile arthritis, including the drug tocilizumab (Actemra), which blocks IL-6 activity.

The approach worked, rapidly resolving the problem in most patients. Since that time, tocilizumab has become a standard therapy for managing severe CRS.

"We've learned how to grade [CRS], we've learned how to treat it," Dr. Grupp said during an FDA advisory committee meeting on Novartis' CD19-targeted therapy. "And IL-6 blockade was really the key."

Another potential side effect of CAR T-cell therapyan off-target effectis a mass die off of B cells, known as B-cell aplasia. CD19 is also expressed on normal B cells, which are responsible for producing antibodies that kill pathogens. These normal B cells are also often killed by the infused CAR T cells. To compensate, many patients must receive immunoglobulin therapy, which provides them with the necessary antibodies to fight off infections.

More recently, another serious and potentially fatal side effectswelling in the brain, or cerebral edemahas been seen in some of the larger trials being conducted to support potential FDA approval of CAR T-cell therapies for patients with advanced leukemias. One company, in fact, decided to halt further development of their leading CAR T-cell therapy after several patients in clinical trials died as a result of treatment-induced cerebral edema.

However, the problem appears to be limited, with the leaders of other trials of CAR T-cell therapies reporting no instances of cerebral edema.

Other so-called neurotoxicitiessuch as confusion or seizure-like activityhave been seen in most CAR T-cell therapytrials. But in nearly all patients the problem is short lived and reversible, Dr. Brentjens said.

There was speculation early on that these neurotoxicities might be related to CRS. But although researchers are still trying to get their hands around the mechanisms, he added, "I think most investigators [in the field] would agree that they're distinct from CRS."

CAR T cells and TCR T cells are engineered to produce special receptors on their surfaces. They are then expanded in the laboratory and returned to the patient.

Credit: National Cancer Institute

Research on CAR T cells is continuing at a swift pace, mostly in patients with blood cancers, but also in patients with solid tumors. As the biopharmaceutical industry has become more involved in the field, for instance, the number of clinical trials testing CAR T cells has expanded dramatically, from just a handful 5 years ago to more than 180 and counting.

Most of the trials conducted to date have used CD19-targeted CAR T cells. But thats changing quickly, in part out of necessity.

Some patients with ALL, for example, don't respond to the CD19-targeted therapy. And even in those who experience a complete response, up to a third will see their disease return within a year, Dr. Fry said. Many of these disease recurrences have been linked to ALL cells no longer expressing CD19, a phenomenon known as antigen loss.

So, in children and young adults with advanced ALL, researchers in NCIs POB are testing CAR T cells that target the CD22 protein, which is also often overexpressed by ALL cells. In the first trial of CD22-targeted CAR T cells, most treated patients had complete remissions, including patients whose cancer had progressed after initially having a complete response to CD19-targeted therapy.

Similar to the case with the CD19-targeted CAR T cells, however, relapses after CD22-targeted treatment are not uncommon, Dr. Fry explained.

"There is definitely room to improve from the standpoint of the durability of remissions," he said.

One potential way to improve durability and perhaps at least forestall antigen loss, if not prevent it altogether, is to attack multiple antigens simultaneously. Several research groups, for example, are testing T cells that target both CD19 andCD22 in early-phase clinical trials.

CHOP researchers are also testing a CAR T cell that targets both CD19 and CD123, another antigen commonly found on leukemia cells. Early studies in animal models have suggested that this dual targeting may prevent antigen loss.

Antigen targets for CAR T-cell therapy have been identified in other blood cancers as well, including multiple myeloma.

Dr. Kochenderfer and his colleagues at NCI, as part of the collaboration with Kite, have developed CAR T cells that target the BCMA protein, which is found on nearly all myeloma cells.

In anearly-phaseclinical trial of BCMA-targeted CAR T cells in patients with advanced multiple myeloma, more than half of the patients had acomplete response to the treatment. Kite has now launched a trial to test the BCMA-targeted T cells in a larger group of patients.

There is some skepticism that CAR T cells will have the same success in solid tumors. Dr. Rosenberg believes that finding suitable antigens to target on solid tumorswhich has been a major challengemay prove to be too difficult in most cases.

"Efforts to identify unique antigens on the surface of solid tumors have largely been unsuccessful," he said.

Researchers estimate that the overwhelming majority of tumor antigens reside inside tumor cells, out of the reach of CARs, which can only bind to antigens on the cell surface.

As a result, as has already been shown in melanoma, Dr. Rosenberg said that he believes other forms of ACT may be better suited for solid tumors.

But that doesn't mean that researchers arent trying with CAR T cells.

For example, investigators are conducting trials of CAR T cells that target the protein mesothelin, which is overexpressed on tumor cells in some of the most deadly cancers, including pancreatic and lung cancers, and the protein EGFRvIII, which is present on nearly all tumor cells in patients with the aggressive brain cancer glioblastoma.

Early reports from these trials, however, have not reported the same success thats been seen with blood cancers.

"As far as targeting antigens on solid tumors the same way we go after CD19, I don't think that's going to work in most cases," Dr. Brentjens acknowledged.

Another key obstacle with solid tumors, he explained, is that components of the microenvironment that surrounds them conspire to blunt the immune response.

So success against solid tumors may require a "super T cell," he said, that has been engineered to overcome the immune-suppressing environment of many advanced solid tumors. Work on a CAR T cell with these propertiesan "armored" CAR T cellis ongoing at Memorial Sloan Kettering, he said.

ACT: TILs, TCRs, and CARs

CAR T cells have garnered the lion's share of the attention when it comes to the cellular therapies that fall under the ACT umbrella. But other forms of ACT have also shown promise in small clinical trials, including in patients with solid tumors.

One approach uses immune cells that have penetrated the environment in and around the tumor, known as tumor-infiltrating lymphocytes (TILs). Researchers at NCI were the first to use TILs to successfully treat patients with advanced cancerinitially in melanoma and later in several other cancers, including cervical cancer. More recently, NCI researchers have developed a technique for identifying TILs that recognize cancer cells with mutations specific to that cancer. In several cases, this approach has led to tumor regressions in patients with advanced colorectal and liver cancer.

The other primary approach to ACT involves engineering patients' T cells to express a specific T-cell receptor (TCR). CARs use portions of synthetic antibodies that can recognize specific antigens only on the surface of cells. TCRs, on the other hand, use naturally occurring receptors that can also recognize antigens that are inside tumor cells. Small pieces of these antigens are shuttled to the cell surface and "presented" to the immune system as part of a collection of proteins called the MHC complex.

To date, TCR T cells have been tested in patients with a variety of solid tumors, showing promise in melanoma and sarcoma.

Other refinements or reconfigurations of CAR T cells are being tested. One approach is the development of CAR T-cell therapies that use immune cells collected not from patients, but from healthy donors. The idea is to create so-called off-the-shelf CAR T-cell therapies that are immediately available for use and don't have to be manufactured for each patient.

The French company Cellectis, in fact, has launched a phase I trial of its off-the-shelf CD19-targeted CAR T-cell product in the United States for patients with advanced acute myeloid leukemia. The company's productwhich is made using a gene-editing technology known as TALENhas already been tested in Europe, including in two infants with ALL who had exhausted all other treatment options. In both cases, the treatment was effective.

Numerous other approaches are under investigation. Researchers, for example, are using nanotechnology to create CAR T cells inside the body, developing CAR T cells with "off switches" as a means of preventing or limiting side effects like CRS, and using the gene-editing technologyCRISPR/Cas9 to more precisely engineer the T cells.

But there is still more to do with existing CAR T-cell therapies, Dr. Fry said.

He is particularly enthusiastic about the potential to use CAR T cells earlier in the treatment process for children with ALL, specifically those who are at high risk (based on specific clinical factors) of their disease returning after their initial chemotherapy, which typically is given for approximately 2 and a half years.

In this scenario, he explained, if early indicators suggested that these high-risk patients weren't having an optimal response to chemotherapy, it could be stopped and the patients could be treated with CAR T cells.

For patients who respond well, "they could be spared 2 more years of chemotherapy," Dr. Fry said. "That's amazing to think about."

See the original post here:
CAR T Cells: Engineering Immune Cells to Treat Cancer ...

Dylan Essner, an Epic Beacon Analyst at Washington University in St. Louis, talked about his work in implementing new documentation tools to streamline data for patients.

Transcription:

Within the CAR T(-cell) build in Epic, I helped mainly with the documentation tools for flow sheets. We have the CRS, ICANS and the ICE flow sheets, and I built all 3 of those flow sheets and included them in 1 flow sheet template that way the providers and nurses can go in and document their ICE, ICANS and CRS documentation. And then some of those--the ICANS and the ICE--have a formula built into the flow sheets that allows it to auto-populate the grade and score of the actual documentation. They just put in the different data points for each flow sheet and then we have a row at the bottom that auto-calculates the grade for each patient, so they dont have to go in and do that.

And then for CRS they actually have to go in and we give them an informational chart they can look at, and then from there they can grade the patient from the bottom row. With that flow sheet data, we also built some smart links that pull the data from those flow sheets into the progress notes, so it automatically just populates into their progress notes making documentation for them a lot easier.

View original post here:
Dylan Essner on Documentation Tools for CAR T-Cell Therapy - Cancer Network