Stem Cell Clinic

GEMoaB Announces First Patient Apheresed in a Phase IA Study With Lead Product Candidate From Rapidly Switchable Universal CAR-T Platform (UniCAR) in…

By adminMarch 9, 2020Stell Cell Research

DRESDEN, Germany, March 9, 2020 /PRNewswire/ --GEMoaB, a biopharmaceutical company focused on the development of next generation immunotherapies for hard-to-treat cancers, today announced that it has apheresed the first patient in a Phase IA study with UniCAR-T-CD123, the lead product candidate from its proprietary UniCAR cellular immunotherapy platform. UniCAR has been designed to ensure excellent control over the universal CAR-T effector cell through a rapidly switchable on/off capability. This is combined with high flexibility to effectively target tumor antigens of choice by re-directing and activating CAR-T effector cells through soluble adapters termed Targeting Modules (TMs). UniCAR-T-CD123 is investigated in late stage, relapsed/refractory Acute Leukemias expressing the CD123 antigen.

The Phase IA study includes patients with CD123 positive relapsed/refractory Acute Myeloid Leukemia (AML) post standard treatment as well as CD123 positive relapsed/refractory Acute Lymphoblastic Leukemia (ALL) post CD19-targeting therapies and will examine the feasibility, safety and potential efficacy of the combined application of a single dose of UniCAR-T and the continuous infusion of the CD123 specific Targeting Module TM123.

"The ability to rapidly switch on and off the CAR-T effector cells of our UniCAR platform and thereby tightly control their activity may help to overcome many of the limitations that current CAR-T therapies face, especially when targeting less differentially expressed antigens and solid tumors," said Prof. Dr. Gerhard Ehninger, GEMoaB's co-founder and Chief Medical Officer. "The start of the first UniCAR clinical studythereforeis not only an important milestone for our company but could also lead to an important advancement in cellular immunotherapy beyond targeting CD19 and BCMA."

According to Prof. Bob Lwenberg, Department of Hematology at Erasmus University Medical Center Rotterdam, The Netherlands, the study could be an important step in the research efforts to improve patient outcomes in relapsed/refractory Acute Leukemias, which belong to the most difficult to treat blood cancers. "Despite recent advances, patients with acute leukemia who progress after currently available treatment approaches, generally have a notoriously poor prognosis with only very limited options. This trial will contribute to the development of a safe and effective cellular immunotherapy against the validated target antigen CD123 in these deadly diseases and potentially offer an alternative to allogeneic hematopoietic stem cell transplants in the future."

About the UniCAR-T-CD123 Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-CD123 in up to 16 CD123 positive patients with relapsed/refractory Acute Leukemias. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application will follow post salvage therapy and lymphodepletion. The study will also investigate persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off in case of side effects through stopping TM infusion. The study will take place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is jointly conducted with Cellex Patient Treatment and supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in more challenging cancers, including solid tumors. Standard CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed targeting modules (TMs). These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen-binding moiety, linked to a small peptide motif recognized by UniCAR-T.

AboutGEMoaB

GEMoaB is a privately-owned, clinical-stage biopharmaceutical company that isaiming to become a globally leading biopharmaceutical company. By advancing its proprietary UniCAR, RevCAR and ATAC platforms, the company will discover, develop, manufacture and commercialize next generation immunotherapies for the treatment of cancer patients with a high unmet medical need.

GEMoaB has a broad pipeline of product candidates in pre-clinical and clinical development for the treatment of hematological malignancies as well as solid tumors. Its clinical stage assets GEM333, an Affinity-Tailored Adaptor for T-Cells (ATAC) with binding specificity to CD33 in relapsed/refractory AML, and GEM3PSCA, an ATAC with binding specificity to PSCA for the treatment of castrate-resistant metastatic prostate cancer and other PSCA expressing late stage solid tumors, are currently investigated in Phase I studies and globally partnered with Bristol-Myers Squibb/Celgene. A Phase IA dose-finding study of the first UniCAR asset, UniCAR-T-CD123 for treatment of relapsed/refractory AML and ALL has been initiated, UniCAR-T-PSMA against CRPC and other PSMA-expressing late-stage solid tumors, is planned to be tested in a Phase I study initiated by H2 2020.

Manufacturing expertise, capability and capacity are key for developing cellular immunotherapies for cancer patients. GEMoaB has established a preferred partnership with its sister company Cellex in Cologne, a world leader in manufacturing hematopoietic blood stem cell products and a leading European CMO for CAR-T cells, co-operating in that area with several large biotech companies.

Forward-looking Statements

This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results and matters discussed in the forward looking statements. Forward looking statements include statements concerning our plans, goals, future events and or other information that is not historical information.

The Company does not assume any liability whatsoever for forward-looking statements. The Company assumes that potential partners will perform and rely on their own independent analyses as the case may be. The Company will be under no obligation to update the Information.

More information can be found at http://www.gemoab.com.

For further information please contact:Constanze Medackc.medack@gemoab.com; Tel.: +49-351-4466-45027

Investor ContactMichael Pehlm.pehl@gemoab.com; Tel.: +49-351-4466-45030

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Complete growth overview on Cryopreservation Equipment in Stem Cells Market in 2020-2025 including top key players Thermo Fisher Scientific, Charter…

By adminMarch 9, 2020Stell Cell Research

Cryopreservation Equipment in Stem Cells Market Insights 2020, is a professional and in-depth study on the current state of the global Cryopreservation Equipment in Stem Cells Industry with a focus on the global market. An elaborate and comprehensive primary analysis report highlights numerous facets such as business enhancement strategies, development factors, financial gain, statistical growth or loss to help readers and clients understand the market on a global scale.

Prominent key players operating in the Global Cryopreservation Equipment in Stem Cells Market: Thermo Fisher Scientific, Charter Medicals, Linde Gas Cryoservices, praxair

The market has witnessed rapid development in the past and present years and is likely to expand in the near future. In the market report, there is a segment for the competitive landscape of the key players operating in the global industry. Overall, the report provides an in-depth insight into the 2020-2025 global Cryopreservation Equipment in Stem Cells market encompassing all important parameters.

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Cell Separation Technologies Market 2020 Analysis Research and Trends Report for 2026 – Galus Australis

By adminMarch 9, 2020Stell Cell Research

Cell Separation Technologies Market

The Cell Separation Technologies Market report is a valuable source of insightful data for business strategists. The report also helps in understanding the global Cell Separation Technologies market through key segments including application, product type, and end user. This analysis is based on various parameters such as CGAR, share, size, production, and consumption. This helps the competitors in taking well-versed business decisions by having overall insights of the market scenario. Report explores the current outlook in global and key regions from the perspective of players, countries, product types and end industries.

The globalmarketforcell separation technologies predicted to cross $6.2 billion by 2026, expanding at a CAGR of 10.0% over the forecast 2020-2026

Cell separation technologies involve the separation of cells from a heterogeneous cell mixture according to their intracellular or extracellular properties. Cell separation has gained importance in the fields of medicine and biology as it is an essential component of cellular therapy and disease diagnosis. The recent expansion of the field of cell separation is linked to an increase the mortality rate due to chronic diseases as majority of these diseases can be treated using cell-based therapies.

The report has also focused on the competitive landscape and the key strategies deployed by the market participants to strengthen their presence in the global Cell Separation Technologies market. Leading players operating in the global Cell Separation Technologies market comprising Mitenyi Biotec GmbH, BD Bioscience, STEMCELL Technologies Terumo BCT, pluriSelect GmbH, EMD Millipore, Life Technologies, also profiled in the report.

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NanoSurface Bio Executes Exclusive License of Heart-on-Chip Technology Launched Into Space – Business Wire

By adminMarch 9, 2020Induced Pluripotent Stem Cells

SEATTLE--(BUSINESS WIRE)--NanoSurface Biomedical announced today that it has executed an exclusive IP license agreement related to innovative heart-on-chip technology developed by researchers at the University of Washington (UW). An experimental system built from the same heart-on-chip technology was launched into space on Friday, March 6, 2020 at 11:50 PM EST aboard SpaceX's 20th resupply mission to the International Space Station (ISS) as part of the Tissue Chips in Space initiative conducted in partnership between the National Center for Advancing Translational Sciences (NCATS) and the ISS U.S. National Laboratory (ISS National Lab). NanoSurface will commercialize the heart-on-chip platform for use by pharmaceutical companies in preclinical drug development.

The heart-on-chip system will spend 30 days aboard the ISS as part of a series of experiments intended to study the effects of microgravity on human cells and tissues. In space we are using the heart-on-chip system in microgravity conditions to help improve our understanding of the aging process and cardiac biology, but this heart-on-chip system also has enormous potential for accelerating the discovery of new medicines back here on Earth, said Deok-Ho Kim, an Associate Professor of biomedical engineering and medicine at Johns Hopkins University, the principal investigator for the heart-on-chip experiment aboard the ISS, and the scientific founder of NanoSurface Bio.

The heart-on-chip platform uses three-dimensional engineered cardiac tissues (3D ECTs) grown from human cardiomyocytes, or beating heart cells, derived from induced pluripotent stem cells (iPSCs). As the 3D ECTs beat, researchers can measure the amount of force generated by each contraction, and then evaluate how that force changes after treating the tissues with candidate drugs. 3D ECTs can be made from cells from either healthy individuals or individuals with diseases, offering great promise in predictive preclinical testing of candidate drugs for safety and efficacy.

I am incredibly excited that the talented team at NanoSurface will be carrying this technology forward for use in the drug development industry, said Nathan Sniadecki, one of the inventors of the heart-on-chip technology and a professor of mechanical engineering at UW. Last year, Professor Sniadecki joined NanoSurfaces board of scientific advisors to guide the commercial development of the technology.

NanoSurface Bios execution of this exclusive license adds significant value to the portfolio of IP it has already licensed from researchers at UW. It is well recognized that the drug development process is extremely slow and expensive. At NanoSurface we are eager to develop technologies that enable the use of human iPSC-derived cells and tissues in preclinical drug development, ultimately leading to better prediction of how drugs will affect patients in the clinic, lowering costs, and speeding life-saving medicines to market, said NanoSurface CEO Michael Cho.

About NanoSurface Biomedical

NanoSurface Biomedical is a biotechnology company based in Seattle, WA that develops stem cell-based assay technologies to accelerate drug development. NanoSurfaces structurally matured cardiac tissue models, assay instruments, and discovery services leverage human stem cell technology to help pharmaceutical companies predictively assess the safety and efficacy of candidate drugs early during preclinical development. NanoSurfaces mission is to help bring life-saving medicines to market in less time and at lower cost. To learn more, visit http://www.nanosurfacebio.com.

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NanoSurface Bio Executes Exclusive License of Heart-on-Chip Technology Launched Into Space - Business Wire

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

By adminMarch 9, 2020Induced Pluripotent Stem Cells

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.

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

Second HIV Patient Reportedly ‘Cured’ – HealthDay

By adminMarch 9, 2020Stem Cell Doctors

MONDAY, March 9, 2020 (HealthDay News) -- It was 12 years ago that a German patient was seemingly cured of HIV. Now doctors in the United Kingdom believe they've finally duplicated that success, this time in a 40-year-old Englishman.

Adam Castillejo was known until recently only as the "London patient." Now, after surviving years of grueling treatments, he says he sees himself as an "ambassador of hope" for others.

Although his doctors publicly describe his case as a long-term remission, experts in interviews have called it a cure for the AIDS-causing virus, according to a report in The New York Times.

"This will inspire people that cure is not a dream," said Dr. Annemarie Wensing, a virologist at the University Medical Center Utrecht in the Netherlands. "It's reachable," she told the Times. Wensing is also co-leader of IciStem, a group of scientists studying stem cell transplants to treat HIV.

Like Timothy Ray Brown, his predecessor, Castillejo was getting treatment for a blood cancer (Castillejo had Hodgkin's lymphoma; Brown had leukemia). Both underwent bone-marrow transplants designed to beat the cancer, not the HIV.

In both cases, the critical transplant was from a donor with a mutation in the CCR5 protein. The Times explained that HIV uses the protein to enter certain immune cells but cannot latch on to the mutated version. In other words, the donor was HIV-resistant.

Castillejo's transplant was in May 2016. He has been off anti-HIV drugs since September 2017. He and Brown are the only patients known to have stayed HIV-free for more than a year after quitting the drugs.

To be cured of both cancer and HIV was "surreal," Castillejo told the newspaper. "I never thought that there would be a cure during my lifetime."

Details of the new case, to be published March 10 in Nature, were scheduled for presentation at this week's Conference on Retroviruses and Opportunistic Infections, in Seattle.

Brown, whose case was described in 2007, is now 52 and living in Palm Springs, Calif. He was far sicker after his procedures than Castillejo, and nearly died.

One of the U.K. doctors, Dr. Ravindra Gupta of University College London, called the new case a game-changer. "Everybody believed after the Berlin patient that you needed to nearly die basically to cure HIV, but now maybe you don't," Gupta told the Times.

Transplants are dangerous and may not be a realistic treatment right now. But experts say the new "cure" may pave the way for related but more practical immune cell-modifying approaches.

There are no guarantees that Castillejo's remission will persist, but Gupta said the indications are good since there are so many similarities with Brown's recovery.

Brown, meanwhile, said he is rooting for Castillejo. "If something has happened once in medical science, it can happen again," Brown said. "I've been waiting for company for a long time."

More information

The U.S. National Library of Medicine has more about living with HIV.

More:
Second HIV Patient Reportedly 'Cured' - HealthDay

Cancerous tumors, surrounding cells illuminated by new imaging agent – Washington University in St. Louis Newsroom

By adminMarch 9, 2020Stem Cell Doctors

Scientists at Washington University School of Medicine in St. Louis have developed a new imaging agent that could let doctors identify not only multiple types of tumors but the surrounding normal cells that the cancer takes over and uses as a shield to protect itself from attempts to destroy it.

The study appears March 9 in the journal Nature Biomedical Engineering.

The imaging agent, referred to as LS301, has been approved for investigational use in small clinical trials atSiteman Cancer Centerat Barnes-Jewish Hospital and Washington University School of Medicine. The first trial will investigate its use in imaging breast cancer.

This unique imaging agent identifies cancer cells as well as other compromised cells surrounding the tumor, saidSamuel Achilefu, the Michel M. Ter-Pogossian Professor of Radiology. Cancer transforms surrounding cells so that it can proliferate, spread to other parts of the body and escape treatment. This imaging compound can detect cancer cells and their supporting cast, the diseased cells that are otherwise invisible.

The compound binds to the activated form of a protein called annexin A2, which is present in many types of solid tumors but not healthy tissue. The activated form of the protein promotes inflammation and invasiveness of these tumors, which allows the cancer to spread.

Solid tumors that contain activated annexin A2 are found in breast, colon, liver, pancreatic, head and neck, and brain cancers. Since the activated form of the protein also is present in the cells that surround the tumor and not normal, healthy cells doctors potentially could use this imaging agent to identify cells the tumor has hijacked. Despite their benign status, these hijacked cells protect the tumor from chemotherapy, radiation and other attempts to kill the cancer cells. Such co-opted cells also conceal cancer stem cells, whose stealth presence can lead to a recurrence of the tumor.

We are coming to the realization that to eradicate cancer, we also need to focus on the microenvironment of the tumor, said Achilefu, who also directs the universitysOptical Radiology Labat theMallinckrodt Institute of Radiologyand is co-leader of the Oncologic Imaging Program at Siteman. Most cancer drugs are designed to target cancer cells. But cancer cells create their own fiefdom, where they impose their own rules. If a normal cell nearby wants to continue living, it must follow the new rules. And slowly these cells come to identify with the tumor rather than their normal identity.

Achilefu expects that with a tumor and its surrounding fiefdom illuminated by the new imaging agent, doctors would have a better chance of removing the entire tumor as well as any areas that are likely to harbor microscopic cancer cells. In past work, Achilefus team has developed cancer goggles that allow surgeons to visualize cancer cells in real time during surgery to remove a tumor. The new imaging agent can be used with these goggles, which are being evaluated in clinical trials. The researchers also are working on a version of the compound that could be used in positron emission tomography (PET) scans, which many cancer patients undergo to assess whether cancer has spread.

As Achilefu and his colleagues saw that the compound lit up the hijacked cells on the periphery of the tumor, they were surprised to see the imaging agent light up parts of the central core of the tumor as well.

We were amazed when we saw this because its extremely difficult to access anything inside a tumor, Achilefu said. There seems to be a type of immune cell that carries the imaging agent into the core of the tumor. So we now see the tumor margin and the core light up. This allows us to imagine a situation in which we could deliver a drug to the outside and the inside of the tumor at the same time. This dual targeting is not something we purposefully designed its not something we ever anticipated.

With this in mind, Achilefus team conducted mouse studies to show that the researchers can attach a chemotherapy drug to the compound and use it to image the tumor and treat the disease simultaneously.

Attaching a chemotherapy drug to this targeted imaging agent could reduce side effects as we are delivering the drug directly to the tumor, he said. If the clinical trials are successful with the imaging, we will move into therapy.

Originally published by the School of Medicine

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Cancerous tumors, surrounding cells illuminated by new imaging agent - Washington University in St. Louis Newsroom

Best Market Research on Stem Cell Therapy Market, Industry / Sector Analysis Report, Regional Outlook & Competitive Market Share & Forecast,…

By adminMarch 9, 2020Stem Cell Clinics

Trusted Business Insights presents the Updated and Latest Study on Stem Cell Therapy Market 2019-2025. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market. It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ WorldWide Stem Cell Therapy Market, Industry / Sector Analysis Report, Regional Outlook & Competitive Market Share & Forecast, 2019 2025

Abstract, Snapshot, Market Analysis & Market Definition: Stem Cell Therapy MarketIndustry / Sector Trends

Stem Cell Therapy Market size was valued at USD 7.8 billion in 2018 and is expected to witness 10.2% CAGR from 2019 to 2025.

U.S. Stem Cell Therapy Market Size, By Type, 2018 & 2025 (USD Million)

Rising prevalence of chronic diseases will positively impact the stem cell therapy market growth. Cardiovascular diseases, neurological disorders and other chronic conditions have resulted in high mortality over past few years. Conventional therapeutic methods and treatments are currently replaced due to lack of efficiency and efficacy. Recently developed stem cell therapies are capable of replacing defective cells to treat diseases that has reduced morbidity drastically. Therefore, people have now started relying on stem cell therapy that has long term positive effects.

Advancements in stem cell therapy in developed regions such as North America and Europe have boosted the industry growth. Since past few years, there have been several researches carried out for stem cell therapy. Currently developed stem cell therapies have shown positive outcomes in treatment of leukemia. Similarly, due to advancements in regenerative medicine, several other chronic conditions such as muscular dystrophy and cardiovascular diseases also have been cured. Aforementioned factors have surged the industry growth. However, high cost of allogenic stem cell therapy may hamper the industry growth to some extent.

Market Segmentation, Outlook & Regional Insights: Stem Cell Therapy Market

Stem Cell Therapy Market, By Type

Allogenic stem cell therapy segment held around 39% revenue share in 2018 and it is anticipated to grow substantially during analysis timeframe. Allogenic stem cell is available as off the shelf therapy and it is easily scalable that helps in providing treatment without delay. Moreover, the procedure includes culturing donor-derived immunocompetent cells that are highly effective in treatment of several diseases. Stem cells obtained in allogenic therapy are free of contaminating tumor cells. This reduces risk for disease recurrence that will surge its demand thereby, stimulating segment growth.

Autologous stem cell therapy segment is estimated to witness 10.1% growth over the forthcoming years. People usually prefer autologous stem cell therapy as it has minimum risk of immunological rejection. However, on introduction of allogenic stem cell therapy, demand for autologous stem cell therapy has declined as it is difficult to scale up. However, there are concerns regarding risk of cross contamination during large scale manufacturing of autologous stem cell lines that will impede segmental growth to some extent.

Stem Cell Therapy Market, By Application

Neurology segment was valued around USD 1.6 billion in 2018 and it is estimated that it will witness significant growth over the forthcoming years. Stem cells are used to replenish the disrupted neurological cells that helps in quick patient recovery. Pluripotent stem cells provide replacement for cells and tissues to treat Alzheimers, Parkinsons disease, cerebral palsy, amyotrophic lateral sclerosis and other neurodegenerative diseases. Thus, pivotal role of stem cells in treating life threatening neurological condition will escalate segment growth.

Cardiovascular segment will witness 10% growth over the analysis timeframe. Considerable segmental growth can be attributed to development in stem cell therapies that have enhanced recovery pace in patients suffering from cardiovascular diseases. Recently developed allogenic stem cell therapies are efficient and easily available that have reduced the mortality rates in cardiovascular patients. Above mentioned factors will propel cardiovascular segment growth in near future.

Germany Stem Cell Therapy Market Size, By Application, 2018 (USD Million)

Stem Cell Therapy Market, By End-users

Hospitals segment held over 56% revenue share in 2018 and it is anticipated to grow significantly in near future. Rising preference for stem cell therapies offered by hospitals proves beneficial for the business growth. Hospitals have affiliations with research laboratories and academic institutes that carry out research activities for developing stem cell therapies. On introduction and approval of any novel stem therapy, hospitals implement it immediately. Associations with research and academic institutes further helps hospitals to upgrade its stem cell treatment offerings that positively impacts the segmental growth.

Clinics segment is expected to grow at around 10% during the forecast timeframe. Clinics specializing in providing stem cell therapies are well-equipped with advanced medical devices and superior quality reagents required for imparting stem cell therapies. However, as clinics offer specialized stem cell therapies, their treatment cost is much higher as compared to hospitals that may reduce its preference.

Stem Cell Therapy Market, By Region

North America stem cell therapy market held around 41.5% revenue share in 2018 and it is estimated to grow substantially in near future. Increasing adoption of novel stem cell therapies will prove beneficial for regional market growth. Moreover, favourable government initiatives have positive impact on the regional market growth. For instance, government of Canada has initiated Strategic Innovation Fund Program that invests in research activities carried out for stem cell therapies enabling development in stem cell therapy. Above mentioned factors are expected to drive the North America market growth.

Asia Pacific stem cell therapy market is anticipated to witness 10.8% growth in near future owing to increasing awareness amongst people pertaining to benefits of advanced stem cell therapies. Additionally, favourable initiatives undertaken by several organizations will promote industry players to come up with innovative solutions. For instance, according to Pharma Focus Asia, members of Asia-Pacific Economic Cooperation collaborated with Life Sciences Innovation Forum to involve professionals having expertise in stem cell therapies from academia and research centers to promote developments in stem cell research. Thus, growing initiatives by organizations ensuring availability of new stem cell therapies will foster regional market growth.

Latin America Stem Cell Therapy Market Size, By Country, 2025 (USD Million)

Key Players, Recent Developments & Sector Viewpoints: Stem Cell Therapy Market

Key industry players in stem cell therapy market include Astellas Pharma Inc, Cellectis, Celyad, Novadip Biosciences, Gamida Cell, Capricor Therapeutics, Cellular Dynamics, CESCA Therapeutics, DiscGenics, OxStem, Mesoblast Ltd, ReNeuron Group and Takeda Pharmaceuticals. Chief industry players implement several initiatives such as mergers and acquisitions to sustain market competition. Also, receiving approvals for stem cell therapy products from regulatory authorities fosters companys growth. For instance, in March 2018, European Commission approved Takedas Alofisel that is off-the-shelf stem cell therapy. Product approval will help company to gain competitive advantage and capture market share.

Stem Cell Therapy Industry Viewpoint

Stem cells industry can be traced back to 1950s. In 1959 first animals were made by in-vitro fertilization by preserving the stem cells. Till 2000, research was being carried out on stem cells to study its therapeutic effect. In 2000, fund allocations were made to research on cells derived from aborted human foetuses. In the same year, scientists derived human embryonic stem cells from the inner cell mass of blastocytes. Later, in 2010, clinical trials for human embryonic stem cell-based therapy were initiated. As technology progressed, stem cell therapy for treating cancer were developed. However, due to ethical issues, the use of stem cells for curing diseases witnessed slow growth for few years. But as the regulatory scenario changed, people started preferring stem cell therapies due to its better efficacy. Stem cell therapy is in developing stage and has numerous growth opportunities in developing economies with high prevalence of chronic diseases.

Key Insights Covered: Exhaustive Stem Cell Therapy Market1. Market size (sales, revenue and growth rate) of Stem Cell Therapy industry.2. Global major manufacturers operating situation (sales, revenue, growth rate and gross margin) of Stem Cell Therapy industry.3. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Stem Cell Therapy industry.4. Market size (sales, revenue) forecast by regions and countries from 2019 to 2025 of Stem Cell Therapy industry.

Research Methodology: Stem Cell Therapy Market

Quick Read Table of Contents of this Report @ WorldWide Stem Cell Therapy Market, Industry / Sector Analysis Report, Regional Outlook & Competitive Market Share & Forecast, 2019 2025

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The Inside Scoop on Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) – MicroCap Daily

By adminMarch 9, 2020Adult Stem Cells

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is an exciting little biotech that has managed to attract legions of shareholders who continue to accumulate. The stock does have a history of big moves up recently seeing another significant pop.

There is a lot to get excited about on NWBO, the Company is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a clinical stage biotechnology company focused on the development of personalized immunotherapy for a broad range of solid tumor cancers. The company has over 190 issued patents and more than 65 pending patent applications worldwide, grouped into 12 patent families. The Company is led by Linda Powers, a successful entrepreneur who worked for many years in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Ms. Powers has served as the Chairman of NW Bio since 2007, and as CEO since 2011. NWBO platform technology is DCVax, which uses activated dendritic cells to mobilize a patients own immune system to attack their cancer.

Northwest lead product is DCVax-L for Glioblastoma multiforme (GBM), the most lethal form of primary brain cancer. The Company has completed two Phase I/II trials and are now well under way with a large Phase III trial, as described below. Northwest is currently conducting a 348-patient double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM. The primary endpoint of the trial is Progression Free Survival, meaning the length of time that a patient continues without disease progression (i.e., recurrence of the tumor). Secondary endpoints include overall survival and other measures. The trial is under way at 51 sites (medical centers) across the US. The sites and the eligibility criteria are listed in the profile of the trial at ClinicalTrials.gov. The trial is also under way in Europe. The lead site is Kings College Hospital in London. Approximately 30 trial sites are also in varying stages of preparation in the U.K. and Germany.

DCVax Direct offers a potential new treatment option for the wide range of clinical situations in which patients tumors are considered inoperable because the patient has multiple tumors, or their tumor cannot be completely removed, or the surgery would cause undue damage to the patient and impair their quality of life. DCVax-Direct is administered by direct injection into a patients tumors. It can be injected into any number of tumors, enabling patients with locally advanced disease or with metastases to be treated. DCVax-Direct can also be injected into tumors in virtually any location in the body: not only tissues at or near the surface of the body but also, with ultra-sound guidance, into interior tissues. Northwest is currently conducting a 60-patient Phase I/II trial of DCVax-Direct for all types of inoperable solid tumors. The trial is under way at MD Anderson in Houston, TX and MD Anderson in Orlando, FL, with additional sites in varying stages of preparation. The Phase I stage of the trial involves dose escalation, testing 3 different dose levels of DCVax-Direct, and confirmation of the optimal dose.

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DCVax-Prostate is designed specifically for late stage, hormone independent prostate cancer. Such cancer involves the spread of micro-metastases beyond the prostate tissue. In most patients, there is no focal tumor which can be surgically removed and used to make lysate, or into which dendritic cells can be directly injected. Instead, the cancer cells are diffuse. We have developed a DCVax product line using a particular proprietary antigen PSMA (Prostate Specific Membrane Antigen) which is found on essentially all late stage (hormone independent) prostate cancer. The PSMA is produced through recombinant manufacturing methods, and is then combined with the fresh, personalized dendritic cells to make DCVax-Prostate.

Northwest is led by Linda Powers, her linkedin page describes her as: Ms. Powers served as Chairman of NW Bio for the last 4 years, and brings more than 25 years experience in corporate transactions and operations, including more than a decade specializing in building biotech companies through Toucan Capital. Ms. Powers is particularly well known for her experience in building biotech companies that are developing cell therapies, including both immune cell therapies (such as NWBios DCVax) and adult stem cell therapies. Such products consisting of living human cells require fundamentally different manufacturing, storage, distribution and handling than do pharmaceutical drugs (pills in bottles). Such living cell products also involve different clinical and regulatory requirements, and different business and cost/pricing models, than traditional drugs. The cell therapy companies which Ms. Powers has been involved in building over the last decade, both in the US and abroad (in Asia, Europe and Israel), are at the forefront of clinical trials and early commercialization. Ms. Powers has served for years on a number of related boards, including the M2Gen Board of the Moffitt Cancer Center, the Board of the Trudeau Institute (a world leader in immunology research) and others. As Chairman of NW Bio, she has brought her lengthy experience to bear in helping to shape NW Bios overall strategy and programs. As CEO, she will now undertake operational responsibilities in addition to continuing her duties as Chairman.

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Currently trading at a $129 million market valuation NWBO has $1.9 million in the treasury, manageable debt and fast growing sales reporting $593k in revenues for the 3 months ended September 30, 2019. NWBO is an exciting story developing in small caps; this little biotech is sitting on drugs in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down. NW Bio lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. The stock has a significant shareholder base that continues to bid this one higher. We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with NWBO.

Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.

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The Inside Scoop on Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) - MicroCap Daily

3D beating heart tissue experiment heads to Space Station – UW Medicine Newsroom

By adminMarch 9, 2020Stem Cell Medicine

Note to editors and reporters: Live coverage on NASA Television of the SpaceX CRS-20 cargo launch carrying this experiment is scheduled at 8:30 p.m. EST, 11:30 p.m. PST March 6 and will be replayed twice on March 7. Coverage of the rendezvous with the International Space Station will be at 5:30 a.m. EST Monday, March 8, with installation at 8:30 a.m. All times are subject to change due if weather or launch conditions are unfavorable

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Space exploration can take a toll on the human heart. Astronauts are at risk for changes in their cardiac function and rhythm. To learn how microgravity and other physical forces in space exact their effects on heart muscle, a Tissue Chips in Space project has now been packed and is awaiting launch to the International Space Station.

The experimental equipment consists of small, compact devices, a little bit larger than cell phone cases. The holders contain a row of tiny, 3-D globs of beating heart tissue grown from pluripotent stem cells, generated from human adult cells. The heart muscle tissue is supported between two flexible pillars that allow it to contract freely, in contrast to the rigid constraints of a Petri dish.

The devices also house a novel invention from the University of Washington. It automatically senses and measures the contractions of the heart tissues, and reduces the amount of time the astronauts will need to spend conducting this study.

The flexible pillars contain tiny magnets, explained UW graduate student Ty Higashi, one of the inventors. When the muscle tissue contracts, the position of the embedded magnets changes, and the motion can be detected by a sensor, he said. That information is then sent down to a laboratory on Earth.

This model will recapitulate, on a miniature scale, what might be happening to the architecture and function of heart muscle cells and tissues in astronauts during a space mission.

The project head is Deok-Ho Kim, a professor in bioengineering, who recently joined the Johns Hopkins University faculty in Baltimore. He and co-investigator, Nathan Sniadecki, a professor in mechanical engineering, began this study two years at the UW Medicine Institute for Stem Cell and Regenerative Medicine (ISCRM). Jonathan Tsui, a postdoc in bioengineering, Ty Higashi, a graduate student in mechanical engineering , and other members of the UW project team, continue the cross-country collaboration in Seattle. The team is working with several NASA and National Institutes of Health groups, and researchers at other universities, on this effort.

Sniadecki said that each of the tissues heading to the International Space Center contain about a half million heart cells.

They act like a full tissue, he explained. They contract, they beat and you can actually see them physically shorten in the dish. Were actually able to see little heart beats from these tissues.

The SpaceX shuttle delivering this scientific payload is expected to leave from Cape Canaveral no earlier than 8:50 p.m. PST (11:50 p.m. EST) Friday, March 6. The exact departure schedule depends on the weather and other factors.

Once on board, the experiment will run for 30 days before being returned to Earth for further analysis. A related space-based experiment will follow skyward later, to see if medications or mechanical interventions can offset what the heart muscle endures during extended space missions.

The space program is looking at ways to travel longer and farther, Sniadecki said. To do so, they need to think about protecting their crews. Having treatments or drugs to protect astronauts during their travel would make long term space travel possible.

Guarding against cardiac problems would be especially critical during space travel at distances never attempted before, such as a mission to Mars, said Sniadecki. This opportunity to really kind of push the frontier for space travel is every engineers dream.

He added, We also hope to gather information that will help in preventing and treating heart muscle damage in people generally, as well as in understanding how aging changes heart muscle.

Microgravity is known to speed up aging, and likely influence other cell or tissue properties. Because aging is accelerated in space, studies on the International Space Station is a way to more quickly assess this process over weeks, instead of years.

I think the medicine side of it is extremely helpful on Earth, too, because what we discover could potentially lead to treatments for counteracting aging, Sniadecki said.

This space medicine research project is funded by the National Center for Advancing Translational Sciences and the National Institute of Biomedical Imaging and Bioengineering. This heart tissue study is part of the national Tissue Chips in Space program.

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3D beating heart tissue experiment heads to Space Station - UW Medicine Newsroom