Stem Cell Clinic

Cell Therapy Industry Applications 2019-Size by Type (Allogenic Therapies), by Technique (Stem Cell Therapy), Global Market Growth by Demand Analysis…

By Somatic Stem Cells

TheGlobal Cell Therapy Marketwas estimated to be valued at USD XX million in 2018 and is projected to reach USD XX million by 2026, at a CAGR of XX% during 2019 to 2026.

Cell therapy involves the administration of somatic cell preparations for the treatment of diseases or traumatic damages. The objective of this study is to provide long term treatment through a single injection of therapeutic cells.

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Growing aging patient population, the rise in cell therapy transplantations globally, and rising disease awareness drive the growth of the market. However, stringent regulatory policies may restrain growth of the market in the forecast period.

The Global Cell Therapy Industry is primarily segmented based on different type, technique, cell source, technology, end users and region

On the basis of type, the market is split into:

On the basis of technique, the market is split into:

On the basis of cell source, the market is split into:

On the basis of technology, the market is split into:

On the basis of end user, the market is split into:

Moreover, the market is classified based on regions and countries as follows:

Key players profiled in the report includes:

These organizations are focusing on growth strategies, such as new product launches, expansions, acquisitions, and agreements & partnerships to expand their operations across the globe.

GlobalCell TherapyIndustry isspread across 121 pages, profiling 10 companies and supported with tables and figures. Inquire more or share a questions if any before the purchase on this report @https://www.orianresearch.com/enquiry-before-buying/1281174

What you can expect from our report: Total Addressable Market [ Present Market Size forecasted to 2026 with CAGR ] Regional level split [North America, Europe, Asia Pacific, South America, Middle East & Africa] Country wise Market Size Split [Important countries with major market share] Market Size Breakdown by Product/ ServiceTypes [ ] Market Size by Application/Industry verticals/ End Users [ ] Market Share and Revenue/Sales of 10-15 Leading Players in the Market Production Capacity of Leading Players whenever applicable Market Trends Emerging Technologies/products/start-ups, PESTEL Analysis, SWOT Analysis, Porters Five Forces, etc. Pricing Trend Analysis Average Pricing across regions Brandwise Ranking of Major Market Players globally

Key Benefits of the Report:

Target Audience:

Research Methodology:

The market is derived through extensive use of secondary, primary, in-house research follows by expert validation and third party perspective, such as, analyst reports of investment banks. The secondary research is the primary base of our study wherein we conducted extensive data mining, referring to verified data products, such as, white papers, government and regulatory published articles, technical journals, trade magazines, and paid data products.

For forecasting, regional demand & supply factors, recent investments, market dynamics including technical growth scenario, consumer behavior, and end use trends and dynamics, and production capacity were taken into consideration. Different weightages have been assigned to these parameters and quantified their market impacts using the weighted average analysis to derive the market growth rate.

The market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs), which typically include:

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Table of Content

1. Introduction2. Research Methodology3. Executive Summary4. Global Cell Therapy Market Overview5. Global Cell Therapy Market, by Type6. Global Cell Therapy Market, by Technique7. Global Cell Therapy Market, by Cell Source8. Global Cell Therapy Market, by Technology9. Global Cell Therapy Market, by End Users10. Global Cell Therapy Market by Region11. Competitive Landscape12. Company Profiles13. Cell Therapy Manufacturing Cost Analysis14. Key InsightsEnd of the reportDisclaimer

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Cell Therapy Industry Applications 2019-Size by Type (Allogenic Therapies), by Technique (Stem Cell Therapy), Global Market Growth by Demand Analysis...

First Pig-Monkey Chimeras Were Just Created in China – Livescience.com

By Embryonic Stem Cells

Two piglets recently born in China look like average swine on the outside, but on the inside, they are (a very small) part monkey.

A team of researchers generated the pig-primate creatures by injecting monkey stem cells into fertilized pig embryos and then implanting them into surrogate sows, according to a piece by New Scientist. Two of the resulting piglets developed into interspecies animals known as chimeras, meaning that they contained DNA from two distinct individuals in this case, a pig and a monkey.

"This is the first report of full-term pig-monkey chimeras," co-author Tang Hai, a researcher at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing, told New Scientist. Eventually, Hai and his colleagues aim to grow human organs in animals for use in transplant procedures. For now, the team plans to stick with monkey cells, as developing human-animal chimeras presents a slew of "ethical issues," the authors noted in a report published Nov. 28 in the journal Protein & Cell.

To create pig-primate chimeras, Hai and his co-authors first grew cells from cynomolgus monkeys (Macaca fascicularis) in lab dishes. The team then altered the cells' DNA by inserting instructions to build a fluorescent protein, which caused the cells to glow a bright green. These luminescent cells gave rise to equally radiant embryonic stem cells, which the researchers then injected into prepared pig embryos. These glowing spots allowed the researchers to track the monkey cells as the embryos grew into piglets.

Related: The 9 Most Interesting Transplants

In total, 4,000 embryos received an injection of monkey cells and were implanted in surrogate sows. The pigs bore 10 piglets as a result of the procedure, but only two of the offspring grew both pig and monkey cells. By scanning for spots of fluorescent green, the team found monkey cells scattered throughout multiple organs, including the heart, liver, spleen, lungs and skin.

In each organ, between one in 1,000 and one in 10,000 cells turned out to be a monkey cells in other words, the interspecies chimeras were more than 99% pig.

Although low, the ratio of monkey to pig cells still outnumbered the maximum amount of human cells ever grown in a human-animal chimera. In 2017, scientists created human-pig chimeras that grew only one human cell for every 100,000 pig cells. The interspecies embryos were only allowed to develop for a month for ethical reasons, including the concern that humans cells might grow in the chimera's brain and grant the animal human-like consciousness, according to New Scientist.

Despite these ethical qualms, the same team of researchers went on to create human-monkey chimeras earlier this year, according to a July report from the Spanish newspaper El Pas. The results of the controversial experiment have not yet been reported, but the scientists said that no human-primate embryos were allowed to develop for more than a few weeks, the paper reported.

Hai and his co-authors may have avoided the ethical issues involved with human-animal chimeras, but one expert wasn't impressed with their interspecies piglets. Stem-cell biologist Paul Knoepfler of the University of California, Davis, told New Scientist that the low ratio of monkey to pig cells seems "fairly discouraging." Additionally, the two chimeras and all eight other piglets died shortly after being born, he noted.

The exact reason for the piglets' death remains "unclear," Hai told New Scientist, but he said that he suspects the deaths are linked to the in vitro fertilization (IVF) procedure rather than the injection of monkey DNA. Other scientists have also found that IVF doesn't consistently work in pigs, according to a 2019 report in the journal Theriogenology.

In the immediate future, Hai and his colleagues aim to increase the proportion of monkey cells to pig cells in future chimeras, and eventually, grow entire monkey organs in their pigs, Hai told New Scientist. In their paper, the authors noted that their work in pigs could help "pave the way" toward the "ultimate goal of human organ reconstruction in a large animal."

Originally published on Live Science.

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First Pig-Monkey Chimeras Were Just Created in China - Livescience.com

Pig-Monkey Chimeras Have Been Brought to Term For The First Time – ScienceAlert

By Embryonic Stem Cells

Pigs engineered to have a small amount of monkey cells have been brought to full term and were even born alive, surviving for a few days after birth. Although the piglets died, it is claimed the experiment - performed in China - marks a major milestone for the future of lab-grown organs.

"This is the first report of full-term pig-monkey chimeras," Tang Hai of the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing told New Scientist.

The research is part of an ongoing effort to develop animals - whether they are sheep or pigs - that can grow human organs we could then harvest for transplants, a process called xenogeneic organogenesis.

Research has been done on both pig and sheep embryos with transplanted human stem cells; in both cases, the embryos continued to develop until the experiment was deliberately terminated.

That's because, due to ethical concerns, these chimeras - organisms that incorporate the genetic material of another species - cannot be cultivated or studied in the later stages of embryonic development. Some scientists worry that some of the human stem cellscould end upin other parts of the animal or even in its brain, with unintended consequences.

For that reason, in this experiment the team used stem cells from crab-eating macaques (Macaca fascicularis). These were imbued with fluorescent proteins so that they would glow under fluorescent light, and derived to produce fluorescing embryonic cells.

These cells were then injected into over 4,000 five-day-old pig embryos fertilised using IVF; the modified pig embryos were subsequently implanted into sows.

This fiddly and painstaking work produced just 10 piglets that made it to full term and were born alive. And only two of these were chimeric, with between one in 1,000 and one in 10,000 functional monkey cells to pig cells.

The monkey cells had migrated to the heart, liver, lungs, spleen and skin of the piglet hosts, but were not found in other organs, such as testes and ovaries, due to the low rate of chimerism, the researchers said.

Sadly, before a week was out, the piglets died - not just the two chimeras, but the other eight normal piglets, too. Because all the pigs died, Hai told New Scientist, the cause of death likely had less to do with chimerism, and more to do with IVF - a procedure that is notoriously tricky in pigs.

The low chimerism rate is also somewhat discouraging. However, the researchers remain optimistic. Although the birth rate was low, and the pigs didn't survive, the team now has a wealth of data they can apply to future experiments.

The scientists are planning to try again, increasing the chimeric cell ratio. And they believe their data may help other scientists working in the field.

"Here, we have used monkey cells to explore the potential of reconstructing chimeric human organs in a large animal model," they wrote in their paper.

"We believe this work will facilitate the development of xenogeneic organogenesis by providing a better understanding of the processes of xenogeneic recognition, fate determination, and the proliferation and differentiation of primate stem cells during porcine development.

"The findings could pave the way toward overcoming the obstacles in the re-engineering of heterogeneous organs and achieve the ultimate goal of human organ reconstruction in a large animal."

The research has been published in Protein & Cell.

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Pig-Monkey Chimeras Have Been Brought to Term For The First Time - ScienceAlert

PHATED to be: Yale researchers give shape to big data – Yale News

By Embryonic Stem Cells

Scientists now have the ability to collect massive amounts of data on lifes most fundamental processes, such as the intricate choreography whereby a handful of embryonic stem cells give rise to trillions of specialized cells throughout the human body. But data doesnt always translate into knowledge unless the relationship of recorded data points can be presented in accurate, meaningful and visible ways.

The lab of Yales Smita Krishnaswamy, associate professor of genetics and computer science, has developed a new algorithm called PHATE that overcomes many of the shortcomings of existing data visualization tools, which are more susceptible to noise and distortion in the relationship of data points.

The panel above shows how PHATE visualizes the differentiation of human embryonic stem cells into neuronal cells, neural stem cells, cardiac cells, and endothelial cells, as compared to the visualizations created by three other technologies.A cleaner, more detailed representation is helpful, for example, for generating promising new hypotheses.

The researchers work is described Dec. 3 in the journal Nature Biotechnology.

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PHATED to be: Yale researchers give shape to big data - Yale News

Cell Harvesting Market a compound annual growth rate (CAGR) of 11.3% for the period of 2018-2023 – Crypto News Byte

By Embryonic Stem Cells

Theglobal market for cell harvestingshould grow from $885 million in 2018 to reach $1.5 billion by 2023 at a compound annual growth rate (CAGR) of 11.3% for the period of 2018-2023.

Report Scope:

The scope of the report encompasses the major types of cell harvesting that have been used and the cell harvesting technologies that are being developed by industry, government agencies and nonprofits. It analyzes current market status, examines drivers on future markets and presents forecasts of growth over the next five years.

The report provides a summary of the market, including a market snapshot and profiles of key players in the cell harvesting market. It provides an exhaustive segmentation analysis of the market with in-depth information about each segment. The overview section of the report provides a description of market trends and market dynamics, including drivers, restraints and opportunities. it provides information about market developments and future trends that can be useful for organizations, including wholesalers and exporters. It provides market positionings of key players using yardsticks of revenue, product portfolio, and recent activities. It further includes strategies adopted by emerging market players with strategic recommendations for new market entrants. Readers will also find historical and current market sizes and a discussion of the markets future potential. The report will help market players and new entrants make informed decisions about the production and exports of goods and services.

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Report Includes:

41 data tables and 22 additional tables Description of segments and dynamics of the cell harvesting market Analyses of global market trends with data from 2017, 2018, and projections of compound annual growth rates (CAGRs) through 2023 Characterization and quantification of market potential for cell harvesting by type of harvesting, procedure, end user, component/equipment and region A brief study and intact information about the market development, and future trends that can be useful for the organizations involved in Elaboration on the influence of government regulations, current technology, and the economic factors that will shape the future marketplace Key patents analysis and new product developments in cell harvesting market Detailed profiles of major companies of the industry, including Becton, Dickinson and Co., Corning, Inc., Fluidigm Corp., General Electric Co., Perkinelmer, Inc., and Thermo Fisher Scientific, Inc.

Summary

Stem cells are unspecialized cells that have the ability to divide indefinitely and produce specialized cells. The appropriate physiological and experimental conditions provided to the unspecialized cells give rise to certain specialized cells, including nerve cells, heart muscle cells and blood cells. Stem cells can divide and renew themselves over long periods of time. These cells are extensively found in multicellular organisms, wherein mammals, there are two types of stem cells embryonic stem cells and adult stemcells. Embryonic stem cells are derived from a human embryo four or five days old that is in the blastocyst phase of development. Adult stem cells grow after the development of the embryo and are found in tissues such as bone marrow, brain, blood vessels, blood, skin, skeletal muscles and liver. Stemcell culture is the process of harvesting the exosomes and molecules released by the stem cells for the development of therapeuticsfor chronic diseases such as cancer and diabetes. The process is widely used in biomedical applications such as therapy, diagnosis and biological drug production. The global cell harvesting market is likely to witness a growth rate of REDACTED during the forecast period of 2018-2023.The value of global cell harvesting market was REDACTED in 2017 and is projected to reach REDACTED by 2023. Market growth is attributed to factors such as increasing R&D spending in cell-based research,the introduction of 3D cell culture technology, increasing government funding, and the growing prevalence of chronic diseases such as cancer and diabetes.

The growing incidence and prevalence of cancer is seen as one of the major factors contributing to the growth of the global cell harvesting market. According to the World Health Organization (WHO), cancer is the second-leading cause of mortality globally and was responsible for an estimated 9.6 million deaths in 2018. Therefore, there is an increasing need for effective cancer treatment solutions globally. Cell harvesting is the preferred method used in cancer cell-related studies including cancer cell databases (cancer cell lines), and other analyses and drug discovery in a microenvironment. The rising prevalence of such chronic diseases has led governments to provide R&D funding to research institutes and biotechnology companies to develop advanced therapeutics. Various 3D cell culture technologies have been developed by researchers and biotechnology companies such as Lonza Group and Thermo Fischer Scientific for research applications such as cancer drug discovery. The application of cell culture in cancer research is leading to more predictive models for research, drug discovery and regenerative medicine applications.

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Platelet-rich plasma (PRP) therapy, a new biotechnology solution that has a heightened interest among researchers in tissue engineering and cell-based therapies, has various applications in the treatment of tissue healing in tendinopathy, osteoarthritis and muscle injury. It has been conventionally employed in orthopedics, maxillofacial surgery, periodontal therapy and sports medicines. PRP therapy can be used in the treatment of fat grafting, acne scars, and hair regrowth.

Major factors driving market growth include increasing healthcare costs and the high rate of adoption for modern medicines in emerging economies such as China and India. It has been estimated that India will witness a CAGR of REDACTED in the cell harvesting market during the forecast period. The active participation of foreign pharmaceutical companies has tapped the Indian healthcare sector with a series of partnerships and mergers and acquisitions, which in turn is positively impacting the growth of the market in this region. Consistent development and clinical trials for stem cell therapies, plus contribution from the government and private sectors through investments and cohesive reimbursement policies in the development of cancer biomarkers, is further fueling market growth. InSweden, a research team at Lund University has developed a device to collect fluid and harvest stem mesenchymal stem cells (MSCs). The device is developed with 3D-printed bio-inert plastics which, when used by doctors, can result in the safe extraction of fluids (medical waste) from the patients body. The liquid is then passed through a gauze filter for purifying thoroughly and MSCs are separated from the fluid by centrifugation and are grown in culture.

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Cell Harvesting Market a compound annual growth rate (CAGR) of 11.3% for the period of 2018-2023 - Crypto News Byte

Mayo Clinic, maker of Gore-Tex outerwear are teaming up in Crohn’s fight – Minneapolis Star Tribune

By Stem Cell Medicine

Based on promising results in an early clinical trial, Mayo Clinic has formed a new joint venture with materials engineering firm W.L. Gore & Associates to spearhead a new therapy using stem cells to repair a painful tissue problem stemming from Crohn's disease.

Mayo and Gore on Tuesday announced the formation of a for-profit company called Avobis Bio ("a vobis" is Latin for "by you"), based in Delaware, where Gore is also based. The privately held company will draw on the expertise of scientists at Mayo and Gore to launch a second-phase clinical trial in the hopes of eventually offering the treatment commercially.

A laboratory director at Mayo Clinic said Avobis Bio's therapy, if successful, may be a first-of-its-kind in health care, involving the delivery of a person's own mesenchymal stem cells on a synthetic "scaffold" that biodegrades over time, eventually leaving behind only native tissue sealing a wound. The first application of the technology is treatment of a health problem called perianal fistulae. But if successful, Avobis Bio may one day offer a variety of tissue and organ-repair therapies combining Mayo's stem cell expertise and Gore's medical materials.

"This is a completely new approach, where we are trying to leverage what the body can do for itself," said Allan Dietz, co-director of the Human Cell Therapy Lab in Mayo's Center for Regenerative Medicine.

Mesenchymal stem cells can naturally convert into other kinds of tissue, like muscle or bone. For the Avobis Bio therapy, the cells are harvested from a biopsy of a person's body fat and cultivated at a Mayo laboratory to high purity. No one knows whether the cells deposited into the wound directly convert into scar tissue, or if the stem cells trigger genetic signals that cause other cells in the surrounding tissue to begin the healing process.

"We provide stem cells in the right frame, at the right time, for the body to recognize the signals that it should begin the healing process," Dietz said. "I think in some ways, it was a required simple first step but it appears to be a major step."

Gore is perhaps best known to the public for its Gore-Tex outerwear, but the privately held $3.7 billion engineering and manufacturing firm sells products in an array of industries, including a line of medical devices designed to repair nonnatural holes in body organs. Mayo has used Gore-made devices for many years.

Several years ago, physician-researchers at the not-for-profit Mayo Clinic in Rochester grew keenly interested in a Gore device called the Bio-A Fistula Plug, a flexible bioabsorbable plug made from a material similar to dissolving stitches.

The plug can be used to repair unnatural canals that form between a person's anal canal and their outer skin, after Crohn's disease weakens surrounding tissues. These canals, also known as perianal fistulae, are painful, disruptive and difficult to treat, doctors said. For patients with Crohn's disease, lifetime incidence of perianal fistulae ranges between 23% and 38%, according to past studies.

In 2017, Mayo announced first-in-human results of their experimental therapy treating Crohn's patients' perianal fistulae using a Gore Bio-A Fistula Plug coated with the patient's own stem cells. The study, run in consultation with the Food and Drug Administration, provided the open-label treatment to a small group of patients whose fistulae had not responded to treatment for a median time of six years.

After initial results proved encouraging, the trial eventually enrolled 20 people. Of the 19 who remained in the trial for at least a year, 76% experienced healing of their fistulae, according to results announced by researchers but not yet published in a journal. If validated in a larger clinical trial, that rate of healing would be dramatically better than outcomes under existing treatments, the companies said.

"We have done work in the past looking at combining cells and materials. For us, the clinical trial results from Mayo were incredibly compelling," said Tiffany Brown, a Gore employee and general manager of Avobis Bio. "It is a challenge to translate how cells behave in the lab to how they will behave in patients. So having that proof in real patients really got the conversation going on how we could work together."

If the therapy is proved safe and effective in larger trials, Brown said about 50,000 Crohn's patients per year could be eligible to get it for perianal fistulae. Although Gore is phasing out general sales of its Bio-A Fistula Plug, the device will be supplied exclusively to Avobis Bio.

Mayo and Gore declined to reveal financial details for Avobis Bio, except to note that both parties are contributing to the limited-liability joint venture. The company has a five-member board of managers, with Mayo appointing two members and Gore appointing three.

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Mayo Clinic, maker of Gore-Tex outerwear are teaming up in Crohn's fight - Minneapolis Star Tribune

Proteostasis Therapeutics to Initiate First Ever Personalized Medicine-Based Clinical Trial, CHOICES, in European CF Patients with Genotypes…

By Stem Cell Medicine

BOSTON, Dec. 11, 2019 /PRNewswire/ --Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF), today announced positive, initial ex-vivo results of PTI's proprietary cystic fibrosis transmembrane conductance regulator (CFTR) modulators, PTI-801, PTI-808, and PTI-428, in individuals with CF who are ineligible for the current standard of care CFTR modulator therapies due to their genotype. The data are part of a pan-European strategic initiative, known as HIT-CF (Human Individualized Therapy of CF), which seeks to accelerate the development of, and access to, personalized therapies for CF patients, beginning with those for whom no currently approved CFTR modulator therapy is indicated.

HIT-CF is sponsored by the European Commission Horizon 2020 program, in which CF-Europe, a patient organization representing more than 48,000 individuals with CF, collaborates and with the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN), which is recruiting adult CF patients into the ex- vivo study through its 43 clinical trial centers. HIT-CF collects tissue samples from CF patients and develops organoids, or miniaturized organs, that are genetically identical to the patient donor, and share the same micro-anatomy as the organ from which they were derived.

As of today, rectal organoids from over 300 subjects have been collected for functional profiling and of those, 65 have been tested for response to PTI's investigational drugs. Early results support the initiation of enrollment of responding subjects into HIT-CF's clinical trial known as "CHOICES" (Crossover trial based on Human Organoid Individual response in CF - Efficacy Study), which is designed to evaluate the translation of organoid ex-vivo response to potential clinical benefit, such as changes in FEV1 and sweat chloride. CHOICES, which is expected to initiate in mid-2020, will be the first ever personalized medicine-based study in CF, with initial data expected by the end of 2020. Fully funded by the HIT-CF, this trial is a placebo controlled, double blind, crossover study with an 8-week treatment period and 6 months of uninterrupted dosing. The results may serve as the basis for a potential Marketing Authorization Application with the European Medicines Agency (EMA) in 2021 through a novel regulatory pathway which is being pursued jointly by Proteostasis and HIT-CF. The CHOICES clinical study is part of PTI's broader clinical development strategy for its CFTR modulator candidates that is already separately funded for the common genotypes.

Results from the HIT-CF project to date will be presented at the Keystone Symposia on Tissue Organoids titled "Tissue Organoids as Models of Host Physiology and Pathophysiology of Disease (J1)" taking place on January 19-23, 2020 in Vancouver, BC, Canada.

"Proteostasis is honored to have been invited to participate in the HIT-CF project and is the only company in the group with a combination of novel CFTR modulators being tested ex-vivo. We are very enthusiastic about the progress of the study," said Geoffrey Gilmartin, M.D., M.M.Sc., Chief Medical Officer of Proteostasis Therapeutics. "In Europe alone, there are more than 2,300 adult patients whose genotypes render them ineligible for approved CFTR modulators and exclude them from participating in clinical trials with this drug class. This project's proposed personalized medicine approach is paving a potential new way to develop and provide access to novel CFTR modulators for patients with the most dire need for treatment options that target the cause of the disease. Additionally, based on an individual patient's disease phenotype and not just the genetic designation, this approach could also create a new path towards more effective treatment for all people with CF."

"The inequality in access to CFTR modulators is an acute problem across Europe where 1 in 5 individuals do not have a F508del mutation. In addition, drug reimbursement policies are leading to an ever-growing gap between patients who do, and those who do not have effective treatment options," said Christiane De Boeck, Work Package Leader at HIT-CF, and Former President of ECFS. "At HIT-CF Europe, we believe that novel strategies such as personalized medicine and development of new treatment options are central to addressing the inequality of access across the continent. We are thrilled with these initial results and look forward to providing additional updates."

About Organoids

Organoids are cell cultures that grow in a culture dish and look similar to the organ from which they are derived. Because organoids are made from stem cells, they contain the same mutations as the person from whom the biopsies are derived. Investigational drugs which target the basic defect of CF can be used in an organoid system to evaluate rare mutations where the drugs may have a positive effect.

Unlike in vitro systems such as human bronchial epithelial (HBE) cells, which are derived from lungs that have been removed from CF patients, or the engineered, rat-derived FRT cell line, the latter has resulted in false positive clinical results, rectal organoids are cultured from tissues obtained through a minimally invasive and painless procedure from donors who then become eligible to participate in a clinical study. Organoids can provide valuable insights for donors, including their likelihood of achieving improvements in pulmonary function and reductions in sweat chloride concentration with CFTR modulators based on the ex-vivo response to those drugs.1

About HIT-CF Europe

HIT-CF Europe is a research project which aims to provide better treatment and better lives for people with cystic fibrosis (CF) and rare mutations. To achieve this, drug candidates are first tested on patient-derived organoids in qualified laboratories across Europe. Subsequently, based on the measured signal in the organoids, a smaller group of patients will be invited to participate in a clinical trial with one or more investigational molecules from a participating pharmaceutical company.

All participating centers are part of the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN). The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement number 755021. For more information, visit http://www.hitcf.org.

About Proteostasis Therapeutics, Inc.

Proteostasis Therapeutics, Inc. is a clinical stage biopharmaceutical company developing small molecule therapeutics to treat cystic fibrosis and other diseases caused by dysfunctional protein processing. Headquartered in Boston, MA, the Proteostasis Therapeutics team focuses on identifying therapies that restore protein function. For more information, visit http://www.proteostasis.com.

Safe Harbor

To the extent that statements in this release are not historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "aim," "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements made in this release include, without limitation, statements regarding the expected presentation at an upcoming conference. Forward-looking statements made in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Such risks and uncertainties include, without limitation, our expectations regarding our participation in HIT-CF's pan-European strategic initiative,the potential of our proprietary combination therapies for the treatment of CF, the potential benefit of our proprietary combination therapies to patients, expected timing of patient enrollment in, data from, the completion of, and reporting top line results of our clinical studies and cohorts for our clinical programs, including our planned Phase 2 program and initiation of a pivotal or registrational study, the possibility final or future results from our drug candidate trials (including, without limitation, longer duration studies) do not achieve positive results or are materially and negatively different from or not indicative of the preliminary results reported by the Company (noting that these results are based on a small number of patients and small data set), uncertainties inherent in the execution and completion of clinical trials (including, without limitation, the possibility that FDA or other regulatory agency comments delay, change or do not permit trial commencement, or intended label, or the FDA or other regulatory agency requires us to run cohorts sequentially or conduct additional cohorts or pre-clinical or clinical studies), in the enrollment of CF patients in our clinical trials in a competitive clinical environment, in the timing of availability of trial data, in the results of the clinical trials, in possible adverse events from our trials, in the actions of regulatory agencies, in the endorsement, if any, by therapeutic development arms of CF patient advocacy groups (and the maintenance thereof), in the commercialization and acceptance of new therapies, and those set forth in our Annual Report on Form 10-K for the year ended December 31, 2018, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and our other SEC filings. We assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACTS:

Investors: David Pitts / Claudia StyslingerArgot Partners212.600.1902 david@argotpartners.com/ claudia@argotpartners.com

Media:David RosenArgot Partners212.600.1902david.rosen@argotpartners.com

1Berkers et al, Rectal Organoids Enable Personalized Treatment of Cystic Fibrosis Cell Reports 26, 17011708,February 12, 2019

SOURCE Proteostasis Therapeutics, Inc.

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Proteostasis Therapeutics to Initiate First Ever Personalized Medicine-Based Clinical Trial, CHOICES, in European CF Patients with Genotypes...

Stem Cell and Regenerative Therapy Market 2019 By Global Industry Size, Share, Growth, Trends, Top Company Profiles and Future Analysis 2026 – Montana…

By Stem Cell Medicine

ReportsnReports recently added a detailed overview and industry professional survey report on the global Stem Cell and Regenerative Therapy Market. In this report, titled Stem Cell and Regenerative Therapy Market Size, Share and Industry Analysis by Technologies, By Product, By Application, By Distribution Channel, and Regional Forecast 2019-2026.

The scope of the report encompasses the major types of Stem Cell and Regenerative Therapy Market that have been used, as well as the major applications being developed by industry, academic researchers and their commercialization offices, and government agencies. It analyzes current market status, examines future market drivers and presents forecasts of growth over the next five years. Technology developments, including the latest trends, are discussed. Other influential factors such as screening strategies for pharmaceuticals have also been included.

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The global Stem Cell and Regenerative Therapy Market is comprehensively profiled in the report, including a detailed study of the markets key drivers and restraints, major market players, and leading segments.

Report Scope:

The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

Report Includes:

28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary:

The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study

Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.

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The latest Stem Cell and Regenerative Therapy Market report provides readers with a deeper understanding of potential target consumers to create a lucrative marketing strategy for the 2019-2026 forecast period. For entrepreneurs seeking information about potential customers, it will be particularly helpful. Selective statements provided by leading vendors would allow entrepreneurs to gain a deeper understanding of the local market and prospective customers.

Table of Contents:

Chapter 1 Introduction

Study Background

Study Goals and Objectives

Reasons for Doing This Study

Scope of Report

Methodology and Information Sources

Geographic Breakdown

Market Breakdown

Analysts Credentials

.Continued

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Stem Cell and Regenerative Therapy Market 2019 By Global Industry Size, Share, Growth, Trends, Top Company Profiles and Future Analysis 2026 - Montana...

AgeX Therapeutics and Lineage Cell Therapeutics Announce Issuance of U.S. Patent for Method of Generating Induced Pluripotent Stem Cells – Yahoo…

By Induced Pluripotent Stem Cells

AgeX Therapeutics, Inc. (NYSE American: AGE) and Lineage Cell Therapeutics, Inc. (NYSE American and TASE LCTX), announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,501,723, entitled "Methods of Reprogramming Animal Somatic Cells" covering what is commonly designated "induced Pluripotent Stem (iPS) cells. The issued claims include methods to manufacture pluripotent cells capable of becoming any cell in the body. The patent has an early priority date, having been filed before the first scientific publication of Shinya Yamanaka, for which he won the Nobel Prize for Physiology or Medicine in 2012.

"This patent broadly describes multiple techniques for reprogramming cells of the body back to the all-powerful stem cell state," said Dr. Michael D. West, CEO of AgeX and first inventor on the patent. "Perhaps more significantly, it includes certain factors that address some of the difficulties currently encountered with iPS cells. It also reflects the foundational work our scientists have undertaken to apply reprogramming technology to age-reversal, specifically, induced Tissue Regeneration (iTR) which is currently a focus of AgeX product development." A video describing the significance of the patent in AgeXs product development is available on the AgeX website.

"The issuance of this patent highlights Lineages dominant position in the field of cell therapy," stated Brian M. Culley, CEO of Lineage. "Our efforts to develop new treatments rely on well-characterized and NIH-approved human cell lines. These lines are not genetically manipulated, which avoids the safety concerns associated with genetic aberrations arising from the creation of iPS cells. We believe the Lineage cell lines provide the safest option for our current clinical-stage programs, particularly in immune-privileged anatomical sites such as the eye (OpRegen for the treatment of dry AMD) and spinal cord (OPC1, for the treatment of spinal cord injury). However, the vast intellectual property estate which underlies our cell therapy platform has never been limited to these particular cell lines. As one example, this newly-issued patent provides us with proprietary methods for producing induced pluripotent stem cells, or, as it was practiced by us prior to Yamanaka, Analytical Reprogramming Technology (ART). In certain settings, an ART/iPS approach might offer important advantages, such as for an autologous treatment or when the selection of preferential attributes from a series of iPS lines is desirable. Questions as to which stem cell technology is preferred ultimately will be answered by clinical safety and efficacy and likely will be indication-specific, so we believe it is in the best interest of our shareholders to generate patented technology which enables us to pursue programs in either or both formats which we believe will ensure the highest probability of success."

Induced Pluripotent Stem Cells (iPS) are typically derived from adult skin or blood cells which have been "reprogrammed" or "induced" to retrace their developmental age and regain the potential to form all of the young cell and tissue types of the body. In 2010 inventors of the -723 patent issued today demonstrated that this reversal of developmental aging even extended to the telomere clock of cell aging. This reprogramming technology provides an alternate source of starting material for the manufacture of potentially any type of human cell needed for therapeutic purposes. Because iPSCs can be derived directly from adult tissues, they can be used to generate pluripotent cells from patients with known genetic abnormalities for drug discovery or as an alternative source of cell types for regenerative therapies.

U.S. Patent No. 10,501,723, entitled "Methods of Reprogramming Animal Somatic Cells" was assigned to Advanced Cell Technology of Marlborough, Massachusetts (now Astellas Institute for Regenerative Medicine) and licensed to Lineage and sublicensed to AgeX Therapeutics for defined fields of use. Inventors of the patent include Michael D. West, CEO of AgeX and previous CEO of Advanced Cell Technology, Karen B. Chapman, Ph.D., and Roy Geoffrey Sargent, Ph.D.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly-defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeX is developing its core product pipeline for use in the clinic to extend human healthspan and is seeking opportunities to establish licensing and collaboration agreements around its broad IP estate and proprietary technology platforms.

Story continues

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of AgeXs Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191210005435/en/

Contacts

Media Contact for AgeX:Bill Douglass Gotham Communications, LLCbill@gothamcomm.com (646) 504-0890

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AgeX Therapeutics and Lineage Cell Therapeutics Announce Issuance of U.S. Patent for Method of Generating Induced Pluripotent Stem Cells - Yahoo...

Patent Granted To Lineage & AgeX – Anti Aging News

By Induced Pluripotent Stem Cells

Lineage Cell Therapeutics and AgeX Therapeutics have been awarded a United States Patent and Trademark Office patent for Methods Of Reprogramming Animal Somatic Cells.

The issuance of this patent highlights Lineages dominant position in the field of cell therapy, stated Brian M. Culley, CEO of Lineage. Our efforts to develop new treatments rely on well-characterized and NIH-approved human cell lines. These lines are not genetically manipulated, which avoids the safety concerns associated with genetic aberrations arising from the creation of iPS cells. We believe the Lineage cell lines provide the safest option for our current clinical-stage programs, particularly in immune-privileged anatomical sites such as the eye (OpRegen for the treatment of dry AMD) and spinal cord (OPC1, for the treatment of spinal cord injury). However, the vast intellectual property estate which underlies our cell therapy platform has never been limited to these particular cell lines. As one example, this newly-issued patent provides us with proprietary methods for producing induced pluripotent stem cells, or, as it was practiced by us prior to Yamanaka, Analytical Reprogramming Technology (ART). In certain settings, an ART/iPS approach might offer important advantages, such as for an autologous treatment or when the selection of preferential attributes from a series of iPS lines is desirable. Questions as to which stem cell technology is preferred ultimately will be answered by clinical safety and efficacy and likely will be indication-specific, so we believe it is in the best interest of our shareholders to generate patented technology which enables us to pursue programs in either or both formats which we believe will ensure the highest probability of success.

This patent broadly describes multiple techniques for reprogramming cells of the body back to the all-powerful stem cell state, said Dr Michael D West, CEO of AgeX and first inventor on the patent. Perhaps more significantly, it includes certain factors that address some of the difficulties currently encountered with iPS cells. It also reflects the foundational work our scientists have undertaken to apply reprogramming technology to age-reversal, specifically, induced Tissue Regeneration (iTR) which is currently a focus of AgeX product development.

Patent 10,501,723 covers induced pluripotent stem cells which includes methods to manufacture iPSs cells that are capable of becoming any cell within the body. This patent has an early priority date having been filed before the first scientific publication, and was assigned to Advanced Cell Technology of Marlborough, Massachusetts and licenced to Lineage as well as being sublicensed to Age X for defined fields of use.

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Patent Granted To Lineage & AgeX - Anti Aging News

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