New York, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Increasing interest of biotechnology companies and scientists in cancer and stem cell research, rising commercial production of biologics like proteins, antibodies and vaccines & drugs have boosted the cell culture market because of which cell culture protein surface coating market has also seen a proportional growth.

According to the current analysis of Reports and Data, the global cell culture protein surface coating market was valued at USD 238.3 million in 2018 and is expected to reach USD 659.1 million by the year 2026, at a CAGR of 13.6%. Cell culture is a process in which cells are grown under controlled physical environment outside their natural environment. Cell culture protein surface coating helps to improve adhesion and growth of in vitro cell culture. These cells are helpful in developing model systems for research, studying cellular functions, stem cell research, drug discovery, and genetic engineering. The growing scope of associated culture industry across the globe has helped the market for cell culture protein surface coating grow.

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With incidents of chronic diseases on the rise around the world, the research, drug development, and clinical trials on various therapies also need to be increased. Therefore, the demand for target industry usage will also have a boost. This will be a significant factor fuelling the growth of this industry. It also helps in cell isolation, which plays a very vital role in the diagnostics and research of chronic diseases. It helps in drug discovery by studying the behavior of the cells and their response to disease and drugs. This technique of drug discovery helps to generate medicines that can be used for the treatment of various diseases such as cancer, genetic disorders, and autoimmune diseases. All these factors have contributed towards a positive dynamic growth curve of this industry, and it is expected to keep growing in the coming years.

North America is recognized for its healthcare-related culture laboratories and research funding. The National Institutes of Health (NIH) extensively finance stem cell research in the United States each year. Moreover, the National Cancer Institute (NCI) allocates high funding for research into cancer disorders and personalized medicine to institutions and companies working with research centers. These aspects boost the significance of cell culture activities. The healthcare expenditure is, therefore, high in the United States and Canada.

Furthermore, improving government initiatives, availability of research funds from private as well as public bodies, and rising awareness about the benefits of this technology are among the key factors propelling the growth of the target market.

Further key findings from the report suggest

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Segments covered in the report:

For the purpose of this study, Reports and Data have segmented the cell culture protein surface coating market on the basis of coating type, protein source, end use and region:

Coating Type (Revenue in USD Billion, 2018 - 2026)

Protein Source (Revenue in USD Billion, 2018 - 2026)

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Regional Outlook (Revenue in USD Million; 20162026)

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When Margaret Lawrence 36 arrived in Ithaca in 1932, she was the only black student in her class. Denied on-campus housing due to her race, the future psychoanalyst and pediatrician once slept in an attic, working as a live-in maid to help pay for her Cornell degree.

Lawrence whose name was Margaret Cornelia Morgan at the time applied in her senior year to the medical school to continue her education at Cornell, but was denied, since twenty-five years ago there was a Negro man admitted, a dean explained, and it didnt work out. That student had died from tuberculosis.

The Cornell Daily Sun June 12, 1936

Of this roster of graduates published in 1936, Margaret Lawrence 36 was the only black student.

Columbia University did accept Lawrence, propelling the alumna to eventually direct the Therapeutic Developmental Nursery at Harlem Hospital and becoming chief of the Developmental Psychiatry Service for Infants and Children for 21 years.

When Lawrence who would be known for her empathy for children patients, according to The New York Times was in medical school, she continually faced the compounded difficulty of sexism and racism as one of 10 women, and the only black woman in her class.

At Cornell, Lawrence was a skilled archer, scoring in the top eight and snagging a spot on the archery team, according to archived editions of The Sun.

She would chronicle these challenges in a book titled Balm in Gilead: Journey of a Healer, written by her daughter, Prof. Sara Lawrence-Lightfoot, sociology, Harvard University. In one recollection, Lawrence described how when she turned 21 and went to register to vote, she was asked to take a literacy test.

The Cornell Daily Sun on May 22, 1934

During her time at Cornell, Lawrence was involved in archery, repeatedly scoring among the top.

Lawrences story resonated with former Cornell University President Frank H. T. Rhodes, who reportedly heard her struggles and penned a short apology letter for the discrimination in 2008.

He wrote her a short letter of sincere and serious apology for the assaults ofdiscrimination and racism she had suffered, Lawrence-Lightfoot said.

According to The New York Times, Lawrence-Lightfood said that her mother appreciated the respectful and heartfelt apology.

Lawrence died on Wednesday in Boston at an assisted living center at the age of 105.

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Margaret Lawrence '36, Who Was Rejected From Cornell's Medical School Because She Was Black, Dies at 105 - Cornell University The Cornell Daily Sun

UT Southwestern, a leading academic medical center in Dallas, will create a new facility in southwest Dallas RedBird Mall to bring more specialized health care to an underserved community at greater risk of disease and early death.

The expansion is expected to lift the southern Dallas economy, too, adding momentum and a high-profile vote of confidence to a major redevelopment project thats already received $22 million in taxpayer subsidies.

UT Southwestern has leased an old Sears site and will convert 150,000 square feet into an outpatient medical center. The nonprofit organization expects to focus on heart disease, cancer, neurological problems and behavioral health, and employ at least 100 health care workers.

It will coordinate and collaborate with Parkland Memorial Hospital, which is creating a smaller facility for primary care in the same mall.

The medical school is renowned for research, and patients at the new UT Southwestern Medical Center at RedBird will be able to participate in clinical trials.

We saw an opportunity at RedBird to really deliver on our mission and commitment, said Dr. Daniel Podolsky, president of UT Southwestern. Its a natural when you look at the map to have this anchor in the south.

Elected officials and community advocates have long tried to attract investment and business to southern Dallas, and most agreed that public and private support were required, said Tennell Atkins, a council member who represents the district that includes RedBird.

Peter Brodsky, a former private equity investor, bought the mall then known as Southwest Center Mall four years ago. He persuaded the city to put up $22 million in cash and loans, largely to rebuild infrastructure.

Brodskys project has several wins already, including a bustling Starbucks and a major apartment complex that broke ground last month. A call center company, Chime Solutions, has moved into the mall and brought almost 400 jobs, with more to come.

Still, UT Southwestern represents another magnitude of impact, said Atkins, whos represented the area for 11 years. UT Southwestern oversees about 3 million outpatient visits a year, along with providing care to over 105,000 hospitalized patients and almost 370,000 emergency room cases. It has about 17,000 employees and an operating budget of $3.2 billion and brings in almost $470 million in faculty research.

This will breathe new life into everything, Atkins said. Merry Christmas, south Dallas!

UT Southwestern has a huge campus north of downtown Dallas, next to Parklands flagship facility and Childrens Medical Center Dallas. It also has smaller medical centers in the Park Cities, Las Colinas, Frisco and Fort Worth and no facilities in the southern half of the metro area.

Dallas-Fort Worth has experienced a building boom in health care, but projects have been concentrated in fast-growing, affluent cities to the north. UT Southwestern and partner Texas Health Resources just finished a new hospital and medical center in Frisco. Earlier this year, rival pediatric providers announced plans for two new childrens facilities in Prosper, just three miles apart.

Southern Dallas has a shortage of primary doctors and specialists, lagging the median supply in all of Dallas County and the nation and the gaps are projected to grow, UT Southwestern said. In southern Dallas, mortality rates are much worse for heart disease, stroke and cancer, according to a local community needs assessment.

There are many factors contributing to that disparity, but one of them is certainly access to health services, Podolsky said.

Ten years from now, the success of the new facility will be judged by the improvement in health outcomes for nearby residents, he said.

But the economic impact matters, too: Whats that old saying? You can do well by doing good, he said.

Some might assume this is a philanthropic venture, driven solely by the need for more health care in that part of the city. Podolsky said theres also a solid business case.

While more people in southern Dallas are uninsured, many residents have good health coverage through their employers. And the population and family spending power are growing.

We believe this will be a very sustainable, viable business, Podolsky said.

Although profit margins may not match some affluent areas of Dallas, he expects the operation to be self-sustaining with a modest margin enough margin to continue to invest.

Brodsky gave UT Southwestern credit for stepping up in a big way, not only for expanding to the south but for being open to moving into a repurposed shopping mall.

Brodsky targeted medical providers because they would generate traffic for the mall, create high-paying jobs and help fill a vital need in the community. But most potential tenants believed it would be a money loser.

Its safe to say we pitched every hospital in town, Brodsky said. The conversations didnt get very far.

UT Southwestern was open-minded about the possibilities of southern Dallas and setting up shop in a mall. Officials took trips to Jackson, Miss., and Nashville, Tenn., to tour malls that had attracted health care services, including major academic medical centers.

They were impressed by how the malls had been reinvented and the communities reenergized by the activity, said Dr. John Warner, executive vice president of health system affairs for UT Southwestern.

We saw the impact on the health of the community and the public engagement, said Warner, who made the trips. They were meeting people where they were.

The RedBird deal is the first time that UT Southwestern has taken such a space for a facility, Podolsky said. And the company signed a 15-year lease.

That shows this isnt just a temporary philanthropic gesture, Brodsky said. It bothers me when people assume that anything coming to southern Dallas is about philanthropy. Thats not true.

He challenges another common assumption in local business: that opportunities are better in more affluent areas up north. They may have higher median incomes, faster growth and more commercial health insurance, but they also have a lot more competition.

Early movers in southern Dallas have plenty of upside, he insisted. But most are waiting to see whether the project works for tenants of the mall as well as residents of the region.

Over two years ago, Brodsky made an impassioned play for a major national retailer that would be an ideal anchor. A company executive said the opportunity sounded fantastic, but the timing wasnt right.

He said, Wed like to be your fifth major tenant, Brodsky said.

Maybe Brodsky should try that pitch now.

Link:

UT Southwestern to bring new medical facility, jobs and investment to RedBird Mall - The Dallas Morning News

Dr. Richard P. Holm, Prairie Doc Published 11:37 p.m. CT Dec. 12, 2019

Rick Holm

This week I spent some time exploring the origins of the word, kind: It comes from Old English gecynd (YEH-kund) or cynn (kyn), meaning nature, race, family. Another Old English word kyndnes (KIND-nes) means nation, which I interpret as a subtle and ancient nod toward kin, kinship and our common bond in support of our country.

Modern dictionaries define the word kindness as the quality or state of being generous, helpful, caring and giving. Synonyms include tactful, good hearted, neighborly, forgiving and gracious.

Sometimes I only understand something when I explore its opposite or antonym. For example, I had to think about mental illness to better understand mental health; about hate to better understand love; about depression to better understand joy. The antonyms of kindness are words like mean, cruel, malicious, spiteful, malevolent, even despicable.

Where is the intersection of kindness and medicine? In years past, admission committees for medical school have searched hard to find the very smartest college graduates and they were able to do it. Certainly, physicians need the intellect to understand the complexity of human health and continue a lifetime of learning. However, we have realized that searching for students by intellect alone might graduate medical students who dont always develop good bedside manners and a capacity for compassion. More recently, some of the best medical schools have added kindness and compassion programs to their curriculum.

I didnt have the benefit of such a program when I went to medical school, however, over my 40-year medical career, Ive learned to recognize the healing power of kindness in medicine. Ive seen it in the nursing staff caring for folks living in a small-town long-term care facility. Ive heard it from medical providers, nurses and technicians caring for people in clinics, ERs, hospitals and in hospice programs. Ive heard it from kind supportive friends who have offered or driven me for chemo; from jolly laughing buddies who raise my mood; from my care team as they gently hook me up for my next infusion; from our kids who call to check on me; and from my loving wife who is at my side warming me when Im chilled, picking up my burdens with unending daily kindnesses as I struggle through these side-affects. Its a good thing she doesnt love me for my hair.

I am happy that our medical schools are teaching young doctors that people deal with illness so much better when it comes with a generous dose of kindness.

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The importance of kindness in medicine - Argus Leader

WACO, Texas (KWTX) Charles Davis is overjoyed to have his son back to full health, after what he calls a terrifying experience that took place last month.

"The phone call that I got led me to believe that my son was okay but he wasn't," says Charles Davis who's son, also named Charles, passed out while in class at Parkdale Elementary school.

Davis says that he arrived at the school and found his son in a wheelchair with his head down.

The school nurse telling him, "We checked his (Charles) vital signs and they were all good and everything was fine with him."

However Davis was unconvinced, "He was not speaking, he was not physically talking, walking or nothing," he said.

Concerned for the well-being of his son, Davis drove him to Providence Health Center in Waco.

Just four hours later, the family says he was transported by ambulance to Dell Children's Medical Center in Austin.

After spending four days in the hospital he was released, but the family says that doctors are still unsure as to what caused the 2nd grader to pass out, only suggesting it might have been a seizure.

Waco ISD spokesperson Josh Wucher gave a statement regarding the incident, "Under Student Health Services guidelines, an ambulance is called for specific medical emergencies including seizures, anaphylactic shock and unresponsiveness which includes no reaction to both verbal and physical cues. In reviewing this incident, our Health Services Coordinator has studied the situation closely and concluded that the care provided was appropriate."

According to medical records that were given to us by the family, Davis' student health log says that he did respond to physical "stimulus" including "squinting eyes when the nurse checked his pupils."

The district says that was a factor in the school not calling an ambulance, because the child physically responded.

However, the family feels that more should have been done.

"I want the next child that goes through what my child went through to be safe," says Davis.

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Parents upset with how school handled their child's medical emergency - KWTX

The Eastland Companion Animal Hospital in Bloomington is asking dog owners if they want to participate in research on using stem cells to treat dogs with arthritis.

Local dogs wouldjoin a double-blind, placebo-controlled studyto show the effectiveness of stem cells in treating large dogs(70 pounds or more) with arthritis in up to two joints of the knee, hip, elbow, or shoulder. The veterinary clinic has partnered with Animal Cell Therapies, who it's worked with before, to bring this study to Bloomington.

Dr. Kathy Petrucci, founder and CEO of Animal Cell Therapies, explained how dogs will receive the treatment.

The dogs that will receive the stem cells will be sedated, Petrucci said. Depending on what joints are affected, they will receive up to two injections in the joint and they will also receive an IV dose of stem cells.

The FDA oversees the cells that are received from donors for the study. Mothers donating these cells are screened for diseases, and cells are tested for any infections to ensure safety.

Stem cell therapy has been controversial, especially related to humans.

I think a lot of the controversy comes from the misunderstanding of the cell types, Petrucci said. The research in stem cells first started centered around embryonic or fetal tissue use. Its controversial to use embryos and fetal tissues for treatment for anything. The fact that we are using a disposable tissue as our cell sources makes it not controversial at all.

Why Umbilical-Derived Cells

Petrucci explained why umbilical-derived cells are more effective in treating arthritis versus other sources.

We looked at fat, bone marrow, embryonic cells, Petrucci said. The embryonic cells are a lot more unpredictable, and the bone marrow cells are more difficult to work with and less predictable. We didnt think the fat cells are as potent as umbilical-derived cells. Umbilical-derived cells are a lot younger and theyre a little bit more predictable. They are more easy to collect. We obtain cells from donors when the tissue would be normally thrown away. Theres no surgery required, no extra biopsies to obtain fat, no bone marrow from research animals. Its a good, ethical source of stem cells.

Umbilical-derived stem cells have proven successful in past studies on treatment for arthritis, according to Petrucci.

We did a study at the University of Florida on elbows only and we had success with that study, Petrucci said. We had good success with dogs under 70 pounds and (less) success with dogs over 70 pounds, so we changed our dose, which is why were testing dogs 70 pounds and over in this study.

Criteria for eligibility includes dogs weighing 70 pounds or more, being one year of age or older, in general good health, no neurologic issues, arthritis in up to two joints of the knee, hip, elbow, or shoulder, and have all four functioning limbs.

Owners must bring their dogs back to the clinic after 30 days to check for progress and complete a questionnaire. About 50 to 100 dogs are expected to participate in the study.

People like you value experienced, knowledgeable and award-winning journalism that covers meaningful stories in Bloomington-Normal. To support more stories and interviews like this one,please consider making a contribution.

Stem Cell Treatment - Excerpt

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Bloomington Vet Joins Study For Stem Cell Therapy To Treat Dogs With Arthritis - WGLT News

Last year, Arie Belldegrun and David Chang, fresh from selling chimeric antigen receptor (CAR)-T pioneer Kite Pharma to Gilead Sciences, launched Allogene with $300m (271m) and a deal with Pfizer to access off-the-shelf cell therapies. The focus then, as now, was on taking CAR-T therapies mainstream by eliminating factors that could restrict them to niche status, such as the complex, costly production process.

Allogenes founding allogeneic technology moves it some way toward that goal, by enabling therapies to be made from donor cells rather than having to engineer cells taken from the patient themselves.

However, even if the allogeneic approach works as Allogene hopes, it will still require a steady supply of donor cells. When Allogene launched, it set its sights on making up to 100 doses from one donor sample.

The finite nature of donated T cells has spurred interest in induced pluripotent stem cells (iPSC), which could serve as a renewable source of materials for off-the-shelf CAR-T therapies. Notchs work to realize that potential caught the attention of Allogenes CEO, David Chang.

Chang said, We believe [it] to be a scalable and potentially more [good manufacturing practice] amenable manufacturing process. It might be amenable for large-scale manufacturing.

The early stage nature of the iPSC technology Notch is yet to enter the clinic means it is unclear whether the approach can live up to those expectations. An inability to show CAR-T doses are free from undifferentiated iPSCs and failure to generate functioning T cells from iPSCs are two potential stumbling blocks.

Allogene has seen enough potential to bet on Notch, though. The deal will see Allogene pay Notch $10m upfront, take a 25% stake in its new partner and commit to a package of milestones.

Notch will take iPSC AlloCAR T cells through preclinical development before Allogene steps in to test them in humans. Allogene will have global rights to any products resulting from the collaboration.

Other companies are also working to develop oncology cell therapies based on iPSCs. Fate Therapeutics is trialling an engineered natural killer cell therapy created from a clonal master iPSC line, while Bayer-backed startup Century Therapeutics recently raised $250m to take iPSC-derived treatments for blood cancers and solid tumors into the clinic. Takeda is also active in the space.

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Allogene allies with Notch to make CAR-T production more scalable - BioPharma-Reporter.com

The report on the global cell therapy market provides qualitative and quantitative analysis for the period from 2017 to 2025.

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NEW YORK, Nov. 12, 2019 /PRNewswire/ -- The report predicts the global cell therapy market to grow with a healthy CAGR over the forecast period from 2019-2025. The study on cell therapy market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific, and RoW for the period of 2017 to 2025.

The report on cell therapy market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, forecasts, and trends in the global cell therapy market over the period of 2017 to 2025. Moreover, the report is a collective presentation of primary and secondary research findings.

Porter's five forces model in the report provides insights into the competitive rivalry, supplier and buyer positions in the market and opportunities for the new entrants in the global cell therapy market over the period of 2017 to 2025. Further, IGR- Growth Matrix gave in the report brings an insight into the investment areas that existing or new market players can consider.

Report Findings1) Drivers Increasing incidences of cancer across the globe Growing aging patient population Rise in cell therapy transplantations2) Restraints The high cost of transplantation treatment Stringent regulatory policies3) Opportunities Automation in cell therapy

Research Methodology

A) Primary ResearchOur primary research involves extensive interviews and analysis of the opinions provided by the primary respondents. The primary research starts with identifying and approaching the primary respondents, the primary respondents are approached include1. Key Opinion Leaders associated with Infinium Global Research2. Internal and External subject matter experts3. Professionals and participants from the industry

Our primary research respondents typically include1. Executives working with leading companies in the market under review2. Product/brand/marketing managers3. CXO level executives4. Regional/zonal/ country managers5. Vice President level executives.

B) Secondary ResearchSecondary research involves extensive exploring through the secondary sources of information available in both the public domain and paid sources. At Infinium Global Research, each research study is based on over 500 hours of secondary research accompanied by primary research. The information obtained through the secondary sources is validated through the crosscheck on various data sources.

The secondary sources of the data typically include1. Company reports and publications2. Government/institutional publications3. Trade and associations journals4. Databases such as WTO, OECD, World Bank, and among others.5. Websites and publications by research agencies

Segment CoveredThe global cell therapy market is segmented on the basis of cell type, therapy type, application, and end-users.

The Global Cell Therapy Market by Cell Type Stem Cell Differentiated Cell

The Global Cell Therapy Market by Therapy Type Allogenic Therapies Autologous Therapies

The Global Cell Therapy Market by Application Autoimmune Diseases Oncology Dermatology Muscoskeletal Therapies Other Applications

The Global Cell Therapy Market by End-Users Hospitals and Clinics Biotechnology and Pharmaceutical Companies Research Institutes

Company Profiles NuVasive, Inc Kolon TissueGene, Inc. JCR Pharmaceuticals Co., Ltd. Osiris Therapeutics, Inc. Stemedica Cell Technologies, Inc. MEDIPOST Celgene Corporation ANTEROGEN.CO., LTD Vericel Corporation

What does this report deliver?1. Comprehensive analysis of the global as well as regional markets of the cell therapy market.2. Complete coverage of all the segments in the cell therapy market to analyze the trends, developments in the global market and forecast of market size up to 2025.3. Comprehensive analysis of the companies operating in the global cell therapy market. The company profile includes analysis of product portfolio, revenue, SWOT analysis and latest developments of the company.4. IGR- Growth Matrix presents an analysis of the product segments and geographies that market players should focus to invest, consolidate, expand and/or diversify.

Read the full report: https://www.reportlinker.com/p05796546/?utm_source=PRN

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

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Global cell therapy market is expected to grow with a healthy CAGR over the forecast period from 2019-2025 - P&T Community

MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)--Promethera Biosciences SA, a global innovator in cell-based medicines and liver diseases, published updated clinical data from the ongoing phase 2a study (HEP101) of its lead product candidate HepaStem in patients with Acute-on-Chronic Liver Failure (ACLF) or acute decompensation (AD) at high risk of developing ACLF. The data were presented in an oral presentation at the Annual Meeting of the American Association for Study of Liver Diseases (AASLD) on November 10, 2019, in Boston, by Prometheras principal investigator Prof. F. Nevens, KULeuven, Belgium. The data set confirmed earlier findings presented at The International Liver Congress - ILC 2019 in April.

Currently, liver transplant is the only rescue treatment for patients suffering from ACLF and to a lesser degree for patients with acute decompensation of the liver (AD). There are no other existing therapies that can rescue the end-stage-liver failure. Promethera is developing HepaStem as an alternative to transplant; it consists of liver derived stem cells that are obtained from ethically donated healthy human organs and expanded in GMP culture conditions. These liver derived signaling stem cells migrate through the blood stream to reach the liver, where they support the tissue regeneration via their potent secretome.

In the trial HEP101, HepaStem has been intravenously infused in single or repeated injections in multiple ascending doses in patients to assess the tolerability and the safety profile of the treatment. The trial which recruited a total of 24 patients, including 16 patients with ACLF and 8 patients with AD has met its primary endpoint.

With one or two repeated doses up to 1.2 million cells per kilogram of body weight, no adverse events related to HepaStem occurred and no clinically significant changes were shown in platelet count, fibrinogen levels, and coagulation factors following HepaStem infusion. The demonstrated safety of two infusions of 1.2 million cells per kilogram of body weight provide solid guidance for conducting the subsequent trials. In addition to the positive safety profile, the study has shown trends in efficacy with improvement in three indicators of liver disease severity; Model for End Stage Liver Disease score (MELD), Child-Pugh score and bilirubin levels, 28 days and three months after treatment initiation. Promethera plans to demonstrate the efficacy of HepaStem at 1.0 million cells per kilogram of body weight in ACLF with a large multicentric double blind placebo-controlled trial (HEP102). The study HEP102 is expected to start end 2019.

We continue to pioneer the use of liver stem cells for the treatment of severe liver diseases and the updated status from the worlds first clinical trial evaluating a cell-based therapy in ACLF gives us confidence about the safety aspects and the broad therapeutic potential of our therapy, said Etienne Sokal, M.D., Ph.D., Prometheras Group Chief Medical Officer. As a potential first tangible alternative to organ transplantation for an ever-growing patient population, HepaStem will advance into a larger efficacy trial in ACLF focusing on a reduced need for transplantation and a decreased mortality.

Prof. Nevens added, With the data set having evolved since we last presented results at this years ILC Congress, the Phase 2a trial provides a strong rationale for further clinical evaluation of the therapeutic concept and has provided a safe dosing regimen which will guide future studies.

About Promethera Biosciences

Promethera Biosciences is a global innovator in liver therapeutics whose mission is to bring life-saving treatments to reduce the need for liver transplantation. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties. In addition to our cell-based pipeline we develop antibody technologies, such as the antiTNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.

Promethera, HepaStem, H2stem, are all registered trademarks of the PROMETHERA group.

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Promethera Biosciences Presents Updated Clinical Results at AASLD 2019 for World's First Stem Cell Therapy Trial using HepaStem in Acute-on-Chronic...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, today reported financial results for the third quarter ended September 30, 2019 and recent business highlights.

Magenta has a big vision: to bring the curative power of immune reset through stem cell transplant to patients with autoimmune diseases, genetic diseases and blood cancers. At ASH next month, we are looking forward to sharing important new data from across our portfolio. These will include clinical data from our MGTA-145 program, which we are developing as a new first-line standard of care for stem cell mobilization. We will also present the first gene therapy data on our CD117-ADC, which we are developing as a non-genotoxic preparation regimen for gene therapy and transplant, said Jason Gardner, D.Phil., Chief Executive Officer and President, Magenta Therapeutics. In addition, earlier this week we presented our first data in autoimmune disease, showing that a single dose of our CD45-ADC led to successful immune reset in disease models of multiple sclerosis, systemic sclerosis and inflammatory arthritis. Immune reset through stem cell transplant has previously demonstrated durable remissions in thousands of patients with autoimmune diseases such as multiple sclerosis and systemic sclerosis, and it is recommended in multiple guidelines in US and Europe.

Recent Business Highlights:

First clinical data for MGTA-145 stem cell mobilization program and groundbreaking CD117-ADC gene therapy data to be presented at the American Society of Hematology (ASH) annual meeting: On November 6th, 2019, Magenta announced that the Company will share results from six abstracts at ASH in December 2019, covering Magentas patient preparation, mobilization and cell therapy programs. The Company will present clinical data for the MGTA-145 stem cell mobilization program, building on the positive early data in the ASH abstract. Magenta is developing MGTA-145 to be the new standard of care for first-line stem cell mobilization, with mobilization and collection taking place in a single day without the use of G-CSF, the current standard of care. The Company will also highlight important proof-of-concept data from the CD117-ADC patient preparation program. In a rhesus model of gene therapy, a single dose of CD117-ADC enabled engraftment of stem cells modified with the -globin gene, the gene that causes sickle cell disease and -thalassemia when mutated. These results showed for the first time that a single dose of CD117-ADC can enable successful gene therapy transplant in non-human primates without the need for chemotherapy or radiation.

First Magenta preclinical immune reset data presented at the American College of Rheumatology (ACR) annual meeting: On November 10th, 2019, Magenta presented the first data on the use of targeted antibody-drug conjugates (ADCs) to reset the immune system and halt progression of autoimmune disease. Results showed that a single dose of C45-ADC removed disease-causing cells, enabled successful reset and rebuild of the immune system and was well tolerated in models of multiple sclerosis, systemic sclerosis and inflammatory arthritis. Further, a single dose of CD45-ADC significantly delayed disease onset in a model of multiple sclerosis that has successfully provided preclinical proof of concept for many clinically validated standard of care therapies.

Exercised option with Heidelberg Pharma for ADCs using an amanitin payload and targeting CD45: On November 11th, 2019, Magenta announced that it had exercised its option with Heidelberg Pharma for exclusive worldwide development and marketing rights for ADCs using an amanitin payload and targeting CD45.

Received Regenerative Medicine Advanced Therapies (RMAT) Designation for MGTA-456 in inherited metabolic disorders: In September 2019, Magenta announced that the FDA granted RMAT designation for MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders, based on encouraging clinical data generated to date in the Companys ongoing Phase II trial. RMAT designation is a dedicated program designed to expedite the development and approval processes for promising pipeline products, including cell therapies. Potential advantages of the RMAT designation include all of the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.

Appointed Senior Vice President, Head of Translational Sciences; Chief Scientific Officer to transition out of Company: In October 2019, Magenta announced that it had hired Jan Pinkas, Ph.D., as Senior Vice President, Head of Translational Sciences. Dr. Pinkas is a seasoned scientist with deep expertise in leading drug development programs, including ADCs. Prior to joining Magenta, he was Head of Translational Research & Development at ImmunoGen, Inc., where he led nonclinical and translational research and development-related activities for all programs in discovery through late-stage clinical development. The Company also announced that Mike Cooke, Ph.D., Chief Scientific Officer, will leave Magenta to pursue other opportunities.

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2019, were $160.6 million compared to $142.6 million on December 31, 2018. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into the second half of 2021.

Research and Development Expenses: Research and development expenses were $16.5 million in the third quarter of 2019, compared to $11.4 million in the third quarter of 2018. The increase was driven primarily by investments in clinical activities for MGTA-145, as well as manufacturing related to our patient preparation programs.

General and Administrative Expenses: General and administrative expenses were $6.1 million for the third quarter of 2019, compared to $5.3 million for the third quarter of 2018. The increase was primarily due to an increase in professional fees and facility costs associated with the growth of the Company.

Net Loss: Net loss was $ 21.0 million for the third quarter of 2019, compared to net loss of $16.0 million for the third quarter of 2018.

About Magenta TherapeuticsHeadquartered in Cambridge, Mass., Magenta Therapeutics is a clinical-stage biotechnology company developing novel medicines for patients with autoimmune diseases, blood cancers and genetic diseases. By creating a platform focused on critical areas of unmet need, Magenta Therapeutics is pioneering an integrated approach to allow more patients to receive one-time, curative therapies by making the process more effective, safer and easier.

Forward-Looking StatementThis press release may contain forward-looking statements, including express or implied statements regarding Magentas future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting pre-clinical and clinical data, projections regarding future revenues and financing performance, our long-term growth, cash, cash equivalents and marketable securities, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our preclinical programs, as well as other statements containing the words anticipate, believe, continue, could, estimate, expect, intend, may, might, plan, potential, project, should, target, will or would and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other risks concerning Magenta's programs and operations are described in additional detail in its registration statement on Form S-1, its Annual Report on Form 10-K filed on March 19, 2019, its Quarterly Reports on Form 10-Q and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

2019

2018

2019

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16,524

11,418

40,494

28,950

6,120

5,284

17,838

13,083

22,644

16,702

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42,033

(22,644)

(16,702)

(58,332)

(42,033)

1,654

687

4,800

1,197

(20,990)

(16,015)

(53,532)

(40,836)

(88)

$

(20,990)

$

(16,015)

$

(53,532)

$

(40,924)

$

(0.54)

$

(0.49)

$

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$

(3.05)

38,824,209

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$

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155,601

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Magenta Therapeutics Reports Third Quarter 2019 Financial Results and Recent Business Highlights - Business Wire

Three faculty members with the International Society for Stem Cell Application (ISSCA) were honored with awards at the organizations recent regenerative medicine conference held at the University of Miami on October 24-27. The awards were sponsored by the Sociedad Internacional en Investigacin, Salud, Desarrollo Empresarial y Tecnologas (SISSDET) and lauded the honorees for their commitment to leadership and education in the field of regenerative medicine.

The three recipients of the awards are Dr. Damian Ariel Siano, Dra. Maritza Novas, and Dra. Silvina Pastrana. All three have continued to partner with the ISSCA and have notable contributions to the field by offering courses in regenerative medicine, helping thousands of doctors around the world add stem cells therapies to their medical practices.

Dr. Damian Ariel Siano is an orthopedic physician from Argentina who has dedicated his professional life to treat sports injuries. He is one of the most renowned sports medicine specialists in South America. Dr. Siano currently works with one of the most famous soccer teams in Argentina, using cell therapies to help professional athletes avoid unnecessary surgery and recuperate quicker from injuries.

Dra. Maritza Novas currently serves as the Director of Research and Development for the Global Stem Cells Group. For the past 10 years, she has dedicated herself to educating doctors in the latest stem cells advancements and conducting stem cell research. Dra. Novas has visited all continents, sharing her knowledge as a stem cells practitioner and researcher.

Dra. Silvina Pastrana is one of the first doctors that helped form the ISSCA. She has become a visionary in the field and is noted for creating her own stem cells protocols and using complementary therapies to get better results in patient who utilize cell therapies. Dra. Pastrana combines both ozone and vitamin C therapies before employing stem cell protocols, obtaining excellent results in treating patients with arthritis.

The ISSCA is committed to helping physicians who want to add regenerative medicine to their practices gain the education and tools to do that, said Benito Novas, Vice President of Public Relations for ISSCA. The three doctors recognized at our recent event at the University of Miami are prime examples of the high-quality instructors that physicians can anticipate working with when then attend one of our conferences. Congratulations to our faculty on receiving this prestigious award, and thank you to SISSDET for recognizing their accomplishments.

ISSCA is a global leader in stem cells research, applications, and education, partnering with major global institutions and locations worldwide to host its independent medical congresses. To learn more about the ISSCA and its all of its past and upcoming events, visit http://www.issca.us

About International Society for Stem Cells Applications

The International Society for Stem Cells Applications (ISSCA) is a multidisciplinary community of scientists and physicians, all of whom aspire to treat diseases and lessen human suffering through advances in science, technology, and the practice of regenerative medicine. Incorporated under the Republic of Korea as a non-profit entity, the ISSCA is focused on promoting excellence and standards in the field of regenerative medicine.

ISSCA bridges the gaps between scientists and practitioners in Regenerative Medicine. Their code of ethics emphasizes principles of morals and ethical conducts.

At ISSCA, their vision is to take a leadership position in promoting excellence and setting standards in the regenerative medicine fields of publication, research, education, training, and certification. ISSCA serves its members through advancements made to the specialty of regenerative medicine. They aim to encourage more physicians to practice regenerativemedicine and make it available to benefit patients both nationally and globally.

For more information, please visit https://www.issca.us/ or send an email to info@stemcellsgroup.com

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ISSCA Faculty Honored with Health Sciences Awards at Conference Held at the University of Miami - PRUnderground

NEW YORK, Nov. 12, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Companys Chief Operating and Chief Medical Officer Ralph Kern MD MHSc will present at the 7th International Stem Cell Meeting, which is hosted by the Israel Stem Cell Society. The Conference will be held November 12-13, in Tel Aviv, Israel.

Ralph Kern, MD, MHSc, said: I welcome the opportunity to participate in the 7th International Stem Cell Meeting where I will share the advances BrainStorm has made with NurOwn. It is a privilege to participate and to exchange ideas with many of the international scientific leaders in stem cell research.

About NurOwn

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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BrainStorm Cell Therapeutics Announces Ralph Kern MD MHSc to Present at the 7th International Stem Cell Meeting - GlobeNewswire

CAMBRIDGE, Mass. & MENLO PARK, Calif.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) and Forty Seven, Inc. (Nasdaq:FTSV) announced today that they have entered into a research collaboration to pursue clinical proof-of-concept for Forty Sevens novel antibody-based conditioning regimen, FSI-174 (anti-cKIT antibody) plus magrolimab (anti-CD47 antibody), with bluebirds ex vivo lentiviral vector hematopoietic stem cell (LVV HSC) gene therapy platform. This collaboration will focus on a conditioning approach aimed to deliver reduced toxicity and will initially target diseases that have the potential to be corrected with transplantation of autologous gene-modified blood-forming stem cells. If successful, the new conditioning regimen could allow for more patients to undergo gene therapy.

Autologous hematopoietic stem cell transplantation (HSCT) and most ex vivo LVV HSC gene therapies require that a patients own stem cells first be depleted from the bone marrow to facilitate the engraftment of the new (or gene-modified) HSCs through a process called conditioning. Conditioning is performed using chemotherapy or radiation, which can place patients at risk for infection and require hospitalization until bone marrow cells have recovered. In addition, conventional conditioning can place patients at risk for secondary malignancy and infertility. As a result, the overall toxicity profile of current conditioning regimens limits the types of patients who are eligible for gene therapy. It is hoped that novel antibody based conditioning regimens could avoid these toxicities.

We are excited about this collaboration, combining our industry-leading LVV HSC gene therapy platform with Forty Sevens novel antibody-based conditioning regimen, said Philip Gregory, chief scientific officer, bluebird bio. We believe that, if successful, this novel conditioning modality could not only increase the number of patients and physicians who may consider gene therapy but also improve the overall risk benefit profile for stem cell-based gene therapy, as well as potentially reduce time and costs associated with hospital visits.

Forty Seven is advancing the pioneering work on CD47 and cKIT from our scientific founder, Irv Weissmans lab. We have shown that antibody blockade of CD47 can synergize with other antibodies targeting cancer to promote tumor engulfment. Based on this experience, coupled with the results of preclinical studies, we are eager to explore this dual-antibody approach for the potential treatment of non-malignant diseases, says Jens Peter Volkmer, M.D., Founder and Vice President of Research and Development at Forty Seven.

Forty Sevens President and Chief Executive Officer, Mark McCamish, M.D., Ph.D., commented, bluebird is a leading gene therapy company and we are excited to collaborate with them. Stem cell transplantation is potentially curative for a variety of blood diseases, including genetic blood disorders like sickle cell disease and beta-thalassemia. If successful, we believe our chemo- and radiation-free, all-antibody approach could expand transplantation beyond genetic blood disorders to a range of indications for which current transplantation approaches are suboptimal. In 2020, we plan to evaluate FSI-174 in healthy volunteers, before initiating a combination study of Forty Sevens novel all-antibody conditioning regimen and bluebirds gene therapy product.

Under the terms of the agreement, bluebird bio will provide its ex vivo LVV HSC gene therapy platform and Forty Seven will contribute its innovative antibody-based conditioning regimen for the collaboration.

About FSI-174 and MagrolimabFSI-174 is a humanized monoclonal antibody targeting cKIT, which is a receptor that is highly expressed on hematopoietic stem cells. Magrolimab is a humanized monoclonal antibody targeting CD47, which is a dont eat me signal to macrophages and is expressed on all cells. Magrolimab is currently being investigated in Phase 2 clinical trials to treat cancer and has established clinical efficacy in four indications, including myelodysplastic syndrome, acute myeloid leukemia, diffuse large B cell lymphoma and follicular lymphoma, with a favorable safety profile in over 350 patients treated, including some patients treated continuously for over two years. When combined, FSI-174 sends a positive signal to macrophages to target blood forming stem cells for removal and magrolimab disengages inhibitory signals that block phagocytosis. Combination of these antibodies has shown efficient removal of blood forming stem cells, allowing for transplantation in pre-clinical models.

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

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

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

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

bluebird bio is a trademark of bluebird bio, Inc.

About Forty Seven Inc.Forty Seven, Inc. is a clinical-stage immuno-oncology company that is developing therapies targeting cancer immune evasion pathways based on technology licensed from Stanford University. Forty Sevens lead program, magrolimab, is a monoclonal antibody against the CD47 receptor, a dont eat me signal that cancer cells commandeer to avoid being ingested by macrophages. This antibody is currently being evaluated in multiple clinical studies in patients with myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkins lymphoma, ovarian cancer and colorectal carcinoma.

For more information, please visit http://www.fortyseveninc.com or contact info@fortyseveninc.com.

Follow Forty Seven on social media: @FortySevenInc, LinkedIn

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," potentially, and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the research and development plans for bluebird bios and Forty Sevens respective platforms and product candidates, the timing and success of Forty Sevens collaboration with bluebird bio, Forty Sevens plans to pursue clinical proof-of-concept for FSI-174 plus magrolimab with the LVV HSC gene therapy platform, the focus on diseases that have the potential to be corrected with transplantation of autologous gene-modified blood-forming stem cells, the tolerability and efficacy of FSI-174 and magrolimab, Forty Sevens plans to continue development of FSI-174 plus magrolimab, as well as related timing for clinical trials of the same.

Any forward-looking statements are based on the companies managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the exploratory antibody-based conditioning platform will not be successful or will not be safe or effective in clinical trials, the risks that the collaboration between bluebird bio and Forty Seven will not continue or be successful, and the risk that the parties will not be successful in advancing the collaboration in development, the risk that potential product candidates that bluebird bio and Forty Seven develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all, the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release and the risk that such product candidates may not be beneficial to patients or successfully commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the companies actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in each companys most recent Form 10-K as well as discussions of potential risks, uncertainties and other important factors in subsequent filings with the Securities and Exchange Commission at http://www.sec.gov. All information contained in this press release are not guarantees of future performance and speak only as of the date hereof, and each of bluebird bio and Forty Seven disclaims any obligation to update this information to reflect future events or circumstances unless required by law.

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bluebird bio and Forty Seven Announce a Research Collaboration to Study an All Antibody Conditioning Regimen for Use in Combination with Autologous...

DetailsCategory: DNA RNA and CellsPublished on Wednesday, 13 November 2019 09:46Hits: 111

AMSTERDAM, The Netherlands I November 12, 2019 I Kiadis Pharma N.V. (Kiadis Pharma or the Company) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, today announced that it has completed a strategic portfolio review and has decided to change its strategy and focus all resources and investments on the companys NK-cell therapy platform and product candidates. The company will discontinue development of ATIR101 and stop its ongoing phase 3 trial.

Kiadis NK-cell program consists of off-the-shelf and haplo donor cell therapy products for the treatment of liquid and solid tumors. Kiadis proprietary off-the-shelf NK-cell platform is based on NK-cells from unique universal donors, expanded and activated ex vivo using our PM21 particle technology. The Kiadis off-the-shelf platform has the potential to make NK-cell therapy products rapidly and economically available for a broad patient population across a potentially wide range of indications.

The companys pipeline includes:

Arthur Lahr, CEO of Kiadis Pharma commented, We believe that our proprietary NK-cell therapy platform has broad potential as stand-alone or adjunctive treatments for patients with both liquid and solid tumors. Our off-the-shelf NK-cell platform is based on NK-cells from unique universal donors, expanded and activated with our PM21 particle technology, to make our NK-cell therapy products rapidly and economically available for patients across a potentially broad range of indications. The proof-of-concept trials for our NK pipeline programs, in which 38 patients have been treated, is very promising and was the basis for our acquisition of Cytosen Therapeutics, Inc. earlier this year. To confirm findings from these trials, we will start two Phase 1/2 clinical trials in 2020. We believe that investing in our NK platform and rapidly advancing development of our off-the-shelf and haplo donor derived NK-cell therapies in solid and liquid tumors will bring value to patients and our investors.

Lahr continued, As part of our strategic portfolio review, we reviewed progress of our phase 3 study, which was designed to show superiority of ATIR101 over the PTCy protocol. We identified that in the phase 3 a higher percentage of patients than expected dropped out of the study before receiving ATIR101. We subsequently collected additional recent external data, which show that outcomes with PTCy have better survival and lower severe GVHD than literature showed when we designed and started the phase 3 study. Based on these data, we no longer believe that the phase 3 ATIR study as currently designed with 250 patients can demonstrate superiority over PTCy and at a minimum would require a much larger trial. In the best interest of patients, we have therefore taken the decision to discontinue the ATIR101 study with immediate effect and are proceeding with close down activities.

RestructuringKiadis is implementing a restructuring program to refocus the organization on its NK-cell therapy platform, which will result in a reduction of approximately half of its workforce, a reduction in external clinical trial costs associated with the phase 3 study, and a reduced company cash burn. The company ended the third quarter of 2019 with approximately 47 million of cash.

About Kiadis K-NK-Cell Therapies Kiadis NK-cell programs consist of off-the-shelf and haplo donor cell therapy products for the treatment of liquid and solid tumors as adjunctive and stand-alone therapies.

Our NK-cell PM21 particle technology enables improved ex vivo expansion and activation of anti-cancer cytotoxic NK-cells supporting multiple high-dose infusions. Kiadis proprietary off-the-shelf NK-cell platform is based on NK-cells from unique universal donors. The Kiadis off-the-shelf K-NK platform can make NK-cell therapy product rapidly and economically available for a broad patient population across a potentially wide range of indications.

Administered as an adjunctive immunotherapeutic on top of HSCT, K-NK002 provides functional, mature and potent NK-cells from a haploidentical family member. In addition, Kiadis is developing K-NK003 for the treatment of relapse/refractory acute myeloid leukemia and has pre-clinical programs evaluating NK-cell therapy for the treatment of solid tumors.

About KiadisFounded in 1997, Kiadis Pharma, is a fully integrated biopharmaceutical company committed to developing innovative cell-based therapies for patients with life-threatening diseases. With headquarters in Amsterdam, the Netherlands, and offices and activities in the US and across Europe, Kiadis Pharma is leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.

Kiadis Pharma is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at http://www.kiadis.com.

SOURCE: Kiadis Pharma

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Kiadis Pharma changes strategy to focus solely on development of Natural Killer (NK) Cell therapeutics and terminates development of ATIR101 | DNA RNA...

HOUSTON, Nov. 12, 2019 /PRNewswire/ -- Marker Therapeutics, Inc.(Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a corporate update and reported financial results for the third quarter ended September 30, 2019.

"We continue to make progress in advancing our next-generation T-cell based immunotherapies for the treatment of hematological malignancies and solid tumors," said Peter L. Hoang, President and CEO of Marker Therapeutics. "Our partner-sponsored MultiTAA T-cell therapy trials at the Baylor College of Medicine continue to show promising results. In addition, we continue to expand our team and build out our infrastructure to support future Marker-sponsored clinical trials. We expect the next 12 to 18 months to be an exciting and productive time for our Company."

Continued Mr. Hoang: "We recently filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for our MultiTAA T-cell therapy as part of a planned Marker Phase 2 study in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia in both the adjuvant and active disease setting. The FDA reviewed our submission and requested additional information regarding certain quality and technical specifications for two reagents supplied by third party vendors that are used in our manufacturing process. Because the FDA requires these data in order to clear the IND, the Marker AML trial has been placed on clinical hold until our complete response to the technical questions is satisfactory to the FDA. While these reagents are not present in the final product, we worked with respective manufacturers of these reagents to satisfy the FDA's questions and subsequently submitted a complete response to the FDA in late October. We currently project to initiate our Phase 2 trial in 2020 and look forward to providing an update on our clinical path forward upon receiving the FDA's feedback."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T-Cell Therapies

Marker Submits Response to FDA Clinical Hold on AML Trial The Company worked with regulatory and quality groups at the respective manufacturers to address the FDA's request and submitted a complete response to the issues raised by the FDA on October 28, 2019. The FDA will respond within 30 daysafter receiving Marker's complete response, indicating whether the hold is lifted and, if not, specifying the reasons the clinical trial remains on hold.Marker expects to initiate its Phase 2 clinical trial of MultiTAA therapy for the treatment of post-transplant AML in 2020.

T Cell-Based Vaccines

Phase 2 Triple Negative Breast Cancer Trial ProgressingMarker continues to advance its T cell-based vaccine program in triple negative breast cancer. To date, results have shown:

Phase 2 Platinum-Sensitive Advanced Ovarian Cancer Trial Update Marker will be discontinuing the development of TPIV200 in patients with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from its Phase 2 study conducted by an independent Data and Safety Monitoring Board (DSMB). Although the DSMB did not express any safety concerns with respect to TPIV200, Marker has elected to suspend the trial because it did not meet the threshold for probability of success based upon the Company's pre-specified criteria. Pending full review of the data, Marker anticipates closing the trial in the first quarter of 2020.

CORPORATE UPDATES

THIRD QUARTER 2019 FINANCIAL RESULTS

Net loss for the quarter ended September 30, 2019 was $5.5 million, compared to a net loss of $4.4 million for the quarter ended September 30, 2018.

Research and development expenses during the three months ended September 30, 2019 were $3.1 million, compared to $1.9 million during the three months ended September 30, 2018. The increase of $1.2 million was primarily attributable to increases in personnel-related expenses, relating to the build-up of Marker's internal infrastructure.

General and administrative expenses were $2.5 million during the three months ended September 30, 2019 as compared to $2.6 million during the three months ended September 30, 2018. The decrease was primarily attributable to $0.6 million of merger-related expenses incurred during the three months ended September 30, 2018, offset by increased expenses in headcount-related and legal and other professional expenses.

CASH POSITION AND GUIDANCE

At September 30, 2019, Marker had cash and cash equivalents of $48.5 million. The Company believes that its existing cash and cash equivalents will fund its current operations through at least the fourth quarter of 2020.

Conference Call and Webcast

The Company will host a webcast and conference call to discuss its third quarter 2019 financial results and provide an update on recent corporate activities today at 5:00 p.m. EST.

The webcast will be accessible in the Investors section of the Company's website at http://www.markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics Third Quarter 2019 Earnings Call."

The archived webcast will be available for replay on the Marker website following the event.

About Marker Therapeutics, Inc.Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

Marker is also advancing a number of innovative peptide and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast cancer and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.

To receive future press releases via email, please visit:https://www.markertherapeutics.com/email-alerts/

Forward-Looking Statement DisclaimerThis release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Marker Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

September 30,

December 31,

2019

2018

ASSETS

Current assets:

Cash and cash equivalents

$ 48,477,670

$ 61,746,748

Prepaid expenses and deposits

1,906,062

141,717

Interest receivable

78,145

108,177

Total current assets

50,461,877

61,996,642

Non-current assets:

Property, plant and equipment, net

438,881

147,668

Right-of-use assets, net

501,714

-

Total non-current assets

940,595

147,668

Total assets

$ 51,402,472

$ 62,144,310

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$ 2,858,808

$ 2,754,572

Lease liability

199,266

-

Warrant liability

129,000

49,000

Total current liabilities

3,187,074

2,803,572

Non-current liabilities:

Lease liability, net of current portion

333,480

-

Total non-current liabilities

333,480

-

Total liabilities

3,520,554

2,803,572

Commitments and contingencies

-

-

Stockholders' equity:

Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively

-

-

Common stock, $0.001 par value, 150 million shares authorized, 45.7 million and 45.4 million shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively

45,723

45,440

Additional paid-in capital

370,290,447

365,400,748

Accumulated deficit

(322,454,252)

(306,105,450)

Total stockholders' equity

47,881,918

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Marker Therapeutics Reports Third Quarter 2019 Operating and Financial Results - P&T Community

A technique called zinc finger nuclease (ZFN) gene editing technology can be used to modify immature red blood cells called precursor cells to boost the production of fetal hemoglobin and help ensure red blood cells maintain a normal shape in people with sickle cell disease (SCD), a study shows.

Sanofi has launched a Phase 1/2 trial (NCT03653247) evaluating the safety, tolerability and efficacy of a BIVV003, a gene editing therapy using the ZFN technology (by Sangamo Therapeutics) in adults with severe SCD. This trial, taking place at four U.S. sites, is currentlyrecruiting eligible patients.

ZFN technology findings will be presented by Samuel Lessard, PhD, a researcher at Sanofi, in the poster, Zinc Finger Nuclease-Mediated Disruption of the BCL11A Erythroid Enhancer Results in Enriched Biallelic Editing, Increased Fetal Hemoglobin, and Reduced Sickling in Erythroid Cells Derived from Sickle Cell Disease Patients, (abstract No. 974) at the 61st Annual Meeting of the American Society of Hematology (ASH), December 710 in Orlando.

Sickle cell is caused by mutations in the HBB gene, which provides instructions for making part of hemoglobin, a protein responsible for transporting oxygen in the blood.

These mutations change the structure of the protein, resulting in the production of abnormal hemoglobin fibers. These fibers tend to stiffen red blood cells, changing their shape from normal disc-like cells to those with a sickle-like shape.

BIVV003 is an investigational gene edited cell therapy being developed under an agreement between Bioverativ, a Sanofi company, and Sangamo.

It uses Sangamos proprietary ZFN gene editing technology to modify a short sequence of the BCL11Agene in red blood precursor cells acquired from the patients own hematopoietic stem cells (stem cells that give rise to other blood cells) to raise production of fetal hemoglobin, the main form of hemoglobin found in fetuses.

Fetal hemoglobin production is normally switched off in adults and largely disappears at ages 6 months to 1 year, but artificial ways of introducing fetal hemoglobin show increasing promise in treating SCD by preventing red blood cells from taking on a damaging sickle shape.

Sangamoannounced the findings from a proof-of-concept ex-vivo(lab) study aiming to validate the ZFN gene editing technology using immature red blood cell isolated from four healthy donors and one sickle cell patient.

Study findings demonstrated that more than 90% of edited donor cells incorporated genetic modifications in both copies of the BCL11A gene, leading to an increase of 27% to 38% in fetal hemoglobin levels compared to baseline (studys start).

Edited cells from the SCD patient also tended to incorporate these modifications in both gene copies. As a result, patient edited cells produced up to 28% more fetal hemoglobin compared to unedited cells.

Patient red blood cells obtained from already edited precursor cells were also less likely to change to a sickle-like shape, supporting BIVV003 as a potential cell therapy for SCD, the study reports. Further experiments in red blood precursor cells from additional SCD patients are underway.

Sangamo is also enrolling patients with transfusion-dependent beta-thalassemia (TDT) in thePhase 1/2 THALES trial (NCT03432364) to evaluate the safety, tolerability, and efficacy of ST-400, another experimental gene-edited cell therapy that uses the same gene-editing approach as BIVV003.

The companyannounced it will present data from the first three THALESpatients at the ASH meeting.

Joana is currently completing her PhD in Biomedicine and Clinical Research at Universidade de Lisboa. She also holds a BSc in Biology and an MSc in Evolutionary and Developmental Biology from Universidade de Lisboa. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells cells that make up the lining of blood vessels found in the umbilical cord of newborns.

Total Posts: 94

Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Tcnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.

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Gene Editing Tool in Ongoing Sickle Cell Trial of BIVV003 Supported by Early Study - Sickle Cell Anemia News

MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)--Promethera Biosciences SA (Promethera) and MEDIPAL HOLDINGS CORPORATION (MEDIPAL) today announced that they have entered into a business alliance agreement. In conjunction with todays alliance, MEDIPAL has decided to increase its shareholdings in the Promethera Group. Details follows below.

The purpose of this alliancePromethera has been developing its lead liver cell-derived technology (HepaStem) in an area of high medical need, primarily for Non-alcoholic steatohepatitis (NASH), Acute-on-chronic liver failure (ACLF) and urea cycle disorder (UCD). Promethera completed the recruitment of 24 patients in its Phase 2a study in Acute-on-chronic liver failure (ACLF) in July 2019. The 3 months follow-up data were presented on 10th November at the AASLD 2019 conference (70th American Association for the Study of the Liver Diseases). In addition, the Phase 2a clinical study in patients with late stage NASH with worlds first cell therapy was initiated in May 2019. MEDIPAL will support Promethera in the commercialization of its products in Japan through the subscription to a private placement of new shares on March 20th, 2019, with the aim to expand the products it handles in the regenerative medicine field going forward.

The purpose of this alliance is to further deepen the cooperative relationship between the two companies by providing access to MEDIPALs know-how and capabilities in the distribution of cellular medicines at ultra-low temperatures. MEDIPAL will support Promethera's clinical trials and aims to provide a steady supply after its product launch.

With about 430 cases per year, the percent of patients receiving a liver transplant in Japan is significantly lower than in the US, where some 8,000 patients receive a transplant every year. Rescue solutions for Japanese patients with fatal liver diseases are performing poorly too. An even closer partnership with MEDIPAL will support us in setting up clinical trials in Japan that could positively impact and contribute to a solution for this considerable medical need in Japan. Building on this partnership, we will accelerate the clinical development of HepaStem towards a subsequent market launch in Japan, which will be a meaningful new development for Japanese patients suffering from end-stage liver disease, said Dr John Tchelingerian, President and CEO of Promethera. Mastering the entire supply chain is a key requirement for an off-the-shelf allogeneic cell therapy product, and MEDIPALs expertise and capabilities in this sector will be very valuable in this regard.

Prometheras HepaStem program can potentially become the worlds first therapeutic product using liver stem cells for the treatment of severe liver diseases, commented Shuichi Watanabe, Chief Executive Officer of MEDIPAL. Liver disease prevalence is rising in Japan and around the world due to an increase in obesity and other metabolic syndromes. The need to deliver effective treatments such as Prometheras is expected to augment rapidly. MEDIPALs system enables strict temperature management and traceability by using SDDU (Specialty Drug Distribution Unit: a liquid nitrogen-based ultra-low cold chain system for drug distribution) and has an extensive expertise in this field. We are very pleased with this partnership and the opportunity to support the development and the logistics of this innovative product candidate with our capabilities.

About MEDIPAL HOLDINGS CORPORATION

Head office

2-7-15, Yaesu Chuo-ku Tokyo 104-8461 Japan

Representative

Shuichi Watanabe, Representative Director, President and CEO

Business

As a holding company, MEDIPAL controls, administers and supports the operating activities of companies in which it holds shares in the Prescription Pharmaceutical Wholesale Business; the Cosmetics, Daily Necessities and OTC Pharmaceutical Wholesale Business; and the Animal Health Products and Food Processing Raw Materials Wholesale Business, and conducts business development for the MEDIPAL Group.

Website

https://www.medipal.co.jp/english

About Promethera Biosciences S.A.

Head office

Watson & Crick Hill, Rue Granbonpr, 11 B-1435 Mont-Saint-Guibert, Belgium

Representative

John Tchelingerian, PhD, President & CEO

Business

Promethera Biosciences is a global innovator in liver therapeutics whose mission is to bring patients life-saving treatments to reduce the need for liver transplantation. Promethera develops and manufactures allogeneic cell-based medicines for liver diseases by using regenerative medicine technology.

Website

https://www.promethera.com/

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Notice of Business Alliance between Promethera Biosciences SA and MEDIPAL HOLDINGS - Business Wire

Stem Cell Banking Marketis expected to reachUSD 5830.41 Million by 2026 fromUSD 1593.9 Million in 2017 during the forecast period. A stem cell bank is a facility, which stores stem cells for future use. Stem cell banking is the process of conserving stem cells at temperatures below the freezing point. These cells used for the treatment of Parkinsons syndrome, cancer, diabetes, heart diseases, and others.

Stem cell banking market is segmented by Type, Banking service, Application, and Geography. Based on service type the sample preservation & storage segment is expected to hold maximum market share during the forecast period due to the increasing adoption of stem cell banking services in key countries, growing numbers of stem cell banks across developing countries, increasing public consciousness about the therapeutic applications of stem cells.

On the basis of application, the personalized banking applications segment is fastest-growing segment owing to increasing adoption of precision medicine across established countries, the growing prevalence of blood & immune system-related disorders amongstnew-borns& children, &growing public worries regarding the clinical abuse of stored stem cell samples.

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North America is expected to hold largest market share during the forecast period. The increasing network of stem cell banking services, ongoing support of stem cell lines for various disease treatment, new technological developments in the field of stem cell collection & preservation techniques, increasing public-private investments for stem cell researches, rising number of stem cell transplantation procedures are pouring the growth of the Stem Cell Banking Market in North America.

Cordlife introduced NICE, a clinically approved non-invasive prenatal test in Indonesia and the Philippines.LifeCodexx AG, a Provider of non-invasive prenatal DNA testing in Europe, declared its partnership with LifeCell International Pvt. Ltd., an Indian mother & baby preventive health care Type, to bring PrenaTesT, qNIPT testing for the first time to India. The qNIPT technology, which detects the presence of foetal trisomy 21 (Down Syndrome) from maternal blood, received CE marking (European Conformity) in December 2016.

Cordlife Group Limited and China Cord Blood Corporation announced that the two companies collaborated in order to support patients across the China, Singapore, Hong Kong, Indonesia, India, the Philippines, and Malaysia to identify suitable cord blood matching units for stem cell therapy.

DO INQUIRY BEFORE PURCHASING REPORT HERE:https://www.maximizemarketresearch.com/inquiry-before-buying/13540

Scope of the report Stem Cell Banking Market:

Stem Cell Banking Market by Type:

Umbilical Cord Stem Cell Adult Stem CellEmbryonic Stem Cell Stem Cell Banking Market by Service Type

Storage Analysis Processing Collection & Transportation Stem Cell Banking Market by Application

Cerebral Palsy Thalassemia Cancer Diseases Diabetes Autism Stem Cell Banking Market by region

North America Europe APAC Latin America MEAKey Players Stem Cell Banking Market:

1. CCBC2. CBR Systems, Inc.3. ViaCord4. Esperite5. Vcanbio6. Boyalife7. LifeCell8. Crioestaminal9. RMS Regrow10. Cryo-cell11. Cordlife Group12. PBKM FamiCord13. Cells4life14. Beikebiotech15. StemCyte

MAJOR TOC OF THE REPORT

Chapter One: Stem Cell Banking Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Stem Cell Banking Market Competition, by Players

Chapter Four: Global Stem Cell Banking Market Size by Regions

Chapter Five: North America Stem Cell Banking Revenue by Countries

Chapter Six: Europe Stem Cell Banking Revenue by Countries

Chapter Seven: Asia-Pacific Stem Cell Banking Revenue by Countries

Chapter Eight: South America Stem Cell Banking Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Stem Cell Banking by Countries

Chapter Ten: Global Stem Cell Banking Market Segment by Type

Chapter Eleven: Global Stem Cell Banking Market Segment by Application

Chapter Twelve: Global Stem Cell Banking Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Stem Cell Banking Market Report at:https://www.maximizemarketresearch.com/market-report/stem-cell-banking-market/13540/

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Originally posted here:

Stem Cell Banking Market 2019: Growth, Trends, Demand, Share, Analysis and Forecast to 2026 - Markets Gazette 24

This is the heart-warming moment a pensioner personally thanked the mum who saved his life with her anonymousstem cell donation- after a 2,300-mile journey.

Jackie Wray, 50, met with her genetic twin, Siegfried Siggi Wahl, 71, in September after the pair spent more than three years communicating anonymously due to the laws surrounding stem cell donations.

Siggi, from Hattersheim in Germany, was diagnosed with chronic myeloid leukaemia in April 2015 after he had suffered a stroke and doctors found the cancer when he was hospitalised.

After initial treatment proved unsuccessful, doctors told Siggi that his best chance of survival was a blood stem cell donation from a person with identical tissue type.

Siegfried Siggi Wahl had an emotional meeting with stem cell donator Jackie Wray (Caters)

Unfortunately nobody in his immediate family proved to be a match, so he then had to turn to the worldwide register to find a stranger willing to help.

Luckily, just six months earlier, Siggis genetic twin Jackie, from, had signed up with blood cancer charity DKMS in 2015 after seeing a TV appeal for a child in urgent need of a donor.

Moving video captures the moment Siggi met his angel Jackie at her restaurant and bar in Great Ayton, North Yorkshire for the first time earlier this year.

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Jackie said: Before we met, I had no idea what Siggi looked like or how old he was it was very difficult when we could only write to each other and I burst into tears every time I read his cards.

When he arrived, there were lots of tears and lots of cuddling Siggi and his wife had made me a photo album with pictures of him during his treatment which just made me cry instantly.

They also bought me a little angel necklace because they say Im his angel and it was just so lovely, I will treasure it forever.

Siggi had to turn to the worldwide register to find a stranger willing to help him (Caters)

Dad-of-two Siggi added: After the many cards we exchanged anonymously, I felt that Jackie has a heart.

She wanted to save people's lives, and such a person deserves a personal thank you, with a big hug, and of course with a lot of tears.

Neither of us could let go when we hugged - for me, she is my angel that saved my life.

Mum-of-two Jackie is planning her second meeting with Siggi in Germany for his birthday in January (Caters)

Jackie is now calling for others to sign up to become a donor with DKMS to help change peoples lives.

The mum-of-two is planning her second meeting with Siggi in Germany for his birthday in January and is looking forward to meeting the rest of his family.

UK law states that whilst donors and their patients can communicate following the transplant, it must remain anonymous for at least the first two years.

After this, if both parties are in agreement, their identities can be revealed and they can make arrangements to meet.

Click here for more details on how to become a potential stem cell donor.

Read more:

Pensioner travels over 2,000 miles to meet stranger who saved his life with stem cell donation - Yahoo Movies

What is flow cytometry and how does it work?Flow cytometry(FCM) is a scientific technique used to measure the physical and biochemical characteristics of cells.1The sample is injected into the flow cytometer instrument, where it is typically focused to flow one cell at a time past light sources and detectors. Tens of thousands of cells can be examined in seconds to determine their morphology, granularity, scattering and transmission of light, or fluorescence of biomarkers, depending on the variation of FCM used.

The first conventional fluorescence-based flow cytometer was developed and commercialized in the late 60s/early 70s in Germany.2 Over the last five decades, FCM has developed rapidly in terms of the number of its applications and the quantity and dimensionality of the data it generates.1,3 Dr. Minh Doan, formerly of the Imaging Platform of the Broad Institute (USA) and now head of Bioimaging Analytics at GlaxoSmithKline in the USA, states, There have been significant advances in all three Vs of flow cytometry data: velocity (throughput/speed of data acquisition), volume (data content), and variety (sample types and signal acquisition technology).

Michael Parsons, manager of the Flow Cytometry Core of the Lunenfeld-Tanenbaum Research Institute in Toronto, Canada, agrees. The two biggest trends in flow cytometry are high content data and the merging of technologies from separate disciplines. For example, the last five years or so have seen the emergence of mass cytometry, which merges the disciplines of flow cytometry and mass spectrometry. In its latest iteration, an image cytometry module has been incorporated to generate unprecedented amounts of content (number of measured parameters) from relatively small amounts of patient tissue. Spectral flow cytometry has also established itself as an important emerging technology. Indeed, mass cytometry can now measure up to 50 features on a single cell simultaneously using antibodies tagged with rare earth metals,4 and imaging flow cytometry allows for 1000s of morphological features and multiple fluorescence markers to be analyzed per cell.3Flow cytometry, therefore, has inarguable potential as a clinical tool for disease diagnosis, prognosis, and therapeutic monitoring. However, some challenges remain in translating the full promise of FCM into clinical practice. Here, some of the current clinical applications of FCM will be discussed, as well as some of the compelling new applications being researched.

Similarly, FCM of liquid biopsies could be used to detect circulating tumor cells in the bloodstream.3 These cells are extremely rare, and with its high sensitivity, FCM is perfectly poised to make a significant impact in this area. This approach has potential for the clinical detection of early-stage cancer as well as the detection of circulating metastatic or drug-resistant cancer cells. For example, a study published earlier this year described label-free liquid biopsy with very high throughput (> 1 million cells/second) for drug-susceptibility testing during leukemia treatment.8

Prior to an organ transplant, FCM can be used to crossmatch the patient's serum with donor lymphocytes to detect antibodies that could result in organ rejection.1 Postoperatively, the analysis of various cell markers on the peripheral blood lymphocytes can indicate early transplant rejection, detect bone marrow toxicity arising from immunosuppressive therapies, and help differentiate infections from organ rejection. For blood transfusions, FCM can be used to detect contamination of blood with residual white blood cells, which can have adverse effects such as pulmonary edema.9Groups such as Dr. Roshini Abrahams at Nationwide Childrens Hospital in Ohio, USA, are using FCM to diagnose primary immunodeficiency disorders with the use of immunophenotyping and functional assays.10 These disorders are caused by genetic mutations that result in defects in the immune system, such as X-linked (Brutons) agammaglobulinemia and X-linked hyper-IgM syndrome. Over 300 of these disorders have been identified thus far, and the causative mutations lower immune defense against the attack of infections.

HIV is, of course, an example of a secondary (acquired) immunodeficiency disorder. FCM analysis of CD4 and other markers on lymphocytes in the peripheral blood is used to monitor the treatment of HIV patients, and a CD4 count <200 cells/mL together with a positive antibody test for HIV is used as a diagnostic for AIDS.1 Secondary immunodeficiencies can also be caused by e.g., substance abuse, malnutrition, other medical conditions, and certain medical treatments. FCM of a panel of markers can be used to confirm suspected cases.1In pregnancy, when a Rhesus blood group D-negative mother carries a D-positive fetus, fetal-maternal bleeding can sensitize the mother to the D-positive blood cells from the fetus and this can be fatal to subsequent D-positive newborns.11 FCM is used to measure the degree of fetal-maternal hemorrhage to determine the correct dose of prophylactics to be administered shortly after delivery.

In addition to oncology and immunology applications, FCM is also used to diagnose a variety of rare hematologic disorders12 as well as autoimmune/autoinflammatory disorders such as spondylarthritis (arthritis of the spine).13 Another area of research that is likely to give rise to increasing clinical applications in the future is that of platelet activity, which is important in many clinical conditions.1,14

Experts suggest that it may be possible to overcome this data analysis hurdle by applying machine learning approaches coupled with further standardization of FCM workflows.3,15 The most exciting applications of high content data revolve around the use of machine learning, in particular, deep learning, to extract relevant meaning from large data sets. Machine learning, coupled with big data, has the potential for driving diagnosis and treatment options tailored to the patients disease in a timely manner, says Dr. Parsons. In addition, Prof. Sadao Ota of RCAST at the University of Tokyo, Japan, points out, We still need to figure out how to design a workflow that convincingly validates diagnostic results, especially if the diagnosis employs the power of machine learning. Such developments are necessary before the rich information content of advanced FCM technology can be fully applied in the clinic.

In terms of other future advances in the field, Prof. Ota specifically makes mention of the potential of cell sorters combined with FCM.16 There are exciting and unique applications of sorters in fields such as cell therapy and regenerative medicine. Also, creating key applications of imaging cell sorters in pharmaceutical fields may accelerate global drug discovery. Dr. Doan concurs, Disease heterogeneity makes it hard to validate findings. Perhaps the use of flow cytometry with sorting capability can help such validation, where events-of-interest collected by flow cytometry can be validated with other downstream assays. Finally, as Dr. Doan notes, With multiple layers of data(types) incorporated altogether, there are now possibilities to do more with less, i.e., label-free sample measurement, which could lead to more direct, faster, and smarter diagnoses. Rare events (e.g., metastatic cancer cells) may soon be detected better than before.References1.Bakke A.C. Clinical Applications of Flow Cytometry. Laboratory Medicine. 2000; 31(2): 97104. doi: 10.1309/FC96-DDY4-2CRA-71FK.2.Herzenberg L.A., Parks D., Sahaf B., Perez O., Roederer M., Herzenberg L.A. The history and future of the fluorescence activated cell sorter and flow cytometry: a view from Stanford. Clinical Chemistry. 2002;48(10):181918273.Doan M., Vorobjev I., Rees P., Filby A., Wolkenhauer O., Goldfeld A.E., Lieberman J., Barteneva N., Carpenter A.E., Hennig H. Diagnostic potential of imaging flow cytometry. Trends in Biotechnology. 2018;36(7):649652. doi: 10.1016/j.tibtech.2017.12.008.4.Olsen L.R, Leipold M.D., Pedersen C.B., Maecker H.T. The anatomy of single cell mass cytometry data. Cytometry Part A. 2019;95(2):156172. doi: 10.1002/cyto.a.23621.5.Laerum O.D., Farsund T. Clinical application of flow cytometry: a review. Cytometry. 1981;2(1):113. doi: 10.1002/cyto.990020102.6.Li J., Wertheim G., Paessler M., Pillai V. Flow cytometry in pediatric hematopoietic malignancies. Clinics in Laboratory Medicine. 2017;37(4):879893. doi: 10.1016/j.cll.2017.07.009.7.Gupta S., Devidas M., Loh M.L., Raetz E.A., Chen S., Wang C., Brown P., Carroll A.J., Heerema N.A., Gastier-Foster J.M., Dunsmore K.P., Larsen E.C., Maloney K.W., Mattano L.A. Jr., Winter S.S., Winick N.J., Carroll W.L., Hunger S.P., Borowitz M.J., Wood B.L. Flow-cytometric vs. -morphologic assessment of remission in childhood acute lymphoblastic leukemia: a report from the Childrens Oncology Group (COG). Leukemia. 2018;32(6):13701379. doi: 10.1038/s41375-018-0039-7.8.Kobayashi H., Lei C., Wu Y., Huang C-J., Yasumoto A., Jona M., Li W., Wu Y., Yalikun Y., Jiang Y., Guo B., Sun C-W., Tanaka Y., Yamada M., Yatomi Y., Goda K. Intelligent whole-blood imaging flow cytometry for simple, rapid, and cost-effective drug-susceptibility testing of leukemia. Lab on a Chip. 2019;19(16):26882698. doi: 10.1039/c8lc01370e.9.Castegnaro S., Dragone P., Chieregato K., Alghisi A., Rodeghiero F., Astori G. Enumeration of residual white blood cells in leukoreduced blood products: Comparing flow cytometry with a portable microscopic cell counter. Transfusion and Apheresis Science. 2016;54(2):266270. doi: 10.1016/j.transci.2015.10.001.10.Abraham R.S., Aubert G. Flow cytometry, a versatile tool for diagnosis and monitoring of primary immunodeficiencies. Clinical and Vaccine Immunology. 2016;23(4):254271. doi: 10.1128/CVI.00001-16.11.Kim Y.A., Makar R.S. Detection of fetomaternal hemorrhage. American Journal of Hematology. 2012;87(4):417423. doi: 10.1002/ajh.22255.12.Bn M.C., Le Bris Y., Robillard N., Wuillme S., Fouassier M., Eveillard M. Flow cytometry in hematological nonmalignant disorders. International Journal of Laboratory Hematology. 2016;38(1):516. doi: 10.1111/ijlh.12438.13.Duan Z., Gui Y., Li C., Lin J., Gober H.J., Qin J., Li D., Wang L. The immune dysfunction in ankylosing spondylitis patients. Bioscience Trends. 2017;11(1):6976. doi: 10.5582/bst.2016.01171.14.Pasalic L. Assessment of platelet function in whole blood by flow cytometry. Methods in Molecular Biology. 2017;1646:349367. doi: 10.1007/978-1-4939-7196-1_27.15.Doan M., Carpenter A.E. Leveraging machine vision in cell-based diagnostics to do more with less. Nature Materials. 2019;18(5):414418. doi: 10.1038/s41563-019-0339-y.16.Ota S., Horisaki R., Kawamura Y., Ugawa M., Sato I., Hashimoto K., Kamesawa R., Setoyama K., Yamaguchi S., Fujiu K., Waki K., Noji H. Ghost cytometry. Science. 2018;360(6394):12461251. doi: 10.1126/science.aan0096.

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The Value and Versatility of Clinical Flow Cytometry - Technology Networks