Stem Cell Clinic

BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn for The European Union – BioSpace

NEW YORK, N.Y., and TEL AVIV, Israel, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today a lease agreement with the Tel Aviv Sourasky Medical Center (Sourasky) in Tel Aviv, Israel, to produce NurOwn in three state-of-the-art cleanrooms. The new facility will significantly increase the Companys capacity to manufacture and ship its product into the European Union and the local Israeli market. The cleanroom facility is part of Souraskys Institute for Advanced Cellular Therapies.

"Sourasky Hospital is a leader in the advancement and manufacturing of cell and gene therapy products and is well-equipped to rapidly scale up and produce NurOwn," stated Prof. Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We look forward to continuing our work with BrainStorm to bring NurOwn to ALS patients and help fulfill the clinical therapy demands for the Companys pipeline programs.

"Sourasky Hospital, known for introducing pioneering solutions into clinical practice and advancing patient care, has a first rate team with the proven experience to produce regenerative products in accordance to the highest standard of cGMP manufacturing," said Chaim Lebovits, CEO of BrainStorm. "This agreement will ensure that we can provide NurOwn to patients after regulatory approval, not only in Israel but we have secured capacity to rapidly scale up production as we advance our investigational treatment across the European Union. We are very pleased to be able to expand our ongoing collaboration with Sourasky Hospital, one of the worlds most innovative and respected medical centers."

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 cause BrainStorm Cell Therapeutics Inc.'s actual 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 at http://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

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.com

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

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BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn for The European Union - BioSpace

Stem Cells Market 2020 Size, Global Trends, Comprehensive Research Study, Development Status, Opportunities, Future Plans, Competitive Landscape and…

Global Stem Cells Market 2020 Global Industry report covers the latest market statistics, industry growth driving factors, size, share, trends, as well as Forecast till 2026. The Global Industrial Stem Cells market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

Get a Sample Copy of the Report https://www.marketreportsworld.com/enquiry/request-sample/15567294

Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources: Embryos formed during the blastocyst phase of embryological development (embryonic stem cells) and Adult tissue (adult stem cells).Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 100 countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Stem Cells market in 2020.COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

To know How COVID-19 Pandemic Will Impact This Market/Industry Request a sample copy of the report https://www.marketreportsworld.com/enquiry/request-covid19/15567294

COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets. The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; over forty countries state of emergency declared; massive slowing of the supply chain; stock market volatility; falling business confidence, growing panic among the population, and uncertainty about future.

Global Stem Cells market competition by top manufacturers, with production, price, revenue (value) and market share for each manufacturer; the TOP PLAYERS including;

For the data information by region, company, type, and application, 2020 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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The Stem Cells Market report examines competitive scenario by analyzing key players in the market. The company profiling of leading market players is included in this report with Porters five forces analysis and Value Chain analysis. Further, the strategies exercised by the companies for expansion of business through mergers, acquisitions, and other business development measures are discussed in the report. The financial parameters which are assessed include the sales, profits and the overall revenue generated by the key players of Market.

Stem Cells Breakdown Data by Type:

Stem Cells Breakdown Data by Application:

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Stem Cells Market by Regions:

Key questions answered in the report:

Highlights of the report which will influence the Stem Cells market:

Major Points from Table of Contents:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.4.1 Global Stem Cells Market Size Growth Rate by Type (2015-2026)1.4.2 Major-Type1.4.3 Independent-Type1.4.4 Administrator-Type1.5 Market by Application1.5.1 Global Stem Cells Market Share by Application (2015-2026)1.5.2 Commercial1.5.3 Commonweal1.5.4 Other1.6 Study Objectives1.7 Years Considered

2 Global Growth Trends2.1 Stem Cells Market Size2.2 Stem Cells Growth Trends by Regions2.2.1 Stem Cells Market Size by Regions (2015-2026)2.2.2 Stem Cells Market Share by Regions (2015-2020)2.3 Industry Trends2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Opportunities

3 Market Share by Key Players3.1 Stem Cells Market Size by Manufacturers3.1.1 Global Stem Cells Revenue by Manufacturers (2015-2020)3.1.2 Global Stem Cells Revenue Market Share by Manufacturers (2015-2020)3.1.3 Global Stem Cells Market Concentration Ratio (CR5 and HHI)3.2 Stem Cells Key Players Head office and Area Served3.3 Key Players Stem Cells Product/Solution/Service3.4 Date of Enter into Stem Cells Market3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Type and Application4.1 Global Stem Cells Market Size by Type (2015-2020)4.2 Global Stem Cells Market Size by Application (2015-2020)

(5, 6, 7, 8, 9, 10, 11) United States, Europe, China, Japan, Southeast Asia, India, Central & South AmericaStem Cells Market Size (2015-2020)Key PlayersStem Cells Market Size by TypeStem Cells Market Size by Application

12 International Players ProfilesCompany DetailsCompany Description and Business OverviewStem Cells IntroductionRevenue in Stem Cells Business (2015-2020)Recent Development

13 Market Forecast 2020-202613.1 Market Size Forecast by Regions13.2 United States13.3 Europe13.4 China13.5 Japan13.6 Southeast Asia13.7 India13.8 Central & South America13.9 Market Size Forecast by Product (2020-2026)13.10 Market Size Forecast by Application (2020-2026)

14 Analysts Viewpoints/Conclusions

15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.1.1 Research Programs/Design15.1.1.2 Market Size Estimation12.1.1.3 Market Breakdown and Data Triangulation15.1.2 Data Source15.1.2.1 Secondary Sources15.1.2.2 Primary Sources15.2 Disclaimer15.3 Author Details

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Chinas scientists accused of playing God by creating monstrous cloned apes and primates with human organs – The Sun

CHINESE scientists have been accused of being real-life Dr Frankensteins who play God by cloning apes and editing the genes of babies.

Some of their work has been dubbed monstrous while other cutting edge research could lead to cures for Parkinson's and Alzheimer's.

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It's important to note that the US and the UK are not immune from conducting tests on animals and in fact carry out THOUSANDS of experiments on primates every year.

However, China has become the capital of research on apes and monkeys believing that our closest relatives hold the key to understanding brain disorders that destroy lives.

Incredibly, the Institute of Neuroscience (ION) in Shanghai, cloned five infant monkeys last year from an adult macaque who had been genetically-edited.

The result was baby primates intentionally born with a mutation that disrupts their wake-sleep cycle.

By giving the monkeys new drugs to treat their pre-existing brain disorders, the scientists hope to develop treatments for illnesses such as Alzheimer's disease.

It's no wonder the ION has been dubbed the "Cern of primate neurobiology".

The Institute successfully cloned two macaque monkeys in 2018 - a world first giving the experts confidence to push ahead with further experiments.

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Heaping praise on the research, the Chinese Academy of Sciences said: "The achievement heralds a new era in which China can produce batches of standardised monkey clones, which will serve as animal models in the research of the brain's cognitive functions, early diagnoses and interventions of diseases, as well as research and development of drugs.

While China allows genetic manipulation on animals it has banned the use of gene-editing on humans but that hasn't stopped some of its scientists "playing God" with unborn children.

Scientist He Jiankui, 35, rocked the scientific world when he revealed he had altered the embryos of twin girls in 2018.

In December last year, it was revealed that a third child born to a different mum had also been gene-edited.

The rogue expert said he used a tool called Crispr to disable a gene that allows the AIDS virus to enter cells in a bid to make the children immune from the disease.

But why have such experiments been dubbed monstrous by others within the scientific community?

Experts claim gene-editing in people could "divide humans into subspecies" and can cause mutations, genetic problems and even cancer.

Dr Kiran Musunuru, an expert in this area from the University of Pennsylvania, called the experiment unconscionable an experiment on human beings that is not morally or ethically defensible.

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Professor Julian Savulescu, of the University of Oxford, said: If true, this experiment is monstrous.

The embryos were healthy. No known diseases. Gene editing itself is experimental and is still associated with off-target mutations, capable of causing genetic problems early and later in life, including the development of cancer.

There are many effective ways to prevent HIV in healthy individuals: for example, protected sex.

Last December, Mr Jiankui was jailed for three years after news of the third child's birth was revealed.

He was convicted of practising medicine without a licence and fined 330,000 by a court in Shenzhen, the Xinhua news agency reported.

One of the most controversial experiments to date was the creation of embryos that were part human and part primate.

Last year, Spaniard Juan Carlos Izpisa Belmonte led a team of Chinese researchers with the end goal of creating monkeys which have entirely human organs such as kidneys or livers.

The organs will then be used for human transplants.

Based in China, the team made the chimeras a single organism with cells from more than one genotype - by injecting human stem cells into a fresh monkey embryo.

Biologist Belmonte previously tried adding human cells to embryos of pigs but the disturbing experiment was not successful.

However, because primates are genetically related to humans, the chances of the new research being successful is much greater.

The scientists also use gene-editing technology to disable certain cell formations in the animals to give the human cells a better chance of thriving.

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In the US and other western democracies, such research is banned however in China, experts are allowed to push the boundaries of scientific ethics.

Importantly, no Frankenstein monster has been born as a result of this research... not yet anyway.

Instead, the hybrid embryos are allowed to develop for around two weeks so their progress can be studied.

Mr Belmonte defended his work with the Chinese, saying: History shows us time and time again that, over time, our ethical and moral standards change and mutate, like our DNA, and what yesterday was ethically unacceptable, if this really represents an advance for the progress of humanity, today it is already an essential part of our lives."

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A similar experiment involved two piglets who were born with monkey cells in December at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing.

The so-called 'pig-monkey chimeras' died a week later.

Away from China, one of the most sinister experiments took place at the University of Munich where two monkeys were given transplanted pig hearts.

The poor creatures died after six months in a study which was deemed a success.

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Chinas scientists accused of playing God by creating monstrous cloned apes and primates with human organs - The Sun

Roeland Nusse receives Canada’s Gairdner International Award | The Dish – Stanford University News

by Krista Conger on May 6, 2020 3:43 pm

ROELAND NUSSE, professor of developmental biology, has received Canadas Gairdner International Awardfor his work on understanding the role of the Wnt signaling pathway in normal development and in cancer.

The Wnt pathway is made up of proteins, including one called Wnt, that transmit signals from outside the cell to the inside to trigger biological functions including gene expression and cell division.

Roeland Nusse was honored with Canadas Gairdner International Award for his work on the Wnt signaling pathway, which plays an important role in normal development and in cancer. (Image credit: Norbert von der Groeben)

The award recognizes excellence in fundamental research that affects human health.

Recipients receive 100,000 Canadian dollars (about $72,000) to use as they wish; Nusse plans to donate his award toUNICEF to help provide protective equipment for health care workers caring for children amid the global COVID-19 pandemic. Nusse is the Reed-Hodgson Professor in Human Biology and the Virginia and Daniel K. Ludwig Professor in Cancer Research.

In 1982, Nusse collaborated withHarold Varmus, then a professor in microbiology and immunology at the University of California, San Francisco, to identify Wnt as a critical cancer-associated gene in a mouse model of breast cancer. Nusse went on to show that the analogous gene in fruit flies, Wingless, plays an important role in regulating normal development. The finding highlighted the connections between normal development and cancer.

More recently, Nusse has focused his research on understanding how Wnt signaling regulates the activity of tissue-specific adult stem cells in response to injury or disease. In 2016, Nusse was awarded a $3million Breakthrough Prizefor his work on Wnt signaling.

Read the full article on the Stanford Medicine website.

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Roeland Nusse receives Canada's Gairdner International Award | The Dish - Stanford University News

Broad Foundation brings together stem cell scientists, engineers and physicians at University of Southern – Mirage News

The Broad Foundation brings together stem cell scientists, engineers and physicians at USC and beyond

Developing new stem cell therapies requires more than a solo biologist having a eureka moment alone in the lab. Real progress relies on collaborations between biologists, engineers and physicians. Thats why The Eli and Edythe Broad Foundation has continued its support of two strategic initiatives: innovation awards bringing together teams of engineers and scientists from USC and Caltech, and clinical research fellowships for physician-scientists.

Engineering new approaches: The Broad Innovation Awards

For the fifth consecutive year, the Broad Innovation Awards are providing critical funding to USC-affiliated faculty members pursuing multi-investigator research collaborations related to stem cells. For the first year, these collaborations are also drawing on the expertise of biomedical engineers from Caltech. Each award provides $200,000 of funding for a one-year project.

Were very excited to be joining our colleagues at USC in pioneering new approaches to advancing stem cell research, said Stephen L. Mayo, chair of the Division of Biology and Biological Engineering at Caltech. Were thankful to The Broad Foundation for supporting cross-town collaborations between scientists with different expertise but common goals.

With support from a Broad Innovation Award, Andy McMahon, the director of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC, is collaborating with Caltech biomedical engineer Long Cai to leverage a new technology for understanding chronic kidney disease. The technology, called seqFISH, provides information about genetic activity taking place in intact tissueenabling the study of the interactions between cells in their native environments.

Dr. Cais seqFISH technology will provide an unprecedented insight into the cellular interplay underlying chronic kidney disease caused by a maladaptive response to acute kidney injury, said McMahon, who is the W.M. Keck Provost and University Professor of Stem Cell Biology and Regenerative Medicine, and Biological Sciences, as well as the chair of the Department of Stem Cell Biology and Regenerative Medicine at USC. We aim to better understand this maladaptive responsewhich is more common in malesin order to find new targets for preventing the progression to chronic kidney disease.

A second Broad Innovation Award brings together USC Stem Cell scientist Rong Lu and Caltech synthetic biologist Michael Elowitz. Their team will study the spatial organization of blood-forming stem and progenitor cells, also called hematopoietic stem and progenitor cells (HSPCs), which reside in the bone marrow. By pinpointing the locations of specific HSPCs, the scientists may find clues to explain why certain HSPCs are so dominantreplenishing the majority of the bodys blood and immune cells after a disruption such as a bone marrow transplantation.

Spatial advantages may be the primary drivers of what we refer to as the clonal dominance of certain HSPCs, said Lu, a Richard N. Merkin Assistant Professor of Stem Cell Biology and Regenerative Medicine, Biomedical Engineering, Medicine, and Gerontology at USC. Understanding the spatial competition between HSPCs could help improve bone marrow transplantation and provide new insights into aging and the development of diseases such as leukemiawhich are associated with clonal dominance.

Elowitz added: Thanks to the Broad Innovation Award and this exciting collaboration with Rong Lu, we will be able to bring a new, synthetic biology approach to record cell histories and read them out in individual cells within their native spatial context, providing new insights into fundamental questions in blood stem cell development.

A third Broad Innovation Award brings together three collaborators at USC: Michael Bonaguidi, an assistant professor of stem cell biology and regenerative medicine, biomedical engineering, and gerontology; Robert Chow, a professor of physiology and neuroscience, and biomedical engineering; and Jonathan Russin, an assistant professor of neurological surgery and associate surgical director for the USC Neurorestoration Center. Their project focuses on finding new approaches to treating epilepsy by studying neural cells called astroglia. These cells perform a variety of key functions that support the health of neurons in the brain, and they may also play a role in modulating epileptic seizures.

Although adults dont tend to generate many new brain cells, humans do produce a limited number of new astroglia, said Bonaguidi. We will examine these newborn astroglia at the single-cell level to better understand their role in epileptic patients, and to lay the groundwork for identifying new treatments.

The doctors are in: The Broad Clinical Research Fellowships

The Broad Clinical Research Fellowships are also entering their fifth consecutive year. These fellowships support stem cell research by physician-scientists and residents who intend to practice medicine in California.

These fellowships provide a very special opportunity for our medical residents to engage deeply in laboratory research, as a complement to their extensive training in patient care, said Laura Mosqueda, Dean of the Keck School of Medicine of USC. This valuable research experience gives them a much more complete perspective on how to meet the challenges of finding the best possible treatments for their patients.

A USC resident physician in general surgery, Kemp Anderson will spend his fellowship studying necrotizing enterocolitis, a very serious intestinal infection that affects nearly 10 percent of premature infants. Specifically, he will explore how a molecule involved in cellular communication, called farnesoid X receptor, or FXR, might contribute to this disease.

If FXR plays a role in compromising intestinal barrier function in these premature infants, then altering the activity of FXR could potentially yield treatment modalities for necrotizing enterocolitis, avoiding the morbidity and mortality associated with surgical intervention, said Anderson, who is performing the research under the mentorship of Christopher Gayer and Mark Frey at Childrens Hospital Los Angeles (CHLA). Im deeply appreciative of the benefactors and the selection committee for awarding me the Broad Clinical Fellowship, as it is allowing me devoted time to focus on this important project, and to become a more well-rounded physician through this academic pursuit.

Brittany Rocque, a resident physician in general surgery, will use her fellowship to seek better ways to predict, detect and diagnose immune rejection in patients who have undergone liver transplantation. Nearly 60 percent of pediatric patients and at least 15 percent of adult patients reject their liver transplants, and this can currently only be confirmed through an invasive surgical biopsy. Rocque is utilizing the technology Imaging Mass Cytometry to identify and analyze the types of immune cells involved in rejection.

My project has the potential to provide a noninvasive option to assess rejection in transplanted patients, and to expand our understanding of immune rejection, said Rocque, who is being co-mentored by Juliet Emamaullee and Shahab Asgharzadeh at CHLA. Im greatly looking forward to applying my passion for transplantation surgery in the context of basic science, and enhancing my appreciation for the nuances of research, thanks to the Broad Clinical Research Fellowship.

A hematology-oncology fellow who will be transitioning to a junior faculty position at USC next year, Caitlin ONeill will study a condition known as clonal hematopoiesis or CH, a phenomenon common in the aging population. CH involves genetic mutations that cause the expansion of a particular population of blood cells without leukemia or related malignancies. CH increases risks for certain health conditions including heart disease.

During her Broad Clinical Research Fellowship, ONeill will look at one mutation seen in patients with CH: a mutation to the gene called Tet methylcytosine dioxygenase 2, or TET2. ONeill will explore if this mutation promotes blood clots, inflammation and heart disease.

The goal is to inform therapies to prevent heart disease and leukemic progression in aging patients with CH, said ONeill, who is working with co-mentors Casey OConnell and Rong Lu at USC. Im very happy to be working on this project, with support from the Broad Clinical Research Fellowship, during my transition to becoming a faculty member at USC.

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Broad Foundation brings together stem cell scientists, engineers and physicians at University of Southern - Mirage News