Study Models the Effect of Herpes Infection on Fetal Brain Development – Pharmacy Times

HSV-1 can spread to the fetal brain during pregnancy and cause lifelong neurological problems, such as cognitive dysfunction, learning disabilities, and dementia.

Three cell-based models shed light on how herpes simplex virus type 1 (HSV-1) infection may contribute to various neurodevelopmental disabilities and long-term neurological problems into adulthood, according to a study published in PLOS Pathogens. HSV-1 can spread to the fetal brain during pregnancy and cause lifelong neurological problems, such as cognitive dysfunction, learning disabilities, and dementia.

Progress in understanding the role of HSV-1 in human fetal brain development has been hampered by restricted access to fetal human brain tissue. Additionally, existing animal models are limited in their applicability to humans. To address the knowledge gap, the investigators generated 3 cell-based neurodevelopmental disorder models, including a 2D layer of cells and a 3D brain-like structure. These models are based on human-induced pluripotent stem cells (hiPSCs), which are immature, embryonic stem cell-like cells. These hiPSCs are generated by genetically reprogramming specialized adult cells.

According to the investigators, HSV-1 infection in neural stem cells derived from hiPSCs resulted in activation of the caspase-3 apoptotic pathway, which initiates programmed cell death. HSV-1 infection also impaired the production of new neurons and hindered the ability of hiPSC-derived neural stem cells to convert into mature neurons through a process called neuronal differentiation.

The study also found that the HSV-1-infected brain organoids mimicked the pathological features of neurodevelopmental disorders in the human fetal brain, including impaired neuronal differentiation and abnormalities in brain structure. In addition, the 3D model showed that HSV-1 infection promotes the abnormal proliferation and activation of non-neuronal cells called microglia, accompanied by the activation of inflammatory molecules, such as TNF-alpha, IL-6, IL-10, and IL-4.

According to the authors, the findings open new therapeutic avenues for targeting viral reservoirs relevant to neurodevelopmental disorders. They added that the study provides novel evidence that HSV-1 infection impaired human brain development and contributes to the neurodevelopmental disorder pathogen hypothesis.

REFERENCE

How herpes infection may impair human fetal brain development [news release]. EurekAlert; October 22, 2020. Accessed May 7, 2021. https://www.eurekalert.org/pub_releases/2020-10/p-hhi101520.php

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Tackling diabetes & ALS with cell therapy – – pharmaphorum

Israeli company Kadimastem is developing regenerative medicine therapies based on differentiated cells derived from human embryonic stem cells to treat diseases such as Amyotrophic lateral sclerosis (ALS) and diabetes. Catherine Longworth spoke with Kadimastems head of diabetes research, Kfir Molakandov to find out more.

In the 1990s, when the first transplant of islets took place, it was hailed as the cure for diabetes. But years later, the potential of islet therapy is yet to be realised due to difficulties finding donors and harvesting cells.

Only a few thousand people have benefited from this therapy as there are not enough donors, says Kfir Molakandov. But even if there were enough donor islets, the standardisation of this therapy is horrible. Every donor is different, and if you offer a therapy, it should be good, reliable, consistent, and the same for everyone.

As the head of diabetes research at Israeli cell therapy company Kadimastem, Molakandov believes they could have the next major diabetes therapy. The Tel-Aviv listed company is leading research and development of a cell therapy comprising functional pancreatic islet cells.

The product in development, IsletRx, is clinical grade pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels. Using micro-encapsulation technology, integrated within IsletRx, the islet cells are protected from attack by the host immune system.

Diabetes is a very hard disease to manage, especially with young children. You have to calculate everything from how much you eat, the amount of insulin to inject, and how much physical exercise to take everything has to be managed! With our therapy, we aim to make it easy by simply putting the functional cells in the patient, Molakandov tells pharmaphorum.

Founded in 2009 by Kadimastems chief scientist Professor Michel Revel, the therapy is based on stem cell research from Israels Weizmann Institute of Science, looking at the potential of restoring activity lost in tissues due to disease damage. After developing treatments for multiple sclerosis, he turned his focus to two main disease areas diabetes and ALS.

Any tissue in the body can be made from the stem cells as they are immature, very easy to work with cells and can proliferate as much as we want to become whatever we want, says Molakandov. We see the cells like clay in our hands that we manipulate in culture and mimic development processes. We have ways to maneuver stem cells to the destination and target tissue we want. We just accelerate the process that takes place in utero over nine months and follow the same stages in a shorter time period.

Kadimastems lead product for ALS, AstroRx, is a cell therapy product containing astrocytes derived from human embryonic stem cells. The astrocyte cells are injected directly into the cerebrospinal cord fluid of the patients to support the dying motor neurons in the brain and spinal cord of ALS patients and slow progression of the disease.

In March 2021, the company completed a Phase 1/2a clinical trial at Jerusalems Hadassah Medical Center, which validated safety and efficacy. The study results show a high safety profile of AstroRx cells and also demonstrated that this particular approach significantly decreased the progression of the disease for three months after AstroRx administration, when measured by ALS Functional Rating Scale-Revised (ALSFRS-S). The company aims to test multiple injections of AstroRx cells in the next round of clinical trials to try to prolong the beneficial effect.

We want to lead a diabetes revolution

Seeking approval

For IsletRx, Kadimastem is working with global regulatory authorities to start pre-clinical studies this year. In April 2021, the company announced it had secured $6.8 million in financing to expedite its research and development programmes.

We anticipate that in about two years our diabetes product will be in clinical trials, says Molakandov. In diabetes, we have managed to demonstrate that we have the capability to manufacture the islets in a good, reproducible way and our proof-of-concept studies show that our cells are capable of ameliorating glycaemia in diabetic animals. In mice, we were able to show the dose escalating needed in order to achieve normal glycaemia, so we know most of the things that we need to know about these cells.

Kadimastem is also developing technology to purify non-relevant cells from the production procedure by selecting the right cells to put in the patient. In fact, Kadimastem is the only cell therapy company with this capability.

It is not a process where you get everything you want you sometimes get impurities, so we have a method and patent to take the right cells and put them in the patient.

For years there was no good external marker, something the cell expresses on its surface, that correlates with the phenotype of mature beta cell. We did a collaboration with scientists at the Weizmann Institute, and we actually managed to identify a single marker that correlates to what is called mature function, so we are using this marker to clear the culture and only use targeted function in the cells that we want.

Although Kadimastem is currently focusing on type 1 and type 2 diabetes, in the future, Molakandov hopes treatment could be available to pre-diabetic people to halt progression of the disease.

Even if you are treated with insulin and you are balanced, the body still may have experienced damage. Not many companies are doing what we do, so we understand the implications and responsibility.

The COVID-19 pandemic has also put diabetes treatment in the spotlight due to people with diabetes being more likely to have serious complications fromthe virus. Clinical observations have also indicated that the condition may be a consequence of the disease.

We want to lead a diabetes revolution, reflects Molakandov. Personally, I think our work now is like the dream of biologists as it combines many disciplines tissue engineering, biomaterials, development, and large-scale production. We feel really proud to understand and execute all these functions simultaneously.

About the interviewee

Kfir Molakandov is head of diabetes research & bioproduction specialist at Kadimastem. His academic and research career have revolved around stem cell research and therapy in diabetes.

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Tackling diabetes & ALS with cell therapy - - pharmaphorum

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Takara Bio Europe AB and PanCryos have announced licensing agreement to enable development of cell-based therapy for diabetes – SelectScience

Takara Bio Europe AB (TBEAB) and PanCryos have announced that they have reached a licensing agreement surrounding TBEABs clinical-grade human embryonic stem (hES) cell lines. PanCryos has established a simplified and effective method to generate stem cell-derived, glucose-responsive beta cells and is one of several customers in TBEABs new out-licensing program, which enables industrial partners to use the clinical-grade hES cells to develop and commercialize breakthrough cell therapy products for previously unmet indications.

Jacqueline Ameri, CEO of PanCryos said, "We are very hopeful that our extensive scientific and industry expertise, combined with TBEABs expertise in clinical-grade hES cell production, will put us in a position to take the crucial next step in the development of our best-in-class, commercially sustainable PanINSULA cell therapy for type 1 diabetes."

This announcement comes following TBEABs successful establishment of a new clinical-grade hES cell line. The derivation work and scale-up were conducted with feeder-free and xeno-free culture conditions under a manufacturing license granted by the Swedish MPA at TBEABs state-of-the-art GMP manufacturing facility in Gteberg, Sweden.

"To our knowledge, this is the first human ES cell line that was derived under GMP conditions based on starting material sourced from prion-free countries, and where the donors were tested within 7 days of the retrieval of the starting material according to FDAs requirement," said Kristina Runeberg, Site Head and Senior Director, Business Development at TBEAB. "We take pride in our rigorous quality and safety standards, and our customers know they can rely on us for high-quality, safe starting material for their cell therapy development."

The out-licensing program is the newest addition to TBEABs ever-expanding portfolio of solutions, including services and GMP-grade media, that support cell therapy applications in Europe. These products and services are also available in North America through TBEABs affiliate Takara Bio USA, Inc.

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Stem Cell Manufacturing Market to 2027 Global Analysis and Forecasts by Type and Application The Courier – The Courier

This market study onStem Cell Manufacturing Marketcovers the global and regional market with an in-depth breakdown of the inclusive growth prospects in the market. Also, it sheds light on the wide-ranging competitive landscape of the global Stem Cell Manufacturing market. It defines about the recent innovations, applications and end users of the market.The report first introduces the market basics like definitions, classifications, applications, and industry chain overview, and then industry policies and plans, product specifications, manufacturing processes, cost structures, and so on.Global Stem Cell Manufacturing market report lends a hand with businesses to thrive in the market by providing them with an array of insights about the market and the industry. Inputs from various industry experts, essential for the detailed market analysis, have been used very carefully to generate this finest market research report.

Stem cell manufacturing market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 18.59 billion by 2027 growing at a CAGR of 6.42% in the above-mentioned forecast period. The growing awareness towards diseases like cancer, hematopoietic disorders and degenerative disorders is going to drive the growth of the stem cell manufacturing market.

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The major players who are leading the market throughout the globe are:

The Stem Cell Manufacturing market report comprises of several market dynamics and estimations of the growth rate and the market value based on market dynamics and growth inducing factors. For generation of an excellent market research report, principal attributes such as highest level of spirit, practical solutions, dedicated research and analysis, innovation, talent solutions, integrated approaches, most advanced technology and commitment plays a key role. The report contains reviews about key players in the market, major collaborations, merger and acquisitions along with trending innovation and business policies. While preparing the winning Stem Cell Manufacturing report, markets on the local, regional as well as global level are explored.

Stem Cell Manufacturing Market Segmentation:

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By Application (Research Applications, Clinical Applications, Cell and Tissue Banking)

By End Users (Hospitals and Surgical Centers, Pharmaceutical and Biotechnology Companies, Clinics, Community Healthcare, Others)

MAJOR TOC OF THE REPORT:-

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Competitive Landscape and Stem Cell ManufacturingMarket Share Analysis

Stem cell manufacturing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to stem cell manufacturing market.

The major players covered in the stem cell manufacturing market report are Thermo Fisher Scientific., Merck KGaA, BD, JCR Pharmaceuticals Co., Ltd., Organogenesis Inc, Osiris, Vericel Corporation, AbbVie Inc., AM-Pharma B.V., ANTEROGEN.CO.,LTD., Astellas Pharma Inc., Bristol-Myers Squibb Company, FUJIFILM Cellular Dynamics, Inc., RHEACELL GmbH & Co. KG, Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd., ViaCyte,Inc., VistaGen Therapeutics Inc, GlaxoSmithKline plc, DAIICHI SANKYO COMPANY, LIMITED, among other domestic and global players. Market share data is available for global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

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Centered Study on Strategy, Development & market Scenario

Global Top Companies Share Analysis in Stem Cell Manufacturing Market

Achieve strategic insights on competitor information to develop powerful industry growth

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To provide a more accurate market forecast, all our reports will be updated before delivery taking into account the effects of COVID-19.

Global Stem Cell Manufacturing Market Scope and Market Size

Stem cell manufacturing market is segmented on the basis of product, application and end users. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Stem Cell Manufacturing Market Country Level Analysis:

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Human Embryonic Stem Cells (HESC) Market 2021 Report Trends In Technological Strategies, Business Advancements And Top-Vendor Landscape To 2030 | GET…

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The report has classified the global Human Embryonic Stem Cells (HESC) industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Human Embryonic Stem Cells (HESC) manufacturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Human Embryonic Stem Cells (HESC) industry.

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The origin of reproductive organs | Penn Today – Penn Today

Early in human development, during the first trimester of gestation, a fetus may have XX or XY chromosomes that indicate its sex. Yet at this stage a mass of cells known as the bipotential gonad that ultimately develops into either ovaries or testes has yet to commit to its final destiny.

While researchers had studied the steps that go into the later stages of this process, little has been known about the precursors of the bipotential gonad. In a new study published in Cell Reports and co-led by Kotaro Sasaki of Penns School of Veterinary Medicine, an international team lays out the detailed development of this key facet of sexual determination in two mammalian models.

Using single-cell transcriptome data, we can get a lot of information about gene expression at each developmental stage, says Sasaki. We can define what the default process is and how it might go awry in some cases. This has never been done in traditional developmental biology. Now we can understand development in molecular terms.

Disorders of sex development (DSD) occur when internal and external reproductive structures develop differently from what would be expected based on an individuals genetics. For example someone with XY chromosomes might develop ovaries. These conditions often affect fertility and are associated with an increased risk of germ cell tumors.

These disorders oftentimes create psychological and physical distress for patients, Sasaki says. Thats why understanding gonadal development is important.

To understand atypical development, Sasaki and colleagues in the current study sought to layout the steps of typical development, working with a mouse model and a monkey model.

The researchers began by examining mouse embryos throughout embryonic development, using molecular markers to track the location of different proteins suspected to be involved in the formation of reproductive structures. They noticed that by day nine of a mouses embryonic development, a structure called the posterior intermediate mesoderm (PIM) lit up brightly with the marker for a gene critical to the development of gonads, kidneys, and the hormone-producing adrenal glands, which are located adjacent to the kidneys.

Zeroing in on the PIM and its progeny cells, the team found that, by day 10.5, these also expressed a marker known to be associated with the bipotential gonad.

People have previously studied the origin of the urogenital organs and the kidney and based on that believed that their origins were very close, Sasaki says. So our hypothesis was that the PIM was the origin of the gonads as well as the kidneys.

To identify the origin of the gonad, they performed lineage tracing, in which scientists label cells in order to track their descendents, which indeed supported the connection between the PIM and the gonads.

To further confirm that the PIM played a similar role in an organism closer to humans in reproductive biology, the researchers made similar observations in embryos from cynomolgus monkeys. Though the developmental timing was different from the mouse, as was expected, the PIM again appeared to give rise to the bipotential gonad.

Digging even deeper into the molecular mechanism of the transition between the PIM and bipotential gonad, the researchers used a cutting-edge technique: single-cell sequencing analysis, whereby they can identify which genes are being turned on during each developmental stage.

Not only were they able to identify genes that were turned onmany of which had never before been associated with reproductive developmentbut they observed a transition state between the PIM and bipotential gonad, called the coelomic epithelium. Comparing the mice and monkey embryos, the researchers came up with a group of genes that were conserved, or shared between the species. Some of these genes are already known to be important for the development of mouse and human ovaries and testes, Sasaki says, and some have been implicated in the development of DSDs.

He notes that in roughly half of patients with DSDs, however, the genetic cause is unknown. So this database were assembling may now be used to predict some additional genes that are important in DSD and could be used for screening and diagnosis of DSDs, or even treatment and prevention.

The study also illuminated the relationship between the origin of the kidneys, adrenal glands, and gonads. They all originate from the PIM, but the timing and positioning is different, Sasaki says.

The adrenal glands, he says, develop from the anterior portion of the PIM, or that section closer to the head and arise early, while the kidney arises later from the posterior portion of the PIM. The gonadal glands span the PIM, with some regions developing earlier and others later.

In future studies, Sasaki and colleagues would like to continue teasing out the details and stages of gonadal development. Sasakis ultimate goal is to coax a patients own stem cells to grow into reproductive organs in the lab.

Some patients with DSDs dont have ovaries and testes, and some cancer patients undergo chemotherapy and completely lose their ovary function, Sasaki says. If you could induce a stem cell to grow into an ovary in the lab, you could provide a replacement therapy for these patients, allowing them to regain normal hormone levels and even fertility. With a precise molecular map to the developing gonad in hand, we are now one step closer to the this goal.

Kotaro Sasaki is an assistant professor in the Department of Biomedical Sciences in the University of Pennsylvania School of Veterinary Medicine.

Sasakis coauthors on the study were Penns Keren Cheng and Yasunari Seita; Kyoto Universitys Akiko Oguchi, Yasuhiro Murakawa, Ikuhiro Okamoto, Hiroshi Ohta, Yukihiro Yabuta, Takuya Yamamoto, and Mitinori Saitou; and Shiga University of Medical Sciences Chizuru Iwatani and Hideaki Tsuchiya. Sasaki and Saitou were corresponding authors.

The study was supported by a JST-ERATO Grant (JPMJER1104), Grant-in-Aid for Specially Promoted Research from JSPS (17H06098), the Pythias Fund, and the Open Philanthropy Fund from Silicon Valley Community Foundation (2019-197906).

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The origin of reproductive organs | Penn Today - Penn Today

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Global Human Embryonic Stem Cells Market Development and trends, CAPEX cycle, innovations, and the dynamic structure forecast 2021-2027 Clark County…

This Report Represents theworldwide Human Embryonic Stem Cells market size(value, consumption, and production), splits the breakdown (data status 2014-2019and forecast to 2026), by manufacturers, region, type, and application. This study also analyzes themarket status, future trends, market drivers, market share, growth rate, opportunities and challenges, sales channels, distributors, risks and entry barriers, and Porters Five Forces Analysis which also includes coronavirus updates.It also has an In-depth analysis of the industrys competitive landscape, restraints, detailed information about different drivers, and global opportunities. Key competitors included in Global Human Embryonic Stem Cells Market areESI BIO, Thermo Fisher, BioTime, MilliporeSigma, BD Biosciences, Astellas Institute of Regenerative Medicine, Asterias Biotherapeutics, Cell Cure Neurosciences, PerkinElmer, Takara Bio, Cellular Dynamics International, Reliance Life Sciences, Research & Diagnostics Systems, SABiosciences, STEMCELL Technologies, Stemina Biomarker Discovery, Takara Bio, TATAA Biocenter, UK Stem Cell Bank, ViaCyte, Vitrolife

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The study objectives of Global Human Embryonic Stem Cells Market are:

Global Human Embryonic Stem Cells market report presentation has been estimated at length and according to expert analysis, is anticipated to entail an impressive growth of xx million USD in 2020 and is projected to further reach a total growth estimation of xx million USD through the forecast till 2026, growing at a CAGR of xx%,and you get accurate CAGR according to Human Embryonic Stem Cells market size which actual exist

Scope of Report:

Human Embryonic Stem Cells Market 2020 global industry research report is a professional and in-depth study on the market size, growth, share, trends, as well as industry analysis. The report begins with an overview of the industry chain structure and describes the upstream. In addition, the report introduces a market competition overview among the major companies and company profiles, besides, market price and channel features are covered in the report. Also, the report analyses market size and forecast in different geographies, types, and end-use segments. Furthermore, market size, the revenue share of each segment, and its sub-segments, as well as forecast figures are also covered in this report.

Human Embryonic Stem Cells Analysis: By Applications

Research, Clinical Trials

Human Embryonic Stem Cells Market: By Product

Totipotent Stem Cells, Pluripotent Stem Cells, Unipotent Stem Cells

Human Embryonic Stem Cells Market Regional Analysis Includes:

There are 15 Chapters to display the Global Human Embryonic Stem Cells market

Chapter 1:: Definition, Specifications and Classification of Human Embryonic Stem Cells , Applications of Human Embryonic Stem Cells , Market Segment by Regions;Chapter 2:: Manufacturing Cost Structure, Raw Material, and Suppliers, Manufacturing Process, Industry Chain Structure;Chapter 3:: Technical Data and Manufacturing Plants Analysis of Human Embryonic Stem Cells, Capacity and Commercial Production Date, Manufacturing Plants Distribution, R&D Status and Technology Source, Raw Materials Sources Analysis;Chapter 4:: Overall Market Analysis, Capacity Analysis (Company Segment), Sales Analysis (Company Segment), Sales Price Analysis (Company Segment);Chapter 5 and 6:: Regional Market Analysis that includes the United States, China, Europe, Japan, Korea & Taiwan, Human Embryonic Stem Cells Segment Market Analysis (by Type);Chapter 7 and 8:: The Human Embryonic Stem Cells Segment Market Analysis (by Application) Major Manufacturers Analysis of Human Embryonic Stem Cells ;Chapter 9:: Market Trend Analysis, Regional Market Trend, Market Trend by Product Type Light Barrier Technology, Lenticular Lens Technology Human Embryonic Stem Cells, Market Trend by Application- Research, Clinical Trials;Chapter 10:: Regional Marketing Type Analysis, International Trade Type Analysis, Supply Chain Analysis;Chapter 11:: The Consumers Analysis of Global Human Embryonic Stem Cells ;Chapter 12:: Human Embryonic Stem Cells Research Findings and Conclusion, Appendix, methodology and data source;Chapter 13, 14, and 15:: Human Embryonic Stem Cells sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix, and data source.

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Should scientists be allowed to grow human embryos in a dish beyond 14 days? Is it scientifically important or morally wrong? – USA TODAY

For more than 30years, scientists have followed a rule they imposed on themselves to avoid growing a human embryo in a lab dish for more than 14 days.

Until recently, the "14-day rule" was largely academic. Scientists couldn't grow themfor that long if they wanted to.

But in 2016, two teams of researchers reached 12days, and in 2019, another group grew monkey embryos for 19 days.

These advances have spurredsome scientists to argue in two recent papersthat the 14-day rule should bemodified or dropped. There's a lot to be learned by pushing embryos out to 28 days, they say.

The regulatory committee of theInternational Society for Stem Cell Research, which lays down guidelines for the scientificfield,has been debating the issuefor months and is expected to issue its final decision this month.

Some ethicists and scientistsare concerned that revising the rule just asit becomes technologically feasible to break it is ridiculous and morally repugnant.

"If you abandoned every rule or law that inhibits you as soon as it inhibits you, we'd live in a lawless world," said Ben Hurlbut, a historian of science at Arizona State University.

And somepeople consider human embryo researchto be unethical at any stage.

"Whether 14 days, 14 months, or anywhere in between, such 'rules'remain contrivances to justify the most unethical kinds of science and to allow for the exploitation of our own vulnerable human offspring," said Tadeusz Pacholczyk, a neuroscientist and director of education at the National Catholic Bioethics Center in Philadelphia.

A single cell is removed from a human embryo to be used in generating embryonic stem cells for scientific research.Advanced Cell Technology via AP

Countries are free to ignore rules set by the society, but scientists for decades have generally abided by them. (In the U.S., there's no national law about the 14-day rule, though some states have their own regulations.)

Some cultures and religions believe that human life begins at conception, or that the human embryo carries a special status from conception onward. Other cultures believe that life starts later in fetal development, or even at birth.

Biologists routinely grow amphibian and mammal embryos in petri dishes, but human embryos are different.

Until about 14 days after conception, the human embryo looks likean undifferentiated blob of cells, which is one of the reasons the two week timeframemade sense, several scientists said.

Robin Lovell-Badge, who sits on the International Stem Cell Society committee that's considering overturning the rule, said scientists will take any changes seriously.

"We've stuck with that rule for over 30 years," he said.

Lovell-Badgefavors extending the limit, as long as the research is scientifically justified and has public support.

Not everyone in the scientific community shares this position.

"It's been a difficult part of the guidelines to get agreement on," Lovell-Badge said. "You have very wide-ranging views."

Some scientists argue there's a lot to be learned by pushing the 14-day rule out another two weeks.

Right now the second two weeks after fertilization is considered a "black box" because so little is known about it, said Insoo Hyun, a professor of bioethics atCase Western and Harvard universities. Heco-wrote a March 5 opinion piece arguing for a careful, stepwiseextension of the 14-day rule.

"You have to really make your case for it,"Hyun said."You have to explain what you want to do and why, have a very clear picture of where the next stopping point is."

Women generally don't know they're pregnant before 28 days, so historically, there has not been tissue from aborted or miscarried fetuses available for research.

The central nervous system, heart and other organs begin to develop during this crucial two-week period. The body plan is established. Cells that will become eggs and sperm start to form. Aspects of theplacenta are set up.

In many ways,days 14 through28 are the most interesting period of human development, Lovell-Badge said. "You can do a whole lot of incredibly valuable research," in that timeframe, he said.

And it's in that window that many things can go wrong in a pregnancy, such as miscarriage or abnormalities.

Perhaps there are treatments that could be developed to fix these problems, if they are better understood,Hyunsaid, just as pregnant women now take vitamin supplements to prevent spina bifida, in which the spine doesn't developproperly.

Do you think scientists should be allowed to grow embryos in a dish beyond 14 days? Share this story.

Developing embryos for another week "will thus illuminate this poorly understood period of our development and bring greater understanding of pregnancy loss and developmental disease,"saidMagdalenaZernicka-Goetz,theBritish scientist who developed the technique for growing human embryos for nearly two weeks.Zernicka-Goetz,author of a 2020 book on human development called "The Dance of Life,"would like to extend the 14-day rule out one week to 21 days.

"This will enable thescientiststo study a period of development that are highly susceptible to developmental failure, something that happens quite frequently in human pregnancy," she wrote in an email, stressing work should be closely regulated"to achieve these potential biomedical advances within an appropriate bi-ethical framework."

Despite their differences, most scientists seem to agreethere's no reason to push development past 28 days.

By onemonth after conception, embryonic tissue is easier to obtain and study and theorgans have formed, leaving fewer questions to answer.

"You wouldn't need to take them much beyond that point anyway," Lovell-Badgesaid.

Pacholczyk, of the Catholic Bioethics Center, said there's simply no justification for 14 days or any other time limit.

"Researchers have been feigning for a long time that the 14-day rule was somehow an ethical tenet grounded in biological facts while in reality it has been little more than a ceremonial 'line in the sand' and it should come as little surprise that they are now seeking to move that line beyond 14 days," he wrote in an email.

Even some who strongly supportscientific research are uncomfortable extending the 14-day rule.

HenryGreely, who directs the Stanford Center for Law and the Biosciences at Stanford University in California, saidthere should be a hard-stop endpointfor embryo research.

"Even though I do not personally give strong moral status to embryos, the idea of doing research on 18-day-oldhuman embryos is disturbing," said Greely, author of the new book "CRISPR People: The Science and Ethics of Editing Humans."

This sequence of images shows the development of embryos after correcting for a genetic error that would otherwise cause a type of inherited heart disease.OHSU

"I'd like to see an endpoint that had some rationale that would make it likely to stick," he said.

Growing an embryo in a lab dish instead of a woman's womb is necessarily different, Greely said, and may not represent a "real" embryo anyway.

"Does a 14-day embryo that is not implanted deep in a woman's uterus tell us anything meaningful about a 14-day embryo that is?" he asked.

Marcy Darnovsky, executive director of the Center for Genetics and Society, a nonprofit advocacy group,said efforts to overturn the 14-day rule are another example of scientific over-reach.

"There's a real problem with scientists who are jumping ahead of the public," she said.

Scientists should not be the ones who get to decide where society's moral boundaries lie,she and Hurlbut said.

"If moves are made to usurp these questions from wider society," Hurlbut said, "it's to the detriment of democracy and to the detriment of sciencecertainly in the long run, and probably in the short run."

Contact Karen Weintraub at kweintraub@usatoday.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

Published10:13 am UTC May. 2, 2021Updated10:13 am UTC May. 2, 2021

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Should scientists be allowed to grow human embryos in a dish beyond 14 days? Is it scientifically important or morally wrong? - USA TODAY

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Brave New World is being reinvented with synthetic embryosand the right reasons – SYFY WIRE

In his 1932 novel Brave New World, Aldous Huxley walks you into a terrifying lab where human embryos and fetuses are being grown in glass containers and genetically engineered to fit into a certain rank of society. It continues to be nightmare fuel for college students everywhere.

Now that we live in an era where science fiction is morphing into science, conceiving artificial embryos sounds like an incarnation of the bookbut couldnt be further from it. Scientists have proven it is possible to synthetically create embryos from stem cells. This is a viable and ethical alternative to studying human or animal embryos, and a new frontier in finding out more about how preimplantation embryos may mutate or fail.

Instead of trying to build a societal hierarchy from human beings born in vitro, researchers Cody Kime, Kiichiro Tomoda and their team from Kyoto University and the RIKEN Center for Biosystems Dynamics Research are using their findings in an effort to find out what can go wrong with embryos in their earliest phases and cause early pregnancy loss. They recently published a study inStem Cell Reportsandare optimistic that the glitches of nature can someday be prevented.

"As you can imagine, there is tremendous power, inevitable risk, and serious ethical responsibility, although using cultured cells we can greatly reduce animal experiments. Perhaps one of the best applications is screening genetic mutations that impede fertility and reproduction,"Kime told SYFY WIRE. "if those mutations are tolerated in our starting stem cell population, we can initiate reprogramming, and see how those mutations affect the synthetic embryo system. From there, we can get a better picture of how those genes may affect human fertility and improve on treatments."

If organoids (even the brain) can be grown for further research, so can embryoids. The team, whose in vitro synthetic embryo systems (SESs)came from mouse stem cells, was trying to successfully recreate totipotency, meaning that the cells would have everything they needed to develop into a whole organism. Totipotency does not last long in embryonic stem cells. Pluripotency, which is the ability to produce some types of necessary cells, but not all, is much easier to achieve. This is still a positive. If the stem cells are at least pluripotent, it might be possible to reprogram them to be totipotent.

There are three types of cells needed for totipotency to happen. They need to be able to generate the embryo, the placenta and the amniotic sac. This is such a fleeting state in mammals because the cells in the embryo multiply and polarize fast to turn into one of those three things.Kime and Tomoda didnt try to do everything at once. The team started by growing pluripotent mouse cells, or epiblast stem cells, responsible for only the fetus. Pluripotent pre-implantation epiblast stem cells are capable of arranging themselves into what at least looks like an embryo before it implants. If they could somehow hit the rewind button on those cells, they would revert them back to a stage before they specialized in just the fetus, the totipotent phase.

"We have seen evidence that something like totipotency may be happening in our reprogramming system, and it arises by taking a later stage embryonic stem cell and treating it with specific natural molecules and nutrients," Kime said."In a way the cell is tricked to reprogram and gain the ability to form the other embryonic lineages."

Reprogramming meant that the scientists would need to be able to tell which genes each cell turned on oroff. They used a process called RNA sequencing, which sees how much RNA is and how many sequences of that RNA is in a sample. RNA (ribonucleic acid) tells DNA how to put together different proteins. Sequencing reveals its transcriptome, or everything that makes up RNA, and allows scientists to better understand cells up close. They observed the gene expression in thousands of cells, which told themwhich cells could be potentially reprogrammed to become totipotent. Hi-res regulation of gene expression could even show what ways cells were changing.It took Kime 5 days of reprogramming attempts, but some of the past epiblast stem cells (EPISCs) finally got there.

The analysis revealed that cells resembling all three types of the early embryo were generated by our unique reprogramming system at the same time," he said. "Our analysis showed, in great detail, that our reprogrammed cells had engaged nearly all early embryo cells, while turning off the genes of the cell type they came from. The most important analysis was comparing our reprogrammed cells to real embryonic cells and finding that, across incredibly rich data, our cells were nearly identical."

The breakthrough has given Kime, Tomoda and their team a portal into what was once unthinkable. Because epiblast stem cells are easily reproduced, they can carry out studies on a much larger scale. They will also be able to explore things that would have not been considered ethical otherwise, such as getting a more in-depth look at how reprogramming happens and screening for gene mutations and other things that could cause a pregnancy to terminate itself. So while their work may be venturing into a brave new world, the intent is the total opposite of the sinister motives in Brave New World.

Whether strawberry ice cream soma will ever be a thing still remains to be seen.

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Brave New World is being reinvented with synthetic embryosand the right reasons - SYFY WIRE

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Of Mice and Men, Monkeys, and Pigs. The Ethics of Chimeric Research. – American Council on Science and Health

A chimera refers to a single organism with cells from different individuals, meaningtwo sets of DNA. This is not necessarily an abnormal state. For example, people undergoing bone marrow transplants will carry the DNA of the donor. Mothers are known to absorb cells of theirin uterochildren.

The findings on cellular communication hold promise for early human development, disease progression and aging, as well as organ transplantation and for testing therapeutics.Salk Institute

The chimeric manifestation that excites most horror is animal-human concoctions ostensibly created for research. One particularly troublingexperimentwas reported recently inCell. This one involved inserting human stem cells into 132 macaque embryos. Macaques are cute little monkeys one of the more human-like animals. Each embryo was examined for up to 19 days before they were terminated or died naturally. [1]

No clear hypothesis or research objectives were articulated other than creating successful monkey-human organisms.The researchers defended the study, claiming it wouldhelp researchers gain a clearer understanding of molecular pathways, allowing for them to continue to improve the integration of human cells into more suitable hosts

Other interested parties raised lots of promises and hopes,claiming, ex post facto:

The findings on cellular communication hold promise for early human development, disease progression and aging, as well as organ transplantation and for testing therapeutics.Salk Institute

Macaques carry disease.

According to theCDC, macaques can be dangerous, with the majority of macaques infected with theHerpes B virus.In fact, so dangerous are these animals that they are barred from import except for experimental use.

the consequences of symptomatic infection may be severe. Viral infection rapidly progresses to central loci in the spinal cord and, eventually, the brain. Of 24 known symptomatic patients whose cases were reviewed in 1992, 19 (79%) died.CDC

Practically, even if the macaque-human model worked, it would not be a viable basis to provide organs for human transplant, another putative goal of this research. So, one might ask, what were the researchers doing?

Ethics, Anyone?

Other scientists disagree with using the chimeric process altogether, noting these goals could be accomplished via less dangerous models. This includes using human embryonic stem cells, which would bemore ethical, suggesting these methods should be used to further research in the future.

Perhaps anticipating these concerns, the researchers of the monkey-chimera experiment took pains to enunciate the ethical dangers of their research, detailing the protective steps taken to assure ethical compliance. Although they tell us that they sought (unidentified) outside counsel and expertise and thankedStanford University Research Ethics Programforhelpful discussions and feedbackduringthe protocol review process,the precise steps undertaken remain obscure.

The responses from ethicists have been both muted and mixed. A report released last week by theNational Academies of Sciences, Engineering, and Medicinespecifically addressed concerns of human-monkey chimeras noting that, human nerve cells might enter animals brains and alter their mental capabilities and if so, there will be no logical point at which the research should be stopped, or it may not be possible later to institute policies to block research that could result in nonhuman animals with unacceptable human capabilities. Not surprisingly, perhaps, federally funding of such research in America is prohibited, barred under theDickey-Wicker Amendment[2].

ButbioethicistKaren Maschke of the Hastings Center in New York says she is satisfied that the work, which passed layers ofinstitutional review and drew on advice from two [unnamed] independent bioethicists, was performed responsibly.

All bioethics are local:

Perhaps not surprisingly, at least some of the ethical input for this research came from the Institute of Primate Translational Medicine and Kunming University of Science and Technology (IPTM, KUST), as the work was purportedlyperformedin China. Even though the research was reported and publicized by theSalk Institute,touting the efforts of the affiliated principal researcher, apparently it was funded almost entirely by five Chinese sources, including the Chinese government and one[almost defunct private] U.S. foundation.

Is there more to the story?

Actually, this wasnt the researchers first chimeric attempt. In 2017, they experimented with inserting humanpluripotent stem cellsintopig embryos 1,400 of them. That experiment, however ethically fraught, did have a definitepurpose. Porcine organs, being of similar size, shape, and biology to human organs, are amenable to human transplants. This was to be a step toward growing animals withorgans that are suitable for transplantation into humans. (Nature)

Sadly, that experiment flopped, dashing the hopes of the Salk researchers to engineer bespoke organs tailored to individual genetic human specifications. And so, apparently looking for a more successful or respectable outcome (and probably funding), the researchers went off in search of a more evolutionarily compatible, if less practically useful, animal model the macaque. Seemingly, they were happily funded by the Chinese, who are quite interested in genetic engineering research. And as they anticipated, the experimental results in the macaque-human model were somewhat better- if practically useless and potentially dangerous.

And what if the hybrid embryos grew into hybrid human monkeys?

Surely, all science, even the most abhorrent, may yield useful knowledge. The question we must pose and re-pose- is at what point do the dangers outweigh the benefits? Indeed, in this experiment, are there even benefits?

According to one expert, public bioethics in America often faces the powerful temptation to use and exploit the vulnerable in biomedical research to gain prestige, professional advancement, the promise of funding, as well as the noble pursuit of knowledge. [3]Sadly, it seems we are seeing the fulfillment of this admonition right before our eyes. And some ethicists now question how much DNA is required before the chimeric entity is declared human, or by what other rubric should this determination be made? [4] The upshot being that below some arbitrarily declared quantum of human stuff, research that would otherwise be prohibited in humans could continue.

In the days of COVID-19, trustin the medical and scientific community is especially crucial; alack of trust in the scientific community iscatastrophic. Scientists, scholars, and relevant authorities collectively wring their hands, trying to persuade the public to trust biomedical experts.But reading this article inCell,all I could think of is Robin CooksPandemic.-This episode should be the stuff of science-fiction. That it has crept into science-mainstream, proudly reported by so noble an institution as the Salk Institute, raises too many questions that should have us all worried.

[1]These monkey-human chimeras were allowed to live for 19 days, a feature rejected or outlawed in most countries. Many western countries have adopted the 14-day limit on embryo research where the embryo has to be destroyed by the fourteenth day. This rule was recommended in the U.K.'s1984 Warnock Reportin the early days ofIVF. In Australia, for example, under theProhibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006, it is illegal for scientists to allow the development of a human embryo outside the body of a woman for more than 14 days.

[2] None of the funds made available in this Act may be used for- research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero (b) For purposes of this section, the term `human embryo or embryos' includes any organism, not protected as a human subject that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

[3] O. Carter Snead,What it Means to be Human: The Case for the Body in Public Bioethics, Harvard University Press Hereis an audio discussion with the author from National Review

[4]Sorry Mate, Youre a MonkeyBioNews

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Of Mice and Men, Monkeys, and Pigs. The Ethics of Chimeric Research. - American Council on Science and Health

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