Category Archives: Stem Cell Research

A recent article in the journal Nature credits Stanford physician-neuroscientist Sergiu Pasca, MD, with blazing a trail toward a more profound understanding of early brain development, and of what can go wrong in the process, using a cell-based research innovation he named "assembloids."

In 2015, Pasca and his colleagues published a paper in Nature Methods describing a fascinating feat: His tinkering with induced pluripotent stem cells, or iPS cells -- former skin cells transformed so that they've acquired an almost magical capacity to generate all the tissues in the body -- had borne a three-dimensional product. From these "magic" iPS cells grew a complex conglomerate of cells capable of modeling specific organs.

Pasca's particular interest was in the brain, and in the experiments detailed in the study, his lab had caused human iPS cells to multiply and differentiate into small spherical clusters of brain tissue suspended in laboratory glassware.

These clusters recapitulated the architecture and physiology of the human cerebral cortex -- the outermost layer of brain tissue, critical to perception, cognition and action. Pasca named these clusters, which grew to several millimeters in diameter and contained millions of cells, "cortical spheroids." Today, researchers around the world are using similar methodology to create models, broadly known as "organoids," to study other parts of the human body.

Two years later, in a study published in Nature, Pasca upped the ante by, first, generating a second kind of neural spheroid -- this time, representative of a deeper part of the developing forebrain called the subpallium -- and, second, by growing this kind of spheroid in conjunction with cortical spheroids, in the same dish.

To the researchers' amazement, spheroids of both types fused together, with nerve cells from subpallial spheroids migrating and poking extensions into the cortical spheroids and establishing working connections with nerve cells of a different type in the latter spheroids, just as occurs in fetal development.

"It's amazing that these cells already self-organize and know what they need to do," Pasca marveled in "Brain Balls," an article I wrote for our magazine, Stanford Medicine, a few years ago.

Pasca sensibly dubbed the two-fused-spheroid combos "assembloids," the Nature recap notes.

But why stop at two? Pasca has since created three-element assembloids composed of spheroids representative of cerebral cortex, spinal cord and skeletal muscle in order to model the circuitry of voluntary movement. He's also shown that stimulating the "cerebral cortex" spheroid can result in contraction of the "muscle" spheroid. (This accomplishment was published in Cell in late 2020.) He has explored other assembloid combinations, as well, such as the fusing of cortical spheroids with spheroids representing the striatum, a brain structure implicated in regulating our movements and responses to rewarding and aversive stimuli.

Because each spheroid begins with skin cells, they can be grown on a personalized basis -- and can therefore be extracted from patients with neurological disorders known or suspected to spring from early developmental aberrations (such as autism or schizophrenia). The cells can then be used to create models to probe these disorders' molecular, cellular and circuit-based deviations from the pathways of normal brain development, allowing scientists to study the brain in way they could never do with a living patient.

From the Nature article:

Assembloids are now at the leading edge of stem-cell research. Scientists are using them to investigate early events in organ development as tools for studying not only psychiatric disorders, but other types of disease as well.

An assembloid is by no means a complete, working brain. But, the article notes, "Pasca stands by the aphorism that all models are wrong, and some are useful. 'There's been important progress in the field in a short period of time,' he says."

Photo courtesy of the Pasca laboratory

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Stanford neuroscientist's 'assembloids' pave the way for innovative brain research - Scope

StemExpress to use utilize the Thermo Fisher Accula rapid PCR testing system to provide event attendees with accurate results in 30 minutes.

Published: Oct. 5, 2021 at 1:33 PM MDT|Updated: 3 hours ago

SACRAMENTO, Calif., Oct. 5, 2021 /PRNewswire/ --StemExpress is proud to announce that they will be the official COVID-19 testing provider for 2021's Meeting on the Mesa, a hybrid event bringing together great minds in the cell and gene biotech sphere. It has partnered with Alliance for Regenerative Medicine to comply with the newly implemented California state COVID-19 vaccination and testing policy regarding gatherings with 1,000 or more attendees. This partnership will allow the vital in-person networking aspect of the event to commence while protecting the health and safety of participants and attendees.

In-person networking commences at the 2021 Cell and Gene Meeting on the Mesa with COVID-19 testing options provided by StemExpress.

As a leading global provider of human biospecimen products, StemExpress understands the incredible impact that Meeting on the Mesa has on the industry and has been a proud participant for many years. For over a decade, StemExpress has provided the cell and gene industry with vital research products and holds valued partnerships with many of this year's participants. As such, it understands the immense value that in-person networking provides and is excited to help bring this element back to the meeting safely and responsibly.

StemExpress has been a trusted provider of widescale COVID-19 testing solutions since early 2020 - providing testing for government agencies, public health departments, private sector organizations, and the public nationwide. For Meeting on the Mesa, StemExpress is offering convenient testing options for unvaccinated attendees and those traveling from outside of the country. Options will include take-home RT-PCR COVID Self-Testing Kits and on-site, rapid PCR testing for the duration of the event. The self-testing kit option allows attendees to test for COVID in the days leading up to the event for a seamless admission and the days following the event to confirm they haven't been exposed. The on-site rapid testing option utilizes the new Thermo Fisher Accula, offering in-person testing at the event with results in around 30 minutes. StemExpress is excited to bring these state-of-the-art COVID testing solutions to the frontlines of the Cell & Gene industry to allow for safe in-person connections.

The StemExpress partnership with Alliance for Regenerative Medicine seeks to empower the entire cell and gene industry with a long-awaited opportunity to return to traditional networking practices. It is well known that innovation doesn't exist in a vacuum - allowing great minds to come together is a sure way to spur scientific growth and advance cutting-edge research, giving hope for future cures.

Cell and Gene Meeting on the Mesa will take place October 12th, 2021, through October 14th, 2021, at Park Hyatt Aviara,7100 Aviara Resort Drive Carlsbad, CA 92011. To learn more about the event, please visit MeetingOnTheMesa.com.

For more information about COVID testing solutions for businesses and events, visit https://www.stemexpress.com/covid-19-testing/.

About StemExpress:

Founded in 2010 and headquartered in Sacramento, California, StemExpress is a leading global biospecimen provider of human primary cells, stem cells, bone marrow, cord blood, peripheral blood, and disease-state products. Its products are used for research and development, clinical trials, and commercial production of cell and gene therapies by academic, biotech, diagnostic, pharmaceutical, and contract research organizations (CRO's).

StemExpress has over a dozen global distribution partners and seven (7) brick-and-mortar cellular clinics in the United States, outfitted with GMP certified laboratories. StemExpress runs its own non-profit supporting STEM initiatives, college and high school internships, and women-led organizations. It is registered with the U.S. Food and Drug Administration (FDA) and is continuously expanding its network of healthcare partnerships, which currently includes over 50 hospitals in Europe and 3 US healthcare systems - encompassing 31 hospitals, 35 outpatient facilities, and over 200 individual practices and clinics.

StemExpress has been ranked by Inc. 500 as one of the fastest-growing companies in the U.S.

About the Alliance for Regenerative Medicine:

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 12-year history, ARM has become the voice of the sector, representing the interests of 400+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

Media Contact: Anthony Tucker, atucker@stemexpress.com

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StemExpress Partners with the Alliance for Regenerative Medicine to Provide COVID-19 Testing for the Cell and Gene Meeting on the Mesa - KKTV 11 News

The updated report on the Canine Stem Cell Therapy market gives a precise analysis of the value chain assessment for the review period of 2021 to 2027. The research includes an exhaustive evaluation of the administration of the key market companies and their revenue-generating business strategies adopted by them to drive sustainable business. The Service industry report further enlists the market shortcomings, stability, growth drivers, restraining factors, opportunities for the projected timeframe.

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LOVELAND, Colo. (CBS4) Some of the first Coloradans to get a third dose of the COVID-19 vaccine say they feel more protected than ever before from the deadly virus. Coloradans who are immunocompromised have been granted permission to get a third dose of the Pfizer or Moderna vaccines in order to increase the efficacy of the vaccines. Those considered healthy have not been granted authorization for so-called booster shots as of the posting of this article.

I have absolutely gotten the COVID vaccine. My first, my second and now my third, said Betsy Craig, a Northern Colorado resident living with Scleroderma.

Craig was diagnosed in 2005 with Scleroderma and was only given 18 months to survive. However, a stem cell transplant helped her regain longevity and a mostly normal lifestyle.

However, viruses ranging from the common flu to COVID-19 pose a real threat to her life.

Because of her weakened immune system, Craigs two doses of vaccine did not give her the roughly 95% efficacy which most vaccinated people with two doses have. So, the CDC and FDA approved people like Craig to receive a third dose of either the Moderna or Pfizer vaccine to increase their protection.

I called the third dose liquid gold, because to me it is. It is the closest thing to protection to keep me breathing, Craig told CBS4s Dillon Thomas.

Dr. Thomas Campbell, Chief Clinical Research Officer for UCHealth, said the vaccines are effective but will need boosters over time.

The primary series we currently do of two doses doesnt work well enough, Campbell said.

Campbell said, once approved by the FDA, vaccinated Americans will likely need to receive routine booster shots to continue to maintain high rates of immunity.

The Pfizer and Moderna vaccines can protect people up to 96%. Compared to the annual flu shot, which only protects people about 50% of the time from the flu, the vaccines are incredibly effective.

However, like other vaccines, they can lose strength over time. Tetanus shots need boosting every 10 years, while flu shots often need to be boosted every year.

Preliminary research shows the COVID-19 Pfizer and Moderna vaccines will likely need boosters every eight months.

Campbell said, currently, only the immunocompromised need their third doses of the vaccines.

Those individuals never achieve adequate immunity with just two doses. They need a third dose just to get to adequate immunity, Campbell said. That is in contrast to people who are otherwise healthy, they respond well to the two-dose series. But, we know from immerging data, the protection wains over time. This doesnt mean the vaccine doesnt work. It just means that it can work better if we give it a third dose.

When getting a third dose of vaccine Coloradans will not have to return to the place they received their initial doses. Experts say there wont be an issue with availability due to demand as we saw when the vaccines first surfaced.

Also, while highly recommended, it isnt required for people to get the same type of vaccine they did for the first two. Campbell said Pfizer and Moderna can be mixed over time if absolutely necessary.

While the FDA works on rolling out booster shots for regularly healthy people, Craig said she is thrilled to have more protection from the virus.

(Forgoing the third dose) is Russian roulette, and I am just not willing to play Russian roulette if I dont have to. It is just relief that I am not going to die if I get sick, Craig said.

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Coloradans Getting Third Dose Of COVID Vaccine Say They Feel More Protected Than Ever - CBS Denver

VANCOUVER, BC, Aug. 17, 2021 /PRNewswire/ -- The global 3D bioprinting market size is expected to reach USD 2,687.8 Million in 2027 at a CAGR of 20.7% during the forecast period, according to the recent report by Emergen Research. Rapid technological advancements in 3D bioprinters, increasing investment to accelerate research and development activities of bioprinters, and rising use of 3D bioprinters to develop biomaterials for drug research and regeneration of joints and ligaments are key factors expected to drive market revenue growth over the forecast period. In addition, numerous advantages of 3D bioprinting in organ reconstruction to treat various end-stage disorders is another key factor contributing to the revenue growth of the market.

3D bioprinting leverages techniques similar to additive manufacturing to mix up growth factors, cells, and biomaterials to create biomedical parts that can mimic natural tissue attributes. 3D bioprinting leverages layer-by-layer technique to add materials called as bioinks to create tissue-like structures that can be used in medical and tissue engineering procedures. Recent advancements in the technique has expanded its scope in drug design and development by creating target tissues and cells for drug research and testing. In addition, 3D bioprinters can be used to reconstruct tissues from any body part and this has further increased its applications for treating various severe and chronic disorders. Significant progress in tissue engineering and production of biomaterials have contributed considerably to the 3D bioprinting market growth.

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3D bioprinters have been extensively used in vaccine research during the COVID-19 pandemic. Bioprinting is widely being used in the development of regenerative medicines, stem cell therapies, drug research and therapies, and tissue and organ reconstruction. Increasing application of 3D bioprinting in cosmetic and pharmaceutical sector is also a key factor contributing to the revenue growth of the market going ahead. However, lack of skilled professionals and technical knowledge, high costs of 3D bioprinting, and limited access to advanced technologies in developing and underdeveloped countries are some key factors expected to restrain market growth to a significant extent over the forecast period.

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For the purpose of this report, Emergen Research has segmented the global 3D bioprinting market on the basis of technology, material, application, and region:

Technology Outlook (Revenue, USD Million; 2017-2027)

Material Outlook (Revenue, USD Million; 2017-2027)

Application Outlook (Revenue, USD Million; 2017-2027)

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Regional Outlook (Revenue, USD Million; 2017-2027)

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The Global Oncology Informatics Market size was valued at USD 4.62 Billion in 2019 and is anticipated to reach USD 8.01 Billion by 2027 at a CAGR of 7.1%. An increase in the awareness of the different types of treatment options for oncology will drive the demand for the oncology informatics market. The major driving factor is the rise in the prevalence of cancer and heavy investment by the government institutes and research organizations.

The Global Nerve Repair and Regeneration Market size was valued at USD 6.05 Billion in 2019 and is forecasted to reach USD 11.62 Billion by 2027 at a CAGR of 9.0%. The market is mainly driven by the rising geriatric population and the increasing prevalence of nerve injuries. The high incidence of neurological disorders among the growing population is expected to drive the Nerve Repair and Regeneration Market growth.

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3D Bioprinting Market Size to Reach USD 2,687.8 Million in 2027 | Increasing Use of 3D Bioprinters in Medical Procedures, Training and Testing Along...

Stem cells are those that don't have a specific purpose.

A stem cell is a cell in a living body with the potential to develop into different types of cells during the early stage. Most cells in a living organism are differentiated cells, meaning they are found in a specific organ and perform particular functions. Red blood cells, for example, are specifically designed to transport oxygen through the blood. Human beings start out as a single cell known as a zygote, which is a fertilized egg. The zygote undergoes cell division into two, then four, eight, sixteen, and so on. The cells begin to differentiate and specialize in specific functions in the body as the zygote develops. The cells that haven't acquired specific purpose are known as stem cells; they can replicate indefinitely unlike differentiated cells that begin to break down after replicating. Once a stem cell divides, it remains as a stem cell or turns into a differentiated cell. This makes them especially intriguing for scientific research.

There are two types of stem cells: embryonic and adult stem cells. Embryonic stem cells are derived from embryos developed through in vitro fertilization in a fertilization clinic. The fertilized eggs are then donated for research purpose with the consent of the donors. Embryonic stem cells develop into specialized cells as the embryo develops. Adult stem cells are found among differentiated cells in an organ or tissue. Their main functions are to repair and maintain the tissue. Unlike embryonic stem cells that are produced by the embryo, researchers are still trying to understand the source of adult stem cells.

Stem cells have three distinct properties regardless of their source; they replicate and renew themselves infinitely, they are unspecialized, and they give rise to differentiated cells. Unlike a nerve cell, blood cells, or muscle cells, stem cells can proliferate. Research conducted in laboratories have revealed that stem cells can yield millions of unspecialized cells with the properties of the parent stem cell.

The properties of stem cells make them excellent and intriguing candidates for research. The embryonic human stem cells provide information concerning the complex process that occurs during the development of life. The primary objective of the research is to understand how undifferentiated cells end up with specific functions. Human stem cells are used to test new drugs and observe how a human body would respond to the medication. Stem cells are also helping researchers study diseases such as cancer and diabetes and how they can be treated. The immediate potential application of stem cell research is the generation of tissues and cells that replace organs once destroyed or removed. A breakthrough would eliminate the dependency on organ transplant, but instead, patients would receive stem cells that would generate the organ. Preliminary research in rodents shows that transplanted stem cells from the bone marrow can generate heart muscle tissues and repair the heart. A bone marrow transplant is already being used as a treatment for some form of cancer in humans.

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What is Stem Cell Research? - WorldAtlas

The International Society for Stem Cell Research (ISSCR) today released updated guidelines for stem cell research and its translation to medicine.

Developed in response to recent scientific and clinical advances, the revised guidelines provide a series of detailed and practical recommendations that set out global standards for how these emerging technologies should be harnessed.

Stem cell research has huge potential it could help pave the way for new therapies for ailments ranging from Parkinsons disease to childhood kidney failure. But scientific advances in this field can present unique ethical and policy issues beyond that seen in other areas of medical research.

The science is advancing at breakneck pace. Just in the past couple of months, we have seen model human embryos grown from skin cells, and the creation of human-monkey embryos for use in research.

The ISSCR has long recognised the need to set clear ethical boundaries for stem cell research. Previous guidelines have provided advice on techniques such as the use of human embryos to create stem cells, and set the required standards when using these technologies to create new medicines.

They have also explicitly banned certain practices, such as reproductive cloning and the sale of unproven therapies that claim to be made of stem cells.

The 2021 guidelines an update on the previous version, released in 2016 aim to set standards for the many recent advances in stem cell and human embryo research. These include chimeric embryos containing cells from humans and other animals, organoids grown from stem cells to create tissue that resembles particular human organs, and models of human embryos arrangements of human cells that mimic the early stages of embryo development.

The guidelines contain a clear requirement for certain new stem cell research approaches only to be conducted after a specialised review process. This review should be independent of the researchers, and include community members as well as people with expertise in the relevant science, ethics and law.

This is beyond what is typically required by a university or research institute where medical research is conducted. Besides evaluating the merit of the proposed research, the new reviews should also consider whether there are alternative ways to do the research, the source of stem cells and how they were obtained, and the minimum time required to reach the research goals, particularly in relation to human embryo and related research.

Specialised review is not a new concept. The previous guidelines required it when researchers made stem cells from human embryos or sought to culture human embryos in the lab. But now researchers will now also be required to seek higher review when they create model embryos such as blastoids, or study the development of animal-human embryos in animal wombs.

Researchers developing new therapies for mitochondrial disease will also be required to seek higher-level review before attempting to transfer to the uterus of a woman human embryos in which affected mitochondria (a part of the cells energy-production apparatus) have been replaced.

Importantly, the revised guidelines also clearly rule out certain activities. These continue to include reproductive cloning and attempts to form a pregnancy in a woman from genetically edited human embryos or from model embryos made from stem cells. Prohibited activities also now include using eggs and sperm made from human stem cells for reproduction, or transferring a human-animal chimeric embryo into the uterus of a woman or an ape.

Read more: China's failed gene-edited baby experiment proves we're not ready for human embryo modification

The guidelines also call for a public conversation about whether we should allow limited lab research on human embryos beyond the existing limit of 14 days development. Historically, it has not been possible to support human embryonic development outside the body beyond this stage. However, recent advances in human embryo culture raise the possibility that this may now be technically feasible.

Extending the amount of time in culture - in terms of days - could potentially yield new treatments for developmental conditions or infertility, but will also raise concerns about whether possible benefits justify this research. Any decisions to overturn this long-held signpost would need to be carefully deliberated and take into consideration existing law, community values and discussion around what the new limit should be.

The revised guidelines also reinforce the need for informed consent for the collection of human material and participation in stem cell clinical trials, and reiterate that no new stem cell treatment should be made available before it is tested for safety and effectiveness in well-designed and publicly visible clinical trials. The ISSCR continues to condemn the commercial use of unproven stem cell treatments.

While stem cell science holds much promise, it is paramount that research is scientifically and ethically rigorous, with appropriate oversight, transparency and public accountability.

The fact these guidelines are driven by experts including stem cell scientists, doctors, ethicists, lawyers and industry representatives from across 14 countries indicates a deep sense of responsibility and integrity within the research community, and a desire to ensure science remains in step with community values.

However, these guidelines are recommendations, not laws.

Researchers will need to abide by their respective national or state regulations and ethical standards. Some countries already have regulatory frameworks that are consistent with the new recommendations. In other places there is no national guidance around laboratory and clinical stem cell research at all, or existing law touches on some but not all of the emerging applications of stem cell research.

Read more: As scientists move closer to making part human, part animal organisms, what are the concerns?

For example, in Australia there is already an established pathway for higher-level review of embryo models created from stem cells. However, the same legislation currently bans any attempt to use mitochondrial transfer techniques to create embryos for research or to achieve a pregnancy both of which are permissible under the new ISSCR guidelines.

Rather than attempting to impose a set of hard-and-fast rules on an ever-evolving research field, the new guidelines attempt to address emerging issues and drive important discussions at domestic level. Ultimately, it is the public and the regulators who will need to set the standards.

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New global guidelines for stem cell research aim to drive ...

The Federal Minister for Health and Aged Care, the Hon Greg Hunt, has announced$18.7 million in funding for the 2020 Stem Cell Mission, which focuses on research that develops and delivers innovative, safe and effective stem cell medicines to improve health outcomes.

Researchers from the University of Sydney have been awarded $6.3 million for three projects which will address blindness in adults, chronic heart failure, and help to improve decisions about access to stem cell interventions.

Deputy-Vice-Chancellor (Research), ProfessorDuncan Ivisoncelebrated the funding success.

This funding will allow our health and medical researchers to undertake important research for the benefit of many Australians and their families, through trials that use stem cell grown heart muscle in patients with no option end-stage heart failure," he said.

Medical Research Future Fund (MRFF) 2020 Stem Cell Mission grants awarded to Sydney researchers include:

The Stem Cell Mission is a priority of the Morrison Governments $20 billion Medical Research Future Fundand will provide $150 million towards research over 9 years.

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$6.3 million for ground-breaking stem cell research projects - News - The University of Sydney

For 40 years, research into early human development has been guided by the principle that after 14 days, an embryo should not be used for research and must be destroyed. This rule has been part of the law of more than 12 countries. But new guidelines released by the International Society for Stem Cell Research have removed this rule. This makes it possible to conduct research on human embryos that are at more advanced stages of development.

Now, countries must revise their laws, policies and guidelines to reflect this change. But first, public debate is crucial to determine the limits of what sort of research should be allowed.

Over the decades human embryo research has allowed us to understand normal and abnormal human development, as well as early genetic diseases and disorders. Studying human embryos, as the earliest forms of human life, can give us insight into why miscarriages occur, and how our complex body systems develop. Human embryos are also important for stem cell research, where researchers try and create cell-based therapies to treat human diseases.

Often, extra embryos are created during in vitro fertilisation procedures. These extra embryos may be donated for research. They are cultured (or grown) in a laboratory and can be studied until they reach day 14 post-creation.

The 14-day rule has served as an international standard since 1990 when it was included in the Human Fertilisation and Embryology Act in the UK. At the time that it was introduced, it was not possible to keep human embryos alive in a laboratory for more than a few days. However, scientists have been recently been able to keep embryos alive for longer periods, between 12 and 13 days. The ethical, legal and social consequences of such research were also important considerations.

Although the 14-day rule has been criticised as being arbitrarily decided, there are a number of reasons for the time frame.

After an egg cell is fertilised by a sperm cell, the resulting embryo consists of a few identical cells. Most embryos will implant in the uterus after the 14th day. After this point, the primitive streak appears, which is the first sign of an embryos developing nervous system. The rule also identified the point at which the embryo shows signs of individuation, because it is no longer possible for the embryo to split into twins after 14 days. Some people reason that due to these events, it is at this stage that a moral being comes into existence, and it would not be ethical to perform research on embryos after this time.

There has been increasing pressure from some researchers to remove the 14-day rule, or at least extend it, as it prevents critical research from being undertaken. Extending the rule would allow important research into early human development to be done. The new guidelines make it possible to do research on embryos older than 14 days if the approval processes of the relevant ethics committees are followed.

A significant problem, however, is that there is no longer any limit on the time frame for research. Would it be permissible to do research on human embryos that are 20 days old or 40 days old? The guidelines specify no limit. The longer a human embryo is allowed to grow, the more recognisably human it becomes. At what point would we regard the research unethical, and at what point does the moral cost outweigh the benefits of research?

Countries around the world take a variety of approaches to human embryo research. Some like Italy and Germany dont allow it at all. Others, like the UK, allow research to continue until the embryo is 14 days old, after which it must be destroyed. There are also some which permit embryo research without identifying a limit. Some, like the US, do not have any law regulating it (but there are guidelines which contain reference to the 14-day rule).

In South Africa, reference to the rule is found in the National Health Act (2003), which states that human embryo research may only be done with permission of the minister, and that the embryos must not be older than 14 days.

International guidelines are not legally binding. But the effect of the revised guidelines is that the international standard for best practice in scientific research has now changed. This means that countries which have implemented the rule in their laws will need to revise them so that they are in line with best practice in science.

Human embryo research is a sensitive topic because people are divided on the moral status of the human embryo. Some people believe that the embryo, as the earliest form of human life, should be protected and not subjected to research at all. Others believe that while an embryo has some moral status, it cannot be protected in the same way as humans are, and may be used for some important research which could ultimately benefit people.

The decision to discard the 14-rule appears to have been made without public input. That does not encourage the public to trust in science, and public engagement should have come before such an an important rule was changed.

There are a number of approaches to working with the revised guidance. Bioethicist Franoise Baylis has suggested that project-specific time limits should be identified, based on the minimum amount of time required to address the stated research objectives. This would mean that some research would still be subject to the 14-day limit, while other studies would be permitted to exceed it. Another approach would be to keep the 14-day limit as the norm, and consider applications to exceed it case by case. Or the limit could be extended to 28 days.

The coming conversations surrounding embryo research will prove to be very important. The proverbial genie is out of the bottle, and public debate is crucial.

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Limits for human embryo research have been changed: this calls for public debate - The Conversation CA

BOSTON, June 17, 2021 /PRNewswire/ -- Next week, June 21-26, stem cell biotechnology company Asymmetrex will participate as a presenter and an exhibitor in the 2021 Annual Meeting of the International Society for Stem Cell Research. In an invited poster presentation (#345) and a company exhibitor display, Asymmetrex will introduce the virtual gathering of international stem cell scientists, physicians, and biotechnologists to its new technology for evaluating the potency of therapeutic tissue stem cells.

Potency tests assure doctors that a medicine has good quality and will be effective for treatment. Although potency tests are common for drug medicines, developing them for stem cell treatments has been difficult. For stem cell treatments, no reliable potency tests have been available.

At the June 21-26, 2021 Annual Meeting of the International Society for Stem Cell Research, stem cell biotechnology company Asymmetrex will present data and examples for a new test for evaluation of the potency of tissue stem cell treatments. The technology, called kinetic stem cell (KSC) counting, can tell doctors the number of live tissue-renewing stem cells in a treatment sample.

The President & CEO of Asymmetrex, James L. Sherley, M.D., Ph.D., explains, "Stem cell medicine has needed a quality and effectiveness index like drug specific activity for pharmaceuticals. What could work better than knowing the number of live tissue stem cells that can restore other tissue cells? That's what our KSC counting TORTOISE TestTM platform can tell doctors: the number of live stem cells in a treatment that can renew an organ or tissue."

Asymmetrex is currently focused on conducting preclinical and clinical evaluations of how well its tissue stem cell-specific data indicate the effectiveness of stem cell treatments in different patients. In his company's presentations at ISSCR 2021, Sherley says that he will also introduce the immediate benefits of KSC counting to stem cell scientists for their tissue stem cell research. "It's a no brainer that now knowing how many tissue stem cells are in experiments will greatly improve stem cell researchand, as a consequence, stem cell medicine."

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA (ARMI) and the Massachusetts Biotechnology Council (MassBio).

Media Contact: James L Sherley, jsherley@asymmetrex.com

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SOURCE Asymmetrex, LLC

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Asymmetrex Will Present a New Test for Therapeutic Stem Cell Potency at the ISSCR 2021 Annual Meeting - BioSpace