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Stem cell therapy for COPD: Cost, effectiveness, and more – Medical News Today

Currently, the Food and Drug Administration (FDA) has not approved the use of stem cell therapy for the treatment of lung conditions, such as chronic obstructive pulmonary disease (COPD).

The American Lung Association says that this lack of approval is due to the fact that these treatments have high costs, unproven benefits, and the potential to cause harm.

COPD is a progressive, incurable disease that affects at least 16 million people in the United States. As current treatments cannot cure COPD, many people with this condition seek alternative therapies, such as stem cell therapy.

Keep reading to learn more about the potential for using stem cells to treat COPD, including cost, clinical trials, and more.

Stem cells are cells from either embryos or adults that can divide and renew. Although they are not specialized, they can become specialized and ultimately function as cells in various body parts.

Due to their regenerative power and ability to function as different types of cells, stem cells can help repair or replace damaged tissue. Scientists are interested in using stem cell therapy in the treatment of several chronic diseases.

However, most researchers and organizations state that there is not yet enough evidence of the effectiveness of stem cell therapy and knowledge about the long-term risks.

A recent summary of research showed that most human studies have indicated that there is little benefit to the therapy. The author notes that researchers need to understand more about many aspects of stem cell therapy, including:

In other words, more large scale studies must take place to prove or disprove stem cell therapys safety and effectiveness for the majority of people.

The American Lung Association joined many other organizations in signing a statement recommending against stem cell therapy for COPD. The concerns of these groups include:

However, stem cell therapy has shown some potential as a treatment option. According to the American Thoracic Society (ATS), the therapy has shown promise in animal studies. The ATS also notes that sufficient human studies are still lacking, so a person should avoid the therapy unless they are participating in a clinical trial.

The National Emphysema Foundation points out that people who have used unproven stem cell therapies are often willing to get further infusions, suggesting a positive experience.

Finally, the Regeneration Center of Thailand offers and supports the use of stem cell therapy to treat COPD and other lung diseases. However, to receive treatment, a person would need to travel to Thailand, adding to the costs of an already potentially expensive procedure.

As the FDA has not approved stem cell therapy for the treatment of COPD, a person will need to cover all of the costs on their own. They will also need to accept all of the risks associated with using an experimental treatment.

Medicare and private insurance companies will not help cover the costs. A person may not be able to use any healthcare savings account money for the procedure either.

Prices are likely to vary among clinics, very few of which, if any, list the treatment costs upfront. A company called DVC Stem offers stem cell therapy in the Cayman Islands and states that the average cost of treatment is between $10,000 and $35,000. It advises people interested in receiving stem cell therapy to join a clinical trial.

Clinical trials are controlled experiments in which researchers test a new treatment in a group of volunteers. The tests help researchers determine how well the treatment works, the possible side effects, and the ideal dosage, among other factors.

Clinical trials take place in phases, with each phase representing a level of confidence in the treatment. Clinical trials typically go through four phases:

A person interested in joining a stem cell therapy clinical trial should talk with their doctor first. The doctor can help determine whether they will be a good fit for a particular study and may be able to recommend a study based on their condition and health.

ClinicalTrials.gov offers people a way to search for clinical trials related to COPD and stem cell therapy. The listed trials are all approved and regulated for safety. The website lists information about the phase of the trial, who is eligible to participate, and other relevant information.

There is limited knowledge about the short- and long-term side effects of stem cell therapy. In other words, more studies are necessary for researchers to understand precisely how stem cell therapy may affect a person living with COPD.

Alternative or complementary therapies are treatments that fall outside the scope of conventional practice in U.S. medicine. People typically receive these therapies alongside conventional treatment to help support mental health, reduce side effects, and improve quality of life.

The American Thoracic Society states that people can try several alternative or complementary therapies for COPD. These include:

Stem cell therapy for COPD is currently not well-understood. Many researchers and organizations, including the American Lung Association, are concerned about the effectiveness and safety of the therapy.

A person can seek stem cell therapy from unapproved clinics, but the treatment often has high costs with no insurance coverage.

As a result, a better approach is to talk with a doctor about joining a registered clinical trial.

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Stem cell therapy for COPD: Cost, effectiveness, and more - Medical News Today

Stem Cell Therapy Global Market Report 2021: COVID-19 Growth And Change To 2030 – Yahoo Finance

Major players in the stem cell therapy market are Anterogen, JCR Pharmaceuticals, Medipost, Osiris Therapeutics, Pharmicell, Astellas Pharma, Cellectis, Celyad, Novadip Biosciences, and Gamida Cell.

New York, April 27, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Stem Cell Therapy Global Market Report 2021: COVID-19 Growth And Change To 2030" - https://www.reportlinker.com/p06064499/?utm_source=GNW

The global stem cell therapy market is expected to grow from $8.62 billion in 2020 to $10.2 billion in 2021 at a compound annual growth rate (CAGR) of 18.3%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $20.87 billion in 2025 at a CAGR of 20%.

The stem cell therapy market consists of the sales of stem cell therapy and related services by entities (organizations, sole traders, and partnerships) that provide stem cell therapy.Stem cell therapy, also known as regenerative medicine, promotes the repair response of diseased patient, dysfunctional or injured tissue using stem cells or their derivatives.

Only goods and services traded between entities or sold to end consumers are included.

The stem cell therapy market covered in this report is segmented by type into allogeneic stem cell therapy, autologous stem cell therapy. It is also segmented by cell source into adult stem cells, induced pluripotent stem cells, embryonic stem cells, by application into musculoskeletal disorders, wounds and injuries, cancer, autoimmune disorders, others, and by end-user into hospitals, clinics.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The high cost of stem cell therapy is expected to limit the growth of the stem cell therapy market.The pressure to contain costs and demonstrate value is widespread.

Political uncertainty and persistent economic stress in numerous countries are calling into question the sustainability of public health care funding.In less wealthy countries, the lack of cost-effective therapies for chronic diseases has impacted the health conditions of the population and has led to a low average life expectancy.

According to the DVCSTEM, the average cost of stem cell therapy in the USA is between $20,000 to $25,000, in Mexico, it is $33,000, in Central America, it is $30,000, and in Asia, it is $50,000, thus restraining the growth of the market.

In September 2019, Vertex Pharmaceuticals Inc, a US-based biopharmaceutical company, announced its decision to acquire Semma Therapeutics, a private biotechnology company, for $950 million.The acquisition is expected to align with Vertexs strategy of investing in scientific innovation that creates transformative medicine for patients with serious diseases.

Semma Therapeutics is a US-based company that is involved in using stem cell therapy for diabetes treatment.

The rising prevalence of chronic diseases contributed to the growth of the stem cell therapy market.Long working hours, limited physical activity, and unhealthy eating and drinking habits contribute to the prevalence of chronic diseases among people, thus driving the need for stem cell therapy.

According to a United Nations article, by 2030, the proportion of global deaths due to chronic diseases is expected to increase to 70% of total deaths.The global burden of chronic diseases is expected to reach about 60%.

The rising prevalence of chronic diseases is expected to drive the stem cell therapy market.

The companies in the stem cell therapy market are increasingly investing in strategic partnerships.The strategic partnership is a mutually beneficial agreement between two companies that do not compete directly with each other.

For instance, in September 2018, CRISPR Therapeutics, a biotechnology company that develops transformative medicine using the gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated for the development and commercialization of allogeneic stem cell therapies for diabetes treatment.

The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. Read the full report: https://www.reportlinker.com/p06064499/?utm_source=GNW

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

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Stem Cell Therapy Global Market Report 2021: COVID-19 Growth And Change To 2030 - Yahoo Finance

Thomas Smeenk on Hemostemix’s autologous stem cell therapy technology and why some call it ‘the fountain of youth’ – InvestorIntel

In a recent InvestorIntel interview, Tracy Weslosky spoke with Thomas Smeenk, Co-Founder, President and CEO of Hemostemix Inc. (TSXV: HEM | OTC: HMTXF), about Hemostemixs autologous stem cell therapy and why he calls the technology the fountain of youth.

In this InvestorIntel interview, which may also be viewed on YouTube (click here to subscribe to the InvestorIntel Channel), Thomas went on to say that Hemostemixs lead product ACP-01 works by treating ischemia (lack of blood circulation) in a patients body. The technology has already been used to treat around 500 patients suffering from ischemia in the heart, arteries, and limb. He added that using the technology many patients were able to save their limbs from otherwise certain amputations. Hemostemix has 91 patents including a patent on the automation of production which enables the company to scale the business exponentially as over a million patients lose their limbs to amputation in North America alone. The technology is now in Phase 2 clinical trial.

To watch the full interview,click here

About Hemostemix Inc.

Hemostemix is a publicly traded autologous stem cell therapy company. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat over 300 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation.

On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract entitled Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy.

To know more about Hemostemix Inc.,click here

Disclaimer:Hemostemix Inc. is an advertorial member of InvestorIntel Corp.

Thisinterview, which was produced by InvestorIntel Corp. (IIC)does not contain, nor does it purport to contain, a summary of all the material information concerning theCompany being interviewed. IIC offers no representations or warranties that any of the information contained in this interview is accurate or complete.

This presentationmay containforward-looking statements within the meaning ofapplicable Canadian securities legislation.Forward-looking statements are based on the opinions and assumptions of managementof the Companyas of the date made. Theyare inherently susceptible to uncertainty and other factors that could cause actual events/results to differ materially from these forward-looking statements.Additional risks and uncertainties, including those that the Company does not know about now or that it currently deems immaterial, may also adversely affect the Companys business or any investment therein.

Anyprojectionsgivenare principally intended for use as objectives and are not intended, and should not be taken, as assurances that the projected results will be obtained by the Company.The assumptions used may not prove to be accurateanda potential decline in the Companys financial condition or results of operations may negatively impact the value of its securities. Prospectiveinvestors are urged to review the Companys profile onwww.Sedar.comand to carry out independent investigations in order to determine their interest in investing in the Company.

If you have any questions surrounding the content of this interview, please emailinfo@investorintel.com.

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Thomas Smeenk on Hemostemix's autologous stem cell therapy technology and why some call it 'the fountain of youth' - InvestorIntel

Mesoblast says its stem cell treatment saved lives of severely ill COVID patients – Stockhead

Mesoblast (ASX:MSB) has released more data from its halted COVID-19 trial, saying its stem cell treatment apparently significantly reduced mortality in severely ill younger patients but the controversial biotech isnt sure it will seek an emergency use authorisation for it.

Mesoblasts remestemcel-L infusion reduced death by 46 per cent in ventilator-dependent patients under age 65, but not in patients 65 and older, the study indicated. When remestemcel-L was combined with the anti-inflammatory medication dexamethasone, it appeared to cut mortality by 75 per cent, compared to when dexamethasone was used alone.

An independent committee stopped the US trial in December after 222 patients had been enrolled, rather than the 300 planned, because the data monitoring board judged the study was unlikely to meet its primary endpoint of a 43 per cent reduction in death at 30 days.

Mesoblast shares plunged by more than a third on the news, and have declined further in the past few months, yesterday closing at a one-year low of $1.83.

At 10.18am this morning, Mesoblast shares were up 10.9 per cent to $2.03, still down significantly from over $5 in September.

On a conference call with analysts this morning, Mesoblast chief executive Dr Silviu Itescu called reduction in mortality exciting and very important and said that perhaps a different dosing regimen might be more effective in older patients, whom he noted have more comorbidities (health problems).

Itescu and chief medical officer Dr Fred Grossman said the company was still in discussions with the FDA about using remestemcel-L to treat graft-versus-host disease in children, a complication of bone marrow transplants.

But Itescu said it was too early to say whether Mesoblast would seek an emergency use authorisation with the FDA for using remestemcel-L as a COVID-19 treatment.

As noted, this study was stopped before its completion, and the signal detection work that weve done has been something thats very very important, and significant enough to warrant these discussions with the FDA for suitable paths forward, Dr Grossman said.

Theres no COVID-19 treatment that substantially reduces mortality, he said.

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Mesoblast says its stem cell treatment saved lives of severely ill COVID patients - Stockhead

Antiviral T cells protected, viable as off-the-shelf treatment for painful complication stem cells – Microbioz India

Infusion of T cells targeting BKV resulted in rapid responses, with 67.7% of patients seeing a complete or partial improvement in symptoms after 14 days. This increased to 81.6% of patients after 28 days post-infusion. No cases of grade 3 or grade 4 graft versus host disease (GVHD) or other infusion-related toxicities occurred.

Addressing a painful complication caused by BKV

BKV-associated hemorrhagic cystitis is an incredibly painful condition that causes significant morbidity in patients and can lead to worse cancer outcomes in the long term. Unfortunately, there are no effective treatments available. We were driven to develop this therapy to provide a better option for these patients, and this has emerged as a safe and effective therapy for patients at MD Anderson based on these results.

Katy Rezvani, M.D., Ph.D., Corresponding Author, Professor of Stem Cell Transplantation and Cellular Therapy

BKV is a human polyomavirus acquired by most people in early youth, Rezvani explained. Held in check by the immune system, BKV typically stays dormant in the cells lining the urinary tract, including the kidney, liver, bladder and ureters.

Allogeneic stem cell transplants, where stem cells come from a matched donor, require patients to be given therapies to suppress the immune system and protect against rejection. However, this can also trigger the BKV to start reproducing and cause severe cystitis, which could lead to hospitalization for days or months. An antiviral called cidofovir was used as a treatment but is associated with significant toxicities.

Recognizing that these viral infections can profoundly impact patient healing, Rezvani and her research team directed the development of antiviral T-cell therapies with the support of the MDS and AML Moon Shot, part of the institutions Moon Shots Program, a collaborative effort to quickly develop scientific discoveries into meaningful clinical improvements that save patients lives.

Starting with blood samples taken from healthy donors, the study team can isolate T cells and grow them to specifically recognize and target an assortment of antigens located on the BKV. These cells are expanded in the clinical good manufacturing practice (GMP) lab, under the direction of Elizabeth J. Shpall, M.D., professor of Stem Cell Transplantation and Cellular Therapy. From every donor, the team can fabricate anywhere from 20 to 50 doses of antiviral T cells, which can be stored until needed, Rezvani said.

In an earlier trial published in the New England Journal of Medicine, these researchers showed that BKV-specific T cells may effectively treat disease with the JC virus, a genetically similar polyomavirus which causes progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal brain infection.

BKV-specific T cells get positive results in trial The current trial enrolled a total of 59 MD Anderson patients experiencing BKV-HC after an allogeneic stem cell transplant. Women accounted for 40.7% of participants and men for 59.3%.

Patients received a single infusion of partially human leukocyte antigen (HLA)-matched T cells, with the option to get additional infusions every 2 weeks, if necessary.

Following infusion, the researchers did not observe any side effects which were probably attributed to the antiviral T cells. Several patients developed delayed cases of low-grade GVHD in the weeks and months after therapy, which were well within the expected rates of GVHD for these patients early after allogeneic stem cell transplant, Rezvani explained.

The median time for patients to have a partial response was 14 days, and the median time to complete response was 21 days. The estimated probability of achieving a complete response was almost 70% by day 45, indicating continuous activity of the infused cells. Responses were durable and no patients saw their symptoms return after a formerly achieved response.

After analyzing participants on the trial, the researchers determined that expansion of the infused T was positively correlated with individual responses.

Were extremely encouraged by the safety of the treatment and the fast answers we have seen in the vast majority of patients, Rezvani said. Because this method is so safe, we have been able to provide this therapy as an outpatient procedure as soon as patients start developing symptoms. This has been life-changing for the patients weve been able to treat thus far.

Ultimately, the researchers aim to validate these findings at a multi-institutional research and bring this treatment option to many more patients in need.

A complete list of cooperating authors and their disclosures are available with the full paper here. In addition to the Moon Shots Program, the study was supported by the National Institutes of Health (R01CA211044-05, CA016672).

Source:

Journal reference:

Olson, Z.,et al.(2021) Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation.Journal of Clinical Oncology.doi.org/10.1200/JCO.20.02608.

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Antiviral T cells protected, viable as off-the-shelf treatment for painful complication stem cells - Microbioz India

Investigating CAR T-Cell Therapy for Use in Different Disease Types – Targeted Oncology

Michael Bishop, MD, a professor of medicine and director of Hematopoietic Stem Cell Transplantation Program at The University of Chicago Medicine, discusses the investigations of and responses to chimeric antigen receptor (CAR) T-cell therapy in different disease types.

One of the settings furthest along in exploring the use of CAR T cells is non-Hodgkin lymphoma, with about 40% to 50% patients are achieving sustainable complete responses with CAR T-cell therapy. There are still significant areas that can be improved upon for this patient population, according to Bishop.

Another disease type where there is potential opportunity to use CAR T cells is acute lymphoblastic leukemia. Bishop says there has been success for children in this setting, and now there is study for adults that will be reporting out soon called the ZUMA-3 trial (NCT02614066), which investigated brexucabtagene autoleucel (KTE-X19). Other studies are looking at the use of allogeneic CAR T-cell therapy in patients with acute lymphoblastic leukemia.

There are also trials in multiple myeloma looking at CAR T-cell therapy. Bishop feels the results for this patient population appear to be very exciting, with higher and more sustained complete response rates, and there is an opportunity to further improve upon those results.

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Investigating CAR T-Cell Therapy for Use in Different Disease Types - Targeted Oncology

Hope, hype and exploitation the wild history of stem cell science – ABC News

Stem cells and regenerative medicine have been heralded since the mid-20th Century as the best hope for curing countless physical ailments.

Decades later, there have been perhaps as many scandals in this field of medicine, as there have been genuine advances in research and application; and the full potential of stem cells is yet to be realised.

Physician-scientist Professor John Rasko de-mystifies the science by sharing stories of some of the field's most influential and infamous figures.

He also explains why there's still plenty of reason to be hopeful.

Flesh Made New: The Unnatural History and Broken Promise of Stem Cells by John Rasko and Carl Power is published by Harper Collins

Professor John Rasko is the Head of Department of Cell and Molecular Therapies at Royal Prince Alfred Hospital, and the Gene and Stem Cell Therapy Program at the centenary Institute, University of Sydney

John is a featured guest of Griffith University's Integrity 20

Listen to John's 2018 Boyer Lectures

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Hope, hype and exploitation the wild history of stem cell science - ABC News

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

Human blastocyst, Getty Images

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.

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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.

Published 10:13 am UTC May. 2, 2021 Updated 10:13 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

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

Stem Cell Therapy Market Trends Evaluation 2021 By Leading Players Updates, Consumer-Demand, Key Strategies, Consumption, Industry Development, Market…

The report offers information on the variety of products and services provided in the market, covering a multitude of operations and activities throughout the global Stem Cell Therapy market value chain. The study analyzes the world Stem Cell Therapy market in terms of production, income, sectoral structure, and export and trade activities. Moreover, technological tendencies in the global Stem Cell Therapy market have been put forward. The growth rate of the market in developed countries like Mexico, Brazil, Argentina, Australia, the EU, Canada, the USA, and in developing countries like India and China is studied in detail. The most important technological advancements in the market are presented in the study.

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Report Introduction:

The report shows market-driven results providing feasibility studies for client requirements. The research covers qualified and verifiable aspects of the global Stem Cell Therapy market. The client requirements are ensured by providing a thorough understanding of market capacities in the real-time scenario. The report examines the profiles of prominent market players, highlighting ratio, capacity, production, revenue, and consumption in terms of geographical areas. The research report has used the numbers and figures in a comprehensive manner with the help of graphical and pictorial representation which represents more clarity on the market.

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Points Covered in the Report

1. Economic and trade-related activities in the global Stem Cell Therapy market. 2. Changes in production systems over the years. 3. The future of the global Stem Cell Therapy market, trends, and challenges. 4. Productivity growth constraints. 5. The shift in consumer preferences and key factors changing the market dynamics. 6. Current and anticipated market size and CAGR in USD billion. 7. Key features and growth rate of the global Stem Cell Therapy industry worldwide. 8. Macro outlook and industry outlook. 9. Market landscape pertaining to the global Stem Cell Therapy market selected countries. 10. Trade scenarios, major export destinations, major countries of import. 11. Digital initiatives by the leading players for capacity building and boosting operational efficiency. 12. Quality, serviceability, financial, policy-related, capacity building constraints associated with the unorganized manufacturers in the market. 13. The report summarizes export opportunities in selected markets.

Stem Cell Therapy Market Analysis by Key Segmentations

By type, Stem Cell Therapy Market is segmented as:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

By Applications, Stem Cell Therapy Market is segmented as:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal Disorders Wounds & Injuries Cardiovascular Diseases Gastrointestinal Diseases Immune System Diseases Other Applications

The international trade, investment, and export promotional strategies implemented by the industrialists, traders, and investors to strengthen the global economic competitiveness are included in the report. The knowledge on these developments given in the report unlocks export and investment opportunities for the stakeholder and other participants in the industry. Quantitative and qualitative analysis to combine the results is done. This study groups the export markets for the products and services in the global Stem Cell Therapy market into three categories: Strategic, Dynamic Growth, and Long-Term Opportunity.

These export markets are ranked based on the criteria including volume ranking, growth ranking, and performance ranking. The volume ranking ranks the global export markets by dollar value, highest to lowest whereas the growth ranking is based on the averaging the Compound Annual Growth Rate (CAGR) of these markets for the years 2010-2015 and 2016-2020. The CAGR of the years 2016-2020 is included to capture the more recent developments. And, performance ranking globally is based on the exports of the main categories. The global commodity prices and the other factors influencing the corresponding categories are taken into consideration. The major driving powers of technological trends such as market, manufacturers, and legislation are studied in detail.

The gist of the report highlights is as follows:

1. This report covers a comprehensive market overview presenting the competitive market scenario among key players, understanding their growth opportunities, and business strategies 2. The factors contributing to the growth, market risks, growth restraining factors are analyzed in this report to help other players in making an informed decision 3. The five-year forecast information will pave the way for futuristic developments and expected market growth 4. A thorough analysis of key Stem Cell Therapy product segments, changing market dynamics will lead to complete market study 5. This research study serves as a complete guide which provides valuable insights and in-depth analysis of various industry verticals

TOC of Stem Cell Therapy Market Report Includes:

1. Industry Overview of Stem Cell Therapy 2. Industry Chain Analysis of Stem Cell Therapy 3. Manufacturing Technology of Stem Cell Therapy 4. Major Manufacturers Analysis of Stem Cell Therapy 5. Global Productions, Revenue and Price Analysis of Stem Cell Therapy by Regions, Creators, Types and Applications 6. Global and Foremost Regions Capacity, Production, Revenue and Growth Rate of Stem Cell Therapy 2015-2020 7. Consumption Volumes, Consumption Value, Import, Export and Trade Price Study of Stem Cell Therapy by Regions 8. Gross and Gross Margin Examination of Stem Cell Therapy 9. Marketing Traders or Distributor Examination of Stem Cell Therapy 10. Worldwide Impacts on Stem Cell Therapy Industry 11. Development Trend Analysis of Stem Cell Therapy 12. Contact information of Stem Cell Therapy 13. New Project Investment Feasibility Analysis of Stem Cell Therapy 14. Conclusion of the Global Stem Cell Therapy Industry 2020 Market Research Report Continued

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Stem Cell Therapy Market Trends Evaluation 2021 By Leading Players Updates, Consumer-Demand, Key Strategies, Consumption, Industry Development, Market...