She was on a tropical vacation when she received a text message: You need to come home to save a life – The Philadelphia Inquirer

At first, it didnt hit Stewart that her donation would help save someones life the potential recipient, unknown to her, was too abstract. But then she thought of her father, a nurse in Reading, and how, years ago, when he was 48, she was just 8. She let herself feel what it would have been like to lose him back then.

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FDA Authorizes Athersys to Initiate a Pivotal Clinical Trial Evaluating MultiStem Cell Therapy in Patients With COVID-19 Induced Acute Respiratory…

CLEVELAND--(BUSINESS WIRE)-- Athersys, Inc. (NASDAQ: ATHX) announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company to initiate a Phase 2/3 pivotal study to assess the safety and efficacy of MultiStem therapy in subjects with moderate to severe acute respiratory distress syndrome (ARDS) induced by the novel coronavirus disease (COVID-19). This program falls under the current Investigational New Drug (IND) application for the Companys completed MUST-ARDS study and, therefore, a new IND does not need to be filed. The Company plans to open the first clinical sites for recruitment of this MACOVIA (MultiStem Administration for COVID-19 Induced ARDS) study this quarter.

According to the World Health Organization (WHO) and other recent clinical and epidemiological data, ARDS is the leading cause of death among COVID-19 infected patients. There are no FDA-approved medicines for the treatment of ARDS. Athersys recently completed a Phase 1/2 study evaluating administration of MultiStem to patients with ARDS and based on the promising data from the study, the program was recently granted Fast Track designation by the FDA.

This trial will be a multicenter study featuring an open-label lead-in followed by a double-blinded, randomized, placebo-controlled Phase 2/3 portion. The primary objectives of the MACOVIA study are to evaluate the safety and efficacy of MultiStem therapy as a treatment for subjects with moderate to severe ARDS due to COVID-19. The primary efficacy endpoint will be number of ventilator-free days through day 28 as compared to placebo, a well-established endpoint for ARDS trials that evaluates an interventions combined impact on survival and liberation from invasive mechanical ventilation. The secondary objectives of this study are to evaluate pulmonary function, all-cause mortality, tolerability and quality of life (QoL) among survivors associated with MultiStem therapy as a treatment for subjects with moderate to severe ARDS due to COVID-19. The study is designed to enroll approximately 400 subjects and will be conducted at leading pulmonary critical care centers throughout the United States. The first cohort of the study will be open-label, with a single active treatment arm to evaluate the safety of the MultiStem product candidate at two dose levels. The second cohort will be a double-blind, randomized, placebo-controlled run-in phase to evaluate the efficacy of MultiStem. The design of the third planned cohort will be based on analysis of the results of the second cohort. The intent-to-treat population will include all randomized subjects (i.e., subjects from the second and third cohorts).

We are grateful for the FDAs timely review and feedback during our design of this pivotal Phase 2/3 study, commented Dr. Eric Jenkins, MD, Senior Medical Director and Head of Clinical Operations at Athersys. With encouraging non-clinical and clinical data, affirmed by the FDAs Fast Track designation for ARDS, Athersys and its collaborating clinical investigators are highly motivated by the FDAs authorization that we may proceed with enrollment of the first open-label cohort to evaluate safety. We are in communication with FDA regarding the enrollment of further cohorts to conduct a scientifically rigorous evaluation of MultiStems safety and efficacy in the treatment of ARDS due to COVID-19. We believe that MultiStem treatment, by modulating patients hyperinflammatory response to highly pathogenic respiratory viruses, including SARS-CoV-2 which causes COVID-19, represents a very promising approach to improving outcomes in patients who suffer the most severe manifestations of these illnesses.

With the spread of COVID-19 and the resulting ARDS cases, there is an immediate need for therapies for the treatment of ARDS. The data from the Companys Phase 1/2 MUST-ARDS study met its primary endpoint of tolerability and participants were evaluated through 28 days on key clinical parameters as well as improvement in pulmonary function. As previously reported, study subjects receiving MultiStem experienced less mortality, more ventilator-free days, and more intensive care unit (ICU)-free days during the 28-day clinical evaluation period than the subjects who received placebo. These differences were observed to be greatest among the prospectively defined patients with more severe ARDS, defined as patients with PaO2/FiO2 above or below 150mmHg. Importantly, among all randomized subjects in the study, 45% of MultiStem treated subjects were off the ventilator within seven days or less, compared to only 20% of placebo recipients. Biomarker analysis confirmed a reduction in inflammatory biomarkers among MultiStem treated subjects. In addition, results from the one-year follow up were consistent with the positive day-28 clinical results and an evaluation of the subjects QoL, as measured by patient-reported EQ-5D-3L self-care responses and visual analogue scale (VAS) pain scores, more positive among patients who received MultiStem. The data from this study were presented at the American Thoracic Society Meeting in May 2019.

MultiStem therapys potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. Since MultiStem is not virus- or pathogen-specific, we believe it has the potential to treat ARDS that develops from a variety of causes, including COVID-19, as well as other pathogen-induced or non-infectious causes of severe lung inflammation leading to ARDS. The Company is in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the advancement of MultiStem to treat patients with ARDS resulting from the COVID-19 epidemic and other potential pandemic outbreaks. For more detailed information on the Companys ARDS program, please visit the ARDS page on the Athersys website.

About ARDS

ARDS is a serious respiratory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, trauma or other events and represents a major cause of morbidity and mortality in the critical care setting. ARDS is associated with a high mortality rate and significant long-term complications and disability among survivors. Among survivors, the condition prolongs ICU and hospital stays and often requires extended convalescence in the hospital and rehabilitation care settings. There are limited interventions and no effective drug treatments for ARDS. There is a large unmet need for a safe treatment that can reduced mortality and improve QoL for those surviving ARDS. Additionally, given the high healthcare resource burden associated with treatment of ARDS patients, a successful therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU, or in the setting of a widespread high pathogenicity respiratory virus pandemic, make those resources more rapidly available to other patients.

About COVID-19

COVID-19 is the infectious disease caused by the most recently discovered human coronavirus, SARS-CoV-2. This new disease was unknown before the outbreak was first discovered in Wuhan, China, in December 2019. Older people and those with underlying medical problems such as high blood pressure, heart problems or diabetes, are more likely to develop serious illness, but even young, previously healthy people can suffer severe disease and complications such as ARDS. Data are still emerging but published case series available today suggest mortality rates among COVID-19 patients who develop ARDS may be as high as 50% to 70%.

About MultiStem

MultiStem cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapys potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. MultiStem represents a unique "off-the-shelf" stem cell product candidate that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon favorable efficacy data, its novel mechanisms of action, and favorable and consistent tolerability data in clinical studies, we believe that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

About Athersys

Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at http://www.athersys.com. Follow Athersys on Twitter at http://www.twitter.com/athersys.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as anticipates, believes, can, continue, could, estimates, expects, intends, may, plans, potential, should, suggest, will, or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the success of our MACOVIA study; our ability to raise capital to fund our operations; our ability to successfully finalize and implement an alliance with BARDA, and the terms of any such alliance, including the amount, if any, of funding that we might receive; the timing and nature of results from MultiStem clinical trials, including our MASTERS-2 Phase 3 clinical trial and the HEALIOS K.K. (Healios) TREASURE and ONE-BRIDGE clinical trials in Japan; the impact on our business, results of operations and financial condition from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of infectious disease in the United States; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints or regulatory issues, which could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for the treatment of ischemic stroke, ARDS, acute myocardial infarction and trauma, and the prevention of graft-versus-host disease and other disease indications; changes in external market factors; changes in our industrys overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; our collaborators ability to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in North America, Europe and Japan; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

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Leading Urology KOLs Host Live Webinar Entitled The Protect PNS for OAB: A Wireless Uro-Stimulation Injectable Technology on April 29 at 5pm ET -…

Leading Urology KOLs Host Live Webinar Entitled The Protect PNS for OAB: A Wireless Uro-Stimulation Injectable Technology on April 29 at 5pm ET  Yahoo Finance

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Stem Cell Research: Uses, Types & Examples

Stem cells are undifferentiated, or blank, cells. This means theyre capable of developing into cells that serve numerous functions in different parts of the body. Most cells in the body are differentiated cells. These cells can only serve a specific purpose in a particular organ. For example, red blood cells are specifically designed to carry oxygen through the blood.

All humans start out as only one cell. This cell is called a zygote, or a fertilized egg. The zygote divides into two cells, then four cells, and so on. Eventually, the cells begin to differentiate, taking on a certain function in a part of the body. This process is called differentiation.

Stem cells are cells that havent differentiated yet. They have the ability to divide and make an indefinite number of copies of themselves. Other cells in the body can only replicate a limited number of times before they begin to break down. When a stem cell divides, it can either remain a stem cell or turn into a differentiated cell, such as a muscle cell or a red blood cell.

Since stem cells have the ability to turn into various other types of cells, scientists believe that they can be useful for treating and understanding diseases. According to the Mayo Clinic, stem cells can be used to:

There are several types of stem cells that can be used for different purposes.

Embryonic stem cells come from human embryos that are three to five days old. They are harvested during a process called in-vitro fertilization. This involves fertilizing an embryo in a laboratory instead of inside the female body. Embryonic stem cells are known as pluripotent stem cells. These cells can give rise to virtually any other type of cell in the body.

Adult stem cells have a misleading name, because they are also found in infants and children. These stem cells come from developed organs and tissues in the body. Theyre used by the body to repair and replace damaged tissue in the same area in which they are found.

For example, hematopoietic stem cells are a type of adult stem cell found in bone marrow. They make new red blood cells, white blood cells, and other types of blood cells. Doctors have been performing stem cell transplants, also known as bone marrow transplants, for decades using hematopoietic stem cells in order to treat certain types of cancer.

Adult stem cells cant differentiate into as many other types of cells as embryonic stem cells can.

Scientists have recently discovered how to turn adult stem cells into pluripotent stem cells. These new types of cells are called induced pluripotent stem cells (iPSCs). They can differentiate into all types of specialized cells in the body. This means they can potentially produce new cells for any organ or tissue. To create iPSCs, scientists genetically reprogram the adult stem cells so they behave like embryonic stem cells.

The breakthrough has created a way to de-differentiate the stem cells. This may make them more useful in understanding how diseases develop. Scientists are hoping that the cells can be made from someones own skin to treat a disease. This will help prevent the immune system from rejecting an organ transplant. Research is underway to find ways to produce iPSCs safely.

Cord blood stem cells are harvested from the umbilical cord after childbirth. They can be frozen in cell banks for use in the future. These cells have been successfully used to treat children with blood cancers, such as leukemia, and certain genetic blood disorders.

Stem cells have also been found in amniotic fluid. This is the fluid that surrounds a developing baby inside the mothers womb. However, more research is needed to help understand the potential uses of amniotic fluid stem cells.

Adult stem cells dont present any ethical problems. However, in recent years, there has been controversy surrounding the way human embryonic stem cells are obtained. During the process of harvesting embryotic stem cells, the embryo is destroyed. This raises ethical concerns for people who believe that the destruction of a fertilized embryo is morally wrong.

Opponents believe that an embryo is a living human being. They dont think the fertilized eggs should be used for research. They argue that the embryo should have the same rights as every other human and that these rights should be protected.

Supporters of stem cell research, on the other hand, believe that the embryos are not yet humans. They note that researchers receive consent from the donor couple whose eggs and sperm were used to create the embryo. Supporters also argue that the fertilized eggs created during in-vitro fertilization would be discarded anyway, so they might be put to better use for scientific research.

With the breakthrough discovery of iPSCs, there may be less of a need for human embryos in research. This may help ease the concerns of those who are against using embryos for medical research. However, if iPSCs have the potential to develop into a human embryo, researchers could theoretically create a clone of the donor. This presents another ethical issue to take into consideration. Many countries already have legislation in place that effectively bans human cloning.

In the United States, federal policy regarding stem cell research has evolved over time as different presidents have taken office. Its important to note that no federal regulation has ever explicitly banned stem cell research in the United States. Rather, regulations have placed restrictions on public funding and use. However, certain states have placed bans on the creation or destruction of human embryos for medical research.

In August 2001, former President George W. Bush approved a law that would provide federal funding for limited research on embryonic stem cells. However, such research had to fit the following criteria:

In March 2009, President Barack Obama revoked former President Bushs statement and released Executive Order 13505. The order removed the restrictions on federal funding for stem cell research. This allowed the National Institutes of Health (NIH) to begin funding research that uses embryonic stem cells. The NIH then published guidelines to establish the policy under which it would fund research. The guidelines were written to help make sure that all NIH-funded research on human stem cells is morally responsible and scientifically relevant.

Stem cell research is ongoing at universities, research institutions, and hospitals around the world. Researchers are currently focusing on finding ways to control how stem cells turn into other types of cells.

A primary goal of research on embryonic stem cells is to learn how undifferentiated stem cells turn into differentiated stem cells that form specific tissues and organs. Researchers are also interested in figuring out how to control this process of differentiation.

Over the years, scientists have developed methods to manipulate the stem cell process to create a particular cell type. This process is called directed differentiation. A recent studyalso discovered the first steps in how stem cells transform into brain cells and other types of cells. More research on this topic is ongoing.

If researchers can find a reliable way to direct the differentiation of embryonic stem cells, they may be able to use the cells to treat certain diseases. For example, by directing the embryonic stem cells to turn into insulin-producing cells, they may be able to transplant the cells into people with type 1 diabetes.

Other medical conditions that may potentially be treated with embryonic stem cells include:

Californias Stem Cell Agency provides a detailed list of the disease programs and clinical trials currently underway in stem cell research. Examples of such projects include:

Researchers are also using differentiated stem cells to test the safety and effectiveness of new medications. Testing drugs on human stem cells eliminates the need to test them on animals.

Stem cell research has the potential to have a significant impact on human health. However, there is some controversy around the development, usage, and destruction of human embryos. Scientists may be able to ease these concerns by using a new method that can turn adult stem cells into pluripotent stem cells, which can change into any cell type. This would eliminate the need for embryonic stem cells in research. Such breakthroughs show that much progress has been made in stem cell research. Despite these advancements, theres still a lot more to be done before scientists can create successful treatments through stem cell therapy.

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Stem Cell Basics I. | stemcells.nih.gov

Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however, such as the pancreas and the heart, stem cells only divide under special conditions.

Until recently, scientists primarily worked with two kinds of stem cells from animals and humans: embryonic stem cells and non-embryonic "somatic" or "adult" stem cells. The functions and characteristics of these cells will be explained in this document. Scientists discovered ways to derive embryonic stem cells from early mouse embryos more than 30 years ago, in 1981. The detailed study of the biology of mouse stem cells led to the discovery, in 1998, of a method to derive stem cells from human embryos and grow the cells in the laboratory. These cells are called human embryonic stem cells. The embryos used in these studies were created for reproductive purposes through in vitro fertilization procedures. When they were no longer needed for that purpose, they were donated for research with the informed consent of the donor. In 2006, researchers made another breakthrough by identifying conditions that would allow some specialized adult cells to be "reprogrammed" genetically to assume a stem cell-like state. This new type of stem cell, called induced pluripotent stem cells (iPSCs), will be discussed in a later section of this document.

Stem cells are important for living organisms for many reasons. In the 3- to 5-day-old embryo, called a blastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lungs, skin, sperm, eggs and other tissues. In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.

Given their unique regenerative abilities, stem cells offer new potentials for treating diseases such as diabetes, and heart disease. However, much work remains to be done in the laboratory and the clinic to understand how to use these cells for cell-based therapies to treat disease, which is also referred to as regenerative or reparative medicine.

Laboratory studies of stem cells enable scientists to learn about the cells essential properties and what makes them different from specialized cell types. Scientists are already using stem cells in the laboratory to screen new drugs and to develop model systems to study normal growth and identify the causes of birth defects.

Research on stem cells continues to advance knowledge about how an organism develops from a single cell and how healthy cells replace damaged cells in adult organisms. Stem cell research is one of the most fascinating areas of contemporary biology, but, as with many expanding fields of scientific inquiry, research on stem cells raises scientific questions as rapidly as it generates new discoveries.

I.Introduction|Next

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Stem Cell Research – Pros and Cons – Explorable.com

All scientists must consider whether the positive effects from their research are likely to be significantly higher than the negative effects.

Stem Cells are crucial to develop organisms. They are nonspecialized cells which have the potential to create other types of specific cells, such as blood-, brain-, tissue- or muscle-cells.

Stem cells are in all of our body and lives, but are far more potent in a fetus (also spelled foetus, ftus, faetus, or ftus) than in an adult body.

Some types of stem cells may be able to create all other cells in the body. Others have the potential to repair or replace damaged tissue or cells.

Embryonic Stem Cells are developed from a female egg after it is fertilized by sperm. The process takes 4-5 days.

Stem cell research is used for investigation of basic cells which develop organisms. The cells are grown in laboratories where tests are carried out to investigate fundamental properties of the cells.

There are stem cells in the both placenta and blood contained in the placenta. Also the primary source of stem cells is from blastocysts. These are fertilized human eggs that were not implanted into a woman.

The controversy surrounding stem cell research led to an intense debate about ethics. Up until the recent years, the research method mainly focused on Embryonic Stem Cells, which involves taking tissue from an aborted embryo to get proper material to study. This is typically done just days after conception or between the 5th and 9th week.

Since then, researchers have moved on to more ethical study methods, such as Induced Pluripotent Stem Cells (iPS). iPS are artificially derived from a non-pluripotent cell, such as adult somatic cells.

This is probably an important advancement in stem cell research, since it allows researchers to obtain pluripotent stem cells, which are important in research, without the controversial use of embryos.

There were two main issues concerning stem cell research with both pros and cons:

The first issue is really not just about stem cell research, as it may be applied to most research about human health.

Since 2007, the second point, concerns about the methods involved, has been less debated, because of scientific developments such as iPS.

As you will most probably notice, the following arguments are not exclusively in use when talking about stem cell research.

Stem cell research can potentially help treat a range of medical problems. It could lead humanity closer to better treatment and possibly cure a number of diseases:

Better treatment of these diseases could also give significant social benefits for individuals and economic gains for society

The controversy regarding the method involved was much tenser when researchers used Embryonic Stem Cells as their main method for stem cell research.

DISCLAIMER:These points are based on the old debate about the methods of stem cells research, from before 2007. Since then, scientists have moved on to use more ethical methods for stem cell research, such as iPS. This section serves as an illustration of the difficult evaluations researchers may have to analyze.

The stem cell-research is an example of the, sometimes difficult, cost-benefit analysis in ethics which scientists need to do. Even though many issues regarding the ethics of stem cell research have now been solved, it serves as a valuable example of ethical cost-benefit analysis.

The previously heated debate seems to have lead to new solutions which makes both sides happier.

Stem Cell pros and cons had to be valued carefully, for a number of reasons.

When you are planning a research project, ethics must always be considered. If you cannot defend a study ethically, you should not and will not be allowed to conduct it. You cannot defend a study ethically unless the presumed cost is lower than expected benefits. The analysis needs to include human/animal discomfort/risks, environmental issues, material costs/benefits, economy etc.

Why was the debate regarding the stem cell research so intense?

First, it was a matter of life - something impossible to measure. And in this case, researchers had to do exactly that: measure life against life.

Both an abortion and someone dying, suffering from a possible curable disease, is a tragedy. Which have the highest value? Does a big breakthrough in the research justify the use of the method in the present?

Would the benefits of studying abortions outweigh the costs? The choice was subjective: Nobody knows all the risks or all the possible outcomes, so we had to value it with our perception of the outcome. Perception is influenced by our individual feelings, morals and knowledge about the issue.

Second, at the time we did not know whether the research was necessary and sufficient to give us the mentioned health benefits.

Third, other consequences of the research are uncertain. Could the research be misused in the future or not? We simply do not know. All knowledge acquired, within research or other arenas, may be used for evil causes in the future - it is impossible to know.

The Stem cell research-debate is an example on how people value various aspects differently. It is also an example of how critics and debate can lead to significant improvements for both sides.

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Pros And Cons Of Stem Cell Research – Popular Issues

Pros and Cons of Stem Cell Research - What are Stem Cells?There has been much controversy in the press recently about the pros and cons of stem cell research. What is the controversy all about? "Stem" cells can be contrasted with "differentiated" cells. They offer much hope for medical advancement because of their ability to grow into almost any kind of cell. For instance, neural cells in the brain and spinal cord that have been damaged can be replaced by stem cells. In the treatment of cancer, cells destroyed by radiation or chemotherapy can be replaced with new healthy stem cells that adapt to the affected area, whether it be part of the brain, heart, liver, lungs, or wherever. Dead cells of almost any kind, no matter the type of injury or disease, can be replaced with new healthy cells thanks to the amazing flexibility of stem cells. As a result, billions of dollars are being poured into this new field.

Pros and Cons of Stem Cell Research - Where Do They Come From?To understand the pros and cons of stem cell research, one must first understand where stem cells come from. There are three main sources for obtaining stem cells - adult cells, cord cells, and embryonic cells. Adult stem cells can be extracted either from bone marrow or from the peripheral system. Bone marrow is a rich source of stem cells. However, some painful destruction of the bone marrow results from this procedure. Peripheral stem cells can be extracted without damage to bones, but the process takes more time. And with health issues, time is often of the essence. Although difficult to extract, since they are taken from the patient's own body, adult stem cells are superior to both umbilical cord and embryonic stem cells. They are plentiful. There is always an exact DNA match so the body's immune system never rejects them. And as we might expect, results have been both profound and promising.

Stem cells taken from the umbilical cord are a second very rich source of stem cells. Umbilical cells can also offer a perfect match where a family has planned ahead. Cord cells are extracted during pregnancy and stored in cryogenic cell banks as a type of insurance policy for future use on behalf of the newborn. Cord cells can also be used by the mother, the father or others. The more distant the relationship, the more likely it is that the cells will be rejected by the immune system's antibodies. However, there are a number of common cell types just as there are common blood types so matching is always possible especially where there are numerous donors. The donation and storage process is similar to blood banking. Donation of umbilical cells is highly encouraged. Compared to adult cells and embryonic cells, the umbilical cord is by far the richest source of stem cells, and cells can be stored up in advance so they are available when needed. Further, even where there is not an exact DNA match between donor and recipient, scientists have developed methods to increase transferability and reduce risk.

Pros and Cons of Stem Cell Research - Embryonic CellsThe pros and cons of stem cell research come to the surface when we examine the third source of stem cells - embryonic cells. Embryonic stem cells are extracted directly from an embryo before the embryo's cells begin to differentiate. At this stage the embryo is referred to as a "blastocyst." There are about 100 cells in a blastocyst, a very large percentage of which are stem cells, which can be kept alive indefinitely, grown in cultures, where the stem cells continue to double in number every 2-3 days. A replicating set of stem cells from a single blastocyst is called a "stem cell line" because the genetic material all comes from the same fertilized human egg that started it. President Bush authorized federal funding for research on the 15 stem cell lines available in August 2001. Other stem cell lines are also available for research but without the coveted assistance of federal funding.

So what is the controversy all about? Those who value human life from the point of conception, oppose embryonic stem cell research because the extraction of stem cells from this type of an embryo requires its destruction. In other words, it requires that a human life be killed. Some believe this to be the same as murder. Against this, embryonic research advocates argue that the tiny blastocyst has no human features. Further, new stem cell lines already exist due to the common practice of in vitro fertilization. Research advocates conclude that many fertilized human cells have already been banked, but are not being made available for research. Advocates of embryonic stem cell research claim new human lives will not be created for the sole purpose of experimentation.

Others argue against such research on medical grounds. Mice treated for Parkinson's with embryonic stem cells have died from brain tumors in as much as 20% of cases.1 Embryonic stem cells stored over time have been shown to create the type of chromosomal anomalies that create cancer cells.2 Looking at it from a more pragmatic standpoint, funds devoted to embryonic stem cell research are funds being taken away from the other two more promising and less controversial types of stem cell research mentioned above.

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Pros And Cons Of Stem Cell Research - Popular Issues

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Myths and Misconceptions About Stem Cell Research …

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There is no shortage of myths and misconceptions when it comes to stem cell research and regenerative medicine. Here we address the most common concerns.

If you have more questions that aren't addressed here, please visit our other Stem Cell FAQ pages.

Is CIRM-funded stem cell research carried out ethically?Where do the embryos come from to create stem cell lines?I'm opposed to abortion. Can embryonic stem cell lines come from aborted fetuses?Does creating stem cell lines destroy the embryo?Are adult stem cells as goodor betterthan embryonic stem cells?Don't iPS cells eliminate the need to use embryos in stem cell research?Can't stem cell research lead to human cloning?

Stem cell research, like any fieldwithin biomedicine, poses social and ethical concerns. CIRM, as well as the broader research community, takes these seriously.

As a state funding body, CIRM has comprehensive policies to govern research, similar to our national counterpart, the National Institutes of Health. CIRM-funded researchers must comply with a comprehensive set of regulations that have been carefully developed and are in accordance with national and international standards.

These regulations were among the first formal policies governing the conduct of stem cell research and are in accordance with recommendations from the National Academies and from the International Society for Stem Cell Research. CIRMs Standards Working Group meets regularly to consider new ethical challenges as the science progresses and to revise standards to reflect the current state of the research.

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CIRM regulationsNational Academies of Science guidelinesInternational Society for Stem Cell Research guidelinesNational Academies of Science podcast about guidelines for embryonic stem cell research More about CIRM-grantee ethics training (4:03)

All the human embryonic stem cell lines currently in use come from four to five day-old embryos left over from in vitro fertilization (IVF) procedures. In IVF, researchers mix a man's sperm and a woman's eggs together in a lab dish. Some of those eggs will become fertilized. At about five days the egg has divided to become a hollow ball of roughly 100 cells called a blastocyst which is smaller than the size of the dot over an i. It is these very early embryos that are implanted into the woman in the hopes that she becomes pregnant.

Each cycle of IVF can produce many blastocysts, some of which are implanted into the woman. The rest are stored in the IVF clinic freezer. After a successful implantation, they must decide what to do with any remaining embryos. There are a few options:

Some embryonic stem cell lines also come from embryos that a couple has chosen not to implant because they carry harmful genetic mutations like the ones that cause cystic fibrosis or Tay Sachs disease. These are discovered through routine genetic testing prior to implantation. Still other embryos might be malformed in some way that causes them to be rejected for implantation into the mother. Embryos with genetic defects or malformations would have been discarded if the couple had not chosen to donate them to stem cell research.

People who donate leftover embryos for research go through an extensive consent process to ensure that they understand embryonic stem cell research. Under state, national and international regulations, no human embryonic stem cell lines can be created without explicit consent from the donor.

Policies vary as to whether women may be paid or otherwise compensated to donate eggs. CIRM does not fund research where women have received payment to donate eggs. Most jurisdictions allow donors to be reimbursed for direct costs such as travel to the clinic or lodging. Some also allow payments or IVF services to be provided to egg donors.

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How do scientists create stem cell lines from left over IVF embryos? (4:11)

No. Embryonic stem cells only come from four to five day old blastocysts or younger embryos. These are eggs that have been fertilized in the laboratory but have not been implanted in a womb.

In most cases, yes. The hollow blastocystwhich is where embryonic stem cells come fromcontains a cluster of 20-30 cells called the inner cell mass. These are the cells that become embryonic stem cells in a lab dish. The process of extracting these cells destroys the embryo.

Dont forget that the embryos were donated from IVF clinics. They had either been rejected for implantation and were going to be destroyed, or the couple had decided to stop storing the embryos for future use. The embryos used to create embryonic stem cell lines were already destined to be destroyed.

There is, however, a second method that creates embryonic stem cell lines without destroying the embryo. Instead, scientists take a single cell from a very early stage IVF embryo and can use that one cell to develop a new line. The process of removing one cell from an early stage embryo has been done for many years as a way of testing the embryo for genetic predisposition to diseases such as Tay Sachs. This process is called preimplantation genetic testing.

Adult stem cells are extremely valuable and have great potential for future therapies. However, these cells are very restricted in what they can do. Unlike embryonic stem cells, which can grow into virtually any cell type in the body, adult stem cells can only follow certain paths.

For example, blood-forming stem cells can grow into mature blood cells, and brain stem cells may be able to grow into mature neurons, but a blood-forming stem cell cant grow into a neuron, and vice versa. Whats more, adult stem cells dont grow indefinitely in the lab, unlike embryonic stem cells, and they arent as flexible in the types of diseases they can treat.

While the news is full of stories about people who had great results from adult stem cell therapies, few of these therapies are part of large, well-designed clinical trials that can test whether a potential therapy is safe and effective. Until some of these large trials take place, with both adult and embryonic stem cells, we won't know which type of stem cell is superior. Even researchers who study adult stem cells advocate working with embryonic cells as well.

CIRM is excited about their potential for treating some diseases. However, our goal is to accelerate new treatments for diseases in need. At this time the most effective way of doing that is by exploring all types of stem cells. That's why CIRM has funded researchers pursuing a wide range of approaches to finding cures for diseases.

See how much of CIRM's funding has gone to different types of stem cells here: Overview of CIRM Stem Cell Research Funding.

Filter our list of all funded CIRM grants to see awards using different cell types.

How are adult stem cell different from embryonic stem cells? (3:29)

Induced pluripotent stem cells, or iPS cells, represent another type of cell that could be used for stem cell research. iPS cells are adult cellsusually skin cellsthat scientists genetically reprogram to behave like embryonic stem cells. The technology used to generate human iPS cells, pioneered by Shinya Yamanaka in 2007, is very promising, which is why CIRM has funded many grants that create and use these cells to study or treat disease. However, iPS cell technology is very new and scientists are looking into whether those cells have the same potential as human embryonic stem cells and whether the cells are safe for transplantation.Many CIRM-funded researchers are working to find better ways of creating iPS cells that are both safe and effective.

Experts agree that research on all types of stem cells is critical. In September 2008, a panel of experts convened by the U.S. National Academy of Sciences stated that the use of human embryonic stem cells is still necessary. As panel chair Richard Hynes of the Massachusetts Institute of Technology stated: It is far from clear at this point which types of cell types will prove to be the most useful for regenerative medicine, and it is likely that each will have some utility.

See a video about creating iPS cells (3:40)

No. Every significant regulatory and advisory body has restrictions on reproductive cloning. The National Academy of Sciences has issued guidelines banning the technique as has the International Society for Stem Cell Research. The California constitution and CIRM regulations specifically prohibit reproductive cloning with its funding.

Updated 2/16

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Myths and Misconceptions About Stem Cell Research ...

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Pros and Cons of Stem Cell Research – The Balance

Debates over the ethics of embryonic stem cell research have divided scientists, politicians, and religious groups for years.

However, promising developments in other areas of stem cell research have led to solutions that help bypass these ethical barriers and win more support from those against embryonic stem cell research; the newer methods don't require the destruction of blastocysts.

Many parties continue to have strong opinions that trigger ongoing debates about stem cell research, and the following pros and cons provide a snapshot of some the points on each side of the issue.

The excitement about stem cell research is primarily due to the medical benefits in areas ofregenerative medicineand therapeutic cloning. Stem cells provide huge potential for finding treatments and cures to a vast array of medical issues:

Different diseasesincluding cancers, Alzheimer's, Parkinson's, and morecan be treated with stem cells by replacing damaged or diseased tissue. This can include neurons that might affect neurological diseases and even entire organs that need to be replaced.

There is endless potential for scientists to learn about human growth and cell development from studying stem cells. For example, by studying how stem cells develop into specific types of cells, scientists potentially could learn how to treat or prevent relevant ailments.

One of the areas of potential is embryonic treatment. This stage of pregnancy is when many birth defects or other potential issues begin. Studying embryonic stem cells possibly could lead to a better understanding of how embryos develop and maybe even lead to treatments that can identify and address potential problems.

Because the cells can replicate at a high rate, a limited number of initial cells eventually can grow into a much greater number to be studied or used in treatment.

Medical benefits such as regenerating organ tissue and therapeutic cell cloning

May hold the answer to curing various diseases, including Alzheimer's, certain cancers and Parkinson's

Research potential for human cell growth and development to treat a variety of ailments

Possibility of use for embryonic treatment

Requires only a small number of cells because of the fast replication rate

The difficulty of obtaining stem cells and the long period of growth required before use

Unproven treatments often come with high rejection rates

Cost can be prohibitive for many patients

Ethical controversy over use of stem cells from lab-fertilized human eggs

Additional ethical issues regarding the creation of human tissues in a lab, such as cloning

Stem cell research presents problems like any form of research, but most opposition to stem cell research is philosophical and theological, focusing on questions of whether we should be taking science this far:

It's not easy to obtain stem cells. Once harvested from an embryo, stem cells require several months of growth before they can be used. Obtaining adult stem cells, such as from bone marrow, can be painful.

As promising as the field is, stem cell treatments still are unproven, and they often have high rejection rates.

The cost also can be prohibitive for many patients, with a single treatment costing well into the thousands of dollars, as of 2018.

The use of embryonic stem cellsforresearchinvolves the destruction of blastocysts formed from laboratory-fertilized human eggs. For those who believe that life begins at conception, the blastocyst is a human life, and to destroy it is unacceptable and immoral.

A similar theological problem is an idea of creating living tissue in a laboratory and whether that represents humans taking on the role of God. This argument also applies to the potential for human cloning. For those who believe God created people, the prospect of people creating people is troublesome.

In 1998, the first published research paper on the topic reported that stem cells could be taken from human embryos. Subsequent research led to the ability to maintain undifferentiated stem cell lines (pluripotent cells) and techniques for differentiating them into cells specific to various tissues and organs.

The debates over the ethics of stem cell research began almost immediately in 1999, despite reports that stem cells cannot grow into complete organisms.

In 20002001, governments worldwide were beginning to draft proposals and guidelines to control stem cell research and the handling of embryonic tissues and reach universal policies. In 2001, the Canadian Institutes of Health Research (CIHR) drafted a list of recommendations for stem cell research. In the U.S., the Clinton administration drafted guidelines for stem cell research in 2000. Australia, Germany, the United Kingdom, and other countries followed suit and formulated their own policies.

Debates over the ethics of studying embryonic stem cells continued for nearly a decade until the use of adult-derived stem cellsknown as induced pluripotent stem cells (IPSCs)became more prevalent and alleviated those concerns.

In the U.S. since 2011, federal funds can be used to study embryonic stem cells, but such funding cannot be used to destroy an embryo.

Use of adult-derived stem cellsknown as induced pluripotent stem cells (IPSCs)from blood, cord blood, skin, and other tissues have been demonstrated as effective in treating different diseases in animal models. Umbilical cord-derived stem cells obtained from the cord blood also have been isolated and used for various experimental treatments. Another option is uniparental stem cells. Although these cell lines are shorter-lived than embryonic cell lines, uniparental stem cells hold vast potential if enough research money can be directed that way: pro-life advocates do not technically consider them individual living beings.

Two recent developments from stem cell research involve the heart and the blood it pumps. In 2016, researchers in Scotland began working on the possibility of generating red blood cells from stem cells in order to create a large supply of blood for transfusions. A few years earlier, researchers in England began working on polymers derived from bacteria that can be used to repair damaged heart tissue.

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Pros and Cons of Stem Cell Research - The Balance

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CareDx Introduces AlloCell: Cell Therapy SurveillanceCareDx Announces Collaborations to Develop Cellular Therapy Diagnostics – BioSpace

SOUTH SAN FRANCISCO, Calif., April 14, 2020 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, announced today a biopharma research partnership for AlloCell. AlloCell is a surveillance solution for patients who have received engineered-cell transplants for allogeneic cell therapy.

Allogeneic cell therapy is a rapidly growing area of clinical development with research underway for applications in oncology, cardiovascular, neurological, autoimmune, and infectious disease. In oncology, initial CAR T-cell therapies were created by genetically modifying a patients own immune cells to target specific cancer cells before transplanting them back into the patient. With allogeneic therapies, the CAR T-cells are manufactured from cells of healthy donors for off-the-shelf use in patients, simplifying the manufacturing process, and reducing patients wait time from diagnosis to treatment.

CareDx has over 20 years of expertise in transplant monitoring, enabling the development of AlloCell to monitor allogeneic cell therapies in partnership with cellular therapy companies.

Allogeneic CAR-T is the next stage of immuno-oncology therapy, and we expect it to have a transformative impact on our patients with an increasing range of indications, said Stefan Ciurea, MD, Associate Professor in the Department of Stem Cell Transplantation and Cellular Therapy from The University of Texas MD Anderson Cancer Center. However, with many different cell therapy constructs expected and variability in patients responses to therapy, there is a significant need for a standardized diagnostic measurement of cellular kinetics and persistence to help personalize treatment. AlloCell has the potential to have significant clinical utility to help manage these allogeneic cell therapy patients.

With the goal of improving transplant patient outcomes at the core of what we do, we are glad to begin cellular therapy collaborations to help patients with life-saving immune cell transplants, said Peter Maag, CEO of CareDx.

About CareDxCareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: http://www.CareDx.com.

CONTACTS:

CareDx, Inc.Sasha KingChief Marketing Officer415-287-2393sking@caredx.com

Investor RelationsGreg Chodaczek347-620-7010investor@caredx.com

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CareDx Introduces AlloCell: Cell Therapy SurveillanceCareDx Announces Collaborations to Develop Cellular Therapy Diagnostics - BioSpace

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