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Can scientists patent life? The question returns to the Supreme Court

The thorny and unresolved question of whether life itself can be patented may come again before the U.S. Supreme Court, if it accepts a motion filed Friday by Santa Monica-based Consumer Watchdog. (H/T to David Jensen's California Stem Cell Report.)

The issue isn't a new one either for the consumer group or the court. Consumer Watchdog launched its challenge of a patent on human stem cells issued to the Wisconsin Alumni Research Foundation, or WARF, in 2006. Since then the battle has been waged before the U.S. Patent Office, which overturned the patent then reinstated a narrower version; and the U.S. Court of Appeals for the Federal Circuit, which hears patent appeals.

The group has challenged the patent on two grounds: first, that the work covered wasn't novel or original, and second, that the Supreme Court has ruled that a "product of nature" can't be patented.

That ruling came in 2013, in a case involving laboratory-isolated DNA. Even then, however, the court left the door open for patents of some biological products, notably "composite DNA," which is synthetically created in the lab.

The court's attempt to split hairs, so to speak, reflects its discomfort with the very question of where to draw the line on what sort of organisms can be patented.

As it happens, that question was placed before the court only indirectly by the Consumer Watchdog motion. The immediate issue is whether the organization had legal standing to appeal the patent office's ruling in the first place. The appeals court threw out its appeal last year on the grounds that it hadn't been injured by WARF's patent, normally a prerequisite for bringing a lawsuit in federal court.

Consumer Watchdog's lawyer, Daniel Ravicher at the Public Patent Foundation, says patent law explicitly allows parties that challenge a patent to appeal an adverse ruling to a higher court. He speculates that the appeals court raised the standing issue on its own last year because it was inclined to uphold the patent, and feared being overturned by the Supreme Court.

"This case is almost identical to the genes case," Ravicher says. His goal is for the Supreme Court to accept its motion and order the appeals court to reconsider the stem cell patent on its merits. If that happens, the underlying issue of the patentability of life is almost certain to land back in the Supreme Court's lap.

All this is happening, researchers say, because WARF made exceptionally broad claims for its patent rights and exercised them very aggressively. This is, in fact, WARF's business; the nonprofit foundation was formed in the 1920s to exploit a patent issued to a University of Wisconsin professor on fortifying food with vitamin D, which it promptly licensed to Quaker Oats. By 1930, the deal was producing $1,000 a day. WARF also owns the rights to the drug Warfarin, which is named after the foundation.

A stem cell patent was originally issued to Wisconsin's James Thomson in 1995 (two more followed later), covering his extraction of stem cells from human embryos. WARF at first maintained that the patents covered the use of any human embryonic stem cells, and even products eventually produced by research using them.

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Can scientists patent life? The question returns to the Supreme Court

Bostons Adult Stem Cell Technology Center, LLC Introduces A New Technology for Monitoring Previously Elusive Adult …

Boston, MA (PRWEB) October 30, 2014

James Sherley says he has been working towards ASCTCs new advance in adult tissue stem cell technology since his days as a principal investigator at the Fox Chase Cancer Center (FCCC) in Philadelphia in the late 1990s. Sherley founded the ASCTC as a new Boston biotech start-up last year. The company holds all the intellectual property developed in Sherleys research over the years since FCCC, first as a professor at the Massachusetts Institute of Technology (MIT), and more recently as a senior scientist at the now closed Boston Biomedical Research Institute.

The basic concept for ASCTCs new technology was first published in 2001, after Sherleys arrival to MIT in 1998. The report introduced the new concept that the characteristic limited cell output of human tissue cell cultures was caused entirely by the special multiplication pattern of adult stem cells in the cultures known as asymmetric cell kinetics. Sherley recounts, My idea was pretty much ignored by everyone, because of a very popular ten-years older hypothesis to explain the short growth period of human cell cultures. The preexisting explanation, which was based on the concept of shortening chromosome ends, called telomeres, is still widely accepted today.

At the time of its first report, Sherleys asymmetric cell kinetics theoretical concept was lacking a quantitative model that could be used to test it. This situation began to change in the summer of 2011, when he met Dr. Frank Abdi, Chief Scientist of the Long Beach California company AlphaSTAR Corporation (ASC). The two were at a research conference organized to bring engineers and biologists together to inspire interdisciplinary research in the new field of bio-mesomechanics.

ASC develops computer simulation analyses to predict the physical failure of complex composite materials used to build aircraft, racing cars, and other high stress transports like the space shuttle. In the ensuing period after the 2011 introduction, ASCTC was founded, and the two companies integrated their respective expertise to produce the first-of-its-kind quantitative asymmetric stem cell kinetics model for human tissue cell cultures.

During its development, Sherley has described the concept for the new technology in brief in biotechnology and pharmaceutical industry forums. However, his talk at the Novel Stem Cells & Vesicles Symposium, organized at Rhode Island Hospital by Brown Universitys National Institutes of Health Stem Cell Biology Center of Biomedical Research Excellence (COBRE), will be the first presentation in an academic research forum. Dr. Sherley will discuss how the asymmetric stem cell kinetics model not only quantitatively accounts for human cell culture properties, but also accounts for features for which the telomerase shortening concept cannot.

By defining human cell culture output in terms of the specific actions of adult tissue stem cells, the new technology provides an exciting new tool for drug development and regenerative medicine. It gives the capability to monitor adult stem cell number, which previously has not been possible. The ability to monitor stem cell number opens a long closed door to many important biomedical applications. These include identifying drugs that would be harmful because of toxicity against tissue stem cells; identifying drugs that might improve normal tissue stem cells repair function; identifying new cancer drugs that attack aberrant cancer tissue stem cells; and providing a means to determine the number of stem cells needed for successful stem cell transplants (e.g., blood stem cell transplants).

As a first commercial target, ASCTC and ASC are developing the new technologys ability to provide an early screen for drug candidates that would fail later at more expensive places along the drug development pipeline due to tissue stem cell toxicity. Toxicity against tissue stem cells is one of the most devastating forms of drug toxicity. The new technology could save the U.S. pharmaceutical industry as much as $4 billion of the estimated $40 billion that it spends on failed drug candidates each year. Besides reducing cost and accelerating development of needed new drugs, the new tissue stem cell monitoring technology would also reduce the exposure of patients to particularly harmful drug candidates.

******************************************************************************************** The Adult Stem Cell Technology Center, LLC (ASCTC) is a Massachusetts life sciences company established in September 2013. ASCTC Director and founder, James L. Sherley, M.D., Ph.D. is the foremost authority on the unique properties of adult tissue stem cells. The companys patent portfolio contains biotechnologies that solve the three main technical problems production, quantification, and monitoring that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells. Currently, ASCTC is employing its technological advantages to pursue commercialization of mass-produced therapeutic human liver cells and facile assays that are early warning systems for drug candidates with catastrophic toxicity due to adverse effects against adult tissue stem cells.

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Bostons Adult Stem Cell Technology Center, LLC Introduces A New Technology for Monitoring Previously Elusive Adult ...

Identifying the source of stem cells

7 hours ago Amy Ralston, MSU biochemist and molecular biologist, has identified a possible source of stem cells, which can advance regenerative and fertility research. Credit: G.L. Kohuth

When most animals begin life, cells immediately begin accepting assignments to become a head, tail or a vital organ. However, mammals, including humans, are special. The cells of mammalian embryos get to make a different first choice to become the protective placenta or to commit to forming the baby.

It's during this critical first step that research from Michigan State University has revealed key discoveries. The results, published in the current issue of PLOS Genetics, provide insights into where stem cells come from, and could advance research in regenerative medicine. And since these events occur during the first four or five days of human pregnancy, the stage in which the highest percentage of pregnancies are lost, the study also has significant implications for fertility research.

Pluripotent stem cells can become any cell in the body and can be created in two ways. First, they can be produced when scientists reprogram mature adult cells. Second, they are created by embryos during this crucial four-day window of a mammalian pregnancy. In fact, this window is uniquely mammalian, said Amy Ralston, MSU assistant professor of biochemistry and molecular biology, and lead author on the study.

"Embryos make pluripotent stem cells with 100 percent efficiency," she said. "The process of reprogramming cells, manipulating our own cells to become stem cells, is merely 1 percent efficient. Embryos have it figured out, and we need to learn how they're doing it."

The researchers' first discovery is that in mouse embryos, the gene, Sox2, appears to be acting ahead of other genes traditionally identified as playing crucial roles in stem cell formation. Simply put, this gene could determine the source of stem cells in mammals. Now researchers are trying to decipher why Sox2 is taking the lead role.

"Now we know Sox2 is the first indicator that a cell is pluripotent," Ralston said. "In fact, Sox2 may be the pre-pluripotent gene. We show that Sox2 is detectable in just one or two cells of the embryo earlier than previously thought, and earlier than other known stem cell genes."

The second discovery is that Sox2 has broader influence than initially thought. The gene appears to help coordinate the cells that make the fetus and the other cells that establish the pregnancy and nurture the fetus.

Future research will focus on studying exactly why Sox2 is playing this role. The team has strong insights, but they want to go deeper, Ralston said.

"Reprogramming is amazing, but it's inefficient," she said. "What we've learned from the embryo is how to improve efficiency, a process that could someday lead to generating stem cells for clinical purposes with a much higher success rate."

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Identifying the source of stem cells

UCLA Gene Discovery Shows How Stem Cells Can Be Activated to Help Immune System Respond to Infection

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Newswise In a study led by Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research member Dr. Julian Martinez-Agosto, UCLA scientists have shown that two genes not previously known to be involved with the immune system play a crucial role in how progenitor stem cells are activated to fight infection. This discovery lays the groundwork for a better understanding of the role progenitor cells can play in immune system response and could lead to the development of more effective therapies for a wide range of diseases.

The two-year study was published online October 30, 2014 ahead of print in the journal Current Biology.

Progenitor cells are the link between stem cells and fully differentiated cells of the blood system, tissues and organs. This maturation process, known as differentiation, is determined in part by the original environment that the progenitor cell came from, called the niche. Many of these progenitors are maintained in a quiescent state or "standby mode" and are ready to differentiate in response to immune challenges (such as stress, infection or disease).

Dr. Gabriel Ferguson, a postdoctoral fellow in the lab of Dr. Martinez-Agosto and first author of the study, built upon the lab's previous research that utilized the blood system of the fruit fly species Drosophila, showing that a specific set of signals must be received by progenitor cells to activate their differentiation into cells that can work to fight infection after injury. Dr. Ferguson focused on two genes previously identified in stem cells but not in the blood system, named Yorkie and Scalloped, and discovered that they are required in a newly characterized cell type called a lineage specifying cell. These cells then essentially work as a switch, sending the required signal to progenitor cells.

The researchers further discovered that when the progenitor cells did not receive the required signal, the fly would not make the mature cells required to fight infection. This indicates that the ability of the blood system to fight outside infection and other pathogens is directly related to the signals sent by this new cell type.

"The beauty of this study is that we now have a system in which we can investigate how a signaling cell uses these two genes Yorkie and Scalloped, which have never before been shown in blood, to direct specific cells to be made," said Dr. Martinez-Agosto, associate professor of human genetics. "It can help us to eventually answer the question of how our body knows how to make specific cell types that can fight infection."

Drs. Martinez-Agosto and Ferguson and colleagues next hope that future studies will examine these genes beyond Drosophila and extend to mammalian models, and that the system will be used by the research community to study the role of the genes Yorkie and Scalloped in different niche environments.

"At a biochemical level, there is a lot of commonality between the molecular machinery in Drosophila and that in mice and humans," said Dr. Ferguson. "This study can further our shared understanding of how the microenvironment can regulate the differentiation and fate of a progenitor or stem cell."

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UCLA Gene Discovery Shows How Stem Cells Can Be Activated to Help Immune System Respond to Infection

New Valley Medical program collects umbilical cord blood

UW Medicine/Valley Medical Center and Puget Sound Blood Center (PSBC) have joined together in a program to collect umbilical cord blood from new mothers who have just given birth. Cord blood is an important source of stem cells that can be used in lifesaving cancer treatment and research.

At the birth center here at Valley Medical Center, we have always been dedicated to providing comprehensive, high quality healthcare for the community we serve, said Judy Roudebush, vice president of Womens and Childrens Services at Valley Medical Center, in a press release. This new partnership between Valley and PSBC will help us to continue to expand care options for our community.

Cord blood is the blood remaining in the umbilical cord and placenta after the birth of a baby. Once considered a waste product that was discarded, umbilical cord blood is now known to be rich in life-saving hematopoietic stem cells the parent cells of all blood cells. About 150 milliliters of cord blood can be collected from each placenta and umbilical cord.

This program provides new moms with an opportunity to save lives at the same time they are bringing a new life into the world, remarked Donna Russell, principal at Donna Russell Consulting, LLC and Cchair of the Valley Medical Center Board of Trustees.

Cord blood collection is a painless procedure that does not interfere with the birth, or with mother-and-child bonding following delivery. There is no risk to either the mother or baby, and no cost associated with the donation. Families interested in donating cord blood at Valley Medical Center have several options for enrollment, depending on the babys due date.

We welcome this opportunity to partner with healthcare providers at Valley Medical Center to introduce a new on-site cord blood collection program, said Dr. James P. AuBuchon, president and CEO of PSBC. Cord blood is an important source for stem cell transplants that can be used to treat patients with leukemia, lymphoma and some metabolic or immune system disorders.

Families interested in donating cord blood should speak to their healthcare providers about how to make arrangements.

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New Valley Medical program collects umbilical cord blood

Human Stomach Made in the Lab Using Stem Cells

Using pluripotent stem cells researchers have been able to build a mini stomach in the lab.REUTERS

In a first, a miniature stomach was created in the lab by scientists using stem cells.

Pluripotent stem cells that can grow into any cell type were used by scientists at Cincinnati Children's Hospital Medical Center to generate the artificial stomach.

The scientists identified the steps in stomach formation in the human embryo and by manipulating these in a petri dishwere able to coax the stem cells to form a mini stomachmeasuring 3 mm in diameter.

They then studied how h.pylori bacteria affected stomach tissues and spread rapidly. The bacteria is responsible for peptic ulcer and stomach cancer.

This first-time molecular generation of a 3D human stomach (called gastric organoid) presents new opportunities for drug discovery, modelling early stages of stomach cancer and studying some of the underpinnings of obesity related diabetes, according to Jim Wells, PhD, principal investigator and a scientist in the divisions of Developmental Biology and Endocrinology at Cincinnati Children's.

The work was conducted in collaboration with researchers at the University of Cincinnati College of Medicine.

The discovery of how to promote formation of three-dimensional gastric tissue with complex architecture and cellular composition is important as mouse models are sometimes not the best fit when studying human ailments, the team said.

The human gastric organoids will be useful to identify biochemical processes in the gut that allow gastric-bypass patients to become diabetes-free soon after surgery before losing significant weight.

Obesity fuelled diabetes and metabolic syndrome are public health challenges, addressing which has been difficult due to lack of reliable laboratory modelling systems.

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Human Stomach Made in the Lab Using Stem Cells

First human stomach tissue grown in lab

US researchers generated functional, three-dimensional human stomach tissue to create miniature stomachs using pluripotent stem cells in a laboratory.

Human pluripotent stem cells can transform into any cell type in the body.

"Until this study, no one had generated gastric cells from human pluripotent stem cells (hPSCs)," said Jim Wells, principal investigator and a scientist at Cincinnati Children's Hospital Medical Center.

"In addition, we discovered how to promote formation of three-dimensional gastric tissue with complex architecture and cellular composition," Wells added.

"This first-time molecular generation of 3D human gastric organoids (hGOs) presents new opportunities for drug discovery, modelling early stages of stomach cancer and studying some of the underpinnings of obesity related diabetes," Wells said.

Differences between species in the embryonic development and architecture of the adult stomach make mouse models less than optimal for studying human stomach development and disease, Wells pointed out.

The key to growing human gastric organoids was to identify the steps involved in normal stomach formation during embryonic development.

By manipulating these normal processes in a petri dish, the scientists were able to coax pluripotent stem cells into becoming stomach cells.

Over the course of a month, these steps resulted in the formation of 3D human gastric organoids that were about 3 mm (1/10th of an inch) in diameter.

The study appeared in the journal Nature.

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First human stomach tissue grown in lab

Seminar on Regenerative Medicine Open to Public

JACKSON, Tenn. (PRWEB) October 30, 2014

Dr. Roy Schmidt and the staff of the Pain Specialist Center will host a free seminar and question-and-answer session about regenerative medicine on Tuesday, Nov. 11 at 6 p.m. Held at the clinic at 15 Stonebridge Blvd. in Jackson, the hour-long event will allow attendees to ask questions about stem cell therapy and platelet rich plasma therapy in a relaxed atmosphere. Guests also will have the chance to talk to individuals who have received regenerative medicine treatments, which focus on helping patients relieve pain by supporting the healing process.

Stem cell therapy focuses on delivering the patients own stem cells to parts of the body that are in need. After adipose tissue (comprised of fat cells) is taken from the patients body, it is made into a stem cell concentrate. That concentrate is injected at the focal point of pain or area that needs healing. Schmidt, who is certified to administer stem cell therapy, was trained by Bioheart Chief Scientific Officer Kristin Comella. Comella has been recognized as a national leader in stem cell therapy.

Platelet rich plasma (PRP) or platelet concentrates have been studied extensively since the 1990s. While similar products previously used in medicine (fibrin glue) were very expensive, PRP provides a cost-effective alternative. Plasma concentrates seek to help the body continue the healing process and strengthen the weakened tissue. It is often used for tendon problems, in addition to issues with ligaments, muscles, meniscus, cartilage, bone, wound and intervertebral discs. The supplemental role of hyperbaric oxygen therapy will be discussed at the event, also.

A board certified anesthesiologist, Schmidt has practiced pain management in the Jackson area for two decades. The Pain Specialist Center provides consultation and pain management services to patients suffering from chronic pain syndromes and terminal cancer pain. Individuals can learn more by going online to http://beyondpills.com, http://nopainmd.com and http://hyperbaricoxygentherapies.com, calling 731-660-2056 or e-mailing info(at)beyondpills(dot)com. Event information is on Facebook at http://www.facebook.com/PainSpecialistCenter.

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Seminar on Regenerative Medicine Open to Public

Mechanism that allows differentiated cell to reactivate as a stem cell revealed

One kind of stem cell, those referred to as 'facultative', form part -- together with other cells -- of tissues and organs. There is apparently nothing that differentiates these cells from the others. However, they have a very special characteristic, namely they retain the capacity to become stem cells again. This phenomenon is something that happens in the liver, an organ that hosts cells that stimulate tissue growth, thus allowing the regeneration of the organ in the case of a transplant. Knowledge of the underlying mechanism that allows these cells to retain this capacity is a key issue in regenerative medicine.

Headed by Jordi Casanova, research professor at the Instituto de Biologa Molecular de Barcelona (IBMB) of the CSIC and at IRB Barcelona, and by Xavier Franch-Marro, CSIC tenured scientist at the Instituto de Biologa Evolutiva (CSIC-UPF), a study published in the journal Cell Reports reveals a mechanism that could explain this capacity. Working with larval tracheal cells of Drosophila melanogaster, these authors report that the key feature of these cells is that they have not entered the endocycle, a modified cell cycle through which a cell reproduces its genome several times without dividing.

"The function of endocycle in living organisms is not fully understood," comments Xavier Franch-Marro. "One of the theories is that endoreplication contributes to enlarge the cell and confers the production of high amounts of protein." This is the case of almost all larval cells of Drosophila.

The scientists have observed that the cells that enter the endocycle lose the capacity to reactivate as stem cells. "The endocycle is linked to an irreversible change of gene expression in the cell," explains Jordi Casanova, "We have seen that inhibition of endocycle entry confers the cells the capacity to reactivate as stem cells."

Cell entry into the endocycle is associated with the expression of the Fzr gene. The researchers have found that inhibition of this gene prevents this entry, which in turn leads to the conversion of the cell into an adult progenitor that retains the capacity to reactivate as a stem cell. Therefore, this gene acts as a switch that determines whether a cell will enter mitosis (the normal division of a cell) or the endocycle, the latter triggering a totally different genetic program with a distinct outcome regarding the capacity of a cell to reactivate as a stem cell.

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The above story is based on materials provided by Institute for Research in Biomedicine (IRB Barcelona). Note: Materials may be edited for content and length.

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Mechanism that allows differentiated cell to reactivate as a stem cell revealed