Category Archives: Adult Stem Cells

What we learn from a fish that can change sex in just 10 days – The Conversation AU

The bluehead wrasse is a fish that lives in small social groups in coral reefs in the Caribbean. Only the male has a blue head signalling his social dominance over a harem of yellow-striped females.

If this male is removed from the group, something extraordinary happens: the largest female in the group changes sex to become male. Her behaviour changes within minutes. Within ten days, her ovaries transform into sperm-producing testes. Within 21 days she appears completely male.

But how does the wrasse change sex, and why did evolution select this system?

Also, given that fish share sex-determining genes with mammals, would an understanding of this provide new insight into how sex works in humans and other animals?

The trigger for sex change in the bluehead wrasse and some other species is social. When the male fish is removed, the largest female immediately senses his absence and adopts full male breeding behaviours the same day.

How this social cue translates into molecular action remains a bit of a mystery, but it probably involves stress. High levels of the stress hormone cortisol are associated with temperature-based sex determination in other fish and reptiles. Cortisol probably alters reproductive function by impacting sex hormone levels.

Stress could be the unifying mechanism that channels environmental information into a change in sex.

Our research traced changes in the activity of all 20,000-odd bluehead wrasse genes during the female to male transformation.

Read more: Sex lives of reptiles could leave them vulnerable to climate change

Unsurprisingly, we found the gene that produces the female hormone (estrogen) rapidly shuts off, and genes responsible for making male hormones (androgens) are turned on.

Hundreds of other genes required for being female (including genes that make egg components) also progressively shut down, while genes required for maleness (including genes that make sperm components) turn on.

We also noticed changes in the activity of developmentally important genes whose roles in sex determination remain unknown. This included genes known to epigenetically regulate the activity of other genes.

Epigenetics refers to regulation above the gene. For example, there are many fish and reptile species in which the sex of developing embryos is determined by environmental cues, such as the temperature at which eggs are incubated. The sex is not determined by different genes, but by the environment impacting the activity of these genes.

Similar mechanisms regulate adult sex change in fish, so this may be important in translating the social cue into molecular action.

Surprisingly, we saw the turn-on of some powerful genes that are active in embryos and stem cells. These genes keep cells in a neutral embryo-like state, from which they can mature (differentiate) into any tissue type. They can also revert differentiated cells to an embryo-like state.

This suggests that transitioning from ovaries to testes in wrasse involves reversing the cell differentiation process something scientists have argued about for decades.

Researchers have identified more than 500 fish species that regularly change sex as adults.

Clown fish begin life as males, then change into females, and kobudai do the opposite. Some species, including gobies, can change sex back and forth. The transformation may be triggered by age, size, or social status.

Read more: Climate change can tip the gender balance, but fish can tip it back

Sex change is an advantage when an individuals reproductive value is greater as one sex when it is small, and greater as the other sex when it grows bigger.

If females benefit more than males from being larger (because they can lay more eggs), male-to-female sex change is most advantageous. But if (as for wrasse) males gain more from being large, because they can better defend their breeding territories and mate with many females, female-to-male sex change is optimal.

Sex change might also advantage a population recovering from overfishing, which often targets larger fish and leaves the population deficient in one sex. Thus, a mechanism for replacing the missing sex would be an advantage.

Male and female wrasse differ in size, colour, behaviour, but especially in their reproductive organs the ovary and testes.

Sex change in the wrasse involves complete remodelling of the gonad from an ovary producing eggs to a testis producing sperm.

This differs from other fish that routinely change sex when they get big enough. Their gonads contain both male and female tissues, and sex change occurs when one outgrows the other. So, fish employ all sorts of strategies to get the most out of sex.

In contrast, humans and other mammals determine sex via a gene on the male-only Y chromosome. This gene triggers the formation of testes in the embryo, which unleash male hormones and direct male development of the baby.

Read more: What makes you a man or a woman? Geneticist Jenny Graves explains

The human sex system is nowhere near as flexible as that of fish or reptiles. There is no evidence any environmental factors influence the sex determination of mammalian embryos, let alone cause sex change in adults.

That said, humans share with all vertebrates (including fish) about 30 genes that control ovary or testis differentiation. Mutation in any of these genes can tilt development toward male or female, resulting in atypical sexual development, but never sex change.

Perhaps an understanding of epigenetic changes in fish sex can offer us valuable insight, as we wrestle with new ideas about human sex and gender.

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What we learn from a fish that can change sex in just 10 days - The Conversation AU

Stem cells: Sources, types, and uses

Cells in the body have specific purposes, but stem cells are cells that do not yet have a specific role and can become almost any cell that is required.

Stem cells are undifferentiated cells that can turn into specific cells, as the body needs them.

Scientists and doctors are interested in stem cells as they help to explain how some functions of the body work, and how they sometimes go wrong.

Stem cells also show promise for treating some diseases that currently have no cure.

Stem cells originate from two main sources: adult body tissues and embryos. Scientists are also working on ways to develop stem cells from other cells, using genetic "reprogramming" techniques.

A person's body contains stem cells throughout their life. The body can use these stem cells whenever it needs them.

Also called tissue-specific or somatic stem cells, adult stem cells exist throughout the body from the time an embryo develops.

The cells are in a non-specific state, but they are more specialized than embryonic stem cells. They remain in this state until the body needs them for a specific purpose, say, as skin or muscle cells.

Day-to-day living means the body is constantly renewing its tissues. In some parts of the body, such as the gut and bone marrow, stem cells regularly divide to produce new body tissues for maintenance and repair.

Stem cells are present inside different types of tissue. Scientists have found stem cells in tissues, including:

However, stem cells can be difficult to find. They can stay non-dividing and non-specific for years until the body summons them to repair or grow new tissue.

Adult stem cells can divide or self-renew indefinitely. This means they can generate various cell types from the originating organ or even regenerate the original organ, entirely.

This division and regeneration are how a skin wound heals, or how an organ such as the liver, for example, can repair itself after damage.

In the past, scientists believed adult stem cells could only differentiate based on their tissue of origin. However, some evidence now suggests that they can differentiate to become other cell types, as well.

From the very earliest stage of pregnancy, after the sperm fertilizes the egg, an embryo forms.

Around 35 days after a sperm fertilizes an egg, the embryo takes the form of a blastocyst or ball of cells.

The blastocyst contains stem cells and will later implant in the womb. Embryonic stem cells come from a blastocyst that is 45 days old.

When scientists take stem cells from embryos, these are usually extra embryos that result from in vitro fertilization (IVF).

In IVF clinics, the doctors fertilize several eggs in a test tube, to ensure that at least one survives. They will then implant a limited number of eggs to start a pregnancy.

When a sperm fertilizes an egg, these cells combine to form a single cell called a zygote.

This single-celled zygote then starts to divide, forming 2, 4, 8, 16 cells, and so on. Now it is an embryo.

Soon, and before the embryo implants in the uterus, this mass of around 150200 cells is the blastocyst. The blastocyst consists of two parts:

The inner cell mass is where embryonic stem cells are found. Scientists call these totipotent cells. The term totipotent refer to the fact that they have total potential to develop into any cell in the body.

With the right stimulation, the cells can become blood cells, skin cells, and all the other cell types that a body needs.

In early pregnancy, the blastocyst stage continues for about 5 days before the embryo implants in the uterus, or womb. At this stage, stem cells begin to differentiate.

Embryonic stem cells can differentiate into more cell types than adult stem cells.

MSCs come from the connective tissue or stroma that surrounds the body's organs and other tissues.

Scientists have used MSCs to create new body tissues, such as bone, cartilage, and fat cells. They may one day play a role in solving a wide range of health problems.

Scientists create these in a lab, using skin cells and other tissue-specific cells. These cells behave in a similar way to embryonic stem cells, so they could be useful for developing a range of therapies.

However, more research and development is necessary.

To grow stem cells, scientists first extract samples from adult tissue or an embryo. They then place these cells in a controlled culture where they will divide and reproduce but not specialize further.

Stem cells that are dividing and reproducing in a controlled culture are called a stem-cell line.

Researchers manage and share stem-cell lines for different purposes. They can stimulate the stem cells to specialize in a particular way. This process is known as directed differentiation.

Until now, it has been easier to grow large numbers of embryonic stem cells than adult stem cells. However, scientists are making progress with both cell types.

Researchers categorize stem cells, according to their potential to differentiate into other types of cells.

Embryonic stem cells are the most potent, as their job is to become every type of cell in the body.

The full classification includes:

Totipotent: These stem cells can differentiate into all possible cell types. The first few cells that appear as the zygote starts to divide are totipotent.

Pluripotent: These cells can turn into almost any cell. Cells from the early embryo are pluripotent.

Multipotent: These cells can differentiate into a closely related family of cells. Adult hematopoietic stem cells, for example, can become red and white blood cells or platelets.

Oligopotent: These can differentiate into a few different cell types. Adult lymphoid or myeloid stem cells can do this.

Unipotent: These can only produce cells of one kind, which is their own type. However, they are still stem cells because they can renew themselves. Examples include adult muscle stem cells.

Embryonic stem cells are considered pluripotent instead of totipotent because they cannot become part of the extra-embryonic membranes or the placenta.

Stem cells themselves do not serve any single purpose but are important for several reasons.

First, with the right stimulation, many stem cells can take on the role of any type of cell, and they can regenerate damaged tissue, under the right conditions.

This potential could save lives or repair wounds and tissue damage in people after an illness or injury. Scientists see many possible uses for stem cells.

Tissue regeneration is probably the most important use of stem cells.

Until now, a person who needed a new kidney, for example, had to wait for a donor and then undergo a transplant.

There is a shortage of donor organs but, by instructing stem cells to differentiate in a certain way, scientists could use them to grow a specific tissue type or organ.

As an example, doctors have already used stem cells from just beneath the skin's surface to make new skin tissue. They can then repair a severe burn or another injury by grafting this tissue onto the damaged skin, and new skin will grow back.

In 2013, a team of researchers from Massachusetts General Hospital reported in PNAS Early Edition that they had created blood vessels in laboratory mice, using human stem cells.

Within 2 weeks of implanting the stem cells, networks of blood-perfused vessels had formed. The quality of these new blood vessels was as good as the nearby natural ones.

The authors hoped that this type of technique could eventually help to treat people with cardiovascular and vascular diseases.

Doctors may one day be able to use replacement cells and tissues to treat brain diseases, such as Parkinson's and Alzheimer's.

In Parkinson's, for example, damage to brain cells leads to uncontrolled muscle movements. Scientists could use stem cells to replenish the damaged brain tissue. This could bring back the specialized brain cells that stop the uncontrolled muscle movements.

Researchers have already tried differentiating embryonic stem cells into these types of cells, so treatments are promising.

Scientists hope one day to be able to develop healthy heart cells in a laboratory that they can transplant into people with heart disease.

These new cells could repair heart damage by repopulating the heart with healthy tissue.

Similarly, people with type I diabetes could receive pancreatic cells to replace the insulin-producing cells that their own immune systems have lost or destroyed.

The only current therapy is a pancreatic transplant, and very few pancreases are available for transplant.

Doctors now routinely use adult hematopoietic stem cells to treat diseases, such as leukemia, sickle cell anemia, and other immunodeficiency problems.

Hematopoietic stem cells occur in blood and bone marrow and can produce all blood cell types, including red blood cells that carry oxygen and white blood cells that fight disease.

People can donate stem cells to help a loved one, or possibly for their own use in the future.

Donations can come from the following sources:

Bone marrow: These cells are taken under a general anesthetic, usually from the hip or pelvic bone. Technicians then isolate the stem cells from the bone marrow for storage or donation.

Peripheral stem cells: A person receives several injections that cause their bone marrow to release stem cells into the blood. Next, blood is removed from the body, a machine separates out the stem cells, and doctors return the blood to the body.

Umbilical cord blood: Stem cells can be harvested from the umbilical cord after delivery, with no harm to the baby. Some people donate the cord blood, and others store it.

This harvesting of stem cells can be expensive, but the advantages for future needs include:

Stem cells are useful not only as potential therapies but also for research purposes.

For example, scientists have found that switching a particular gene on or off can cause it to differentiate. Knowing this is helping them to investigate which genes and mutations cause which effects.

Armed with this knowledge, they may be able to discover what causes a wide range of illnesses and conditions, some of which do not yet have a cure.

Abnormal cell division and differentiation are responsible for conditions that include cancer and congenital disabilities that stem from birth. Knowing what causes the cells to divide in the wrong way could lead to a cure.

Stem cells can also help in the development of new drugs. Instead of testing drugs on human volunteers, scientists can assess how a drug affects normal, healthy tissue by testing it on tissue grown from stem cells.

Watch the video to find out more about stem cells.

There has been some controversy about stem cell research. This mainly relates to work on embryonic stem cells.

The argument against using embryonic stem cells is that it destroys a human blastocyst, and the fertilized egg cannot develop into a person.

Nowadays, researchers are looking for ways to create or use stem cells that do not involve embryos.

Stem cell research often involves inserting human cells into animals, such as mice or rats. Some people argue that this could create an organism that is part human.

In some countries, it is illegal to produce embryonic stem cell lines. In the United States, scientists can create or work with embryonic stem cell lines, but it is illegal to use federal funds to research stem cell lines that were created after August 2001.

Some people are already offering "stem-cells therapies" for a range of purposes, such as anti-aging treatments.

However, most of these uses do not have approval from the U.S. Food and Drug Administration (FDA). Some of them may be illegal, and some can be dangerous.

Anyone who is considering stem-cell treatment should check with the provider or with the FDA that the product has approval, and that it was made in a way that meets with FDA standards for safety and effectiveness.

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Stem cells: Sources, types, and uses

If you want to ban fetal tissue research, sign a pledge to refuse its benefits – The Coloradoan

Irving Weissman and Joseph McCune, Opinion contributors Published 5:00 a.m. MT Jan. 24, 2020

Severe Trump administration restrictions mean millions of Americans of all political and religious stripes won't benefit from fetal tissue research.

Last summer the Trump administration curtailed federal funding of medical research using human fetal tissue; the new rulestook effect Oct. 1. More recently, the administration addedrestrictions that are even more severe.

Immediately, important work at two NIH-supported labs in Montana and California that are fighting the AIDS epidemic stopped because they were testing new medications against HIV using mice with human immune systems derived from human fetal tissue. In the near term, all National Institutes of Health (NIH) funding of research using fetal tissuewill likely cease.

More than 30years ago, we invented SCID-hu mice for biomedical research on diseases affecting humans, by implanting human fetal blood-forming and immune system tissuesinto mice whose immune systems had been silenced. The implanted immune tissues came from an aborted fetus, and allowed our otherwise immune-deficient mice to exist and be vulnerable to viruses that infect humans.

Tissues from living infants would not have worked;they are too far along in development and nearly impossible to obtain. This mouse model (and later versions of it) became the only living system, outside of a human, in which advanced therapies for diseases like AIDS and other viral infections could be evaluated before they were given to people.

Our work with human fetal tissue proceeded with the highest level of caution and vigilance. We received advice from bioethicists, clergyand government officials, which led to the establishment of strict guidelines that are still used today. No woman was asked or paid to terminate a pregnancy, the termination process was unaltered, and the women were asked for donation of the organs only after they had decided to terminate the pregnancy. Thus, obtaining the fetal tissue for medical research had no impact on ending pregnancies.

Since then, mice with transplanted human fetal tissues have been successfully used by scientists to identify blood stem cells and to devise treatments now availableor in clinical trialsfor cancer, various viral infections, Alzheimers disease, spinal cord injuries, and other diseases of the nervous system. Such diseases kill or cripple many Americans including pregnant women, fetusesand newborn infants. Many of them have only a short window of opportunity wherein a new therapy can treat them, and a delay can be fatal.

National Institutes of Health in Bethesda, Maryland, on Oct. 21, 2013.(Photo: *, Kyodo)

The Trump administration's new rules are tantamount to a funding ban. In academic labs, the experiments are done by students and fellows in training, and the new rules block any NIH-funded students or fellows from working with human fetal tissue. Those who imposed the banmust bear responsibility for the consequences: People will suffer and die for lack of adequate treatments.

Americans pay the price:Trump administration's 'scientific oppression' threatens US safety and innovation

At a December 2018 meeting at NIH,after hearing scientific evidence about alternative research methods such as the use of adult cells, experts concluded that the use of fetal tissue is uniquely valuable. Nonetheless, the administration severely restricted the use of fetal tissue, thereby denying millions of Americans the fruits of such research Americans of all political stripes, since deadly viruses and cancers do not care who you vote for.

These restrictions subvert the NIH mission, which is to advance medicine and protect the nations health. To the extent that it was motivated by the religious beliefs of those in charge, it bluntly transgresses the American principle of separation of church and state. As a result, both believers and non-believers will die.

Of course, all who take the Hippocratic Oathto "do no harm,"which includes all medical doctors, will always offer and deliver all types of therapies that are available.

Restricting science: Trump EPA's cynical 'transparency' ploy would set back pollution science and public health

However, we believe that thoseresponsible forthis de facto ban, and perhapsthose who agree with them, should personally accept its consequences. We challenge them tobe true to their beliefs. They should pledge to never accept any cancer therapy, any AIDS medication, any cardiac drug, any lung disease treatment, any Alzheimers therapy, or any other medical advance that was developed using fetal tissue including our mice. Its a long list, one that you can learn about from us here. Should this apply to you, be faithful and be bold: Take the pledge.

Irving Weissman is a Professor of Pathology and Developmental Biology and the Director of the Stanford Institute of Stem Cell Biology and Regenerative Medicine and Ludwig Center for Cancer Stem Cell at Stanford University School of Medicine. Joseph McCune is Professor Emeritus of Medicine from the Division of Experimental Medicine at the University of California, San Francisco. The views expressed here are solely their own.

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If you want to ban fetal tissue research, sign a pledge to refuse its benefits - The Coloradoan

Tiny organs grown from snake glands produce real venom – Science Magazine

Researchers grew tiny venom glands from nine different snake species, including the cape coral cobra.

By Erin MalsburyJan. 23, 2020 , 11:00 AM

Venomous snakes kill or permanently injure more than a half-million people every year. Yet researchers still know surprisingly little about the biology behind venom, complicating efforts to develop treatments. A new advance could help: Researchers have successfully grown miniature organs from snake stem cells in the lab that function just like snake venom glands; they even produce real venom.

Its a breakthrough, says Jos Mara Gutirrez, a snake venom toxicologist at the University of Costa Rica, San Jos, who was not involved in the study. This work opens the possibilities for studying the cellular biology of venom-secreting cells at a very fine level, which has not been possible in the past. The advance could also help researchers study the venom of rare snakes that are difficult to keep in captivity, he says, paving the way for new treatments for a variety of venoms.

Researchers have been creating miniorgansor organoidsfrom adult human and mouse stem cells for years. These so-called pluripotent cells are able to divide and grow into new types of tissues throughout the body; scientists have coaxed them into tiny livers, guts, and even rudimentary brains. But scientists hadnt tried the technique with reptile cells before.

Nobody knew anything about stem cells in snakes, says Hans Clevers, a molecular biologist at the Hubrecht Institute and one of the worlds leading organoid scientists. We didnt know if it was possible at all. To find out, Clevers and colleagues removed stem cells from the venom glands of nine snake speciesincluding the cape coral cobra and the western diamondback rattlesnakeand placed them in a cocktail of hormones and proteins called growth factors.

To the teams surprise, the snake stem cells responded to the same growth factors that work on human and mouse cells. This suggests certain aspects of these stem cells originated hundreds of millions of years ago in a shared ancestor of mammals and reptiles.

Miniature, lab-grown snakevenom glands

By the end of 1 week submerged in the cocktail, the snake cells had grown into little clumps of tissue, a half-millimeter across and visible to the human eye. When the scientists removed the growth factors, the cells began to morph into the epithelial cells that produce venom in the glands of snakes.The miniorgans expressed similar genes as those in real venom glands, the team reports today inCell.

The snake organoids even produced venom; a chemical and genetic analysis of the secretions revealed that they match the venom made by the real snakes. The labmade venom is dangerous as well: It disrupted the function of mouse muscle cells and rat neurons in a similar way to real venom.

Scientists didnt know whether the many toxins found in snake venom are made by one general type of cell or specialized, toxin-specific cells. By sequencing RNA in individual cells and examining gene expression, Cleverss team determined that both real venom glands and organoids contain different cell types that specialize in producing certain toxins. Organoids grown using stem cells from separate regions of the venom gland also produce toxins in different proportions, indicating that location within the organ matters.

The proportions and types of toxins in venom differ amongand even withinspecies. That can be problematic for antivenom production, says study author Yorick Post, a molecular biologist at the Hubrecht Institute. Most antivenoms are developed using one type of venom, so they only work against one type of snakebite.

Now that Clevers and his colleagues created a way to study the complexity of venom and venom glands without handling live, dangerous snakes, they plan to compile a biobank of frozen organoids from venomous reptiles around the world that could help researchers find broader treatments. This would make it much easier to create antibodies, Clevers says. The biobank could also be a rich resource for identifying new drugs, he adds. (Scientists think snake venom may hold the keyfor treatments against pain, high blood pressure, and cancer, for instance.)

Another new study, published earlier this month inNature, could also help. Researchers have assembled anear-complete genome for the Indian cobrathat could aid drug development. The organoids created by Cleverss team will provide an unprecedented and incredibly important new avenue to complement genomic information for venomous snakes, says the senior author of the cobra study, molecular biologist Somasekar Seshagiri of the SciGenom Research Foundation. Theyve done an amazing job making this work.

*Correction, 23 January, 1:35 p.m.: An earlier version of this story misspelledSomasekar Seshagiri's name.

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Tiny organs grown from snake glands produce real venom - Science Magazine

Asymmetrex Partners in Manufacturing USA Institute January 23, 2020The Advanced Regenerative Manufacturing Institute – PR Web

BOSTON (PRWEB) January 23, 2020

Asymmetrex LLC is part of a new public-private Manufacturing USA initiative, the Advanced Regenerative Manufacturing Institute (ARMI). Headquartered in Manchester, New Hampshire, ARMI is the 12th Manufacturing USA Institute. ARMI brings together a consortium of over 100 partner organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs.

Approximately $80 million from the federal government will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities. As part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States, ARMI will lead the Advanced Tissue Biofabrication (ATB) Manufacturing USA Institute on behalf of the Department of Defense.

Under the umbrella of Manufacturing USA, a public-private network that invests in the development of world-leading manufacturing technologies, ARMI will work to integrate and organize the fragmented collection of industry practices and domestic capabilities in tissue Biofabrication technology to better position the US relative to global competition. ARMI will also focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.

We need to develop 21st century tools for engineered tissue manufacturing that will allow these innovations to be widely available similar to how a 15th century tool (the printing press) allowed knowledge to spread widely during the Renaissance, said inventor Dean Kamen, ARMIs chairman.

ARMIs efforts are supported by forty-seven industrial partners, twenty-six academic and academically affiliated partners, and fourteen government and nonprofit partners. The ARMI partnership continues to grow.

About AsymmetrexAsymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The companys patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the AlphaSTEM Test) for use in stem cell transplantation therapies and pre-clinical drug evaluations. For more information, please visit http://www.asymmetrex.com.

About ARMIThe Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of over 150 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit http://www.ARMIUSA.org.

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Asymmetrex Partners in Manufacturing USA Institute January 23, 2020The Advanced Regenerative Manufacturing Institute - PR Web

Genmab Announces European Marketing Authorization for DARZALEX (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontli…

Copenhagen, Denmark; January 20, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in December 2019. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

With this approval, newly diagnosed patients with multiple myeloma who are eligible for ASCT may have the opportunity for treatment with a DARZALEX-containing regimen. We are extremely pleased that DARZALEX has received this latest approval and we look forward to the combination of DARZALEX plus bortezomib, thalidomide and dexamethasone being launched in Europe, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval was based on the Phase III CASSIOPEIA (MMY3006) study sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. Data from this study was published in The Lancet and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

About the CASSIOPEIA (MMY3006) studyThis Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC, including 1,085 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or treatment with bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 16,830 new patients were expected to be diagnosed with multiple myeloma and approximately 10,480 people were expected to die from the disease in the Western Europe in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy6. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with core sites in Utrecht, the Netherlands and Princeton, New Jersey, U.S.

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Genmab Announces European Marketing Authorization for DARZALEX (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontli...

Video: In 40 years, babies could be made in the lab from skin cells – Genetic Literacy Project

The birds and the bees as we know them are changing. A new process called in vitro gametogenesis (IVG) is currently being developed, and if successful, it will completely transform the way humans think about reproduction.

In 20 to 40 years, people will still have sex. But when they want to make babies, theyll go to a lab, predicts Stanford University Professor Henry T. Greely. Its also the premise of his book The End of Sex and the Future of Human Reproduction.

The process of IVG creates sperm and egg cells in a lab from just about any adult cell. IVG uses skin or blood cells to reverse engineer a special type of cells calledinduced pluripotent stem cells(iPSCs).

IVG could eliminate the need for egg and sperm donors. With IVG, post-menopausal women could generate viable eggs. Same-sex couples could make a biological family. Virtually anyone with skin would have the ability to produce eggs or sperm.

Although 40 years might seem a lifetime away, theres a lot to figure out before we can safely, ethically, and responsibly add in vitro gametogenesis to our list of fertility treatment options.

Read full, original post: IVG: Making Babies From Skin Cells

See the article here:
Video: In 40 years, babies could be made in the lab from skin cells - Genetic Literacy Project

What meat eaters really think about veganism new research – The Conversation UK

Most people in the UK are committed meat eaters but for how long? My new research into the views of meat eaters found that most respondents viewed veganism as ethical in principle and good for the environment.

It seems that practical matters of taste, price, and convenience are the main barriers preventing more people from adopting veganism not disagreement with the fundamental idea. This could have major implications for the future of the food industry as meat alternatives become tastier, cheaper and more widely available.

My survey of 1,000 UK adult men and women found that 73% of those surveyed considered veganism to be ethical, while 70% said it was good for the environment. But 61% said adopting a vegan diet was not enjoyable, 77% said it was inconvenient, and 83% said it was not easy.

Other possible barriers such as health concerns and social stigma seemed not to be as important, with 60% considering veganism to be socially acceptable, and over half saying it was healthy.

The idea that most meat eaters agree with the principles of veganism might seem surprising to some. But other research has led to similar conclusions. One study for example, found that almost half of Americans supported a ban on slaughterhouses.

The prevalence of taste, price, and convenience as barriers to change also mirrors previous findings. One British survey found that the most common reason by far people gave for not being vegetarian is simply: I like the taste of meat too much. The second and third most common reasons related to the high cost of meat substitutes and struggling for meal ideas.

These findings present climate and animal advocates with an interesting challenge. People are largely aware that there are good reasons to cut down their animal product consumption, but they are mostly not willing to bear the personal cost of doing so.

Decades of food behaviour research has shown us that price, taste and convenience are the three major factors driving food choices. For most people, ethics and environmental impact simply do not enter into it.

Experimental research has also shown that the act of eating meat can alter peoples views of the morality of eating animals. One study asked participants to rate their moral concern for cows. Before answering, participants were given either nuts or beef jerky to snack on.

The researchers found that eating beef jerky actually caused participants to care less about cows. People seem not to be choosing to eat meat because they think there are good reasons to do so they are choosing to think there are good reasons because they eat meat.

In this way, the default widespread (and, lets be honest, enjoyable) behaviour of meat eating can be a barrier to clear reasoning about our food systems. How can we be expected to discuss this honestly when we have such a strong interest in reaching the conclusion that eating meat is okay?

Fortunately, things are changing. The range, quality, and affordability of vegan options has exploded. My survey was conducted in September 2018, a few months before the tremendously successful release of Greggs vegan sausage roll.

Since then, we have seen an avalanche of high-quality affordable vegan options released in the British supermarkets, restaurants and even fast food outlets. These allow meat eaters to easily replace animal products one meal at a time. When Subway offers a version of its meatball marinara that is compatible with your views on ethics and the environment, why would you choose the one made from an animal if the alternative tastes the same?

The widespread availability of these options means that the growing number of vegans, vegetarians and flexitarians in the UK have more choice than ever. Not only will this entice more people to try vegan options, but it will make it far easier for aspiring vegetarians and vegans to stick to their diets.

With consumer choice comes producer competition, and here we will see the magic of the market. If you think those looking to cut down their meat consumption are spoilt for choice in 2020, just wait to see the effect of these food giants racing to make their vegan offerings better and cheaper as they compete for a rapidly growing customer segment.

We may be about to witness an explosion in research to perfect plant-based meat analogues. Meanwhile, the development of real animal meat grown from stem cells without the animals is gaining pace.

While these replacements get tastier, more nutritious and cheaper over the next ten years, meat from animals will largely stay the same. It is no wonder the animal farming industry is nervous. Demand for meat and dairy is falling drastically while the market for alternatives has skyrocketed.

In the US, two major dairy producers have filed for bankruptcy in recent months, while a recent report estimated that the meat and dairy industries will collapse in the next decade.

This leaves the average meat eater with a dilemma. Most agree with the reasons for being vegan but object to the price, taste, and convenience of the alternatives.

As these alternatives get cheaper, better and more widespread, meat eaters will have to ask themselves just how good the alternatives need to be before they decide to consume in line with their values. Being one of the last people to pay for needless animal slaughter because the alternative was only pretty good will not be a good look in the near future.

Originally posted here:
What meat eaters really think about veganism new research - The Conversation UK

Here’s What Meat-Eaters Really Think of Veganism, According to a New Study – ScienceAlert

Most people in the UK are committed meat eaters but for how long? My new research into the views of meat eaters found that most respondents viewed veganism as ethical in principle and good for the environment.

It seems that practical matters of taste, price, and convenience are the main barriers preventing more people from adopting veganism not disagreement with the fundamental idea.

This could have major implications for the future of the food industry as meat alternatives become tastier, cheaper and more widely available.

My survey of 1,000 UK adult men and women found that 73 percent of those surveyed considered veganism to be ethical, while 70 percent said it was good for the environment.

But 61 percent said adopting a vegan diet was not enjoyable, 77 percent said it was inconvenient, and 83 percent said it was not easy.

Other possible barriers such as health concerns and social stigma seemed not to be as important, with 60 percent considering veganism to be socially acceptable, and over half saying it was healthy.

The idea that most meat eaters agree with the principles of veganism might seem surprising to some. But other research has led to similar conclusions. One study for example, found that almost half of Americans supported a ban on slaughterhouses.

The prevalence of taste, price, and convenience as barriers to change also mirrors previous findings. One British survey found that the most common reason by far people gave for not being vegetarian is simply: "I like the taste of meat too much." The second and third most common reasons related to the high cost of meat substitutes and struggling for meal ideas.

These findings present climate and animal advocates with an interesting challenge. People are largely aware that there are good reasons to cut down their animal product consumption, but they are mostly not willing to bear the personal cost of doing so.

Decades of food behaviour research has shown us that price, taste and convenience are the three major factors driving food choices. For most people, ethics and environmental impact simply do not enter into it.

Experimental research has also shown that the act of eating meat can alter peoples' views of the morality of eating animals. One study asked participants to rate their moral concern for cows. Before answering, participants were given either nuts or beef jerky to snack on.

The researchers found that eating beef jerky actually caused participants to care less about cows. People seem not to be choosing to eat meat because they think there are good reasons to do so they are choosing to think there are good reasons because they eat meat.

In this way, the default widespread (and, let's be honest, enjoyable) behaviour of meat eating can be a barrier to clear reasoning about our food systems. How can we be expected to discuss this honestly when we have such a strong interest in reaching the conclusion that eating meat is okay?

Fortunately, things are changing. The range, quality, and affordability of vegan options has exploded. My survey was conducted in September 2018, a few months before the tremendously successful release of Greggs' vegan sausage roll.

Since then, we have seen an avalanche of high-quality affordable vegan options released in the British supermarkets, restaurants and even fast food outlets. These allow meat eaters to easily replace animal products one meal at a time.

When Subway offers a version of its meatball marinara that is compatible with your views on ethics and the environment, why would you choose the one made from an animal if the alternative tastes the same?

The widespread availability of these options means that the growing number of vegans, vegetarians and flexitarians in the UK have more choice than ever. Not only will this entice more people to try vegan options, but it will make it far easier for aspiring vegetarians and vegans to stick to their diets.

With consumer choice comes producer competition, and here we will see the magic of the market. If you think those looking to cut down their meat consumption are spoilt for choice in 2020, just wait to see the effect of these food giants racing to make their vegan offerings better and cheaper as they compete for a rapidly growing customer segment.

We may be about to witness an explosion in research to perfect plant-based meat analogues. Meanwhile, the development of real animal meat grown from stem cells without the animals is gaining pace.

While these replacements get tastier, more nutritious and cheaper over the next ten years, meat from animals will largely stay the same. It is no wonder the animal farming industry is nervous. Demand for meat and dairy is falling drastically while the market for alternatives has skyrocketed.

In the US, two major dairy producers have filed for bankruptcy in recent months, while a recent report estimated that the meat and dairy industries will collapse in the next decade.

This leaves the average meat eater with a dilemma. Most agree with the reasons for being vegan but object to the price, taste, and convenience of the alternatives.

As these alternatives get cheaper, better and more widespread, meat eaters will have to ask themselves just how good the alternatives need to be before they decide to consume in line with their values. Being one of the last people to pay for needless animal slaughter because the alternative was only "pretty good" will not be a good look in the near future.

Chris Bryant, PhD Candidate, University of Bath.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Opinions expressed in this article don't necessarily reflect the views of ScienceAlert editorial staff.

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Here's What Meat-Eaters Really Think of Veganism, According to a New Study - ScienceAlert

Mutations in Donor Stem Cells Could Harm the Health of Patients with Cancer, Study Finds – Curetoday.com

Research findings show that rare mutations from donor stem cells can be passed onto patients who receive them, potentially causing health concerns.

Researchers from Washington University School of Medicine in St. Louis discovered this while analyzing bone marrow samples from 25 adult patients with acute myeloid leukemia (AML).

Heart damage, graft-versus-host disease and, potentially, new leukemias, are the risks associated with these mutations.

There have been suspicions that genetic errors in donor stem cells may be causing problems in cancer patients, but until now we didnt have a way to identify them because they are so rare, senior author Dr. Todd E. Druley, an associate professor of pediatrics, said in a news release. This study raises concerns that even young, healthy donors blood stem cells may have harmful mutations and provides strong evidence that we need to explore the potential effects of these mutations further.

The harmful mutations were found in surprisingly young donors, explained the researchers. Healthy donors ranged in age from 20 to 58, with an average age of 26 years old. Interestingly, the mutations, because they are so rare, were not detected using usual genome sequencing techniques.

In the study, the researchers sequenced 80 genes that are associated with AML using a technique called error-corrected sequencing. They found at least one harmful genetic mutation in 11 of the 25 donors. Eighty-four percent of the mutations identified in the donor samples were potentially harmful and 100% of the harmful mutations were found in the recipients the most common mutation seen is a gene associated with heart disease.

We didnt expect this many young, healthy donors to have these types of mutations, Druley said. We also didnt expect 100% of the harmful mutations to be engrafted into the recipients. That was striking.

These harmful mutations persisted over time, and many increased in frequency, explained the researchers.

In addition, 75% of patients who received at least one harmful mutation developed chronic graft-versus-host disease. In patients who didnt receive a mutation, 50% developed the condition. Graft-versus-host disease either acute or chronic, can occur in patients who receive an allogeneic transplant, which consists of donor stems cells versus a patients own stem cells.

The researchers plan to examine the mutations in a larger study to answer the questions that this study revealed.

Transplant physicians tend to seek younger donors because we assume this will lead to fewer complications co-author Dr. Sima T. Bhatt, an assistant professor of pediatrics who treats pediatric patients with blood cancers at Siteman Kids at St. Louis Childrens Hospital and Washington University School of Medicine, said in a news release. But we now see evidence that even young and healthy donors can have mutations that will have consequences for our patients. We need to understand what those consequences are if we are to find ways to modify them.

Originally posted here:
Mutations in Donor Stem Cells Could Harm the Health of Patients with Cancer, Study Finds - Curetoday.com