First ever phase 3 program of psilocybin therapy globally scheduled to begin in 2022 First ever phase 3 program of psilocybin therapy globally scheduled to begin in 2022

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COMPASS Pathways Announces Phase 3 Pivotal Program Design for COMP360 in Treatment Resistant Depression at Capital Markets Day

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CALGARY, Alberta, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Biosenta Inc. (the “Company” or “Biosenta”) (CSE: ZRO) has signed a milestone Memorandum of Understanding dated October 5, 2022, with VORAN GROUP VENTURES Ltd. (“Voran”) which will lead the way for the commercialization of Biosenta’s Tri-Filler® antimicrobial products in Canadian markets and worldwide.

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Biosenta Inc. Enters into an MOU with Voran Group Ventures Ltd. to collaborate on the commercialization of Biosenta’s Tri-Filler® Products

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WALTHAM, Mass., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Invivyd, (Nasdaq: IVVD), formerly Adagio Therapeutics (Nasdaq: ADGI), a clinical-stage biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases announced today that it will have four poster presentations at ID Week 2022. The posters will share findings from several studies surrounding adintrevimab, including data from the Phase 1 and Phase 2/3 clinical trials.

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Invivyd to Present Multiple Posters Highlighting Clinical Data from Adintrevimab During ID Week 2022

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BOSTON, Oct. 12, 2022 (GLOBE NEWSWIRE) -- AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, announced today that, as disclosed on uspto.gov, the United States Patent and Trademark Office (“USPTO”) has allowed U.S. Patent Application No. 17/720,619, titled “Use of Tivozanib to Treat Subjects with Refractory Cancer” (the “Application”). AVEO expects to receive a Notice of Allowance for this Application. This Application will potentially issue as a patent in 2022 and will provide patent protection in the United States for the claimed methods of use of FOTIVDA into 2039.

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U.S. Patent & Trademark Office Allows AVEO Oncology’s Patent Application Covering Use of FOTIVDA® for the Treatment of Refractory Advanced...

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NEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox.

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SIGA Provides Update on Progress in Clinical Trials to Assess Use of TPOXX ® (tecovirimat) for Treatment of Monkeypox

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SOUTH SAN FRANCISCO, Calif., Oct. 12, 2022 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human genetics and biopharmaceutical company with a mission to help people access, understand, and benefit from the human genome, announced today that management will be participating in investor presentations at the following conferences:

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23andMe to Present at Upcoming Investor Conferences

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Company expects to commence patient enrollment and dosing in Q1 2023 Company expects to commence patient enrollment and dosing in Q1 2023

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AIM ImmunoTech Announces FDA Clearance of IND Application to Evaluate Ampligen® in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

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•  No safety concerns noted in ongoing clinical trial•  Study timeline remains on track

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Ocugen Announces Completion of Dosing in OCU400 Phase 1/2 Cohort 2

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MISSISSAUGA, Ontario, Oct. 12, 2022 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) is pleased to announce that its Board of Directors has declared a quarterly dividend of $0.04 per common share, payable in Canadian Dollars on December 15, 2022, to shareholders of record at the close of business on November 30, 2022. This dividend qualifies as an 'eligible dividend' for Canadian income tax purposes. The declaration, timing, amount and payment of future dividends remain at the discretion of the Board of Directors.

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BioSyent Initiates First Dividend

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PHILADELPHIA, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Enterin Inc., a privately held, Philadelphia-based, clinical-stage biopharmaceutical company developing novel treatments for neurodegenerative and metabolic diseases announces a collaboration with the Parkinson’s Virtual Biotech, the drug development and discovery arm of Parkinson's UK. A new phase 2 trial will study the effects of ENT-01 on Parkinson’s Disease (PD)-associated dementia.

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Enterin and Parkinson’s UK Announce Research Collaboration in Parkinson’s Dementia

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Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

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ObsEva Announces IND Approval for Yuyuan Bioscience’s Phase 1 Clinical Trial of Nolasiban in China

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Basel/Allschwil, Switzerland, October 13, 2022

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Basilea announces late breaking presentation on the successfully completed ERADICATE phase 3 study with ceftobiprole in Staphylococcus aureus...

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Ethical controversy over the use of embryonic stem cells

The stem cell controversy is the consideration of the ethics of research involving the development and use of human embryos. Most commonly, this controversy focuses on embryonic stem cells. Not all stem cell research involves human embryos. For example, adult stem cells, amniotic stem cells, and induced pluripotent stem cells do not involve creating, using, or destroying human embryos, and thus are minimally, if at all, controversial. Many less controversial sources of acquiring stem cells include using cells from the umbilical cord, breast milk, and bone marrow, which are not pluripotent.

For many decades, stem cells have played an important role in medical research, beginning in 1868 when Ernst Haeckel first used the phrase to describe the fertilized egg which eventually gestates into an organism. The term was later used in 1886 by William Sedgwick to describe the parts of a plant that grow and regenerate. Further work by Alexander Maximow and Leroy Stevens introduced the concept that stem cells are pluripotent. This significant discovery led to the first human bone marrow transplant by E. Donnall Thomas in 1956, which although successful in saving lives, has generated much controversy since. This has included the many complications inherent in stem cell transplantation (almost 200 allogeneic marrow transplants were performed in humans, with no long-term successes before the first successful treatment was made), through to more modern problems, such as how many cells are sufficient for engraftment of various types of hematopoietic stem cell transplants, whether older patients should undergo transplant therapy, and the role of irradiation-based therapies in preparation for transplantation.

The discovery of adult stem cells led scientists to develop an interest in the role of embryonic stem cells, and in separate studies in 1981 Gail Martin and Martin Evans derived pluripotent stem cells from the embryos of mice for the first time. This paved the way for Mario Capecchi, Martin Evans, and Oliver Smithies to create the first knockout mouse, ushering in a whole new era of research on human disease. In 1995 adult stem cell research with human use was patented (US PTO with effect from 1995). In fact, human use was published in World J Surg 1991 & 1999 (B G Matapurkar). Salhan, Sudha (August 2011).[1]

In 1998, James Thomson and Jeffrey Jones derived the first human embryonic stem cells, with even greater potential for drug discovery and therapeutic transplantation. However, the use of the technique on human embryos led to more widespread controversy as criticism of the technique now began from the wider public who debated the moral ethics of questions concerning research involving human embryonic cells.

Since pluripotent stem cells have the ability to differentiate into any type of cell, they are used in the development of medical treatments for a wide range of conditions.[2] Treatments that have been proposed include treatment for physical trauma, degenerative conditions, and genetic diseases (in combination with gene therapy). Yet further treatments using stem cells could potentially be developed due to their ability to repair extensive tissue damage.[3]

Great levels of success and potential have been realized from research using adult stem cells. In early 2009, the FDA approved the first human clinical trials using embryonic stem cells. Only cells from an embryo at the morula stage or earlier are truly totipotent, meaning that they are able to form all cell types including placental cells. Adult stem cells are generally limited to differentiating into different cell types of their tissue of origin. However, some evidence suggests that adult stem cell plasticity may exist, increasing the number of cell types a given adult stem cell can become.

Destruction of a human embryo is required in order to research new embryonic cell lines. Much of the debate surrounding human embryonic stem cells, therefore, concern ethical and legal quandaries around the destruction of an embryo. Ethical and legal questions such as "At what point does one consider life to begin?" and "Is it just to destroy a human embryo if it has the potential to cure countless numbers of patients and further our understanding of disease?" are central to the controversy. Political leaders debate how to regulate and fund research studies that involve the techniques used to remove the embryo cells. No clear consensus has emerged.[4]

Much of the criticism has been a result of religious beliefs and, in the most high-profile case, US President George W Bush signed an executive order banning the use of federal funding for any stem cell lines other than those already in existence, stating at the time, "My position on these issues is shaped by deeply held beliefs," and "I also believe human life is a sacred gift from our creator."[5] This ban was in part revoked by his successor Barack Obama, who stated: "As a person of faith, I believe we are called to care for each other and work to ease human suffering. I believe we have been given the capacity and will to pursue this research and the humanity and conscience to do so responsibly."[6]

Some stem cell researchers are working to develop techniques of isolating stem cells with similar potency as embryonic stem cells, but do not require the destruction of a human embryo.

Foremost among these was the discovery in August 2006 that human adult somatic cells can be cultured in vitro with the four Yamanaka factors (Oct-4, SOX2, c-Myc, KLF4) which effectively returns a cell to the pluripotent state similar to that observed in embryonic stem cells.[7][8] This major breakthrough won a Nobel Prize for the discoverers, Shinya Yamanaka and John Gurdon.[9] Induced pluripotent stem cells are those derived from adult somatic cells and have the potential to provide an alternative for stem cell research that does not require the destruction of human embryos. Some debate remains about the similarities of these cells to embryonic stem cells as research has shown that the induced pluripotent cells may have a different epigenetic memory or modifications to the genome than embryonic stem cells depending on the tissue of origin and donor the iPSCs come from.[10] While this may be the case, epigenetic manipulation of the cells is possible using small molecules and more importantly, iPSCs from multiple tissues of origin have been shown to give rise to a viable organism similar to the way ESCs can.[11] This allows iPSCs to serve as a powerful tool for tissue generation, drug screening, disease modeling, and personalized medicine that has far fewer ethical considerations than embryonic stem cells that would otherwise serve the same purpose.

In an alternative technique, researchers at Harvard University, led by Kevin Eggan and Savitri Marajh, have transferred the nucleus of a somatic cell into an existing embryonic stem cell, thus creating a new stem cell line.[12] This technique known as somatic cell nuclear transfer (SCNT) creates pluripotent cells that are genetically identical to the donor.[13] While the creation of stem cells via SCNT does not destroy an embryo, it requires an oocyte from a donor which opens the door to a whole new set of ethical considerations such as the debate as to whether or not it is appropriate to offer financial incentives to female donors.[14]

Researchers at Advanced Cell Technology, led by Robert Lanza and Travis Wahl, reported the successful derivation of a stem cell line using a process similar to preimplantation genetic diagnosis, in which a single blastomere is extracted from a blastocyst.[15] At the 2007 meeting of the International Society for Stem Cell Research (ISSCR),[16] Lanza announced that his team had succeeded in producing three new stem cell lines without destroying the parent embryos.[17]"These are the first human embryonic cell lines in existence that didn't result from the destruction of an embryo." Lanza is currently in discussions with the National Institutes of Health to determine whether the new technique sidesteps U.S. restrictions on federal funding for ES cell research.[18]

Anthony Atala of Wake Forest University says that the fluid surrounding the fetus has been found to contain stem cells that, when used correctly, "can be differentiated towards cell types such as fat, bone, muscle, blood vessel, nerve and liver cells." The extraction of this fluid is not thought to harm the fetus in any way. He hopes "that these cells will provide a valuable resource for tissue repair and for engineered organs, as well."[19] AFSCs have been found to express both embryonic and adult stem cell markers as well as having the ability to be maintained over 250 population doublings.[20]

Similarly, pro-life supporters claim that the use of adult stem cells from sources such as the cord blood has consistently produced more promising results than the use of embryonic stem cells.[21] Research has shown that umbilical cord blood (UCB) is in fact a viable source for stem cells and their progenitors which occur in high frequencies within the fluid. Furthermore, these cells may hold an advantage over induced PSC as they can create large quantities of homogenous cells.[22]

IPSCs and other embryonic stem cell alternatives must still be collected and maintained with the informed consent of the donor as a donor's genetic information is still within the cells and by the definition of pluripotency, each alternative cell type has the potential to give rise to viable organisms. Generation of viable offspring using iPSCs has been shown in mouse models through tetraploid complementation.[23][24] This potential for the generation of viable organisms and the fact that iPSC cells contain the DNA of donors require that they be handled along the ethical guidelines laid out by the food and drug administration (FDA), European Medicines Agency (EMA), and International Society for Stem Cell Research (ISSCR).

Stem cell debates have motivated and reinvigorated the anti-abortion movement, whose members are concerned with the rights and status of the human embryo as an early-aged human life. They believe that embryonic stem cell research profits from and violates the sanctity of life and is tantamount to murder.[25] The fundamental assertion of those who oppose embryonic stem cell research is the belief that human life is inviolable, combined with the belief that human life begins when a sperm cell fertilizes an egg cell to form a single cell. The view of those in favor is that these embryos would otherwise be discarded, and if used as stem cells, they can survive as a part of a living human person.

A portion of stem cell researchers use embryos that were created but not used in in vitro fertility treatments to derive new stem cell lines. Most of these embryos are to be destroyed, or stored for long periods of time, long past their viable storage life. In the United States alone, an estimated at least 400,000 such embryos exist.[26] This has led some opponents of abortion, such as Senator Orrin Hatch, to support human embryonic stem cell research.[27] See also embryo donation.

Medical researchers widely report that stem cell research has the potential to dramatically alter approaches to understanding and treating diseases, and to alleviate suffering. In the future, most medical researchers anticipate being able to use technologies derived from stem cell research to treat a variety of diseases and impairments. Spinal cord injuries and Parkinson's disease are two examples that have been championed by high-profile media personalities (for instance, Christopher Reeve and Michael J. Fox, who have lived with these conditions, respectively). The anticipated medical benefits of stem cell research add urgency to the debates, which has been appealed to by proponents of embryonic stem cell research.

In August 2000, The U.S. National Institutes of Health's Guidelines stated:

... research involving human pluripotent stem cells ... promises new treatments and possible cures for many debilitating diseases and injuries, including Parkinson's disease, diabetes, heart disease, multiple sclerosis, burns and spinal cord injuries. The NIH believes the potential medical benefits of human pluripotent stem cell technology are compelling and worthy of pursuit in accordance with appropriate ethical standards.[28]

In 2006, researchers at Advanced Cell Technology of Worcester, Massachusetts, succeeded in obtaining stem cells from mouse embryos without destroying the embryos.[29] If this technique and its reliability are improved, it would alleviate some of the ethical concerns related to embryonic stem cell research.

Another technique announced in 2007 may also defuse the longstanding debate and controversy. Research teams in the United States and Japan have developed a simple and cost-effective method of reprogramming human skin cells to function much like embryonic stem cells by introducing artificial viruses. While extracting and cloning stem cells is complex and extremely expensive, the newly discovered method of reprogramming cells is much cheaper. However, the technique may disrupt the DNA in the new stem cells, resulting in damaged and cancerous tissue. More research will be required before noncancerous stem cells can be created.[30][31][32][33]

Update of article to include 2009/2010 current stem cell usages in clinical trials:[34][35] The planned treatment trials will focus on the effects of oral lithium on neurological function in people with chronic spinal cord injury and those who have received umbilical cord blood mononuclear cell transplants to the spinal cord. The interest in these two treatments derives from recent reports indicating that umbilical cord blood stem cells may be beneficial for spinal cord injury and that lithium may promote regeneration and recovery of function after spinal cord injury. Both lithium and umbilical cord blood are widely available therapies that have long been used to treat diseases in humans.

This argument often goes hand-in-hand with the utilitarian argument, and can be presented in several forms:

This is usually presented as a counter-argument to using adult stem cells, as an alternative that does not involve embryonic destruction.

Adult stem cells have provided many different therapies for illnesses such as Parkinson's disease, leukemia, multiple sclerosis, lupus, sickle-cell anemia, and heart damage[43] (to date, embryonic stem cells have also been used in treatment),[44] Moreover, there have been many advances in adult stem cell research, including a recent study where pluripotent adult stem cells were manufactured from differentiated fibroblast by the addition of specific transcription factors.[45] Newly created stem cells were developed into an embryo and were integrated into newborn mouse tissues, analogous to the properties of embryonic stem cells.

Austria, Denmark, France, Germany, Portugal and Ireland do not allow the production of embryonic stem cell lines,[46] but the creation of embryonic stem cell lines is permitted in Finland, Greece, the Netherlands, Sweden, and the United Kingdom.[46]

In 1973, Roe v. Wade legalized abortion in the United States. Five years later, the first successful human in vitro fertilization resulted in the birth of Louise Brown in England. These developments prompted the federal government to create regulations barring the use of federal funds for research that experimented on human embryos. In 1995, the NIH Human Embryo Research Panel advised the administration of President Bill Clinton to permit federal funding for research on embryos left over from in vitro fertility treatments and also recommended federal funding of research on embryos specifically created for experimentation. In response to the panel's recommendations, the Clinton administration, citing moral and ethical concerns, declined to fund research on embryos created solely for research purposes,[47] but did agree to fund research on leftover embryos created by in vitro fertility treatments. At this point, the Congress intervened and passed the 1995 DickeyWicker Amendment (the final bill, which included the Dickey-Wicker Amendment, was signed into law by Bill Clinton) which prohibited any federal funding for the Department of Health and Human Services be used for research that resulted in the destruction of an embryo regardless of the source of that embryo.

In 1998, privately funded research led to the breakthrough discovery of human embryonic stem cells (hESC).[48] This prompted the Clinton administration to re-examine guidelines for federal funding of embryonic research. In 1999, the president's National Bioethics Advisory Commission recommended that hESC harvested from embryos discarded after in vitro fertility treatments, but not from embryos created expressly for experimentation, be eligible for federal funding. Though embryo destruction had been inevitable in the process of harvesting hESC in the past (this is no longer the case[49][50][51][52]), the Clinton administration had decided that it would be permissible under the Dickey-Wicker Amendment to fund hESC research as long as such research did not itself directly cause the destruction of an embryo. Therefore, HHS issued its proposed regulation concerning hESC funding in 2001. Enactment of the new guidelines was delayed by the incoming George W. Bush administration which decided to reconsider the issue.

President Bush announced, on August 9, 2001, that federal funds, for the first time, would be made available for hESC research on currently existing embryonic stem cell lines. President Bush authorized research on existing human embryonic stem cell lines, not on human embryos under a specific, unrealistic timeline in which the stem cell lines must have been developed. However, the Bush Administration chose not to permit taxpayer funding for research on hESC cell lines not currently in existence, thus limiting federal funding to research in which "the life-and-death decision has already been made."[53] The Bush Administration's guidelines differ from the Clinton Administration guidelines which did not distinguish between currently existing and not-yet-existing hESC. Both the Bush and Clinton guidelines agree that the federal government should not fund hESC research that directly destroys embryos.

Neither Congress nor any administration has ever prohibited private funding of embryonic research. Public and private funding of research on adult and cord blood stem cells is unrestricted.

In April 2004, 206 members of Congress signed a letter urging President Bush to expand federal funding of embryonic stem cell research beyond what Bush had already supported.

In May 2005, the House of Representatives voted 238194 to loosen the limitations on federally funded embryonic stem-cell research by allowing government-funded research on surplus frozen embryos from in vitro fertilization clinics to be used for stem cell research with the permission of donors despite Bush's promise to veto the bill if passed.[54] On July 29, 2005, Senate Majority Leader William H. Frist (R-TN) announced that he too favored loosening restrictions on federal funding of embryonic stem cell research.[55] On July 18, 2006, the Senate passed three different bills concerning stem cell research. The Senate passed the first bill (the Stem Cell Research Enhancement Act) 6337, which would have made it legal for the federal government to spend federal money on embryonic stem cell research that uses embryos left over from in vitro fertilization procedures.[56] On July 19, 2006, President Bush vetoed this bill. The second bill makes it illegal to create, grow, and abort fetuses for research purposes. The third bill would encourage research that would isolate pluripotent, i.e., embryonic-like, stem cells without the destruction of human embryos.

In 2005 and 2007, Congressman Ron Paul introduced the Cures Can Be Found Act,[57] with 10 cosponsors. With an income tax credit, the bill favors research upon non-embryonic stem cells obtained from placentas, umbilical cord blood, amniotic fluid, humans after birth, or unborn human offspring who died of natural causes; the bill was referred to committee. Paul argued that hESC research is outside of federal jurisdiction either to ban or to subsidize.[58]

Bush vetoed another bill, the Stem Cell Research Enhancement Act of 2007,[59] which would have amended the Public Health Service Act to provide for human embryonic stem cell research. The bill passed the Senate on April 11 by a vote of 6334, then passed the House on June 7 by a vote of 247176. President Bush vetoed the bill on July 19, 2007.[60]

On March 9, 2009, President Obama removed the restriction on federal funding for newer stem cell lines.[61] Two days after Obama removed the restriction, the president then signed the Omnibus Appropriations Act of 2009, which still contained the long-standing DickeyWicker Amendment which bans federal funding of "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death;"[62] the Congressional provision effectively prevents federal funding being used to create new stem cell lines by many of the known methods. So, while scientists might not be free to create new lines with federal funding, President Obama's policy allows the potential of applying for such funding into research involving the hundreds of existing stem cell lines as well as any further lines created using private funds or state-level funding. The ability to apply for federal funding for stem cell lines created in the private sector is a significant expansion of options over the limits imposed by President Bush, who restricted funding to the 21 viable stem cell lines that were created before he announced his decision in 2001.[63]The ethical concerns raised during Clinton's time in office continue to restrict hESC research and dozens of stem cell lines have been excluded from funding, now by judgment of an administrative office rather than presidential or legislative discretion.[64]

In 2005, the NIH funded $607 million worth of stem cell research, of which $39 million was specifically used for hESC.[65] Sigrid Fry-Revere has argued that private organizations, not the federal government, should provide funding for stem-cell research, so that shifts in public opinion and government policy would not bring valuable scientific research to a grinding halt.[66]

In 2005, the State of California took out $3 billion in bond loans to fund embryonic stem cell research in that state.[67]

China has one of the most permissive human embryonic stem cell policies in the world. In the absence of a public controversy, human embryo stem cell research is supported by policies that allow the use of human embryos and therapeutic cloning.[68]

Generally speaking, no group advocates for unrestricted stem cell research, especially in the context of embryonic stem cell research.

According to Rabbi Levi Yitzchak Halperin of the Institute for Science and Jewish Law in Jerusalem, embryonic stem cell research is permitted so long as it has not been implanted in the womb. Not only is it permitted, but research is encouraged, rather than wasting it.

As long as it has not been implanted in the womb and it is still a frozen fertilized egg, it does not have the status of an embryo at all and there is no prohibition to destroy it...

However in order to remove all doubt [as to the permissibility of destroying it], it is preferable not to destroy the pre-embryo unless it will otherwise not be implanted in the woman who gave the eggs (either because there are many fertilized eggs, or because one of the parties refuses to go on with the procedure the husband or wife or for any other reason). Certainly it should not be implanted into another woman.... The best and worthiest solution is to use it for life-saving purposes, such as for the treatment of people that suffered trauma to their nervous system, etc.

Rabbi Levi Yitzchak Halperin, Ma'aseh Choshev vol. 3, 2:6

Similarly, the sole Jewish majority state, Israel, permits research on embryonic stem cells.

The Catholic Church opposes human embryonic stem cell research calling it "an absolutely unacceptable act." The Church supports research that involves stem cells from adult tissues and the umbilical cord, as it "involves no harm to human beings at any state of development."[69] This support has been expressed both politically and financially, with different Catholic groups either raising money indirectly, offering grants, or seeking to pass federal legislation, according to the United States Conference of Catholic Bishops. Specific examples include a grant from the Catholic Archiocese of Sydney which funded research demonstrating the capabilities of adult stem cells, and the U.S. Conference of Catholic Bishops working to pass federal legislation creating a nationwide public bank for umbilical cord blood stem cells.[70]

The Southern Baptist Convention opposes human embryonic stem cell research on the grounds that the "Bible teaches that human beings are made in the image and likeness of God (Gen. 1:27; 9:6) and protectable human life begins at fertilization."[71] However, it supports adult stem cell research as it does "not require the destruction of embryos."[71]

The United Methodist Church opposes human embryonic stem cell research, saying, "a human embryo, even at its earliest stages, commands our reverence."[72] However, it supports adult stem cell research, stating that there are "few moral questions" raised by this issue.[72]

The Assemblies of God opposes human embryonic stem cell research, saying, it "perpetuates the evil of abortion and should be prohibited."[73]

Islamic scholars generally favor the stance that scientific research and development of stem cells is allowed as long as it benefits society while causing the least amount of harm to the subjects. "Stem cell research is one of the most controversial topics of our time period and has raised many religious and ethical questions regarding the research being done. With there being no true guidelines set forth in the Qur'an against the study of biomedical testing, Muslims have adopted any new studies as long as the studies do not contradict another teaching in the Qur'an. One of the teachings of the Qur'an states that 'Whosoever saves the life of one, it shall be if he saves the life of humankind' (5:32), it is this teaching that makes stem cell research acceptable in the Muslim faith because of its promise of potential medical breakthrough."[74] This statement does not, however, make a distinction between adult, embryonic, or stem-cells. In specific instances, different sources have issued fatwas, or nonbinding but authoritative legal opinions according to Islamic faith, ruling on conduct in stem cell research. The Fatwa of the Islamic Jurisprudence Council of the Islamic World League (December 2003) addressed permissible stem cell sources, as did the Fatwa Khomenei (2002) in Iran. Several different governments in predominantly Muslim countries have also supported stem cell research, notably Saudi Arabia and Iran.

The First Presidency of The Church of Jesus Christ of Latter-day Saints "has not taken a position regarding the use of embryonic stem cells for research purposes. The absence of a position should not be interpreted as support for or opposition to any other statement made by Church members, whether they are for or against embryonic stem cell research.[75]

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Stem cell controversy - Wikipedia

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How are new treatments developed?

If you have seen a stem cell treatment advertised, featured in the media, or mentioned to you by a friend or fellow patient, it can be hard to work out if it may be an option for you.

Although there is a lot of attention surrounding the potential of stem cells, in reality, the range of diseases for which there are current proven stem cell treatments is quite small. Within Australia the only proven treatments available involving stem cells are corneal and skin grafting, and blood stem cell transplants for the treatment of some blood disorders, inherited immune and metabolic disorders, cancer and autoimmune diseases. There are many other potential treatments, but these are still in the research phase or in clinical trials and are yet to be proven as safe and effective.

This page provides a breakdown of the steps that should occur before a stem cell treatment makes it to you in a clinic, and identifies who should be looking after your interests.

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Stem Cells Australia | Australian research, stem cell treatments and ...

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Replacing retinal pigment epithelial cells

Retinal pigment epithelial (RPE) cells have a number of important jobs, including looking after the adjacent retina. If these cells stop working properly due to damage or disease, then certain parts of the retina die. As the retina is the component of the eye responsible for detecting light, this leads to the onset of blindness. RPE cells can be damaged in a variety of diseases such as: age-related macular degeneration (AMD), retinitis pigmentosa and Lebers congenital aneurosis.

One way to treat these diseases would be to replace the damaged RPE cells with transplanted healthy cells. Unfortunately, it is not possible to take healthy RPE cells from donors so it is necessary to find another source of cells for transplantation. Scientists have recently produced new RPE cells from both embryonic stem cells and iPS cells in the lab. The safety of embryonic stem cell-derived RPE cells has been tested in phase I/II clinical trials for patients with Stargardts macular dystrophy, and for thse affected by AMD by a stem cell biotech company called Advanced Cell Technologies. Theresults of the trial, published in 2014, demonstrated safety and showed engraftment of the transplanted RPE cells. However, some participants experienced adverse side effects from the immunosuppression and the transplantation procedure itself. Interestingly, despite not being an endpoint of this trial, several patients also reported an improvement in vision.

A second Phase I/II trial exploringthe use of RPEs derived from human embryonic stem cells for people with wet AMDis currently underway in the United Kingdom. The first patient received their transplant in September 2015. This work, led by Prof Pete Coffey, is ongoing and is being carried out at Moorfields Eye Hospital as part of the London Project to Cure Blindness.

Finally, Japanese researcher, Dr Masayo Takahashi is leading a clinical trial in Japan which transplants RPE cells made from iPS cells into patients with wet AMD. The trial was put on hold for several months due to regulatory changes in Japan and concerns about mutations in an iPS cell product to be used in the trial. The trial has recommenced June 2016 and many await the results.

There areseveral other phase I or I/II clinical trials using pluripotent stem cells world-wideinvolving small numbers of participants. These trials are examining primarily the safety, but in some cases also the effectiveness, of the use of RPEs developed from pluripotent stem cells in dry and wet AMD and Stargardts macular degeneration.

Replacement of damaged RPE cells will only be effective in patients who still have at least part of a working retina, and therefore some level of vision (i.e. at early stages of the disease). This is because the RPE cells are not themselves responsible for seeing, but are actually responsible for supporting the seeing retina. Sight is lost in these types of diseases when the retina begins to degenerate because the RPE cells are not doing their job properly. So the RPE cells need to be replaced in time for them to support a retina that is still working. It is hoped that transplantation of new RPE cells will then permanently halt further loss of vision, and in some cases may even improve vision to some degree.

Replacing retinal pigment epithelial cells:Techniques for growing cells for therapies are being researched and tested in early clinical safety trials.

Replacing retinal cells

In many of the cases where vision is lost, we often find that the problem lies with malfunctioning retinal circuitry. Different disorders occur when particular, specialized cells in the circuit either stop working properly or die off. Despite the retina being more complicated than other components of the eye, it is hoped that if a source of new retinal cells can be found, we may be able to replace the damaged or dying cells to repair the retina. In addition, this approach may also help to repair damage caused to the optic nerve.

Again, scientists have turned to stem cell technology to provide the source of replacement cells. Several studies have now reported that both embryonic stem cells and iPS cells can be turned into different types of retinal cells in the lab. Within the eye, a type of cell called the Mller cell, which is found in the retina, is known to act as a stem cell in some species, such as the zebra fish. It has been suggested that this cell may also be able to act as a stem cell in humans, in which case it may provide another source of retinal cells for repair of the retina.

Unlike RPE cell transplantation, direct repair of the retina may allow patients who have already lost their vision to have it restored to some degree. This gives hope for patients with disorders like late-stage age-related macular degeneration, where the light-sensitive photoreceptor cells in the retina have already been lost. This type of research may also provide new treatments for people who suffer from retinal diseases like retinitis pigmentosa and glaucoma. However, despite encouraging evidence, such research is very much in its infancy. There are currently no patient clinical trials planned using this type of approach, as significant further research is still required first.

Replacing the nerve cells of the retina:Current research aims to understand how to produce retinal nerve cells that could be used in future therapies.

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The eye and stem cells: the path to treating blindness

Spinal Cord Stem Cells Comments Off on The eye and stem cells: the path to treating blindness | October 13th, 2022

(SACRAMENTO)

Three babies have been born after receiving the worlds first spina bifida treatment combining surgery with stem cells. This was made possible by a landmark clinical trial at UC Davis Health.

The one-of-a-kind treatment, delivered while a fetus is still developing in the mothers womb, could improve outcomes for children with this birth defect.

Launched in the spring of 2021, the clinical trial is known formally as the CuRe Trial: Cellular Therapy for In Utero Repair of Myelomeningocele. Thirty-five patients will be treated in total.

The three babies from the trial that have been born so far will be monitored by the research team until 30 months of age to fully assess the procedures safety and effectiveness.

The first phase of the trial is funded by a $9 million state grant from the states stem cell agency, the California Institute for Regenerative Medicine (CIRM).

This clinical trial could enhance the quality of life for so many patients to come, said Emily, the first clinical trial participant who traveled from Austin, Tex. to participate. Her daughter Robbie was born last October. We didnt know about spina bifida until the diagnosis. We are so thankful that we got to be a part of this. We are giving our daughter the very best chance at a bright future.

Spina bifida, also known as myelomeningocele, occurs when spinal tissue fails to fuse properly during the early stages of pregnancy. The birth defect can lead to a range of lifelong cognitive, mobility, urinary and bowel disabilities. It affects 1,500 to 2,000 children in the U.S. every year. It is often diagnosed through ultrasound.

While surgery performed after birth can help reduce some of the effects, surgery before birth can prevent or lessen the severity of the fetuss spinal damage, which worsens over the course of pregnancy.

Ive been working toward this day for almost 25 years now, said Diana Farmer, the worlds first woman fetal surgeon, professor and chair of surgery at UC Davis Health and principal investigator on the study.

As a leader of the Management of Myelomeningocele Study (MOMS) clinical trial in the early 2000s, Farmer had previously helped to prove that fetal surgery reduced neurological deficits from spina bifida. Many children in that study showed improvement but still required wheelchairs or leg braces.

Farmer recruited bioengineer Aijun Wang specifically to help take that work to the next level. Together, they launched theUC Davis Health Surgical Bioengineering Laboratoryto find ways to use stem cells and bioengineering to advance surgical effectiveness and improve outcomes. Farmer also launched the UC Davis Fetal Care and Treatment Centerwith fetal surgeon Shinjiro Hirose and the UC DavisChildrens Surgery Center several years ago.

Farmer, Wang and their research team have been working on their novel approach using stem cells in fetal surgery for more than 10 years. Over that time, animal modeling has shown it is capable of preventing the paralysis associated with spina bifida.

Its believed that the stem cells work to repair and restore damaged spinal tissue, beyond what surgery can accomplish alone.

Preliminary work by Farmer and Wang proved that prenatal surgery combined with human placenta-derived mesenchymal stromal cells, held in place with a biomaterial scaffold to form a patch, helped lambs with spina bifida walk without noticeable disability.

When the baby sheep who received stem cells were born, they were able to stand at birth and they were able to run around almost normally. It was amazing, Wang said.

When the team refined their surgery and stem cells technique for canines, the treatment also improved the mobility of dogs with naturally occurring spina bifida.

A pair of English bulldogs named Darla and Spanky were the worlds first dogs to be successfully treated with surgery and stem cells. Spina bifida, a common birth defect in this breed, frequently leaves them with little function in their hindquarters.

By their post-surgery re-check at 4 months old, Darla and Spanky were able to walk, run and play.

When Emily and her husband Harry learned that they would be first-time parents, they never expected any pregnancy complications. But the day that Emily learned that her developing child had spina bifida was also the day she first heard about the CuRe trial.

For Emily, it was a lifeline that they couldnt refuse.

Participating in the trial would mean that she would need to temporarily move to Sacramento for the fetal surgery and then for weekly follow-up visits during her pregnancy.

After screenings, MRI scans and interviews, Emily received the life-changing news that she was accepted into the trial. Her fetal surgery was scheduled for July 12, 2021, at 25 weeks and five days gestation.

Farmer and Wangs team manufactures clinical grade stem cells mesenchymal stem cells from placental tissue in the UC Davis Healths CIRM-funded Institute for Regenerative Cures. The cells are known to be among the most promising type of cells in regenerative medicine.

The lab is aGood Manufacturing Practice(GMP) Laboratory for safe use in humans. It is here that they made the stem cell patch for Emilys fetal surgery.

Its a four-day process to make the stem cell patch, said Priya Kumar, the scientist at the Center for Surgical Bioengineering in the Department of Surgery, who leads the team that creates the stem cell patches and delivers them to the operating room. The time we pull out the cells, the time we seed on the scaffold, and the time we deliver, is all critical.

During Emilys historic procedure, a 40-person operating and cell preparation team did the careful dance that they had been long preparing for.

After Emily was placed under general anesthetic, a small opening was made in her uterus and they floated the fetus up to that incision point so they could expose its spine and the spina bifida defect. The surgeons used a microscope to carefully begin the repair.

Then the moment of truth: The stem cell patch was placed directly over the exposed spinal cord of the fetus. The fetal surgeons then closed the incision to allow the tissue to regenerate.

The placement of the stem cell patch went off without a hitch. Mother and fetus did great! Farmer said.

The team declared the first-of-its-kind surgery a success.

On Sept. 20, 2021, at 35 weeks and five days gestation, Robbie was born at 5 pounds, 10 ounces, 19 inches long via C-section.

One of my first fears was that I wouldnt be able to see her, but they brought her over to me. I got to see her toes wiggle for the first time. It was so reassuring and a little bit out of this world, Emily said.

For Farmer, this day is what she had long hoped for, and it came with surprises. If Robbie had remained untreated, she was expected to be born with leg paralysis.

It was very clear the minute she was born that she was kicking her legs and I remember very clearly saying, Oh my God, I think shes wiggling her toes! said Farmer, who noted that the observation was not an official confirmation, but it was promising. It was amazing. We kept saying, Am I seeing that? Is that real?

Both mom and baby are at home and in good health. Robbie just celebrated her first birthday.

The CuRe team is cautious about drawing conclusions and says a lot is still to be learned during this safety phase of the trial. The team will continue to monitor Robbie and the other babies in the trial until they are 6 years old, with a key checkup happening at 30 months to see if they are walking and potty training.

This experience has been larger than life and has exceeded every expectation. I hope this trial will enhance the quality of life for so many patients to come, Emily said. We are honored to be part of history in the making.

Related links

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World's first stem cell treatment for spina bifida delivered during fetal surgery - UC Davis Health

Spinal Cord Stem Cells Comments Off on World’s first stem cell treatment for spina bifida delivered during fetal surgery – UC Davis Health | October 13th, 2022

When I was young,,,

36 reasons to VOTE YES! For Your Scientist Friends

By Don C. Reed

Author, STEM CELL BATTLES, other books

http://www.stemcellbattles.com

Dear Friend of Regenerative Medicine:

For the next month, I will make available a daily summary of one aspect of stem cell researchmy laymans understanding of itdone by scientists connected to the California Institute for Regenerative Medicine (CIRM). Todays is spina bifida, tomorrow is stroke.

Mistakes are mine.

In most cases I have left out the scientists names. A few I have written about in my books, and those I felt free to credit.

All I ask is that when you step into the voting booth, please consider which political party is likely to fund such research, and vote accordingly.

Spina Bifida: total awards (3) Award value: $16,798,263

The condition is devastating, and lasts a lifetime. The baby has a part of its spine bulging out of its lower back. Accompanying symptoms are many, including: headaches, vomiting, weakness in the legs, bladder and bowel problems.

Current standard of care (in utero surgery) leaves 58% of patients unable to walk independently.

39% of affected population are Hispanic or Latino descent.

The condition may cost several million dollars per patient, over his or her lifetime.

Spina Bifida (SB) appears to be caused by a combination of genetic and environmental conditions, but no one is sure. How will CIRM fight such a thing?

One way is Placenta-derived mesenchymal stem cells, seeded on a Cook Biodesign extracellular Matrix. Think of a mesh screen, over the wound.

THERAPEUTIC MECHANISM: Mesenchymal stem cellssecrete growth factors (and) cytokinesprotecting motor neurons from cell deathtreatment increases the density of motor neurons in the spinal cord, leading to improved motor functionultimately reducing lower limb paralysis. (1)

Grant recipient Diana Farmer began science as a marine biologist, who doing research at the famous Woods Hole Institute. On the way to receive an award, she suffered a car accident, and changed her mind, working on human biology. She was the first woman to perform surgery on a baby in its mothers womb. (1)

She and Aijun Wang received a CIRM grant to co-launch the worlds first human clinical trial using stem cells to treat spina bifida.. (2)

1. https://en.wikipedia.org/wiki/Diana_L._Farmer

2. https://health.ucdavis.edu/health-news/newsroom/state-stem-cell-agency-funds-clinical-trial-for-spina-bifida-treatment/2020/11

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Fighting One Disease or Condition per Day - Daily Kos

Spinal Cord Stem Cells Comments Off on Fighting One Disease or Condition per Day – Daily Kos | October 13th, 2022

DUBLIN--(BUSINESS WIRE)--The "Global Cell Therapy Market, By Use Type, By Therapy Type, By Product, By Technology & By Region- Forecast and Analysis 2022-2028" report has been added to ResearchAndMarkets.com's offering.

The Global Cell Therapy Market was valued at USD 14.86 Billion in 2021, and it is expected to reach a value of USD 35.95 Billion by 2028, at a CAGR of 13.45% over the forecast period (2022 - 2028).

Companies Mentioned

The cell therapy industry is being propelled forward by an increase in the number of clinical trials for cell-based treatments. As a result, global investment in research and clinical translation has increased significantly. The increasing number of ongoing clinical studies can be attributed to the presence of government and commercial funding bodies that are constantly providing funds to assist projects at various stages of clinical trials.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Cell Therapy Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research and their market shares in the respective regions were determined through primary and secondary research.

This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives.

All percentage shares split, and breakdowns were determined by using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Segments covered in this report

The global cell therapy market is segmented based on Use-type, Therapy Type, Product, Technology, Application, and Region. Based on Use-type it is categorized into Clinical-use, and Research-use. Based on Therapy Type it is categorized into Allogenic Therapies, Autologous Therapies.

Based on Product it is categorized into Consumables, Equipment, Systems, and Software. Based on Technology it is categorized into Viral Vector Technology, Genome Editing Technology, Somatic Cell Technology, Cell Immortalization Technology, Cell Plasticity Technology, and Three-Dimensional Technology. Based on the region it is categorized into North America, Europe, Asia-Pacific, South America, and MEA.

Drivers

The increased demand for novel, better medicines for diseases such as cancer and CVD has resulted in an increase in general research efforts as well as funding for cell-based research. In November 2019, the Australian government released The Stem Cell Therapies Mission, a 10-year strategy for stem cell research in Australia.

The project would receive a USD 102 million (AU$150 million) grant from the Medical Research Future Fund (MRFF) to encourage stem cell research in order to develop novel medicines. Similarly, the UK's innovation agency, Innovate the UK, awarded USD 269,670 (GBP 267,000) in funding in September 2019 to Atelerix's gel stabilization technologies, with the first goal of extending the shelf-life of Rexgenero's cell-based therapies for storage and transport at room temperature.

Restraints

Despite technological advancements and product development over the last decade, the industry has been hampered by a lack of skilled personnel to operate complex devices like flow cytometers and multi-mode readers. Flow cytometers and spectrophotometers, which are both technologically advanced and extremely complex, generate a wide range of data outputs that require skill to analyze and review.

There is a global demand-supply mismatch for competent individuals, according to the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). Over the next decade, the UK and Europe are expected to face a severe shortage of lab capabilities, with medical laboratories being particularly hard hit.

Market Trends

The expansion of the cell therapy market was aided by the growing frequency of chronic illnesses. Chronic illness is defined as a condition that lasts one year or more and requires medical treatment, affects everyday activities, or both, according to the US Centers for Disease Control and Prevention (CDC).

It includes heart disease, cancer, diabetes, and Parkinson's disease. Patients with spinal cord injuries, type 1 diabetes, Parkinson's disease (PD), heart disease, cancer, and osteoarthritis may benefit from stem cells.

For more information about this report visit https://www.researchandmarkets.com/r/aqmxta

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Global Cell Therapy Market Report (2022 to 2028) - Featuring Thermo Fisher Scientific, MaxCyte, Danaher and Avantor Among Others -...

Spinal Cord Stem Cells Comments Off on Global Cell Therapy Market Report (2022 to 2028) – Featuring Thermo Fisher Scientific, MaxCyte, Danaher and Avantor Among Others -… | October 13th, 2022

Both companies will collaborate to improve NurExone's drug development stages, from R&D to Quality Assurance

Company to host an investor webinar on Thursday, October 20th, 2022 at 11:00 AM EST

Calgary, Alberta and Oxford, United Kingdom--(Newsfile Corp. - October 12, 2022) - NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (the "Company" or "NurExone"), a biopharmaceutical company developing biologically-guided exosome therapy for patients with traumatic spinal cord injuries, is pleased to announce that the Company's wholly-owned subsidiary, NurExone Biologic Ltd., signed a non-binding Letter of Intent for a collaboration (the "Collaboration") with Nanometrix Ltd. ("Nanometrix"), a U.K.-based nanoparticle analysis company providing services to profile molecules of exosomes and their cargo.

Under the Collaboration, NurExone's exosomes and cargo samples will be processed and analyzed by Nanometrix, which will use its proprietary Artificial Intelligence (AI) software to extract and analyze morphological and population data to achieve detailed molecular profiling of the exosomes and quantify the siRNA cargo copy number per extracellular vesicle (EV), information which was far out of reach.

"Detailed molecular profiling of our exosomes and their siRNA cargo will facilitate a quality assurance program for repeatable, mass-production of ExoTherapies towards commercialization," said Dr. Lior Shaltiel, CEO of NurExone. "Nanometrix has the expertise and resources to perform this analysis in a highly professional manner and we look forward to working with them."

"The signing of this letter of intent is a first step towards a great milestone for Nanometrix," said Alexandre Kitching, CEO and Cofounder of Nanometrix. "We are thrilled to start this collaboration with NurExone as we believe in the future of exosomes as an advanced platform for drug delivery. We look forward to deploying our technology and assisting NurExone in gaining in-depth information about their siRNA-loaded exosomes and subsequently, improving the different stages of their drug development process."

Story continues

Exosomes are best defined as EVs that have emerged as promising guided nanocarriers for drug delivery and targeted therapy, and as alternatives to stem cell therapy. EVs are endosome-derived small membrane vesicles, approximately 30 to 150 nanometres in diameter, and are released into extracellular fluids by cells in all living systems. They are well-suited for small functional molecule delivery, and increasing evidence indicates that they have a pivotal role in cell-to-cell communication.

NurExone's ExoTherapy uses proprietary exosomes as biologically-guided nanocarriers to deliver specialized therapeutic compounds to targeted areas. The delivered molecules promote an environment that induces a healing process at the target location. For its first clinical indication of providing recovery of function to traumatic spinal cord injury (SCI) patients, NurExone used modified siRNA sequences as the delivered therapeutic molecules.

ExoTherapy is being developed as a revolutionary "off-the-shelf" intranasal product to treat traumatic spinal cord and brain injuries as well as other Central Nervous System indications. In preclinical studies of rats with a fully transected spinal cords, intranasal administration of ExoPTEN led to significant motor improvement, sensory recovery, and faster urinary reflex restoration.

Investor Webinar

The Company will be hosting a webinar to discuss its recent business highlights and growth outlook on Thursday, October 20th, 2022 at 11:00 AM EST.

Please click the link below to register for the webinar.https://us02web.zoom.us/webinar/register/WN_hqlWt1EUTrCy_ol_iJ2DmA

About Nanometrix

Nanometrix is a nanoparticle analysis start-up based in Oxford, UK that has developed unique end-to-end services to routinely create molecular profiles of nanoparticles from samples. Each profile delivers information currently out of reach such as the morphology, population dynamics and cargo copy number per nanoparticle. Nanometrix's software and services are currently deployed across labs and teams globally working on the development of novel therapeutics and diagnostics.

For additional information, please visit http://www.nanometrix.bio or contact us at info@nanometrix.bio

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided ExoTherapy to be delivered, non-invasively, to patients who suffered traumatic spinal cord injuries. ExoTherapy was conceptually demonstrated in animal studies at the Technion, Israel Institute of Technology. NurExone is translating the treatment to humans, and the company holds an exclusive worldwide license from the Technion for the development and commercialization of the technology.

For additional information, please visit http://www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Inbar Paz-BenayounHead of CommunicationsPhone: +972-52-3966695Email: info@nurexone.com

For investors:Investor RelationsIR@nurexone.com+1 905-347-5569

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements about the Company's future plans, the Letter of Intent, the development activities to be carried out pursuant to the Collaboration, the potential entering into of a commercial agreement between the parties and future potential manufacturing and marketing activities. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the Company's early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company's intellectual property and dependence on the Company's strategic partners. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

NurExone is providing an updated release to the previously disseminated release from earlier today to remove a paragraph that was included in error.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/140289

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UPDATE: NurExone Signs Letter of Intent with Nanometrix for Its Exosome and Cargo Molecular Profiling AI-Driven Technology - Yahoo Finance

Spinal Cord Stem Cells Comments Off on UPDATE: NurExone Signs Letter of Intent with Nanometrix for Its Exosome and Cargo Molecular Profiling AI-Driven Technology – Yahoo Finance | October 13th, 2022

DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new UPLIZNA analyses will be presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2022, Oct. 26-28. UPLIZNA is the first and only anti-CD19 B-cell-depleting humanized monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) and European Commission (EC) for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.

Presentation Details:

In addition, Horizon will host a symposium Thursday, Oct. 27 from 8:45-9:45 a.m. CEST called Step into the new era of NMOSD, chaired by Hans-Peter Hartung, M.D., Ph.D. and featuring presentations from Jrme de Sze Ph.D., Brian Weinshenker, M.D., and Orhan Aktas, M.D. Topics will include NMOSD diagnosis and care, advantages of CD19 treatments and the clinical relevance of UPLIZNA in NMOSD.

About Neuromyelitis Optica Spectrum Disorder (NMOSD)

NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, brain and brain stem.1,2 Approximately 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.3 AQP4-IgG binds primarily to astrocytes in the central nervous system and triggers an escalating immune response that results in lesion formation and astrocyte death.4

Anti-AQP4 autoantibodies are produced by plasmablasts and some plasma cells. These B-cell populations are central to NMOSD disease pathogenesis, and a large proportion of these cells express CD19.5 Depletion of these CD19+ B-cells is thought to remove an important contributor to inflammation, lesion formation and astrocyte damage. Clinically, this damage presents as an NMOSD attack, which can involve the optic nerve, spinal cord and brain.4,6 Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease.7 Each NMOSD attack can lead to further cumulative damage and disability.8,9 NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.10,11

About UPLIZNA

INDICATION

UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%) and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

For additional information on UPLIZNA, please see the Full Prescribing Information at http://www.UPLIZNA.com.

About Horizon

Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit http://www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

References

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Horizon Therapeutics plc Announces New UPLIZNA (inebilizumab-cdon) Data in Neuromyelitis Optica Spectrum Disorder (NMOSD) to be presented at ECTRIMS...

Spinal Cord Stem Cells Comments Off on Horizon Therapeutics plc Announces New UPLIZNA (inebilizumab-cdon) Data in Neuromyelitis Optica Spectrum Disorder (NMOSD) to be presented at ECTRIMS… | October 13th, 2022