The ISSCR Issues Statement on Human Germ Line Genome Modification

The International Society for Stem Cell Research has released a statement calling for a moratorium on attempts to apply nuclear genome editing of the human germ line in clinical practice

Sunday, 22 March 2015

In a statement released on Thursday, the International Society for Stem Cell Research called for a moratorium on attempts at clinical application of nuclear genome editing of the human germ line to enable more extensive scientific analysis of the potential risks of genome editing and broader public discussion of the societal and ethical implications.

Technologies used to introduce changes into the DNA sequence of cells have advanced rapidly, making genome editing increasingly simple. Genome editing is feasible, not just in the somatic cells of an adult organism, but also in early embryos, as well as the gametes (sperm and egg) that carry the inheritable, germ line DNA. Research involving germ line nuclear genome editing has been performed to date in many organisms, including mice and monkeys, and applications to human embryos are possible.

The ISSCR statement raises significant ethical, societal and safety considerations related to the application of nuclear genome editing to the human germ line in clinical practice. Current genome editing technologies carry risks of unintended genome damage, in addition to unknown consequences. Moreover, consensus is lacking on what, if any, therapeutic applications of germ line genome modification might be permissible.

The statement calls for a moratorium on attempts to apply nuclear genome editing of the human germ line in clinical practice, as scientists currently lack an adequate understanding of the safety and potential long term risks of germ line genome modification. Moreover, the ISSCR asserts that a deeper and more rigorous deliberation on the ethical, legal and societal implications of any attempts at modifying the human germ line is essential if its clinical practice is ever to be sanctioned.

In calling for the above moratorium, the ISSCR is not taking a position on the clinical testing of mitochondrial replacement therapy, a form of germ line modification that entails replacing the mitochondria (found outside the nucleus) in the eggs of women at risk of transmitting certain devastating diseases to their children.

Source: International Society for Stem Cell Research

Contact: Michelle Quivey

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ZenMaster

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For more on stem cells and cloning, go to CellNEWS at

http://cellnews-blog.blogspot.com/

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ISSCR Decries Negative Impact of Stem Cell Injunction on Science and Medicine

ISSCR Decries Negative Impact of Stem Cell Injunction on Science and Medicine

Saturday, 04 September 2010

Vital progress in stem cell research by hundreds of U.S. laboratories is threatened after last week’s injunction prohibiting federal funding for the study of human embryonic stem cells (hESCs). The president of the International Society for Stem Cell Research (ISSCR), Elaine Fuchs, Rockefeller University, U.S., stated that the setbacks for advancing biomedical research on stem cells and translating this knowledge into new and improved treatments for patients are already considerable, and escalate with each day the injunction continues.

Sir Ian Wilmut, MRC Centre for Regenerative Medicine, UK, agrees.

“Any disruption of this [hESC] research, such as that imposed by the present injunction, will have a chilling effect on research throughout the world.”

“To advance the potential of stem cells for regenerative medicine, researchers must be able to study hESCs and uncover their special ability to make every cell of our body, including adult stem cells,” said Dr. Fuchs.

“Information on hESCs is essential so that we can discover new niches for adult stem cells in more tissues, learn how they differ from hESCs, and begin to understand how to expand the more limited capacity of adult stem cells. Without government funds to support this research, U.S.-based scientists and physicians will be impeded in developing the blueprint for stem cell therapies that will save lives.”

As a result of the injunction, the National Institutes of Health (U.S.) has announced that review and issuance of pending grant applications and grant renewals has been suspended until further notice. Grants affected include some long-standing research supported during the Bush administration that involve some of the top physician scientists in the U.S.

Stem cell researchers in the U.S. are now left guessing as to the full impact on their research and in some cases, the future of their laboratories and expertly trained staff. Early-career scientists, who often rely solely on federal research funding and on short-term results to establish longer-term funding, are particularly vulnerable to a cessation in funding of any duration.

The ISSCR is further concerned that the ramifications will extend internationally. ISSCR Vice President Shinya Yamanaka, Kyoto University, Japan and Gladstone Institutes, U.S., notes the potential impact on decisions for legislating hESC research in Japan.

“President Obama’s decision to facilitate hESC research had a huge impact on the decision of the Japanese government to permit hESC research. I am afraid that this new injunction may therefore negatively affect the Japanese regulations in this regard, thereby inhibiting the future of both hESC and induced pluripotent stem cell (iPSC) research.”

“The U.S. makes an enormous contribution to biomedical research, and U.S.-derived stem cells form the cornerstone of worldwide research efforts,” Dr. Wilmut added.

Research using hESCs has been supported by the U.S. government since 2002 and provides critical insight into human development and disease that is needed to advance our understanding and treatment of a wide range of diseases and conditions. The ISSCR remains committed to supporting all forms of stem cell research, advocating that both embryonic and adult stem cell research move forward in parallel to realize the full promise of regenerative medicine.

Source: International Society for Stem Cell Research

Additional Information:

United States District Court for Washington D.C. Preliminary Injunction (Aug. 23, 2010)
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv1575-44
NIH notification regarding applications for grants and contracts that involve human embryonic stem cells (hESCs) (Aug. 30, 2010)
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-126.html
Statement from NIH Director Francis Collins (Aug. 26, 2010) http://www.nih.gov/about/director/08262010statement_stemcellinjunction.htm
Justice Department Motion to Stay and Notice of Appeal (Aug. 31, 2010)
http://www.nih.gov/about/director/stemcell/appeal_08312010.pdf
http://www.nih.gov/about/director/stemcell/stay_08312010.pdf

Motion to Stay includes a Declaration of NIH Director Francis Collins detailing the impact on intra- and extra-mural research: “… The preliminary injunction issued in this case will have extraordinary adverse effects not only on the prospects of delivering new therapies to patients suffering from numerous diseases and disorders but also on scientific progress from the wider biomedical research community…”

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ZenMaster

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For more on stem cells and cloning, go to CellNEWS at
http://cellnews-blog.blogspot.com/

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ISSCR Launches Web Site Providing Information on Stem Cell Treatments

ISSCR Launches Web Site Providing Information on Stem Cell Treatments Tuesday, 08 June 2010

The International Society for Stem Cell Research (ISSCR) announced today that it has launched “A Closer Look at Stem Cell Treatments“, a Web site to arm patients, their families and doctors with information they need to make decisions about stem cell treatments. The Web site was developed in response to the growing number of aggressive marketing campaigns on the Internet and elsewhere offering stem cell treatments. The ISSCR urges individuals to be cautious and to learn the facts before making any decision.

“Stem cells do hold tremendous promise for the treatment of many serious diseases. Yet there are organizations out there that are preying on patients’ hopes, offering stem cell treatments – often for large sums of money – for conditions where the current science simply does not support its benefit or safety,” said Irving Weissman, MD, President of the ISSCR.

“We want to stress through this initiative that there are internationally accepted medical criteria for getting new medicines into clinics. Patients have a right to know if the clinic or treatment they are considering adheres to these criteria. We feel it is an obligation of the ISSCR to both a) alert patients and caregivers about clinics and other entities that are selling unproven ‘stem cell’ therapies, and b) help shepherd real stem cell advances from discovery to successful patient treatments as rapidly as possible. ”

Currently there are only a small number of stem cell treatments that have been shown to be beneficial in rigorous studies. These mostly pertain to diseases or conditions of the blood, as well as skin grafts and corneal repair. The ISSCR is concerned that stem cell treatments are being marketed to patients worldwide for a variety of medical conditions, without having the mechanisms in place to ensure safety or likely benefit. Without these safeguards, patients may be put at risk.

The Web site offers several tools for patients to evaluate a prospective clinic or treatment including a list of questions to ask about the treatment and providers, as well as resources that explain fundamental scientific principles of stem cell biology and the implications for stem cell treatments. Ultimately, the Web site will list stem cell clinics and whether they do or do not provide the ISSCR with information showing that appropriate oversight and other patient protections are in place.

Visitors to http://www.closerlookatstemcells.org/ can submit, for review, a clinic or treatment they have seen advertised. The treatment providers will be asked to present evidence that a) a medical ethics committee is involved to protect patients’ rights; and b) there is supervision by an official regulatory body such as the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA) for the trial or approved use of a treatment for specific diseases or conditions.

“We want patients to feel they have access to critical information they might otherwise not have, so they can make the best decision for their individual situation,” said Patrick Taylor, JD, Chair of the ISSCR Task Force on Unproven Stem Cell Treatments.

"The key to ensuring that treatments are safe and effective is a well-established path from basic research to clinical care, through carefully constructed studies and independent review. The criteria selected by the task force are simple to apply, but of extraordinary power in promoting progress while protecting patients."

The International Society for Stem Cell Research (ISSCR) is an independent, non-profit organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.
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ZenMaster

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For more on stem cells and cloning, go to CellNEWS at
http://cellnews-blog.blogspot.com/

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