On May 27, 2021, the International Society for Stem Cell Research (ISSCR) released an updated version of its Guidelines for Stem Cell Research and Clinical Translation. One primary and noteworthy update in the 2021 guidelines is the dismissal of the “14-day rule” regarding human embryo experimentation.

 

The ISSCR was founded in 2002 and appointed itself as an international organization claiming to be dedicated to “all aspects of stem cell research and its clinical translation,” and the development of “high standards in practical and ethical aspects of relevant research and its applications.”[i] While it discusses the mission of creating guidelines to serve as an international standard and ensure that regulatory standards are being met even in countries where legislation regarding human stem cell research has not been passed, it is ultimately a room of scientists with no authority and no real public input writing guidelines for other scientists.

 

The ISSCR released its first set of guidelines in 2006[ii] which focused primarily on human embryonic stem cells. Then in 2008[iii] another set of guidelines was released, which focused on clinical translation of stem cell therapies, called “essential if these were to realize their potential for regenerative medicine.”[iv] In 2016,[v] the guidelines were once again modified and included information on research involving human embryos. “Key advances that the new 2021 Guidelines cover include the following: the culture of human embryos and stem-cell-derived models of embryo development, both embryo-like entities and specific organ-like structures (organoids); chimeras; in vitro gametogenesis from cells; mitochondrial replacement techniques; somatic and germline genome editing.”[vi] The ISSCR seems intent on mutilating and dismembering embryos in every way possible in the name of science.

 

 

What is the 14-day rule?

 

The 14-day rule was first proposed in the U.S. in 1979 and in the U.K. in 1984 and was taken up by the ISSCR as part of its self-regulation of embryo experiments.  The 14-day rule says that human embryos should not be “grown” in the laboratory past 14 days from fertilization.  The quasi-ethical justification was supposedly that this stops experimentation before formation of the primitive streak (the inception of the nervous system) and loss of ability to form twins when the “ingredients” for the formation of the individual embryo’s organs are set in motion.  In reality, scientists were unable to grow embryos in the lab for more than 7 or 8 days, so this was an easy rule to keep while presenting a flimsy façade of scientists respecting ethics and embryos.

 

In 2016, the ISSCR listed in vitro culture “of any intact human preimplantation embryo or organized embryo-like cellular structure with human organismal potential, regardless of derivation method, beyond 14 days or formation of the primitive streak” under its list of “prohibited research activities.”[vii] In other words: no laboratory experiments on living human embryos beyond 14 days. So, what has changed? According to the ISSCR, around the time the 2016 guidelines were released, several papers were published indicating that “it was possible to culture intact preimplantation human embryos up to the equivalent of 13-day post-implantation embryos, i.e., shortly before gastrulation, which begins around 14 days in humans.”[viii] Other objects of research, such as mouse embryos, have been cultured beyond that developmental stage, and monkey embryos have been cultured in the lab to 20 days. The ISSCR claims that this is one reason that “there is now building pressure to extend or even abolish this [14-day] limit in order to permit research into very important stages of human embryo development, about which we know little, but where many cases of miscarriage or birth defects are likely to have their origins.”[ix]  In plain language, now that scientists have the ability to grow human embryos in the lab beyond 14 days, they want to do those experiments.

 

The ISSCR wants to abolish what little unofficial protections exist for the smallest and weakest among us, zero- to 14-day-old embryos, in the name of scientific discovery; statements about potentially finding the source of birth defects and the cause of miscarriages are meant only to justify desires for manipulation of young human beings. During week three of a human embryo’s development, he or she undergoes development of the primitive streak previously mentioned. Each cell receives a signal and turns on a gene which causes each cell to become unique and create a sort of "blueprint" for the body during gastrulation. Drugs, alcohol, and other toxic substances can be particularly harmful to a human embryo during this development phase.

 

It is fascinating that ISSCR and others in the scientific community appear to care so much about protecting embryos during the gastrulation stage who are wanted by experimenting on unwanted embryos in the gastrulation stage, or even perhaps embryos explicitly created to be experimental subjects. An embryo is an embryo is an embryo. ISSCR would like to mask the humanity of embryos by signaling their virtues of scientific advancement and all the good they can do for other embryos (while ignoring the ones who are being prodded and poked, vivisected, and left for dead in petri dishes once they have served their “purposes”).

 

Growing embryos in a lab for experimentation while claiming a supposed benefit to other, more important humans, is exploitative, dehumanizing, and goes against our country’s founding principle of all being created equal. The 14-day rule should indeed be abolished; it should instead be replaced with the zero-day rule.[x]

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[i] Robin Lovell-Badge, et al., ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update, Stem Cell Reports, ISSCR, https://doi.org/10.1016/j.stemcr.2021.05.012, May 27, 2021.

[ii] ISSCR, Guidelines for the Conduct of Human Embryonic Stem Cell Research, Version I, https://www.isscr.org/docs/default-source/all-isscr-guidelines/hesc-guidelines/isscrhescguidelines2006.pdf?sfvrsn=91f5f996_0, December 21, 2006.

[iii] Insoo Hyan, et al., New ISSCR Guidelines Underscore Major Principles for Responsible Translational stem Cell Research, https://doi.org/10.1016/j.stem.2008.11.009, December 4, 2008.

[iv] Robin Lovell-Badge, et al., ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update, Stem Cell Reports, ISSCR, https://doi.org/10.1016/j.stemcr.2021.05.012, May 27, 2021.

[v] ISSCR, Guidelines for Stem Cell Research and Clinical Translation, https://www.isscr.org/docs/default-source/all-isscr-guidelines/guidelines-2016/isscr-guidelines-for-stem-cell-research-and-clinical-translationd67119731dff6ddbb37cff0000940c19.pdf?sfvrsn=e31478c5_4, May 12, 2016.

[vi] Robin Lovell-Badge, et al., ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update, Stem Cell Reports, ISSCR, https://doi.org/10.1016/j.stemcr.2021.05.012, May 27, 2021.

[vii] ISSCR, Guidelines for Stem Cell Research and Clinical Translation, https://www.isscr.org/docs/default-source/all-isscr-guidelines/guidelines-2016/isscr-guidelines-for-stem-cell-research-and-clinical-translationd67119731dff6ddbb37cff0000940c19.pdf?sfvrsn=e31478c5_4 , May 12, 2016.

[viii] Robin Lovell-Badge, et al., ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update, Stem Cell Reports, ISSCR, https://doi.org/10.1016/j.stemcr.2021.05.012, May 27, 2021.

[ix] Robin Lovell-Badge, et al., ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update, Stem Cell Reports, ISSCR, https://doi.org/10.1016/j.stemcr.2021.05.012, May 27, 2021.

[x] Tara Sander Lee, Ph.D., David A. Prentice, Ph.D., Lila Rose, Policy Makers Must Prevent Unethical ‘Baby in a Bottle’ Science Experiments, Newsweek, https://www.newsweek.com/policymakers-must-prevent-unethical-baby-bottle-science-experiments-opinion-1589006, May 7, 2021.

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