Guidelines and Regulations Necessary as Stem Cell Field Advances

With the rapid growth of the stem cell field and advances in regenerative medicine, it is critically important that researchers earn and retain the public trust. To that end we must operate under agreed-upon guidelines that ensure ethical activities, transparency, and sound science.

Recently several countries have promulgated policy and regulatory changes meant to address some of the issues raised by cutting-edge research and scientific advances that have ethical and societal implications. The ISSCR’s Guidelines for Stem Cell Research and Clinical Translation provide an internationally agreed-upon set of principles that have been widely adopted around the world, and this informs our comments on some of the latest developments in the regulatory arena.

Making the ISSCR Voice Heard
Our efforts to support stem cell research and its translation to medicine are key to what we do in support of evidence-based science and the work of our members around the world. When we learn of new regulations or proposed policies or guidelines, we mobilize our Public Policy Committee to review them and respond based on ISSCR guidelines.

• Japan: The ISSCR supports recent guidelines from the Ministry of Education, Culture, Sports, Science and Technology that lift a prohibition on chimera human-to-animal embryos research beyond 14 days. The new rules build on the ISSCR Guidelines recommendation 2.1.5, enabling a new generation of research that could potentially lead to the production of human organs for transplantation.

  • In 2016, the NIH proposed lifting a moratorium on this research, but never finalized a policy change.

• China: After news claiming the creation of gene-edited babies in China, the government drafted new regulations that seek to weigh the ethical, societal, and scientific challenges related to new biomedical technologies, including stem cells and germline gene editing. The regulations require the consideration of scientific necessity and rationale of the research, qualifications of the researcher and institution, and protocols to mitigate public health risks.

  • The ISSCR submitted comments to the country’s National Health Commission Medical and Medical Administration Bureau that express the need to comply with ethical research standards, standards of informed consent, and international standards for human embryo genome modification, among others. We encourage China to continue engaging on these issues with the international community.

Raising Awareness Within the Field
At the ISSCR International Symposium in Amsterdam, we worked with the European Molecular Biology Organization (EMBO) to develop a pre-meeting session on the ethical and policy challenges of organoid research and regenerative medicine applications. Key regulators and policymakers from the European Union and leading ethicists and scientists talked about challenges presented by recent advances in stem cell research and explored the ethical challenges of neural organoid development. The panel also provided practical advice for researchers who will need to consider the regulatory and ethical challenges of translating stem cells to the clinic, and they discussed the challenges of biobanking.

Concern for Science Funding
The ISSCR continues to monitor issues of concern around funding and support for stem cell research around the world and meets with policy makers to underscore the importance of basic research to advancing science. In Europe, the Parliament will finish debating Horizon Europe and the future of science policy on the continent this month, but the funding decisions will be delayed until the end of the year. In Canada, we applaud the restoration of funding for the Stem Cell Network; earlier this year the ISSCR urged the government to continue funding collaborative research networks.

In the U.S., the president proposed a budget for the National Institutes of Health that was nearly five billion USD below the current level, and a cut of nearly one billion USD for the National Science Foundation. The proposal includes a modest increase for the Food and Drug Administration. The ISSCR signed a letter of support for increasing NIH funding, along with more than 300 patient groups, scientific societies, research institutions, health professionals, educators, and industry. The NIH budget will be debated in committees and eventually voted on by Congress this year.  

It is more important than ever to stand up for science and support the breadth of stem cell research. The ISSCR will lend our voice to policy debates involving scientific research and the future of healthcare, and we hope you will support that effort. To become involved in advocating for science, please contact Eric Anthony at eanthony@isscr.org.

See you in Los Angeles for ISSCR 2019!

Douglas Melton
ISSCR President, 2018-2019