New stem cell research guidelines

International guidelines governing stem cell research have been updated including new review processes for using stem cell-derived human embryos. 

The updated recommendations, released by the International Society for Stem Cell Research (ISSCR) and published in Nature, describe the ethical principles and best practices for translational and clinical research involving stem cells.

Murdoch Children's Research Institute Theme Director of Cell Biology Professor Melissa Little, the incoming ISSCR president, played a key role in compiling the guidelines and will oversee their implementation.

University of Melbourne Professor Megan Munsie, who was part of the global taskforce that drafted the new recommendations, said the changes responded to the emerging areas of research that have great scientific potential yet were not fully addressed by the previous guidelines and may raise issues for researchers, regulators and the public. 

"The updated guidelines set an invaluable benchmark for lab research and clinical practice," she said. "While national regulations and existing ethical frameworks will need to be taken into consideration, these global guidelines provide a basis to respond to developments in the field and drive important discussions around stem cell research."

"A major feature of the new guidelines is they recognise that some areas of stem cell research require 'specialised' scientific and ethical review – that includes community members and people with expertise in the relevant science, ethics and law – beyond that usually required and conducted at an institutional level."

Key recommendations in the updated guidelines include:

• Clarifying how research involving stem cell-derived models of 'complete' human embryos should only be conducted following rigorous independent and specialised scientific and ethical review
• Specifying that transferring human stem cells into post-natal animals- a technique commonly used in research - would not require specialised oversight, but attempts to gestate non-human embryos containing human stem cells in an animal would warrant higher level review
• Calling for a public conversation on whether limited lab research of human embryos beyond 14-days should be allowed. This area of research may lead to new treatments for developmental conditions and infertility
• Outlining a path forward for consideration of the ethical and safety issues around germline genome editing research, a useful tool for preventing transmission of harmful genetic diseases and conditions to children
• Requiring attempts to achieve pregnancy using mitochondrial replacement techniques be reviewed through a specialised oversight process to evaluate scientific and safety issues. Mitochondrial diseases, which occur when structures that produce energy for a cell malfunction, may be prevented by transferring the mitochondrial DNA from a healthy egg donor. The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 was introduced into the Federal Parliament in March, paving the way for legalising mitochondrial donation in Australia

Professor Little, the first Australian ISSCR president, said she was incredibly proud of the proactive role that the organisation had, and continued to play, in guiding appropriate scientific behaviour and regulatory frameworks in countries across the globe.

The guidelines were updated through a two-year collaboration with international experts and leaders in areas of stem cell science, ethics, and law.

"New scientific approaches are continuing emerge in all areas, but notably around stem cell science," Professor Little said. "Some of these emerging technologies present ethical challenges, even when the benefit to human health may be the long-term objective. This is particularly so in research modelling the human embryo and transferring human stem cells into animal embryos.

"The fact that these guidelines have been developed by the research community itself indicates a deep sense of responsibility and integrity and an active desire to ensure that the science is in step with the community."

To view the full guidelines click here