New international guidelines for stem cell research

Responding to advances in science, revised Guidelines for Stem Cell Research and Clinical Translation have been published by the International Society for Stem Cell Research.

Stem cell research is an emerging and innovative field, and the guidelines were updated to “encompass a broader and more expansive scope of research and clinical endeavour while maintaining the fundamental principles of the research and application”. New recommendations address recent scientific advances involving embryos, stem cell-based embryo models, chimeras, organoids, and genome editing.

The Guidelines were revised with the support of a comprehensive Task Force. Australia was represented in the working group by Professor Megan Munsie, University of Melbourne, and Head -Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia; Prof. Munsie is also an active contributor to AusBiotech’s Regenerative Medicine Advisory Group.

The primary goals of stem cell research are to advance scientific understanding, to generate evidence for addressing unmet medical and public health needs, and to develop safe and efficacious therapies for patients.

As the field advances, it is important to balance the excitement over the growing number of clinical trials for serious diseases with the requirement to rigorously evaluate the safety and effectiveness of each potential new intervention. The Guidelines offers a number of recommendations, and is built on a set of widely-shared ethical principles, and complement existing legal frameworks.

Stem cell therapies are part of the broader regenerative medicine (RM) ecosystem. Australia holds a strong and vibrant RM industry ecosystem with an internationally-recognised translational research, clinical trials framework and clinical centres. With more than 30 companies in Australia developing products and over 30 clinical trials in progress, Australia is globally competitive in this space.

Globally, the RM sector has more than 1,000 clinical trials in progress, and in 2020 alone it attracted USD$19.9B, doubling from the previous year. Global companies are also turning their attention to the RM sector and we are seeing more gene and cell therapies being brought to Australia for patient access.

Download and read the ISSCR Guidelines here.

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