ISSCR News
The ISSCR Forms Embryo Models Working Group
Since the ISSCR released its May 2021 update to the Guidelines for Stem Cell Research and Clinical Translation, research with stem cell-based embryo models has evolved rapidly. During the extensive conversations leading up to the 2021 guidelines update, many of the embryo models that are being used today did not exist. The speed of embryo model research has resulted in new challenges for oversight committees, policymakers, funders, and journal editors grappling with how to assess the unique aspects of the science and the associated ethical and regulatory issues.
The ISSCR Responds to Ranking Member Cassidy’s Request for Information on NIH Reform
On 27 October 2023, the ISSCR submitted comments to Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy’s Request for Information on reforming the National Institutes of Health (NIH).
The ISSCR Statement on New Research with Embryo Models
The ISSCR supports research with embryo models derived from human pluripotent stem cells that is conducted with scientific and ethical rigor. ISSCR encourages researchers to continue to follow the ISSCR Guidelines for Stem Cell Research and Clinical Translation when considering research in this emerging area. Recent work presented at the ISSCR 2023 Annual Meeting in Boston, USA this month and additional research posted online as preprints shortly thereafter highlights the rapid pace of progress in the development of stem cell-based embryo models. To aid public understanding of this progress and assist the media in accurate reporting, the ISSCR provides the following information.
The ISSCR Comments on the Australian Mitochondrial Donation Bill
The ISSCR provided formal support of the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 in a letter to Chair Wendy Askew and Deputy Chair Rachel Siewert of the Senate Community Affairs Legislation Committee in Australia.
The ISSCR Comments on EMA Draft Guidance on Registry-based Studies
The ISSCR recently delivered comments on the draft Guideline on Registry-based Studies (EMA/502388/2020). Among other points, the letter stated support the crucial role of the European Medicines Agency (EMA) in overseeing the development of safe and effective new products and the draft Guideline on Registry-based Studies. The Society also encouraged EMA to clarify the appropriate uses for patient registries to prevent them from being abused by businesses seeking to prematurely commercialize unproven stem cell-based interventions.
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