ISSCR News


The ISSCR Statement on New Research with Embryo Models
Press Release Kym Kilbourne Press Release Kym Kilbourne

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.

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The ISSCR Files Amicus Brief Supporting FDA’s Authority to Regulate Unproven Stem Cell-Based Interventions
Press Release, Policy Kym Kilbourne Press Release, Policy Kym Kilbourne

The ISSCR Files Amicus Brief Supporting FDA’s Authority to Regulate Unproven Stem Cell-Based Interventions

The International Society for Stem Cell Research (ISSCR) filed an amicus curiae brief today to support the U.S. government’s appeal in U.S. v. California Stem Cell Treatment Center, Inc., a case that ruled the Food and Drug Administration (FDA) cannot regulate dangerous unproven stem cell-based interventions.

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The ISSCR Comments on EMA Draft Guidance on Registry-based Studies
Policy Keith Alm Policy Keith Alm

The ISSCR Comments on EMA Draft Guidance on Registry-based Studies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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