ISSCR News
The ISSCR Responds to FDA’s Draft Guidance on Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
On 29 July 2024, the ISSCR submitted comments on the Food and Drug Administration’s draft guidance for Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. ISSCR supports FDA’s desire to share their recommendations for determining the appropriate cell safety testing and offers comments to complement FDA's initiative. Specifically, ISSCR requests clarification on genomic testing requirements and proposes adjustments to the guidance on sequencing depth and cytogenetic testing. Additionally, ISSCR recommends using both sequencing and cytogenetic testing to ensure comprehensive safety assessments.
ISSCR Guidelines for Stem Cell Research and Clinical Translation Document Now Available in Korean
The ISSCR is pleased to announce the availability of the Korean language version of the Guidelines for Stem Cell Research and Clinical Translation.
Valentina Greco Takes on New Position as President of the ISSCR
The ISSCR is thrilled to announce Valentina Greco, Yale School of Medicine, Genetics Department & Yale Stem Cell Center USA, as its President. Her term began at the ISSCR 2024 Annual Meeting held in Hamburg, Germany that concluded on Saturday, 13 July 2024.
ISSCR Standards for Human Stem Cell Use in Research Document Now Available in Japanese
The ISSCR is pleased to announce the availability of the Japanese language version of the Standards for Human Stem Cell Use in Research.
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.
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