The International Society for Stem Cell Research (ISSCR) released an update of its 2021 Guidelines for Stem Cell Research and Clinical Translation today. The targeted update addresses important advances successful nan improvement and exertion of quality stem cell-based embryo models (SCBEMs) and recommendations for investigation oversight outlined successful a achromatic insubstantial from nan ISSCR Embryo Models Working Group published successful June.
SCBEMs are three-dimensional stem cell-derived structures that replicate cardinal aspects of early embryonic development. These innovative models connection unprecedented imaginable to heighten our knowing of quality developmental biology and reproductive science.
This Guidelines update underscores nan ISSCR's patient committedness to proactively addressing nan ethical and regulatory considerations that travel technological advances. Stem cell-based embryo models are transforming really we study early quality development, and it is captious that this advancement is supported by clear guidance, a beardown consciousness of responsibility, and world consensus. I commend nan ISSCR Embryo Models Working Group for their thoughtful and forward-looking activity successful ensuring our guidelines germinate successful measurement pinch this quickly advancing field."
Hideyuki Okano, ISSCR President
The ISSCR Guidelines person agelong served arsenic nan world benchmark for technological and ethical rigor, offering trusted guidance for oversight and transparency successful stem compartment research. They support nan improvement of regulatory frameworks successful countries wherever specified systems are still emerging. Adherence to nan guidelines provides assurance that investigation is conducted pinch integrity and caller therapies are safe, effective, and grounds based.
The revisions included successful nan 2025 update to nan Guidelines are constricted to SCBEM technologies and are nan consequence of a targeted, deliberative process led by Amander Clark, University of California, Los Angeles, USA, and Janet Rossant, Hospital for Sick Children, Toronto, Canada. This focused attack enabled nan ISSCR to respond thoughtfully to a defined technological and oversight need, and to connection updated world guidance for researchers, diary editors, regulators, funders, and nan public. The ISSCR intends to proceed utilizing this agile, collaborative exemplary to reside evolving areas of stem compartment investigation that warrant updated, globally harmonized oversight standards.
Key revisions
- Replaces nan classification of models arsenic "integrated" aliases "non-integrated" pinch nan inclusive word "SCBEMs."
- Proposes that each 3D SCBEMs person a clear technological rationale, person a defined endpoint and beryllium taxable to an due oversight mechanism.
- Reiterates that each SCBEMs are successful vitro models and must not beryllium transplanted successful nan uterus of a surviving animal aliases quality host.
- Includes a caller proposal that prohibits nan ex vivo civilization of SCBEMS to nan constituent of imaginable viability – alleged ectogenesis.