ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update

Robin Lovell-Badge
Eric Anthony
Roger A. Barker
Tania Bubela
Ali H. Brivanlou
Melissa Carpenter
R. Alta Charo
Amander Clark
Ellen Clayton
Yali Cong
George Q. Daley
Jianping Fu
Misao Fujita
Andy Greenfield
Steve A. Goldman
Lori Hill
Insoo Hyun
Rosario Isasi
Jeffrey Kahn
Kazuto Kato
Jin-Soo Kim
Jonathan Kimmelman
Jürgen A. Knoblich
Debra Mathews
Nuria Montserrat
Jack Mosher
Megan Munsie
Hiromitsu Nakauchi
Luigi Naldini
Gail Naughton
Kathy Niakan
Ubaka Ogbogu
Roger Pedersen
Nicolas Rivron
Heather Rooke
Janet Rossant
Jeff Round
Mitinori Saitou
Douglas Sipp
Julie Steffann
Jeremy Sugarman
Azim Surani
Jun Takahashi
Fuchou Tang
Leigh Turner
Patricia J. Zettler
Xiaomei Zhai
This document was written by the 45 members of the International Society for Stem Cell Research (ISSCR) task force charged with revising the Society’s guidelines for stem cell and related biological research. Such revision was necessary, as the task force put it, to “evolve[e] with the science” (2021:1399). They explain their deliberative procedure and highlight the differences between the 2016 and 2021 editions of the guidelines. While the new guidelines persist in the prohibition of research on human germline genome editing, the task force responds to 2016 revelations of new possibilities for culturing human embryos beyond 13 days and what it describes as “building pressure” to revise the 14-day rule via a category change. From 2016 to 2021, In vitro culture of intact human preimplantation embryos went from Category 3—that is, not allowed—to Category 2, indicating approval with specialized oversight. The task force indicates that such research should be balanced with “ethical and societal concerns” and recommends fostering public dialogue about the permissibility of such research. Nonetheless, the guidelines soften the regulations on later stages of human embryo research.