Guidelines for the Field of Stem Cell Research and Regenerative Medicine
As a service to the field, the ISSCR develops guidelines that address the international diversity of cultural, political, legal, and ethical issues associated with stem cell research and its translation to medicine. The guidelines maintain and underscore widely shared principles in science that call for rigor, oversight, and transparency in all areas of practice. Adherence to these principles provides assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based.
Responding to advances in science, the guidelines were updated in 2021 to encompass a broader and more expansive scope of research and clinical endeavor while maintaining the fundamental principles of the research and application. The 2021 guidelines include new recommendations to address the recent scientific advances involving embryos, stem cell-based embryo models, chimeras, organoids, and genome editing.
Accessing the 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation update, online or PDF file:
Use the Table of Contents on the left to navigate to each main section of the updated ISSCR Guidelines;
Visit the Key Topics, which are intended to assemble areas of the ISSCR Guidelines update related to the topic onto one page; and
Download a clickable PDF (top left on this page)
For more context, refer to the following papers written by members off the 2021 ISSCR Guidelines Steering Committee and additional resources:
“ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 Update,” by Lovell-Badge et al., ISSCR Guidelines Taskforce (Stem Cell Reports)
“ISSCR Guidelines for the Transfer of Human Pluripotent Stem Cells and Their Direct Derivatives into Animal Hosts,” by Hyun et al. (Stem Cell Reports)
"New Guidelines for Stem Cell and Embryo Research from the ISSCR," by Anthony et al. (Cell Stem Cell)
"ISSCR Guidelines Uphold Human Right to Science for Benefit of All," by Robin Lovell-Badge, Zubin Master, and Bartha Knoppers (Nature)
Consider attending the ISSCR 2021 Annual Meeting 21-26 June (virtually). This year's meeting kicks off with a special session updating attendees discussing recommendations in the ISSCR Guidelines update members of the task force.
ISSCR's Guidelines for Stem Cell Research and Clinical Translation are strictly copyrighted by the society. Contact firstname.lastname@example.org for more information.
The U.S. Food and Drug Administration has published four final guidance documents that are part of a comprehensive policy framework to address how the agency plans to support and expedite the development of regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). These guidance documents build upon FDA’s risk-based, flexible regulatory framework, and underscore the agency’s commitment to help bring new and innovative treatment options to patients.
The first two final guidance documents are:
- Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
- Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception
The final guidance on minimal manipulation and homologous use are intended to provide clarity in the determination of whether HCT/Ps are subject to FDA’s premarket review requirements. The final guidance on the same surgical procedure exception is intended to provide clarity as to whether an establishment may qualify for an exception from the requirements under Part 1271 by meeting the exception in 21 CFR 1271.15(b).
The FDA also published two final guidances intended to aid in the effort to bring innovative, safe, and effective products to patients as efficiently as possible:
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
- Evaluation of Devices Used with Regenerative Medicine Advanced Therapies
The final guidance on expedited programs describes several programs, such as Fast Track designation and Breakthrough Therapy designation, that are available to sponsors of regenerative medicine therapies, and information about the requirements for, and benefits of, the new RMAT designation program that was created by the 21st Century Cures Act The final device guidance, which FDA is publishing as required by section 3034 of the 21st Century Cures Act, provides the agency’s current thinking about concepts related to the evaluation of devices used in the recovery, isolation and delivery of RMATs.