The ISSCR Holds Second Meeting With UK Regulators on Artificial Intelligence in Stem Cell Therapy
The International Society for Stem Cell Research (ISSCR) held its second Broader Scope Scientific Advice meeting with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) on October 29, 2025, focusing on the use of artificial intelligence (AI) in developing stem cell therapies.
The session explored key topics including the current state and challenges of AI, machine learning, and digitalization systems for automation in cell and gene therapy; applications of AI in autologous iPSC-derived RPE cell therapy; and AI-based image analysis for in-process characterization and decision-making during iPSC generation.
Representatives from the MHRA included experts in quality assessment, standards and compliance, and stem cell banking. In addition to the presenters, representatives from ISSCR included members of the Board of Directors, the Manufacturing, Clinical Translation, and Regulatory Committee (MCTR), and ISSCR members with expertise in integrating AI into the development of stem cell therapies
The meeting follows a previous ISSCR–MHRA discussion that addressed the manufacture and testing of induced pluripotent stem cell (iPSC) banks and derived products, as well as genomic heterogeneity in pluripotent stem cell therapeutics.
A summary of the latest meeting will be published on the ISSCR website once finalized. Summaries of earlier discussions with regulatory agencies are also available online.
Meeting Summaries
Pharmaceuticals and Medical Devices Agency (PMDA) Meeting
8 November 2024 | Tokyo, Japan
European Medicines Agency (EMA) Meeting
10 April 2024 | Online
Medicines and Healthcare products Regulatory Agency (MHRA) Meeting
15 May 2023 | Online
U.S. Food and Drug Administration (FDA) Meeting
13 December 2022 | Online
About ISSCR
With nearly 5,000 members from more than 80 countries, the International Society for Stem Cell Research (@ISSCR) is the preeminent global, cross-disciplinary, science-based organization dedicated to stem cell research and its translation to the clinic. The ISSCR mission is to promote excellence in stem cell science and applications to human health.