ISSCR News
The ISSCR Introduces CDMO Directory, a Screening Tool to Support Researchers Advancing Toward Clinical Translation
The International Society for Stem Cell Research (ISSCR) is developing a new CDMO Directory, a web-based resource designed to help Society members identify contract development and manufacturing organizations (CDMOs) with capabilities relevant to their research and clinical translation needs.
Led by the ISSCR Manufacturing, Clinical Translation, and Regulatory (MCTR) Committee, the directory is intended to help bridge the gap between researchers and manufacturers by consolidating key information about participating CDMOs in one centralized resource. The directory will be available to the ISSCR’s nearly 5,000 members across the world staring on 19 October.
CDMOs may participate in the directory by completing a questionnaire developed to capture information researchers consider important when selecting a manufacturing partner. Responses are used to populate each organization’s profile. Through the CDMO Directory, the ISSCR is providing researchers moving toward clinical translation with a practical resource for exploring manufacturing capabilities and beginning conversations with potential partners.
The ISSCR Responds to FDA’s Draft Guidance on Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
On 1 September, the ISSCR submitted comments to the Food and Drug Administration’s draft guidance for Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing. ISSCR supports FDA’s desire to share the Agency’s current thinking on the type of prior knowledge (i.e., public and platform knowledge) that may be scientifically appropriate to leverage to advance product development.
The ISSCR Releases Summary of Meeting With UK Regulators on the Use of AI to Develop Stem Cell Therapies
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.
The ISSCR Responds to FDA’s Draft Guidance on Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations
On 24 November, the ISSCR submitted comments on the Food and Drug Administration's draft guidance for Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations. ISSCR appreciates FDA’s willingness to consider alternative trial designs for cellular and gene therapy products. To support this effort, ISSCR requests additional guidance on managing manufacturing changes within adaptive or master protocols; decentralized trials for small populations; long-term follow-up; using surrogate endpoints and biomarkers; and trial design selection.
The ISSCR Commends Government of India on Pursuing Strengthened Regulatory Oversight of Cell- and Stem Cell-Derived Products
Last week, the ISSCR sent a letter to India’s Ministry of Health and Family Welfare commending the Government of India for pursuing draft amendments that would strengthen and clarify India’s regulatory framework for cell- and stem cell-derived products.
In the letter, shared in response to draft amendments to India’s Drugs Rules, 1945, the ISSCR notes the importance of rigorous regulatory review and manufacturing standards for cell- and stem cell-based products to protect patients.
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