ISSCR News
The ISSCR Responds to FDA’s Draft Guidance on Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations
On 24 November, the ISSCR submitted comments on the Food and Drug Administration's draft guidance for Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations.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.
New Podcast Episode. Building a Better Barrier: Modeling the Human gut Epithelium
The human intestinal epithelial barrier comprises diverse proliferative, secretory and absorptive cell types that facilitate nutrient digestion and absorption and protect against harmful environmental agents. The barrier and its function can vary between individuals due to genetic differences thus impact processes such as digestion, drug metabolism, and drug sensitivity. Our guests today investigated the effect of diverse culture conditions on the cell type composition, gene expression profiles, and maturation status of human pluripotent stem cell-derived intestinal epithelial cells in three different model systems. Their research provides insight into the relevant conditions and systems for modeling specific intestinal functions and highlights the importance of personalized intestinal model systems.
The ISSCR, Society for Developmental Biology, and the Allen Institute to Host First Collaborative Scientific Symposium
The event will take place 23-25 September 2026 in Seattle, USA
For the first time, the International Society for Stem Cell Research (ISSCR), the Society for Developmental Biology (SDB), and the Allen Institute are collaborating to present a three-day scientific symposium led by early-career scientists. The Stem Cell & Developmental Biology Early Career Symposium is designed to nurture the next generation of researchers and provide a platform for professional growth while fostering collaboration at the intersection of developmental biology and stem cell science.
Scientists Use Stem Cells to Move Closer to Large-Scale Manufacturing of Platelets
Platelets are small, disc-shaped cell fragments in the blood that are essential to stop bleeding and to initiate blood clotting after injury. Platelet transfusions in patients with severe trauma or medical conditions, including bone marrow disease, leukemia, or sepsis, can be lifesaving. Despite being a standard clinical practice, platelet transfusions face issues related to the availability of blood donations from which platelets are isolated, the relatively short shelf life of purified platelets, and the risk of an immune response in patients receiving platelets from unmatched donors.
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