Drs. Shuibing Chen and Hans Clevers, members of the Steering Committee for the ISSCR Consortium on Advanced Stem Cell-Based Models in Drug Discovery and Development, discuss the need to accelerate the responsible integration of stem cell–derived models into preclinical drug development. Their conversation reflects growing regulatory and policy momentum around new approach methodologies (NAMs) and underscores the importance of rigorous standards, regulatory alignment, and cross-sector collaboration to improve reproducibility and advance more predictive, human-relevant therapies.

Building on its long-standing leadership in global standards, ethics, and policy, the ISSCR is uniquely positioned to convene industry, academia, and regulators around this effort. The initiative also reflects the Society’s expanding industry engagement, with industry membership increasing nearly 180% over the past five years – creating new opportunities for strategic partnerships to address shared scientific and translational challenges.

Treating Frailty with Stem Cells – In a clinical trial, mesenchymal stem cell therapy improved walking distance and physical function in older adults with frailty.

Combined Bone & Bone Marrow Organoids – Researchers developed a scalable iPSC-derived bone marrow organoid that models human lympho-myeloid hematopoiesis and disease.

CAR-NK Progenitors Prevent Relapse – Engineered pluripotent stem cell–derived CAR-expressing NK progenitor cells reduced minimal residual disease and prevented relapse in leukemia models following chemotherapy.

Whole-Body Single-Cell Mapping – Scientists have developed a 3D single-cell-resolution map of mouse organs and the whole neonatal body.

Photo Reference: Courtesy of Drs. Shuibing Chen and Hans Clevers

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