by Bioengineer.org –
The International Society for Stem Cell Research (ISSCR) has unveiled an innovative and comprehensive resource entitled Best Practices for the Development of Pluripotent Stem Cell-Derived Cellular Therapies, marking a pivotal advancement in the domain of regenerative medicine. This dynamic, interactive guide is meticulously designed to expedite the translation of human pluripotent stem cell (PSC)-derived therapies from the research bench to clinical trials and eventual commercial availability. By synthesizing the expertise of global leaders in the field, the ISSCR aims to address the multifaceted challenges inherent in developing PSC-based cellular treatments.
Central to the document is an in-depth framework that navigates developers through critical decision-making junctures essential for ensuring the safety, efficacy, and regulatory compliance of PSC-derived products. Covering seven meticulously organized sections, the guidance spans the breadth of translational development, including PSC line selection, sourcing and qualification of raw materials, preclinical validations, manufacturing standards, and clinical trial design. Importantly, the resource is jurisdictionally neutral, allowing it to serve as a universally applicable blueprint adaptable across international regulatory landscapes.
