IPRP Reflection Paper
General Principles to Address the Nature and Duration of Follow-up for Subjects of Clinical Trials Using Cell Therapy Products
The Reflection Paper on “General Principles to Address the Nature and Duration of Follow-up for Subjects of Clinical Trials Using Cell Therapy Products” prepared by the Cell Therapy Working Group (WG) has been endorsed by the IPRP Management Committee at its meeting in November 2018.
Unlike typical pharmaceuticals, cell therapy products are complex and pose potential safety risks due to unique specific characteristics of the cells, the final product, the disease for which it is intended, and the context in which the cells will be used.
This Reflection Paper provides perspectives from the IPRP Cell Therapy WG on factors to be considered when deciding on the nature and duration of clinical follow-up for patients receiving cell therapy products. The recommendations stated in this paper are applicable to monitoring patients for safety only. Monitoring for efficacy depends on additional factors that are not discussed below. Furthermore, this document does not address clinical follow-up for patients who have received genetically modified cells.
Please visit the Cell Therapy WG page for more information.