Abstract

Challenge and Solution of Cellular Pharmacokinetic Considerations For Cell Therapy

Thai-Yen Ling, Associate Professor, National Taiwan University

In the field of cell therapy, application of cells is not only regarded as “a treatment protocol", but also to consider cells as a medical product: “the cell drugs". However, different to the drugs of small molecular, which have been regulated by well-established evaluation process of preclinical pharmacokinetic/pharmacodynamic (PK/PD) studies in order to apply for the investigational new drug application (IND) and new drug application (NDA), methods used to assess the bio-distribution of transplanted cells and related metabolic information and therapeutic effect mechanisms are still limited. Our study demonstrated that fluorescent nanodiamonds (FND) labeling techniques of cell toward accurate quantification and bio-distribution for cell-transplantation in PK/PD studies may substitute for radiographic calibration, Q-PCR and immunohistochemical analysis for PK/PD in preclinical animal studies. FND has the properties of high biocompatibility, non-toxicity, low chemical activity and stable optical properties. The technique can be applied to different kind of immune cells, stem cells, and any other cells using for cell therapy. Taken altogether, transplanted cells by FND labeling could be accurately located and quantified for the distribution of experimental animals in vivo, and the techniques will provide the essential information of cellular PK/PD evaluation in preclinical studies of cell therapy to assist IND process for cell drug development.