Preclinical Study: A Bottleneck Impedes the Progress of Regenerative Medicine

Stem cell biology and regenerative medicine are rapidly moving from translational research to the clinics. For this, preclinical testing models are considered important both in the discovery-phase and proof-of-concept (POC) studies prior to their entry into clinics. Preclinical experimental animal models play an important role in determining stem cell potency and assays related to safety that are considered mandatory by the regulatory authorities of various countries. This article focuses on problems in choosing the right kind of testing models of cell-based products intended for use of humans. Clinical translational research demands answers of many such questions; this article describes some of them and explains the inherent limitations.