Large Animal Model Efficacy Testing Is Needed Prior to Launch of a Stem Cell Clinical Trial

Abstract

Stem cell therapeutics, as other therapeutic strategies, must surmount multiple requirements before reaching the phase of clinical trials. These requirements can be onerous in terms of time and funding and could, thereby, lead to abandonment of many promising therapeutics. One of these requirements is the perceived necessity of conducting large animal efficacy studies-especially pig studies-prior to initiating a clinical trial. The value of such a strategy, despite acceptance by experts, has never been demonstrated scientifically, raising the question of whether bias rather than evidence hampers the development of new therapeutic strategies.