Commercialization of trials for peripheral artery disease

Abstract

Cell-based clinical studies for peripheral arterial dis-ease (PAD) are moving forward at a brisk pace, to early pivotal trials, a fact that offers considerable hope and encouragement for the cardiovascular regenera-tive fi eld. Doors are opening to novel agents, further insights and important questions, while some aspects of clinical development, such as multiple dosing, opti-mal administration techniques and bio-equivalence testing, remain to be addressed. The regenerative approach to advanced PAD is dynamic, and open to creative input from industry and clinical scientists, but mandatory for the success of the clinical trial process and commercialization of its products, is that a level of collaboration be undertaken among those invested in this fi eld, particularly regarding optimiza-tion of trial design and recruitment. The International Society for Cellular Therapy (ISCT) focuses on driving the translation of scien-tifi c research and developing technology platforms essential to cell therapy. In keeping with its goal of expediting the development of cell therapies and advancing global patient access, ISCT has given priority to creating forums directed toward emerg-ing cell therapeutics and commercialization perspec-tives. This goal takes on particular importance as pivotal cell therapy studies have commenced regard-ing acute myocardial infarction, refractory angina, congestive heart failure and PAD. Results will have signifi cant bearing on subsequent trials. Therefore, ensuring that clinical trial design and endpoints are well selected and that investigators have the tools to evaluate comparative cell types and select the most appropriate among them, is crucial to the fi eld at this time. These imperatives align well with key missions of ISCT: to foster open-code development of specifi c cell products targeting specifi c diseases, and to pro-vide regulatory agencies with a background and data integral to their decision-making processes. With the Cardiovascular Research Foundation (CRF), ISCT convened a strategic Clinical Development Focus Group in January 2011 at the Sixth International Conference on Cell Therapy for Cardiovascular Dis-eases (IC3D), involving experts from academia and industry for a focused discussion on clinical studies in advanced PAD.