Positioning a Scientific Community on Unproven Cellular Therapies: The 2015 International Society for Cellular Therapy Perspective

Currently, there are many unproven or insufficiently proven cell-based treatments commercially available for hopeful individuals seeking cures for a variety of conditions. Typically, these so-called “therapies” are currently being advertised, sold and administered to patients, although they fail to achieve recognized biological/medical standards of proof for safety or efficacy. In addition, they are often expensive and offered outside the cover of routine clinical care for treatments, outside the realm of conventional clinical trials supervised and monitored by regulatory agencies. This paper summarizes a position document to be published by the International Society for Cellular Therapy (ISCT) as an open manuscript intended for professionals and patient associations. Avoiding a systematic overview of the relevant peer-reviewed literature and investigations, its purpose is to examine multiple aspects of unproven cell therapy interventions including definitions, manufacturing issues, regulations, economic factors and communication. With this document, the ISCT intends to promote a cooperative approach to facilitate the development of safe and effective therapies while minimizing and balancing risks for patients to ultimately establish a coalition of stakeholders that fulfill the vision of a broad, pro-patient cell therapy alliance...