Preclinical Assessment of Living Therapeutic Materials: State-of-Art and Challenges

Living Therapeutic Materials represent a promising technology to tackle therapeutic problems that classical materials cannot address. Despite the advancements on new functions of these devices, new applications, and new fabrication methods, the preclinical evaluation of Living Therapeutic Materials is still very limited and new challenges appear when incorporating the living devices in contact with the host. This is a critical bottleneck in the path to translation to the clinic. Therefore, we have compiled the literature on Living Therapeutic Materials, with a focus on microorganism-based living therapeutic materials, and summarized the investigations carried out to assess their biocompatibility, safety, and efficacy. We have split the investigations in three parts: in vitro, ex vivo, and in vivo assessments, where we describe common practices and remaining challenges.