A novel is defined as new and not resembling something formerly known or used. Novel technologies are technologies that have not been previously identified, and are new and different from anything that has been done, experienced, or made previously. Biotherapies (gene and cell therapies) hold great promise in regenerative medicine for treating diseases. Novel frontiers are being explored with new technologies and therapies, including with extracellular vesicles that include exosomes, nanomolecules, and cytokines, and are shifting the paradigm by addressing diseases with unfulfilled or unmet needs in the current healthcare system. For example, exosomal cargos have been compared with stem cells for clinical and therapeutic potential and have been noted for the lack of inherent risks associated with cell-based therapies, including the lack of replicating potential and the risk of malignant transformation of stem cells; and the lack of off-target immunogenic responses. Around 79 clinical trials have been registered globally, and 11 clinical trials have been completed demonstrating positive diagnostic and therapeutic effects in cancers and neurodegenerative and hematological diseases.Cytokines represent another novel approach to addressing unmet needs in various malignant and nonmalignant diseases. Studies are ongoing with cytokines as administered therapeutically and when managing their adverse effects due to immune effector cell therapies. Optimizing the immunomodulatory effects of cytokines often involves balancing the beneficial and deleterious effects of a wide array of exogenous and endogenous cytokines. These approaches offer great potential for treating rare and life-threatening diseases and must be regulated by evidence-based practices laid down by the competent authorities.
Identify and explore current novel technologies and therapies in the field of Biotherapies and Regenerative Medicine.
Determine and employ tools to translate novel technologies into safe novel therapies in the clinic.
Manage and evaluate the safety, efficacy and potency of novel therapies.