Cell secretome as a potential anticancer therapeutic agent: composition, mechanisms, preclinical evidence, and translational challenges

Clinical advancement requires immediate consensus on an optimal perinatal-sourced candidate, mandatory priming/EV depletion, validated quantitative potency assays, and Good Manufacturing Practice (GMP)-compliant manufacturing. With coordinated effort, first-in-human phase I trials could commence by 2028-2029, offering a novel, off-the-shelf paracrine therapy for solid tumors.