Preclinical efficacy and safety evaluation of a topical mesenchymal stem cell derived conditioned media gel for oral mucositis management
Preclinical evaluation shows topical mesenchymal stem cell-derived conditioned media (MSC-CM) gels (5%, 10%, 15%) are safe and accelerate healing in 5-fluorouracil–induced oral mucositis and radiation wound models. NOAEL was 100% MSC-CM in 28-day toxicity studies; the 15% formulation produced 100% survival and near-complete mucosal recovery, while 10% accelerated radiation wound closure and induced local IL-20 and IL-17 signaling, supporting translational development for oral mucositis supportive care.
Why it mattersIn 5-FU oral mucositis models, 15% MSC-CM gel achieved 100% survival, prompting prioritization of IND-enabling clinical studies.