This project aimed to establish quality parameters for a bioproduct obtained from cells expanded on a 3D scaffold, instead of expanded on plastic, for the first time. Through a detailed proteomic analysis of BM-MSCs and their secretome when cultured inside the Nichoid scaffold, we could compare the new bioproduct to the standard from flat culture. Our findings suggest that the Nichoid environment significantly influences gene expression and protein secretion profiles, reflecting potential quality markers for the efficacy and safety of BM-MSC-derived products.
Furthermore, this project focused on a class of paediatric diseases with limited approved medications, for which therapies are based on off-label drugs with significant side effects. Current paediatric treatments focus on supportive care (oxygen therapy, ventilation, and physiotherapy) and symptom management rather than curing the disease. We show here that the Nichoid secretome promotes wound healing, it's non toxic and product quality is maintained after storage. We estabished a regulatory pathway, target population, intellectual property strategy, health technology assessment and a business plan to advance the TRL of a new therapeutic product for paediatric patients. The outcome of this project will provide a national and international reference point for the industrial production of MSCs secretome to treat ChILD and then extending this approach to treat adult patients with ILD, and potentially other pathologies, including chronic intestinal disease and osteoarticular diseases.
