The nTRACK NPs have been widely characterized from the physical and chemical standpoint. Technological transfer from lab-scale to large scale has been successfully conducted according to the GMP standards. Moreover, extensive characterization of the scale-up nanoparticles has been run according to the regulatory recommendations. From the safety and toxicological viewpoint, it’s been demonstrated that standardized nanoparticle cell loading is safe and non-toxic. No observable adverse effects have been found nor cellular functionality has been affected or modified by the cytosolic presence of the nanoparticles. Head-to-head (nps loaded cells vs non-nps loaded cells) in vitro assays established that no changes in the cytokine secretion of the cells used. Moreover, the subcellular fate of the nanoparticles and protein corona after nanoparticle cell internalization have been demonstrated. A complete set of in vitro and in vivo studies under GLP rules has been carried out that there were no remarkable toxicological effects. The in vivo imaging studies with small and large animals reached the proof-of-concept for the stem cell visualization longitudinally. Machine learning algorithms have been developed and trained based on the imaging studies (radiomics) delivering reliable for cell quantification and early assessment of treatment effectiveness. All the experimental activities conducted in accordance with the regulatory context, although undefined at the beginning of the project, but improved upon project completion after consultation with competent authorities such as EMA, FDA, BfArM and Paul-Erlich Institute. Beyond the project, a working group focused on defining a regulatory framework for this type of nanomaterials will be set up.
The nTRACK project has been broadly disseminated to different stakeholders: EU citizens, scientific audience, industry, and authorities. The project dissemination has been through scientific conferences, regular newsletters and thematic articles for scientific popularization, peer-reviewed papers, open day events with specific focus on biotech and pharma industry and, thematic conferences on Stem Cell NanoImaging and a Regulatory Workshop. Moreover, it’s been promoted a collaborative push with other EU-funded under the same topic: StarStem and iNanobit projects.
In order to define a competitive landscape, patent search has been performed every 6 month. During the lifetime of the project around 800 patents have been found using the established set of key words and analysed. From these patents, 155 have been selected as relevant and presented in an internal report. Besides patent search, literature overview, clinical trials documents and press releases have been used as method to determine the key players in the fields of stem cell production, imaging, and nanoparticles for biomedicine use. Based on this analysis, a general and individualized businesses plans have been defined. One patent application is currently under review.
