Predict the safety and success of cell-based therapy
The goal of the nTRACK project is to develop cell-tracking methodology based on an innovative, highly sensitive multimodal nano-imaging agent. Cell-based therapy forms a promising approach to treat various diseases for which conventional therapies are ineffective. However, the prediction of the success or failure of cell therapy is challenged by the current lack of methods to track the bio distribution and fate of the transplanted cells. The nTRACK nano-imaging agent is developed to allow the visualisation and longitudinal monitoring of the transplanted stem cells in real time.
The project partners in a consortium led by Leitat Technological Center are: Bar Ilan University, Pluristem Therapeutics, University Medical Center of Johannes Gutenberg University Mainz, MJR PharmJet, BET Solutions, National Centre for Scientific Research “Demokritos”, Vall d’Hebron Research Institute, Vivotecnia Research, RIVM, Asphalion, and Cambridge Nanomaterials Technology.
Because of the innovative nature of a nanotechnology-based imaging agent and its combined use within an advanced cell therapy, the regulatory classification and appropriate regulatory pathway is not straightforward. RIVM’s role is to ensure that the regulatory aspects are taken into account at an early stage of development.
Lessons learnt from the regulatory process with nTRACK will be extrapolated into general recommendations for steps to be taken by developers of similar products at various stages of the development process. In addition, any potential gaps and ambiguities identified in the relevant European regulatory frameworks will be communicated publicly, and specifically to national competent authorities and policymakers.
RIVM's Centre for Health Protection is involved in the nTRACK project.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 761031.