We evaluated the feasibility and performed a risk–benefit analysis of the storage and widespread distribution of stromal lenticules for clinical application using a new systematic tool (European Good Tissue and cells Practices II—EuroGTP II tool), specifically designed for assessing the risk, safety and efficacy of substances of human origin. Three types of potential tissue preparations for human stromal lenticules were evaluated: cryopreserved, dehydrated and decellularized. The tool helps to identify an overall risk score (0–2: negligible; 2–6: low; 6–22: moderate; > 22: high) and suggests risk reduction strategies. For all the three types of products, we found the level of risk to be as “moderate”. A process validation, pre-clinical in vitro and in vivo evaluations and a clinical study limited to a restricted number of patients should therefore be performed in order to mitigate the risks. Our study allowed to establish critical points and steps necessary to implement a new process for safe stromal lenticule preparation by the eye banks to be used in additive keratoplasty. Moreover, it shows that the EuroGTP II tool is useful to assess and identify risk reduction strategies for introduction of new Tissue and Cellular Therapies and Products into the clinical practice.
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We thank all EuroGTP II Study Group (Associates and Collaborative Partners and Invited experts) who provided insight and expertise that greatly assisted the EuroGTP II Project. For more details on the Associated Partners and the Collaborative Partners and Invited Experts: http://goodtissuepractices.eu/index.php/partners.
This work was supported by the European Union’s Health Programme (2014–2020), Grant Agreement Number: 709567—EuroGTP II—HP-PJ-2015. This study represents the views of the authors only and is their sole responsibility; it does not reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.
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Trias, E., Gallon, P., Ferrari, S. et al. Banking of corneal stromal lenticules: a risk-analysis assessment with the EuroGTP II interactive tool. Cell Tissue Bank 21, 189–204 (2020). https://doi.org/10.1007/s10561-020-09813-8
- Stromal lenticules
- Eye banking
- Additive keratoplasty
- Risk assessment