Banking of corneal stromal lenticules: a risk-analysis assessment with the EuroGTP II interactive tool
Por:
Trias, E, Gallon, P, Ferrari, S, Piteira, AR, Tabera, J, Casaroli-Marano, RP, Parekh, M, Ruzza, A, Franch, A, Ponzin, D
Publicada:
1 jun 2020
Ahead of Print:
1 feb 2020
Resumen:
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.
Filiaciones:
Trias, E:
Hosp Clin Barcelona, Adv Therapy Unit, Escala 3,Planta 1 Criopreservacio, Barcelona 08036, Spain
Gallon, P:
Fdn Banca Occhi Veneto, Venice, Italy
Ferrari, S:
Fdn Banca Occhi Veneto, Venice, Italy
Piteira, AR:
BTB, BST, Barcelona, Spain
IIB St Pau, Biomed Res Inst, SGR1113, Barcelona, Spain
Tabera, J:
BTB, BST, Barcelona, Spain
IIB St Pau, Biomed Res Inst, SGR1113, Barcelona, Spain
Casaroli-Marano, RP:
BTB, BST, Barcelona, Spain
IIB St Pau, Biomed Res Inst, SGR1113, Barcelona, Spain
Univ Barcelona, Dept Surg, Sch Med, Barcelona, Spain
Univ Barcelona, Hosp Clin Barcelona, Barcelona, Spain
Parekh, M:
Fdn Banca Occhi Veneto, Venice, Italy
UCL, Inst Ophthalmol, London, England
Ruzza, A:
Fdn Banca Occhi Veneto, Venice, Italy
Franch, A:
SS Giovanni & Paolo Hosp, Dept Ophthalmol, ULSS3 Serenissima, Venice, Italy
Ponzin, D:
Fdn Banca Occhi Veneto, Venice, Italy
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