EURO GTP II
The main goal of this 36-moth project is to develop common Good Tissue Practices (Euro-GTP II) for European Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), that address the study extent (retrospective, concurrent, prospective and short and long term) needed for human application of the tissues/cells in a safe and effective manner.
- Determining methodologies for assessing the risks associated to novel tissues/cells
- Determining methodologies for assessing the extent of the studies needed to provide enough quality, safety and efficacy data for the use of tissues/cells
- Determining the follow up programs, according to the inputs of the previous issues, to ensure safety and support the evaluation of the clinical efficacy
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist.
Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication.
This project aims to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity.
A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication.
This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE.
There are 4 specific Work Packages:
WP5 Good Practices for demonstrating safety and quality through recipient follow-up – Generic requirements
WP 6 Good Practices for demonstrating safety and quality through recipient follow-up– Tissues
WP7 Good Practices for demonstrating safety and quality through recipient follow-up– HSC
WP8 Good Practices for demonstrating safety and quality through recipient follow-up – ART
WP 9 T&C Database and Interactive assessment tool
The project is coordinated by the Spanish Banc De Sang I Teixits (BST) and has started on the 1st of April.
CNT is responsible for WP5 and is assisted in its effort by some Italian collaborating partners, namely Fondazione Banca degli Occhi, Banca Multitessuto di Treviso, GITMO e Dipartimento di Fisiopatologia Policlinico Umberto I.