The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective implementation.
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 aim 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.
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Annually more than 20,000 volunteer unrelated blood stem cell donations are undertaken. Living donors donate their cells for patients in need of a transplant. The EU plays an important role in the provision of these products. In 2016 the EU countries provided 6,817 blood stem donations internationally and 3,194 donations were provided nationally.

WMDA plays a key role in the international exchange of blood stem cell products by providing a search tool for healthcare professionals and by setting standards for international exchange. In order to harmonise international exchange and speed up the logistics of the search process WMDA is applying for a Framework Partnership Agreement with the EU.

Volunteers have the right to receive accurate information about their risks to donate their blood stem cells. Since 2002 donor safety has become a highly visible issue. In that time WMDA has started up a reporting system for adverse events and reactions. It is important to reassure potential donors that there are systems in place to protect them from adverse outcomes and that there is a continuous learning system which is informed by global reporting. The next step is to collaborate with regulatory authorities in order to improve dissemination.
In the area of import from third countries it is important to harmonise and to collaborate between EU Member States. At the moment 14% of the adult volunteer donations and 30% of the cord blood products are imported from third countries. To avoid delay for patients waiting on their transplant information needs to be available that can be shared between Competent Authorities and healthcare professionals facilitating searches.
The current ICT infrastructure to support the search process and request for a donation is delaying adequate treatment for patients. Innovation of the ICT infrastructure will help physicians to find a donor with a few clicks in the database.
This proposal describes how WMDA and EU can collaborate from 2018-2021.
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