Reasons for A FACTT Action
Cells with tolerogenic function (e.g. tolAPC and Tregs) have become a promising immunotherapeutic tool to treat AID, severe allergies, or to improve transplantation outcomes. The main advantage of CTT over current available therapies is that they have the potential to restore the underlying problem long-term without compromising protective immunity. After 15 years of intense research, these cellular therapies have recently entered the stage of clinical trials. However, the lack of standardised and validated protocols to compare the tolerogenicity of the cellular products and for immune monitoring of patients makes it difficult to compare individual trials, decelerating the potential progress of the CTT field.
A FACTT: how to achieve the objective
The objective of the A FACTT Action is to focus and accelerate the field by setting up standardised protocols between different centres, allowing for comparisons between CTT products and trial outcomes. In particular, comparative functional parameters (‘tolerogenicity’) and safety of CTT products will be defined and validated. Furthermore, protocols for immune monitoring of CTT application to patients will be standardised and implemented in clinical trials.
The expected result is that the implementation of these standardised protocols will allow for the comparison between different CTT products and the outcomes of CTT trials, helping to answer important outstanding questions, including ‘which type of CTT is best for a certain disease’, and ‘how best to produce these cells’.
The only way to achieve this objective is to build a network of CTT experts. Due to the specialised nature of the field, relatively few groups are conducting CTT in Europe and world-wide. Therefore, there is a very strong need for a network of experts at European level.
Short-term and long-term benefits of A FACTT
The short-term benefits of A FACTT will be that through the standardisation of protocols to measure CTT functionality and trial outcome, the efforts of different groups can be combined, avoiding redundancy and increasing the power of CTT studies. Thus, A FACTT will allow for more cost effective and comparable research and clinical trial data to be generated within the network. This will lead to a better understanding of the MoA of CTT, greatly accelerating implementation of CTT in the clinic. In addition, the Action will lead to improved dissemination of knowledge to interested parties, including the pharmaceutical industry, the public and regulatory authorities. It will also help the training and mobility of Early-Stage Researchers (ESR), and will result in the submission of grant proposals for further multi-centre trials.
The long-term benefit of A FACTT will be that it will minimise the adverse effects of treatment on patients, rendering the life-long treatment with immunosuppressive drugs obsolete. Furthermore, because CTT-based therapies are well suited for individualised therapeutic approaches, they have curative potential for some of these diseases.
Finally, by improving patient health and well-being, CTT can reduce the economic burden of chronic and debilitating diseases in Europe and the rest of the world.
Who will benefit from A FACTT?
The outcomes of A FACTT are both at the scientific and societal/economic level. This Action is aimed at advancing the scientific and medical expertise within the CTT field, and to enhance quality of life of patients and the society by improving therapies for several debilitating diseases and conditions. Although Europe, together with the USA, is at the forefront of CTT, more could be done to solidify Europe’s role as a major player in this field. By setting up and leading this network (which will also be open to CTT groups outside of Europe), European groups will improve their expertise in all aspects of developing and clinically implementing CTT, making them more visible and attractive for high quality researchers and clinicians to join their groups.