Welcome back to the TREGeneration newsletter!
With our annual newsletter we would like to update you about the TREGeneration project.
In this second issue we summarize the work performed and results achieved by the consortium in the first 18 months of the project, plus our plans for the future.
What has the TREGeneration team achieved so far?
The project is now well under way. Within the first 18-months we have:
Established and validated production of different Treg cell infusion products from donors at all clinical centres.
Begun recruiting and treating patients for our new Phase I/II chronic GVHD clinical trials in Portugal, Belgium and Italy. To date, we have treated 8 patients in Lisbon (Phase I) and 7 in Liège (Phase I) and enrolled 3 patients in Bologna (Phase I), with treatment starting in November.
For consistent evaluation, we have developed harmonized case report forms to collect patient data from all of our trials.
Standardized our protocols for flow cytometry analysis between the centres to ensure transferability of our results.
Established and optimized our novel high-throughput sequencing and analysis pipeline in Berlin, allowing us to begin profiling samples of infused products as well as recipients’ blood.
Held both our Kick-off meeting (at the coordinating institution, iMM Lisbon, Portugal) and our first annual General Assembly (hosted by our Regensburg partner, Germany), fostering discussions on progress and future plans.
- Set up communication frameworks and negotiated a handover from GABO:mi to iMM for continued project management.
- Put our dissemination plan into action. Press releases have been distributed for every partner, we have developed the project logo and a LinkedIn social media presence, launched the website and attended several scientific and medical society meetings to promote our research.
How will TREGeneration drive progress beyond the state of the art?
- The application of original donor-derived regulatory T-cells with an immune modulatory function to the treatment of chronic GVHD has never before been tested and so has a clear potential impact on future strategies to address this currently untreatable disease. By directly comparing results of the different trials our study aims to identify the most promising regenerative treatments to progress to Phase II/III clinical trials.
- Aside from the novel clinical application of Tregs, we have also developed novel processes to manufacture these cells for infusion, which will be applicable beyond the scope of this project.
- The multiplex analysis under development for evaluating markers of tissue damage is currently not commercially available and novel in depth sequencing studies will produce a level of output that we have not yet seen applied to clinical trials.
- Our scientific SME partner, Alacris, is developing new techniques with the first patient samples provided by the TREGeneration consortium to analyse in a platform that already filed a patent application.
- As a consortium of European partners conducting ground-breaking regenerative medicine clinical trials with detailed laboratory follow-up studies, all the conditions are present to generate scientific outputs of the highest level. This will increase the visibility of European institutions and thus the attractiveness of Europe as a location to develop new therapies.
New Project Management Contact
As of 1st July 2016 the coordinating institution iMM Lisboa will now take charge of project management and dissemination. We are sorry to say goodbye to our previous project manager Sybille Freitag from GABO:mi, but the new management team at the iMM will strive to ensure the continued smooth running of the project.
Project Management contact: firstname.lastname@example.org
The 3rd TREGeneration General Assembly Meeting will take place in Marseille, France on March 24-25, 2017. We plan to invite a scientific advisory board member and a relevant external speaker. Further details will be posted on the TREGeneration website as soon as they are available.
Our GA meeting is planned to coincide with the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), which several TREGeneration partners plan to also attend.
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