We are pleased to report that VISICORT has been granted a 6-month no-cost extension from the European Commission to continue the project’s ongoing major research activities following delays caused by the COVID19 pandemic. This extension will provide the consortium with additional time for data collection and analysis from our three multi-centre clinical studies which are analysing bio-samples and clinical outcomes from more than 700 human subjects and for the manufacture of allogeneic mesenchymal stromal cells for the initiation of the VISICORT clinical trial to be conducted at Charité University Hospital and Charité Research Organisation in Berlin. The new end-date for VISICORT FP7-funded research is March 31st 2021. The consortium is also pursuing future funding opportunities to build new innovative and collaborative projects in the areas of corneal transplantation and corneal diseases.
VISICORT results were presented at EU-MSC2, a bi-annual event, organized by the Leiden University Medical Center in The Netherlands. The meeting assembles researchers, clinicians and cell product developers working within EU-sponsored research consortia, that focus on mesenchymal stromal cell (MSC) therapy for immune-related disorders and tissue regeneration. EU-MSC2, a much-anticipated event provides excellent opportunities for networking, exploring new funding opportunities and the dissemination of results contributing to MSC knowledge-sharing, research and development.
VISICORT Coordinator Professor Matthew Griffin, of the National University of Ireland Galway, presented VISICORT’s clinical trial in his September 5, 2019 talk entitled: A phase 1 clinical trial of allogeneic MSC in corneal re- transplant recipients: from pre-clinical evidence to regulatory approval.
“An outstanding project within the VISICORT consortium is a Phase 1B clinical trial testing the safety and feasibility of intravenously administered allogeneic mesenchymal stromal cells (allo-MSC) as an immunotherapy for patients at high risk of keratoplasty. Following recent regulatory and ethical approval for the first clinical study on the risk therapy for cell therapy in risk keratoplasty, the inclusion of the first patients is imminent.”
VISICORT’s clinical trial is listed on the BeCAT web page. BeCAT, the Berlin Center for Advanced Therapy is Charité’s an amalgamation of cross-disciplinary project teams that develop and manufacture Advanced Therapy Medicinal Products (ATMP) for somatic cell therapeutics, gene therapeutics, and tissue engineering biotechnological tissue. Read about BeCAT and VISICORT (in German and English) here.
VISICORT PI Uwe Pleyer at Charité Universitätsmedizin Berlin organized a seminar entitled “Autologe Stammzelltherapie zur Prophylaxe der Immunreaktion bei Risikokeratoplastik”. The Anterior Segment Symposium on April 27th, 2019 in Berlin included a presentation on the VISICORT project with the aim to recruit potential patients for the Phase 1 trial.
Pictured above Prof. Dr Rieck and Prof. Dr Uwe Pleyer
The Alliance for Regenerative Medicine’s March 14, 2019 newsletter included a recent update on the VISICORT clinical trial regulatory approval. You can read the piece in the newsletter’s Clinical Updates section.
The VISICORT project has reached an exciting milestone having recently received regulatory and ethical approval to proceed with the first clinical trial of a cell therapy in high-risk corneal transplantation.
To prepare for the launch of the trial, Prof. Matthew Griffin, Prof. Thomas Ritter, Dr. Siobhan Gaughan and Ms Aoife Duffy of NUI Galway, Ireland and Mr. Peadar Mac Gabhann of Biostór Ireland Ltd. visited the CHARITÉ RESEARCH ORGANISATION (CRO), in Berlin on Thursday 28th February 2019 (see picture) The meeting was hosted by the CRO clinical trial team of Dr. Andreas Hüser, Dr. Rita Hertrampf, Ms Juliane Schnorr, Dr. Maximilian Posch and Ms. Jeanette Lehmann and by Prof. Uwe
The VISICORT trial will be a Phase 1B clinical trial to test the safety and feasibility of intravenous allogeneic mesenchymal stromal cells (allo-MSC) as an immunotherapy for patients receiving a second or greater full-thickness corneal transplant who are at high risk of rejection. If the trial demonstrates that allo-MSC therapy is well tolerated in high-risk corneal transplant recipients, it will open the door to a Phase 2 trial to more clearly test its potential to reduce the occurrence of rejection and promote the long-term survival of repeat corneal transplant.
Fittingly, the trial will be carried out at Charité University where some of the most important
During the meeting, the VISICORT partners discussed and agreed on many of the organisational details of the trial and developed a time-line for allo-MSC manufacture and patient enrolment over the next year. The VISICORT clinical trial team are looking forward to meeting up again for further discussions with the entire consortium at a Plenary Meeting which will be held in Galway on Thursday 14th and Friday 15th March 2019.
- Trio of VISICORT PIs will present at 2021 CDx Biomarkers and Biobanking BioTec Pharma SummitJanuary 15, 2021 - 10:29 am
- VISICORT consortium meets on November 27, 2020December 10, 2020 - 12:31 pm
- Corneal Transplant Follow-up Study II (CTFS II) – Does tissue matching reduce the risk of rejection in corneal transplants?December 7, 2020 - 3:11 pm
- VISICORT receives a 6-month extensionNovember 6, 2020 - 5:06 pm
- Exploitation news: A collaboration with Epimune GmbH beginsAugust 18, 2020 - 11:13 am
- 2020 COP&S conference coordinated by VISICORT PI Dr Bertrand Fabres slated for November 12 & 13thAugust 17, 2020 - 3:36 pm
- VISICORT presented at Ophthalmology changing event, BerlinAugust 17, 2020 - 1:37 pm
This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 602470. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.