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 month 60 VISICORT plenary meeting was hosted by the National University of Ireland Galway on March 13 and 14, 2019. The 2.5-day meeting included a work package update from each partner and round table discussions to drive the project results forward.
A Memorandum of Understanding to establish the VISICORT Virtual Research Community was signed by members in attendance.
Special thanks to Dr Rita Lawlor, Biobank and Model Bank Director and Research Coordinator at ARC-NET (Applied Research on Cancer Network) at the University of Verona. Rita is a member of VISICORT’s External Advisory Group. Rita’s input to the meeting was highly valuable and much appreciated by all partners.
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.
Managing Director of Biostór Ireland Peadar MacGabhann will present “Establishment Of The VISICORT Foundation Biobank For Eye Disease” at the Biobanking Summit 2019 which will be held in Porto, Portugal on February 14th and 15th. Here, VISICORT Biobank brochures will be on hand for education and information, and to promote the use of it by researchers.
The Biobanking 2019 conference will bring together the world’s leading experts in biorepositories, policy makers, and scientific actors to strengthen knowledge in biobanking as well as explore future advances in the field of
Read the entire meeting agenda here.
Professor John Armitage, Emeritus Professor of Cryobiology in the Bristol Medical School and former Director of Bristol Tissue Bank, has been awarded an Officer of the Most Excellent Order of the British Empire (OBE) for his services to corneal transplantation.
With a PhD in cardiac cryopreservation, Professor Armitage set up the Bristol Eye Bank with Professor David Easty, then Head of Ophthalmology, and Professor Ben Bradley, former Medical Director of UK Transplant.
Since 1986 the Bristol Eye Bank has been a leader in corneal preservation and supply for transplantation around the UK, growing to become one of the largest of similar initiatives across Europe. Within the UK this transformed corneal transplantation from an out-of-hours emergency procedure to an elective operation that could be planned weeks in advance.
Professor Armitage, now part of the NHS, continues to lead research into corneal transplant outcomes and transplant immunology through the University of Bristol.
Speaking about his award, John commented: ‘I am truly delighted to have my work recognised in this way. The award also reflects the impact of the work by the Bristol Eye Bank and recognises the collective effort of Bristol University staff, ophthalmology colleagues in the Bristol Eye Hospital and collaborating organisations including NHS Blood and Transplant and the Royal College of Ophthalmologists. However, above all, I must acknowledge the thoughtfulness and generosity of the families of eye donors, without whom tissue and organ transplantation would not be possible.’
More details can be found at: http://www.bristol.ac.uk/news/
The VISICORT Foundation Biobank (VFB) of tears, peripheral blood mononuclear cells, plasma, aqueous humour and donor and recipient corneal tissue samples is available to academic researchers, applied research institutes and pharmaceutical research centres for eye disease research purposes. For more information and to make enquiries, please see our brochure.
Prof Conor Murphy, Royal College of Surgeons in Ireland has co-authored a new ophthalmology text with Mr Mark Batterbury. The book is entitled “Ophthalmology: An Illustrated Colour Text”. Although primarily aimed at medical students, the text will appeal to those practising or studying fields closely related to ophthalmology, including optometry, orthoptics and ophthalmic nursing too.
Divided into four sections, the first contains essential anatomy and physiology. The second describes ophthalmic diseases using a predominantly anatomically-ordered approach. The third deals with a collection of special topics, some disease-related, others covering clinical management. The final part focusses on clinical problem-solving.
This is the fourth edition of an award-winning text. It has been extensively reviewed, modified and updated to ensure its relevance to people across the world requiring an introductory text in ophthalmology. The Special Investigations chapter has been rewritten and illustrated to show how modern imaging devices help in diagnosis and monitoring. One new chapter reviews a range of global ophthalmic problems and another provides an overview of eye problems in children. The book is also available as an ebook (online).
VISICORT Coordinator Prof Matthew Griffin and PI Prof Thomas Ritter amongst many other NUI Galway researchers participated at the Galway Science and Technology Festival Exhibition Day on Sunday, 25 November 2018. The VISICORT display in the Bailey Allen Hall of the National University of Ireland Galway exhibited models and props which helped to explain cornea transplantation and future plans for cell therapy to a general audience. A set of stir tank bioreactors was on display to illustrate the technology required to produce large batches of human bone marrow-derived mesenchymal stromal cells (MSCs) for use as a cell therapy.
Pictured above at the VISICORT display at the Galway Science and Technology Festival: Prof Matthew Griffin, NUI Galway
A new study has just been published by VISICORT researchers in the leading open access journal Frontiers in Immunology today, 20 November 2018. The study “Third-party allogeneic mesenchymal stromal cells prevent rejection in a pre-sensitized high-risk model of corneal transplantation” was completed by the National University of Ireland Galway team of Paul Lohan, Nick Murphy, Oliver Treacy, Kevin Lynch, Maurice Morcos, Bingling Chen, Aideen E. Ryan, Matthew D. Griffin and Thomas Ritter.
The study shows for the first time that intravenous administration of third-party allogeneic mesenchymal stromal cells (MSC from neither the new cornea recipient nor the cornea donor) results in distinct immune modulatory effects that overcome pre-existing anti-donor immunity to prolong rejection-free survival of corneal allografts in a laboratory model of high-risk corneal transplantation. The experimental cell therapy regimen described in the paper appears to be compatible with prior cryo-preservation and with co-administration of a relevant immunosuppressive drug. These findings open the door to clinical translation of “off-the-shelf” allogeneic MSC products for recipients of high-risk corneal transplants who continue to suffer from very poor long-term graft survival rates. The results of this experimental study have formed the basis of a regulatory submission for the VISICORT Phase Ib clinical trial in patients receiving a second or greater transplant who are at high risk of rejection. This trial will determine the safety and feasibility of co-administration of allogeneic MSC and MMF in the setting of high-risk corneal transplantation.
A major task within the VISICORT project entails three multi-centre clinical studies to analyze bio-samples from more than 700 human subjects. This important aspect of VISICORT is being coordinated by Prof Dr Jesper Hjörtdal at the Aarhus University Hospital NBG in Denmark.
A multi-centre, “cross-sectional” clinical analysis study involves people (goal: 420 participants) with existing corneal transplants (CT) and healthy adult volunteers. Secondly, a multi-centre “prospective study” involves people who are new recipients of corneas (goal: 300 participants). In both studies, the participants are divided into groups in order to draw comparisons and draw inferences. The groups involved in these two studies include people with corneal transplant/s and healthy adult volunteers who are at the ophthalmology clinic for a check-up. The study subjects will be monitored, or “followed” for 3 years or more where repeat bio-samples, including blood and tears, are drawn periodically. Anyone willing, who can give informed consent and falls into one of the designated categories is able to take part in the study. Results of comprehensive ophthalmic examinations, corneal thickness measurements, and endothelial cell density tests will be stored in a secure clinical database system. These large studies aim to discover a biomarker present in the bio-samples which will help clinicians identify people who are at high risk for corneal transplant rejection episodes.
A third, multi-centre “clinical variables” study is also part of the VISICORT research plan. Here, people who have had a corneal transplant will be followed for a 3-year period where bio-samples will be collected and analyzed. Clinicians will be gaining knowledge regarding adverse immune outcomes from CT procedures in order to help validate and field test biomarker-based surveillance strategies. A highly detailed clinical follow-up will be available for the participants involved. A broad survey of clinical variables, immunosuppression practices, any complications and graft outcomes will be included.
Best practice standard care will be followed at each of the 5 clinical sites: Aarhus University Hospital (Denmark), Charité Universitätsmedizin Berlin (Germany), Royal Victoria Eye and Ear Hospital (Dublin, Republic of Ireland), Bristol Eye Hospital (U.K.) and the University Hospital Center (CHU) of Nantes (France).
At the moment, our recruitment targets are nearly achieved. In the cross-sectional clinical analysis study, we have collected bio-samples from 413 participants. We are nearly at our goal! For the multi-centre prospective study, 332 participants are involved. This exceeds our target. Finally, our clinical variable study has 588 people enrolled currently.*
*These figures were last updated on 23 January 2019.
- VISICORT PIs present at Societas Ophthalmologica EuropæaJune 24, 2019 - 8:20 am
- International Clinical Trials Day 2019, GalwayJune 10, 2019 - 10:38 am
- Interview: Lisa Imrie, U of Edinburgh uses the VISICORT BiobankMay 31, 2019 - 7:58 am
- New VISICORT publication from NUI Galway teamMay 21, 2019 - 11:11 am
- Prof Ritter presents at ARVO 2019, CanadaMay 13, 2019 - 9:06 am
- PI Conor Murphy presents VISICORT at Royal Victoria Eye and Ear HospitalMay 1, 2019 - 1:25 pm
- VISICORT presentation in Berlin aims to recruit potential patients to the clinical trialApril 29, 2019 - 8:22 am
- VISICORT PI Nico Degauque, INSERM presents at Swedish Registry for Corneal TransplantApril 26, 2019 - 9:52 am
- Two VISICORT PIs involved in new COST ActionApril 11, 2019 - 2:47 pm
- Partners at CCMI offer training workshopsMarch 26, 2019 - 12:27 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.