VISICORT PI Nico Degauque, INSERM presents at Swedish Registry for Corneal Transplant

VISICORT PI Nicolas Degauque from INSERM in Nantes was an invited speaker at the annual meeting for participants in the Swedish Registry for Corneal Transplant which for many years have served as the registry for all Swedish and Danish patients undergoing corneal transplantation. The meeting took place at Riksgränsen at the very north of Sweden on April 11, 2019. Through Nico’s talk entitled “Innate-like functions of human TEMRA CD8 and their involvement in kidney allograft outcome”, he presented the recent advances in identifying biomarkers for transplant survival learned from kidney transplantations. It is the hope that the extension of these studies can provide biomarkers for corneal transplant survival.

The meeting was attended by VISICORT partners John Armitage from the University of Bristol and Jesper Hjortdal, Aarhus University Hospital.


VISICORT trial news announced in ARM March newsletter

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.

VISICORT at Biobanking Summit 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 biosampling for precision medicine, drug development and health research.

Read the entire meeting agenda here.

VISICORT PI Prof John Armitage, University of Bristol has been awarded an OBE in the Queen’s New Year Honours

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/2018/december/john-armitage.html

VISICORT exhibits at Galway Science & Technology Festival 2018

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

 

New VISICORT study in Frontiers in Immunology

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.

Immune outcomes in human CT studies edge near recruitment targets

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 plenary meeting hosted by Charité and CRO

VISICORT partners met October 11 and 12, 2018 in Berlin to provide research updates and share future plans for the next six months of the project. After opening remarks by host Prof Uwe Pleyer of Charité and Andreas Hüser of CRO, Mark Sweetnam of Pintail Limited reminded partners of upcoming and remaining reporting obligations and deadlines. Coordinator Prof Matt Griffin of NUI Galway presented an update on the clinical trial planning, cell manufacturing process, regulatory submission and ethics and safety of MSC therapies. BioStór‘s Niall Walsh and Peadar MacGabhann raised important future considerations for the use of the VISICORT biobank and exploitation of these resources. Henrik Sejersen of Aarhus University Hospital reported upon the human subject enrolment, follow-up and clinical outcomes. A second clinical site tour will ensue to aid with data collection on all patients. Nico Degauque of the Center for Research in Transplantation and Immunology at INSERM presented an update on the multi-platform immune response profiles of human corneal transplantation. A new tool flow cytometry analysis tool CYBERSORT will be used in tandem with classical methods. Khadar Dudekula of SynthSys discussed her current targetted proteomics results and progress on the selection of protein biomarker candidates from the Fíos analyses. In addition, SynthSys PhD candidate Lisa Imrie presented her research project ideas for input from the VISICORT consortium and the potential exploitation of the VISICORT biobank. Fíos‘ Max Bylesjo shared recent advances in the integrated analysis of the proteomic and transcriptomic datasets. Pintail‘s Danielle Nicholson led a discussion on dissemination and potential amendments to the website and educational materials for patients. A tour of the Charité Research Organization ensued on the first day, and the meeting closed with a roundtable discussion to drive the project to completion. All aspects of the project requiring a follow up were addressed.

Cell therapy products present transport challenges in a rapidly changing world

VISICORT PI Peadar Mac Gabhann of Biostór was interviewed and presented a case study in cell therapy transports in the September 2018 CELL SERIES newsletter. In the interview, Peadar describes his experience within VISICORT: “Each transport of cell therapy products requires in-depth, case-by-case analysis & validation. This is very difficult to anticipate and plan in our rapidly changing world.”

Read the entire interview on page 7 here:  Cell Series Pre-Event Newsletter.

VISICORT clinical trial takes its first steps

VISICORT celebrates its first validation shipment of Stromal Cells from CCMI Galway to Charité Research Organisation (CRO) in Berlin for the commencement of the VISICORT clinical trial.

In the pictures below, Aoife Duffy, Manufacturing Manager at Centre for Cell Manufacturing Ireland (CCMI) at the National University of Ireland Galway is holding the first cell shipment. Cells were manufactured by CCMI in Galway and transport was performed by Biostór Ireland – a “Known Shipper” with the Irish Aviation Authority (IAA). This is the first of 7 shipments to be carried out during 2018 to establish the safety and tolerability of two intravenous infusions of allogeneic human bone marrow-derived mesenchymal stromal cells (allogenic-BM-MSC) and evaluate the potential efficacy of pre-transplant intravenous infusions of allogenic-BM-MSC to reduce the risk of acute rejection of corneal re-transplants.

As a Known Consignor, Biostór can ship cells without the use of X-ray scans. All air cargo and truck shipments are now subject to X-Ray scan. X-rays would be hazardous to the MSCs. Becoming “Known” involved Garda Vetting, the completion of a 1-day of Aviation Security Training course, writing a comprehensive Air Cargo Security Manual and SOPs, and a site audit by IAA.

Biostór’s Peadar MacGabhann comments, “Becoming a Known Consignor with the IAA was worth it and ensures that Biostór can support future VISICORT cell therapy trials and ensure the project reaches the conclusions that were planned at the outset. how this will impact the project.”

Feature image photo credit: Wellcome Collection with a Creative Commons 4.0 International license