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.
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’s concept, mission and progress will be presented by Peadar MacGabhann, Managing Director of Biostór at the Biobanking 2019 meeting in Porto. The two-day meeting runs for the 14th and 15th of February 2019 and is part of the Biotech Pharma Summit conference series. The event will bring together the world’s leading experts in biorepositories, policymakers, 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 about Biostór Ireland’s role within VISICORT here.
More information about the Biobanking 2019 meeting can be found here.
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
EU funded projects VISICORT, ADIPOA-2, AUTOSTEM and NEPHSTROM coordinated by the Regenerative Medicine Institute (REMEDI) at National University of Ireland, Galway exhibited at a unique outreach activity targeted at primary school students. The event called the START competition was the brainchild of the Health Research Board (Ireland)’s Trials Methodology Research Network (HRB-TMRN) in Galway. In celebration of International Clinical Trials Day and to draw attention to clinical research conducted in Ireland, young people were invited to design, conduct and report on a randomized clinical trial. On May 18, 2018, three of the short-listed schools assembled at the University in Galway to visit interactive exhibitions, talk with researchers, perform mini-experiments, take part in lively science demonstrations and collect their prizes. The winning school was St. Joseph’s National School from Kinvara, County Galway.
Special thanks to Dr Siobhan Gaughan who organized the stand, Georgina Shaw who prepared the stem cell plates and to NUI Galway volunteers Dr Tina Harte, Dr Cathal Ó Flatharta, Dr. Nahidul Islam, Hannah Egan, Niamh Leonard, Dr. Emily Growney Kalaf, Claire Dooley and Dulan Hasantha Jayasooriya who volunteered their time to work with the young people on behalf of the EU funded project, STEM promotion. The STEMinator cards used at the exhibition were designed by Cúram, NUI Galway. Also thank you to Lauren, Alibhe and Charlotte for creating the stem cell models.
Read more about the START competition here.
PI Dr Jesper Hjortdal (right) and Henrik Sejersen (left), Clinical Optometrist at the University Hospital Aarhus in Denmark presented VISICORT at the ARVO 2018 conference. The Association for Research in Vision and Ophthalmology (ARVO) meeting was held from 29 April – 3 May in Honolulu, Hawaii USA. This year’s theme was ‘Imaging in the Eye’. The VISICORT study was titled “Comparison of DMEK and DSAEK in high and low risk posterior lamellar keratoplasty”.
ARVO is the largest and most respected eye and vision research organization in the world. With nearly 12,000 researchers as members from over 75 countries, ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. The poster session is very popular as many colleagues pass by and give comments.
A VISICORT study was published recently in Stem Cells. The body of research entitled “Inter‐Species Incompatibilities Limit the Immunomodulatory Effect of Human Mesenchymal Stromal Cells in the Rat” by Paul Lohan, Oliver Treacy, Maurice Morcos, Ellen Donohoe, Yvonne O’Donoghue, Aideen E Ryan, Stephen J Elliman, Thomas Ritter and Matthew D Griffin was accepted for publication on 13 April 2018.
Mesenchymal stem/stromal cells (MSC) are an immunomodulatory cell population which are under pre‐clinical and clinical investigation for a number of inflammatory conditions including transplantation. In this study, a well‐established rat corneal transplantation model was used to test the ability of human MSC to prolong corneal allograft rejection‐free survival using a pre‐transplant intravenous infusion protocol previously shown to be efficacious with allogeneic rat MSC. Surprisingly, pre‐transplant administration of human MSC had no effect on corneal allograft survival. In vitro, human MSC failed to produce nitric oxide and upregulate IDO and, as a consequence, could not suppress rat T‐cell proliferation. Furthermore, human MSC were not activated by rat pro‐inflammatory cytokines. Thus, interspecies incompatibility in cytokine signalling leading to failure of MSC licensing may explain the lack of in vivo efficacy of human MSC in a rat tissue allotransplant model. Inter‐species incompatibilities should be taken into consideration when interpreting pre‐clinical data efficacy data in the context of translation to clinical trial.
The VISICORT consortium was hosted by Biostór Ireland in Wexford on April 26 – 27 2018 for a plenary meeting.
After work package updates were provided, the focus of the meeting became future plans for the remaining months of the project. Discussions focussed on the clinical trial timeline, the publication plans, the future of the VISICORT bio-bank, mechanisms to apply for funding to pursue additional studies, the biomarker analyses, and the “gold mine” of data sets and the potential for clinical and metabolomic studies.
Jesper Hjortdal presents human subject enrolment, follow-up and clinical data analysis.
Prof Thomas Ritter, NUI Galway presented Dr Paul Lohan’s VISICORT findings at the Cornea and Ocular Surface Biology and Pathology meeting. The conference was held in Ventura, California from February 18-23 2018. The 2018 conference theme was ‘Defining the Mechanisms Through Which the Cornea, Tear Film and Immune System Operate Under Pathological Conditions’. Thomas’ presentation was titled “Mesenchymal stem cell therapies for efficient treatment of immune-mediated diseases of the eye”.
The Cornea and Ocular Surface Biology and Pathology conference programme can be found here.
Henrik Sejersen, Clinical Optometrist and VISICORT researcher at the Department of Ophthalmology, University Hospital Aarhus took to the road to visit clinical trial sites undertaking the recruitment and execution of VISICORT’s clinical studies. This VISICORT clinical study monitor tour resulted from a lively discussion at the most recent plenary meeting hosted by the University of Bristol on the 26th and 27th of October 2017. One resulting action item from the meeting entailed visits by Henrik to four clinical trial sites with a view to promoting the completeness and accuracy of clinical data on the cross-sectional and longitudinal studies. Remarking on the tour Henrik stated, “It has been a fantastic trip around Europe; a tight schedule with monitoring visits in 4 different countries in 5 days. But it was worth the effort. Together with the local investigators, I went through the majority of the prospective and some cross-sectional patients and compared data from their records with the Vims System. In general, the sites have done a good job, but there were some small variations in the way we type in and analyze our results. That has now been addressed, and the data reliability and accuracy has been increased. Going through that many data I found astounding few mistypes which support the brilliant job the research staff is doing. Each site has now been encouraged to do self-monitoring in the future.”
VISICORT coordinator, Prof. Matthew Griffin of the Regenerative Medicine Institute (REMEDI) at the National University of Ireland, Galway commented: “The VISICORT project is gathering detailed clinical data from new and established corneal transplant recipients at five leading Ophthalmology Centres in Europe. This information will become more and more valuable as time goes by. Of most importance to our research goals, it will allow us to link the molecular signatures in samples taken from the patients early after transplantation to rejection and other harmful events that occur months or years later. We have successfully developed an excellent web-based database that stores this information securely and confidentially. However, accurate and consistent data collection at each site also requires high-level training and dedicated attention to detail from the research teams at each site. Mr Sejersen’s tour of the clinical research sites at Dublin, Bristol, Berlin and Nantes have helped to consolidate the great team spirit that has grown up among the VISICORT researchers involved the project across these sites. This “human touch” element is critical to ensuring that the clinical information gathered throughout the project will be of the highest quality”.
The photos below document the 4-stop tour to the Royal College of Surgeons in Ireland, Dublin, University of Bristol, UK, Charité University Hospital Berlin, and the Institute of Transplantation-Urology- Nephrology at Inserm in Nantes.
Stop one was at the Royal College of Surgeons in Ireland with Diana Malata.
Stop two was at the Department of Clinical Sciences at the University of Bristol with Gemma Brimson.
During stop three at Charité University Hospital Berlin, Henrik reviewed the data with Prof Uwe Pleyer and VISICORT fellow Nina Steinhorst.
The last stop was in Nantes at Inserm’s Institute of Transplantation-Urology- Nephrology. Here, Henrik met with Bertrand Favres, and clinical nurses Catherine Ivan and Adeline Chenu.
- 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.