The VISICORT Study
Research type
Research Study
Full title
Adverse Immune Signatures and their Prevention in Corneal Transplantation (The VISICORT study)
IRAS ID
154984
Contact name
John Armitage
Contact email
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
VISICORT is an EU-based and -funded multidisciplinary project that will create a new level of understanding of adverse immune responses to tissue transplants and implants by extensively studying a specific form of tissue transplantation and will apply this knowledge to improve clinical outcomes. The research programme will generate novel diagnostic and prognostic tests for adverse immune responses in transplant/implant patients. The project will subsequently develop an innovative strategy for preventing adverse immune response and improving long-term outcome of tissue transplants by administration of immunomodulatory stromal stem cells (iSSC), that is, supporting cells capable of self-renewal and differentiation.
The VISICORT programme consists of multiple Work Packages (WPs). The University of Bristol will act as the lead for the UK clinical site involved in WP2 and will provide the clinical data and tissue samples needed to generate novel diagnostic and prognostic tests for adverse immune responses to tissue transplants and implants. The other clinical sites participating in WP2 are in Denmark, Germany, France and Ireland. All the clinical sites will work to parallel protocols and seek ethical review in their respective host countries. This ethics application seeks approval for the UK arm of WP2 only.
This study comprises two parts:
Part 1 will involve recruitment of patients with established full-thickness corneal transplantation (FT-CT) and posterior lamellar corneal transplantation (PL-CT), together with non-transplanted control subjects including healthy volunteers, from University Hospitals Bristol NHS Foundation Trust (UH Bristol).
Part 2 will involve recruitment of new patients undergoing FT-CT and PL-CT from UH Bristol.Data and samples will be collected from participants during routine ophthalmic appointments and, where necessary, specific follow-up appointments. Participants in Part 1 will be involved in the study for up to 3 months and those in Part 2 for up to 3 years as part of follow-up appointments.
REC name
South West - Frenchay Research Ethics Committee
REC reference
15/SW/0098
Date of REC Opinion
3 Jul 2015
REC opinion
Further Information Favourable Opinion