The University of Birmingham has launched a trial that could lead to a ground-breaking new way of treating people with two types of chronic liver disease.
Up to 56 patients are being recruited to take part in the MERLIN trial, which will investigate the safety and efficacy of a new cellular immunotherapy in patients with either Primary Sclerosing Cholangitis (PSC) or Autoimmune Hepatitis (AIH).
Both PSC and AIH involve inflammation of the bile ducts, which can result in significant liver damage. Many of those affected end up needing a liver transplant, and current options for treating PSC and AIH are limited.
The new cell therapy being trialled is a single infusion of specially selected mesenchymal stromal cells (MSCs) which will be administered to participants. The first patient has recently received the cells at Queen Elizabeth Hospital Birmingham, which is run by University Hospitals Birmingham NHS Foundation Trust. Further clinical centres at John Radcliffe Hospital, Oxford, and Queen’s Medical Centre, Nottingham, are due to open later this year. It is anticipated that the trial will run until autumn next year.
The trial is sponsored by the University of Birmingham and coordinated by the Inflammation–Advanced and Cellular Therapy team in the Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham. The trial is funded by Project MERLIN and the NIHR Birmingham Biomedical Research Centre.
Chief Investigator Professor Phil Newsome, of the University of Birmingham’s Institute of Immunology and Immunotherapy and Deputy Director of NIHR Birmingham Biomedical Research Centre, said: “I am very excited about the potential benefits of this treatment for patients with PSC and AIH.
“There is good evidence that the selected cells being used in this new immunotherapy can reduce liver inflammation and improve liver function. The initial aims are to prove the safety and efficacy of the treatment and it could possibly be used in future trials to treat other immune and inflammatory diseases.
“We are indebted to the whole MERLIN team who worked so hard to bring about this trial and patients who have given up their time to be considered for this trial.”
The cell product being administered in the MERLIN trial is called ORBCEL-C™ and was discovered by Dr Steve Elliman, Chief Scientific Officer at Orbsen Therapeutics in Ireland.
Dr Elliman said: "We are optimistic taking the ORBCEL-C immunotherapy to the clinic as a solution to slow or stop these chronic autoimmune liver diseases. On behalf of Orbsen, we are privileged to be engaged with some of the European Union's leading researchers and institutions in the MERLIN program.”
ORBCEL-C is being manufactured for the trial by NHS Blood and Transplant in Birmingham. The trial is the culmination of the MERLIN Project, which also involved researchers from the University of Padua, Erasmus Medical Centre and BioInVision Inc.
Anyone aged over 18 with PSC or AIH who is interested in joining the trial can contact the trial management team in Birmingham at email@example.com for more information. Specific inclusion criteria must be satisfied before admission to the trial. Depending on the results achieved a further trial with a larger patient cohort may be warranted.