University of Birmingham trials a new stromal cell immunotherapy for chronic liver disease

The University of Birmingham has launched a trial which 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 and many of those affected end up needing a liver transplant. 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 at Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham. It is funded by the EU FP7 Project MERLIN (Grant agreement no: 602363) and 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 at Orbsen Therapeutics in Ireland.

Steve Elliman, Chief Scientific Officer at Orbsen Therapeutics, 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.

Depending on the results achieved a further trial with a larger patient cohort may be warranted. Anyone aged over 18 with PSC or AIH who is interested in joining the trial can contact the trial management team in Birmingham for more information. Specific inclusion criteria must be satisfied before admission to the trial.

For more information please contact Emma McKinney, Communications Manager (Health Sciences), University of Birmingham, tel: +44 (0) 121 414 6681, or contact the press office on +44 (0) 7789 921 165.

• The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
• The trial is being sponsored and coordinated by the University of Birmingham and is being funded by the EU FP7 Project MERLIN (Grant Agreement: 602363)
• MERLIN has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 602363.
• For more information, contact the MERLIN team at the University of Birmingham.
• The full partners in the MERLIN project are: University of Birmingham (UK, Project Co-ordinator); Orbsen Therapeutics Limited (Ireland); Erasmus Medical Centre (The Netherlands); Università degli Studi di Padova (Italy); BioInVision Inc., (United States); NHS Blood and Transplant (UK) and Pintail Limited (Ireland).
• University Hospitals Birmingham NHS Foundation Trust (UHB) runs the Queen Elizabeth Hospital Birmingham, Birmingham Chest Clinic, Heartlands Hospital, Good Hope Hospital, Solihull Hospital and various community services across the region. The Trust has regional centres for trauma, burns, plastics, neurosciences, dermatology and cancer. It also has centres of excellence for vascular, bariatric and pathology services, as well as the treatment of MRSA and other infectious diseases. We also have expertise in HIV/AIDS, premature baby care, bone marrow transplants and thoracic surgery. UHB has the largest solid organ transplantation programme in Europe and runs Umbrella, the sexual health service for Birmingham and Solihull. It is also home to the West Midlands Adult Cystic Fibrosis Centre and a nationally-renowned weight management clinic and research centre. The Queen Elizabeth Hospital Birmingham is a Major Trauma Centre treating the most severely injured casualties from across the region. The hospital’s single site 100-bed critical care unit is the largest in Europe. The Trust hosts the Institute of Translational Medicine (ITM) and leads the West Midlands Genomics Medicine Centre as part of the national 100,000 Genomes Project. UHB is also proud to host the Royal Centre for Defence Medicine (RCDM) at the Queen Elizabeth Hospital Birmingham. The RCDM provides dedicated training for defence personnel and is a focus for medical research.
• The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:

1. Funds, supports and delivers high quality research that benefits the NHS, public health and social care
2. Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
3. Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
4. Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
5. Partners with other public funders, charities and industry to maximise the value of research to patients and the economy.

• The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.