MERLIN
Research type
Research Study
Full title
An adaptive, single arm, multi-centre phase IIa multi-disease clinical trial investigating the safety and activity of the use of a single infusion of selected Mesenchymal Stromal Cells (MSC) to reduce liver inflammation in the treatment of patients with primary sclerosing cholangitis and autoimmune hepatitis.
IRAS ID
205917
Contact name
Rebecca Storey
Contact email
Sponsor organisation
The University of Birmigham
Eudract number
2016-000181-36
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
MERLIN seeks to investigate whether patients with primary sclerosing cholangitis (PSC) or autoimmune hepatitis (AIH) can be safely and effectively treated with a therapy called mesenchymal stromal cells (MSC).
MSC are found in almost every part of the body. They are known to play a role in tissue repair, renewal and inflammation. When extracted, and used as treatment, they have been shown to reduce the body’s immune response when it is overactive and causing damage. This anti-inflammatory effect of MSC has been utilised in many clinical trials to treat conditions associated with inflammation such as graft versus host disease (GVHD) and crohns disease with success.
The MSC to be used in the MERLIN trial are derived and grown from human umbilical cords as they are readily accessible. The umbilical cords will be ethically collected from mothers after childbirth. After collection, the MSC are purified and grown outside the body, before being infused directly into the body. The preparation of MSC we will use is called ORBCEL-C™. This is an 'off the shelf' product consisting of a purer and selected form of MSC.
MERLIN will determine a safe and effective dose of ORBCEL-C™ as well as analyse the clinical application and the effects of ORBCEL-C™ in patients with PSC and AIH. This will be the first clinical trial utilising MSC therapy in PSC and AIH patients.
ORBCEL-C™ has not been used in a clinical trial previously however our fundamental laboratory studies have shown ORBCEL-C™ to be safe and effective in reducing liver inflammation. Furthermore over 400 clinical trials have confirmed safety of various preparations of MSC therapy in various clinical settings with no reported major adverse events. There have been some small early phase studies in liver disease that have safely treated patients with MSC and exhibited clinical efficacy.REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0032
Date of REC Opinion
22 Mar 2017
REC opinion
Further Information Favourable Opinion