Phase 2a Clinical Trial for Investigational Cell Therapy Now Recruiting Primary Sclerosing Cholangitis and Autoimmune Hepatitis Patients

Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are both rare and chronic liver diseases. They cause the bile ducts in the liver to become inflamed, resulting in severe liver damage. Many patients with these conditions eventually necessitate a liver transplant and other treatment options are very limited.

A new clinical trial, sponsored by the University of Birmingham (UoB), has just been initiated. Researchers believe an investigational cell therapy could be efficacious for these two conditions. They say there is a substantial amount of evidence that the treatment could both reduce inflammation in the liver and improve overall liver function. They have even noted that it could potentially be utilized for other inflammatory or immune conditions.

The MERLIN Trial

The MERLIN Trial is a Phase 2a clinical trial investigating a cellular immunotherapy product called ORBCEL-C. This therapy was first discovered by a doctor in Ireland named Steve Elliman. The trial’s Chief Investigator is Phil Newsome, a professor at UoB.

ORBCEL-C is a singular infusion of mesenchymal stromal cells. The trial will evaluate the safety and efficacy of one infusion of the therapy for patients with either AIH or PSC.

A total of 56 patients will be recruited to participate in this investigation. Participants must be over the age of 18 and be diagnosed with either PSC or AIH. For additional information and all inclusion criteria, interested patients should contact the trial team at merlin@trials.bham.ac.uk.

If the results from this Phase 2a trial are positive, an additional trial utilizing a larger number of patients will be initiated. Right now, researchers are optimistic about the outcomes this new therapy could have for these patient populations. Stay tuned to hear updates on this investigation.

You can read more about this clinical trial here.


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