Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIH

This study is called MERLIN and it's looking into a new treatment called Orbcel-C, made from special cells from umbilical cords. It's for people with two types of liver conditions: Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH). Our main goals are to find out the safest dose of Orbcel-C and to see if it can help calm down the inflammation in the liver. This is an early-stage trial, so we're starting with a small number of people to learn more about this potential new medicine. If successful, it could lead to larger studies in the future, bringing us closer to new treatments for these conditions.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Birmingham

Enrolment target

Start

07 Dec 2018

Estimated completion

01 Oct 2025

Cholangitis, Sclerosing Hepatitis, Autoimmune

What is this study about?

This study, called MERLIN, is an important first step in testing a new treatment called Orbcel-C for two specific liver conditions: Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH). Both of these conditions involve inflammation in the liver, which can cause serious problems over time. Orbcel-C is made from special cells found in umbilical cords, and we believe these cells might help to reduce this inflammation.

The main purpose of this early study is quite simple: we need to find the safest possible dose of Orbcel-C. Because it's a new treatment, we'll start with small doses and slowly increase them, carefully watching for any side effects. This helps us ensure that whatever dose we give is safe for people. Once we find the safest dose, we'll also start to look for early signs that the treatment is working. We'll do this by checking different markers in your blood, which can tell us if the inflammation in your liver is going down.

It's important to understand that this is an early-stage study (Phase 1/2). This means we're not yet testing if Orbcel-C cures these conditions, but rather if it's safe and shows any promising activity against them. If this study gives us good results, it would mean we can then plan larger, more detailed studies to really understand how well Orbcel-C works and if it can become a regular treatment option for people with PSC and AIH.

Key takeaways

This study is testing a new cell treatment called Orbcel-C for liver conditions PSC and AIH.
The main goals are to find the safest dose of Orbcel-C and look for early signs it reduces liver inflammation.
It's an early-stage study, meaning we are focusing on safety and initial activity, not yet on finding a cure.
Participation involves a single treatment infusion and several follow-up visits for monitoring.
Patients with confirmed PSC or AIH who meet specific health criteria are eligible.

Who may be eligible?

This study is looking for adults aged 18 and over who have either Primary Sclerosing Cholangitis (PSC) or Autoimmune Hepatitis (AIH).

If you have PSC, your diagnosis needs to be officially confirmed, and blood tests should show ongoing liver issues. Your liver test results should also be fairly stable before you join the study. For those with AIH, your diagnosis must also be confirmed by a specialist, and your liver tests must show active inflammation. You'll also need to have been on your usual AIH medication, at a steady dose, for at least 24 weeks before joining.

There are also some reasons why you might not be able to join, which the study team will discuss with you. These could include other serious health conditions or medications you are taking that might interfere with the study treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed diagnosis of Primary Sclerosing Cholangitis (PSC) or Autoimmune Hepatitis (AIH)?
If you have PSC, do your blood tests show ongoing liver issues that are fairly stable?
If you have AIH, are you on stable doses of your usual medication for at least 24 weeks?
Are you willing to attend multiple follow-up appointments and have blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a single infusion of the study treatment, Orbcel-C, into your vein. Before and after this treatment, you’ll have several visits to the clinic for check-ups. These visits will involve blood tests to track your liver health and general well-being, as well as physical exams to monitor how you're feeling. Initially, these visits will be more frequent, especially in the first two weeks after the infusion, so we can closely watch for any effects of the treatment. The total duration of your participation in the study will involve follow-up visits for several months after the single infusion.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to scientific understanding of your condition and potentially finding a new treatment. While Orbcel-C is experimental, there's a chance it could help reduce your liver inflammation. However, as with any new treatment, there are potential risks, including side effects from the infusion or the treatment itself. The research team will monitor you very closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Verified postcode
Birmingham, United Kingdom

Common questions

What is Orbcel-C?

It's a new experimental treatment made from special cells taken from human umbilical cords, which we hope can help reduce inflammation.

What are PSC and AIH?

They are two types of liver conditions where the body's immune system wrongly attacks its own liver, causing inflammation.

Is this a cure for my condition?

No, this is an early-stage study to find a safe dose and see if the treatment shows any promising activity, not to find a cure yet.

How will I receive the treatment?

You will receive the Orbcel-C treatment as a single infusion into a vein, similar to a drip.

How long will I be in the study?

You will have follow-up visits over several months after receiving the single treatment infusion.