Active — Not RecruitingPhase 1/2

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

United Kingdom18 participantsStarted 2018-12-07

Plain-language summary

MERLIN is an adaptive, single arm, multi-centre, phase IIa multi-disease clinical trial. It is designed to: i) Determine dose safety of ORBCEL-C™ (selected Mesenchymal stromal cells derived from human umbilical cord) ii) Evaluate treatment activity through assessment of biomarkers (for patients treated at the highest safe dose only (HSD)) This trial will determine the Highest Safe Dose (HSD) that can be administered by observing for occurrence of dose limiting toxicity (DLT). Upon completion of this trial we hope to be able to justify and conduct separate, larger scale trials using ORBCEL-C™.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 at Visit 1
. Diagnosis of PSC at Visit 1 as evidenced clinically by:
. Chronic biochemical cholestasis (elevated serum alkaline phosphatase (ALP) above the upper limit of normal (ULN) and/or gamma-glutamyl transpeptidase (GGT) above the ULN) ≥6 months duration AND
. Radiological AND/OR histological evidence of clinically documented PSC
. Serum ALP ≥ 1.5 x ULN at Visit 1
. Any serum ALP value change is \<40% using two sets of laboratory values obtained during screening:

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose finding and incidence of treatment emergent adverse events (safety and tolerability) in all PSC and AIH Patients

Timeframe: Visit 3 to Visit 5 -14 days

Incidence of treatment emergent adverse events (safety and tolerability) for PSC and AIH patients treated at the Highest Safe Dose (HSD) only

Timeframe: Visit 3 to Visit 8 - 56 days

Activity and Safety at the Highest Safe Dose (HSD) of ORBCEL-C in PSC patients, by measure of change in Alkaline Phosphatase (ALP)

Timeframe: Baseline to Visit 8 - Approximately 80 days

Activity at the Highest Safe Dose (HSD) of ORBCEL-C in AIH patients, by measure of change in Alanine Aminotransferase (ALT)

Timeframe: Baseline to Visit 8 - Approximately 80 days

Trial details

NCT IDNCT02997878

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-23

View on ClinicalTrials.gov More Cholangitis, Sclerosing trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 at Visit 1
. Diagnosis of PSC at Visit 1 as evidenced clinically by:
. Chronic biochemical cholestasis (elevated serum alkaline phosphatase (ALP) above the upper limit of normal (ULN) and/or gamma-glutamyl transpeptidase (GGT) above the ULN) ≥6 months duration AND
. Radiological AND/OR histological evidence of clinically documented PSC
. Serum ALP ≥ 1.5 x ULN at Visit 1
. Any serum ALP value change is \<40% using two sets of laboratory values obtained during screening:

Exclusion criteria

What they're measuring

Dose finding and incidence of treatment emergent adverse events (safety and tolerability) in all PSC and AIH Patients

Timeframe: Visit 3 to Visit 5 -14 days

Incidence of treatment emergent adverse events (safety and tolerability) for PSC and AIH patients treated at the Highest Safe Dose (HSD) only

Timeframe: Visit 3 to Visit 8 - 56 days

Activity and Safety at the Highest Safe Dose (HSD) of ORBCEL-C in PSC patients, by measure of change in Alkaline Phosphatase (ALP)

Timeframe: Baseline to Visit 8 - Approximately 80 days

Activity at the Highest Safe Dose (HSD) of ORBCEL-C in AIH patients, by measure of change in Alanine Aminotransferase (ALT)

Timeframe: Baseline to Visit 8 - Approximately 80 days