Clinical Trial

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

Study acronym: Merlin
Unknown Phase 1/2
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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™.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT02997878
Lead Sponsor University of Birmingham
Collaborators: NHS Blood and Transplant
Conditions Cholangitis, Sclerosing, Hepatitis, Autoimmune
Enrollment 18 participants
Start Date 2018-12-07
Primary Completion 2023-11-23 (estimated)
Study Completion 2025-10-01 (estimated)
Updated on ClinicalTrials.gov 2024-07-11