Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIH (NCT02997878) | Clinical Trial Compass
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-Câ„¢ (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-Câ„¢.
Who can participate
Age range18 Years
SexALL
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
✕. Age ≥ 18 at Visit 1
✕. Established pre-existing clinical diagnosis of AIH confirmed by clinical expert review consistent with the simplified IAIHG criteria (http://www.mdcalc.com/simplified-scoring-autoimmune-hepatitis-aih/) and must include history of a liver biopsy reported compatible with AIH
✕. Active AIH defined by ALT ≥ 1.1 x ULN
What they're measuring
1
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
2
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
3
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
4
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