drugset / Trial / NCT02997878
Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIH
Phase 1/2
Active not recruiting
18 enrolled
University of Birmingham
NHS Blood and Transplant · collab
Non-randomizedParallel-groupOpen-labelTreatment
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™.
Timeline
- Start
- 2018-12-07
- Primary completion
- 2023-11-23
- Completion
- 2025-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ORBCEL-C | Cell therapy | 0.5 cells/kg | Intravenous |
| Subject | ORBCEL-C | Cell therapy | 1 cells/kg | Intravenous |
| Subject | ORBCEL-C | Cell therapy | 2.5 cells/kg | Intravenous |