Clinical Trial: A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & AiH

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional




Official Title: An Adaptive,Multicentre, Phase IIa, Multi-disease Trial Investigating the Safety & Activity of a Single Infusion of Selected Mesenchymal Stromal Cells in the Treatment of Patients With Primary Scl

Brief 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

This trial has two main stages:

  • Stage 1 will determine the maximum tolerated dose that can be administered by observing for occurrence of dose limiting toxicity (DLT).
  • Stage 2 will use the maximum tolerated dose found in stage 1 to and further determine safety and activity outcomes of ORBCEL-C.

Upon completion of this trial we hope to be able to justify and conduct separate, larger scale trials using ORBCEL-C.