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