drugset / Trial / NCT01540292

Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders

NCT01540292

Phase 1/2 Terminated 13 enrolled University of Liege
NaSingle-groupOpen-labelTreatment

Summary

This project aims to assess safety and efficacy of allogeneic Mesenchymal stem Cell (MSC) in Crohn's disease refractory or intolerant to conventional therapies. Twenty patients with active refractory Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) \> 220 despite conventional treatment will be included over 4 years in this phase I-II trial. This will be a pilot open label trial. Patients will be treated with 2 successive injections of allogeneic MSC at baseline and 4 weeks later. Patients will be followed up at weeks 2, 4, 8 and 12.

Timeline

Start
2013-02-01
Primary completion
2015-12-31
Completion
2015-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject mesenchymal stem cells Cell therapy 1.5e+06 cells/kg Intravenous

Indications