Clinical Trial: An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease
Brief Summary: Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using third party human cultured cells will be safe and effective
Detailed Summary:
Sponsor: R.P.Herrmann
Current Primary Outcome: Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy [ Time Frame: Six weeks ]
Original Primary Outcome: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy [ Time Frame: Six weeks ]
Current Secondary Outcome:
- Incidence of infusional toxicity [ Time Frame: Six weeks ]Subjects will receive mesenchymal stromal cell therapy, 2X10E6/kg weekly by IV infusion for 4 weeks and will be assessed for 4 hours post infusion
- Induction of remission [ Time Frame: Six weeks ]Crohn's disease activity index assessed as below 150
- Improved quality of life [ Time Frame: Six weeks ]Increase in IBDQ and SF-36 scores measured at six weeks
- Endoscopic improvement. [ Time Frame: Six weeks ]Crohn's disease endoscopic improvement score will be measured at repeat endoscopy six weeks after start of treatment
Original Secondary Outcome: Incidence of infusional toxicity [ Time Frame: Six weeks ]
Information By: Royal Perth Hospital
Dates:
Date Received: March 22, 2010
Date Started: January 2010
Date Completion:
Last Updated: June 7, 2015
Last Verified: June 2015
