NCT01090817

An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease

A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: R.P.Herrmann · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Mesenchymal stromal cells (MSC) for infusion	MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-06-01
• Completion: 2015-06-01
• First posted: 2010-03-23
• Last updated: 2015-06-09

Locations

1 site across 1 country: Australia