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

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

Inclusion Criteria:

• Colonic or small bowel Crohn's disease based on endoscopic appearances and histology
• Refractory to induction with infliximab or adalimumab; or have lost response to these agents; or have had side effects precluding their further use
• Where there has been loss of response to one of these agents, the other must be tried before being eligible
• Crohn's disease activity score (CDAI) 250 or more.
• C-reactive protein >10mg/L
• Surgery must have been offered to the subject (if appropriate) and declined
• Signed informed consent

Exclusion Criteria:

• Active sepsis, perforating disease. Coexistent perianal fistulous disease is permitted, providing no co-existent infection within previous 4 weeks
• Chronic stricturing disease in isolation
• Coexistent CMV disease
• Prior history of malignancy
• Pregnant or unwilling to practice contraceptive therapy or breast feeding females
• Last biologic therapy must be greater than 4 weeks prior, must be on stable corticosteroid dose for 14 days prior, during therapy and for 14 days after therapy, must be on stable immunomodulator dose (eg, azathioprine) for 14 days prior, during therapy and for 14 days after.