Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula

Phase I Study of Dose Escalation of Human Allogenic Adipose-derived Stem Cells (ALLO-ASC) to Evaluate Safety and Efficacy in Patients With Crohn's Fistula

Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.

Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.

However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.

Inclusion Criteria:

• Diagnosed with Crohn's disease
• Crohn's fistula which has been lasted at least for 3 months
• Negative for beta-HCG pregnancy test

Exclusion Criteria:

• Medical history with Variant Creutzfeldt Jacobs Disease
• Allergic to anesthetics or bovine protein or fibrin glue
• autoimmune disease other than Crohn's disease
• Infectious disease
• Sepsis or active tuberculosis
• pregnant or breast feeding woman
• Inflammatory Bowel disease other than Crohn's disease
• active crohn's disease with CDAI score > 200
• malignant tumor
• fistula's diameter > 2 cm