Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula (ALLO-ASC)

Anterogen

Status and phase: Completed; Phase 1

Conditions: Crohn

Treatments: Biological: Allogenic human adipose-derived stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440699

ALLO-ASC-101

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Treatment

Experimental group

Description:

For ALLO-ASC 1xE7 cells/ml,3 patients are to be enrolled. If there is no safety issue, 3 more patients will be enrolled to be treated with ALLO-ASC 3xE7 cells/ml.

Treatment:

Biological: Allogenic human adipose-derived stem cells