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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn

Intervention / Treatment
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* Biological: Allogenic human adipose-derived stem cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Biological: Allogenic human adipose-derived stem cells<br>* ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL.<br>* Other names: ALLO-ASC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety (Laboratory screening, adverse effects, immunological response, local tolerance) |  | Week8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with sustained efficacy | Proportion of patients with more than 50% healed fistula at Month 8 Following up whether there is a recurrence at Month 8 | Month 8 | 
| Proportion of patients with adverse effects | Evaluate the safety at 8 months whether any kind of AE occurs. | at month 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's fistula