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

Phase 1

Completed

• Conditions: Crohn
• Interventions: Biological: Allogenic human adipose-derived stem cells

• Registration Number: NCT01440699
• Lead Sponsor: Anterogen Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Primary Completion: 2012-10-11
• Study Completion: 2012-11-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Allogenic human adipose-derived stem cells	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.

Primary Outcome Measures

Name	Time	Method
General safety (Laboratory screening, adverse effects, immunological response, local tolerance)	Week8

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Keonghee Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yeonsei Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of