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

Crohn Clinical Trial

— ALLO-ASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440699
• Other study ID #: ALLO-ASC-101
• Status: Completed
• Phase: Phase 1
• Start date: September 2011
• Est. completion date: November 8, 2012

Study information

• Verified date: September 2011
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 8, 2012
• Est. primary completion date: October 11, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn
• Fistula

Intervention

Biological:
• Allogenic human adipose-derived stem cells
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.

Locations

Country	Name	City	State
Korea, Republic of	Keonghee Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yeonsei Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General safety (Laboratory screening, adverse effects, immunological response, local tolerance)		Week8
Secondary	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
Secondary	Proportion of patients with adverse effects	Evaluate the safety at 8 months whether any kind of AE occurs.	at month 8