NCT01440699

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Anterogen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-11
• Completion: 2012-11-08
• First posted: 2011-09-26
• Last updated: 2023-08-25

Locations

3 sites across 1 country: South Korea