NCT01623453

Follow-up Study of Autologous Adipose-derived Stem Cells (ANTG-ASC) for the Complex Fistula (ANTG-ASC-211)

A Follow-up Study to Evaluate the Sustained Healing Effect the Patients Who Showed Complete Closure of Fistula the Previous ANTG-ASC-210 Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Anterogen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.

Conditions

• Perianal Fistula
• Primary; Complex

Interventions

Type	Name	Description
BIOLOGICAL	Autologous adipose derived stem cells(low dose group)	low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
BIOLOGICAL	Autologous adipose derived stem cells(high dose group)	high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-06-20
• Last updated: 2016-11-23

Locations

2 sites across 1 country: South Korea