Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula

Complex Perianal Fistula Clinical Trial

— ANTG-ASC-210  

Official title:

Phase II Study to Evaluate Efficacy and Safety of ANTG-ASC (Autologous Cultured Adipose-derived Stem Cells) on the Complex Fistula Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01314092
• Other study ID #: ANTG-ASC-210
• Status: Terminated
• Phase: Phase 2
• First received: March 8, 2011
• Last updated: November 21, 2016
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: March 2011
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Mesenchymal stem cells derived from adipose tissue are pluripotent to differentiate into myocytes, adipocytes or others. They have an immunosuppressive activity. Complex perianal fistula is difficult to cure and easy to relapse. Autologous adipose stem cells have shown efficacy and safety on Crohn's fistula in phase 1 study. Based on these results, the investigators would apply autologous adipose stem cells on complex perianal fistula to evaluate their efficacy and safety.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a patient who has complex perianal fistula

• a patient who is negative in pregnancy test

• a patient who has submitted a written consent

Exclusion Criteria:

• a patient who has participated in other clinical studies within 30 days before this clinical trial or has not passed 5 fold period of a half-life of other investigational drugs.

• a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases

• a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue

• a patient who has an autoimmune disease

• a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)

• a patient who has sepsis or active tuberculosis

• a patient who is pregnant or breast feeding

• a patient who has inflammatory Bowel disease

• over 2cm in diameter of fistula

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Perianal Fistula
• Fistula

Intervention

Biological:
• Autologous cultured 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.
• Autologous cultured 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.

Locations

Country	Name	City	State
Korea, Republic of	Soon cheun Hyang university bucheon hospital	Bucheon-si
Korea, Republic of	DaeHang Hospital	Seoul
Korea, Republic of	Ewha womwn university mokdong hospital	Seoul
Korea, Republic of	Samsung seoul Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	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	Number of patients with complete closure of fistula (week 8)	Proportion of patients with completely closed fistula (week 8)	8 weeks	No
Secondary	Grade of investigator's satisfaction	Grade of investigator's satisfaction (8 weeks after final dose); very satisfaction; satisfaction; somewhat satisfaction; unsatisfaction; very unsatisfaction	8 weeks	No
Secondary	Number of patients with closed fistula	proportion of patients with completely closed fistula (every visits); proportion of patients with more than 50 % closed fistula (every visits)	8 weeks	No
Secondary	Photo of target fistula	Taking picture of target fistula at Day 0 and Week 4, 6, 8	8 weeks	No
Secondary	Number of patients with adverse events	Number of patients with any kinds of adverse events (Day 0, every visits)	8 weeks	Yes