MedTrace Logo

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

NCT01623453 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2016-11-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Anterogen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • KJ Park · Seoul National University Hospital

  • DS Kim · Daehang Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623453 on ClinicalTrials.gov