Clinical Trials of Autologous Cultured Adipose-derived Stem Cells (ANTG-ASC) on Complex Fistula (ANTG-ASC-210)

A

Anterogen

Status and phase

Terminated
Phase 2

Conditions

Complex Perianal Fistula

Treatments

Biological: Autologous cultured adipose derived stem cells(high dose group)
Biological: Autologous cultured adipose derived stem cells(low dose group)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01314092
ANTG-ASC-210

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups

Group 1
Experimental group
Description:
Low dose group
Treatment:
Biological: Autologous cultured adipose derived stem cells(low dose group)
Group 2
Experimental group
Description:
high dose group
Treatment:
Biological: Autologous cultured adipose derived stem cells(high dose group)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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