Trial | NCT01314092  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    15
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.
Study Started
Jan 31
2011
Primary Completion
Sep 30
2014
Study Completion
Sep 30
2014
Last Update
Nov 23
2016
Estimate

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.

  • Other names: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group1: low dose group

Biological 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.

  • Other names: mesenchymal stem cell, ANTG-ASC, adipose derived stem cell, Group2: high dose group

Group 1 Experimental

Low dose group

Group 2 Experimental

high dose group

Criteria 

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
No Results Posted