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

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.

Inclusion Criteria:

• the patients who have participated in ANTG-ASC-210 clinical trial
• the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
• the patients who submit written informed consents and is able to obey requirements of trials

Exclusion Criteria:

• 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 a symptom of septicemia or active tuberculosis (contain tuberculosis of anus and rectum)
• a patient who is pregnant or breast feeding
• a patient who is not willing to use effective contraceptive methods during the study
• a patient who has inflammatory Bowel disease
• a patient who is sensitive to fibrin glue
• a patient who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker (who smoked more than 20 cigarettes a day)
• a patient who is not able to understand the objective of this study or to comply with the study requirements
• a patient who is considered to have a significant disease which can impact the study by investigator
• a patient who is considered not suitable for the study by investigator
• a patient who had a history of surgery for malignant tumor within the last five years (except carcinoma in situ)
• a patient who has multisystemic wasting syndrome (such as tuberculosis, Diabetes, Thyroid disorders, tumor, etc.)
• a patient who has taken cytotoxic drugs (such as immunosuppressants, corticosteroid, cytotoxic chemotherapy, anticoagulants, etc.) during long-term