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

Anterogen

Status

Terminated

Conditions

Primary; Complex

Perianal Fistula

Treatments

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

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

Study type

Observational

Funder types

Industry

Identifiers

NCT01623453

ANTG-ASC-211

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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