Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula (ANTG-ASC-203)

Anterogen

Status: Completed

Conditions: Fistula; Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01314079

ANTG-ASC-203

Details and patient eligibility

About

This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the patients who have participated in ANTG-ASC-202 clinical trial
• the patients who have experienced with Adipoplus in ANTG-ASC-202 trials
• the patients who submit written consents and is able to obey requirements of trials

Exclusion criteria

• pregnant or breast feeding
• autoimmune disease other than Crohn's disease
• infectious diseases including HBV, HCV or HIV
• who is not willing to use effective contraceptive methods during the study.
• active tuberculosis
• moderate to severe active or worsened Crohn's disease
• who have received Infliximab during or after ANTG-ASC-202 trial