Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula

Anterogen Co., Ltd.37 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn's Disease Fistula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

DaeHang Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul Asan Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Number of patients with Sustained efficacy of complete closure of fistula

Proportion of patients whose fistula has been completely closed.

Time frame: Month 4, 10

Secondary Outcomes

Number of patients with sustained efficacy of closure of fistula

Proportion of patients with more than 50% closed of fistula (Month 2, 4, 10)

Time frame: Month 2, 4, 10

Number of patients with any adverse event

number of patients with any adverse event (Month 2, 4, 10)

Time frame: Month 2, 4, 10

Grade of Investigator's satisfaction

Grade of Investigator's satisfaction (Month 2, 4, 10) 1. very satisfaction 2. satisfacttion 3. somewhat satisfaction 4. unsatisfaction 5. very unsatisfaction

Time frame: Month 2, 4, 10

Data from ClinicalTrials.gov

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