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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Fistula Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DaeHang Hospital, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of patients with Sustained efficacy of complete closure of fistula

Time frame: Month 4, 10

Proportion of patients whose fistula has been completely closed.

Secondary outcomes

Number of patients with sustained efficacy of closure of fistula

Time frame: Month 2, 4, 10

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

Time frame: Month 2, 4, 10

number of patients with any adverse event (Month 2, 4, 10)
Grade of Investigator's satisfaction

Time frame: Month 2, 4, 10
Grade of Investigator's satisfaction (Month 2, 4, 10)
- very satisfaction
- satisfacttion
- somewhat satisfaction
- unsatisfaction
- very unsatisfaction

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study title

Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)

Acronym: ANTG-ASC-203

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Mar 14, 2011
Registry last updated: Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed