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

Crohn's Disease Clinical Trial

— ANTG-ASC-203  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314079
• Other study ID #: ANTG-ASC-203
• Status: Completed
• Phase: N/A
• First received: March 8, 2011
• Last updated: November 21, 2016
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Fistula

Locations

Country	Name	City	State
Korea, Republic of	DaeHang Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Asan Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Sustained efficacy of complete closure of fistula	Proportion of patients whose fistula has been completely closed.	Month 4, 10	No
Secondary	Number of patients with sustained efficacy of closure of fistula	Proportion of patients with more than 50% closed of fistula (Month 2, 4, 10)	Month 2, 4, 10	No
Secondary	Number of patients with any adverse event	number of patients with any adverse event (Month 2, 4, 10)	Month 2, 4, 10	Yes
Secondary	Grade of Investigator's satisfaction	Grade of Investigator's satisfaction (Month 2, 4, 10); very satisfaction; satisfacttion; somewhat satisfaction; unsatisfaction; very unsatisfaction	Month 2, 4, 10	No