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NCT01314079 Clinical Trial

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
Secondary ID
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

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
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