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

NCT ID: NCT01314079

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease Fistula

Keywords

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Crohn's fistula Autologous adipose derived stem cell

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anterogen Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CS You, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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DaeHang Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul Asan Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ANTG-ASC-203

Identifier Type: -

Identifier Source: org_study_id