NCT01314079

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 23, 2016

Status Verified

March 1, 2012

Enrollment Period

2.3 years

First QC Date

March 8, 2011

Last Update Submit

November 21, 2016

Conditions

Crohn's DiseaseFistula

Keywords

Crohn's fistulaAutologous adipose derived stem cell

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Sustained efficacy of complete closure of fistula

    Proportion of patients whose fistula has been completely closed.

    Month 4, 10

Secondary Outcomes (3)

  • Number of patients with sustained efficacy of closure of fistula

    Month 2, 4, 10

  • Number of patients with any adverse event

    Month 2, 4, 10

  • Grade of Investigator's satisfaction

    Month 2, 4, 10

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who have participated in phase II clinical trial (ANTG-ASC-202) and injected with Adipoplus at least once.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

DaeHang Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Asan Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Crohn DiseaseFistula

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • CS You, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 14, 2011

Study Start

April 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 23, 2016

Record last verified: 2012-03

Locations

KR(3)