Follow-up Study of Autologous Cultured Adipose-derived St... | NCT01314079

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

NCT01314079

Sponsor

Anterogen Co., Ltd.

Status

Completed

Last Update Posted

Nov 23, 2016Estimated

Enrollment

37Actual

Phase

Not provided

Conditions

Crohn's Disease
Fistula

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Mar 8, 2011

First Submission Date that Met QC Criteria

Mar 11, 2011

First Posted Date

Mar 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2016

Last Update Posted Date

Nov 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Number of patients with any adverse event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CS You, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DaeHang Hospital		Seoul			South Korea
Samsung Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D005402	Fistula

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided