Long-term Observational Study to Evalution the Safety and... | NCT03458624

Studies
Long-term Observational Study to Evalution the Safety and Efficacy of FURESTEM-AD Inj.

NCT03458624

Sponsor

Kang Stem Biotech Co., Ltd.

Status

Unknown status

Last Update Posted

Mar 8, 2018Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Atopic Dermatitis

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Aug 12, 2016Actual

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Apr 3, 2017

First Submission Date that Met QC Criteria

Mar 7, 2018

First Posted Date

Mar 8, 2018Actual

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

Mar 7, 2018

Last Update Posted Date

Mar 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis

Detailed Description

This is a observational study, single center, open label, study of safety and Efficacy of FURESTEM-AD Inj. in subjects with moderate to severe Atopic Dermatitis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Not applicable-observational study		Not applicable-observational study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the number of adverse events Safety of FURESTEM-AD Inj.	The severity of each adverse enent was classified according to CTCAE v4.0	3 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline		3 years
Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria:

In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects participating in this observational study originally participated in study FURESTEM-AD Inj. [NCT01927705]

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tae-Yun Kim	Seoul St. Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul ST. Mary's Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided