Long-term Follow-up Study to Evaluate the Safety and Expl... | NCT04730024

Studies
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj

NCT04730024

Sponsor

Kang Stem Biotech Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Jan 29, 2021Actual

Enrollment

102Estimated

Phase

Not provided

Conditions

Atopic Dermatitis

Interventions

Not applicable(observational study)

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2022Estimated

Primary Completion Date

Jun 30, 2030Estimated

Completion Date

Jun 30, 2030Estimated

First Submitted Date

Jan 25, 2021

First Submission Date that Met QC Criteria

Jan 25, 2021

First Posted Date

Jan 29, 2021Actual

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

Jan 25, 2021

Last Update Posted Date

Jan 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study

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

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

102Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Not applicable(observational study)	Other	Not applicable(observational study)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)		for 5 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)		for 5 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject who enrolled K0104 Clinical Trial(parent study).
Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial
Subjects who are judged to be unsuitable for other researchers to participate in the research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

In this study (K0104-E), it was planned to select subjects who participated in the K0104 clinical trial, a parent study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eundoek Yeo	Contact	82-2-888-1592		edyeo@kangstem.com
Seulbi Lee	Contact	82-2-888-1592		sblee@kangstem.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongguk University Medical Center		Ilsan			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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