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NCT03458624 Clinical Trial

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

Atopic Dermatitis Clinical Trial

Official title:
Observational Study to Evaluate the Safety and Efficacy of FURESTEM-AD Inj. in Moderate to Severe Atopic Dermatitis Patients Who Participated in Phase 1/2a Clinical Trial of FURESTEM-AD Lnj.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03458624
Other study ID # KSTHD_FURESTEM_AD_EXT
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 3, 2017
Last updated March 7, 2018
Start date July 1, 2016
Est. completion date December 31, 2018

Study information
Verified date February 2018
Source Kang Stem Biotech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 14
Est. completion date December 31, 2018
Est. primary completion date August 12, 2016
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul ST. Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline 3 years
Secondary Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value 3 years
Secondary Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point 3 years
Secondary Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value 3 years
Secondary Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value 3 years
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