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

Kang Stem Biotech Co., Ltd.14 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atopic Dermatitis

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul ST. Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Evaluate the number of adverse events Safety of FURESTEM-AD Inj.

The severity of each adverse enent was classified according to CTCAE v4.0

Time frame: 3 years

Secondary Outcomes

Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline

Time frame: 3 years

Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value

Time frame: 3 years

Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point

Time frame: 3 years

Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value

Time frame: 3 years

Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value

Time frame: 3 years

Data from ClinicalTrials.gov

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