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

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03458624

Enrollment

Registered

2018-03-08

Start date

2016-07-01

Completion date

2018-12-31

Last updated

2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

FURESTEM-AD Inj., Stem cells

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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	3 years
Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point	3 years
Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value	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	3 years

Countries

South Korea

Outcome results