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.

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

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Not applicable-observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Kang Stem Biotech Co., Ltd.
• Investigators: Principal Investigator: Tae-Yun Kim, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): August 12, 2016
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Stem cells; FURESTEM-AD Inj.
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: KSTHD_FURESTEM_AD_EXT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No