Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

EHL Bio Co., Ltd.11 enrolled

Overview

This study aims to evaluate safety in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an observational study of patients participated in Phase 1 clinical trials, no drug is administered in this study.

Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12, 18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj. Time perspective is both retrospective and prospective.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atopic Dermatitis

Interventions

ADSTEM Inj.DRUG

1. ADSTEM Inj. 1.0x10\^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial. 2. ADSTEM Inj. 3.0x10\^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who participated in Phase I clinical trials * Patients who voluntarily agreed to participate in the study Exclusion Criteria: * Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study

Locations (1)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Outcomes

Primary Outcomes

Tumor formation

The number of subjects with treatment-related tumor formation

Time frame: 60months after treatment of ADSTEM Inj.

Secondary Outcomes

Adverse events

The number of subjects with treatment-related adverse events

Time frame: 60months after treatment of ADSTEM Inj.

Data from ClinicalTrials.gov

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