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

Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03252340

Enrollment

Registered

2017-08-17

Start date

2017-09-19

Completion date

2022-09-27

Last updated

2023-02-15

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

Conditions

Atopic Dermatitis

Brief summary

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.

Detailed description

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.

Interventions

DRUGADSTEM Inj.

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.

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tumor formation	60months after treatment of ADSTEM Inj.	The number of subjects with treatment-related tumor formation

Secondary

Measure	Time frame	Description
Adverse events	60months after treatment of ADSTEM Inj.	The number of subjects with treatment-related adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026