NCT03252340

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
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: EHL Bio Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ADSTEM 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.

Timeline

• Start date: 2017-09-19
• Primary completion: 2022-08-17
• Completion: 2022-09-27
• First posted: 2017-08-17
• Last updated: 2023-02-15

Locations

1 site across 1 country: South Korea