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

EHL Bio

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Drug: ADSTEM Inj.

Study type: Observational

Funder types: Industry

Identifiers

NCT03252340

30902 (Other Grant/Funding Number)

AD-CP-17-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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

Trial design

11 participants in 1 patient group

Drug: ADSTEM Inj.

Description:

Participants in Phase I clinical trials treated with ADSTEM Inj.

Treatment:

Drug: ADSTEM Inj.