Safety and Efficacy of ADSTEM Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate safety, tolerance, and efficacy in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of autologous mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine clinically proper dose capacity of the ADSTEM Inj. and step 2 is to evaluate exploratory efficacy of the ADSTEM Inj. at the proper dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EHL Bio Co., Ltd.
• Treatments: Remestemcel-l

Criteria

Inclusion Criteria:

• Of either gender, aged ≥19 and ≤70 years

• Atopic dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria

• Subacute and chronic atopic subjects who have atopic dermatitis symptoms continually at least 6 months

• Subjects with over moderate atopic dermatitis (SCORAD score > 20)

• Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

• Subjects who have systemic infection

• Subjects who have human Immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)

• Subjects who need to take the medicine which is prohibited during this study

• Subjects who have asthma

• Subjects who can not stop treatment with topical steroids (group 1~5), oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the treatment visit

• Pregnant, breast-feeding women or women who plan to become pregnant during this study (Females of childbearing potential must have a negative urine pregnancy test)

• Subjects who currently participate in other clinical trial or participated in other clinical trial within 30 days

• Subjects who had a serious adverse events during stem cell therapy

• Subjects who had a hypersensitivity to antibiotics or antimycotics

• Subjects who creatinine value is more than two times of the upper limit of the normal range at screening test

• Subjects who aspartate transaminase/alkaline transaminase (AST/ALT) value is more than three times of the upper limit of the normal range at screening test

• Subjects who have any other condition which the investigator judges would make patients unsuitable for study participation