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

NCT ID: NCT02888704

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed Description

Atopic dermatitis (AD) is a type of inflammation of the skin. It results in itchy, swollen, red, and cracked skin. The symptoms typically start in childhood with changing severity over the years. The pathogenesis of AD is characterized by excessive type 2 helper T cell mediated inflammatory responses, resulting in B lymphocyte mediated increase in serum level of immunoglobulin E (IgE). Subsequent degranulation of mast cells by IgE releases various inflammatory mediators, which recruit the lymphocytes and eosinophils into the lesion.

Current clinical management of AD includes topical corticosteroids and systemic immunosuppressants. However, these drugs have been reported to carry the risk of side-effects and severe.

Several recent studies including ours have demonstrated that mesenchymal stem cells (MSCs) could suppress allergic responses in AD. MSCs have been known to interact with cell types of both innate and adaptive immune systems, which results in the suppressive effect on proliferation, differentiation, and activation of immune cells including T cells, B cells, dendritic cells, and natural killer cells. Indeed, a number of studies have reported that the immunomodulatory ability of MSCs can be usefully applied for the treatment of autoimmune and inflammation-related diseases such as asthma, rhinitis, and dermatitis. Therefore, MSCs has possibility as a new drug for AD.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Mesenchymal stem cells

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention: Biological: ADSTEM Inj.

1. ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study.

2. ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study.

Group Type: EXPERIMENTAL

ADSTEM Inj. (Adult human mesenchymal stem cells)

Intervention Type: DRUG

Comparison of different dosages of the drug in the aspect of safety and efficacy.

Interventions

ADSTEM Inj. (Adult human mesenchymal stem cells)

Comparison of different dosages of the drug in the aspect of safety and efficacy.

Intervention Type: DRUG

Other Intervention Names

ADSTEM Inj.

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EHL Bio Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young-joon Seo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Countries

South Korea

Other Identifiers

30902

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AD-CP-15-1

Identifier Type: -

Identifier Source: org_study_id