Trial | NCT02888704  Report issue

Title

Safety and Efficacy of ADSTEM Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis
Phase I Clinical Trial to Evaluate the Safety, Tolerance, and Exploratory Efficacy of ADSTEM Inj. in Patients With Moderate to Severe, Subacute and Chronic Atopic Dermatitis

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    13
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.
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.
Study Started
Jul 31
2016
Primary Completion
Dec 31
2017
Study Completion
Dec 31
2017
Last Update
Dec 22
2017

Drug ADSTEM Inj. (Adult human mesenchymal stem cells)

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

  • Other names: ADSTEM Inj.

intervention: Biological: ADSTEM Inj. Experimental

ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study. ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study.

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
No Results Posted