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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ADSTEM Inj. (Adult human mesenchymal stem cells)

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Mesenchymal stem cells

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chungnam National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention: Biological: ADSTEM Inj.

Arm Description

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.

Outcomes

Primary Outcome Measures

The number of subjects with treatment-related adverse events as assessed by CTCAE version 4.03

physical exam, vital sign, laboratory findings, and adverse drug reactions

Secondary Outcome Measures

The reduction ratio of scoring atopic dermatitis (SCORAD) index as contrasted with baseline value

The variation of SCORAD index as contrasted with baseline value

The variation of each index score of SCORAD index as contrasted with baseline value

TBSA, erythema, edema/papulation, oozing/crusting, excoriation, lichenification, dryness, pruritus, and insomnia

The variation of the degrees of disease as contrasted with baseline value

The variation of investigator's global assessment (IGA) as contrasted with baseline value

The variation of eczema area and severity index (EASI) total score as contrasted with baseline value

The variation of total immunoglobulin E (IgE) in serum as contrasted with baseline value

The variation of total prostaglandin E2 (PGE2) in serum as contrasted with baseline value

The variation of total eosinophil cationic protein (ECP) in serum as contrasted with baseline value

The variation of total Chemokine ligand 17 (CCL17) in serum as contrasted with baseline value

The variation of total Chemokine ligand 27 (CCL27) in serum as contrasted with baseline value

Full Information

NCT ID

NCT02888704

First Posted

August 15, 2016

Last Updated

December 20, 2017

Sponsor

EHL Bio Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02888704

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EHL Bio Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic dermatitis, Mesenchymal stem cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention: Biological: ADSTEM Inj.

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ADSTEM Inj. (Adult human mesenchymal stem cells)

Other Intervention Name(s)

ADSTEM Inj.

Intervention Description

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

Primary Outcome Measure Information:

Title

The number of subjects with treatment-related adverse events as assessed by CTCAE version 4.03

Description

physical exam, vital sign, laboratory findings, and adverse drug reactions

Time Frame