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

NCT02888704 | Completed Phase 1

• 2 other identifiers: AD-CP-15-130902
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks follow-up after treatment

Secondary Outcomes (11)

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

  12 weeks follow-up after treatment

• The variation of SCORAD index as contrasted with baseline value

  12 weeks follow-up after treatment

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

  12 weeks follow-up after treatment

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

  12 weeks follow-up after treatment

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

  12 weeks follow-up after treatment

Study Arms (1)

intervention: Biological: ADSTEM Inj.

EXPERIMENTAL

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.

Drug: ADSTEM Inj. (Adult human mesenchymal stem cells)

Interventions

ADSTEM Inj. (Adult human mesenchymal stem cells) DRUG

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

Also known as: ADSTEM Inj.

intervention: Biological: ADSTEM Inj.

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EHL Bio Co., Ltd.: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, 35015, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Young-joon Seo, M.D., Ph.D

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 5, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)