Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)

NCT ID: NCT03269773

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-25
• Study Completion Date: 2019-06-20

Brief Summary

This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FURESTEM-AD Inj.

hUCB-MSC 5.0x10\^7 cells

Group Type: EXPERIMENTAL

FURESTEM-AD Inj.

Intervention Type: BIOLOGICAL

0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL).

Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)

Interventions

FURESTEM-AD Inj.

0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL).

Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL

Intervention Type: BIOLOGICAL

Placebo

0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Of either gender, aged >=19

2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria

3. Chronic Atopic Dermatitis that has been present for at least 3 years

4. EASI>=12 at screening and baseline visit

5. IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit

6. Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks

7. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria

1. Subjects with medical history or surgery/procedure history

2. Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)

3. Subjects who need prohibited medication during clinical period

4. Pregnant, breast-feeding women or women who plan to become pregnant during this study

5. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks

6. Any other condition which the investigator judges would make patient unsuitable for study participation

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

Sponsors

Kang Stem Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pusan National University Hospital

Busan, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Dongguk University Medical Center

Ilsan, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Catholic Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Chung-Ang University Healthcare System

Seoul, , South Korea

Hanyang University Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

K0102

Identifier Type: -

Identifier Source: org_study_id