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

Kangstem Biotech

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Other: Placebo; Biological: FURESTEM-AD Inj.

Study type: Interventional

Funder types: Industry

Identifiers

NCT03269773

K0102

Details and patient eligibility

About

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

Enrollment: 197 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 2 patient groups, including a placebo group

FURESTEM-AD Inj.

Experimental group

Description:

hUCB-MSC 5.0x10\^7 cells

Treatment:

Biological: FURESTEM-AD Inj.

Placebo

Placebo Comparator group

Treatment:

Other: Placebo