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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FURESTEM-AD Inj.
Placebo
Sponsored by
Kang Stem Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Stem cell, Cell therapy, skin disease, Umbilical cord Blood, UCB-MSC, hUCB-MSC, AD, furestem, dermatitis, eczema

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pusan National University Hospital
  • Chonnam National University Hospital
  • Dongguk University Medical Center
  • Gachon University Gil Medical Center
  • Catholic Medical Center
  • Asan Medical Center
  • Chung-Ang University Healthcare System
  • Hanyang University Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FURESTEM-AD Inj.

Placebo

Arm Description

hUCB-MSC 5.0x10^7 cells

Outcomes

Primary Outcome Measures

over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)

Secondary Outcome Measures

over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)
Change and rafe of change in EASI index
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points
over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)
Change and rafe of change in SCORAD index
Change and rafe of change in Body Surface Area (BSA)
Change in total serum Immunoglobulin E (IgE)
Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)
Total number of use and consumed amount of rescue medicine

Full Information

First Posted
October 5, 2016
Last Updated
September 10, 2019
Sponsor
Kang Stem Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03269773
Brief Title
Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)
Official Title
A 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kang Stem Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Stem cell, Cell therapy, skin disease, Umbilical cord Blood, UCB-MSC, hUCB-MSC, AD, furestem, dermatitis, eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FURESTEM-AD Inj.
Arm Type
Experimental
Arm Description
hUCB-MSC 5.0x10^7 cells
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
FURESTEM-AD Inj.
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
Time Frame
12 week
Secondary Outcome Measure Information:
Title
over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)
Time Frame
12 week
Title
Change and rafe of change in EASI index
Time Frame
24weeks
Title
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1
Time Frame
24weeks
Title
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points
Time Frame
24weeks
Title
over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)
Time Frame
24weeks
Title
Change and rafe of change in SCORAD index
Time Frame
24weeks
Title
Change and rafe of change in Body Surface Area (BSA)
Time Frame
24weeks
Title
Change in total serum Immunoglobulin E (IgE)
Time Frame
24weeks
Title
Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)
Time Frame
24weeks
Title
Total number of use and consumed amount of rescue medicine
Time Frame
24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Of either gender, aged >=19 Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria Chronic Atopic Dermatitis that has been present for at least 3 years EASI>=12 at screening and baseline visit IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit 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 Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: Subjects with medical history or surgery/procedure history 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) Subjects who need prohibited medication during clinical period Pregnant, breast-feeding women or women who plan to become pregnant during this study Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks Any other condition which the investigator judges would make patient unsuitable for study participation
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Dongguk University Medical Center
City
Ilsan
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Catholic Medical Center
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Healthcare System
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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