NCT01927705

Brief Summary

The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj. by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately subacute and chronic Atopic Dermatitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 6, 2016

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

August 20, 2013

Last Update Submit

October 5, 2016

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisStem cellCell therapyskin diseasefurestemADhUCB-MSCUCB-MSCUmbilical cord Blood

Outcome Measures

Primary Outcomes (1)

  • over 50% reduction ratio of SCORAD INDEX as contrasted with baseline value

    4 weeks follow-up after treatment

Secondary Outcomes (6)

  • SCORAD Total Score

    4 weeks follow-up after treatment

  • the degrees of disease

    4 weeks follow-up after treatment

  • Valuation of IGA

    4 weeks follow-up after treatment

  • each index of SCORAD INDEX

    4 weeks follow-up after treatment

  • serum Total IgE

    4 weeks follow-up after treatment

  • +1 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

FURESTEM-AD Inj. 1. 2.5 x 10\^7 stem cells after registration. FURESTEM-AD Inj. 2. 5.0 x 10\^7 stem cells after registration.

Biological: FURESTEM-AD Inj.

Interventions

FURESTEM-AD Inj.BIOLOGICAL
Treatment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Of either gender, aged ≥20 and ≤60 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 at the baseline visit
  • Subjects who have asthma at the baseline visit
  • Treatment with oral corticosteroids, oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the baseline visit
  • Treatment with topical steroids, antibiotics within 2 weeks before the baseline visit
  • Subjects who already took or need to take the medicine which is prohibited to take during the clinical study.
  • 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 at Screening and Baseline)
  • Subjects who currently participate in other clinical trial or participated in other clinical trial within 30 days
  • Creatinine value ≥ 2 Upper limit of the normal range at screening test
  • AST/ALT value ≥ 2 Upper limit of the normal range at screening test
  • Any other condition which the investigator judges would make patient unsuitable for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic Medical Center

Seoul, Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Dermatitis, AtopicSkin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Taeyoon Kim

    Catholic Medical Center

    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 20, 2013

First Posted

August 23, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 6, 2016

Record last verified: 2015-08

Locations

KR(1)