NCT03458624

Brief Summary

Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1 month

First QC Date

April 3, 2017

Last Update Submit

March 7, 2018

Conditions

Atopic Dermatitis

Keywords

FURESTEM-AD Inj.Stem cells

Outcome Measures

Primary Outcomes (1)

  • Evaluate the number of adverse events Safety of FURESTEM-AD Inj.

    The severity of each adverse enent was classified according to CTCAE v4.0

    3 years

Secondary Outcomes (5)

  • Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline

    3 years

  • Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value

    3 years

  • Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point

    3 years

  • Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value

    3 years

  • Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value

    3 years

Study Arms (1)

Not applicable-observational study

Not applicable-observational study

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects participating in this observational study originally participated in study FURESTEM-AD Inj. \[NCT01927705\]

You may qualify if:

  • Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\[NCT02221258\]
  • Subject who understands and voluntarily sign an informed consent form

You may not qualify if:

  • In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul ST. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tae-Yun Kim

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2017

First Posted

March 8, 2018

Study Start

July 1, 2016

Primary Completion

August 12, 2016

Study Completion

December 31, 2018

Last Updated

March 8, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)