NCT03252340

Brief Summary

This study aims to evaluate safety in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an observational study of patients participated in Phase 1 clinical trials, no drug is administered in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

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 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 19, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

4.9 years

First QC Date

August 8, 2017

Last Update Submit

February 14, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Tumor formation

    The number of subjects with treatment-related tumor formation

    60months after treatment of ADSTEM Inj.

Secondary Outcomes (1)

  • Adverse events

    60months after treatment of ADSTEM Inj.

Study Arms (1)

Drug: ADSTEM Inj.

Participants in Phase I clinical trials treated with ADSTEM Inj.

Drug: ADSTEM Inj.

Interventions

ADSTEM Inj.DRUG

1. ADSTEM Inj. 1.0x10\^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial. 2. ADSTEM Inj. 3.0x10\^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.

Drug: ADSTEM Inj.

Eligibility Criteria

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

Patients who participated in Phase I clinical trials

You may qualify if:

  • Patients who participated in Phase I clinical trials
  • Patients who voluntarily agreed to participate in the study

You may not qualify if:

  • Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, 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

  • Young-joon Seo, M.D, Ph.D

    Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 17, 2017

Study Start

September 19, 2017

Primary Completion

August 17, 2022

Study Completion

September 27, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)