Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

February 14, 2023 updated by: EHL Bio Co., Ltd.

Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12, 18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj.

Time perspective is both retrospective and prospective.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chungcheongnam-do
      • Daejeon, Chungcheongnam-do, Korea, Republic of
        • Chungnam National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who participated in Phase I clinical trials

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Drug: ADSTEM Inj.
Participants in Phase I clinical trials treated with ADSTEM Inj.
Drug: ADSTEM Inj.
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor formation
Time Frame: 60months after treatment of ADSTEM Inj.
The number of subjects with treatment-related tumor formation
60months after treatment of ADSTEM Inj.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 60months after treatment of ADSTEM Inj.
The number of subjects with treatment-related adverse events
60months after treatment of ADSTEM Inj.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EHL Bio Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2017

Primary Completion (Actual)

August 17, 2022

Study Completion (Actual)

September 27, 2022

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-CP-17-1
  • 30902 (Other Grant/Funding Number: Republic of Korea Ministry of Food and Durg Safety)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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