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

NCT ID: NCT03252340

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-19

Study Completion Date

2022-09-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Drug: ADSTEM Inj.

Participants in Phase I clinical trials treated with ADSTEM Inj.

ADSTEM Inj.

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EHL Bio Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young-joon Seo, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

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Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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30902

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AD-CP-17-1

Identifier Type: -

Identifier Source: org_study_id

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