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NCT03252340 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03252340
Other study ID # AD-CP-17-1
Secondary ID 30902
Status Completed
Phase
First received
Last updated
Start date September 19, 2017
Est. completion date September 27, 2022

Study information
Verified date February 2023
Source EHL Bio Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date September 27, 2022
Est. primary completion date August 17, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ADSTEM Inj.
ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial. ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.

Locations
Country Name City State
Korea, Republic of Chungnam National University Hospital Daejeon Chungcheongnam-do

Sponsors (1)
Lead Sponsor Collaborator
EHL Bio Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor formation The number of subjects with treatment-related tumor formation 60months after treatment of ADSTEM Inj.
Secondary Adverse events The number of subjects with treatment-related adverse events 60months after treatment of ADSTEM Inj.
See also
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