Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03252340|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment|
|Atopic Dermatitis||Drug: ADSTEM Inj.|
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|
|Actual Enrollment :||11 participants|
|Official Title:||Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis|
|Actual Study Start Date :||September 19, 2017|
|Estimated Primary Completion Date :||September 19, 2022|
|Estimated Study Completion Date :||September 19, 2022|
Drug: ADSTEM Inj.
Participants in Phase I clinical trials treated with ADSTEM Inj.
Drug: ADSTEM Inj.
- Tumor formation [ Time Frame: 60months after treatment of ADSTEM Inj. ]The number of subjects with treatment-related tumor formation
- Adverse events [ Time Frame: 60months after treatment of ADSTEM Inj. ]The number of subjects with treatment-related adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252340
|Korea, Republic of|
|Chungnam National University Hospital|
|Daejeon, Chungcheongnam-do, Korea, Republic of|
|Principal Investigator:||Young-joon Seo, M.D, Ph.D||Chungnam National University Hospital|