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Completed

NCT Number: NCT03252340

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADSTEM Inj.

Drug
  • 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.

Primary outcomes

  1. Tumor formation

    Time frame: 60months after treatment of ADSTEM Inj.

    The number of subjects with treatment-related tumor formation

Secondary outcomes

  1. Adverse events

    Time frame: 60months after treatment of ADSTEM Inj.

    The number of subjects with treatment-related adverse events

Sponsors and collaborators

Lead sponsor

EHL Bio Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2017
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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