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Trial record 52 of 154 for:    Dermatitis, Atopic, 8

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03252340
Recruitment Status : Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
EHL Bio Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment
Atopic Dermatitis Drug: ADSTEM Inj.

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.


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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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.




Primary Outcome Measures :
  1. Tumor formation [ Time Frame: 60months after treatment of ADSTEM Inj. ]
    The number of subjects with treatment-related tumor formation


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 60months after treatment of ADSTEM Inj. ]
    The number of subjects with treatment-related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who participated in Phase I clinical trials
Criteria

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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, Korea, Republic of
Sponsors and Collaborators
EHL Bio Co., Ltd.
Investigators
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Principal Investigator: Young-joon Seo, M.D, Ph.D Chungnam National University Hospital

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Responsible Party: EHL Bio Co., Ltd.
ClinicalTrials.gov Identifier: NCT03252340     History of Changes
Other Study ID Numbers: AD-CP-17-1
30902 ( Other Grant/Funding Number: Republic or Korea Ministry of Food and Drug Safety )
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases