Atopic DermatitisNCT03252340
Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
An observational study of Atopic Dermatitis, run by EHL Bio Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ADSTEM Inj.
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2017to 27 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who participated in Phase I clinical trials
Who may be able to join
- Patients who participated in Phase I clinical trials
- Patients who voluntarily agreed to participate in the study
Who cannot join
- Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Chungcheongnam-do
About this study
Official title: Observational Study to Evaluate the 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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- ADSTEM Inj.
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug: ADSTEM Inj. | Participants in Phase I clinical trials treated with ADSTEM Inj. Receives: Drug: ADSTEM Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor formation
The number of subjects with treatment-related tumor formation
Measured: 60months after treatment of ADSTEM Inj.
Secondary outcomes (1)
Adverse events
The number of subjects with treatment-related adverse events
Measured: 60months after treatment of ADSTEM Inj.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start19 Sep 2017
- Primary completion17 Aug 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- EHL Bio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-joon Seo, M.D, Ph.D, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252340
- Sponsor's protocol ID
- AD-CP-17-1
- Other IDs
- 30902
- Status last verified
- Feb 2023
- First submitted
- 8 Aug 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03252340
- Acronym / sponsor ID
- AD-CP-17-1
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- EHL Bio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: ADSTEM Inj. | – | Drug: ADSTEM Inj.Participants in Phase I clinical trials treated with ADSTEM Inj. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in Phase I clinical trials
Key inclusion criteria (2 listed)
- Patients who participated in Phase I clinical trials
- Patients who voluntarily agreed to participate in the study
Key exclusion criteria (1 listed)
- Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Drug: ADSTEM Inj. |
Primary outcome
Tumor formation
Time frame: 60months after treatment of ADSTEM Inj.
The number of subjects with treatment-related tumor formation
1 secondary outcome
Adverse events
Time frame: 60months after treatment of ADSTEM Inj.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-joon Seo, M.D, Ph.D principal investigator
Chungnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by EHL Bio Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor formation (time frame: 60months after treatment of ADSTEM Inj.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.