Atopic DermatitisPhase 1NCT02888704
Safety and Efficacy of ADSTEM Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis
A Phase 1 study testing ADSTEM Inj. (Adult human mesenchymal stem cells) in people with Atopic Dermatitis, run by EHL Bio Co., Ltd. at 1 site in South Korea.
Trial summary
This study aims to evaluate safety, tolerance, and efficacy in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of autologous mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine clinically proper dose capacity of the ADSTEM Inj. 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. (Adult human mesenchymal stem cells)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 1
- 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
Who may be able to join
- Of either gender, aged ≥19 and ≤70 years
- Atopic dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
- Subacute and chronic atopic subjects who have atopic dermatitis symptoms continually at least 6 months
- Subjects with over moderate atopic dermatitis (SCORAD score > 20)
- Subjects who understand and voluntarily sign an informed consent form
Who cannot join
- Subjects who have systemic infection
- Subjects who have human Immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)
- Subjects who need to take the medicine which is prohibited during this study
- Subjects who have asthma
- Subjects who can not stop treatment with topical steroids (group 1~5), oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the treatment visit
- Pregnant, breast-feeding women or women who plan to become pregnant during this study (Females of childbearing potential must have a negative urine pregnancy test)
Show all 12Show fewer
- Subjects who currently participate in other clinical trial or participated in other clinical trial within 30 days
- Subjects who had a serious adverse events during stem cell therapy
- Subjects who had a hypersensitivity to antibiotics or antimycotics
- Subjects who creatinine value is more than two times of the upper limit of the normal range at screening test
- Subjects who aspartate transaminase/alkaline transaminase (AST/ALT) value is more than three times of the upper limit of the normal range at screening test
- Subjects who have any other condition which the investigator judges would make patients unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, 35015
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerance, and Exploratory Efficacy of ADSTEM Inj. in Patients With Moderate to Severe, Subacute and Chronic Atopic Dermatitis
This study aims to evaluate safety, tolerance, and efficacy in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of autologous mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine clinically proper dose capacity of the ADSTEM Inj. and step 2 is to evaluate exploratory efficacy of the ADSTEM Inj. at the proper dose.
Read the detailed description
Atopic dermatitis (AD) is a type of inflammation of the skin. It results in itchy, swollen, red, and cracked skin. The symptoms typically start in childhood with changing severity over the years. The pathogenesis of AD is characterized by excessive type 2 helper T cell mediated inflammatory responses, resulting in B lymphocyte mediated increase in serum level of immunoglobulin E (IgE). Subsequent degranulation of mast cells by IgE releases various inflammatory mediators, which recruit the lymphocytes and eosinophils into the lesion.
Current clinical management of AD includes topical corticosteroids and systemic immunosuppressants. However, these drugs have been reported to carry the risk of side-effects and severe.
Several recent studies including ours have demonstrated that mesenchymal stem cells (MSCs) could suppress allergic responses in AD. MSCs have been known to interact with cell types of both innate and adaptive immune systems, which results in the suppressive effect on proliferation, differentiation, and activation of immune cells including T cells, B cells, dendritic cells, and natural killer cells. Indeed, a number of studies have reported that the immunomodulatory ability of MSCs can be usefully applied for the treatment of autoimmune and inflammation-related diseases such as asthma, rhinitis, and dermatitis. Therefore, MSCs has possibility as a new drug for AD.
- Conditions
- Atopic Dermatitis
- Being tested
- ADSTEM Inj. (Adult human mesenchymal stem cells)
- Keywords
- Atopic dermatitis, Mesenchymal stem cells
- 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. (Adult human mesenchymal stem cells)Drug
Also called ADSTEM Inj.
Comparison of different dosages of the drug in the aspect of safety and efficacy.
| Study group | Role | What they receive |
|---|---|---|
| intervention: Biological: ADSTEM Inj. | Experimental | 1. ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study.
2. ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study. Receives: Drug: ADSTEM Inj. (Adult human mesenchymal stem cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with treatment-related adverse events as assessed by CTCAE version 4.03
physical exam, vital sign, laboratory findings, and adverse drug reactions
Measured: 12 weeks follow-up after treatment
Secondary outcomes (11)
The reduction ratio of scoring atopic dermatitis (SCORAD) index as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of SCORAD index as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of each index score of SCORAD index as contrasted with baseline value
TBSA, erythema, edema/papulation, oozing/crusting, excoriation, lichenification, dryness, pruritus, and insomnia
Measured: 12 weeks follow-up after treatment
The variation of the degrees of disease as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of investigator's global assessment (IGA) as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of eczema area and severity index (EASI) total score as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of total immunoglobulin E (IgE) in serum as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of total prostaglandin E2 (PGE2) in serum as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of total eosinophil cationic protein (ECP) in serum as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of total Chemokine ligand 17 (CCL17) in serum as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
The variation of total Chemokine ligand 27 (CCL27) in serum as contrasted with baseline value
Measured: 12 weeks follow-up after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT02888704
- Sponsor's protocol ID
- AD-CP-15-1
- Other IDs
- 30902
- Status last verified
- Dec 2017
- First submitted
- 15 Aug 2016
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety, Tolerance, and Exploratory Efficacy of ADSTEM Inj. in Patients With Moderate to Severe, Subacute and Chronic Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02888704
- Acronym / sponsor ID
- AD-CP-15-1
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Mesenchymal stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- EHL Bio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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, tolerance, and efficacy in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of autologous mesenchymal stem cells. The study is composed of two steps. Step 1 is to determine clinically proper dose capacity of the ADSTEM Inj. and step 2 is to evaluate exploratory efficacy of the ADSTEM Inj. at the proper dose.
Detailed description
Atopic dermatitis (AD) is a type of inflammation of the skin. It results in itchy, swollen, red, and cracked skin. The symptoms typically start in childhood with changing severity over the years. The pathogenesis of AD is characterized by excessive type 2 helper T cell mediated inflammatory responses, resulting in B lymphocyte mediated increase in serum level of immunoglobulin E (IgE). Subsequent degranulation of mast cells by IgE releases various inflammatory mediators, which recruit the lymphocytes and eosinophils into the lesion.
Current clinical management of AD includes topical corticosteroids and systemic immunosuppressants. However, these drugs have been reported to carry the risk of side-effects and severe.
Several recent studies including ours have demonstrated that mesenchymal stem cells (MSCs) could suppress allergic responses in AD. MSCs have been known to interact with cell types of both innate and adaptive immune systems, which results in the suppressive effect on proliferation, differentiation, and activation of immune cells including T cells, B cells, dendritic cells, and natural killer cells. Indeed, a number of studies have reported that the immunomodulatory ability of MSCs can be usefully applied for the treatment of autoimmune and inflammation-related diseases such as asthma, rhinitis, and dermatitis. Therefore, MSCs has possibility as a new drug for AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention: Biological: ADSTEM Inj. | Experimental | Drug: ADSTEM Inj. (Adult human mesenchymal stem cells)1. ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study. 2. ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once for the duration of the study. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Of either gender, aged ≥19 and ≤70 years
- Atopic dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
- Subacute and chronic atopic subjects who have atopic dermatitis symptoms continually at least 6 months
- Subjects with over moderate atopic dermatitis (SCORAD score > 20)
- Subjects who understand and voluntarily sign an informed consent form
Key exclusion criteria (12 listed)
- Subjects who have systemic infection
- Subjects who have human Immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)
- Subjects who need to take the medicine which is prohibited during this study
- Subjects who have asthma
- Subjects who can not stop treatment with topical steroids (group 1~5), oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the treatment visit
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. (Adult human mesenchymal stem cells)Also: ADSTEM Inj.Comparison of different dosages of the drug in the aspect of safety and efficacy. | Drug | intervention: Biological: ADSTEM Inj. |
Primary outcome
The number of subjects with treatment-related adverse events as assessed by CTCAE version 4.03
Time frame: 12 weeks follow-up after treatment
physical exam, vital sign, laboratory findings, and adverse drug reactions
11 secondary outcomes
The reduction ratio of scoring atopic dermatitis (SCORAD) index as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of SCORAD index as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of each index score of SCORAD index as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of the degrees of disease as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of investigator's global assessment (IGA) as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of eczema area and severity index (EASI) total score as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of total immunoglobulin E (IgE) in serum as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of total prostaglandin E2 (PGE2) in serum as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of total eosinophil cationic protein (ECP) in serum as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of total Chemokine ligand 17 (CCL17) in serum as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
The variation of total Chemokine ligand 27 (CCL27) in serum as contrasted with baseline value
Time frame: 12 weeks follow-up after treatment
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 22 Dec 2017.
- Individual participant dataSharing planned: No
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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?
A Phase 1 study testing ADSTEM Inj. (Adult human mesenchymal stem cells) in people with 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 5 inclusion and 12 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 22 Dec 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The number of subjects with treatment-related adverse events as assessed by CTCAE version 4.03 (time frame: 12 weeks follow-up after treatment). 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 22 Dec 2017.