Atopic DermatitisPhase 1/2NCT01927705
Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis (AD)
A Phase 1/2 study testing FURESTEM-AD Inj. in people with Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- FURESTEM-AD Inj.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to May 2015
- Phase
- Phase 1/2
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Of either gender, aged ≥20 and ≤60 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 at the baseline visit
- Subjects who have asthma at the baseline visit
- Treatment with oral corticosteroids, oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the baseline visit
- Treatment with topical steroids, antibiotics within 2 weeks before the baseline visit
- Subjects who already took or need to take the medicine which is prohibited to take during the clinical study.
- 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 at Screening and Baseline)
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- Subjects who currently participate in other clinical trial or participated in other clinical trial within 30 days
- Creatinine value ≥ 2 Upper limit of the normal range at screening test
- AST/ALT value ≥ 2 Upper limit of the normal range at screening test
- Any other condition which the investigator judges would make patient unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis
The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj. by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately subacute and chronic Atopic Dermatitis.
Read the detailed description
Atopic dermatitis is recurring and chronic Allergic eczema which accompanies serious itching and xeroderma. Atopic dermatitis has special features such as increase of acidophil, high expression ratio of IgE in the blood. Recently, Atopic dermatitis is estimated to developing for 10 to 20 percent of the population in the world. However, there is no distinguished treatment to completely recover. Especially, most of diagnosis are made when the patients are younger than 5 years old. Moreover, 50 percent of them get diagnose Atopic dermatitis between 6 month and 24 month. According to the National epidemiological investigation conducted by the Korean Academy of Pediatric Allergy and Respiratory Disease, Outbreak ratio of Atopic dermatitis continually increase for the past decade. Accordingly, it has become a major social concern. It is really important for the patients to care and diagnose as soon as they find out symptoms of Atopic dermatitis. The reason is that 50 to 75 percent of the Atopic dermatitis patients are suffering from Allergies which cause asthma and rhinitis. Recently, It has been reported that Mesenchymal stem cells have special abilities to restrict the growth of lymphocyte non-specific and to restrict the activation of lymphocyte by the stimulus of mitogen or antigen. It is also reported that the restrict of lymphocyte by Mesenchymal stem cells does not need HLA-matching unlike the case of T-cell. It has been found that Mesenchymal stem cells' ability of autoimmune induction is weak because of low expression of antigen like HLA-DR. It is also discovered that Mesenchymal stem cells do not cause autoimmune side-effect even though we inject them in the body. When the body get infected by the pathogens, innate immune response operate as the primary defence mechanism. at this time, there are some receptors reacting first such as TLR(toll-like receptor) and NLR(nucleotide-binding oligomerization domain) which is located in the cytoplasm of a cell. It is reported that the activities of TLR which is expressed by Mesenchymal stem cells play an important roles about immunomodulatory ability of Mesenchymal stem cells. Furthermore, human Umbilical Cord Blood derived-Universal Stem Cells( hUCB-USCs) manifest TLR and NLR of Mesenchymal Stem cells at the same time. when those receptors become activation, it maximize ability of immunomodulatory. Therefore, hUCB-USCs can be utilized to cure intractable autoimmune disease like Atopic dermatitis. Further, It has huge possibility as cell therapy products for autoimmune disease.
- Conditions
- Atopic Dermatitis
- Being tested
- FURESTEM-AD Inj.
- Keywords
- Atopic dermatitis, Stem cell, Cell therapy, skin disease, furestem, AD, hUCB-MSC, UCB-MSC, Umbilical cord Blood
- Medical subject headings
- Dermatitis, Atopic, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURESTEM-AD Inj.Biological
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | FURESTEM-AD Inj. 1. 2.5 x 10^7 stem cells after registration.
FURESTEM-AD Inj. 2. 5.0 x 10^7 stem cells after registration. Receives: Biological: FURESTEM-AD Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
over 50% reduction ratio of SCORAD INDEX as contrasted with baseline value
Measured: 4 weeks follow-up after treatment
Secondary outcomes (6)
SCORAD Total Score
Measured: 4 weeks follow-up after treatment
the degrees of disease
Measured: 4 weeks follow-up after treatment
Valuation of IGA
Measured: 4 weeks follow-up after treatment
each index of SCORAD INDEX
TBSA, erythema, edema/papulation, oozing, excoriations, dryness, lichenification, pruritus, insomnia.
Measured: 4 weeks follow-up after treatment
serum Total IgE
Measured: 4 weeks follow-up after treatment
Valuation of EASI
Measured: 4 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 posted23 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionMay 2015
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taeyoon Kim, Principal investigator, Catholic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927705
- Sponsor's protocol ID
- KSB-AD
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2013
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01927705
- Acronym / sponsor ID
- KSB-AD
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Stem cell, Cell therapy, skin disease, furestem, AD, hUCB-MSC, UCB-MSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Aug 2013 (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.
The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj. by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately subacute and chronic Atopic Dermatitis.
Detailed description
Atopic dermatitis is recurring and chronic Allergic eczema which accompanies serious itching and xeroderma. Atopic dermatitis has special features such as increase of acidophil, high expression ratio of IgE in the blood. Recently, Atopic dermatitis is estimated to developing for 10 to 20 percent of the population in the world. However, there is no distinguished treatment to completely recover. Especially, most of diagnosis are made when the patients are younger than 5 years old. Moreover, 50 percent of them get diagnose Atopic dermatitis between 6 month and 24 month. According to the National epidemiological investigation conducted by the Korean Academy of Pediatric Allergy and Respiratory Disease, Outbreak ratio of Atopic dermatitis continually increase for the past decade. Accordingly, it has become a major social concern. It is really important for the patients to care and diagnose as soon as they find out symptoms of Atopic dermatitis. The reason is that 50 to 75 percent of the Atopic dermatitis patients are suffering from Allergies which cause asthma and rhinitis. Recently, It has been reported that Mesenchymal stem cells have special abilities to restrict the growth of lymphocyte non-specific and to restrict the activation of lymphocyte by the stimulus of mitogen or antigen. It is also reported that the restrict of lymphocyte by Mesenchymal stem cells does not need HLA-matching unlike the case of T-cell. It has been found that Mesenchymal stem cells' ability of autoimmune induction is weak because of low expression of antigen like HLA-DR. It is also discovered that Mesenchymal stem cells do not cause autoimmune side-effect even though we inject them in the body. When the body get infected by the pathogens, innate immune response operate as the primary defence mechanism. at this time, there are some receptors reacting first such as TLR(toll-like receptor) and NLR(nucleotide-binding oligomerization domain) which is located in the cytoplasm of a cell. It is reported that the activities of TLR which is expressed by Mesenchymal stem cells play an important roles about immunomodulatory ability of Mesenchymal stem cells. Furthermore, human Umbilical Cord Blood derived-Universal Stem Cells( hUCB-USCs) manifest TLR and NLR of Mesenchymal Stem cells at the same time. when those receptors become activation, it maximize ability of immunomodulatory. Therefore, hUCB-USCs can be utilized to cure intractable autoimmune disease like Atopic dermatitis. Further, It has huge possibility as cell therapy products for autoimmune disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: FURESTEM-AD Inj.FURESTEM-AD Inj. 1. 2.5 x 10^7 stem cells after registration. FURESTEM-AD Inj. 2. 5.0 x 10^7 stem cells after registration. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Of either gender, aged ≥20 and ≤60 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 (10 listed)
- Subjects who have systemic infection at the baseline visit
- Subjects who have asthma at the baseline visit
- Treatment with oral corticosteroids, oral antibiotics, whole body photochemotherapy, immunosuppressive drug within 4 weeks before the baseline visit
- Treatment with topical steroids, antibiotics within 2 weeks before the baseline visit
- Subjects who already took or need to take the medicine which is prohibited to take during the clinical 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 |
|---|---|---|
| FURESTEM-AD Inj. | Biological | Treatment |
Primary outcome
over 50% reduction ratio of SCORAD INDEX as contrasted with baseline value
Time frame: 4 weeks follow-up after treatment
6 secondary outcomes
SCORAD Total Score
Time frame: 4 weeks follow-up after treatment
the degrees of disease
Time frame: 4 weeks follow-up after treatment
Valuation of IGA
Time frame: 4 weeks follow-up after treatment
each index of SCORAD INDEX
Time frame: 4 weeks follow-up after treatment
serum Total IgE
Time frame: 4 weeks follow-up after treatment
Valuation of EASI
Time frame: 4 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 6 Oct 2016.
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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.
Taeyoon Kim principal investigator
Catholic Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FURESTEM-AD Inj. in people with Atopic Dermatitis, run by Kang Stem Biotech 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 10 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 6 Oct 2016. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
over 50% reduction ratio of SCORAD INDEX as contrasted with baseline value (time frame: 4 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 6 Oct 2016.