Atopic DermatitisNCT03458624
Long-term Observational Study to Evalution the Safety and Efficacy of FURESTEM-AD Inj.
An observational study of Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2016to 31 Dec 2018
- 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: Subjects participating in this observational study originally participated in study FURESTEM-AD Inj. [NCT01927705]
Who may be able to join
- Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
- Subject who understands and voluntarily sign an informed consent form
Who cannot join
- In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Evaluate the Safety and Efficacy of FURESTEM-AD Inj. in Moderate to Severe Atopic Dermatitis Patients Who Participated in Phase 1/2a Clinical Trial of FURESTEM-AD Lnj.
Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis
Read the detailed description
This is a observational study, single center, open label, study of safety and Efficacy of FURESTEM-AD Inj. in subjects with moderate to severe Atopic Dermatitis.
- Conditions
- Atopic Dermatitis
- Keywords
- FURESTEM-AD Inj., 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.
| Study group | Role | What they receive |
|---|---|---|
| Not applicable-observational study | Not applicable-observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the number of adverse events Safety of FURESTEM-AD Inj.
The severity of each adverse enent was classified according to CTCAE v4.0
Measured: 3 years
Secondary outcomes (5)
Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline
Measured: 3 years
Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value
Measured: 3 years
Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point
Measured: 3 years
Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value
Measured: 3 years
Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Jul 2016
- Primary completion12 Aug 2016
- Study completion31 Dec 2018 (estimated)
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
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tae-Yun Kim, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458624
- Sponsor's protocol ID
- KSTHD_FURESTEM_AD_EXT
- Status last verified
- Feb 2018
- First submitted
- 3 Apr 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Safety and Efficacy of FURESTEM-AD Inj. in Moderate to Severe Atopic Dermatitis Patients Who Participated in Phase 1/2a Clinical Trial of FURESTEM-AD Lnj.
- ClinicalTrials.gov ID
- NCT03458624
- Acronym / sponsor ID
- KSTHD_FURESTEM_AD_EXT
- Conditions
- Atopic Dermatitis
- Keywords
- FURESTEM-AD Inj., Stem cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 12 Aug 2016 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 Mar 2018 (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.
Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis
Detailed description
This is a observational study, single center, open label, study of safety and Efficacy of FURESTEM-AD Inj. in subjects with moderate to severe Atopic Dermatitis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not applicable-observational study | – | –Not applicable-observational study |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in this observational study originally participated in study FURESTEM-AD Inj. [NCT01927705]
Key inclusion criteria (2 listed)
- Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
- Subject who understands and voluntarily sign an informed consent form
Key exclusion criteria (1 listed)
- In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the number of adverse events Safety of FURESTEM-AD Inj.
Time frame: 3 years
The severity of each adverse enent was classified according to CTCAE v4.0
5 secondary outcomes
Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline
Time frame: 3 years
Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value
Time frame: 3 years
Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point
Time frame: 3 years
Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value
Time frame: 3 years
Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- 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.
Tae-Yun Kim principal investigator
Seoul St. Mary's 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 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 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: status not confirmed, as of the sponsor's last update on 8 Mar 2018. 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?
Results are not available in the source record.
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?
Evaluate the number of adverse events Safety of FURESTEM-AD Inj. (time frame: 3 years). 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 8 Mar 2018.