PsoriasisPhase 1NCT02918123
Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis
A Phase 1 study testing FURESTEM-CD Inj. in people with Psoriasis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to severe in plaque-type psoriasis injection for 4weeks. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- FURESTEM-CD Inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2018to Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-65 years old(both sexes)
- Have been diagnosed with plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis[PsA] may be enrolled)
- Psoriasis Area and Severity Index (PASI) score >= 12 at screening
- BSA(Body Surface Area) >= 10 percentage at screening
- Have had at least one of the following conventional systemic agent for the treatment of psoriasis,
- MTX, Cyclosporine, Photochemotherapy, TNF-alpha inhibitor or IL-12/IL-23 inhibitor
- Subject who would agree to avoid prolonged sun exposure, use of tanning booths or other ultraviolet light sources during the clinical study
- Subject who understands and voluntarily signs the informed consent form
Who cannot join
- Subject who has other types of psoriasis (eg. Erythrodermic, guttate, or pustular)
- Have a history of chronic or recurrent infectious disease
- Have received phototherapy or any systemic medications/treatments within 4 weeks of screening that could affect psoriasis or PASI evaluation
- Have used topical medications/treatments within 2 weeks of screening that could affect psoriasis or PASI evaluation
- Have used any systemic immunosuppressants within 4 weeks of screening
- Have been administered with the following biological agents that could affect plaque-type psoriasis
Show all 25Show fewer
- Etanercept - within 4 weeks of screening
- Adalimumab, alefacept, infliximab - within 2 months of screening
- Ustekinumab - within 4 weeks of screening
- Other investigational biological agents - within 4 weeks of screening/five half-lives(whichever was longer)
- 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)
- Have been administered any types of investigational drugs within the previous 4 weeks or five half-lives of the investigational agent, whichever is longer
- Subject who already took or need to take medicine which is prohibited during the clinical study
- Subject who has sever dyshepatia (Creatinine value ≥ 2X Upper limit of the normal range at screening test)
- Subject who has severe renal dysfunction (AST/ALT value ≥ 2X Upper limit of the normal range at screening test)
- Have received a live viral or bacterial vaccination within 3 months of screening
- Have had a BCG(Bacillus Calmette-Guérin) vaccination within 12 months of screening
- Have a transplanted organ(with the exception of a corneal transplant > 3 months prior to screening)
- Have any known malignancy or have a history of malignancy
- Have a history of hypersensitivity, heavy metal poisoning etc. to drugs which are composed of similar components or have undergone allergy immunotherapy previously for prevention of anaphylactic reactions
- Have had a serious infection (eg. Sepsis, pneumonia or pyelonephritis), or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Positive for Hepatitis B virus(HBV) surface antigen or anti-Hepatitis C virus antibody screening
- Known to have had a substance abuse(drug or alcohol) problem within 12 months of screening
- Subject who experienced stem cell therapy
- Any other conditions which the PI suspect the patient to be unsuitable for the clinical
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic Univ. Korea Seoul, St. Marry's Hospital
Seoul, 06591
Tae-yoon Kim
About this study
Official title: Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis.
Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to severe in plaque-type psoriasis injection for 4weeks.
Read the detailed description
This is a phase 1, single center, randomized, open label, study of safety of FURESTEM-CD Inj. in subjects with moderate to severe plaque psoriasis.
Approximately 9~18 subjects will be administrated FURESTEM-CD Inj.
FURESTEM-CD Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability and capable of differentiating into a wide range of cell types. Therefore, FURSTEM-CD Inj. has huge possibility as cell therapy products for plaque-type Psoriasis patients.
- Conditions
- Psoriasis
- Being tested
- FURESTEM-CD Inj.
- Keywords
- Psoriasis, Plaque psoriasis, Stem cell, Cell therapy, Furestem, Mesenchymal stem cell, MSC, Umbilical cord blood, hUCB-MSC, UCB-MSC
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURESTEM-CD Inj.Biological
Also called hUCB-MSCs
Patients will be treated FURESTEM-CD Inj. Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 1. FURESTEM-CD Inj. 5.0x10^7 cells
2. FURESTEM-CD Inj. 1.0x10^7 cells
3. FURESTEM-CD Inj. 2.0x10^8 cells Receives: Biological: FURESTEM-CD Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of adverse events
Measured: 4 weeks follow-up after treatment
safety lab tests, physical examination, ECG, vital signs
Measured: 4 weeks follow-up after treatment
variation of Cytokine, PASI, BSA
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 posted28 Sep 2016 (estimated)
- Study start17 Jan 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taeyoon Kim, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918123
- Sponsor's protocol ID
- KSB-PsO
- Status last verified
- Mar 2018
- First submitted
- 27 Sep 2016
- Last updated
- 14 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis.
- ClinicalTrials.gov ID
- NCT02918123
- Acronym / sponsor ID
- KSB-PsO
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Plaque psoriasis, Stem cell, Cell therapy, Furestem, Mesenchymal stem cell, MSC, Umbilical cord blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 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.
Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to severe in plaque-type psoriasis injection for 4weeks.
Detailed description
This is a phase 1, single center, randomized, open label, study of safety of FURESTEM-CD Inj. in subjects with moderate to severe plaque psoriasis.
Approximately 9~18 subjects will be administrated FURESTEM-CD Inj.
FURESTEM-CD Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability and capable of differentiating into a wide range of cell types. Therefore, FURSTEM-CD Inj. has huge possibility as cell therapy products for plaque-type Psoriasis patients.
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-CD Inj.1. FURESTEM-CD Inj. 5.0x10^7 cells 2. FURESTEM-CD Inj. 1.0x10^7 cells 3. FURESTEM-CD Inj. 2.0x10^8 cells |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 19-65 years old(both sexes)
- Have been diagnosed with plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis[PsA] may be enrolled)
- Psoriasis Area and Severity Index (PASI) score >= 12 at screening
- BSA(Body Surface Area) >= 10 percentage at screening
- Have had at least one of the following conventional systemic agent for the treatment of psoriasis,
Key exclusion criteria (25 listed)
- Subject who has other types of psoriasis (eg. Erythrodermic, guttate, or pustular)
- Have a history of chronic or recurrent infectious disease
- Have received phototherapy or any systemic medications/treatments within 4 weeks of screening that could affect psoriasis or PASI evaluation
- Have used topical medications/treatments within 2 weeks of screening that could affect psoriasis or PASI evaluation
- Have used any systemic immunosuppressants within 4 weeks of screening
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-CD Inj.Also: hUCB-MSCsPatients will be treated FURESTEM-CD Inj. Subcutaneous injection | Biological | Treatment |
Primary outcome
number of adverse events
Time frame: 4 weeks follow-up after treatment
safety lab tests, physical examination, ECG, vital signs
Time frame: 4 weeks follow-up after treatment
variation of Cytokine, PASI, BSA
Time frame: 4 weeks follow-up after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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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
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?
A Phase 1 study testing FURESTEM-CD Inj. in people with Psoriasis, 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 8 inclusion and 25 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 14 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunji Kang (82-2-2036-7533, ejkang@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of adverse events (time frame: 4 weeks follow-up after treatment). The study lists 3 primary outcomes in all. 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 14 Mar 2018.