Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis
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ClinicalTrials.gov Identifier: NCT02918123 |
Recruitment Status : Unknown
Verified March 2018 by Kang Stem Biotech Co., Ltd..
Recruitment status was: Recruiting
First Posted : September 28, 2016
Last Update Posted : March 14, 2018
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Condition or disease | Intervention/treatment | Phase |
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Psoriasis | Biological: FURESTEM-CD Inj. | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis. |
Actual Study Start Date : | January 17, 2018 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment
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Biological: FURESTEM-CD Inj.
Patients will be treated FURESTEM-CD Inj. Subcutaneous injection
Other Name: hUCB-MSCs |
- 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 ]
- number of adverse events, safety lab tests, physical examination, vital signs [ Time Frame: 144 weeks follow-up after treatment (Extension study) ]

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Ages Eligible for Study: | 19 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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
Exclusion Criteria:
- 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
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Have been administered with the following biological agents that could affect plaque-type psoriasis
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918123
Contact: Eunji Kang | 82-2-2036-7533 | ejkang@kangstem.com |
Korea, Republic of | |
The Catholic Univ. Korea Seoul, St. Marry's Hospital | Recruiting |
Seoul, Korea, Republic of, 06591 | |
Contact: Tae-yoon Kim |
Principal Investigator: | Taeyoon Kim | Seoul St. Mary's Hospital |
Responsible Party: | Kang Stem Biotech Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02918123 |
Other Study ID Numbers: |
KSB-PsO |
First Posted: | September 28, 2016 Key Record Dates |
Last Update Posted: | March 14, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Psoriasis Plaque psoriasis Stem cell Cell therapy Furestem |
Mesenchymal stem cell MSC Umbilical cord blood hUCB-MSC UCB-MSC |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |