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About
Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to severe in plaque-type psoriasis injection for 4weeks.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Have had at least one of the following conventional systemic agent for the treatment of psoriasis,
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
Have been administered with the following biological agents that could affect plaque-type psoriasis
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
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
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Central trial contact
Eunji Kang
Data sourced from clinicaltrials.gov
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