Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis

Exclusion Criteria

• •1. Subject who has other types of psoriasis (eg. Erythrodermic, guttate, or pustular)
• •2. Have a history of chronic or recurrent infectious disease
• •3. Have received phototherapy or any systemic medications/treatments within 4 weeks of screening that could affect psoriasis or PASI evaluation
• •4. Have used topical medications/treatments within 2 weeks of screening that could affect psoriasis or PASI evaluation
• •5. Have used any systemic immunosuppressants within 4 weeks of screening
• •6. 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)
• •7. 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)
• •8. Have been administered any types of investigational drugs within the previous 4 weeks or five half-lives of the investigational agent, whichever is longer
• •9. Subject who already took or need to take medicine which is prohibited during the clinical study
• •10. Subject who has sever dyshepatia (Creatinine value ≥ 2X Upper limit of the normal range at screening test)
• •11. Subject who has severe renal dysfunction (AST/ALT value ≥ 2X Upper limit of the normal range at screening test)
• •12. Have received a live viral or bacterial vaccination within 3 months of screening
• •13. Have had a BCG(Bacillus Calmette-Guérin) vaccination within 12 months of screening
• •14. Have a transplanted organ(with the exception of a corneal transplant \> 3 months prior to screening)
• •15. Have any known malignancy or have a history of malignancy
• •16. 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
• •17. 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
• •18. Positive for Hepatitis B virus(HBV) surface antigen or anti-Hepatitis C virus antibody screening
• •19. Known to have had a substance abuse(drug or alcohol) problem within 12 months of screening
• •20. Subject who experienced stem cell therapy
• •21. Any other conditions which the PI suspect the patient to be unsuitable for the clinical