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

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ClinicalTrials.gov Identifier: NCT02918123
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date March 14, 2018
Actual Study Start Date  ICMJE January 17, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
Safety of FURESTEM-CD Inj. [ Time Frame: 4 weeks follow-up after treatment ]
Evaluate the number of adverse events, including clinically significant changes in physical examination, safety lab tests, ECG, vital signs, Cytokine, PASI, BSA
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 5, 2016)
number of adverse events, safety lab tests, physical examination, vital signs [ Time Frame: 144 weeks follow-up after treatment (Extension study) ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis
Official Title  ICMJE Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis.
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Biological: FURESTEM-CD Inj.
Patients will be treated FURESTEM-CD Inj. Subcutaneous injection
Other Name: hUCB-MSCs
Study Arms  ICMJE Experimental: Treatment
  1. FURESTEM-CD Inj. 5.0x10^7 cells
  2. FURESTEM-CD Inj. 1.0x10^7 cells
  3. FURESTEM-CD Inj. 2.0x10^8 cells
Intervention: Biological: FURESTEM-CD Inj.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 19-65 years old(both sexes)
  2. Have been diagnosed with plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis[PsA] may be enrolled)
  3. Psoriasis Area and Severity Index (PASI) score >= 12 at screening
  4. BSA(Body Surface Area) >= 10 percentage at screening
  5. 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
  6. Subject who would agree to avoid prolonged sun exposure, use of tanning booths or other ultraviolet light sources during the clinical study
  7. Subject who understands and voluntarily signs the informed consent form

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eunji Kang 82-2-2036-7533 ejkang@kangstem.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918123
Other Study ID Numbers  ICMJE KSB-PsO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kang Stem Biotech Co., Ltd.
Study Sponsor  ICMJE Kang Stem Biotech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Taeyoon Kim Seoul St. Mary's Hospital
PRS Account Kang Stem Biotech Co., Ltd.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP