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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.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: FURESTEM-CD Inj. Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
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
Biological: FURESTEM-CD Inj.
Patients will be treated FURESTEM-CD Inj. Subcutaneous injection
Other Name: hUCB-MSCs



Primary Outcome Measures :
  1. number of adverse events [ Time Frame: 4 weeks follow-up after treatment ]
  2. safety lab tests, physical examination, ECG, vital signs [ Time Frame: 4 weeks follow-up after treatment ]
  3. variation of Cytokine, PASI, BSA [ Time Frame: 4 weeks follow-up after treatment ]

Other Outcome Measures:
  1. 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)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Eunji Kang 82-2-2036-7533 ejkang@kangstem.com

Locations
Korea, Republic of
The Catholic Univ. Korea Seoul, St. Marry's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Tae-yoon Kim         
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
Investigators
Principal Investigator: Taeyoon Kim Seoul St. Mary's Hospital

Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02918123     History of Changes
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

Keywords provided by Kang Stem Biotech Co., Ltd.:
Psoriasis
Plaque psoriasis
Stem cell
Cell therapy
Furestem
Mesenchymal stem cell
MSC
Umbilical cord blood
hUCB-MSC
UCB-MSC

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases