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

Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis.

Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to severe in plaque-type psoriasis injection for 4weeks.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Biological: FURESTEM-CD Inj.

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
• Enrollment (Anticipated): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • The Catholic Univ. Korea Seoul, St. Marry's Hospital
    • Contact: Tae-yoon Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; FURESTEM-CD Inj. 5.0x10^7 cells; FURESTEM-CD Inj. 1.0x10^7 cells; FURESTEM-CD Inj. 2.0x10^8 cells	Biological: FURESTEM-CD Inj.; Patients will be treated FURESTEM-CD Inj. Subcutaneous injection; Other Names: hUCB-MSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of adverse events	4 weeks follow-up after treatment
safety lab tests, physical examination, ECG, vital signs	4 weeks follow-up after treatment
variation of Cytokine, PASI, BSA	4 weeks follow-up after treatment

Other Outcome Measures

Outcome Measure	Time Frame
number of adverse events, safety lab tests, physical examination, vital signs	144 weeks follow-up after treatment (Extension study)

Collaborators and Investigators

• Sponsor: Kang Stem Biotech Co., Ltd.
• Investigators: Principal Investigator: Taeyoon Kim, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimate): September 28, 2016

Study Record Updates

• Last Update Posted (Actual): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Psoriasis; Mesenchymal stem cell; Cell therapy; MSC; Stem cell; Plaque psoriasis; Umbilical cord blood; hUCB-MSC; UCB-MSC; Furestem
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: KSB-PsO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No