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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02918123
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kang Stem Biotech Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Taeyoon Kim
Principal Investigator Affiliation Seoul St. Mary's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment

FURESTEM-CD Inj. 5.0x10^7 cells FURESTEM-CD Inj. 1.0x10^7 cells FURESTEM-CD Inj. 2.0x10^8 cells

Interventions

Biological: - FURESTEM-CD Inj.

Patients will be treated FURESTEM-CD Inj. Subcutaneous injection

Contact a Trial Team

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International Sites

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic Univ. Korea Seoul, St. Marry's Hospital

Seoul, , 06591

Site Contact

Tae-yoon Kim

[email protected]

82-2-2036-7533

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