NCT02918123Unknown1 期
Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis.
Kang Stem Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年1月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- number of adverse events
研究概览
简要总结
Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to severe in plaque-type psoriasis injection for 4weeks.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-65 years old(both sexes)
- •Have been diagnosed with plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis[PsA] may be enrolled)
- •Psoriasis Area and Severity Index (PASI) score >= 12 at screening
- •BSA(Body Surface Area) >= 10 percentage at screening
- •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
- •Subject who would agree to avoid prolonged sun exposure, use of tanning booths or other ultraviolet light sources during the clinical study
- •Subject who understands and voluntarily signs the informed consent form
排除标准
- •Subject who has other types of psoriasis (eg. Erythrodermic, guttate, or pustular)
- •Have a history of chronic or recurrent infectious disease
- •Have received phototherapy or any systemic medications/treatments within 4 weeks of screening that could affect psoriasis or PASI evaluation
- •Have used topical medications/treatments within 2 weeks of screening that could affect psoriasis or PASI evaluation
- •Have used any systemic immunosuppressants within 4 weeks of screening
- •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)
- •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)
- •Have been administered any types of investigational drugs within the previous 4 weeks or five half-lives of the investigational agent, whichever is longer
- •Subject who already took or need to take medicine which is prohibited during the clinical study
- •Subject who has sever dyshepatia (Creatinine value ≥ 2X Upper limit of the normal range at screening test)
- •Subject who has severe renal dysfunction (AST/ALT value ≥ 2X Upper limit of the normal range at screening test)
- •Have received a live viral or bacterial vaccination within 3 months of screening
- •Have had a BCG(Bacillus Calmette-Guérin) vaccination within 12 months of screening
- •Have a transplanted organ(with the exception of a corneal transplant > 3 months prior to screening)
- •Have any known malignancy or have a history of malignancy
- •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
- •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
- •Positive for Hepatitis B virus(HBV) surface antigen or anti-Hepatitis C virus antibody screening
- •Known to have had a substance abuse(drug or alcohol) problem within 12 months of screening
- •Subject who experienced stem cell therapy
- •Any other conditions which the PI suspect the patient to be unsuitable for the clinical
研究组 & 干预措施
Treatment
Experimental
- FURESTEM-CD Inj. 5.0x10^7 cells
- FURESTEM-CD Inj. 1.0x10^7 cells
- FURESTEM-CD Inj. 2.0x10^8 cells
干预措施: FURESTEM-CD Inj. (Biological)
结局指标
主要结局
number of adverse events
时间窗: 4 weeks follow-up after treatment
variation of Cytokine, PASI, BSA
时间窗: 4 weeks follow-up after treatment
safety lab tests, physical examination, ECG, vital signs
时间窗: 4 weeks follow-up after treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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