KCT0007072进行中（未招募）未知
Clinical assessment on the safety and potential efficacy of mesenchymal stem cells preconditioned with ethionamide (ET-STEM) in patients with Frontotemporal dementia (FTD)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) Korean male or female at 40-85 years of age
- •2) Diagnosis of one of the 3 subtyes of FTD according to the diagnostic criteria for 3 subtypes of FTD ? Probable bvFTD (behavior variant FTD)
- •? svPPA (semantic variant primary progressive aphasia)
- •? nfvPPA (nonfluent/agrammatic variant primary progressive aphasia)
- •3) K-MMSE = 10
- •4) Subjects with trusted caregivers who regularly contact the subjects and can accompany the subjects when visiting the hospital.
- •5) Negative result of amyloid PET imaging
- •6) A subject who is informed of the clinical trial and signs a consent form (If unable to sign, a consent from a legally acceptable representative is required)
排除标准
- •1) Subjects with dementia cause by other than FTD (i.e. infection of central nervous system, Creutzfeld-Jacob disease, severer head trauma, Huntington's disease, Parkinson's disease, Alzheimer's disease and vascular dementia)
- •2) Subjects with psychological disorder. (i.e. depression, schizophremia, bipolar disorder, etc) (except for subjects who were misdiagnosed with psychological disease due to the initial neuropsychiatric symptoms of FTD)
- •3) Subjects with uncontrolled hypotension, hypertension, diabetes and thyroid disease.
- •4) Subjects with a cancer (including brain tumor)
- •5) Subjects with bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of <150,000/mm3, PT = 1.5 INR, or aPTT = 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti platelet therapy
- •6) Woman of childbearing age who refused to practice medically acceptable contraceptive method (post menopausal patient with no menstruation for at least 12 months is considered as infertile)
- •7) Pregnant or lactating females
- •8) History of stroke within 3 months prior to study enrollment
- •9) Substance/alcohol abuse
- •10) Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
- •11) A subject in whom Ommaya reservoir insertion and general anesthesia are considered difficult
- •12) Abnormal Laboratory findings at Screening
- •? Hemoglobin > 9.5g/dL for male and < 9.0g/dL for female
- •? Total WBC Count < 3000/mm3
- •? Total Bilirubin = 3mg/dL
- •? AST/ALT = 100 IU/L
- •13) Suspected active lung disease based on chest X-ray at Screening
- •14) Positive hepatitis B nuclear antibody and hpatitis C antibody
- •15) Subjects who the principal investigator considers inappropriate for participation in the study due to the possible harmful effect on the subjects, difficulty in study completion, or previous or current medical conditions that may disturb evlauation of study results
- •16) Subjects who the principal investigator considers impossible to comply with clinical research procedures.
研究者
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