EUCTR2016-004804-77-IT进行中（未招募）1 期
A prospective study to assess safety and efficacy of the use of bone-marrow derived MESenchymal stromal cells as immunomodulatory therapy for children and young adults with severe and difficult-to-treat frequentlyrelapsing or steroid-dependent idiopathic NEPHrotic syndrome: the MESNEPH study - MESNEPH STUDY
BAMBINO GESU' CHILDREN'S HOSPITA0 个研究点目标入组 20 人开始时间: 2018年9月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males and females aged 5 to 40 years.
- •Steroid-dependent or multirelapsing INS patients with 2 or more relapses in the previous year in spite of prednisone and/or one or more other immunosuppressive steroid-sparing agent. Only patients reported to invariably relapse upon treatment tapering or withdrawal who are on stable (from at least 1 month) complete (<0.3 g/24h for adults or <4 mg/h/m2 for children) or partial (<3.5 g/24h for adults or <40 mg/h/m2 for children) remission of the INS will be included. Rituximab treatment can have been previously performed but reconstitution of B cells, defined as total CD19/CD20 lymphocyte count above 5% of total lymphocytes by cytofluorimetry, must have occurred and must be recorded.
- •Histological diagnosis of MCD, FSGS, mesangial proliferative glomerulonephritis.
- •Written informed consent (or consent from parents or tutors for underage patients, as appropriate).
- •If applicable, female participants must have pregnancy test by beta-HCG dosing and be negative.
- •Patients of child-bearing or child-fathering potential must be willing to practice and must contact their physician to agree with him/her on the most appropriate approach for birth control from the time of enrollment in this study and for 3 months after receiving the latest MSC infusion.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Advanced renal failure (creatinine clearance less than 20 ml/min/1.73m2), calculated using the Schwartz formula or the Cockroft-Gault formula, as appropriate;
- •Refractory or persistent NS;
- •Genetic mutations associated with intrinsic abnormalities of the glomerular barrier;
- •Pregnancy or lactating;
- •Women of childbearing potential without following a scientifically accepted form of contraception;
- •Infectious pathogen testing positive for active infection;
- •Legal incapacity;
- •Evidence of an uncooperative attitude;
- •Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia.
- •Any evidence that patient will not be able to complete the trial follow-up.
研究者
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