A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Efficacy and Safety
研究概览
简要总结
The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.
详细描述
Inclusion criteria:
- Male or non-pregnant females age 16 to 65 years inclusive.
- Written informed consent obtained from patient or parents/guardian.
- Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
- Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant females age 16 to 65 years inclusive.
- •Written informed consent obtained from patient or parents/guardian.
- •Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
- •Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis
排除标准
- •Patients with any of the following are not eligible for enrollment into the study:
- •Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
- •Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
- •Those persons directly involved in the conduct of the study.
- •Serum creatinine more than 250 µmol/L.
- •White blood cell (WBC) count of less than 3.5 X 109/L.
- •Active peptic ulcer disease.
- •Active systemic infection.
- •History of alcohol or substance abuse.
- •History of malignancy within previous 5 years.
- •Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
研究组 & 干预措施
Human Umbilical Cord derived MSCs
干预措施: Human Umbilical Cord derived MSCs (Biological)
Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Efficacy and Safety
时间窗: 6 months
The efficacy measure is remission of nephritis (combined partial and complete remission) at 6 months defined as * Stabilization or improvement in renal function and * Urinary RBC of less than 10 per HPF and * Reduction of proteinuria to less than 3 g/day if baseline proteinuria was more than 3 g/day and at least a 50% reduction in proteinuria, or to less than 1 g/day if the baseline proteinuria was in the subnephrotic range.
次要结局
未报告次要终点