NCT01843387已完成1 期
A Randomized, Controlled, Dose-Escalation Pilot Study to Assess the Safety and Efficacy of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Diabetic Nephropathy and Type 2 Diabetes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The primary objective of the study is to assess the safety and tolerability of MPC therapy
研究概览
简要总结
The study investigates the safety, tolerability and efficacy of a single intravenous infusion of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic nephropathy and type 2 diabetes.
详细描述
This study is taking place in Melbourne, Australia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are ≥ 50 and ≤ 85 years old
- •Subjects diagnosed with type 2 diabetes at least 2 years prior to Screening
- •Subjects with diabetic nephropathy and CKD stage 3b-4
- •Albumin-to-creatinine ratio (ACR) from a spot urine sample >30 and < 3000 mg/g at Screening
- •Subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) for at least 12 weeks prior to Screening.
- •HbA1c < 10.0% at Screening
排除标准
- •Prior participation in any stem cell study
- •Women of childbearing potential
- •Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
- •History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of >3 alcoholic beverages (i.e. > 21 alcoholic beverages per week)
- •Body weight >150 kg
- •Subjects with non-diabetic renal disease e.g. known polycystic kidney disease
- •Subjects with a history of a renal transplant or who have had prior dialysis within 3 months of Screening and/or have not maintained a stable level of kidney function within 3 months of Screening
- •Current or history within 6 months of Screening of NYHA Class III or IV heart failure
- •Myocardial infarction or stroke within 6 months prior to Screening
- •Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease or other disorder which in the Investigator's opinion would interfere with the subjects ability to complete the trial, would require administration of treatment that could affect the interpretation of the efficacy and safety variables or would preclude safe involvement in the study
结局指标
主要结局
The primary objective of the study is to assess the safety and tolerability of MPC therapy
时间窗: 60 Weeks
Outcomes include the following safety parameters: * Number of and percent of subject with adverse events and serious adverse events * Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms * Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)
次要结局
- Exploratory assessment of the efficacy of MPC therapy(12 Weeks)
研究者
研究点 (2)
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