NCT00733876已完成1 期
Phase I Clinical Trial, Dose-escalating Intra-aortic Infusion of Allogeneic , Bone Marrow-derived Multipotent Stromal Cells to Prevent and Treat Post-operative Acute Kidney Injury in Patients Who Require On-pump Cardiac Surgery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Absence of MSC-specific Adverse or Serious Adverse Events
研究概览
简要总结
The purpose of this trial is to determine if the administration of allogeneic MSCs at defined doses is safe in patients who are at high risk of developing significant Acute Kidney Injury (AKI) after undergoing on-pump cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented ischemic coronary heart and/or valvular heart disease:Acceptable candidate for elective CABG and/or Cardiac Valve Surgery
- •Patients at high risk for post-op AKI:Age 18 or older if at high risk for post-op AKI because of underlying Diabetes mellitus (type I or II), CHF, COPD Chronic Kidney Disease (CKD) stage 1-4
- •Patients at high risk for post-op AKI :age > 65 or combinations
- •Patent femoral artery without aortic aneurysm
- •Ability to give informed consent.
排除标准
- •Presence of ongoing local or systemic infection
- •Younger than 18
- •Participation in another clinical trial
- •Pregnancy
- •Contraindication to general anesthesia
- •Dialysis patient (CKD-6) or patient with CKD-5
- •History of malignancy except non-melanoma skin cancer
- •Occluded Groin arteries
- •Uncontrolled Diabetes mellitus (HbA1c > 10, history of diabetic ketoacidosis or osmolar coma within the last three months)
- •Non-healing foot ulcers.
- •Clinical evidence of severe peripheral vascular disease (ABI < 0.3)
- •Coronary Angiogram < 7 days before surgery
- •Inadequate pre-operative time to obtain baseline kidney function data due to urgent/emergent surgery
- •Unstable myocardium (evolving myocardial infarction), cardiogenic shock
结局指标
主要结局
Absence of MSC-specific Adverse or Serious Adverse Events
时间窗: In hospital, monthly x 6, yearly x 3
次要结局
未报告次要终点
研究者
研究点 (4)
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