NCT04869761已完成1 期
Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study
LaTonya J. Hickson2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse events and/or serious adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years.
- •Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m^2
- •Spot urine albumin:creatinine ≥30 mg/g unless on Renin-angiotensin-aldosterone system (RAAS) inhibition.
- •Ability to give informed consent.
排除标准
- •Hemoglobin A1c greater than or equal to 11%.(in individuals with diabetes mellitus)
- •Anemia (hemoglobin less than 9g/dL)
- •Body weight greater than 150 kg or BMI greater than 50
- •Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control)
- •Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
- •Glomerulonephritis not in partial or complete remission for 6 months (or estimated/measured proteinuria greater than 10 grams/day)
- •Active glomerulonephritis (glomerular disease) include: ANCA associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
- •Nephrotic syndrome defined as proteinuria greater than 3.5g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5g/L) and edema
- •Autosomal dominant or recessive polycystic kidney disease
- •Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
- •Active immunosuppression therapy (including prednisone greater than or equal to 10mg daily)
- •Kidney transplantation history
- •Solid organ transplantation history
- •Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias
- •Liver cirrhosis
- •Chronic obstructive pulmonary disease, asthma
- •History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
- •Pregnancy
- •Active malignancy
- •Active infection
- •Active hepatitis B or C, or HIV infection
- •History of allergic reaction to cellular products (ie. blood transfusions, platelets)
- •Active tobacco use
- •Illicit drug use and excessive alcohol use presence of psychosocial issues (e.g., uncontrolled mental illness, unpredictable childcare or eldercare responsibilities, irregular/inflexible work schedule) that may interfere with the ability to complete all study procedures
- •Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits
- •Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies
- •Inability to give informed consent
研究组 & 干预措施
Dose Arm 1
Experimental
Subjects with chronic kidney disease will receive allogeneic adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10^6 cells at day 0 and month 3.
干预措施: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions (Drug)
Dose Arm 2
Experimental
Subjects with chronic kidney disease will receive a single intravenous infusion of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) of 150x10^6 cells at day 0.
干预措施: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion (Drug)
结局指标
主要结局
Adverse events and/or serious adverse events
时间窗: 22 months
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
次要结局
未报告次要终点
研究者
LaTonya J. Hickson
Principal Investigator
Mayo Clinic
研究点 (2)
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