NCT05362786已完成1 期
Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease
LaTonya J. Hickson2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 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 intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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/1.73m2
- •If eGFR 45-55 ml/min/1.73m2, then albumin:creatinine ratio ≥300 mg/g or proteinuria ≥300 mg/day despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
- •If eGFR 25-44 ml/min/1.73m2, must have urine albumin:creatinine ratio ≥30mg/g despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
- •Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy
- •Ability to give informed consent
排除标准
- •Anemia (hemoglobin <9 g/dL)
- •Body weight >150 kg or BMI >50
- •Uncontrolled hypertension: sustained systolic blood pressure (SBP) >150 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications
- •Chronic hypotension history: sustained SBP <85 mmHg
- •Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day),
- •Active glomerulonephritis (glomerular diseases with evidence of active urinary sediment, serology or biopsy findings) including ANCA-associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance
- •Autosomal dominant or recessive polycystic kidney disease
- •Nephrotic syndrome defined as proteinuria >3.5 g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5 g/L) and edema.
- •Proteinuria >5 g/day (with or without nephrotic syndrome).
- •Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
- •Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily)
- •Kidney transplantation history
- •Solid organ transplantation history
- •Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 6 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia)
- •History of liver cirrhosis
- •Chronic obstructive pulmonary disease or asthma requiring daily medication
- •History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
- •Unwilling to use contraception for at least 2 months after MSC infusion if sexually active and able to become pregnant or father a child.
- •Active malignancy
- •Active infection (e.g. systemic or specific organ involvement such as pneumonia or osteomyelitis)
- •Recent COVID-19 infection within the last 3 months
- •History of hepatitis B or C (without cure), 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 to give informed consent
研究组 & 干预措施
Dose Arm 1
Experimental
Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in two intravenous infusions of 100x10^6 cells at time zero and three months
干预措施: Allogeneic adipose-derived mesenchymal stem cells (MSC) (Drug)
Dose Arm 2
Experimental
Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) single intravenous infusion of 200x10^6 cells
干预措施: Allogeneic adipose-derived mesenchymal stem cells (MSC) (Drug)
结局指标
主要结局
Adverse events and/or serious adverse events
时间窗: 15 months
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
Change in eGFR Value
时间窗: 6 months
Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min)
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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