Intra-arterially Delivered Autologous Mesenchymal Stem/Stromal Cell Therapy in Patients With Diabetic Kidney Disease: A Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The Researchers will assess the safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose (fat) tissue-derived mesenchymal stem/stromal cells (MSC) in patients with progressive diabetic kidney disease (DKD).
详细描述
This is a single center, open-label dose-escalating study assessing safety, tolerability, dosing effect, and early signals of efficacy of intra-arterially delivered autologous (from self) adipose tissue-derived mesenchymal stem/stromal cells (MSC) in 30 patients with progressive diabetic kidney disease (DKD). DKD will be defined as chronic kidney disease (CKD; estimated glomerular filtration rate; eGFR<60 mL/min/1.73m2) in the setting of diabetes mellitus (type 2; on anti-diabetes therapy) without overt etiologies of CKD beyond concomitant hypertension. Progressive DKD will be considered as eGFR 25-55 ml/min/1.73m2 with a) eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated Tangri 4-variable (age, sex, eGFR, urinary albumin-creatinine ratio) kidney failure risk equation. Fifteen subjects will be placed in one of two cell dosage arms in a parallel design with single-kidney MSC administration at Day 0 and Month 3. Subjects will be followed a total of 15 months from time of initial cell administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus (on anti-diabetes drug therapy)
- •Age 45-75 years
- •eGFR 25-55 ml/min/1.73m2 at time of consent with: a) eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated Tangri 4-variable (age, sex, eGFR, urinary albumin-creatinine ratio) kidney failure risk equation https://kidneyfailurerisk.com/
- •Primary cause of kidney disease is diabetes without suspicion of concomitant kidney disease beyond hypertension
- •Spot urine albumin:creatinine ≥30 mg/g unless on RAAS inhibition
- •Ability to give informed consent
排除标准
- •Hemoglobin A1c≥11%
- •Pregnancy
- •Active malignancy
- •Active Immunosuppression therapy
- •Kidney transplantation history
- •Concomitant glomerulonephritis
- •Nephrotic syndrome
- •Solid organ transplantation history
- •Autosomal dominant or recessive polycystic kidney disease
- •Known renovascular disease
- •Kidney failure (hemodialysis, peritoneal dialysis, or kidney transplantation)
- •Active tobacco use
- •Body weight >150 kg or BMI>50
- •Uncontrolled hypertension: Systolic blood pressure (SBP) >180 mmHg despite antihypertensive therapy
- •Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure within 6 months
- •Evidence of hepatitis B or C, or HIV infection, chronic
- •Anticoagulation therapy requiring heparin bridging for procedures.
- •History of methicillin-resistant staphylococcus aureus colonization
- •Recent plastic, chemical or surgical manipulation of adipose tissue for cosmetic purposes within 6 months
- •Inability to give informed consent
- •Potentially unreliable subjects and those judged by the investigator to be unsuitable for the study
研究组 & 干预措施
Lower Dose MSC
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.
干预措施: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose (Biological)
Higher Dose MSC
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose
干预措施: Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose (Biological)
结局指标
主要结局
Adverse Events
时间窗: Baseline through Month 15
The percentage of Adverse Events associated with MSC intervention per treatment arm
次要结局
- Kidney Function(pretreatment, month 12)
研究者
LaTonya J. Hickson
Principal Investigator
Mayo Clinic