NCT06969807招募中2 期
Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cell (Amimestrocel ) in Patients With Diabetic Kidney Disease
Chinese PLA General Hospital9 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年6月9日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Urine protein
研究概览
简要总结
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are ≥18 and ≤ 80 years old.
- •Diagnosed with type 2 diabetes mellitus.
- •Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years.
- •The 24-hour urine protein quantification is continuously ≥ 3.5 g, or the urine albumin-to-creatinine ratio (UACR) > 1000 mg/g.
- •The estimated glomerular filtration rate (eGFR) ≥ 15 ml/min/1.73m² (calculated according to the CKD-EPI formula).
- •The blood pressure can be controlled at BP ≤ 160/100 mmHg.
- •Glycated hemoglobin (HbA1c) < 9%.
- •Willing and able to provide written informed consent.
排除标准
- •Patients with kidney diseases not caused by diabetes mellitus.
- •Patients who have received treatment with systemic immunosuppressants (such as cyclosporine A, tacrolimus, mycophenolate mofetil, etc.) within 30 days before enrollment and the duration of treatment exceeds one week.
- •Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc.
- •A history of cerebral hemorrhage or cerebral infarction within the past six months (except for those with a history of lacunar cerebral infarction without residual limb movement disorders, cognitive and language function disorders).
- •Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L).
- •Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment.
- •Patients with active infections of hepatitis B or hepatitis C viruses (the copy number of HBV DNA or HCV RNA exceeds the upper limit of the normal value); patients with active tuberculosis; patients with severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc.
- •Patients with a history of malignant tumors within the past five years.
- •Patients with a known history of severe allergy to component blood or blood products, or patients with a history of allergy to heterologous proteins.
- •Lactating women, or female patients who have a pregnancy plan or an egg donation plan from the start of the study to the follow-up period, and male patients (or their partners) who have a childbearing plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures.
- •Active infection within one week before enrollment and requiring treatment with intravenous antibiotics.
- •Patients who have participated in other interventional clinical trials within three months before enrollment.
- •The research physician deems that the patient's condition is not suitable for participating in this clinical study.
研究组 & 干预措施
Amimestrocel
Experimental
patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 14, 28, and week 8, 12, 16, 20, 24.
干预措施: Amimestrocel (Drug)
结局指标
主要结局
Urine protein
时间窗: Change from baseline at 28 weeks
Urine protein will be measured on 24h urine samples
estimated Glomerular Filtration Rate(eGFR)
时间窗: Change from baseline at 28 weeks
GFR will be estimated by CKD-EPI
Urine protein
时间窗: Change from baseline at 24 weeks
Urine protein will be measured on 24h urine samples
estimated Glomerular Filtration Rate(eGFR)
时间窗: Change from baseline at 24 weeks
GFR will be estimated by CKD-EPI
次要结局
- fasting blood glucose(Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- HbA1c(Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Urinary Albumin/Creatinine Ratio(UACR)(Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement)(proportion of study participants within outcome at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- proportion of major adverse cardiac events(MACE) and all-cause mortality(proportion of study participants within outcome at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Mechanism exploration(Change from baseline at 4,12,28 weeks and 12 months)
- changes in retinal imaging(Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Changes in peripheral nerve injury(Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Changes in symptoms(Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Changes in the quality of life scale(Change from baseline at 28 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Adverse Event and Serious Adverse Event（SAE）(within 28 weeks after received Amimestrocel)
- secondary malignant disease(within 24 months after received Amimestrocel)
- HbA1c(Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- fasting blood glucose(Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Urinary Albumin/Creatinine Ratio(UACR)(Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement)(proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- proportion of major adverse cardiac events(MACE) and all-cause mortality(proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Mechanism exploration(Change from baseline at 4,12,24 weeks and 12 months)
- changes in retinal imaging(Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Changes in peripheral nerve injury(Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Changes in symptoms(Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
- Changes in the quality of life scale(Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion)
研究者
Chen Xiangmei
Principal Investigator
Chinese PLA General Hospital
研究点 (9)
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