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临床试验/NCT02801890
NCT02801890已完成1 期

Autologous AD-MSC Transplantation in Peritoneal Dialysis Patients With Ultra Filtration Failure and Evaluation of Cellular and Molecular Effects of Mesenchymal Stem Cell Infusion on Peritoneal Fibrosis

Royan Institute1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Systemic infection

研究概览

简要总结

Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using the potential features of MSCs in the treatment of fibrosis may offer new insights into reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion effects in clinical, cellular and molecular levels.

So in this trial, we will evaluate the effects of this intervention after intravenous injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after first injection.

详细描述

Chronic kidney disease is defined as a reduced glomerular filtration rate, increased urinary albumin excretion, or both, and is an increasing public health issue. Prevalence is estimated to be 8-16% worldwide. Stage 5 CKD is often called end-stage kidney disease and usually means that the patient requires renal replacement therapy (RRT), which may involve a kidney transplant or a form of dialysis. One of the options in RRT is continuous ambulatory peritoneal dialysis (CAPD). CAPD is characterized by a continuous removal of extracellular fluid by peritoneal membrane. It should be noted that like any other peritoneal dialysis therapy, CAPD has Short or long-term complications and UFF is the most common functional disorder in which the peritoneal ultrafiltration membrane damaged.

This project intends to evaluate, the role of autologous mesenchymal stem cells in improvement of peritoneal membrane function in peritoneal dialysis patients who have ultrafiltration failure up to 6 months.

In this study, 10 male and female subjects who are on peritoneal dialysis for at least two years and have ultrafiltration failure with age range of 18 to 70 years will be enrolled. Patients will be selected from peritoneal dialysis patients attending the peritoneal dialysis ward of Dr. Shariati hospital. The main inclusion criteria is to be on peritoneal dialysis for at least last two years and having Ultrafiltration failure. After obtaining the consent form, a sample of fat tissue will be obtained by a general surgeon under sterilized condition from patients and then in the specialized lab, the mesenchymal stem cells will be separated and cultured to reach appropriate numbers (106/kg). The cells will be injected through peripheral vein in hospital setting. Patients will be followed-up (clinically and laboratory) at baseline and at week 3, week 6, month 3, month 4 and month 6. The clinical assessment and peritoneal function tests will be performed in each visit. Outcome measures: The main outcome measures that periodically will be assessed include: D/P cr, D/P urea, D0/D glucose, PET, KT/V urea, Glomerular filtration rate (GFR)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • peritoneal dialysis for at least last two years and
  • Ultrafiltration failure
  • Both genders
  • Age 18-70 years
  • inform consent signing

排除标准

  • Inability of patients to attend visits and regular testing
  • Estimated lifetime less than one year
  • Use of immunosuppressive drugs
  • Coagulative disorders

结局指标

主要结局

Systemic infection

时间窗: 6months

Evaluation the rate of systemic infection in patients with UFF after cell therapy.

Hepatic failure

时间窗: 6 months

Evaluation the rate of hepatic failure in patients with UFF after cell therapy.

Renal failure

时间窗: 6 months

Evaluation the rate of renal failure in patients with UFF after cell therapy.

次要结局

  • peritoneal membrane transport function(6 months)
  • Ratio of dialysate glucose concentrations (D/D glucose )(6 months)
  • Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).(6 months)
  • Ratio of 4-hour dialysate/plasma urea (D/P urea )(6 months)
  • Glomerular filtration rate (GFR):(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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