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Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)

2017年4月26日 更新者:Royan Institute

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

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.

研究概览

地位

完全的

详细说明

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)

研究类型

介入性

注册 (实际的)

10

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. peritoneal dialysis for at least last two years and
  2. Ultrafiltration failure
  3. Both genders
  4. Age 18-70 years
  5. inform consent signing

Exclusion Criteria:

  1. Inability of patients to attend visits and regular testing
  2. Estimated lifetime less than one year
  3. Use of immunosuppressive drugs
  4. Pregnancy
  5. Malignancy
  6. Coagulative disorders

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:AD-MSC
The patients with ultra filtration failure (UFF) underwent AD-MSC injection.
Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
安慰剂比较:Placebo
The patients with ultra filtration failure (UFF) underwent Placebo injection.
Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Systemic infection
大体时间:6months
Evaluation the rate of systemic infection in patients with UFF after cell therapy.
6months
Hepatic failure
大体时间:6 months
Evaluation the rate of hepatic failure in patients with UFF after cell therapy.
6 months
Renal failure
大体时间:6 months
Evaluation the rate of renal failure in patients with UFF after cell therapy.
6 months

次要结果测量

结果测量
措施说明
大体时间
Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).
大体时间:6 months
Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.
6 months
Ratio of 4-hour dialysate/plasma urea (D/P urea )
大体时间:6 months
Evaluation the change of D/P in patients with UFF after cell therapy.
6 months
Ratio of dialysate glucose concentrations (D/D glucose )
大体时间:6 months
Evaluation the change of D/D glucose in patients with UFF after cell therapy.
6 months
peritoneal membrane transport function
大体时间:6 months
Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)
6 months
Glomerular filtration rate (GFR):
大体时间:6 months
Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Soroosh Shekarchian, MD、Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
  • 研究主任:Nasser Aghdami, MD,PhD、Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
  • 研究主任:Gholamreza Pourmand, MD、Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
  • 研究主任:Iraj Najafi, MD、Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
  • 首席研究员:Sudabeh Alatab, MD、Sudabeh
  • 首席研究员:Reza Moghadasali, PhD、Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年8月1日

初级完成 (实际的)

2017年2月1日

研究完成 (实际的)

2017年3月1日

研究注册日期

首次提交

2016年6月12日

首先提交符合 QC 标准的

2016年6月12日

首次发布 (估计)

2016年6月16日

研究记录更新

最后更新发布 (实际的)

2017年4月27日

上次提交的符合 QC 标准的更新

2017年4月26日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • Royan-kidney-006

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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