Treatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells
2017年10月23日 更新者：The Affiliated Hospital of Xuzhou Medical University
The Biological Characteristics of Adipose Tissue-derived Mesenchymal Stem Cells and Its Role in the Treatment of Chronic Renal Failure
To investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its treatment effects on chronic renal failure.
研究概览
详细说明
This study aims to investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its effect on oxidative stress, inflammation and mitochondrial damage.We intend to use blood oxygen level-dependent magnetic resonance imaging(BOLD-MRI), emission computed tomography(ECT) and enhanced magnetic resonance imaging to monitor renal oxygenation, tissue perfusion and renal function.Ultimately, we evaluate the treatment effects of AMSCs on chronic renal failure through these observations mentioned above.We hope to delay the progression of renal function in patients with chronic renal failure, and save huge social cost for dialysis by these research.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
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
-
-
Jiangsu
-
Xuzhou、Jiangsu、中国、221000
- 招聘中
- The Affiliated Hospital of Xuzhou Medical University
-
接触：
- Dong Sun, MD
- 电话号码：15862158578
- 邮箱：sundong126@yahoo.com
-
-
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 75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:
- Enroll the chronic renal failure patients without dialysis in the department of nephrology of Affiliated Hospital of Xuzhou Medical University from January 2017 to December 2018.
- The patients enrolled were not treated with drugs that affect the renal blood flow and oxygen consumption, such as ACEI, ARB, calcium channel blockers, diuretics, vasodilators and other related factors within 2 weeks.
Exclusion Criteria:
- Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis.
- Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).
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 |
|---|---|
|
有源比较器：Treatment group
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure.
|
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.
其他名称：
|
|
安慰剂比较：Control group
Treatment of chronic renal failure patients with conventional methods.
|
Conventional treatment were used to treat patients with chronic renal failure.
其他名称：
|
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 |
|---|---|---|
|
serum creatinine
大体时间：after 3 months of adipose tissue-derived mesenchymal stem cells treatment
|
intravenous blood sampling
|
after 3 months of adipose tissue-derived mesenchymal stem cells treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
glomerular filtration rate
大体时间：after 3 months of adipose tissue-derived mesenchymal stem cells treatment
|
emission computed tomography
|
after 3 months of adipose tissue-derived mesenchymal stem cells treatment
|
|
apparent relaxation rate
大体时间：after 3 months of adipose tissue-derived mesenchymal stem cells treatment
|
blood oxygen level dependent magnetic resonance imaging
|
after 3 months of adipose tissue-derived mesenchymal stem cells treatment
|
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
- 研究主任：Dong Sun, MD、The Affiliated Hospital of Xuzhou Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Tayebati SK, Tomassoni D, Di Cesare Mannelli L, Amenta F. Effect of treatment with the antioxidant alpha-lipoic (thioctic) acid on heart and kidney microvasculature in spontaneously hypertensive rats. Clin Exp Hypertens. 2016;38(1):30-8. doi: 10.3109/10641963.2015.1047950. Epub 2015 Jul 24.
- Prasad GV. Metabolic syndrome and chronic kidney disease: Current status and future directions. World J Nephrol. 2014 Nov 6;3(4):210-9. doi: 10.5527/wjn.v3.i4.210.
- Maugeri N, Rovere-Querini P, Baldini M, Baldissera E, Sabbadini MG, Bianchi ME, Manfredi AA. Oxidative stress elicits platelet/leukocyte inflammatory interactions via HMGB1: a candidate for microvessel injury in sytemic sclerosis. Antioxid Redox Signal. 2014 Mar 1;20(7):1060-74. doi: 10.1089/ars.2013.5298. Epub 2014 Jan 17.
- Sun D, Eirin A, Zhu XY, Zhang X, Crane JA, Woollard JR, Lerman A, Lerman LO. Experimental coronary artery stenosis accelerates kidney damage in renovascular hypertensive swine. Kidney Int. 2015 Apr;87(4):719-27. doi: 10.1038/ki.2014.343. Epub 2014 Oct 22.
- Eirin A, Ebrahimi B, Zhang X, Zhu XY, Woollard JR, He Q, Textor SC, Lerman A, Lerman LO. Mitochondrial protection restores renal function in swine atherosclerotic renovascular disease. Cardiovasc Res. 2014 Sep 1;103(4):461-72. doi: 10.1093/cvr/cvu157. Epub 2014 Jun 19.
- Islam MN, Das SR, Emin MT, Wei M, Sun L, Westphalen K, Rowlands DJ, Quadri SK, Bhattacharya S, Bhattacharya J. Mitochondrial transfer from bone-marrow-derived stromal cells to pulmonary alveoli protects against acute lung injury. Nat Med. 2012 Apr 15;18(5):759-65. doi: 10.1038/nm.2736.
- Eirin A, Zhu XY, Ebrahimi B, Krier JD, Riester SM, van Wijnen AJ, Lerman A, Lerman LO. Intrarenal Delivery of Mesenchymal Stem Cells and Endothelial Progenitor Cells Attenuates Hypertensive Cardiomyopathy in Experimental Renovascular Hypertension. Cell Transplant. 2015;24(10):2041-53. doi: 10.3727/096368914X685582. Epub 2014 Nov 21.
- Katsuno T, Ozaki T, Saka Y, Furuhashi K, Kim H, Yasuda K, Yamamoto T, Sato W, Tsuboi N, Mizuno M, Ito Y, Imai E, Matsuo S, Maruyama S. Low serum cultured adipose tissue-derived stromal cells ameliorate acute kidney injury in rats. Cell Transplant. 2013;22(2):287-97. doi: 10.3727/096368912X655019. Epub 2012 Sep 7.
- Donizetti-Oliveira C, Semedo P, Burgos-Silva M, Cenedeze MA, Malheiros DM, Reis MA, Pacheco-Silva A, Camara NO. Adipose tissue-derived stem cell treatment prevents renal disease progression. Cell Transplant. 2012;21(8):1727-41. doi: 10.3727/096368911X623925. Epub 2012 Feb 2.
- Zhu XY, Ebrahimi B, Eirin A, Woollard JR, Tang H, Jordan KL, Ofori M, Saad A, Herrmann SM, Dietz AB, Textor SC, Lerman A, Lerman LO. Renal Vein Levels of MicroRNA-26a Are Lower in the Poststenotic Kidney. J Am Soc Nephrol. 2015 Jun;26(6):1378-88. doi: 10.1681/ASN.2014030248. Epub 2014 Sep 30.
- Takasato M, Er PX, Chiu HS, Maier B, Baillie GJ, Ferguson C, Parton RG, Wolvetang EJ, Roost MS, Chuva de Sousa Lopes SM, Little MH. Kidney organoids from human iPS cells contain multiple lineages and model human nephrogenesis. Nature. 2015 Oct 22;526(7574):564-8. doi: 10.1038/nature15695. Epub 2015 Oct 7. Erratum In: Nature. 2016 Aug 11;536(7615):238.
- Liu Y. Cellular and molecular mechanisms of renal fibrosis. Nat Rev Nephrol. 2011 Oct 18;7(12):684-96. doi: 10.1038/nrneph.2011.149.
- Sun D, Eirin A, Ebrahimi B, Textor SC, Lerman A, Lerman LO. Early atherosclerosis aggravates renal microvascular loss and fibrosis in swine renal artery stenosis. J Am Soc Hypertens. 2016 Apr;10(4):325-35. doi: 10.1016/j.jash.2016.01.019. Epub 2016 Jan 28.
- Ma YY, Sun D, Li J, Yin ZC. Transplantation of endothelial progenitor cells alleviates renal interstitial fibrosis in a mouse model of unilateral ureteral obstruction. Life Sci. 2010 May 22;86(21-22):798-807. doi: 10.1016/j.lfs.2010.03.013. Epub 2010 Mar 20.
- Sun D, Bu L, Liu C, Yin Z, Zhou X, Li X, Xiao A. Therapeutic effects of human amniotic fluid-derived stem cells on renal interstitial fibrosis in a murine model of unilateral ureteral obstruction. PLoS One. 2013 May 28;8(5):e65042. doi: 10.1371/journal.pone.0065042. Print 2013.
- Eirin A, Zhu XY, Krier JD, Tang H, Jordan KL, Grande JP, Lerman A, Textor SC, Lerman LO. Adipose tissue-derived mesenchymal stem cells improve revascularization outcomes to restore renal function in swine atherosclerotic renal artery stenosis. Stem Cells. 2012 May;30(5):1030-41. doi: 10.1002/stem.1047.
- Zhu XY, Urbieta-Caceres V, Krier JD, Textor SC, Lerman A, Lerman LO. Mesenchymal stem cells and endothelial progenitor cells decrease renal injury in experimental swine renal artery stenosis through different mechanisms. Stem Cells. 2013 Jan;31(1):117-25. doi: 10.1002/stem.1263.
- Roemeling-van Rhijn M, Reinders ME, de Klein A, Douben H, Korevaar SS, Mensah FK, Dor FJ, IJzermans JN, Betjes MG, Baan CC, Weimar W, Hoogduijn MJ. Mesenchymal stem cells derived from adipose tissue are not affected by renal disease. Kidney Int. 2012 Oct;82(7):748-58. doi: 10.1038/ki.2012.187. Epub 2012 Jun 13.
- Warner L, Glockner JF, Woollard J, Textor SC, Romero JC, Lerman LO. Determinations of renal cortical and medullary oxygenation using blood oxygen level-dependent magnetic resonance imaging and selective diuretics. Invest Radiol. 2011 Jan;46(1):41-7. doi: 10.1097/RLI.0b013e3181f0213f.
- Ebrahimi B, Gloviczki M, Woollard JR, Crane JA, Textor SC, Lerman LO. Compartmental analysis of renal BOLD MRI data: introduction and validation. Invest Radiol. 2012 Mar;47(3):175-82. doi: 10.1097/RLI.0b013e318234e75b.
- Saad A, Crane J, Glockner JF, Herrmann SM, Friedman H, Ebrahimi B, Lerman LO, Textor SC. Human renovascular disease: estimating fractional tissue hypoxia to analyze blood oxygen level-dependent MR. Radiology. 2013 Sep;268(3):770-8. doi: 10.1148/radiol.13122234. Epub 2013 Jun 20.
- Li Q, Li J, Zhang L, Chen Y, Zhang M, Yan F. Diffusion-weighted imaging in assessing renal pathology of chronic kidney disease: A preliminary clinical study. Eur J Radiol. 2014 May;83(5):756-62. doi: 10.1016/j.ejrad.2014.01.024. Epub 2014 Feb 7.
- Inoue T, Kozawa E, Okada H, Inukai K, Watanabe S, Kikuta T, Watanabe Y, Takenaka T, Katayama S, Tanaka J, Suzuki H. Noninvasive evaluation of kidney hypoxia and fibrosis using magnetic resonance imaging. J Am Soc Nephrol. 2011 Aug;22(8):1429-34. doi: 10.1681/ASN.2010111143. Epub 2011 Jul 14.
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)
2017年1月1日
初级完成 (预期的)
2018年12月31日
研究完成 (预期的)
2018年12月31日
研究注册日期
首次提交
2017年10月19日
首先提交符合 QC 标准的
2017年10月23日
首次发布 (实际的)
2017年10月26日
研究记录更新
最后更新发布 (实际的)
2017年10月26日
上次提交的符合 QC 标准的更新
2017年10月23日
最后验证
2017年10月1日
更多信息
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.