Back to resultsTreatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells
Primary Purpose
Mesenchymal Stem Cells, Chronic Kidney Diseases, Renal Interstitial Fibrosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Treatment group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Mesenchymal Stem Cells focused on measuring Adipose Tissue-derived Mesenchymal Stem Cells, Chronic Kidney Diseases
Eligibility Criteria
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).
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure.
Treatment of chronic renal failure patients with conventional methods.
Outcomes
Primary Outcome Measures
serum creatinine
intravenous blood sampling
Secondary Outcome Measures
glomerular filtration rate
emission computed tomography
apparent relaxation rate
blood oxygen level dependent magnetic resonance imaging
Full Information
NCT ID
NCT03321942
First Posted
October 19, 2017
Last Updated
October 23, 2017
Sponsor
The Affiliated Hospital of Xuzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03321942
Brief Title
Treatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells
Official Title
The Biological Characteristics of Adipose Tissue-derived Mesenchymal Stem Cells and Its Role in the Treatment of Chronic Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its treatment effects on chronic renal failure.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenchymal Stem Cells, Chronic Kidney Diseases, Renal Interstitial Fibrosis
Keywords
Adipose Tissue-derived Mesenchymal Stem Cells, Chronic Kidney Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Treatment of chronic renal failure patients with conventional methods.
Intervention Type
Drug
Intervention Name(s)
Treatment group
Other Intervention Name(s)
Stem cells treatment group
Intervention Description
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.
Intervention Type
Drug
Intervention Name(s)
Control group
Other Intervention Name(s)
Conventional treatment group
Intervention Description
Conventional treatment were used to treat patients with chronic renal failure.
Primary Outcome Measure Information:
Title
serum creatinine
Description
intravenous blood sampling
Time Frame
after 3 months of adipose tissue-derived mesenchymal stem cells treatment
Secondary Outcome Measure Information:
Title
glomerular filtration rate
Description
emission computed tomography
Time Frame
after 3 months of adipose tissue-derived mesenchymal stem cells treatment
Title
apparent relaxation rate
Description
blood oxygen level dependent magnetic resonance imaging
Time Frame
after 3 months of adipose tissue-derived mesenchymal stem cells treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Sun, MD
Phone
15862158578
Email
sundong126@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Sun, MD
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Sun, MD
Phone
15862158578
Email
sundong126@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26207883
Citation
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.
Results Reference
background
PubMed Identifier
25374814
Citation
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.
Results Reference
background
PubMed Identifier
24070090
Citation
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.
Results Reference
background
PubMed Identifier
25337776
Citation
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.
Results Reference
background
PubMed Identifier
24947415
Citation
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.
Results Reference
background
PubMed Identifier
22504485
Citation
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.
Results Reference
background
PubMed Identifier
25420012
Citation
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.
Results Reference
background
PubMed Identifier
22963874
Citation
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.
Results Reference
background
PubMed Identifier
22305061
Citation
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.
Results Reference
background
PubMed Identifier
25270070
Citation
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.
Results Reference
background
PubMed Identifier
26444236
Citation
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.
Results Reference
background
PubMed Identifier
22009250
Citation
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.
Results Reference
background
PubMed Identifier
26879682
Citation
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.
Results Reference
background
PubMed Identifier
20331991
Citation
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.
Results Reference
background
PubMed Identifier
23724119
Citation
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.
Results Reference
background
PubMed Identifier
22290832
Citation
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.
Results Reference
background
PubMed Identifier
23097349
Citation
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.
Results Reference
background
PubMed Identifier
22695328
Citation
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.
Results Reference
background
PubMed Identifier
20856128
Citation
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.
Results Reference
background
PubMed Identifier
22183077
Citation
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.
Results Reference
background
PubMed Identifier
23788716
Citation
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.
Results Reference
background
PubMed Identifier
24581595
Citation
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.
Results Reference
background
PubMed Identifier
21757771
Citation
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.
Results Reference
background
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Treatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells
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