Treatment of Chronic Renal Failure With Adipose Tissue-derived Mesenchymal Stem Cells
23. oktober 2017 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Jiangsu
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Xuzhou, Jiangsu, Kina, 221000
- Rekruttering
- The Affiliated Hospital of Xuzhou Medical University
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Ta kontakt med:
- Dong Sun, MD
- Telefonnummer: 15862158578
- E-post: sundong126@yahoo.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Treatment group
Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure.
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Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.
Andre navn:
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Placebo komparator: Control group
Treatment of chronic renal failure patients with conventional methods.
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Conventional treatment were used to treat patients with chronic renal failure.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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serum creatinine
Tidsramme: after 3 months of adipose tissue-derived mesenchymal stem cells treatment
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intravenous blood sampling
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after 3 months of adipose tissue-derived mesenchymal stem cells treatment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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glomerular filtration rate
Tidsramme: after 3 months of adipose tissue-derived mesenchymal stem cells treatment
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emission computed tomography
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after 3 months of adipose tissue-derived mesenchymal stem cells treatment
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apparent relaxation rate
Tidsramme: after 3 months of adipose tissue-derived mesenchymal stem cells treatment
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blood oxygen level dependent magnetic resonance imaging
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after 3 months of adipose tissue-derived mesenchymal stem cells treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Dong Sun, MD, The Affiliated Hospital of Xuzhou Medical University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2017
Primær fullføring (Forventet)
31. desember 2018
Studiet fullført (Forventet)
31. desember 2018
Datoer for studieregistrering
Først innsendt
19. oktober 2017
Først innsendt som oppfylte QC-kriteriene
23. oktober 2017
Først lagt ut (Faktiske)
26. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- XYFY2016-KL031-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
produkt produsert i og eksportert fra USA
Nei
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