SVF (Adipose Tissue Derived MSC) Based Therapy for CKD.

Summary

1. To assess the safety of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD). 2. To assess the efficacy of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD).

Timeline

Start

2019-04-01

Primary completion

2024-03-31

Completion

2025-03-31

Publications

• Background Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
• Background Gilbertson DT, Liu J, Xue JL, Louis TA, Solid CA, Ebben JP, Collins AJ. Projecting the number of patients with end-stage renal disease in the United States to the year 2015. J Am Soc Nephrol. 2005 Dec;16(12):3736-41. doi: 10.1681/ASN.2005010112. Epub 2005 Nov 2.
• Background Prevalence of Chronic Kidney Disease (CKD) and Identification of Associated risk Factors among Rulral Population by Mass Screening. Hasan MJ , Kashem MA,, Rahman MH, Quddhush R , Rahman M, Sharmeen A, Islam N. CBMJ 2012;1(1):20-26.
• Background Wyld M, Morton RL, Hayen A, Howard K, Webster AC. A systematic review and meta-analysis of utility-based quality of life in chronic kidney disease treatments. PLoS Med. 2012;9(9):e1001307. doi: 10.1371/journal.pmed.1001307. Epub 2012 Sep 11.
• Background Collins AJ, Foley RN, Chavers B, Gilbertson D, Herzog C, Johansen K, Kasiske B, Kutner N, Liu J, St Peter W, Guo H, Gustafson S, Heubner B, Lamb K, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Thompson B, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Daniels F, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers P, Agodoa L. 'United States Renal Data System 2011 Annual Data Report: Atlas of chronic kidney disease & end-stage renal disease in the United States. Am J Kidney Dis. 2012 Jan;59(1 Suppl 1):A7, e1-420. doi: 10.1053/j.ajkd.2011.11.015. No abstract available.
• Background Perico N, Remuzzi G. Chronic kidney disease: a research and public health priority. Nephrol Dial Transplant. 2012 Oct;27 Suppl 3:iii19-26. doi: 10.1093/ndt/gfs284. Epub 2012 Jul 3. No abstract available.
• Background Rivera JA, O'Hare AM, Harper GM. Update on the management of chronic kidney disease. Am Fam Physician. 2012 Oct 15;86(8):749-54.
• Background Benigni A, Morigi M, Remuzzi G. Kidney regeneration. Lancet. 2010 Apr 10;375(9722):1310-7. doi: 10.1016/S0140-6736(10)60237-1.
• Background Riordan NH, Ichim TE, Min WP, Wang H, Solano F, Lara F, Alfaro M, Rodriguez JP, Harman RJ, Patel AN, Murphy MP, Lee RR, Minev B. Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis. J Transl Med. 2009 Apr 24;7:29. doi: 10.1186/1479-5876-7-29.
• Background Schipper HS, Prakken B, Kalkhoven E, Boes M. Adipose tissue-resident immune cells: key players in immunometabolism. Trends Endocrinol Metab. 2012 Aug;23(8):407-15. doi: 10.1016/j.tem.2012.05.011. Epub 2012 Jul 12.
• Background Reinders ME, Fibbe WE, Rabelink TJ. Multipotent mesenchymal stromal cell therapy in renal disease and kidney transplantation. Nephrol Dial Transplant. 2010 Jan;25(1):17-24. doi: 10.1093/ndt/gfp552. Epub 2009 Oct 26.
• Background Peired AJ, Sisti A, Romagnani P. Mesenchymal Stem Cell-Based Therapy for Kidney Disease: A Review of Clinical Evidence. Stem Cells Int. 2016;2016:4798639. doi: 10.1155/2016/4798639. Epub 2016 Sep 19.
• Background Kokai LE, Rubin JP, Marra KG. The potential of adipose-derived adult stem cells as a source of neuronal progenitor cells. Plast Reconstr Surg. 2005 Oct;116(5):1453-60. doi: 10.1097/01.prs.0000182570.62814.e3.
• Background Lin CS, Xin ZC, Deng CH, Ning H, Lin G, Lue TF. Defining adipose tissue-derived stem cells in tissue and in culture. Histol Histopathol. 2010 Jun;25(6):807-15. doi: 10.14670/HH-25.807.
• Background Lin F. Adipose tissue-derived mesenchymal stem cells: a fat chance of curing kidney disease? Kidney Int. 2012 Oct;82(7):731-3. doi: 10.1038/ki.2012.158.
• Background Huixi Li1, 2, Guiting Lin1*, and Tom F Lue1 Potential application of adipose tissue-derived stem cells for urological disease. Bladder 2014;1(1). DOI: 10.14440/bladder.2014.23
• Background Stashower M, Smith K, Williams J, Skelton H. Stromal progenitor cells present within liposuction and reduction abdominoplasty fat for autologous transfer to aged skin. Dermatol Surg. 1999 Dec;25(12):945-9. doi: 10.1046/j.1524-4725.1999.99098.x.
• Background Halvorsen YC, Wilkison WO, Gimble JM. Adipose-derived stromal cells--their utility and potential in bone formation. Int J Obes Relat Metab Disord. 2000 Nov;24 Suppl 4:S41-4. doi: 10.1038/sj.ijo.0801503.
• Background Moseley TA, Zhu M, Hedrick MH. Adipose-derived stem and progenitor cells as fillers in plastic and reconstructive surgery. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):121S-128S. doi: 10.1097/01.prs.0000234609.74811.2e.
• Background Kidney disease: how could stem cells help?. http://www.eurostemcell.org /factsheet/kidney-disease-how-could-stem-cells-help
• Background Reinders ME, de Fijter JW, Roelofs H, Bajema IM, de Vries DK, Schaapherder AF, Claas FH, van Miert PP, Roelen DL, van Kooten C, Fibbe WE, Rabelink TJ. Autologous bone marrow-derived mesenchymal stromal cells for the treatment of allograft rejection after renal transplantation: results of a phase I study. Stem Cells Transl Med. 2013 Feb;2(2):107-11. doi: 10.5966/sctm.2012-0114. Epub 2013 Jan 24.
• Background Eirin A, Lerman LO. Mesenchymal stem cell treatment for chronic renal failure. Stem Cell Res Ther. 2014 Jul 4;5(4):83. doi: 10.1186/scrt472.
• Background Rehman J, Traktuev D, Li J, Merfeld-Clauss S, Temm-Grove CJ, Bovenkerk JE, Pell CL, Johnstone BH, Considine RV, March KL. Secretion of angiogenic and antiapoptotic factors by human adipose stromal cells. Circulation. 2004 Mar 16;109(10):1292-8. doi: 10.1161/01.CIR.0000121425.42966.F1. Epub 2004 Mar 1.
• Background Meliga E, Strem BM, Duckers HJ, Serruys PW. Adipose-derived cells. Cell Transplant. 2007;16(9):963-70. doi: 10.3727/096368907783338190.
• Background Thum T, Bauersachs J, Poole-Wilson PA, Volk HD, Anker SD. The dying stem cell hypothesis: immune modulation as a novel mechanism for progenitor cell therapy in cardiac muscle. J Am Coll Cardiol. 2005 Nov 15;46(10):1799-802. doi: 10.1016/j.jacc.2005.07.053. Epub 2005 Oct 17.
• Background Banas A, Teratani T, Yamamoto Y, Tokuhara M, Takeshita F, Osaki M, Kawamata M, Kato T, Okochi H, Ochiya T. IFATS collection: in vivo therapeutic potential of human adipose tissue mesenchymal stem cells after transplantation into mice with liver injury. Stem Cells. 2008 Oct;26(10):2705-12. doi: 10.1634/stemcells.2008-0034. Epub 2008 Jun 5.
• Background Villanueva S, Carreno JE, Salazar L, Vergara C, Strodthoff R, Fajre F, Cespedes C, Saez PJ, Irarrazabal C, Bartolucci J, Figueroa F, Vio CP. Human mesenchymal stem cells derived from adipose tissue reduce functional and tissue damage in a rat model of chronic renal failure. Clin Sci (Lond). 2013 Aug;125(4):199-210. doi: 10.1042/CS20120644.
• Background Quimby JM, Webb TL, Habenicht LM, Dow SW. Safety and efficacy of intravenous infusion of allogeneic cryopreserved mesenchymal stem cells for treatment of chronic kidney disease in cats: results of three sequential pilot studies. Stem Cell Res Ther. 2013 Apr 30;4(2):48. doi: 10.1186/scrt198.
• Background Zhang L, Li K, Liu X, Li D, Luo C, Fu B, Cui S, Zhu F, Zhao RC, Chen X. Repeated systemic administration of human adipose-derived stem cells attenuates overt diabetic nephropathy in rats. Stem Cells Dev. 2013 Dec 1;22(23):3074-86. doi: 10.1089/scd.2013.0142. Epub 2013 Aug 21.
• Background Papazova DA, Oosterhuis NR, Gremmels H, van Koppen A, Joles JA, Verhaar MC. Cell-based therapies for experimental chronic kidney disease: a systematic review and meta-analysis. Dis Model Mech. 2015 Mar;8(3):281-93. doi: 10.1242/dmm.017699. Epub 2015 Jan 29.
• Background Malaga-Dieguez L, Bouhassira D, Gipson D, Trachtman H. Novel therapies for FSGS: preclinical and clinical studies. Adv Chronic Kidney Dis. 2015 Mar;22(2):e1-6. doi: 10.1053/j.ackd.2014.10.001.
• Background You D, Jang MJ, Lee J, Suh N, Jeong IG, Sohn DW, Kim SW, Ahn TY, Kim CS. Comparative analysis of periprostatic implantation and intracavernosal injection of human adipose tissue-derived stem cells for erectile function recovery in a rat model of cavernous nerve injury. Prostate. 2013 Feb 15;73(3):278-86. doi: 10.1002/pros.22567. Epub 2012 Jul 20.
• Background Ezquer FE, Ezquer ME, Parrau DB, Carpio D, Yanez AJ, Conget PA. Systemic administration of multipotent mesenchymal stromal cells reverts hyperglycemia and prevents nephropathy in type 1 diabetic mice. Biol Blood Marrow Transplant. 2008 Jun;14(6):631-40. doi: 10.1016/j.bbmt.2008.01.006. Epub 2008 Apr 14.
• Background Fischer UM, Harting MT, Jimenez F, Monzon-Posadas WO, Xue H, Savitz SI, Laine GA, Cox CS Jr. Pulmonary passage is a major obstacle for intravenous stem cell delivery: the pulmonary first-pass effect. Stem Cells Dev. 2009 Jun;18(5):683-92. doi: 10.1089/scd.2008.0253.
• Background Zonta S, De Martino M, Bedino G, Piotti G, Rampino T, Gregorini M, Frassoni F, Dal Canton A, Dionigi P, Alessiani M. Which is the most suitable and effective route of administration for mesenchymal stem cell-based immunomodulation therapy in experimental kidney transplantation: endovenous or arterial? Transplant Proc. 2010 May;42(4):1336-40. doi: 10.1016/j.transproceed.2010.03.081.
• Background Bi B, Schmitt R, Israilova M, Nishio H, Cantley LG. Stromal cells protect against acute tubular injury via an endocrine effect. J Am Soc Nephrol. 2007 Sep;18(9):2486-96. doi: 10.1681/ASN.2007020140. Epub 2007 Jul 26.
• Background Lee SR, Lee SH, Moon JY, Park JY, Lee D, Lim SJ, Jeong KH, Park JK, Lee TW, Ihm CG. Repeated administration of bone marrow-derived mesenchymal stem cells improved the protective effects on a remnant kidney model. Ren Fail. 2010;32(7):840-8. doi: 10.3109/0886022X.2010.494803.
• Background Semedo P, Correa-Costa M, Antonio Cenedeze M, Maria Avancini Costa Malheiros D, Antonia dos Reis M, Shimizu MH, Seguro AC, Pacheco-Silva A, Saraiva Camara NO. Mesenchymal stem cells attenuate renal fibrosis through immune modulation and remodeling properties in a rat remnant kidney model. Stem Cells. 2009 Dec;27(12):3063-73. doi: 10.1002/stem.214.

Drugs

Indications