Atieh Makhlough1, Soroosh Shekarchian2, Reza Moghadasali3, Behzad Einollahi4, Mona Dastgheib2, Ghasem Janbabaee5, Seyedeh Esmat Hosseini2, Nasrin Falah2, Fateme Abbasi2, Hossein Baharvand3, Nasser Aghdami6. 1. Department of Nephrology, Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran. 2. Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran. 3. Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran; Department of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran. 4. Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Baqiyatallah Hospital, Tehran, Iran. 5. Gastrointestinal Cancer Research Center, Mazandaran University of Medical Sciences, Sari, Iran. 6. Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, The Academic Center for Education, Culture and Research (ACECR), Tehran, Iran. Electronic address: nasser.aghdami@royaninstitute.org.
Abstract
BACKGROUND: Chronic kidney disease (CKD) is a progressive loss of kidney function and structure that affects approximately 13% of the population worldwide. A recent meta-analysis revealed that cell-based therapies improve impaired renal function and structure in preclinical models of CKD. We assessed the safety and tolerability of bone marrow-mesenchymal stromal cell (MSC) infusion in patients with CKD. METHODS: A single-arm study was carried out at one center with 18-month follow-up in seven eligible patients with CKD due to different etiologies such as hypertension, nephrotic syndrome (NS) and unknown etiology. We administered an intravenous infusion (1-2 × 106 cells/kg) of autologous cultured MSCs. The primary endpoint was safety, which was measured by number and severity of adverse events. The secondary endpoint was decrease in the rate of decrease in estimated glomerular filtration rate (eGFR). We compared kidney function during the follow-up visits to baseline and 18 months prior to the intervention. RESULTS: Follow-up visits of all seven patients were completed; however, we have not observed any cell-related adverse events during the trial. Changes in eGFR (P = 0.10) and serum creatinine (P = 0.24) from 18 months before cell infusion to baseline in comparison with baseline to 18 months were not statistically significant. CONCLUSIONS: We showed safety and tolerability of a single-dose infusion of autologous MSCs in patients with CKD.
BACKGROUND:Chronic kidney disease (CKD) is a progressive loss of kidney function and structure that affects approximately 13% of the population worldwide. A recent meta-analysis revealed that cell-based therapies improve impaired renal function and structure in preclinical models of CKD. We assessed the safety and tolerability of bone marrow-mesenchymal stromal cell (MSC) infusion in patients with CKD. METHODS: A single-arm study was carried out at one center with 18-month follow-up in seven eligible patients with CKD due to different etiologies such as hypertension, nephrotic syndrome (NS) and unknown etiology. We administered an intravenous infusion (1-2 × 106 cells/kg) of autologous cultured MSCs. The primary endpoint was safety, which was measured by number and severity of adverse events. The secondary endpoint was decrease in the rate of decrease in estimated glomerular filtration rate (eGFR). We compared kidney function during the follow-up visits to baseline and 18 months prior to the intervention. RESULTS: Follow-up visits of all seven patients were completed; however, we have not observed any cell-related adverse events during the trial. Changes in eGFR (P = 0.10) and serum creatinine (P = 0.24) from 18 months before cell infusion to baseline in comparison with baseline to 18 months were not statistically significant. CONCLUSIONS: We showed safety and tolerability of a single-dose infusion of autologous MSCs in patients with CKD.
Authors: Sandra Villanueva; Fernando González; Eduardo Lorca; Andrés Tapia; Valentina G López; Rocío Strodthoff; Francisca Fajre; Juan E Carreño; Ricardo Valjalo; César Vergara; Manuel Lecanda; Jorge Bartolucci; Fernando E Figueroa; Maroun Khoury Journal: Kidney Res Clin Pract Date: 2019-06-30