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IRCT2015052415841N2 IRCT 2015-07-19 Vice chancellor for research, Tehran University of Medical Sciences Effects of mesenchymal stem cells therapy in peritoneal dialysis patients Evaluation of clinical effects of mesenchymal stem cell therapy in peritoneal dialysis patients with ultrafiltration failure, a clinical trial 2015-10-01 anticipated 10 Complete https://irct.ir/trial/14988 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Chronic kidney disease. Intervention 1: Historical control: no intervention or injection will be done in this group. Intervention 2: Intervention group: Single peripheral injection of autologous mesenchymal stem cells (1,000,000/kg). The mesenchymal stem cells will be separated from fat tissue and then the cells will be cultured and proliferated in specialized lab until they reach enough numbers and then they will be injected through peripheral. The injection will be performed only one time.
public Dr. Sudabeh Alatab
Urology Research Cente, Sina Hospital, Hassan-Abad Sq. Emam Khomeini St.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 sudabehalatab@yahoo.com Urology Research Center,Tehran University of Meical Scienses scientific Dr. Gholamreza Pourmand
Urology Research Center, Sina Hospital, Hassan-Abad Sq. Emam Khomeini St.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 gh_pourmand@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients on peritoneal dialysis; Both sexes; Age between 18-70 years; Being on peritoneal dialysis for at least last two years; Having Ultrafiltration failure Exclusion criteria: Patients who cannot come for regular visits; Patients with less than 1 year survival; Patients on immunosuppressive medications; Pregnancy; Malignancy; Coagulative disorders 18 years 50 years Both N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Treatment - Other Historical control: no intervention or injection will be done in this group. Intervention group: Single peripheral injection of autologous mesenchymal stem cells (1,000,000/kg). The mesenchymal stem cells will be separated from fat tissue and then the cells will be cultured and proliferated in specialized lab until they reach enough numbers and then they will be injected through peripheral. The injection will be performed only one time. D/P cr. Timepoint: Before and at week 3, week 6, month 3, month 4 and month 6. Method of measurement: Ratio of 4-hour dialysate/plasma creatinine. D/P urea. Timepoint: Before and at week 3, week 6, month 3, month 4 and month 6. Method of measurement: Ratio of 4-hour dialysate/plasma urea. D0/D glucose. Timepoint: Before and at week 3, week 6, month 3, month 4 and month 6. Method of measurement: Ratio of dialysate glucose concentrations at end and at start of tests. Peritoneal Equilibration Test (PET). Timepoint: Before and at week 3, week 6, month 3, month 4 and month 6. Method of measurement: Assessment of peritoneal membrane transport function by machine. Glomerular filtration rate (GFR). Timepoint: Before and at week 3, week 6, month 3, month 4 and month 6. Method of measurement: MDRD formula. Kt/V urea. Timepoint: Before and at week 3, week 6, month 3, month 4 and month 6. Method of measurement: Dialyzer clearance of urea * dialysis time/ volume of distribution of urea. Vice chancellor for research, Tehran University of Medical Sciences Approved 2015-04-29 Sciences Ethics committee of Tehran University of Medical Sciences 6th floor, central building of TUMS, Ghods street, Keshavarz Blv, Tehran, Iran Tehran Iran (Islamic Republic of)