]>
IRCT20201108049311N8 IRCT 2024-01-25 Tabriz University of Medical Sciences The secretome of mesenchymal stem cells derived from the placenta and its secretions in the treatment of catheter infection in hemodialysis patients The secretome of pre-conditioned placenta-derived mesenchymal stem cells as an antimicrobial lock in hemodialysis patients with catheter infection: A triple-blinded randomized clinical trial 2024-03-20 anticipated 30 Complete https://irct.ir/trial/74703 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Thirty men and women ESRD patients under hemodialysis will be randomly assigned into two groups receiving secretome (n=15) and vancomycin/ceftazidime+heparin (n= 15) using the random block method using blocks 4 and 6 through RAS (Random Allocation Software) and allocation ratio 1:1. To conceal the allocation, the secretome, vancomycin/ceftazidime, and heparin will be placed in opaque vials numbered from 1 to 30. Participants will receive vials numbered 1 to 30 based on the order of entering the study. Preparing the vials and numbering them will be done based on the generated random sequence by a person not involved in the research, Blinding description: This study will be triple-blinded. In this way, the doctor will introduce the patients to receive secretome, vancomycin/ceftazidime, and heparin and will not be aware of the grouping. Participating volunteers will not know about receiving secretome, vancomycin/ceftazidime, heparin, or other drugs. Secretome, vancomycin/ceftazidime, and heparin will be placed in similar and coded vials. In addition, the placebo will be identical in appearance (shape and color), taste, and smell with secretome. In addition, due to the coding of patients and the lack of clarity in the grouping of patients, the data analyzer will be also blinded. 3 End-stage renal disease patients under more than six month of hemodialysis treatment and diagnosis of permanent catheter infection. Intervention 1: Control group: Under catheter antibiotic lock with vancomycin/ceftazidime+heparin (The injected dose will be determined based on blood culture results) three times a week for 15 days. Intervention 2: Intervention group: Under catheter with educated secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) (It will be produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% three times a week for 15 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Dr. Farahnoosh Farnood
Kidney Research Center, one floor, Imam Reza training and Research Center, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) ۵۱۶۶۶۱۴۷۵۶ +98 41 3336 9331 farnoodkidney@gmail.com Tabriz University of Medical Sciences scientific Dr. Abolfazl Barzegari
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences, Tabriz, Iran
Tabriz Iran (Islamic Republic of) ۵۱۶۶۶۱۴۷۵۶ +98 41 3336 7929 barzegari.abolfazl@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with end-stage kidney disease under hemodialysis for at least six month and permanent catheter infection with diagnosis of blood culture and clinical symptoms Age between 18 and 80 years Willingness to participate in the study Under hemodialysis for two or three times a week 18 years 80 years Both Having symptoms of severe sepsis such as decreased level of consciousness and low blood pressure Having a temporary catheter Having symptoms of acute thromboembolism N18.6 End stage renal disease Treatment - Drugs Treatment - Drugs Control group: Under catheter antibiotic lock with vancomycin/ceftazidime+heparin (The injected dose will be determined based on blood culture results) three times a week for 15 days Intervention group: Under catheter with educated secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) (It will be produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% three times a week for 15 days Incidence of infection. Timepoint: 15 days after the beginning of the intervention. Method of measurement: Checking the occurrence of ague (body temperature above 37 °C). The presence of suppuration and redness in the catheter site. Timepoint: 15 days after the beginning of the intervention. Method of measurement: Observationally. Tabriz University of Medical Sciences Approved 2023-05-08 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)