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
The effect of educated secretome of mesenchymal stem cells as an antimicrobial lock in hemodialysis patients with catheter infection
Design
This study will have one control group in parallel with the random block method. The type of study will be triple-blinded in phase 3 on 30 patients.
Settings and conduct
In this clinical trial study, 30 ESRD patients undergoing hemodialysis who will be referred to the Tabriz Hemodialysis and Organ Transplantation Center are randomly divided into 2 groups of 15 people, the intervention group will receive educated secretome of mesenchymal stem cells and the control group will receive vancomycin ampoule/ceftazidime+heparin for 15 days at the catheter site. The method of blinding will be triple-blinded and all the names and personal information of the patients will be coded at the time of data collection and will remain completely confidential.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- 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
2- Age between 18 and 80 years
3- Willingness to participate in the study
4- Under hemodialysis for two or three times a week
Exclusion criteria:
1- having symptoms of severe sepsis such as decreased level of consciousness and low blood pressure
2- Having a temporary catheter
3- Having symptoms of acute thromboembolism
Intervention groups
1- Under catheter antibiotic lock with vancomycin or ceftazidime and heparin 2- Under catheter with educated secretome of mesenchymal stem cells
Main outcome variables
Examining the incidence of infection and ague
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049311N8
Registration date:2024-01-25, 1402/11/05
Registration timing:prospective
Last update:2024-01-25, 1402/11/05
Update count:0
Registration date
2024-01-25, 1402/11/05
Registrant information
Name
Seyyedeh Mina Hejazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
smhjz.biotech@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The secretome of mesenchymal stem cells derived from the placenta and its secretions in the treatment of catheter infection in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Having symptoms of severe sepsis such as decreased level of consciousness and low blood pressure
Having a temporary catheter
Having symptoms of acute thromboembolism
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.131
Health conditions studied
1
Description of health condition studied
End-stage renal disease patients under more than six month of hemodialysis treatment and diagnosis of permanent catheter infection
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
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)
2
Description
The presence of suppuration and redness in the catheter site
Timepoint
15 days after the beginning of the intervention
Method of measurement
Observationally
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Hemodialysis and Organ Transplantation Center
Full name of responsible person
Dr. Mohammadreza Ardalan
Street address
Imam Reza hospital, Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 3992
Email
ardalan34@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz university of medical sciences, Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farahnoosh Farnood
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Kidney Research Center, one floor, Imam Reza training and Research Center, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 9331
Email
farnoodkidney@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Barzegari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 7929
Email
barzegari.abolfazl@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolfazl Barzegari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 7929
Email
barzegari.abolfazl@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD