A clinical trial to compare the effectiveness of peripheral blood mononuclear cell (PBMC) with platelet rich plasma in vesicoureteral reflux patients before and after treatment
To compare the effectiveness of peripheral blood mononuclear cell (PBMC) with platelet rich plasma in vesicoureteral reflux patients before and after treatment.
Design
A before after, community-based clinical trial including 20 patients suffering from vesicoureteral reflux
Settings and conduct
The study population will be selected from the patients with vesicoureteral reflux referring to Imam Reza Hospital, Mashhad, Iran, and will be administered peripheral blood mononuclear cell with platelet rich plasma for treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age less than 14 years old; grade 1 to 4 of vesicoureteral reflux; having indication for surgical intervention such as repeated pyelonephritis or creation of new scars in renal nuclear scan.
Exclusion criteria: Urinary tract infection; Secondary vesicoureteral reflux; reflux grading 5; history of anti-reflux surgery.
Intervention groups
The intervention group will receive 5 cc peripheral blood mononuclear cell with platelet rich plasma that has been taken from each patient him/her-self and has been prepared.
Main outcome variables
The status and grade of reflux
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190117042391N1
Registration date:2019-02-15, 1397/11/26
Registration timing:prospective
Last update:2019-02-15, 1397/11/26
Update count:0
Registration date
2019-02-15, 1397/11/26
Registrant information
Name
Amin Mirsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
mirsania9411@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of peripheral blood mononuclear cell (PBMC) with platelet rich plasma in vesicoureteral reflux patients before and after treatment
Public title
The treatment of patients with vesicoureteral reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 14 years old
Grade 1 to 4 of vesicoureteral reflux
Having indication for surgical intervention such as repeated pyelonephritis or the creation of new scars in the renal nuclear scan
Exclusion criteria:
Urinary tract infection
Reflux grade 5
Secondary vesicoureteral reflux
History of anti-reflux surgery
Age
To 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.MUMS.REC.1397.252
Health conditions studied
1
Description of health condition studied
Vesicoureteral reflux
ICD-10 code
N13.7
ICD-10 code description
Vesicoureteral-reflux-associated uropathy
Primary outcomes
1
Description
The status and grade of reflux
Timepoint
Before and 3 months after intervention.
Method of measurement
Cystography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: this group will receive 5 cc peripheral blood mononuclear cell with platelet rich plasma that has been taken from each patient him/her-self and has been prepared.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amin Mirsani
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Mirsania941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
913753459
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amin Mirsani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Mirsania941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Mirsani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Mirsania941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Mirsani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Mirsania941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Amin Mirsani provides the data analysis to the applicants via email: Mirsania941@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.