The effect of autologous peripheral blood cells transplantation along with platelet rich plasma in the treatment of patients with vesicoureteral reflux
Evaluation of efficacy and side effects of injection, peripheral blood cells with platelet growth factors in treatment of urinary reflux
Design
A total of 17 patients with vesicourethral reflux who met our inclusion criteria, were evaluated. the study performed without control group and blindness. 17 patients included for phase-1 trial. Endoscopic injection was made by one surgeon in all patients in 6 o’clock and 0.5 cm away from the ureteral orifice. They were followed by renal ultrasonography and radiologic VCUG at 3and 18 months after the injection . The success of the injection was determination of no VUR on the following VCUGs. If the VUR persisted, the second injection was performed 3 months after the first one
Settings and conduct
Patients undergo stem cell injection in the operating room. The patient has a urethra catheter and a double j catheter. The next day the urethra catheter is removed. And 45 days later the double j catheter is removed. Then the treatment response is measured 3 and 6 months later by sonography, U/C, U/A and cystography. Re-injections will be needed in specific cases and a thoughtful treatment response will be provided.the study set in Imam-Reza hospital in Mashhad, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient with reflux grade 2, 3 or 4 grade
No surgical treatment has been performed so far
Exclusion criteria:
The patient is in the acute phase of urinary tract infection
Patient with renal failure due to reflux
Patient with grade 1 or 5 reflux
Intervention groups
Patients diagnosed with vesicourethral reflux, undergo stem cell injection in the vesicourethral junction.
Main outcome variables
vesicourethral reflux cure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033489N4
Registration date:2020-04-28, 1399/02/09
Registration timing:retrospective
Last update:2020-04-28, 1399/02/09
Update count:0
Registration date
2020-04-28, 1399/02/09
Registrant information
Name
Salman Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2553
Email address
soltanis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2011-10-22, 1390/07/30
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
2014-05-22, 1393/03/01
Actual recruitment end date
2016-01-01, 1394/10/11
Trial completion date
2016-09-10, 1395/06/20
Scientific title
The effect of autologous peripheral blood cells transplantation along with platelet rich plasma in the treatment of patients with vesicoureteral reflux
Public title
The effect of autologous peripheral blood cells transplantation along with platelet rich plasma in the treatment of patients with vesicoureteral reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with re flux grade 2, 3 or 4 grade
No surgical treatment has been performed so far
Exclusion criteria:
The patient is in the acute phase of urinary tract infection
Patient with renal failure due to re flux
Patient with grade 1 or 5 re flux
Age
From 15 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
1
re injection
Actual sample size reached:
17
More than 1 sample in each individual
Actual sample size in each individual:
1
bilateral vesicoureteral reflux
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
Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2635-07-07, 2014/04/16
Ethics committee reference number
Ethics committee of Mashhad University of Medical Sciences
Health conditions studied
1
Description of health condition studied
Vesicoureteral reflux
ICD-10 code
N13.7
ICD-10 code description
Vesicoureteral-reflux
Primary outcomes
1
Description
Reflux Grade
Timepoint
Determination of urinary reflux grade at baseline, three and six months after intervention
Method of measurement
Ultrasound, Cystography, U/A, U/C
Secondary outcomes
empty
Intervention groups
1
Description
This study aimed to evaluate the therapeutic efficacy of endoscopic subureteric injection of autologous peripheral blood cells along with platelet-rich plasma. Each injection contained whole blood cells with platelet growth factors derived from the peripheral blood of the patient. The blood were collected and sent to specialized laboratories for the isolation of peripheral blood cells and platelet growth factor preparation. the resultant material injected endoscopically into the subureteric region of the bladder.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Mashhad
Full name of responsible person
Dr Maliheh Keshvari Shirvan
Street address
Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
keshvarim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maliheh Keshvari Shirvan
Street address
Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
Keshvarim@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
Maliheh Keshvari Shirvan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
keshvarim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maliheh Keshvari Shirvan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
keshvarim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maliheh Keshvari Shirvan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Bahar Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3885
Email
keshvarim@mums.ac.ir
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
No more information to declare
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
patients information are shareable after making them anonymous
When the data will become available and for how long
6 months after publication
To whom data/document is available
all
Under which criteria data/document could be used
medicine-related researchers
From where data/document is obtainable
Dr.Maliheh Keshvari
What processes are involved for a request to access data/document