Study of the therapeutic effect of using stem cells derived from peripheral blood in spinal fusion in patients with thoracolumbar fractures And comparing it with conventional therapy without using stem cells
Design
The 30 patients are placed in parallel in two groups of 15.
Settings and conduct
In the operating room of the Neurosurgery Department of Shahid Kamyab Hospital, Mashhad, the intervention group using stem cells and surgical operation of the spinal column are subjected to posterior instrumentation and fusion with allograft , and the control group undergoes only a posterior column
instrumentation And fusion with the allograft.
method:First, patients are checked for serum hemoglobin levels then under sterile venous blood conditions in triple blood bags Contains 63ml CPD-A.Then 500 ml of normal saline is injected 0.9% to the patient and 6 hours after sampling, hemoglobin is rechecked . Then the centrifuge stem cells were extracted from the peripheral blood through two centrifuges and used during the operation with allograft bone.A 0.5 cc sample is sent for flow cytometry
Participants/Inclusion and exclusion criteria
Conditions of entry: 1- The age of the patient is between 20-60 years;
2- The patient's level of consciousness when admitted 2-15
; 3. The need for spine surgery.
Exit Conditions: 1. Has specific diseases such as HIV +, HBV +, HCV +
2- Pregnancy
3- Probability of patient not following
4. Having previous bone malignancy
5. Pelvic fracture
6-Background illnesses including osteoporosis
7. Use steroid
Intervention groups
intervention group: Patients with thoracolumbar fractures undergoing spinal surgery along with the use of stem cells at the time of surgery
Control group: Patients with thoracolumbar fracture that undergo the usual surgical procedure
Main outcome variables
Evaluation of bone fracture fusion of spinal CT scan with fine cats based on Glassman grading
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100407003647N2
Registration date:2019-10-13, 1398/07/21
Registration timing:retrospective
Last update:2019-10-13, 1398/07/21
Update count:0
Registration date
2019-10-13, 1398/07/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
8592180 0511
Email address
ehsaeemr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-19, 1396/06/28
Expected recruitment end date
2018-05-30, 1397/03/09
Actual recruitment start date
2017-09-19, 1396/06/28
Actual recruitment end date
2018-05-30, 1397/03/09
Trial completion date
2019-05-15, 1398/02/25
Scientific title
Evaluation of the therapeutic effects of using peripheral blood stem cells in spinal fusion in patients with thoracolumbar fractures
Public title
treatment effect of peripheral blood stem cells in repair of fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 20-60 years
GCS:12-15
spine surgery is needed
Exclusion criteria:
HIV+,HBV+,HCV+
pregnancy
Probability of patient not following
Previous bone malignancy
Pelvic fracture
Background illnesses including osteoporosis
Taking steroids
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethice certificate school of medicin- mashhad university of medical science
Street address
fadaeeian eslam
City
mashhad
Province
Razavi Khorasan
Postal code
9166637477
Approval date
2017-03-11, 1395/12/21
Ethics committee reference number
IR.MUMS.REC.1395.633
Health conditions studied
1
Description of health condition studied
thoracolumbar fracture fusion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of bone fracture fusion of spinal CT scan with fine cats based on Glassman grading
Timepoint
12 months after spinal surgery
Method of measurement
Interpretation of CT scan with subtle cats of the spine performed by the surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Uses of Mesenchymal cell derived from peripheral blood
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid kamyab Hospital
Full name of responsible person
mohammad reza ehsaee
Street address
fadaeeian eslam
City
mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3802 6441
Email
ehsaeemr@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
daneshgah street
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3843 9070
Email
TafaghodiM@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
mohammadreza ehsaee
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
fadaeen eslam
City
mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3802 6441
Email
ehsaeemr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohammadreza ehsaee
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
fadaeian eslam
City
mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3802 6441
Email
ehsaeemr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohmmad reza ehsaee
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
fadaeian eslam
City
mashhad
Province
Razavi Khorasan
Postal code
9166637477
Phone
+98 51 3802 6441
Email
ehsaeemr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available