Effects of Intrathecal Transplantation of Autologous Schwann Cell and Bone Marrow Mesenchymal Stromal Cell on Urodynamic Parameters in Patients With Complete Spinal Cord Injury: Results From a Non-Randomized Open-Label Phase 1/2 Pilot Study
Assessing the effect of intrathecal transplantation of combination of autologous Schwann cell and bone marrow mesenchymal stromal cell on urodynamic parameters in patients with complete spinal cord injury
Design
This study is a non-randomized, uncontrolled, and open-label phase 1/2 pilot trial on 12 patients.
Settings and conduct
This study includes 12 patients undergoing transplantation of a combination of autologous Schwann cell and bone marrow mesenchymal stem cell. Patients will be assessed in terms of the study outcomes before and 6 months after treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 18 and 60
Root lesion less than three level
Complete spinal cord injury (class A in ASIA scale)
The patient who fills informed consent
Exclusion criteria:
Systemic diseases like diabetes, Cancer, Advanced neuropathy, Myopathy, Neuromuscular disorder, etc.
Epilepsy
Concurrent lesions of peripheral nerve including traumatic lesion
Brain damage
Intervention groups
Intervention group: In this group, patients' stem cells were isolated by bone marrow aspiration and Schwann cells by removing part of the sural nerve and after culturing and preparing the cells, at a concentration of one million cells per milliliter through Lumbar punctures are transplanted.
Main outcome variables
Primary outcomes: Bladder Maximum Capacity, Maximum Pressure of Detrusor in Filling, Maximum Pressure of Detrusor in Voiding.
Secondary outcomes: Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047277N4
Registration date:2020-10-19, 1399/07/28
Registration timing:registered_while_recruiting
Last update:2020-10-19, 1399/07/28
Update count:2
Registration date
2020-10-19, 1399/07/28
Registrant information
Name
saeed oraee yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
saeed_o_yazdani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-01, 1399/04/11
Expected recruitment end date
2020-12-31, 1399/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Intrathecal Transplantation of Autologous Schwann Cell and Bone Marrow Mesenchymal Stromal Cell on Urodynamic Parameters in Patients With Complete Spinal Cord Injury: Results From a Non-Randomized Open-Label Phase 1/2 Pilot Study
Public title
The effect of combination therapy with mesenchymal stem cells and Schwann cells on urological parameters in patients with complete spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60
Root lesion less than three level
Complete spinal cord injury (class A in ASIA scale)
The patient who fills informed consent
Exclusion criteria:
Systemic diseases like diabetes, Cancer, Advanced neuropathy, Myopathy, Neuromuscular disorder, etc.
Epilepsy
Concurrent lesions of peripheral nerve including traumatic lesion
Brain damage
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
12
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.SBMU.MSP.REC.1399.153
Health conditions studied
1
Description of health condition studied
Complete spinal cord injuries
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Bladder Maximum Capacity
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
2
Description
Maximum Pressure of Detrusor in Filling
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
3
Description
Maximum Pressure of Detrusor in Voiding
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
4
Description
Bladder Compliance
Timepoint
Before and 6 months after treatment
Method of measurement
Urodynamic study
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and 6 months after treatment
Method of measurement
Incontinence quality of life questionnaire
Intervention groups
1
Description
Intervention group: In this group, patients' stem cells were isolated by bone marrow aspiration and Schwann cells by removing part of the sural nerve and after culturing and preparing the cells, at a concentration of one million cells per milliliter through Lumbar punctures are transplanted.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Oraee Yazdani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Shohadaye Tajrish Hospital, Tajrish Ave.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
saeed_o_yazdani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Oraee Yazdani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Shohadaye Tajrish Hospital, Tajrish Ave.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
saeed_o_yazdani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh Tavanaei
Position
Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
19899 , Shahrdari St, Tehran, Tehran Province, Iran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Email
rtavanaei@sbmu.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Details of statistical analysis results will be provided to applicants only
When the data will become available and for how long
starting 12 months after publication
To whom data/document is available
Principal investigator of other clinical trial.
Under which criteria data/document could be used
Only the results of statistical data analysis are allowed and raw data is not available to other researchers.
From where data/document is obtainable
Requests must be made via email saeed_o_yazdani@SBMU.ac.ir.
What processes are involved for a request to access data/document
The applicant must send the reason for his request and resume to the email saeed_o_yazdani@SBMU.ac.ir. After review by the principal researcher, the data will be provided to the applicant at its discretion.