Protocol summary
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Study aim
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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
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Design
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This study is a randomized, controlled, and open-label phase 1/2 trial on 32 patients.
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Settings and conduct
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This study includes 32 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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
Control group: Patients with complete spinal cord injury who were evaluated without intervention during the follow-up period.
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Main outcome variables
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Primary outcomes: Bladder Maximum Capacity, Maximum Pressure of Detrusor in Filling, Maximum Pressure of Detrusor in Voiding.
Secondary outcomes: Quality of Life
General information
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Reason for update
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Natural urological changes in spinal cord injury patients over time will be a factor in the bias in the study results. Due to the nature of phase one and two of the article and the purpose of investigating the possible effectiveness of the intervention and creating reliable data for larger studies, including phase 3 trials, adding a control group to the intervention was necessary and important.
The patients in this study were randomly assigned with a sealed envelopes from the date of the first patient's enrollment, and the trial status was changed from non-randomized to randomized. The term of "pilot study" was removed from the title.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200502047277N4
Registration date:
2020-10-19, 1399/07/28
Registration timing:
registered_while_recruiting
Last update:
2023-02-13, 1401/11/24
Update count:
2
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Registration date
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2020-10-19, 1399/07/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-01, 1399/04/11
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Expected recruitment end date
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2022-05-01, 1401/02/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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 Randomized Open-Label Phase 1/2
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Public title
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The effect of combination therapy with mesenchymal stem cells and Schwann cells on urological parameters in patients with complete spinal cord injury
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Study subjects are divided into two equal groups by block randomization. The tool of randomization was sealed envelops.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-30, 1399/04/10
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Ethics committee reference number
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IR.SBMU.MSP.REC.1399.153
Health conditions studied
1
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Description of health condition studied
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Complete spinal cord injuries
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ICD-10 code
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T09.3
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ICD-10 code description
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Injury of spinal cord, level unspecified
Primary outcomes
1
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Description
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Bladder Maximum Capacity
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Timepoint
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Before and 6 months after treatment
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Method of measurement
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Urodynamic study
2
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Description
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Maximum Pressure of Detrusor in Filling
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Timepoint
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Before and 6 months after treatment
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Method of measurement
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Urodynamic study
3
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Description
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Maximum Pressure of Detrusor in Voiding
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Timepoint
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Before and 6 months after treatment
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Method of measurement
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Urodynamic study
4
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Description
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Bladder Compliance
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Timepoint
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Before and 6 months after treatment
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Method of measurement
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Urodynamic study
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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Before and 6 months after treatment
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Method of measurement
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Incontinence quality of life questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: Patients with complete spinal cord injury will be evaluated according the fullow up period without intervention
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Details of statistical analysis results will be provided to applicants only
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When the data will become available and for how long
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starting 12 months after publication
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To whom data/document is available
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Principal investigator of other clinical trial.
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Under which criteria data/document could be used
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Only the results of statistical data analysis are allowed and raw data is not available to other researchers.
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From where data/document is obtainable
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Requests must be made via email saeed_o_yazdani@SBMU.ac.ir.
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What processes are involved for a request to access data/document
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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.
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Comments
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