Protocol summary
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Study aim
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Assessment of the combination of artificial dura and umbilical cord and placenta-derived mesenchymal stem cell exosomes in patients with complete spinal cord injury.
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Design
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This study is a non-randomized, controlled, four-arm parallel-group, phase 2 trial on 20 patients.
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Settings and conduct
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This study includes 20 patients having acute complete spinal cord injury. All the patients will be followed their standard spinal surgery in the hospital and assigned non-randomly in four groups to receive new treatments. Patients will be assessed in terms of the study outcomes before treatment, 3, 6, and 12 months after injury.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Traumatic spinal cord injury
36 months have passed since the spinal cord injury
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Exclusion criteria:
History of previous spinal surgery
Amputation
Having underlying diseases affecting the diagnosis and treatment process (such as diabetes mellitus, osteopenia, spinal cord injury, etc.)
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Intervention groups
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Patients in the present study will be non-randomly assigned to three groups including the patients treated with artificial dura and exosome group, the patients treated with artificial dura group, patients treated with exosome alone, and the control group which receives the standard therapy.
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Main outcome variables
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Primary outcomes: Sensory and motor scores of the American Spinal Injury Association Impairment Scale, mean of the Spinal Cord Independence Measure III scores of patients.
General information
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Reason for update
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According to the definition of the inclusion criteria, the patients who were initially included in the study had been up to six months since their injury, unfortunately, at the beginning of the study, only the word acute was written in the definitions of the protocol title, which has been corrected. On the other hand, to include patients with chronic phases, the time interval from the injury was changed to 36 months.
Due to the possible effects of exosome, we needed to add the exosome treatment group alone so that the clinical trial does not suffer from problems in terms of methodology and results, and the results of other groups can be compared with this group. The source of the exosomes was added and the study population edited.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200502047277N1
Registration date:
2020-10-02, 1399/07/11
Registration timing:
registered_while_recruiting
Last update:
2023-03-25, 1402/01/05
Update count:
2
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Registration date
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2020-10-02, 1399/07/11
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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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2020-09-02, 1399/06/12
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Expected recruitment end date
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2023-03-21, 1402/01/01
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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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Safety and Efficacy Assessment of Combination of Artificial Dura and Umbilical Cord and Placenta Mesenchymal Stem Cell-Derived Exosomes in Patients with Acute, Sub-acute and Chronic Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
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Public title
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Effect of the combination of artificial dura and umbilical cord and placenta mesenchymal stem cell-derived exosomes 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:
Traumatic spinal cord injury
Time from injury up to 36 months
Complete spinal cord injury (class A in ASIA scale)
Written informed consent
Exclusion criteria:
History of previous spinal surgery
Amputation
Having underlying diseases affecting the diagnosis and treatment process (such as: diabetes mellitus, osteopenia, spinal cord injury, etc.)
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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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:
60
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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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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2020-09-01, 1399/06/11
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Ethics committee reference number
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IR.SBMU.MSP.REC.1399.235
Health conditions studied
1
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Description of health condition studied
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Complete spinal cord injury
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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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Motor score of the American Spinal Injury Association Impairment Scale
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Timepoint
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Before treatment, 3, 6, and 12 months after injury.
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Method of measurement
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Physical examination
2
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Description
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Sensory score of the American Spinal Injury Association Impairment Scale
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Timepoint
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Before treatment, 3, 6, and 12 months after injury.
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Method of measurement
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Physical examination
3
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Description
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Mean of the "Spinal Cord Independence Measure III" scores of patients
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Timepoint
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Before treatment, 3, 6, and 12 months after injury.
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Method of measurement
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Spinal Cord Independence Measure III questionnaire
Intervention groups
1
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Description
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Intervention group: In this group, patients underwent spinal decompression surgery in the injured area and the patient's dura will be repaired by artificial dura made of polyethylene terephthalate, then pre-prepared umbilical cord and placenta-derived mesenchymal stem cell exosomes were injected in the injury area.
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Category
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Treatment - Other
2
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Description
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Intervention group: In this group, patients underwent spinal decompression surgery in the injured area and the patient's dura will be repaired by artificial dura made of polyethylene terephthalate.
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Category
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Treatment - Other
3
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Description
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Control group: In this group, patients underwent standard spinal decompression surgery in the injured area and standard physiotherapy will be prescribed for him.
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Category
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Treatment - Other
4
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Description
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Intervention group: In this group, patients underwent standard spine decompression surgery in the injured area, and umbilical cord and placenta-derived mesenchymal stem cell exosomes were injected in each patient.
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Category
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Treatment - 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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Undecided - It is not yet known if there will be 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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through email request
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When the data will become available and for how long
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12 month
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To whom data/document is available
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Principal investigator of other clinical trials
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Under which criteria data/document could be used
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official request
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From where data/document is obtainable
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direct request to email
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What processes are involved for a request to access data/document
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evaluation of the validity of the applicant
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Comments
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