Protocol summary
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Study aim
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Safety assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury
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Design
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A non-randomized open-labeled controlled trial with a sample size of 10, based on 5 patients in the main intervention group (cell transplantation) and another 5 patients with similar characteristics as control (without intervention)
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Settings and conduct
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Patient recruitment, mucosal biopsy, and bone marrow aspiration are performed in Shohada Tajrish Hospital. Olfactory Ensheathing Cells (OECs) and Mesenchymal Stem Cells (MSCs) isolation, characterization, and culture for transplantation are done in clean room.The injection of both types of cells prepared for spinal cord injury is also done by a neurosurgeon at Shohada's Tajrish Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:1-Traumatic thoracic spinal cord injury 2-Complete loss of sensory and motor function below the injury (ASIA Category A) 3-Time from injury at least 6 months 4-No mental disturbances in patient 5-Good patient motivation and cooperation and confirmation of written informed consent
Exclusion criteria:1-Coexisting lesion of the nervous system 2-Transection lesions of the spinal cord due to sharp objects 3-Spinal stenosis in parts other than the damaged area 4-Muscle atrophy or joint ossification 5-Severe systemic disease such as neoplasm and diabetes 6-Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy
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Intervention groups
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1-Main group: Co-transplantation of autologous Olfactory Ensheathing Cells and Mesenchymal Stem Cells into lesioned area of spinal cord
2-Control group: Without intervention
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Main outcome variables
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Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells
General information
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Reason for update
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the lack of a sufficient number of patients with the specified age range and the opinion of the neurologist on the safety of performing this procedure on chronic patients due to their stable condition
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160110025930N2
Registration date:
2018-09-29, 1397/07/07
Registration timing:
prospective
Last update:
2020-08-06, 1399/05/16
Update count:
2
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Registration date
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2018-09-29, 1397/07/07
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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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2018-10-06, 1397/07/14
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Expected recruitment end date
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2019-03-05, 1397/12/14
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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 assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury
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Public title
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Safety investigation of simultaneous injection of olfactory ensheathing cells and mesenchymal stem cells in treatment of 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 thoracic spinal cord injury
Complete loss of sensory and motor function below the injury (ASIA Category A)
Time from injury at least 6 months (chronic phase)
No mental disturbances in patient
Good patient motivation and cooperation and confirmation of written informed consent
Exclusion criteria:
Coexisting lesion of the nervous system
Transection lesions of the spinal cord due to sharp objects
Spinal stenosis in parts other than the damaged area
Muscle atrophy or joint ossification
Severe systemic disease such as neoplasm and diabetes
Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy
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Age
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From 18 years old to 70 years old
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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:
10
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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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Other
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Other design features
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10 enrolled patients of the study are divided into two groups: the main treatment group is transplanted with autologous olfactory ensheathing cells and mesenchymal stem cells and there is no cell therapy intervention in the control group.
Ethics committees
1
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Ethics committee
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Approval date
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2018-03-17, 1396/12/26
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Ethics committee reference number
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IR.TMU.REC.1396.737
Health conditions studied
1
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Description of health condition studied
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Spinal Cord Injury
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ICD-10 code
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G95.20
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ICD-10 code description
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Unspecified cord compression
Primary outcomes
1
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Description
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Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in patients with complete spinal cord injury in order to safety assessment for this intervention.
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Timepoint
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1, 6, and 12 months post cell transplantation
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Method of measurement
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1-General physical assessments and laboratory tests like blood, serum, and urine analysis 2- Spinal radiological assessments with MRI imaging
Intervention groups
1
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Description
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Intervention group: Patients with complete spinal cord injury who are co-transplanted with autologous Olfactory Ensheathing Cells (OECs) (isolated from olfactory mucosa) and Mesenchymal Stem Cells (MSCs) (isolated from bone marrow aspirate) which is injected into lesioned spinal cord in a ratio of 50:50 and cell dose of about 20-30 million.
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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 who are under routine cares and no extra action is performed on them.
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Category
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N/A
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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Tarbiat Modares University
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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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Undecided - It is not yet known if there will be 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