Safety assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury
Design
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)
Settings and conduct
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 Stem Cell Technology Research Center.The injection of both types of cells prepared for spinal cord injury is also done by a neurosurgeon at Shohada's Tajrish Hospital.
Participants/Inclusion and exclusion criteria
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 up to 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
Intervention groups
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
Main outcome variables
Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025930N2
Registration date:2018-09-29, 1397/07/07
Registration timing:prospective
Last update:2018-09-29, 1397/07/07
Update count:2
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Masoud Soleimani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4508
Email address
soleim_m@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2019-03-05, 1397/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury
Public title
Safety investigation of simultaneous injection of olfactory ensheathing cells and mesenchymal stem cells in treatment of spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic thoracic spinal cord injury
Complete loss of sensory and motor function below the injury (ASIA Category A)
Time from injury up to 6 months (acute and intermediate phases)
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
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
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.
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.
Timepoint
1, 6, and 12 months post cell transplantation
Method of measurement
1-General physical assessments and laboratory tests like blood, serum, and urine analysis 2- Spinal radiological assessments with MRI imaging
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
Control group: Patients with complete spinal cord injury who are under routine cares and no extra action is performed on them.