Safety and Efficacy Assessment of Combination of Artificial Dura and Exosome in Patients with Acute and Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
Assessment of the combination of artificial dura and exosome in patients with acute and complete spinal cord injury.
Design
This study is a non-randomized, controlled, three-arm parallel-group, phase 2 trial on 20 patients.
Settings and conduct
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 three groups to receive new treatments. Patients will be assessed in terms of the study outcomes before treatment, 3, 6, and 12 months after injury.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Traumatic spinal cord injury
Time from injury up to 6 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.)
Intervention groups
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, and the control group which receives the standard therapy.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047277N1
Registration date:2020-10-02, 1399/07/11
Registration timing:registered_while_recruiting
Last update:2020-10-02, 1399/07/11
Update count:2
Registration date
2020-10-02, 1399/07/11
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
2020-09-02, 1399/06/12
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Efficacy Assessment of Combination of Artificial Dura and Exosome in Patients with Acute and Complete Spinal Cord Injury: A Single-blinded Controlled Clinical Trial
Public title
Effect of the combination of artificial dura and exosome in patients with acute and complete spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic spinal cord injury
Time from injury up to 6 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.)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
2020-09-01, 1399/06/11
Ethics committee reference number
IR.SBMU.MSP.REC.1399.235
Health conditions studied
1
Description of health condition studied
Complete acute spinal cord injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Motor score of the American Spinal Injury Association Impairment Scale
Timepoint
Before treatment, 3, 6, and 12 months after injury.
Method of measurement
Physical examination
2
Description
Sensory score of the American Spinal Injury Association Impairment Scale
Timepoint
Before treatment, 3, 6, and 12 months after injury.
Method of measurement
Physical examination
3
Description
Mean of the "Spinal Cord Independence Measure III" scores of patients
Timepoint
Before treatment, 3, 6, and 12 months after injury.
Method of measurement
Spinal Cord Independence Measure III questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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 stem cell exosomes were injected in the injury area.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
3
Description
Control group: In this group, patients underwent standard spinal decompression surgery in the injured area and standard physiotherapy will be prescribed for him.