Protocol summary
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Study aim
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Evaluation of the efficacy of autograft/allograft stem cells and Schwann cells transplantation in patients with complete chronic and subacute spinal cord injuries
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Design
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This study is a controlled and open-label phase 2 clinical trial on 90 patients.
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Settings and conduct
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This study included 90 patients in two control and intervention groups who underwent a combination of autologous Schwann cell and autograft/allograft stem cells. Patients are evaluated for the results of the study before, 6, and 12 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 levels
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
Amputation
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 from the patient or allograft stem cells from the umbilical cord, and Schwann cells were extracted by removing part of the sural nerve. After culturing and preparing the cells, MSC cells were transplanted at a concentration of 1 million cells per ml and SC cells at a concentration of 1 million cells per ml prepared through a puncture lumbar in the L4 / L5 region.
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Main outcome variables
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Sensory and motor score of the American Spinal Injury Association Impairment Scale, Spinal Cord Independence Measure III, quality of life, pain, urinary function, quality of life dependent on urinary incontinence, neurogenic bowel dysfunction, diffusion tensor imaging and fiber tractography, and constipation in the patients
General information
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Reason for update
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The clinical trial method was conducted as randomized to increase the accuracy of the study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200502047277N8
Registration date:
2022-06-12, 1401/03/22
Registration timing:
prospective
Last update:
2024-03-26, 1403/01/07
Update count:
1
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Registration date
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2022-06-12, 1401/03/22
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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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2022-06-21, 1401/03/31
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Expected recruitment end date
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2022-08-22, 1401/05/31
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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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Evaluation of the efficacy of autograft/allograft stem cells and schwann cells transplantation in patients with complete chronic and subacute spinal cord injuries: A phase II randomized controlled study.
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Public title
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Effect of autograft/allograft combination of bone marrow stem cells and Schwann cells on complete chronic and subacute spinal cord injuries.
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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 levels
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
Amputation
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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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:
90
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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 envelopes.
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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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2011-10-11, 1390/07/19
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Ethics committee reference number
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IR.SBMU.MSP.REC.1401.053
Health conditions studied
1
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Description of health condition studied
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Cronic and subacute 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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Mean of the motor score of the American Spinal Injury Association Impairment Scale
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Timepoint
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Before treatment, 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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Mean of the sensory score of the American Spinal Injury Association Impairment Scale
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Timepoint
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Before treatment, 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, 6, and 12 months after injury.
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Method of measurement
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Spinal Cord Independence Measure III questionnaire
4
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Description
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Quality life of the patients
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Timepoint
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Before treatment and 6 months after injury.
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Method of measurement
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WHOQOL-BREF Quality of Life questionnaire
5
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Description
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Pain of the patients
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Timepoint
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Before treatment and 6 months after injury.
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Method of measurement
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Questionnaire of the International SCI Pain Basic Data Set (ISCIPBDS) version 2.
6
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Description
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Neurogenic bowel dysfunction score
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Timepoint
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Before treatment and 6 months after injury.
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Method of measurement
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Questionnaire of neurogenic bowel dysfunction
7
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Description
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Level of the constipation of the patients
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Timepoint
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Before treatment and 6 months after injury.
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Method of measurement
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Cleavland constipation questionnaire.
8
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Description
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Incontinence quality of life
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Timepoint
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Before treatment and 6 months after injury.
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Method of measurement
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Incontinence quality of life questionnaire
9
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Description
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Urinary Tract Function
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Timepoint
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Before treatment and 6 months after injury.
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Method of measurement
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INTERNATIONAL SPINAL CORD INJURY LOWER URINARY TRACT FUNCTION BASIC DATA SET Questionnaire
10
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Description
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Diffusion tensor imaging and fiber tractography of spine and brain
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Timepoint
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Before treatment and 6 months after injury.
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Method of measurement
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Diffusion tensor imaging and fiber tractography
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 from the patient or allograft stem cells from the umbilical cord, and Schwann cells were extracted by removing part of the sural nerve. After culturing and preparing the cells, MSC cells were transplanted at a concentration of 1 million cells per ml and SC cells at a concentration of 1 million cells per ml prepared through a puncture lumbar in the L4 / L5 region.
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Category
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Treatment - Other
2
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Description
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Control group: In this group, patients with spinal cord injury were treated with a standard physiotherapy and rehabilitation program.
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Category
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Rehabilitation
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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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