The purpose of study is to determine whether autologous mononuclear cells deriving from the bone marrow are effective in the treatment of spinal cord injury.
Recruitment process: The investigators selects the candidate of the study that fulfill the inclusion criteria and not violate any exclusion criteria from patients with spinal cord injury that admitted to the department of neurosurgery - Danang hospital. The investigators then ask the patients and patients family for informed consent. The patients that submit the informed consent to participate is recruited to the study. Procedure description: The patients is moved to operation theater at the day of the procedure. The bone marrow of the patients is harvested by two investigators. The mononuclear cells of the bone marrow is extracted from the bone marrow by using gravity centrifugation with Ficoll Paque 1.073. The mononuclear cells is transferred to 5 mL syringe and handed back to the investigator. The investigator will transplant the whole cell preparation back to the patients by lumbar injection. A final supernatant layer of the preparation is also sent to the lab for microbiological and endotoxin testings. One small portion of the cell preparation is sent to the laboratory for cell count and cluster of distribution tests. The patient is transferred back to the patient room and monitor for the outcomes at 2 weeks, 4 weeks, 2 months, 4 months, 6 months. All of the data is entered, stored and monitored via the eCB database system of TRI Cente, Kobe. Data Analysis: Primary Endpoint: A list is prepared for each subject with the name of AE developed, its severity and seriousness, causal relationship with the treatment, and outcome. In addition, the incidence of AEs in all cases and the 95% confidence interval are estimated. For each AE type, the incidence, incidence by severity, and incidence by seriousness are calculated in addition to estimation of the rate of each AE and its 95% confidence interval in all cases. Secondary Endpoint: Regarding secondary endpoints, the Wilcoxon signed rank test is used to compare the baseline value at registration and value at 6 months after cell transplantation. In addition, assuming the scores in each secondary endpoint to be consecutive scores, a linear mixed model with time point as a fixed effect and cases as random effects is fitted to the data at registration and 2 and 6 months after cell transplantation after assuming an appropriate covariance structure between time points to assess their chronological changes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Danang Hospital
Da Nang, Da Nang City, Vietnam
RECRUITINGSafety profile and adverse effects of the procedure
Causal relationship, incidence, severity, and seriousness of all adverse events (AEs) experienced following cell transplantation up to the day of the final observation are assessed.
Time frame: 6 months from the time when patients receive the treatment
Motor function
Motor function score in the neurological classification of spinal cord injury: Amount of change from the time of registration to 6 months after cell transplantation
Time frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
Sensory function
Sensory function score in the neurological classification of spinal cord injury (light touch sensation score + pinprick sensation score): Amount of change from the time of registration to 6 months after cell transplantation
Time frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
ASIA Impairment Scale
Change on the ASIA impairment scale from the time of registration to 6 months after cell transplantation
Time frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.