Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury (DNH)
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|ClinicalTrials.gov Identifier: NCT02923817|
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection||Phase 2|
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.
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.
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.
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
|Experimental: Treatment||Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection|
- Safety profile and adverse effects of the procedure [ Time Frame: 6 months from the time when patients receive the treatment ]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.
- Motor function [ Time Frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation ]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
- Sensory function [ Time Frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation ]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
- ASIA Impairment Scale [ Time Frame: At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation ]Change on the ASIA impairment scale from the time of registration to 6 months after cell transplantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923817
|Contact: Ba Ngoc Nguyen, MDfirstname.lastname@example.org|
|Contact: Lam Huu Nguyen, MDemail@example.com|
|Danang, Vietnam, 59000|
|Contact: Ba Ngoc Nguyen, MD +84905238311 firstname.lastname@example.org|
|Principal Investigator: Ba N Nguyen, MD|
|Sub-Investigator: Lam h Nguyen, MD|
|Sub-Investigator: Anh TN Pham, MD|
|Sub-Investigator: Bach N Nguyen, MD|
|Sub-Investigator: Tri H Le, MD|
|Sub-Investigator: Phong H Tong, BSc.|
|Sub-Investigator: Nam VK Le, BPharm.|
|Sub-Investigator: Thanh H Le, BSc|
|Principal Investigator:||Ba Ngoc Nguyen, MD||Danang Hospital|
|Study Director:||Yoshihisa Suzuki, MD, PhD.||Kitano Hospital|