Phase I-II Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety profile and adverse effects of the procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with spinal cord injuries classified as A-B on the ASIA impairment scale
- •Patients injured 3 weeks to 1 year previously
- •Patients with partial spinal cord injury demonstrated by diagnostic imaging
- •Patients aged between 20 and 60 years at the acquisition of informed consent
- •Patients who submitted written informed consent by themselves
排除标准
- •Patients with a completely transected spinal cord
- •Patients with central spinal cord injury
- •Patients with organ failure with SOFA score of 3 points or higher
- •Patients in whom hepatitis B, hepatitis C, human immunodeficiency virus infection, or leukemia infection cannot be denied
- •Patients with malignant tumour or a history of malignant tumour within 5 years
- •Patients with following disease/disorder:
- •Myeloproliferative disorder or myelodysplastic syndrome Poorly controlled ischemic heart disease Autoimmune disease Spinal stenosis Limb paralysis due to central nervous system disorder not attributed to spinal cord injury Hepatic dysfunction Renal dysfunction Poorly controlled psychiatric disorder Complex multiple trauma
- •Patients who are participating in other clinical trials or who completed participation within 6 months
- •Patients who are pregnant or possibly pregnant
- •Other patients who are judged to be ineligible by investigators
结局指标
主要结局
Safety profile and adverse effects of the procedure
时间窗: 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.
次要结局
- ASIA Impairment Scale(At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation)
- Motor function(At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation)
- Sensory function(At 2 weeks, 4 weeks, 2 months, 4 months, 6 months after the transplantation)
研究者
Ngoc Ba Nguyen
Vice-director
Da Nang Hospital