A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants with adverse events after transplantation.
研究概览
简要总结
This study is designed to assess the safety and effect of autologous adipose derived stem cell (ADSCs) transplantation in acute spinal cord injury patients.
- To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and the complication after ADSCs transplantation.
- To evaluate the effect of ADSCs isolation and expansion procedure.
- To determine if functional outcome is improved following ADSCs transplantation in acute spinal cord injury patient, using pre-transplantation spinal cord function as the control.
详细描述
The research has carried out in Phase II which is designed as randomized controlled trials.
Selection of patients began in Feb,2013, 48 patients are divided in two group according to a 2:1 ratio (the number of candidates as treated: the candidates as control).
The effectiveness of preliminary trial are evaluated by assessing Frankel/ASIA motor grade, measuring electrophysiological parameters, enhanced MRI and urinary and bowel function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to give voluntary (patients may not be able to write) consent.
- •Must be able to understand study information provided to him.
- •Patients with complete spinal cord < 2 weeks in acute category
- •The level of spinal cord injury must be categorized at A level in terms of ASIA Impairment scale.
- •Age should be between 19-60 years
- •Both male and female
排除标准
- •Support respiration by machine
- •Melanoma within 5 years
- •Infectious diseases including HIV and Hepatitis B, C
- •Brain damage or multiple trauma
- •Body temperature higher 38 ℃ or acute disorder
- •Anemia or thrombocytopenia
- •Angina , myocardial infarction , heart disease , embolic disease , chronic renal failure, glomerular disease and chronic obstructive pulmonary disease.
- •Congenital or acquired immunodeficiency disorder
- •Muscular dystrophy or muscle stiffness
- •Non-conscious or voice disorders
- •Treatment with cytotoxic drugs ( immunosuppressive drugs , corticosteroids and cytotoxic drugs) during the clinical trials .
- •Participating in another clinical trial within 3 months
- •Other serious disease or disorder can seriously affect the ability to participate in research.
- •Women who are pregnant or lactating .
- •Allergy to antibiotics and anesthetics .
- •Do not agree to participate in research
结局指标
主要结局
Number of Participants with adverse events after transplantation.
时间窗: 24 months
Number of Participants with adverse events is as a measure of safety and tolerability after ADSC transplantation. Adverse events can be impaired liver and kidney, immunosuppression or immune deficiency, hypersensitivity, anaphylactic shock, meningitis symptoms, etc.
次要结局
- Changes of spinal cord edema in the MRI at the lesion site(24 months)
- Urinary and bowel function Improvement(24 months)
- Muscle contraction force measurement(24 months)
- Significant clinical improvement in ASIA impairment scale and general condition.(24 months)