Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease to Assess the Safety and the Efficacy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Safety: To demonstrate absence of complications at the site of spinal fusion
研究概览
简要总结
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. After the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.
详细描述
Following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from iliac crest for the purpose of receiving autologous multipotent mesenchymal stem cells. The cells will be cultivated for 3 passages (for 3 - 4 weeks) in order to expand them to sufficient quantity. Suspension of the cultured AMSC will then be sterilely packed and transported to the surgery site. During the posterolateral spine fusion operation, 1.5 ml of cell suspension will be mixed with 5 cc of beta-tricalcium phosphate foam (Vitoss™, Orthovita) and 3.5 ml of patient's blood, and inserted between the transverse processes of the lumbar spine.
All subjects will be hospitalized and followed up as per standard medical care rules used in the investigational site hospital for this type of intervention.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
- •patients indicated for fusion therapy,
- •patients between 18-55 years, both sexes,
- •patients able to provide written informed consent.
排除标准
- •previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,
- •osteoporosis,
- •diabetes mellitus,
- •pregnancy or breastfeeding,
- •women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
- •fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube),
- •coagulopathy,
- •malnutrition, primary biliary cirrhosis,
- •skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
- •gastrostomy,
- •any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....),
- •alcohol or drug abuse,
- •cancer (compulsory clinical oncological screening),
- •ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.
研究组 & 干预措施
Human AMSC (passage 3) 3P in 1.5 mL
Patient receiving the investigational medicinal product - suspension of human autologous MSC 3P in 1.5 mL
干预措施: Suspension of human autologous MSC 3P in 1.5 ml (Drug)
结局指标
主要结局
Safety: To demonstrate absence of complications at the site of spinal fusion
时间窗: 1 year
Complications at the site of spinal fusion and other treatment-related adverse events will be recorded in ten patients at Visits I through VII. All adverse events (AEs) will be classified by seriousness, severity and relationship to hAMSC application. All AEs will be collected as symptoms spontaneously reported by the patient, clinically relevant changes and abnormalities observed by the Investigator (clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations) Intensity The following 3-point rating scale will be used for rating of the intensity of each AE: Mild: Awareness of signs or symptoms, but no disruption of usual activity Moderate: Event sufficient to affect usual activities (disturbing) Severe: Inability to work or perform usual activities (unacceptable)
次要结局
- Efficacy: To assess the quality of spinal fusion by X-ray imaging(1 year)
- Efficacy: To assess the quality of life determined by Oswestry Questionnaire.(1 year)
- Efficacy: To assess the quality of spinal fusion measured by computed tomography (CT).(1 year)