A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Lumbar Spinal Fusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 8
- 主要终点
- Lumbar fusion progression as assessed by CT scan
研究概览
简要总结
Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and functional improvement. However, pseudarthrosis and failure to relieve low back pain are unfortunately still frequent, irrespective of the type of procedures and grafts used by the surgeon.
The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
- •Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1)
- •Unresponsive to non-operative treatment for at least 6 months
排除标准
- •Lumbar disc disease requiring treatment at more than one level
- •Previous failed fusion at the involved lumbar level
- •Local active or latent infection at the involved lumbar level
- •Positive serology for hepatitis B, hepatitis C, HIV
- •Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator
研究组 & 干预措施
ALLOB® cells with ceramic scaffold
ALLOB® cells with ceramic scaffold Implantation
干预措施: ALLOB® cells with ceramic scaffold (Drug)
结局指标
主要结局
Lumbar fusion progression as assessed by CT scan
时间窗: 12 months
Functional Disability using Oswestry Disability Index
时间窗: 12 months
Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements
时间窗: 12 months
次要结局
- Percentage of patients having a rescue surgery(12 months)
- Global Disease Evaluation using a Visual Analogue Scale(12 months)
- Potential occurrence of any AE or SAE related to the product or to the procedure(36 months)
- Pain using a Visual Analogue Scale(12 months)
- Functional Disability using Oswestry Disability Index(12 months)
- Lumbar fusion progression as assessed by CT scan(12 months)