A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Rescue Interbody Fusion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Functional Disability using Oswestry Disability Index
研究概览
简要总结
Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision surgeries are unfortunately associated with higher procedure-related complication rates, technical difficulties, longer operative time, and quite disappointing and unreliable success rates for both fusion and clinical results.
The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in rescue interbody 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 —（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
- •Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1
排除标准
- •More than two failed interbody fusions at the involved lumbar level(s)
- •Instrumentation failure requiring revision surgery
- •Local active or latent infection at the involved lumbar level(s)
- •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® Implantation
干预措施: ALLOB® (Drug)
结局指标
主要结局
Functional Disability using Oswestry Disability Index
时间窗: 12 months
Lumbar fusion progression as assessed by CT scan
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
- Pain using a Visual Analogue Scale(12 months)
- Global Disease Evaluation 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)
- Percentage of patients having a rescue surgery(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(36 months)