A Pivotal Phase 2b/3, Multicentre, Randomised, Open, Controlled Study on the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Non-Infected Hypotrophic Non-Union Fractures
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 16
- 主要终点
- 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
研究概览
简要总结
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite.
Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009).
This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design.
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
- 18 Years 至 65 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
- •Diagnosis of a non-infected hypotrophic non-union fracture of a long bone of at least 6 months at the time of treatment
- •Normal hematology function
排除标准
- •Positive serology for HIV, hepatitis B, hepatitis C, syphilis, HTLV-1
- •Presence or previous history, or risk factors for diseases caused by prions
- •Renal impairment, hepatic impairment
- •Patient with poorly controlled diabetes mellitus, severe arterial diseases and/or neuropathy
- •Insufficient fracture stability
- •Recent osteosynthesis material or bone graft
- •Multifocal fracture/non-unions
研究组 & 干预措施
PREOB® Implantation
Each patient will undergo a single administration of PREOB® into the non-union site, under local or loco-regional anesthesia.
干预措施: PREOB® Implantation (Drug)
Bone Autograft
Each patient will be treated by Bone Autograft according to standard-of-care procedure of the investigating site.
干预措施: Bone Autograft (Procedure)
结局指标
主要结局
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
Global Disease Evaluation as perceived by the patient using a Visual Analogue Scale
时间窗: 12 months
Radiological healing progression using the RUS(T) as assessed by CT scan
时间窗: 12 months
次要结局
- Pain using a Visual Analogue Scale(12 months)
- Weight-bearing using Likert Scale(12 months)
- Well-being score as assessed by the SF-12 questionnaire(12 months)
- Radiological improvement using the RUS(T) as assessed by X-ray(12 months)