Treatment of Osteonecrosis of the Femoral Head by Implantation of Preosteoblastic Cells: a Randomized, Controlled, Single Blind Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Percentage of responder subjects
研究概览
简要总结
Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated.
The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment.
Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed.
This Phase 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. The primary goal of this study was to investigate the safety and efficacy of the implantation of the investigational product PREOB® (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a follow-up period of up to 5 years.
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
- Single (Outcomes Assessor)
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
- •ARCO stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by conventional X-ray and magnetic resonance imaging (MRI) of the hip
- •Aged 18 or higher
- •Ability to provide a written, dated and signed informed consent prior to any study-related procedure to understand and comply with study requirements
排除标准
- •Evidence of malignant disorder in the past five years
- •Positive serology for hepatitis B, hepatitis C, HIV
- •Patient unable to undergo a MRI
研究组 & 干预措施
Core decompression/PREOB® implantation
Core decompression/autologous osteoblastic cells (PREOB®) implantation
干预措施: Core decompression/PREOB® implantation (Drug)
Core decompression/BMC implantation
Core decompression/bone marrow concentrate (BMC) implantation
干预措施: Core decompression/BMC implantation (Drug)
结局指标
主要结局
Percentage of responder subjects
时间窗: 24 months
Response defined as the absence of progression to fractural stage (ARCO stage III or higher) \& a clinically significant pain improvement
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: 60 months
次要结局
- Percentage of responder subjects(3, 6, 12 and 36 months)
- Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray(3, 6, 12, 24 and 36 months)
- Change from baseline in VAS pain score(3, 6, 12, 18, 24, 36 and 48 months)
- Change from baseline in WOMAC® score(3, 6, 12, 18, 24, 36 and 48 months)
- Change from baseline in Lequesne score(3, 6, 12, 18, 24, 36 and 48 months)
- Proportion of subjects undergoing a total hip arthroplasty(6, 12, 24 and 36 months)
- Time to hip fracture(36 months)