Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements
研究概览
简要总结
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility and susceptibility to fracture.
Osteoporosis is one of the most common and debilitating chronic diseases, and a global health concern with a high prevalence not only in Western countries, but also in Asia and Latin America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent. Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of pharmacological treatments, osteoporosis remains a significant health problem for patients who do not respond to the available treatments or fail to comply with their regimens.
The present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic patients who do not respond to pharmacological treatments.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of severe osteoporosis
- •Non-response to anti-osteoporotic treatment for over 2 years
- •Normal hematology function
- •Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
排除标准
- •Positive serology for hepatitis B, hepatitis C, HIV, syphilis, HTLV-1
- •Current or past medical disease that could interfere with the evaluation of the efficacy, as judged by the investigator
- •Severe renal or hepatic impairment
研究组 & 干预措施
PREOB® Intravenous Infusion
干预措施: PREOB® Intravenous Infusion (Drug)
结局指标
主要结局
Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements
时间窗: 12 months
Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan
时间窗: 72 hours
次要结局
- Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA)(12 months)
- Measurement of bone formation and resorption markers(12 months)
- Well-being score using SF-36 questionnaire(12 months)
- Occurrence of new vertebral fractures as assessed by X-ray(12 months)
- Pain measured by the Visual Analogue Scale(12 months)