ISRCTN10637905已完成不适用
A multicentre, randomised and comparative clinical study of the efficacy and safety of Ostem™ (autologous cultured osteoblasts) injection to treat fractures
Individual sponsor (South Korea)0 个研究点目标入组 77 人开始时间: 2008年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Long bone fracture (femur, tibia, radius, ulna, humerus) patients
- •2. Aged 15 and 65 years, either sex
- •3. Approximately six weeks after the first open or closed reduction, the score of callus formation was lower than 3 points
- •4. Individuals who have completed a written consent form
排除标准
- •1. Patient who is oversensitive to bovine protein
- •2. Patients with a known history of anaphylaxis to gentamicin
- •3. Patients with acute infection in bone defects
- •4. Patients who have communicable disease (positive reaction against human immunodeficiency virus [HIV], hepatitis C virus [HCV], hepatitis B virus [HBV], cytomegalovirus [CMV], syphilis, human T-lymphotropic virus [HTLV])
- •5. Patients diagnosed by the investigators to have psychological disorders
- •6. Patients whose score of callus formation was higher than 4 points
研究者
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