JPRN-jRCTc032200027已完成1 期
Autologous concentrated bone marrow transplantation for idiopathic osteonecrosis of femoral head. - ACBM for IONF
Yasuhiro Homma0 个研究点目标入组 2 人开始时间: 2020年5月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Safety of autologous concentrated bonemarrow transplantation using a point of care device for idiopathic osteonecrosis of the femoral head was validated.The study was completed without problems,with no serious adverse events.The appropriateness of proceeding to next study to test an efficacy of this procedure was demonstrated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 50age old（—）
- 性别
- All
入选标准
- •1) Idiopathic osteonecrosis of femoral head; Stage 1,2, and 3A
- •2) Age more than 20 years old
排除标准
- •1) Patients with abnormal platelet counts in peripheral blood
- •2) Patient who smoke s a lot (Brinkman index > 600)
- •3) Treatment with anticoagulants (except for Bi aspirine)
- •4) Uncontrolled diabetes mellitus:HbA1c not lower than 9.0% according to latest laboratory data obtained within 14 days before registration
- •5) Patients with malignancy
- •6) Patients less than 6 months after onset of cardiac infarction or cerebral infarction
- •7) Predictive survival period is les s than 1 year
- •8) Active infectious disease (HBV, HCV, HIV, syphilis)
- •9) Dialysis patients
- •10) Less than 20 years old
- •11) Patiens with dementia or coma
- •12) Previous surgical history for proximal femur
- •13) Anesthesist has determined that it is not suitable for general anesthesia
- •14) Doctor has determined that it is not suitable for this clinical study
研究者
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