EUCTR2006-004521-28-GB进行中（未招募）1 期
A multi-centre phase I/II safety and tolerability study following the infusion of expanded autologous progeny of an adult CD34 positive stem cell subset to patients with recent tibial fractures.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients aged 17 years and above
- •Confirmed closed tibial fracture
- •Normal blood count
- •Normal coagulation screen
- •Life expectancy of at least 12 months
- •Able to give written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients below the age of 17 years
- •Pregnant or lactating women
- •Patients with unexplained abnormal baseline laboratory results
- •Patients who test positive for HIV, HTLV, Hepatitis B or C, have a chronic inflammatory disease, autoimmune disease or who are on chronic immunosupressive medications.
- •Patients with a history of alcohol or drug abuse within 3 months of screening
- •Patients with evidence of cancer or cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in-situ cervical carcinoma)
- •Patients unable to give written informed consent
- •Patients who have been involved in any other trial that has not completed the required follow-up period.
研究者
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