A Phase I Safety Study Following the Infusion of Expanded Autologous Progeny of an Adult CD34+ Stem Cell Subset to Patients With Recent Tibial Fractures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To assess the safety of expanded autologous progeny of an adult CD34+ stem cell subset when introduced into the tibial artery and to determine absence of adverse events at the maximum dose of cells of 1,000,000,000 cells in a dose escalation regime.
研究概览
简要总结
The aim of this trial is to determine the safety and tolerability of expanded autologous progeny of an adult CD34+ (haemopoietic) stem cell subset when infused directly into the tibial artery of patients with recent tibial fracture. The trial will also seek to determine clinical improvement or deterioration by measurement of clinical parameters such as, length of time to union of the fracture, changes in bone mineral density, improvements in pain scores (VAS), functional ability (TUGT) and IPAQ scores.
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
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed closed tibial fracture on one limb only
- •Normal blood count
- •Normal coagulation screen
- •Life expectancy of at least 12 months
- •Ability to give written informed consent
排除标准
- •Patients with additional lower limb injuries
- •Patients with abnormal lower limb vasculature
- •Pregnant or lactating women
- •Unexplained abnormal baseline laboratory results
- •Males and females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study
- •Subjects who test positive for HTLV, HIV, hepatitis B or hepatitis C, have a chronic inflammatory disease, autoimmune disease or are on chronic immunosuppressive medications
- •History of alcohol or drug abuse within 3 months of screening
- •Subjects with evidence (clinical, laboratory, or imaging) of cancer or cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma)
- •Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period
- •Patients unable to give written informed consent
结局指标
主要结局
To assess the safety of expanded autologous progeny of an adult CD34+ stem cell subset when introduced into the tibial artery and to determine absence of adverse events at the maximum dose of cells of 1,000,000,000 cells in a dose escalation regime.
时间窗: 1 year
次要结局
- To assess improvement in bony union as measured by imaging modalities and determine whether there are any significant improvements in early restoration of function as reported by the patients.(1 year)