A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 37
- 主要终点
- Wound Size, Amputation or Survival
研究概览
简要总结
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.
详细描述
This prospective, randomized, double-blind, placebo controlled study will assess the efficacy and safety of autologous ACPs administered intramuscularly into the lower extremity of subjects with CLI who lack surgical or endovascular revascularization options.
A total of approximately 95 subjects will be randomized to treatment with ACP-01 or placebo using a 2:1 randomization scheme, respectively, stratified by site.
The study will continue until all subjects treated experience the study event (either de novo gangrene, doubling of wound size, major amputation, or death) or are event-free for at least 26 weeks. Subjects treated will be followed for no longer than 52 weeks.
One futility analysis for potentially stopping study enrollment will be performed.
Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including intramuscular injection of the investigational medicinal product (IMP = ACP-01 or placebo). The IMP will be administered in addition to any conventional treatment the subject is receiving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is diagnosed with critical limb ischemia.
- •Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
- •Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
- •Subject must be on standard of care medical therapy for peripheral vascular disease.
- •Male or female age 18 and above.
- •Non-pregnant, non-lactating female.
- •Subject is able to understand and provide voluntary signed informed consent.
排除标准
- •Uncorrected aorto-iliac occlusive disease.
- •Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
- •Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
- •Lower extremity non-treated active infection.
- •Hypercoagulable state.
- •Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
- •Inability to communicate that may interfere with clinical evaluation.
- •Recent major non-vascular operation.
- •Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
- •Severe aortic stenosis.
- •Renal failure.
- •Hepatic failure.
- •Major stroke.
- •Diagnosis of malignancy.
- •Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
- •Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
- •Bleeding diathesis.
- •Participation at the same time in another investigational product or device study.
- •Chronic cytotoxic drug treatment.
- •Life expectancy of less than 6 months.
- •Subject unlikely to be available for follow-up.
- •Acute worsening of CLI.
结局指标
主要结局
Wound Size, Amputation or Survival
时间窗: Baseline vs. 1 year
Number of subject with doubling of wound size, major amputation or death
次要结局
- Ulcer Size(Baseline vs. 1 year)
- Pain Level(Baseline vs. 1 year)