NCT01351610已完成1 期
Open, Randomized, Mono-Centre, Two-Parallel Group Clinical Phase I/II Trial on the Evaluation of Tolerability and Efficacy of an Intravenous Infusion of Human Bone Marrow Derived Autologous, CD34-Negative Mesenchymal Stem Cells for the Treatment of Critical Limb Ischemia in Patients With Advanced Peripheral Arterial Occlusive Disease Subsequent to Percutaneous Transluminal Angioplasty
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Collection of adverse events
研究概览
简要总结
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with peripheral arterial occlusive disease (symptomatic PAOD), diagnosis of CLI defined as persistent, recurring ischemic rest pain for at least 2 weeks, and/or ulceration or gangrene of the foot or toe, with an ABPI </= 0.5,
- •Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories,
- •Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator,
- •Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator,
排除标准
- •Patients with wounds of a severity of greater than grade 2 on the Wagner Scale,
- •Patients with life-threatening ventricular arrhythmia,
- •Patients with unstable angina pectoris,
- •Patients with severe congestive heart failure (i.e. NYHA Stage IV),
- •Patients with uncontrolled hypertension (defined as diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg during screening),
- •Patients with an uncontrolled diabetes mellitus (HbA1c > 9%),
- •Patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment,
- •Patients who are unsuitable for a MSC stem cell therapy in the opinion of the investigator,
研究组 & 干预措施
Group B
Experimental
干预措施: PTA (Procedure)
Group A
Experimental
干预措施: PTA + Infusion of MSC_Apceth (Biological)
结局指标
主要结局
Collection of adverse events
时间窗: one year
Safety laboratory values
时间窗: 1 year
Analysis of inflammation markers
时间窗: 1 year
ECG findings
时间窗: 1 year
次要结局
- Comparison of course of haemodynamic and vascular processes(1 year)
研究者
研究点 (1)
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