NCT00951210已完成1 期
Phase I Study of Intramuscular (IM) Injections of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia. PLX-PAD Are Mesenchymal-Like Stromal Cells Derived From a Full Term Placenta.
Pluristem Ltd.4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年8月1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
- 12
- 试验地点
- 4
- 主要终点
- Immunological reaction
研究概览
简要总结
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with ABI < 0.6 or/and TBI < 0.4
- •Rutherford category 4-5
- •Non candidate for revascularization or endovascular intervention based on unfavorable vascular anatomy or significant co-morbid medical conditions as confirmed by vascular study (e.g., angiogram, MRA) obtained within 3 months prior screening visit and signed approval of vascular surgeon. The decision to classify the subject as a non-candidate will be made by the investigator and confirmed by an independent third party vascular surgeon who is not participating in the study.
- •In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
- •Those diabetic subjects who are on optimal diabetes medication, with an HbA1c < 8%
排除标准
- •Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
- •Wounds with severity greater than Grade 2 on the Wagner Scale
- •Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged.
- •ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior to enrollment.Patients with severe congestive heart failure (i.e. NYHA Stage IV)
- •In the opinion of the investigator, the patient is unsuitable for cellular therapy.
结局指标
主要结局
Immunological reaction
时间窗: 3 months
Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (4)
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