NCT03006770已完成3 期
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
Pluristem Ltd.113 个研究点 分布在 7 个国家目标入组 213 人开始时间: 2017年5月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 113
- 主要终点
- Time to major amputation or death (AFS)
研究概览
简要总结
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.
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
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female subjects between ages 45-99 years of age.
- •CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)
- •Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI >1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)
- •Subject unsuitable for revascularization (by any method) in the index leg.
- •Ischemic lesions in the index leg stable for at least 2 weeks.
- •Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).
- •Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.
- •Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study.
- •Subject understood, agreed and provided informed consent. Patients must give written informed consent before any assessment is performed .
排除标准
- •Non-atherosclerotic PAD (e.g. Buerger's disease).
- •CLI with major tissue loss (Rutherford Category 6) in either leg.
- •Evidence of active infection (e.g., cellulitis, osteomyelitis).
- •Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening.
- •Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.
- •Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.
- •Life expectancy of less than 6 months.
- •Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.
- •Severe congestive heart failure symptoms (New York Heart Association [NYHA] class III-IV).
- •Uncontrolled severe hypertension.
- •Diabetes mellitus with HbA1c >10%.
- •Current or history of proliferative retinopathy.
- •Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections.
- •Subjects with international normalized ratio (INR) >
- •Subject on renal replacement therapy or planned to start renal replacement therapy within 3 months of first screening visit.
- •Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s), unless in long-term follow-up phase.
- •Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor.
- •Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin.
- •History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine.
- •Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
- •Active malignancy or history of malignancy within 5 years prior to study entry.
- •In the opinion of the investigator, the subject is unsuitable for participating in the study.
- •Chronic liver disease Child Pugh class B\C
结局指标
主要结局
Time to major amputation or death (AFS)
时间窗: Up to 36 months from enrollment
次要结局
- Time to first occurrence of any of the events (in index leg)-major amputation, revascularization due to worsening of CLI, All-cause mortality.(Up to 36 months from enrollment)
- Time to major amputation of the index leg.(Up to 36 months from enrollment)
- Change from baseline in ischemic pain as assessed by numerical rating scale (NRS) at 6 months.(6 months from enrollment)
- Proportion of subjects with complete healing of all ischemic lesions i.e., ulcers and necroses in the index leg at 12 months.(12 months from enrollment)
- Time (days) from randomization to occurrence of death.(Up to 36 months from enrollment)
研究者
研究点 (113)
Loading locations...
相似试验
已完成
3 期
A Study of Ocrelizumab in Participants With Primary Progressive Multiple SclerosisMultiple Sclerosis, Primary ProgressiveNCT01194570Hoffmann-La Roche735
已完成
3 期
Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer PatientsExtensive-stage Small-cell Lung CancerNCT04902885Jiangsu Simcere Pharmaceutical Co., Ltd.95
已完成
3 期
A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT02031744Hoffmann-La Roche530
招募中
3 期
QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical CancerMETASTATIC CERVICAL CANCERNCT05446883Qilu Pharmaceutical Co., Ltd.498
已完成
3 期
A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) MutationNon-Squamous Non-Small Cell Lung CancerNCT01887886Hoffmann-La Roche10