EUCTR2015-005532-18-DE进行中（未招募）1 期
A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Phase III Study 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 who are Unsuitable for Revascularization (PACE Study)
Pluristem Ltd.0 个研究点目标入组 300 人开始时间: 2016年6月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult male or female subjects between ages 45-99 years of age at the
- •time of screening.
- •2. Subjects with a diagnosis of PAD due to atherosclerosis at the stage of
- •CLI, with minor tissue loss from arterial disease, up to the ankle level
- •(the line between the top of the two malleoli) (black toe due to CLI is
- •acceptable if not infected).
- •3. Total area of ischemic lesions =20cm2 (not including black toes).
- •4. Total area of ischemic lesions in the heel =10cm2.
- •5. AP =70 mmHg or TP =50 mmHg in the index leg. If a subject has both
- •ABI >1.4 or both AP and TP are not measureable or not reliable,
- •inclusion may be based on TcPO2 =30 mmHg.
- •6. Subject unsuitable for revascularization (by any method) in the index
- •leg based on unfavorable risk-benefit assessment of a multidisciplinary
- •team including a vascular surgeon, and an interventionist/endovascular
- •specialist (who might be a vascular surgeon,
- •angiologist/cardiologist/internist, interventional radiologist), and, if
- •relevant, an anesthesiologist, confirmed once during Screening Period.
- •Unsuitability to revascularization is based any of the following:
- •? Anatomic considerations as: inappropriate target artery,
- •diffuse/extensive tibial and/or peroneal artery lesions, inadequate distal
- •? Technical considerations as: inappropriate bypass conduit
- •?Failed revascularization (with persistence of CLI as defined in this
- •? Medical considerations: subject's comorbidities.
- •7. Ischemic lesions in the index leg must not have closed during the
- •Screening Period, nor significantly worsened.
- •8. Ischemic ulcers in the index leg without tendon or bone exposure
- •during Screening Period, unless the exposure is secondary to a minor
- •amputation and there are no signs of osteomyelitis as per clinical
- •assessment and imaging.
- •9. Under treatment for cardiovascular risk factors: hypertension,
- •hyperlipidemia, diabetes, in accordance with applicable guidelines, in
- •order to achieve their stabilization. Concomitant therapy should include
- •a statin (or other lipid lowering drugs as part of standard of care) and an
- •anti-platelet agent (e.g., clopidogrel, aspirin, etc.) for at least 2 weeks
- •prior to randomization as part of standard of care (unless
- •contraindicated or unless subject is under chronic oral anticoagulation).
- •Subject has received recommendations on lifestyle changes (including
- •smoking cessation) prior to randomization.
- •10. 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:
- •a. Oral/intravaginal/transdermal combined estrogen and progestogen
- •containing hormonal contraception for at least 3 months prior to
- •b. Oral/injectable/implantable progestogen-only hormonal
- •contraception for at least 3 months prior to screening
- •c. An intrauterine device (IUD) or intrauterine hormone-releasing
- •system (IUS)
- •Any female subject who is surgically sterile, or with bilateral tubal
- •occlusion, or whose partner is vasectomized, or who reliably applies
- •sexual abstinence or who is postmenopausal (2 years without menses)
- 另有 7 项未显示
排除标准
- •1. Non-atherosclerotic PAD
- •2. CLI with major tissue loss (Rutherford Category 6) in either leg.
- •3. Evidence of active infection in either leg (e.g., cellulitis,
- •osteomyelitis).
- •4. Subject having undergone surgical revascularization or major
- •amputation, in either leg, less than 1mth prior to screening, or
- •endovascular revascularization or minor amputation less than 2wks prior
- •to screening
- •5. Planned or potential need for major/minor amputation or any
- •revascularization of either leg during the Screening Period and up to
- •1mth following randomization according to Investigator's or treating
- •physician judgment/decision.
- •6. Aortoiliac stenosis or common femoral artery stenosis =70%, or
- •otherwise suspicion of inadequate inflow to the index leg up to 3 months
- •prior to screening by any imaging modality.
- •7. Current evidence or sign supporting an assessment of life expectancy
- •of less than 6mths
- •8. Stroke or acute myocardial infarction/unstable angina within 3mths
- •prior to randomization
- •9. Severe congestive heart failure symptoms (New York Heart
- •Association class III- IV) at screening
- •10. Life-threatening ventricular arrhythmia except in subjects with an
- •implantable cardiac-defibrillator at screening
- •11. Uncontrolled severe hypertension during screening period
- •12. Diabetes mellitus with HbA1c >10% at screening
- •13. Current or history of proliferative retinopathy (for all known diabetic
- •subjects there will be no evidence of proliferative retinopathy in a retinal
- •examination performed within 3mths before First Screening Visit or
- •during screening)
- •14. Known active untreated Hepatitis B virus or Hepatitis C virus
- •infections at screening
- •15. A subject with known human immunodeficiency virus infection,
- •acquired immunodeficiency syndrome, severe uncontrolled inflammatory
- •disease or severe uncontrolled autoimmune disease
- •16. Pre-existing significant coagulopathies that put the subject at an
- •increased risk of blood clotting or bleeding according to the
- •Investigator's judgment
- •17. Subjects under chronic anticoagulant therapy taking warfarin with
- •international normalized ratio (INR)>2 or treated with Direct Oral
- •Anticoagulants, for atrial fibrillation and\or prosthetic heart valves, and
- •or thromboembolic events, unless this therapy can be safely
- •discontinued or modified around the time of PLX-PAD/placebo injections
- •based on the study Investigator's discretion.
- •18. Aspartate transaminase or alanine transaminase >3×ULN. Subjects
- •with higher levels may be included if the condition associated with the
- •increase in those liver enzymes is known and considered clinically stable
- •19. Subject on renal replacement therapy or planned to start renal
- •replacement therapy within 3 months of first screening visit.
- •20. Known history of drug or alcohol abuse in the past 3yrs
- •21. Subject is currently enrolled in, or has not yet completed a period of
- 另有 11 项未显示
研究者
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