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临床试验/NCT01679990
NCT01679990已完成2 期

A Phase II, Randomized, Double-Blind, Multicenter, Multinational, Placebo-Controlled, Parallel- Groups Study to Evaluate the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Treatment of Subjects With Intermittent Claudication (IC)

Pluristem Ltd.59 个研究点 分布在 4 个国家目标入组 180 人开始时间: 2012年11月5日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
180
试验地点
59
主要终点
Log ratio of week 52 maximal walking distance(MWD)to baseline MWD
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of the study is to establish the safety profile of

Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups:

  1. Double treatment of PLX-PAD low dose
  2. Double treatment of PLX-PAD high dose
  3. Double treatment of Placebo
  4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment.

The study will be comprised of 5 stages:

Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection

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, Care Provider)

入排标准

年龄范围
45 Years 至 85 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 45 to 85 years of age (inclusive) at the time of screening visit.
  • •Subjects with a diagnosis of peripheral artery disease, secondary to atherosclerosis, confirmed by one of the following criteria assessed at the screening visit:
  • •Resting ankle-brachial index (ABI) ≤ 0.80 or
  • •Resting ABI ≤ 0.90 and >20% decrease in ABI from rest to exercise when measured within 1 minute after treadmill exercise or
  • •Toe-brachial index (TBI) ≤ 0.60
  • •Lifestyle-limiting, moderate to severe claudication (symptoms present and stable for > 6 months and not significantly changed within the past 3 months prior to screening).
  • •Evidence of significant (>50%) stenosis infra-inguinal occlusive disease as confirmed by documented results from Duplex, MRA, CTA and/or contrast angiogram completed within 3 months prior to screening.
  • •The longest maximal walking distance (MWD) from the Screening Period exercise treadmill tests (ETT), utilizing a modified Gardner Protocol (Appendix I), must be between 1 and 10 minutes (inclusive).
  • •Subjects who have persistent claudication symptoms despite having been recommended an exercise program if feasible, and or despite having been on a stable dose of Cilostazol, if indicated. Subjects should be Cilostazol free for at least 2 weeks prior to the first ETT.
  • •Subjects should be receiving standard of care drugs for vascular disease including anti-platelet agent(s) and statin medication, as well as anti-hypertensive medication(s) and oral hypoglycemic agents/insulin, if indicated.
  • •Signed written informed consent.

排除标准

  • •Ischemic rest pain; ulceration or gangrene (Fontaine class III-IV; Rutherford category 4-6).
  • •Failed lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within the prior one month of screening.
  • •Planned revascularization (surgical or endovascular intervention) within 12 months after screening.
  • •Lower extremity arteries inflow obstruction (defined as a greater than 50% stenosis of aorta, iliac and/or common femoral arteries).
  • •History of Buerger's disease.
  • •Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 180 mmHg during screening).
  • •Uncontrolled diabetes defined as glucose control HbA1c > 9% at screening.
  • •Life-threatening ventricular arrhythmia - except in subjects with an implantable cardiac-defibrillator.
  • •Serum Creatinine level>2.5mg/dl.
  • •SGPT (ALT), SGOT (AST) >2.5 x upper limit of normal range.
  • •Hemoglobin < 10 g/dl.
  • •Unstable cardiovascular disease defined as myocardial infarction (STEMI or NSTEMI) within 3 months prior to screening, or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged episodes.
  • •Transient Ischemic Attack (TIA)/Stroke within 3 months prior to screening.
  • •Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage III to IV).
  • •Subjects with Implant of mechanical prosthetic heart valve(s).
  • •Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
  • •Severe, active infection of the involved extremity(ies), including osteomyelitis, fasciitis, or severe/purulent cellulitis.
  • •History of malignancy within 5 years prior screening requiring chemotherapy and/or radiotherapy and/or immunotherapy, excluding basal or squamous cell carcinoma of the skin.
  • •Exercise is limited by any condition other than IC, including but not limited to congestive heart failure, chronic pulmonary disease, angina pectoris, or degenerative joint disease.
  • •Uninterrupted use of warfarin or non-steroidal anti-inflammatory agents (with the exception of ibuprofen at doses up to 1,200 mg/day or Diclofenac at dose of 75mg/day).
  • •Subjects who are on oral anticoagulant therapy (warfarin, dabigatran, apixaban, endoxaban and rivaroxaban). Unless, upon primary care physician and/or Investigator's discretion the subjects who are on warfarin treatment can switch to Low Molecular Weight Heparin treatment (such as: Clexane) 5-7 days prior study treatment administration and return to warfarin treatment 24 hours post study treatment administration.
  • •Subjects who are taking immunosuppressive treatment (including high dose steroids).
  • •Known allergies to protein products (Bovine serum, or recombinant trypsin) used in the cell production process.
  • •Known sensitivity to Gentamycin.
  • •Known sensitivity to antihistamine drugs.
  • •History of hospitalization due to allergic/hypersensitivity reaction to any substance (e.g. Food or drug).
  • •Medical history of Human Immunodeficiency Virus (HIV) or syphilis positivity at time of screening.
  • •Known active Hepatitis B, or Hepatitis C infection at the time of screening.
  • •Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide).
  • •In the opinion of the Investigator, the subject is unsuitable for participating in the study.
  • •Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).
  • •Subjects that have prior exposure to gene or cell based therapy.
  • •Subjects who are legally detained in an official institute.

研究组 & 干预措施

PLX-PAD high dose +Placebo

Experimental

High dose+Placebo

干预措施: high dose +Placebo (Biological)

PLX-PAD high doses

Active Comparator

PLX-PAD double high dose

干预措施: PLX-PAD high doses (Biological)

Placebo

Placebo Comparator

Double Placebo doses

干预措施: Double Placebo (Biological)

PLX-PAD Low dose

Experimental

PLX-PAD double low doses

干预措施: PLX-PAD Low dose (Biological)

结局指标

主要结局

Log ratio of week 52 maximal walking distance(MWD)to baseline MWD

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Pluristem Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (59)

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