EUCTR2011-004091-12-DE进行中（未招募）1 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) - PLX-PAD 1204-01
Pluristem Ltd.0 个研究点目标入组 150 人开始时间: 2012年7月23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
- 150
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
入选标准
- •1. Adult male or female subjects between 45 to 85 years of age (inclusive) at the time of screening visit.
- •2. 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
- •3. 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)
- •4. Evidence of significant (>50%) stenosis infra-inguinal occlusive disease (distal to the common femoral artery) as confirmed by documented results from Duplex, MRA, CTA and/or contrast angiogram completed within 3 months prior to screening
- •5. 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).
- •6. 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 a vasodilatator prescribed for IC (including Cilostazol, Pentoxifylline, Naftidrofuryl, and prostanoids) if indicated. For Subjects that were previously receiving a vasodilatator, they should be washed out for at least 2 weeks prior to the first ETT.
- •7. 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.
- •8. Signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Ischemic rest pain; ulceration or gangrene (Fontaine class III-IV; Rutherford category 4-6).
- •2. Failed lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within the prior one month of screening.
- •3. Planned revascularization (surgical or endovascular intervention) within 12 months after screening.
- •4. Lower extremity arteries inflow obstruction (defined as a greater than 50% stenosis of aorta, iliac and/or common femoral arteries)
- •5. History of Buerger’s disease.
- •6. Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure >180mmHg during screening).
- •7. Uncontrolled diabetes defined as glucose control HbA1c > 8% (64mmol/mol) at screening.
- •8. Life-threatening ventricular arrhythmia - except in subjects with an implantable cardiac-defibrillator.
- •9. Serum Creatinine level>2.5mg/dl.
- •10. SGPT (ALT), SGOT (AST) >2.5 x upper limit of normal.
- •11. Hemoglobin < 10 g/dl.
- •12. 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.
- •13. Transient Ischemic Attack (TIA)/Stroke within 3 months prior to screening.
- •14. Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage III to IV).
- •15. Subjects with Implant of mechanical prosthetic heart valve(s).
- •16. Pulmomary disease requiring supplemental oxygen treatment on a daily basis.
- •17. Active significant infection including but not limited to osteomyelitis, fasciitis, or severe/purulent cellulitis.
- •18. History of malignancy within 5 years prior to screening including basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the treated leg (a subject with BCC or SCC of the opposite leg can be included).
- •19. 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.
- •20.Subjects who are on oral anticoagulant therapy. Unless, upon primary care physician and/or Investigator’s discretion treatment can be safely interrupted/discontinued around each IP injection to reduce risk of hemorrhage
- •21. Immunocompromised subjects for any reason, at screening.
- •22. Known allergies to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum, or recombinant trypsin used in the cell production process.
- •23. Known sensitivity to Gentamycin.
- •24. Known sentitivity to antihistamine drugs.
- •25. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic/hypersensitivity reactions.
- •26. History of acute transfusion reaction or history of autologous/allogeneic bone marrow or solid organ transplantation.
- •27. History of uncontrolled Asthma (GINA III-IV) or chronic urticarial.
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