<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01679990</url>
  </required_header>
  <id_info>
    <org_study_id>PLX 1204-01</org_study_id>
    <nct_id>NCT01679990</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)</brief_title>
  <official_title>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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pluristem Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pluristem Ltd.</source>
  <brief_summary>
    <textblock>
      The objective of the study is to establish the safety profile of&#xD;
&#xD;
      Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects&#xD;
      comprising of 4 treatment groups:&#xD;
&#xD;
        1. Double treatment of PLX-PAD low dose&#xD;
&#xD;
        2. Double treatment of PLX-PAD high dose&#xD;
&#xD;
        3. Double treatment of Placebo&#xD;
&#xD;
        4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will&#xD;
           receive the assigned treatment twice to the affected leg, within 12-weeks interval&#xD;
           between each treatment.&#xD;
&#xD;
      The study will be comprised of 5 stages:&#xD;
&#xD;
      Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by&#xD;
      additional injection after 12 weeks and with follow-up of 12 months post second injection&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 5, 2012</start_date>
  <completion_date type="Actual">February 9, 2019</completion_date>
  <primary_completion_date type="Actual">March 29, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Log ratio of week 52 maximal walking distance(MWD)to baseline MWD</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Intermittent Claudication</condition>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>PLX-PAD Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PLX-PAD double low doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLX-PAD high doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PLX-PAD double high dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Double Placebo doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLX-PAD high dose +Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose+Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PLX-PAD Low dose</intervention_name>
    <arm_group_label>PLX-PAD Low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PLX-PAD high doses</intervention_name>
    <arm_group_label>PLX-PAD high doses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Double Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>high dose +Placebo</intervention_name>
    <arm_group_label>PLX-PAD high dose +Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male or female subjects between 45 to 85 years of age (inclusive) at the time of&#xD;
             screening visit.&#xD;
&#xD;
          -  Subjects with a diagnosis of peripheral artery disease, secondary to atherosclerosis,&#xD;
             confirmed by one of the following criteria assessed at the screening visit:&#xD;
&#xD;
               -  Resting ankle-brachial index (ABI) ≤ 0.80 or&#xD;
&#xD;
               -  Resting ABI ≤ 0.90 and &gt;20% decrease in ABI from rest to exercise when measured&#xD;
                  within 1 minute after treadmill exercise or&#xD;
&#xD;
               -  Toe-brachial index (TBI) ≤ 0.60&#xD;
&#xD;
          -  Lifestyle-limiting, moderate to severe claudication (symptoms present and stable for &gt;&#xD;
             6 months and not significantly changed within the past 3 months prior to screening).&#xD;
&#xD;
          -  Evidence of significant (&gt;50%) stenosis infra-inguinal occlusive disease as confirmed&#xD;
             by documented results from Duplex, MRA, CTA and/or contrast angiogram completed within&#xD;
             3 months prior to screening.&#xD;
&#xD;
          -  The longest maximal walking distance (MWD) from the Screening Period exercise&#xD;
             treadmill tests (ETT), utilizing a modified Gardner Protocol (Appendix I), must be&#xD;
             between 1 and 10 minutes (inclusive).&#xD;
&#xD;
          -  Subjects who have persistent claudication symptoms despite having been recommended an&#xD;
             exercise program if feasible, and or despite having been on a stable dose of&#xD;
             Cilostazol, if indicated. Subjects should be Cilostazol free for at least 2 weeks&#xD;
             prior to the first ETT.&#xD;
&#xD;
          -  Subjects should be receiving standard of care drugs for vascular disease including&#xD;
             anti-platelet agent(s) and statin medication, as well as anti-hypertensive&#xD;
             medication(s) and oral hypoglycemic agents/insulin, if indicated.&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ischemic rest pain; ulceration or gangrene (Fontaine class III-IV; Rutherford category&#xD;
             4-6).&#xD;
&#xD;
          -  Failed lower extremity arterial reconstruction (surgical or endovascular) or&#xD;
             sympathectomy within the prior one month of screening.&#xD;
&#xD;
          -  Planned revascularization (surgical or endovascular intervention) within 12 months&#xD;
             after screening.&#xD;
&#xD;
          -  Lower extremity arteries inflow obstruction (defined as a greater than 50% stenosis of&#xD;
             aorta, iliac and/or common femoral arteries).&#xD;
&#xD;
          -  History of Buerger's disease.&#xD;
&#xD;
          -  Uncontrolled hypertension (defined as diastolic blood pressure &gt; 100 mmHg or systolic&#xD;
             blood pressure &gt; 180 mmHg during screening).&#xD;
&#xD;
          -  Uncontrolled diabetes defined as glucose control HbA1c &gt; 9% at screening.&#xD;
&#xD;
          -  Life-threatening ventricular arrhythmia - except in subjects with an implantable&#xD;
             cardiac-defibrillator.&#xD;
&#xD;
          -  Serum Creatinine level&gt;2.5mg/dl.&#xD;
&#xD;
          -  SGPT (ALT), SGOT (AST) &gt;2.5 x upper limit of normal range.&#xD;
&#xD;
          -  Hemoglobin &lt; 10 g/dl.&#xD;
&#xD;
          -  Unstable cardiovascular disease defined as myocardial infarction (STEMI or NSTEMI)&#xD;
             within 3 months prior to screening, or unstable angina - characterized by increasingly&#xD;
             frequent episodes with modest exertion or at rest, worsening severity, and prolonged&#xD;
             episodes.&#xD;
&#xD;
          -  Transient Ischemic Attack (TIA)/Stroke within 3 months prior to screening.&#xD;
&#xD;
          -  Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage III to IV).&#xD;
&#xD;
          -  Subjects with Implant of mechanical prosthetic heart valve(s).&#xD;
&#xD;
          -  Pulmonary disease requiring supplemental oxygen treatment on a daily basis.&#xD;
&#xD;
          -  Severe, active infection of the involved extremity(ies), including osteomyelitis,&#xD;
             fasciitis, or severe/purulent cellulitis.&#xD;
&#xD;
          -  History of malignancy within 5 years prior screening requiring chemotherapy and/or&#xD;
             radiotherapy and/or immunotherapy, excluding basal or squamous cell carcinoma of the&#xD;
             skin.&#xD;
&#xD;
          -  Exercise is limited by any condition other than IC, including but not limited to&#xD;
             congestive heart failure, chronic pulmonary disease, angina pectoris, or degenerative&#xD;
             joint disease.&#xD;
&#xD;
          -  Uninterrupted use of warfarin or non-steroidal anti-inflammatory agents (with the&#xD;
             exception of ibuprofen at doses up to 1,200 mg/day or Diclofenac at dose of 75mg/day).&#xD;
&#xD;
          -  Subjects who are on oral anticoagulant therapy (warfarin, dabigatran, apixaban,&#xD;
             endoxaban and rivaroxaban). Unless, upon primary care physician and/or Investigator's&#xD;
             discretion the subjects who are on warfarin treatment can switch to Low Molecular&#xD;
             Weight Heparin treatment (such as: Clexane) 5-7 days prior study treatment&#xD;
             administration and return to warfarin treatment 24 hours post study treatment&#xD;
             administration.&#xD;
&#xD;
          -  Subjects who are taking immunosuppressive treatment (including high dose steroids).&#xD;
&#xD;
          -  Known allergies to protein products (Bovine serum, or recombinant trypsin) used in the&#xD;
             cell production process.&#xD;
&#xD;
          -  Known sensitivity to Gentamycin.&#xD;
&#xD;
          -  Known sensitivity to antihistamine drugs.&#xD;
&#xD;
          -  History of hospitalization due to allergic/hypersensitivity reaction to any substance&#xD;
             (e.g. Food or drug).&#xD;
&#xD;
          -  Medical history of Human Immunodeficiency Virus (HIV) or syphilis positivity at time&#xD;
             of screening.&#xD;
&#xD;
          -  Known active Hepatitis B, or Hepatitis C infection at the time of screening.&#xD;
&#xD;
          -  Pregnant or breast-feeding women or women of childbearing age not protected by an&#xD;
             effective contraceptive method of birth control (such as double barrier, oral or&#xD;
             parenteral hormonal, intrauterine device and spermicide).&#xD;
&#xD;
          -  In the opinion of the Investigator, the subject is unsuitable for participating in the&#xD;
             study.&#xD;
&#xD;
          -  Subject is currently enrolled in, or has not yet completed a period of at least 30&#xD;
             days since ending other investigational device or drug trial(s).&#xD;
&#xD;
          -  Subjects that have prior exposure to gene or cell based therapy.&#xD;
&#xD;
          -  Subjects who are legally detained in an official institute.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Denham, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Trials of Texas, Inc. 7940 Floyd Curl drive, Suite 700, San Antonio, Texas 78229</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Hampsey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampa Bay Medical research, 3251 McMullen Booth Road, STE 303, Clearwater, FL 33761</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Schulyer Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University,Durham, North Carolina, 27705, USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bret Weichmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida research Network, LLC 6800NW 9th Blvd Suite1, Gainesville, Florida 32605</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey W Olin, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular Institute, Mount Sinai School of Medicine , One Gustave L. Levy Place, New York, NY 10029</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alan T Hirsch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular Division, MMC 508, University of Minnesota Medical school, Minneapolis, MN 55455</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sibu P. Saha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky, Lexington, KY 40506-0057</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David L Fried, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omega Medical Research, Warwick, RI 02886</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berthold Amann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Franziskus-Krankenhaus, Berlin Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norbert Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Carl Gustav Carus, Dresden, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sigrid Nikol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASKLEPIOS Klinik St. Georg, Hamburg Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Malcolm Foster, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turkey Creek Medical Center, Knoxville TN 37934</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kathleen Cullen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DMI Research, 6699 90th Ave. North, Pinellas Park FL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohler Emile, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital of the University of Pennsylvania, Philadelphia, PA 19104</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nadarajah Janaki, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aiyan Diabetes Center, Evans, GA 30809</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Reuven Zimlichman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Edith Wolfson Medical Center,62 HaLohamim Street, Holon, Israel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Changyoung Lim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHA Bundang Medical Center, CHA University, 59 Yatap-ro Bundang-Gu, Seongnam-Si, Gyeonggi-do 463-712, Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Weonyong Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hallym University Sacred Heart Hospital 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 431-796, Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sungwon Chung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Hospital 179 Gudeok-Ro Seo-Gu, Busan, 602-739, Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yousun Hong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaeseung Shin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kwangjo Cho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dong-A University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dokyun Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Health Insurance Service Ilsan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joonhyuk Kong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kangbuk Samsung Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefan Betge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Jena</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Holger Reinecke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Münster</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Oliver Müller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinik Heidelberg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erwin Blessing, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Karlsbad-Langensteinbach</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Zeller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universtiäts-Herzzentrum Freiburg und Bad-Krozingen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christine Espinola-Klein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johannes Gutenberg University Mainz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiology, P. C. and Center for Therapeutic Angiogenesis</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Bay Medical Research</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Researc Network, LLC</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DMI Research</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Nadarajah Janaki</name>
      <address>
        <city>Evans</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Research Foundation</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40506-0057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Division, MMC, University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Institute, Mount Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Mohler Emile</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Center</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turkey Creek Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>10820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universtiäts-Herzzentrum Freiburg und Bad-Krozingen</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franziskus-Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASKLEPIOS Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>97747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRH Klinikum Karlsbad-Langensteinbach</name>
      <address>
        <city>Karlsbad</city>
        <zip>76307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Mor&quot; Instituite, Horev M.C</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edith Wolson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Seo-gu</city>
        <state>Busan</state>
        <zip>602-715</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan</city>
        <state>Gyeonggi-do</state>
        <zip>425-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Health Insurance Service Ilsan Hospital</name>
      <address>
        <city>Ilsandong-gu, Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>410-719</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi-do</state>
        <zip>443-380</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Sungwon Chung</name>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Weonyong Lee</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>431-796</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Changyoung Lim</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>463-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>110-746</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Israel</country>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 2, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Intermittent Claudication</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01679990
org study id: PLX 1204-01
nct id: NCT01679990
lead sponsor: 
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Log ratio of week 52 maximal walking distance(MWD)to baseline MWD
time frame: 12 months
arm group label: PLX-PAD Low dose
arm group type: Experimental
description: PLX-PAD double low doses
arm group label: PLX-PAD high doses
arm group type: Active Comparator
description: PLX-PAD double high dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Double Placebo doses
arm group label: PLX-PAD high dose +Placebo
arm group type: Experimental
description: High dose+Placebo
intervention type: Biological
intervention name: PLX-PAD Low dose
arm group label: PLX-PAD Low dose
intervention type: Biological
intervention name: PLX-PAD high doses
arm group label: PLX-PAD high doses
intervention type: Biological
intervention name: Double Placebo
arm group label: Placebo
intervention type: Biological
intervention name: high dose +Placebo
arm group label: PLX-PAD high dose +Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Douglas Denham, DO
role: Principal Investigator
affiliation: Clinical Trials of Texas, Inc. 7940 Floyd Curl drive, Suite 700, San Antonio, Texas 78229
last name: James Hampsey, MD
role: Principal Investigator
affiliation: Tampa Bay Medical research, 3251 McMullen Booth Road, STE 303, Clearwater, FL 33761
last name: Schulyer Jones, MD
role: Principal Investigator
affiliation: Duke University,Durham, North Carolina, 27705, USA
last name: Bret Weichmann, MD
role: Principal Investigator
affiliation: Florida research Network, LLC 6800NW 9th Blvd Suite1, Gainesville, Florida 32605
last name: Jeffrey W Olin, DO
role: Principal Investigator
affiliation: Cardiovascular Institute, Mount Sinai School of Medicine , One Gustave L. Levy Place, New York, NY 10029
last name: Alan T Hirsch, MD
role: Principal Investigator
affiliation: Cardiovascular Division, MMC 508, University of Minnesota Medical school, Minneapolis, MN 55455
last name: Sibu P. Saha, MD
role: Principal Investigator
affiliation: University of Kentucky, Lexington, KY 40506-0057
last name: David L Fried, MD
role: Principal Investigator
affiliation: Omega Medical Research, Warwick, RI 02886
last name: Berthold Amann, MD
role: Principal Investigator
affiliation: Franziskus-Krankenhaus, Berlin Germany
last name: Norbert Weiss, MD
role: Principal Investigator
affiliation: Universitätsklinikum Carl Gustav Carus, Dresden, Germany
last name: Sigrid Nikol, MD
role: Principal Investigator
affiliation: ASKLEPIOS Klinik St. Georg, Hamburg Germany
last name: Malcolm Foster, MD
role: Principal Investigator
affiliation: Turkey Creek Medical Center, Knoxville TN 37934
last name: Kathleen Cullen, MD
role: Principal Investigator
affiliation: DMI Research, 6699 90th Ave. North, Pinellas Park FL
last name: Mohler Emile, M.D
role: Principal Investigator
affiliation: Hospital of the University of Pennsylvania, Philadelphia, PA 19104
last name: Nadarajah Janaki, M.D
role: Principal Investigator
affiliation: Aiyan Diabetes Center, Evans, GA 30809
last name: Reuven Zimlichman, MD
role: Principal Investigator
affiliation: Edith Wolfson Medical Center,62 HaLohamim Street, Holon, Israel
last name: Changyoung Lim, MD
role: Principal Investigator
affiliation: CHA Bundang Medical Center, CHA University, 59 Yatap-ro Bundang-Gu, Seongnam-Si, Gyeonggi-do 463-712, Korea
last name: Weonyong Lee, MD
role: Principal Investigator
affiliation: Hallym University Sacred Heart Hospital 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 431-796, Korea
last name: Sungwon Chung, MD
role: Principal Investigator
affiliation: Pusan National University Hospital 179 Gudeok-Ro Seo-Gu, Busan, 602-739, Korea
last name: Yousun Hong, MD
role: Principal Investigator
affiliation: Ajou University School of Medicine
last name: Jaeseung Shin, MD
role: Principal Investigator
affiliation: Korea University
last name: Kwangjo Cho, MD
role: Principal Investigator
affiliation: Dong-A University Hospital
last name: Dokyun Kim, MD
role: Principal Investigator
affiliation: National Health Insurance Service Ilsan Hospital
last name: Joonhyuk Kong, MD
role: Principal Investigator
affiliation: Kangbuk Samsung Hospital
last name: Stefan Betge, MD
role: Principal Investigator
affiliation: Universitätsklinikum Jena
last name: Holger Reinecke, MD
role: Principal Investigator
affiliation: Universitätsklinikum Münster
last name: Oliver Müller, MD
role: Principal Investigator
affiliation: Universitätsklinik Heidelberg
last name: Erwin Blessing, MD
role: Principal Investigator
affiliation: Klinikum Karlsbad-Langensteinbach
last name: Thomas Zeller, MD
role: Principal Investigator
affiliation: Universtiäts-Herzzentrum Freiburg und Bad-Krozingen
last name: Christine Espinola-Klein, MD
role: Principal Investigator
affiliation: Johannes Gutenberg University Mainz
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country: Germany
country: Israel
country: Korea, Republic of
country: United States
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Intermittent Claudication