<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/NCT03006770</url>
  </required_header>
  <id_info>
    <org_study_id>PLX-CLI-03</org_study_id>
    <nct_id>NCT03006770</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pluristem Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pluristem Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III&#xD;
      study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular&#xD;
      Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with&#xD;
      Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>Phase 3</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to major amputation or death (AFS)</measure>
    <time_frame>Up to 36 months from enrollment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first occurrence of any of the events (in index leg)-major amputation, revascularization due to worsening of CLI, All-cause mortality.</measure>
    <time_frame>Up to 36 months from enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to major amputation of the index leg.</measure>
    <time_frame>Up to 36 months from enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ischemic pain as assessed by numerical rating scale (NRS) at 6 months.</measure>
    <time_frame>6 months from enrollment</time_frame>
    <description>NRS measures the intensity or magnitude of sensations and subject feelings and the relative strength of attitudes and opinions about specific stimuli, on a scale of 0 to 10 with a score of zero denoting &quot;no pain at all&quot; and a score of 10 denoting &quot;worst possible pain&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with complete healing of all ischemic lesions i.e., ulcers and necroses in the index leg at 12 months.</measure>
    <time_frame>12 months from enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (days) from randomization to occurrence of death.</measure>
    <time_frame>Up to 36 months from enrollment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Critical Limb Ischemia (CLI)</condition>
  <arm_group>
    <arm_group_label>PLX-PAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PLX-PAD will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PLX-PAD</intervention_name>
    <description>Local intramuscular (IM) injections of PLX-PAD in the index leg.</description>
    <arm_group_label>PLX-PAD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Local intramuscular (IM) injections of Placebo in the index leg.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult male or female subjects between ages 45-99 years of age.&#xD;
&#xD;
          2. CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)&#xD;
&#xD;
          3. Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI&#xD;
             &gt;1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)&#xD;
&#xD;
          4. Subject unsuitable for revascularization (by any method) in the index leg.&#xD;
&#xD;
          5. Ischemic lesions in the index leg stable for at least 2 weeks.&#xD;
&#xD;
          6. Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to&#xD;
             a minor amputation).&#xD;
&#xD;
          7. Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia,&#xD;
             diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin&#xD;
             and an anti-platelet agent for at least 2 weeks prior to randomization.&#xD;
&#xD;
          8. Women of childbearing potential must have a negative serum pregnancy test at screening&#xD;
             and must be willing to use at least one highly effective birth control method&#xD;
             throughout the study.&#xD;
&#xD;
          9. Subject understood, agreed and provided informed consent. Patients must give written&#xD;
             informed consent before any assessment is performed .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-atherosclerotic PAD (e.g. Buerger's disease).&#xD;
&#xD;
          2. CLI with major tissue loss (Rutherford Category 6) in either leg.&#xD;
&#xD;
          3. Evidence of active infection (e.g., cellulitis, osteomyelitis).&#xD;
&#xD;
          4. Subject having undergone surgical revascularization or major amputation less than 1&#xD;
             month prior to screening, or endovascular revascularization or minor amputation less&#xD;
             than 2 weeks prior to screening.&#xD;
&#xD;
          5. Planned or potential need for major/minor amputation or any revascularization within 1&#xD;
             month of study entry upon investigator's judgment.&#xD;
&#xD;
          6. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of&#xD;
             inadequate inflow to the leg.&#xD;
&#xD;
          7. Life expectancy of less than 6 months.&#xD;
&#xD;
          8. Stroke or acute myocardial infarction/unstable angina within 3 months prior to&#xD;
             screening.&#xD;
&#xD;
          9. Severe congestive heart failure symptoms (New York Heart Association [NYHA] class&#xD;
             III-IV).&#xD;
&#xD;
         10. Uncontrolled severe hypertension.&#xD;
&#xD;
         11. Diabetes mellitus with HbA1c &gt;10%.&#xD;
&#xD;
         12. Current or history of proliferative retinopathy.&#xD;
&#xD;
         13. Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome&#xD;
             (AIDS) infections.&#xD;
&#xD;
         14. Subjects with international normalized ratio (INR) &gt;2.&#xD;
&#xD;
         15. Subject on renal replacement therapy or planned to start renal replacement therapy&#xD;
             within 3 months of first screening visit.&#xD;
&#xD;
         16. Subject is currently enrolled in, or has not yet completed a period of at least 30&#xD;
             days since ending another investigational device or drug trial(s), unless in long-term&#xD;
             follow-up phase.&#xD;
&#xD;
         17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar&#xD;
             sympathectomy, wound dressing containing cells or growth factors, or topical platelet&#xD;
             derived growth factor.&#xD;
&#xD;
         18. Known allergies to any of the following: DMSO, human serum albumin, bovine serum&#xD;
             albumin.&#xD;
&#xD;
         19. History of allergic/hypersensitivity reaction to any substance having required&#xD;
             hospitalization and/or treatment with IV steroids/epinephrine.&#xD;
&#xD;
         20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis.&#xD;
&#xD;
         21. Active malignancy or history of malignancy within 5 years prior to study entry.&#xD;
&#xD;
         22. In the opinion of the investigator, the subject is unsuitable for participating in the&#xD;
             study.&#xD;
&#xD;
         23. Chronic liver disease Child Pugh class B\C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UCI Medical Center 101 The City Drive S. Bldg 55 Rm 334 Orange, CA 92868</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Center ∣ Department of Surgery ∣ UC Davis Health 4860 Y street, Sacramento, CA suite #3400, 95817</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Center,Department of Surgery,UC Davis Health,4860 Y street</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136-1015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cardiac and Vascular Institute Baptist Health South Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center (TMC) (Tufts-New England Medical Center)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111-1552</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North.</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Medical Center</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health Comprehensive Wound Healing Center</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai St. Luke's hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019-1147</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center,Durham,2424 Erwin Road Hock Plaza</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Heart Clinical Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Plastic Surgery ,Ut Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Virgin Mary&quot; EOOD,Clinic of Vascular Surgery</name>
      <address>
        <city>Burgas</city>
        <zip>8127</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Sveti Nokolay Chudotvorets EOOD - Lom,Surgery Department,Address 2, Todor Kableshkov str.</name>
      <address>
        <city>Lom</city>
        <zip>3600</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;St. Georgi&quot; EAD,Clinic: Vascular Surgery and Angiology 66 &quot;Peshtersko Shosse&quot; Blvd., 8th floor, Hirurgicheski blok</name>
      <address>
        <city>Plovdiv</city>
        <zip>4001</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMBAL Kanev AD - Ruse,Department of Vascular Surgery Address: 2, Nezavisimost str</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Medica&quot; Ruse Department of Vascular Surgery 35, &quot;Riga&quot;, Str Post code: 7013 Ruse, Bulgaria</name>
      <address>
        <city>Ruse</city>
        <zip>7013</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT National Heart Hospital EAD,Clinic of Vascular Surgery and angiology</name>
      <address>
        <city>Sofia</city>
        <zip>1309</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic MHAT Tokuda, Vascular Surgery and Angiology 51B &quot;Nikola Vaptzarov&quot; Blvd</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;St. Ekaterina&quot; EAD, Departement of Vascular Surgery</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cevni ambulance</name>
      <address>
        <city>Hodonín</city>
        <zip>69501</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angiologicka ambulance</name>
      <address>
        <city>Ostrava Dubina</city>
        <zip>700 30</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna Fakultni Nemocnice v Praze</name>
      <address>
        <city>Prague</city>
        <zip>12802</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intitute of Clinical and Experimental Medicine</name>
      <address>
        <city>Praha 4</city>
        <zip>140 21</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krajska zdravotni a.s., Masarykova nemocnice o.z.</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>40113</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Angiologie Universitätsklinikum Leipzig AöR Liebigstr. 20 04103 Leipzig, Germany</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medinos Klinikum Sonneberg Abteilung für Kardiologie/Angiologie - Studienambulanz Neustadter Straße 61 96515 Sonneberg Germany</name>
      <address>
        <city>Sonneberg</city>
        <state>Thueringen</state>
        <zip>96515</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitats-Herzzentrum Freiburg</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Centrum fur Herz - Kreislauf - und Gefassmedizin - Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Berlin-Buch, Klinik fur Angiologie</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <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>Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St.Georg-Angiologische Ambulanz</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Kösching Krankenhausstr. 19, 85092 Kösching Germany</name>
      <address>
        <city>Kösching</city>
        <zip>85092</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Muenster</name>
      <address>
        <city>Muenster</city>
        <zip>48155</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz</name>
      <address>
        <city>Szekesfehervar</city>
        <state>Fejer</state>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent Imre Egyetemi Oktato Korhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1115</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flor Ferenc County Hospital</name>
      <address>
        <city>Kistarcsa</city>
        <zip>2143</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>B-A-Z County and University Teaching Hospital</name>
      <address>
        <city>Miskolc</city>
        <zip>3526</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Josa Andras Megyei Korhaz</name>
      <address>
        <city>Nyíregyháza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)</name>
      <address>
        <city>Pecs</city>
        <zip>7624</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <zip>78100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blood Vessel Day Care at Clalit Community Horev Center, Horev Center</name>
      <address>
        <city>Haifa</city>
        <zip>3434119</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Surgery Department, Hadassah Ein Karem MC</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Surgery Department Rabin Medical Center Beilinson Hospital, 39 Jabotinski St. Petah Tikva Israel 4941492</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiological Department, The Baruch Padeh Medical Center</name>
      <address>
        <city>Poriyya 'Illit</city>
        <zip>15208</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem Sistina Hospital,Thoracic and Vascular Surgery</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Re-Medika General Hospital,Cardiovascular Surgery</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Special Hospital for Surgical Diseases Zan Mitrev Clinic ,Cardiovascular Surgery</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cathedra and Clinic of Vascular Surgery and Angiology-Klinika Chirurgii Naczyniowej i Angiologii</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy,Intensywnego Nadzoru Kardlologleznego,</name>
      <address>
        <city>Wrocław</city>
        <zip>51-124</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vascular Research Clinical Research Centre Beaufort Way Southmead Hospital Westbury on Trym Bristol</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hull And East Yorkshire Women And Children's Hospital-Hull And East Yorkshire Hospitals Nhs Trust</name>
      <address>
        <city>Hull</city>
        <zip>HU32JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Vascular Research, St George's Hospital</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>North Macedonia</country>
    <country>Poland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
    <country>Macedonia, The Former Yugoslav Republic of</country>
  </removed_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 23, 2020</last_update_submitted>
  <last_update_submitted_qc>December 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2020</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>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT03006770
org study id: PLX-CLI-03
nct id: NCT03006770
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Time to major amputation or death (AFS)
time frame: Up to 36 months from enrollment
measure: Time to first occurrence of any of the events (in index leg)-major amputation, revascularization due to worsening of CLI, All-cause mortality.
time frame: Up to 36 months from enrollment
measure: Time to major amputation of the index leg.
time frame: Up to 36 months from enrollment
measure: Change from baseline in ischemic pain as assessed by numerical rating scale (NRS) at 6 months.
time frame: 6 months from enrollment
description: NRS measures the intensity or magnitude of sensations and subject feelings and the relative strength of attitudes and opinions about specific stimuli, on a scale of 0 to 10 with a score of zero denoting "no pain at all" and a score of 10 denoting "worst possible pain".
measure: Proportion of subjects with complete healing of all ischemic lesions i.e., ulcers and necroses in the index leg at 12 months.
time frame: 12 months from enrollment
measure: Time (days) from randomization to occurrence of death.
time frame: Up to 36 months from enrollment
arm group label: PLX-PAD
arm group type: Experimental
description: PLX-PAD will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.
intervention type: Biological
intervention name: PLX-PAD
description: Local intramuscular (IM) injections of PLX-PAD in the index leg.
arm group label: PLX-PAD
intervention type: Biological
intervention name: Placebo
description: Local intramuscular (IM) injections of Placebo in the index leg.
arm group label: Placebo
criteria: 
gender: All
minimum age: 45 Years
maximum age: 99 Years
healthy volunteers: No
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country: Bulgaria
country: Czechia
country: Germany
country: Hungary
country: Israel
country: North Macedonia
country: Poland
country: United Kingdom
country: United States
country: Austria
country: Macedonia, The Former Yugoslav Republic of
responsible party type: Sponsor
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia