<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/NCT02264288</url>
  </required_header>
  <id_info>
    <org_study_id>CCT-PDA-002-DFU-002</org_study_id>
    <nct_id>NCT02264288</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With and Without Peripheral Arterial Disease</brief_title>
  <official_title>A Phase 2 Multicenter, Randomized, Doubleblind, Placebo-Controlled, Dose Range Finding Study to Evaluate the Efficacy and Safety of Intramuscular Injection of Human Placenta-derived Cells (Pda-002) in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celularity Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celularity Incorporated</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo&#xD;
      controlled, dose range finding study. The study will enroll approximately 133 subjects in&#xD;
      four treatment groups. The primary objective of the study is to assess the efficacy and&#xD;
      safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without&#xD;
      PAD. The secondary objective is to explore potential clinical efficacy by assessing changes&#xD;
      in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI),&#xD;
      Transcutaneous oxygen measurements (TcPO2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business decision with all subjects completing at least 1 year follow-up&#xD;
  </why_stopped>
  <start_date type="Actual">October 23, 2014</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete wound closure of the index ulcer</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Complete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety (adverse events [type, frequency, and severity of AEs, and relationship of AEs to study drug], laboratory abnormalities, and hospitalizations</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to ulcer closure</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The time period for the index ulcer to close</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Brachial Index (ABI ) and Toe-Brachial Index (TBI)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>ABI and TBI will be calculated by dividing the systolic blood pressure at the ankle or toe by the systolic blood pressures (Doppler technique) in the arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>50% Closure of Index Ulcer</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The proportion of subjects with at least 50% closure of the index ulcer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcutaneous oxygen</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Transcutaneous oxygen measurements determine the oxygen level in tissue below the skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to amputation, ulcer opening closing, gangrene and infection</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Time to major amputation (above the ankle) of treated leg, minor amputations, to re-opening of ulcer, time to doubling / halving of index ulcer total surface area from baseline, de novo gangrene and foot wound infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wagner Grading Scale</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene by using the following grades: grade 0 (pre-or postulcerative lesion), grade 1 (partial/full thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene), and grade 5 (whole foot gangrene).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutherford Criteria</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The Rutherford classification is a clinical staging system for describing peripheral arterial disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-item Short Form Health Survey (SF-36)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>A validated measurement of health related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetic Foot Ulcer Scale Short Form (DFS-SF) index ulcer</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>A measurement of the impact of diabetic foot ulcer on a patient's quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change in Neuropathy (PGICN)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Assessment of changes in neuropathy over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life: EuroQOL-5D- health utility index assessment (EQ-5D)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>A standardized instrument used as a measure of health outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of all ulcers</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The total number of ulcers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leg rest pain score</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>A visual analog scale (VAS) graded from 0 (pain free) to Grade 10 (maximum pain)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Diabetic Foot</condition>
  <arm_group>
    <arm_group_label>3 x 10^6 cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human Placenta Derived cells (PDA-002) administered intramuscularly (IM) on Study Days 1 and 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 x 10^6 cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 x 10^6 cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identically matching placebo administered IM on Study Days 1 and 8</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>3 x 10^6 cells</intervention_name>
    <description>3 x 10^6 cells administered on Study Days 1 and 8</description>
    <arm_group_label>3 x 10^6 cells</arm_group_label>
    <other_name>PDA-002</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>10 x 10^6 cells</intervention_name>
    <description>10 x 10^6 Human Placenta Derived cells (PDA-002) administered on Study Days 1 and 8</description>
    <arm_group_label>10 x 10^6 cells</arm_group_label>
    <other_name>PDA-002</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>30 x 10^6 cells</intervention_name>
    <description>30 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8</description>
    <arm_group_label>30 x 10^6 cells</arm_group_label>
    <other_name>PDA-002</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Identical matching placebo administered IM on Study Days 1 and 8</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females, at least 18 years of age or older at the time of signing the&#xD;
             informed consent document.&#xD;
&#xD;
          2. Understand and voluntarily sign an informed consent document prior to any study&#xD;
             related assessments/procedures are conducted.&#xD;
&#xD;
          3. Able to adhere to the study visit schedule and other protocol requirements.&#xD;
&#xD;
          4. Diabetes mellitus Type 1 or Type 2.&#xD;
&#xD;
          5. Diabetic foot ulcer with severity of Grade 1 (full thickness only) or Grade 2 on the&#xD;
             Wagner Grading Scale (Appendix A) of greater than one month duration which has not&#xD;
             adequately responded to conventional ulcer therapy with a size of at least of 1cm2&#xD;
             except if present on the toe. The maximum lesion size range in the index ulcer is ≤&#xD;
             10cm2. The measurement of the index ulcer is to be evaluated and measured after&#xD;
             debridement (if necessary) at the Screening Visit. If located on the plantar aspect of&#xD;
             the foot, the index ulcer must be able to be adequately offloaded in the assessment of&#xD;
             the investigator.&#xD;
&#xD;
          6. No planned revascularization or amputation over the next 3 months after Screening&#xD;
             visit, in the opinion of the Investigator.&#xD;
&#xD;
          7. Screening should not begin until at least 14 days after a failed reperfusion&#xD;
             intervention and at least 30 days after a successful reperfusion intervention.&#xD;
&#xD;
          8. Subjects should be receiving appropriate medical therapy for hypertension and diabetes&#xD;
             any other chronic medical conditions for which they require ongoing care.&#xD;
&#xD;
          9. A female of childbearing potential must have a negative serum pregnancy test at&#xD;
             Screening and a negative urine pregnancy test prior to treatment with study therapy.&#xD;
             In addition, sexually active FCBP must agree to use 2 of the following adequate forms&#xD;
             of contraception methods simultaneously such as: oral, injectable, or implantable&#xD;
             hormonal contraception; tubal ligation; IUD; barrier contraceptive with spermicide or&#xD;
             vasectomized partner for the duration of the study and the Follow-up Period.&#xD;
&#xD;
         10. Males (including those who have had a vasectomy) must agree to use barrier&#xD;
             contraception (latex condoms) when engaging in reproductive sexual activity with FCBP&#xD;
             for the duration of the study and the Follow-up Period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any significant medical condition, laboratory abnormality, or psychiatric illness that&#xD;
             would prevent the subject from participating in the study.&#xD;
&#xD;
          2. Any condition including the presence of laboratory abnormalities, which places the&#xD;
             subject at unacceptable risk if he or she were to participate in the study.&#xD;
&#xD;
          3. Any condition that confounds the ability to interpret data from the study.&#xD;
&#xD;
          4. Pregnant or lactating females.&#xD;
&#xD;
          5. Subjects with a body mass index &gt; 45 kg/m2 at Screening.&#xD;
&#xD;
          6. AST (SGOT) or ALT (SGPT) &gt; 2.5 x the upper limit of normal (ULN) at Screening.&#xD;
&#xD;
          7. Patient on renal dialysis for abnormal kidney function.&#xD;
&#xD;
          8. An ABI &lt; 0.4 and or TBI &lt; 0.3 in the leg with the index ulcer.&#xD;
&#xD;
          9. Bilirubin level &gt; 2 mg/dL (unless subject has known Gilbert's disease) at Screening.&#xD;
&#xD;
         10. Untreated chronic infection or treatment of any infection with systemic antibiotics,&#xD;
             including the ulcer site, must be free of antibiotics within 1 week prior to dosing&#xD;
             with IP.&#xD;
&#xD;
         11. Active osteomyelitis, infection, or cellulites at or adjacent to the index ulcer.&#xD;
             Patients with a history of being treated for an osteomyelitis without a surgical&#xD;
             resection.&#xD;
&#xD;
         12. Index ulcer that has decreased or increased in size by ≥ 30% during the&#xD;
             Screening/Run-In/ Pre-Treatment Period.&#xD;
&#xD;
         13. Active Charcot Neuroarthropathy in the foot with the index ulcer&#xD;
&#xD;
         14. Pain at rest due to limb ischemia.&#xD;
&#xD;
         15. Uncontrolled hypertension (defined as diastolic blood pressure &gt; 100 mmHg or systolic&#xD;
             blood pressure &gt; 180 mmHg during Screening at 2 independent measurements taken while&#xD;
             subject is sitting and resting for at least 5 minutes).&#xD;
&#xD;
         16. Poorly controlled diabetes mellitus (hemoglobin A1c &gt; 12% or a screening serum glucose&#xD;
             of ≥ 300mg/dl).&#xD;
&#xD;
         17. Untreated proliferative retinopathy.&#xD;
&#xD;
         18. History of malignant ventricular arrhythmia, CCS Class III-IV angina pectoris,&#xD;
             myocardial infarction/ percutaneous coronary intervention (PCI) / coronary artery&#xD;
             bypass graft (CABG) in the preceding 6 months prior to signing the informed consent&#xD;
             form (ICF), pending coronary revascularization in the following 3 months, transient&#xD;
             ischemic attack/cerebrovascular accident in the preceding 6 months, prior to signing&#xD;
             the ICF, and/or New York Heart Association [NYHA] Stage III or IV congestive heart&#xD;
             failure.&#xD;
&#xD;
         19. Abnormal ECG: new right bundle branch block (BBB) ≥ 120 msec in the preceding 3 months&#xD;
             prior to signing the ICF.&#xD;
&#xD;
         20. Uncontrolled hypercoagulation syndrome.&#xD;
&#xD;
         21. Life expectancy less than at 2 years at the time of signing the ICF due to concomitant&#xD;
             illnesses.&#xD;
&#xD;
         22. In the opinion of the Investigator, the subject is unsuitable for cellular therapy.&#xD;
&#xD;
         23. History of malignancy within 5 years prior to signing the ICF except basal cell or&#xD;
             squamous cell carcinoma of the skin or remote history of cancer now considered cured&#xD;
             or positive Pap smear with subsequent negative follow-up.&#xD;
&#xD;
         24. History of hypersensitivity to any of the components of the product formulation&#xD;
             (including bovine or porcine products, dextran 40, and dimethyl sulfoxide [DMSO]).&#xD;
&#xD;
         25. Subject has received an investigational agent -an agent or device not approved by the&#xD;
             US Food and Drug Administration (FDA) for marketed use in any indication- within 90&#xD;
             days (or 5 half-lives, whichever is longer) prior to treatment with study therapy or&#xD;
             planned participation in another therapeutic study prior to the completion of this&#xD;
             study.&#xD;
&#xD;
         26. Subject has received previous investigational gene or cell therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Solveig Ericson, MD</last_name>
    <role>Study Director</role>
    <affiliation>Celularity Incorporated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiology PC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TFi Medical</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Valley Foot and Ankle Specialist</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carl T. Hayden Veterans Affairs Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Arthritis and Rheumatology Research, PLLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aung Foothealth Clinics and Advanced Wound Care Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Arkansas Baptist Clinic</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeffrey A Klemes DPM</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research Inc.</name>
      <address>
        <city>Castro Valley</city>
        <state>California</state>
        <zip>94546-5306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reliance Clinical Research</name>
      <address>
        <city>Chino</city>
        <state>California</state>
        <zip>91710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limb Preservation Platform, INC.</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94035-5821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center Lombardi Cancer Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007-2197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of West Florida Inc - Clearwater</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barry University</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Network, LLC</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solutions Through Advanced Research Inc.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GF Professional Research Group Corporation</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Well Pharma Medical Research Corporation</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med-Care Research Inc</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podiatry 1st</name>
      <address>
        <city>Belleville</city>
        <state>Illinois</state>
        <zip>62226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois at Chicago Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Foot &amp; Ankle Institute</name>
      <address>
        <city>Des Plaines</city>
        <state>Illinois</state>
        <zip>60016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rosalind Franklin University of Medicine and Science</name>
      <address>
        <city>North Chicago</city>
        <state>Illinois</state>
        <zip>60064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Center of Illinois</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CGH Medical Center Main Clinic</name>
      <address>
        <city>Sterling</city>
        <state>Illinois</state>
        <zip>61081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Foot Care</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Hospital</name>
      <address>
        <city>Randallstown</city>
        <state>Maryland</state>
        <zip>21133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revive Research Institute</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Englewood Hospital and Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Michael J. De Marco, DPM</name>
      <address>
        <city>Tinton Falls</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean City Foot and Ankle Assoc</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Animas Foot and Ankle</name>
      <address>
        <city>Gallup</city>
        <state>New Mexico</state>
        <zip>87301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Gerard J. Furst, DPM, PLLC</name>
      <address>
        <city>East Setauket</city>
        <state>New York</state>
        <zip>11733</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syracuse VA Medical Center</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Hospitals University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates of Central Pennsylvania</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Health Systems</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Vein and Vascular Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complete Family Foot Care - McAllen Office</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501-2930</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endeavor Clinical Trials PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SAM Clinical Research Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Foot &amp; Ankle Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1Foot 2Foot Centre for Foot &amp; Ankle Care PC</name>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <zip>23434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Milwaukee Foot &amp; Ankle Specialists</name>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peripheral Arterial Disease</keyword>
  <keyword>Diabetic Foot</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 24, 2022</submitted>
    <submission_canceled>February 9, 2022</submission_canceled>
    <submitted>February 9, 2022</submitted>
    <returned>March 3, 2022</returned>
  </pending_results>
  <!-- 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/NCT02264288
org study id: CCT-PDA-002-DFU-002
nct id: NCT02264288
lead sponsor: 
has dmc: Yes
The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo
      controlled, dose range finding study. The study will enroll approximately 133 subjects in
      four treatment groups. The primary objective of the study is to assess the efficacy and
      safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without
      PAD. The secondary objective is to explore potential clinical efficacy by assessing changes
      in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI),
      Transcutaneous oxygen measurements (TcPO2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Complete wound closure of the index ulcer
time frame: Up to 4 months
description: Complete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks
measure: Safety (adverse events [type, frequency, and severity of AEs, and relationship of AEs to study drug], laboratory abnormalities, and hospitalizations
time frame: Up to 24 months
description: An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.
measure: Time to ulcer closure
time frame: Up to 6 months
description: The time period for the index ulcer to close
measure: Ankle Brachial Index (ABI ) and Toe-Brachial Index (TBI)
time frame: Up to 6 months
description: ABI and TBI will be calculated by dividing the systolic blood pressure at the ankle or toe by the systolic blood pressures (Doppler technique) in the arm
measure: 50% Closure of Index Ulcer
time frame: Up to 24 months
description: The proportion of subjects with at least 50% closure of the index ulcer
measure: Transcutaneous oxygen
time frame: Up to 6 months
description: Transcutaneous oxygen measurements determine the oxygen level in tissue below the skin
measure: Time to amputation, ulcer opening closing, gangrene and infection
time frame: Up to 24 months
description: Time to major amputation (above the ankle) of treated leg, minor amputations, to re-opening of ulcer, time to doubling / halving of index ulcer total surface area from baseline, de novo gangrene and foot wound infection
measure: Wagner Grading Scale
time frame: Up to 24 months
description: The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene by using the following grades: grade 0 (pre-or postulcerative lesion), grade 1 (partial/full thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene), and grade 5 (whole foot gangrene).
measure: Rutherford Criteria
time frame: Up to 6 months
description: The Rutherford classification is a clinical staging system for describing peripheral arterial disease.
measure: 36-item Short Form Health Survey (SF-36)
time frame: Up to 6 months
description: A validated measurement of health related quality of life
measure: Diabetic Foot Ulcer Scale Short Form (DFS-SF) index ulcer
time frame: Up to 6 months
description: A measurement of the impact of diabetic foot ulcer on a patient's quality of life.
measure: Patient Global Impression of Change in Neuropathy (PGICN)
time frame: Up to 24 months
description: Assessment of changes in neuropathy over time
measure: European Quality of Life: EuroQOL-5D- health utility index assessment (EQ-5D)
time frame: Up to 6 months
description: A standardized instrument used as a measure of health outcome
measure: Number of all ulcers
time frame: Up to 24 months
description: The total number of ulcers
measure: Leg rest pain score
time frame: Up to 24 months
description: A visual analog scale (VAS) graded from 0 (pain free) to Grade 10 (maximum pain)
arm group label: 3 x 10^6 cells
arm group type: Experimental
description: Human Placenta Derived cells (PDA-002) administered intramuscularly (IM) on Study Days 1 and 8
arm group label: 10 x 10^6 cells
arm group type: Experimental
description: 10 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
arm group label: 30 x 10^6 cells
arm group type: Experimental
description: 30 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
arm group label: Placebo
arm group type: Placebo Comparator
description: Identically matching placebo administered IM on Study Days 1 and 8
intervention type: Biological
intervention name: 3 x 10^6 cells
description: 3 x 10^6 cells administered on Study Days 1 and 8
arm group label: 3 x 10^6 cells
other name: PDA-002
intervention type: Biological
intervention name: 10 x 10^6 cells
description: 10 x 10^6 Human Placenta Derived cells (PDA-002) administered on Study Days 1 and 8
arm group label: 10 x 10^6 cells
other name: PDA-002
intervention type: Biological
intervention name: 30 x 10^6 cells
description: 30 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
arm group label: 30 x 10^6 cells
other name: PDA-002
intervention type: Other
intervention name: Placebo
description: Identical matching placebo administered IM on Study Days 1 and 8
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Solveig Ericson, MD
role: Study Director
affiliation: Celularity Incorporated
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country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Foot Ulcer
submitted: January 24, 2022
submission canceled: February 9, 2022
submitted: February 9, 2022
returned: March 3, 2022