<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/NCT03297814</url>
  </required_header>
  <id_info>
    <org_study_id>PAD2UJCTC</org_study_id>
    <nct_id>NCT03297814</nct_id>
  </id_info>
  <brief_title>Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)</brief_title>
  <official_title>A Randomized, Double Blind, Placebo Controlled Trial, Investigating the Effect of Intramuscular Injection of Allogenic Platelet Lysate for the Treatment of PAD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sophia Al-Adwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral&#xD;
      arterial disease (PAD)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allogenic platelet rich plasma (PRP) will be collected from blood group AB donors. This&#xD;
      plasma will be tested for the presence of any chronic infectious blood borne disease.&#xD;
&#xD;
      Platelet lysate will be then prepared from the tested PRP to be intramuscularly injected in&#xD;
      patients with PAD&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 18, 2018</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>Phase 1/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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency and nature of adverse events occurring during a 6-month period following platelet lysate injection(s). This will be assessed by physical examination combined with a report with chemistry blood tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI</measure>
    <time_frame>12 months</time_frame>
    <description>Positive changes in patients' Ankle brachial index (ABI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure</measure>
    <time_frame>12 months</time_frame>
    <description>Positive changes in patients' Toe pressure (mm Hg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2</measure>
    <time_frame>12 months</time_frame>
    <description>Positive changes in patients' Transcutaneous oxygen pressure (TcPO2)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Platelet lysate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet lysate</intervention_name>
    <description>Intramuscular injection of platelet lysate</description>
    <arm_group_label>Platelet lysate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>intramuscular injection of normal saline</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Competent and willing to give informed consent, and to be available for all baseline&#xD;
             treatment and follow up examinations required by the protocol.&#xD;
&#xD;
          -  Gender: Male or female.&#xD;
&#xD;
          -  Age group &gt; 50 years.&#xD;
&#xD;
          -  Established Critical limb ischemia (CLI), clinically and hemodynamically confirmed as&#xD;
             per Rutherford 3, 4 and 5 with angiographic evidence of significant infra-inguinal&#xD;
             arterial occlusive disease.&#xD;
&#xD;
          -  History of intermittent claudication for &gt; eight weeks.&#xD;
&#xD;
          -  Limited exercise due to moderate to severe claudication.&#xD;
&#xD;
          -  Resting ABI &lt; 0.6, toe pressure ≤ 60 mm Hg, Toe Brachial index (TBI) &lt;0.6, or TcPO2 ≤&#xD;
             60 mmHg in the foot.&#xD;
&#xD;
          -  Not eligible for surgical or radiological revascularization, and doesn't respond to&#xD;
             best standard care delivered as confirmed by a vascular surgeon and/or physician.&#xD;
&#xD;
          -  Fairly controlled diabetes (Hemoglobin A1c &lt;10%).&#xD;
&#xD;
          -  Normal liver enzymes, serum creatinine &lt; 1.4&#xD;
&#xD;
          -  Normal platelet count.&#xD;
&#xD;
          -  On regular medication for hypertension if any.&#xD;
&#xD;
          -  No evidence of malignancy&#xD;
&#xD;
          -  Body mass index &lt;30.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with child bearing potential, pregnant and lactating women.&#xD;
&#xD;
          -  Rheumatoid Arthritis.&#xD;
&#xD;
          -  History of neoplasm or malignancy in the past 10 years.&#xD;
&#xD;
          -  Reported unstable cardiovascular disease, heart failure or symptomatic postural&#xD;
             hypotension within 6 months before screening.&#xD;
&#xD;
          -  Leg edema&#xD;
&#xD;
          -  Inflammatory or progressive fibrotic disorder&#xD;
&#xD;
          -  Renal insufficiency or failure&#xD;
&#xD;
          -  History of infectious disorder (Human immunodeficiency virus (HIV) and/or hepatitis&#xD;
             viruses).&#xD;
&#xD;
          -  Chronic inflammatory disease&#xD;
&#xD;
          -  History of stroke or myocardial infarction (&lt; 3 months).&#xD;
&#xD;
          -  Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdalla Awidi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cell Therapy Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sofia Adwan, Msc</last_name>
    <phone>00962796175617</phone>
    <email>sophia.adwan@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cell Therapy Center</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sofia Adwan, PhD</last_name>
      <phone>962-6-5355000</phone>
      <phone_ext>23960</phone_ext>
      <email>sophia.adwan@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>hanan Jafar, PhD</last_name>
      <phone>00962-6-5355000</phone>
      <phone_ext>23960</phone_ext>
      <email>hanan.jafar@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Sophia Al-Adwan</investigator_full_name>
    <investigator_title>Clinical Co-ordinator</investigator_title>
  </responsible_party>
  <keyword>Peripheral arterial disease</keyword>
  <keyword>Platelet lysate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03297814
org study id: PAD2UJCTC
nct id: NCT03297814
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral
      arterial disease (PAD)
Allogenic platelet rich plasma (PRP) will be collected from blood group AB donors. This
      plasma will be tested for the presence of any chronic infectious blood borne disease.

      Platelet lysate will be then prepared from the tested PRP to be intramuscularly injected in
      patients with PAD
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 6 months
description: Frequency and nature of adverse events occurring during a 6-month period following platelet lysate injection(s). This will be assessed by physical examination combined with a report with chemistry blood tests.
measure: Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI
time frame: 12 months
description: Positive changes in patients' Ankle brachial index (ABI)
measure: Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure
time frame: 12 months
description: Positive changes in patients' Toe pressure (mm Hg)
measure: Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2
time frame: 12 months
description: Positive changes in patients' Transcutaneous oxygen pressure (TcPO2)
arm group label: Platelet lysate
arm group type: Active Comparator
description: A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval
arm group label: placebo
arm group type: Placebo Comparator
description: A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval
intervention type: Biological
intervention name: Platelet lysate
description: Intramuscular injection of platelet lysate
arm group label: Platelet lysate
intervention type: Biological
intervention name: Placebo
description: intramuscular injection of normal saline
arm group label: placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Abdalla Awidi, MD
role: Study Director
affiliation: Cell Therapy Center
last name: Sofia Adwan, Msc
phone: 00962796175617
email: sophia.adwan@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Jordan
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jordan
investigator full name: Sophia Al-Adwan
investigator title: Clinical Co-ordinator
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: Undecided