<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/NCT02979912</url>
  </required_header>
  <id_info>
    <org_study_id>PEDUJCTC</org_study_id>
    <nct_id>NCT02979912</nct_id>
  </id_info>
  <brief_title>Autologous Platelet Lysate in Corneal Epithelial Defects</brief_title>
  <official_title>The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanan Jafar</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous&#xD;
      platelet lysate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal&#xD;
      epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing&#xD;
      of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored&#xD;
      ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be&#xD;
      taken in multiple doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 2019</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops</measure>
    <time_frame>2 months</time_frame>
    <description>Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the efficacy by clinical judgment</measure>
    <time_frame>6 months</time_frame>
    <description>Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Persistent Corneal Epithelial Defect</condition>
  <arm_group>
    <arm_group_label>Platelet Lysate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Lysate</intervention_name>
    <description>Eye drops of Platelet Lysate</description>
    <arm_group_label>Platelet Lysate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cognitive ability to understand and sign the consent form.&#xD;
&#xD;
          2. Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment&#xD;
             (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic&#xD;
             eye-drops).&#xD;
&#xD;
          3. Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy,&#xD;
             corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal&#xD;
             lesions due to a foreign body.&#xD;
&#xD;
          4. Good compliance with the study regimen and availability for the duration of the entire&#xD;
             study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Corneal ulcers which developed tissue scars.&#xD;
&#xD;
          2. Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdallah Awidi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cell Therapy Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cell Therapy Center</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Hanan Jafar</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Persistent corneal epithelial defect</keyword>
  <keyword>Platelet Lysate</keyword>
  <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/NCT02979912
org study id: PEDUJCTC
nct id: NCT02979912
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous
      platelet lysate.
Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal
      epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing
      of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored
      ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be
      taken in multiple doses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops
time frame: 2 months
description: Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.
measure: Assessment of the efficacy by clinical judgment
time frame: 6 months
description: Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect
arm group label: Platelet Lysate
arm group type: Experimental
description: Autologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks.
intervention type: Biological
intervention name: Platelet Lysate
description: Eye drops of Platelet Lysate
arm group label: Platelet Lysate
criteria: 
gender: All
minimum age: 21 Years
maximum age: 78 Years
healthy volunteers: No
last name: Abdallah Awidi, MD
role: Study Director
affiliation: Cell Therapy Center
facility: 
country: Jordan
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jordan
investigator full name: Hanan Jafar
investigator title: Researcher
sharing ipd: Undecided