<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/NCT01668862</url>
  </required_header>
  <id_info>
    <org_study_id>KRPL/HPL-TE/11-12/003</org_study_id>
    <nct_id>NCT01668862</nct_id>
  </id_info>
  <brief_title>A Study to Determine Safety &amp; Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)</brief_title>
  <official_title>A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasiak Research Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasiak Research Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of&#xD;
      human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study&#xD;
      is being conducted in 2 centers in India. The primary end points are Visual Analog Score&#xD;
      (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is&#xD;
      improvement in ultrasonography form randomization to End of study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">October 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Visual Analog Score (VAS)</measure>
    <time_frame>Day 0, Month 1, Month 2, End of Study - Month 3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3</measure>
    <time_frame>Day 0, End of study - Month 3</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient rated tennis elbow evaluation (PRTEE Score)</measure>
    <time_frame>Day 0, Month 1, Month 2, End of study-Month 3</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The American Shoulder and Elbow Society score</measure>
    <time_frame>Dya 0, Month 1, Month 2, End of study-Month 3</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Lateral Epicondylitis (Tennis Elbow)</condition>
  <arm_group>
    <arm_group_label>Study arm A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will receive one injection of Corticosteroid in the lateral epicondyle space</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous Human Platelet Lysate</intervention_name>
    <description>Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space</description>
    <arm_group_label>Study arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <description>Subjects will receive one injection of Corticosteroid in the lateral epicondyle space</description>
    <arm_group_label>Control Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with clinical diagnosis of tennis elbow within the last 3 months&#xD;
&#xD;
          -  Subjects both male and female, aged 18-60 years (both inclusive)&#xD;
&#xD;
          -  Subjects who are willing to give informed consent and adhere to the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects aged less than 18 and more than 60 years&#xD;
&#xD;
          -  Subjects with autoimmune diseases&#xD;
&#xD;
          -  Subjects with immuno-compromised system&#xD;
&#xD;
          -  Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin&#xD;
&#xD;
          -  Subjects taking concomitant therapy that might interfere with the study results in&#xD;
             investigators opinion or who had concomitant other injury of the tennis elbow tendons.&#xD;
&#xD;
          -  Subjects who have received treatment with corticosteroid injections within the last 6&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anant Joshi, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASMI</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolas Antao, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillway Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gauresh Palekar, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Surya Orthopedic Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kaushal Shah, Phd</last_name>
    <phone>+91-22-41173472</phone>
    <email>kaushal.shah@kasiakresearch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kasiak Research Pvt Ltd</name>
      <address>
        <city>Thane</city>
        <state>Maharashtra</state>
        <zip>400610</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaushal Shah, Phd</last_name>
      <phone>+91-22-4117472</phone>
      <email>kaushal.shah@kasiakresearch.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>July 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</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>Tennis Elbow</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/NCT01668862
org study id: KRPL/HPL-TE/11-12/003
nct id: NCT01668862
lead sponsor: 
has dmc: Yes
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of
      human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study
      is being conducted in 2 centers in India. The primary end points are Visual Analog Score
      (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is
      improvement in ultrasonography form randomization to End of study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Visual Analog Score (VAS)
time frame: Day 0, Month 1, Month 2, End of Study - Month 3
measure: Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3
time frame: Day 0, End of study - Month 3
measure: Patient rated tennis elbow evaluation (PRTEE Score)
time frame: Day 0, Month 1, Month 2, End of study-Month 3
measure: The American Shoulder and Elbow Society score
time frame: Dya 0, Month 1, Month 2, End of study-Month 3
arm group label: Study arm A
arm group type: Other
description: Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space
arm group label: Control Arm B
arm group type: Other
description: Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
intervention type: Biological
intervention name: Autologous Human Platelet Lysate
description: Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
arm group label: Study arm A
intervention type: Drug
intervention name: Corticosteroid
description: Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
arm group label: Control Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Anant Joshi, Dr.
role: Principal Investigator
affiliation: ASMI
last name: Nicolas Antao, Dr.
role: Principal Investigator
affiliation: Hillway Clinic
last name: Gauresh Palekar, Dr.
role: Principal Investigator
affiliation: Surya Orthopedic Clinic
last name: Kaushal Shah, Phd
phone: +91-22-41173472
email: kaushal.shah@kasiakresearch.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: Tennis Elbow