<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/NCT03264573</url>
  </required_header>
  <id_info>
    <org_study_id>MSCs, PRP, Scar</org_study_id>
    <nct_id>NCT03264573</nct_id>
  </id_info>
  <brief_title>Role of Stem Cells, Platelet Rich Plasma in Treatment of Scars</brief_title>
  <official_title>Role of Stem Cells, Platelet Rich Plasma and Combination of Them in Treatment of Scars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heba Mohamed Saad Eldien</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M.A. Eloteify</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ahmed Kamal Osman</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>G.M. Hafsa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Objectives of this randomized controlled trial aiming to establishing a protocol of post&#xD;
      scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem&#xD;
      cell injection in improvement of atrophic scar after scar revision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty patients with atrophic scar since one to five years including 25 males and 15 females&#xD;
      with ages ranging from ten to 35 years with main age of 22.68 will be divided into four&#xD;
      groups each included ten patients. One group will be treated with scar revision only (control&#xD;
      group or group I), 2nd group will be injected with PRP after scar revision, 3rd group will be&#xD;
      injected with ADSCs after scar revision and the 4th group will be injected with a combination&#xD;
      of PRP and ADSCs after scar revision. All groups were assisted pre-operative and six months&#xD;
      post-operative. Complications, Scar width, Vancouver scar scale (VSS), surgeon assessment&#xD;
      scar scale and patient assessment scar scale will be considered the outcome measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction (Patient Assessment Scar Scale)</measure>
    <time_frame>6 months</time_frame>
    <description>Patient Assessment Scar Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Doctor satisfaction (Vancouver Scar Scale)</measure>
    <time_frame>6 months</time_frame>
    <description>Vancouver Scar Scale (VSS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Atrophic Scar</condition>
  <arm_group>
    <arm_group_label>stem cell, PRP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adipose derived MSCs, versus Platelet rich plasma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stem cell, Stem cell and PRP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Stem cell</intervention_name>
    <description>after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells</description>
    <arm_group_label>Stem cell, Stem cell and PRP</arm_group_label>
    <arm_group_label>stem cell, PRP</arm_group_label>
    <other_name>PRP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MSCs</intervention_name>
    <description>manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells</description>
    <arm_group_label>Stem cell, Stem cell and PRP</arm_group_label>
    <arm_group_label>stem cell, PRP</arm_group_label>
    <other_name>Stem cell and PRP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with atrophic scar.&#xD;
&#xD;
          -  Age group: 5 years up to 35 years.&#xD;
&#xD;
          -  No previous medications, surgeries or laser therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with hypertrophic or pigmented scar.&#xD;
&#xD;
          -  Patient with any blood disease.&#xD;
&#xD;
          -  Patients with lipodystrophy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Heba Mohamed Saad Eldien</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Atrophic scar</keyword>
  <keyword>PRP</keyword>
  <keyword>ADSCs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</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/NCT03264573
org study id: MSCs, PRP, Scar
nct id: NCT03264573
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The Objectives of this randomized controlled trial aiming to establishing a protocol of post
      scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem
      cell injection in improvement of atrophic scar after scar revision.
Forty patients with atrophic scar since one to five years including 25 males and 15 females
      with ages ranging from ten to 35 years with main age of 22.68 will be divided into four
      groups each included ten patients. One group will be treated with scar revision only (control
      group or group I), 2nd group will be injected with PRP after scar revision, 3rd group will be
      injected with ADSCs after scar revision and the 4th group will be injected with a combination
      of PRP and ADSCs after scar revision. All groups were assisted pre-operative and six months
      post-operative. Complications, Scar width, Vancouver scar scale (VSS), surgeon assessment
      scar scale and patient assessment scar scale will be considered the outcome measurements.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Patient satisfaction (Patient Assessment Scar Scale)
time frame: 6 months
description: Patient Assessment Scar Scale
measure: Doctor satisfaction (Vancouver Scar Scale)
time frame: 6 months
description: Vancouver Scar Scale (VSS)
arm group label: stem cell, PRP
arm group type: Active Comparator
description: Adipose derived MSCs, versus Platelet rich plasma
arm group label: Stem cell, Stem cell and PRP
arm group type: Active Comparator
description: Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma
intervention type: Biological
intervention name: Stem cell
description: after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells
arm group label: Stem cell, Stem cell and PRP
arm group label: stem cell, PRP
other name: PRP
intervention type: Device
intervention name: MSCs
description: manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells
arm group label: Stem cell, Stem cell and PRP
arm group label: stem cell, PRP
other name: Stem cell and PRP
criteria: 
gender: All
minimum age: 10 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Heba Mohamed Saad Eldien
investigator title: Professor
mesh term: Atrophy