<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/NCT03259217</url>
  </required_header>
  <id_info>
    <org_study_id>stem cell in DFU</org_study_id>
    <nct_id>NCT03259217</nct_id>
  </id_info>
  <brief_title>Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers</brief_title>
  <official_title>Prospects of Clinical Application of Mesenchymal Stem Cells Seeded in Chitosan Scaffold for Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This study will assess the efficacy of application of stem cell in healing of chronic&#xD;
      diabetic foot ulcer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic foot ulcers are a significant and rapidly growing complication of diabetes and its&#xD;
      effects on wound healing. Over half of diabetic patients who develop a single ulcer will&#xD;
      subsequently develop another ulcer of which the majority will become chronic non-healing&#xD;
      ulcers. Over the past decade, the outcomes for patients with ulcers have not improved,&#xD;
      despite advances in wound care.These data suggest the importance and necessity of alternative&#xD;
      and more effective treatment option for diabetic patients with non-healing ulcers. (Blumberg&#xD;
      et al 2012). Stem cell therapy has emerged as a novel therapeutic approach for various&#xD;
      diseases including wound repair and tissue regeneration. Mesenchymal stem cells(MSCs)&#xD;
      represent an important stem cell population with multipotent capabilities that may have high&#xD;
      utility for translational clinical applications. MSCs can differentiate into a variety of&#xD;
      cell types, especially fascia originated cells, and provide soluble factors for regeneration&#xD;
      of tissues and organs(Şener et al 2015). Adipose tissue is an abundant source of mesenchymal&#xD;
      stem cells, which have shown an improved outcome in wound healing studies. Adipose tissue&#xD;
      derived stem cells (ASCs )are pluripotent stem cells with the ability to differentiate into&#xD;
      different lineages and to secrete paracrine factors initiating tissue regeneration process.&#xD;
      The abundant supply of fat tissue, ease of isolation, extensive proliferative capacities ex&#xD;
      vivo, and their ability to secrete pro-angiogenic growth factors make them an ideal cell type&#xD;
      to use in therapies for the treatment of nonhealing wounds(Hassan et al 2014), However the&#xD;
      hostile microenviroment may interfere with viability and efficiency of MSCs injection&#xD;
      specially in ischemic tissue , thus increasing needs for new strategies for further&#xD;
      improvement of the stem cell therapy of diabetic wounds. Curcumin loaded chitosan&#xD;
      nanoparticles into collagen-alginate is a novel biodegradable and biocompatible material that&#xD;
      might help a lot in regenerative efficiency in ischemic wound healing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>Phase 1</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>complete healing</measure>
    <time_frame>6 months</time_frame>
    <description>full epithelization of chronic diabetic foot ulcer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of healing</measure>
    <time_frame>6 months</time_frame>
    <description>percentage of patients achieving 50 % wound closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of ulcer recurrence</measure>
    <time_frame>one year</time_frame>
    <description>percentage of patients whose ulcer recurred</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stem Cell Transplant</condition>
  <arm_group>
    <arm_group_label>stem cell product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>stem cell transplant</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stem Cell Product</intervention_name>
    <description>Adipose tissue derived mesenchymal stem cell seeded in Curcumin loaded chitosan nanoparticles into collagen-alginate</description>
    <arm_group_label>stem cell product</arm_group_label>
    <other_name>mesenchymal stem cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diabetic patient with diagnosis of neuropathic or neuro-ischemic DFU&#xD;
&#xD;
          2. Chronic non healed diabetic foot ulcer (The wound was determined as non-healing and&#xD;
             chronic when the wound was treated with current standard care for diabetic foot ulcer&#xD;
             by a wound care specialist for at least 3 months prior to the therapy with less than&#xD;
             40% of wound closure)&#xD;
&#xD;
          3. Strict diabetes control with HbA1c ≤ 7.5%&#xD;
&#xD;
          4. Grade 1 or 2 ulcer on the Wagner scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- Critical ischemia of the target limb, defined by pain at rest and an ankle systolic&#xD;
             pressure &lt; 50 mm Hg, or a toe systolic pressure &lt; 30 mm Hg 2- DFU clinically infected&#xD;
             as defined by the IDSA/IWGDF criteria, osteomyelitis confirmed by MRI, or other&#xD;
             evidence of infection is present 3- Surgery or surgical revascularisation &lt; 2months 4-&#xD;
             Collagen tissue diseases , malignant and hematological diseases onset of myocardial&#xD;
             infarction or cerebral infarction within the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walaa Khalifa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>lecturer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Walaa Khalifa, MD</last_name>
    <phone>+20882303620</phone>
    <email>dr.walaaanwar@yahoo.com</email>
  </overall_contact>
  <results_reference>
    <citation>1-Blumberg SN1, Berger A, Hwang L, Pastar I, Warren SM, Chen W: The role of stem cells in the treatment of diabetic foot ulcers,Diabetes Res Clin Pract. 2012 Apr;96(1):1-9. 2-Hassan WU1, Greiser U, Wang W . Role of adipose-derived stem cells in wound healing Wound Repair Regen. 2014 May-Jun;22(3):313-25 3-Şener LT, Albeniz I1 . Challenge of Mesenchymal Stem Cells Against Diabetic Foot Ulcer : Curr Stem Cell Res Ther. 2015;10(6):530-4.</citation>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Walaa Anwar Mohamed Khalifa</investigator_full_name>
    <investigator_title>DR</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</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/NCT03259217
org study id: stem cell in DFU
nct id: NCT03259217
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will assess the efficacy of application of stem cell in healing of chronic
      diabetic foot ulcer
Diabetic foot ulcers are a significant and rapidly growing complication of diabetes and its
      effects on wound healing. Over half of diabetic patients who develop a single ulcer will
      subsequently develop another ulcer of which the majority will become chronic non-healing
      ulcers. Over the past decade, the outcomes for patients with ulcers have not improved,
      despite advances in wound care.These data suggest the importance and necessity of alternative
      and more effective treatment option for diabetic patients with non-healing ulcers. (Blumberg
      et al 2012). Stem cell therapy has emerged as a novel therapeutic approach for various
      diseases including wound repair and tissue regeneration. Mesenchymal stem cells(MSCs)
      represent an important stem cell population with multipotent capabilities that may have high
      utility for translational clinical applications. MSCs can differentiate into a variety of
      cell types, especially fascia originated cells, and provide soluble factors for regeneration
      of tissues and organs(Şener et al 2015). Adipose tissue is an abundant source of mesenchymal
      stem cells, which have shown an improved outcome in wound healing studies. Adipose tissue
      derived stem cells (ASCs )are pluripotent stem cells with the ability to differentiate into
      different lineages and to secrete paracrine factors initiating tissue regeneration process.
      The abundant supply of fat tissue, ease of isolation, extensive proliferative capacities ex
      vivo, and their ability to secrete pro-angiogenic growth factors make them an ideal cell type
      to use in therapies for the treatment of nonhealing wounds(Hassan et al 2014), However the
      hostile microenviroment may interfere with viability and efficiency of MSCs injection
      specially in ischemic tissue , thus increasing needs for new strategies for further
      improvement of the stem cell therapy of diabetic wounds. Curcumin loaded chitosan
      nanoparticles into collagen-alginate is a novel biodegradable and biocompatible material that
      might help a lot in regenerative efficiency in ischemic wound healing
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete healing
time frame: 6 months
description: full epithelization of chronic diabetic foot ulcer
measure: Rate of healing
time frame: 6 months
description: percentage of patients achieving 50 % wound closure
measure: rate of ulcer recurrence
time frame: one year
description: percentage of patients whose ulcer recurred
arm group label: stem cell product
arm group type: Experimental
description: stem cell transplant
intervention type: Drug
intervention name: Stem Cell Product
description: Adipose tissue derived mesenchymal stem cell seeded in Curcumin loaded chitosan nanoparticles into collagen-alginate
arm group label: stem cell product
other name: mesenchymal stem cells
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Walaa Khalifa, MD
role: Principal Investigator
affiliation: lecturer
last name: Walaa Khalifa, MD
phone: +20882303620
email: dr.walaaanwar@yahoo.com
citation: 1-Blumberg SN1, Berger A, Hwang L, Pastar I, Warren SM, Chen W: The role of stem cells in the treatment of diabetic foot ulcers,Diabetes Res Clin Pract. 2012 Apr;96(1):1-9. 2-Hassan WU1, Greiser U, Wang W . Role of adipose-derived stem cells in wound healing Wound Repair Regen. 2014 May-Jun;22(3):313-25 3-Şener LT, Albeniz I1 . Challenge of Mesenchymal Stem Cells Against Diabetic Foot Ulcer : Curr Stem Cell Res Ther. 2015;10(6):530-4.
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Walaa Anwar Mohamed Khalifa
investigator title: DR
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: Undecided