<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/NCT03031509</url>
  </required_header>
  <id_info>
    <org_study_id>DFSC-2017（CR）-01</org_study_id>
    <nct_id>NCT03031509</nct_id>
  </id_info>
  <brief_title>Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）</brief_title>
  <official_title>Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai East Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai East Hospital</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>
      The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial&#xD;
      cells transplant in nonunion of limb fracture patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, patients of nonunion after limb fracture will be treated with human amniotic&#xD;
      epithelial cells. Clinical and radiological assessment is performed.&#xD;
&#xD;
      hAECs developing from the epiblast as early as 8 days after fertilization, recent data&#xD;
      reported indicate that hAECs possess proper osteogenic differentiation potential and a&#xD;
      localized modulatory influence on the early tissue remodeling process, making these cells a&#xD;
      promising stem cell source for bone regeneration after fractures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>time for bone union</measure>
    <time_frame>6 months</time_frame>
    <description>Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain in fracture site</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>limb functional score</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Nonunion Fracture</condition>
  <arm_group>
    <arm_group_label>hAECs treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>debridement surgery</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>debridement surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Amniotic Epithelial Cells</intervention_name>
    <description>Human Amniotic Epithelial Cells transplant after debridement</description>
    <arm_group_label>hAECs treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>debridement</intervention_name>
    <description>debridement</description>
    <arm_group_label>debridement surgery</arm_group_label>
    <arm_group_label>hAECs treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with nonunion of limbs by x-ray and bone scan;&#xD;
&#xD;
          -  compliance to treatment and long term follow-up;&#xD;
&#xD;
          -  be able and willing to participate in the study;&#xD;
&#xD;
          -  written informed consent before study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or breastfeeding;&#xD;
&#xD;
          -  patients with malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active&#xD;
             Hepatitis), in a immunosuppressant therapy ( chemotherapy or steroids), OR health&#xD;
             status, mental diseases, which will influence the study;&#xD;
&#xD;
          -  patients undergoing any other treatment that are not related to this study;&#xD;
&#xD;
          -  others considered not appropriate selected patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>XIA LI, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai East Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xia LI, Dr.</last_name>
    <phone>86-21-38804518</phone>
    <phone_ext>14185</phone_ext>
    <email>daxia868@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai East Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>021</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>LIN LI</last_name>
      <phone>86-021-61569006</phone>
      <phone_ext>9829</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Miki T, Lehmann T, Cai H, Stolz DB, Strom SC. Stem cell characteristics of amniotic epithelial cells. Stem Cells. 2005 Nov-Dec;23(10):1549-59. doi: 10.1634/stemcells.2004-0357. Epub 2005 Aug 4.</citation>
    <PMID>16081662</PMID>
  </reference>
  <reference>
    <citation>Si J, Dai J, Zhang J, Liu S, Gu J, Shi J, Shen SG, Guo L. Comparative investigation of human amniotic epithelial cells and mesenchymal stem cells for application in bone tissue engineering. Stem Cells Int. 2015;2015:565732. doi: 10.1155/2015/565732. Epub 2015 Mar 5.</citation>
    <PMID>25834575</PMID>
  </reference>
  <reference>
    <citation>Jiawen S, Jianjun Z, Jiewen D, Dedong Y, Hongbo Y, Jun S, Xudong W, Shen SG, Lihe G. Osteogenic differentiation of human amniotic epithelial cells and its application in alveolar defect restoration. Stem Cells Transl Med. 2014 Dec;3(12):1504-13. doi: 10.5966/sctm.2014-0118. Epub 2014 Nov 3.</citation>
    <PMID>25368378</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>June 2, 2017</last_update_submitted>
  <last_update_submitted_qc>June 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nonunion Fracture of limb</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Fractures, Ununited</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/NCT03031509
org study id: DFSC-2017（CR）-01
nct id: NCT03031509
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial
      cells transplant in nonunion of limb fracture patients.
In this study, patients of nonunion after limb fracture will be treated with human amniotic
      epithelial cells. Clinical and radiological assessment is performed.

      hAECs developing from the epiblast as early as 8 days after fertilization, recent data
      reported indicate that hAECs possess proper osteogenic differentiation potential and a
      localized modulatory influence on the early tissue remodeling process, making these cells a
      promising stem cell source for bone regeneration after fractures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time for bone union
time frame: 6 months
description: Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site.
measure: pain in fracture site
time frame: 1 year
measure: limb functional score
time frame: 1 year
arm group label: hAECs treatment
arm group type: Experimental
description: Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery
arm group label: debridement surgery
arm group type: Sham Comparator
description: debridement surgery
intervention type: Biological
intervention name: Human Amniotic Epithelial Cells
description: Human Amniotic Epithelial Cells transplant after debridement
arm group label: hAECs treatment
intervention type: Procedure
intervention name: debridement
description: debridement
arm group label: debridement surgery
arm group label: hAECs treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: XIA LI, Dr.
role: Principal Investigator
affiliation: Shanghai East Hospital
last name: Xia LI, Dr.
phone: 86-21-38804518
phone ext: 14185
email: daxia868@163.com
facility: 
contact: 
country: China
citation: Miki T, Lehmann T, Cai H, Stolz DB, Strom SC. Stem cell characteristics of amniotic epithelial cells. Stem Cells. 2005 Nov-Dec;23(10):1549-59. doi: 10.1634/stemcells.2004-0357. Epub 2005 Aug 4.
PMID: 16081662
citation: Si J, Dai J, Zhang J, Liu S, Gu J, Shi J, Shen SG, Guo L. Comparative investigation of human amniotic epithelial cells and mesenchymal stem cells for application in bone tissue engineering. Stem Cells Int. 2015;2015:565732. doi: 10.1155/2015/565732. Epub 2015 Mar 5.
PMID: 25834575
citation: Jiawen S, Jianjun Z, Jiewen D, Dedong Y, Hongbo Y, Jun S, Xudong W, Shen SG, Lihe G. Osteogenic differentiation of human amniotic epithelial cells and its application in alveolar defect restoration. Stem Cells Transl Med. 2014 Dec;3(12):1504-13. doi: 10.5966/sctm.2014-0118. Epub 2014 Nov 3.
PMID: 25368378
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Fractures, Ununited
sharing ipd: Undecided