<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/NCT02204358</url>
  </required_header>
  <id_info>
    <org_study_id>2012022</org_study_id>
    <nct_id>NCT02204358</nct_id>
  </id_info>
  <brief_title>Treatment of Infertility by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells</brief_title>
  <official_title>Clinical Study of the Treatment of Infertility Caused by Severe Intrauterine Adhesions by Collagen Scaffold Loaded With Autologous Bone Marrow Stem Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial&#xD;
      dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide&#xD;
      clinical evidence for the treatment of uterine infertility&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infertility is defined as a women fails to become pregnant after having a normal sex life for&#xD;
      two years without contraception. There is no effective treatment to the infertility caused by&#xD;
      severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation.&#xD;
      The existing drugs, physical or surgical treatments had no significant effects to severe&#xD;
      intrauterine adhesions.Collagen is the main component of the extracellular matrix with good&#xD;
      biocompatibility, and it has been approved for the reparation of skin and oral mucosa by&#xD;
      State Food and Drug Administration. Bone marrow stem cells have been used in the clinical&#xD;
      treatment of blood diseases, and achieved good results. In this study, collagen scaffold and&#xD;
      autologous bone marrow stem cells are combined, and they showed good biological safety&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</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>Reduction of intrauterine scar area,the change of intrauterine adhesion</measure>
    <time_frame>up to 3 months</time_frame>
    <description>hysteroscope ,understanding improvement of uterine cavity form,the degree and nature of adhesion or the vanishment of intrauterine adhesion,and the reduction of scar and its area,comparing with pre-operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of endometrial thickness</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of endometrial thickness</measure>
    <time_frame>up to 2 months</time_frame>
    <description>Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>menstrual blood volume The change of menstrual blood volume</measure>
    <time_frame>baseline and 1 month</time_frame>
    <description>Understanding the menstrual blood volume after surgery ,the number of sanitary napkins per day ,and number of days,comparing with pre-operation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>rate of pregnancy</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Infertility</condition>
  <condition>Intrauterine Adhesions</condition>
  <condition>Endometrial Dysplasia</condition>
  <arm_group>
    <arm_group_label>autologous bone marrow stem cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>autologous bone marrow stem cells</intervention_name>
    <description>Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.&#xD;
If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.</description>
    <arm_group_label>autologous bone marrow stem cells</arm_group_label>
    <other_name>infertility</other_name>
    <other_name>severe intrauterine adhesions</other_name>
    <other_name>endometrial dysplasia</other_name>
    <other_name>collagen scaffold</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertility caused by serious intrauterine adhesions or endometrial dysplasia&#xD;
&#xD;
          -  Hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia&#xD;
&#xD;
          -  Monitoring of endometrial cycle&#xD;
&#xD;
          -  Sign a consent form&#xD;
&#xD;
          -  Follow the test plan and follow-up process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal chromosome karyotype&#xD;
&#xD;
          -  Congenital uterine malformations&#xD;
&#xD;
          -  Severe endometriosis&#xD;
&#xD;
          -  Severe adenomyosis&#xD;
&#xD;
          -  Contraindications to pregnancy&#xD;
&#xD;
          -  Contraindications to bone marrow collection&#xD;
&#xD;
          -  Contraindications to hormone replacement therapy&#xD;
&#xD;
          -  Medical history of pelvic tumors or receiving pelvic radiotherapy&#xD;
&#xD;
          -  Unable to adhere to the hospital examination and follow-up, or carrying on other&#xD;
             treatment during follow-up period&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yali HU, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yali Hu, MD PhD</last_name>
    <phone>02583304616</phone>
    <phone_ext>66808</phone_ext>
    <email>819241652@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yali HU, MD,PhD</last_name>
      <phone>02583304616</phone>
      <phone_ext>66808</phone_ext>
      <email>dtylhu@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation>
    <investigator_full_name>Yali Hu</investigator_full_name>
    <investigator_title>MD,PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Tissue Adhesions</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/NCT02204358
org study id: 2012022
nct id: NCT02204358
lead sponsor: 
has dmc: Yes
Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial
      dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide
      clinical evidence for the treatment of uterine infertility
Infertility is defined as a women fails to become pregnant after having a normal sex life for
      two years without contraception. There is no effective treatment to the infertility caused by
      severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation.
      The existing drugs, physical or surgical treatments had no significant effects to severe
      intrauterine adhesions.Collagen is the main component of the extracellular matrix with good
      biocompatibility, and it has been approved for the reparation of skin and oral mucosa by
      State Food and Drug Administration. Bone marrow stem cells have been used in the clinical
      treatment of blood diseases, and achieved good results. In this study, collagen scaffold and
      autologous bone marrow stem cells are combined, and they showed good biological safety
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of intrauterine scar area,the change of intrauterine adhesion
time frame: up to 3 months
description: hysteroscope ,understanding improvement of uterine cavity form,the degree and nature of adhesion or the vanishment of intrauterine adhesion,and the reduction of scar and its area,comparing with pre-operation
measure: The change of endometrial thickness
time frame: up to 1 month
description: Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
measure: The change of endometrial thickness
time frame: up to 2 months
description: Measure the endometrial thickness and endometrial blood supply during ovulation by ultrasound by the same trained medical sonographers,comparing with pre-operation.
measure: menstrual blood volume The change of menstrual blood volume
time frame: baseline and 1 month
description: Understanding the menstrual blood volume after surgery ,the number of sanitary napkins per day ,and number of days,comparing with pre-operation.
measure: rate of pregnancy
time frame: 2 years
arm group label: autologous bone marrow stem cells
arm group type: Experimental
description: Using collagen scaffold loaded with autologous bone marrow stem cells to treat severe intrauterine adhesions or endometrial dysplasia.
intervention type: Procedure
intervention name: autologous bone marrow stem cells
description: Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.
If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits.
arm group label: autologous bone marrow stem cells
other name: infertility
other name: severe intrauterine adhesions
other name: endometrial dysplasia
other name: collagen scaffold
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yali HU, MD,PhD
role: Principal Investigator
affiliation: Vice-president of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
last name: Yali Hu, MD PhD
phone: 02583304616
phone ext: 66808
email: 819241652@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
investigator full name: Yali Hu
investigator title: MD,PhD
mesh term: Infertility
mesh term: Tissue Adhesions