<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/NCT03816852</url>
  </required_header>
  <id_info>
    <org_study_id>SCLnow-HNRM-01</org_study_id>
    <nct_id>NCT03816852</nct_id>
  </id_info>
  <brief_title>The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency</brief_title>
  <official_title>Clinical Study on the Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sclnow Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sclnow Biotechnology Co., Ltd.</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>
      Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI&#xD;
      treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode,&#xD;
      meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the&#xD;
      stem cell therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of&#xD;
      function of the ovaries before age 40, which has the features of menstrual disorder with high&#xD;
      gonadotropic hormone and low estrogen. The morbidity of POI is about 0.1% among woman before&#xD;
      40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary&#xD;
      amenorrhea. Recent years research shows different sources of stem cell could be used to POI,&#xD;
      and with effective results.&#xD;
&#xD;
      Above all, this experiment designed to as a single center, random, and control experiment.&#xD;
      treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular&#xD;
      follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Others&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Menstrual changes</measure>
    <time_frame>270 days</time_frame>
    <description>Observe the change of patients with irregular menstrual cycle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kupperman score</measure>
    <time_frame>270 days</time_frame>
    <description>Mild: &lt;14; moderate: 14-26; serious: &gt;26</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hormone level</measure>
    <time_frame>270 days</time_frame>
    <description>Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follicular development</measure>
    <time_frame>270 days</time_frame>
    <description>Observe the size of ovarian follicles in each cycle.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Premature Ovarian Failure</condition>
  <arm_group>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>hucMSCs</intervention_name>
    <description>Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion</description>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_label>Low dose group</arm_group_label>
    <arm_group_label>Medium dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet diagnostic criteria of European Society of Human Reproduction and Embryology&#xD;
&#xD;
          -  No hormonotherapy and chinese traditional medicine within 3 months;&#xD;
&#xD;
          -  Understand and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with congenital adrenocortical hyperplasia;&#xD;
&#xD;
          -  Patient with Cushing syndrome;&#xD;
&#xD;
          -  Patient with Thyroid dysfunction;&#xD;
&#xD;
          -  Patient with hyperprolactinemia;&#xD;
&#xD;
          -  Patient with pituitary amenorrhea or hypothalamic amenorrhea;&#xD;
&#xD;
          -  Patient with HIV, hepatitis;&#xD;
&#xD;
          -  Gene defect (eg. Turner syndrome, fragile X syndrome)&#xD;
&#xD;
          -  Serious drug allergy history;&#xD;
&#xD;
          -  Suffering from thrombophlebitis, thromboembolism including venous thrombosis and&#xD;
             arterial thrombosis;&#xD;
&#xD;
          -  History of treatment of ovarian cysts or ovarian surgery&#xD;
&#xD;
          -  With high tumor marker;&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Receive other treatments that may affect the efficacy and safety of stem cells;&#xD;
&#xD;
          -  Do not understand or without sign informed consent;&#xD;
&#xD;
          -  The attending physician believes that it is not suitable for participating in this&#xD;
             trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guangzhi Liu, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Henan Provincial People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Premature Ovarian Failure</keyword>
  <keyword>Premature Ovarian Insufficiency</keyword>
  <keyword>mesenchymal stem cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Primary Ovarian Insufficiency</mesh_term>
    <mesh_term>Menopause, Premature</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/NCT03816852
org study id: SCLnow-HNRM-01
nct id: NCT03816852
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluate the safety of human umbilical cord mesenchymal stem cells (hucMSCs) in POI
      treatment; Evaluate the effective hucMSCs in POI treatment. Compare different infusion mode,
      meanwhile compare with hormone replacement therapy (HRT) withdrawal, so that assessing the
      stem cell therapy.
Premature ovarian insufficiency (POI) or premature ovarian failure (POF), is the loss of
      function of the ovaries before age 40, which has the features of menstrual disorder with high
      gonadotropic hormone and low estrogen. The morbidity of POI is about 0.1% among woman before
      40 years, 10-28% among woman with primary amenorrhea, and 4-18% among woman with secondary
      amenorrhea. Recent years research shows different sources of stem cell could be used to POI,
      and with effective results.

      Above all, this experiment designed to as a single center, random, and control experiment.
      treat POI patients wit human umbilical cord mesenchymal stem cells (MSCs). After regular
      follow-up and analysis, assessing the safety and effective of MSCs in POI treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Menstrual changes
time frame: 270 days
description: Observe the change of patients with irregular menstrual cycle
measure: Kupperman score
time frame: 270 days
description: Mild: <14; moderate: 14-26; serious: >26
measure: hormone level
time frame: 270 days
description: Test the level change of Follicle-Stimulating Hormone (FSH), estrogen (E2), and Anti Mullerian Hormone (AMH)
measure: Follicular development
time frame: 270 days
description: Observe the size of ovarian follicles in each cycle.
arm group label: High dose group
arm group type: Experimental
description: Intravenous infusion with hucMSCs, 9*10^7 cells, 30ml
arm group label: Medium dose group
arm group type: Experimental
description: Intravenous infusion with hucMSCs, 6*10^7 cells, 30ml
arm group label: Low dose group
arm group type: Experimental
description: Intravenous infusion with hucMSCs, 3*10^7 cells, 30ml
intervention type: Biological
intervention name: hucMSCs
description: Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion
arm group label: High dose group
arm group label: Low dose group
arm group label: Medium dose group
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: No
last name: Guangzhi Liu, Dr
role: Study Director
affiliation: Henan Provincial People's Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Primary Ovarian Insufficiency
mesh term: Menopause, Premature