<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/NCT03762967</url>
  </required_header>
  <id_info>
    <org_study_id>23032018</org_study_id>
    <nct_id>NCT03762967</nct_id>
  </id_info>
  <brief_title>Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility</brief_title>
  <official_title>Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State-Financed Health Facility &quot;Samara Regional Medical Center Dinasty&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State-Financed Health Facility &quot;Samara Regional Medical Center Dinasty&quot;</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>
      Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is&#xD;
      a common finding in male infertility. Often semen with a decreased sperm concentration may&#xD;
      also show significant abnormalities in sperm morphology and motility that affect Male&#xD;
      fertility. The purpose of this study is to assess the ability of Autologous Adipose-Derived&#xD;
      Adult Stromal Vascular Fraction (SVF) cells to stimulate Sertoli and spermatogonia cells and&#xD;
      affect male fertility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label study to evaluate efficiency of administration of Autologous&#xD;
      Adipose-Derived Adult Stromal Vascular Fraction (SVF) in the testis in patients with&#xD;
      oligospermia and azoospermia.&#xD;
&#xD;
      Forty men with several form oligozoospermia and azoospermia will be recruited for the study.&#xD;
      20 patients with same diagnosis served as a control with standard medications.Other patients&#xD;
      -10 with oligospermia and 10 with azoospermia will receive standard medication and SVF&#xD;
      injections.&#xD;
&#xD;
      The diagnosis of Azoospermia (Oligospermia) will be established on the basis of two and more&#xD;
      semen analysis evaluations done at separate occasions and detailed history taking, physical&#xD;
      examination and investigations (blood tests include hormon levels as testosteron. follicle&#xD;
      stimulating hormone (FSH), luteinizing hormone (LH). karyotyping and testosterone levels, and&#xD;
      may include testicular biopsy or transrectal ultrasound if indicated.&#xD;
&#xD;
      This study affect only Pretesticular and Testicular forms, without chromosomal aberration.&#xD;
      SVF can produce a lot of cytokines ( as EGF, FGF, NGF, PDGF, VEGF, IGF, GMCSF, GCSF, TGF,&#xD;
      Erythropoetin, TPO, BMP, HGF, GDF, Neurotrophins, MSF, SGF, GDF and growth factors) moreover&#xD;
      the microvesicles and exosomes released by this cells can prevent cells from apoptosis and&#xD;
      stimulate regenerative process of surrounding tissues and cells.&#xD;
&#xD;
      SVF will be transplanted by an andrological surgeon through a standard surgical approach.&#xD;
      Subjects will be monitored frequently for a total of one year after cell injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sperm concentration in ejaculate</measure>
    <time_frame>1, 2, 3 month</time_frame>
    <description>Sperm quantity and quality will be evaluated with automatic sperm cout analyzer a month, two and three after injection of SVF. Total measures - 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spermatozoa in testicular biopsy</measure>
    <time_frame>3 month</time_frame>
    <description>Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Testosterone</measure>
    <time_frame>3 month</time_frame>
    <description>Testosterone will be measured a three month after injection of SVF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibin-B</measure>
    <time_frame>3 month</time_frame>
    <description>Inhibin-B will be measured a three month after injection of SVF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follicle stimulating hormone (FSH)</measure>
    <time_frame>3 month</time_frame>
    <description>Follicle stimulating hormone will be measured a three month after injection of SVF.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Azoospermia</condition>
  <condition>Oligozoospermia</condition>
  <arm_group>
    <arm_group_label>Lipoaspiration and SVF introduction I.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard therapy I.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with azoospermia that introduce with Standard therapy only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipoaspiration and SVF introduction II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard therapy II.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with oligospermia that introduce with Standard therapy only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Lipoaspiration and SVF introduction.</intervention_name>
    <description>Lipoaspiration, isolation of SVF and introduction into testis Interstitium.</description>
    <arm_group_label>Lipoaspiration and SVF introduction I.</arm_group_label>
    <arm_group_label>Lipoaspiration and SVF introduction II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard therapy.</intervention_name>
    <description>Standard therapy include to give up bad habits, to establish a healthy diet, to eliminate excessive physical exertion. eliminate. In the case of endocrine disorders, hormone therapy is prescribed.</description>
    <arm_group_label>Lipoaspiration and SVF introduction I.</arm_group_label>
    <arm_group_label>Lipoaspiration and SVF introduction II</arm_group_label>
    <arm_group_label>Standard therapy I.</arm_group_label>
    <arm_group_label>Standard therapy II.</arm_group_label>
    <other_name>healthy diet, physical exertion eliminate. hormone therapy.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  idiopathic oligozoospermia (spermatozoid number &lt;2x10^6/mL) - 10 patients&#xD;
&#xD;
          -  cryptozoospermia/azoospermia - 10 patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age before 18 or after 60 years old&#xD;
&#xD;
          -  heart insufficiency. stroke (during 1 year)&#xD;
&#xD;
          -  anemia&#xD;
&#xD;
          -  blood disease&#xD;
&#xD;
          -  pelvis bone trauma&#xD;
&#xD;
          -  chronic diseases in decompensation stage&#xD;
&#xD;
          -  skin diseases&#xD;
&#xD;
          -  tuberculosis&#xD;
&#xD;
          -  hyperprolactinaemia&#xD;
&#xD;
          -  hyper or hypothyreosis&#xD;
&#xD;
          -  obstructive zoospermia&#xD;
&#xD;
          -  sperm stimulating hormone therapy&#xD;
&#xD;
          -  Men with previous surgery in testis&#xD;
&#xD;
          -  Men with infectious genital diseases and anatomical abnormalities of the genital tract&#xD;
&#xD;
          -  Those with major medical problems such as malignancy, hepatitis B . C, etc. HIV&#xD;
&#xD;
          -  Chromosomal aberration (e.g. Y microdeletion, trisomy….)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Tyumina, M.D. P.h.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Medical Centre Dinasty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Centre Dinasty</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State-Financed Health Facility &quot;Samara Regional Medical Center Dinasty&quot;</investigator_affiliation>
    <investigator_full_name>Volchkov Stanislav</investigator_full_name>
    <investigator_title>Deputy director, Quality assurance director</investigator_title>
  </responsible_party>
  <keyword>Autologous Stem Cell</keyword>
  <keyword>Male infertility</keyword>
  <keyword>Adipose-Derived stem cell</keyword>
  <keyword>Azoospermia</keyword>
  <keyword>Oligospermia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azoospermia</mesh_term>
    <mesh_term>Oligospermia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
  </intervention_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/NCT03762967
org study id: 23032018
nct id: NCT03762967
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is
      a common finding in male infertility. Often semen with a decreased sperm concentration may
      also show significant abnormalities in sperm morphology and motility that affect Male
      fertility. The purpose of this study is to assess the ability of Autologous Adipose-Derived
      Adult Stromal Vascular Fraction (SVF) cells to stimulate Sertoli and spermatogonia cells and
      affect male fertility.
This is an open-label study to evaluate efficiency of administration of Autologous
      Adipose-Derived Adult Stromal Vascular Fraction (SVF) in the testis in patients with
      oligospermia and azoospermia.

      Forty men with several form oligozoospermia and azoospermia will be recruited for the study.
      20 patients with same diagnosis served as a control with standard medications.Other patients
      -10 with oligospermia and 10 with azoospermia will receive standard medication and SVF
      injections.

      The diagnosis of Azoospermia (Oligospermia) will be established on the basis of two and more
      semen analysis evaluations done at separate occasions and detailed history taking, physical
      examination and investigations (blood tests include hormon levels as testosteron. follicle
      stimulating hormone (FSH), luteinizing hormone (LH). karyotyping and testosterone levels, and
      may include testicular biopsy or transrectal ultrasound if indicated.

      This study affect only Pretesticular and Testicular forms, without chromosomal aberration.
      SVF can produce a lot of cytokines ( as EGF, FGF, NGF, PDGF, VEGF, IGF, GMCSF, GCSF, TGF,
      Erythropoetin, TPO, BMP, HGF, GDF, Neurotrophins, MSF, SGF, GDF and growth factors) moreover
      the microvesicles and exosomes released by this cells can prevent cells from apoptosis and
      stimulate regenerative process of surrounding tissues and cells.

      SVF will be transplanted by an andrological surgeon through a standard surgical approach.
      Subjects will be monitored frequently for a total of one year after cell injection.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.
primary purpose: Treatment
masking: None (Open Label)
measure: sperm concentration in ejaculate
time frame: 1, 2, 3 month
description: Sperm quantity and quality will be evaluated with automatic sperm cout analyzer a month, two and three after injection of SVF. Total measures - 3.
measure: Spermatozoa in testicular biopsy
time frame: 3 month
description: Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.
measure: Testosterone
time frame: 3 month
description: Testosterone will be measured a three month after injection of SVF.
measure: Inhibin-B
time frame: 3 month
description: Inhibin-B will be measured a three month after injection of SVF.
measure: Follicle stimulating hormone (FSH)
time frame: 3 month
description: Follicle stimulating hormone will be measured a three month after injection of SVF.
arm group label: Lipoaspiration and SVF introduction I.
arm group type: Experimental
description: Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
arm group label: Standard therapy I.
arm group type: Active Comparator
description: Patients with azoospermia that introduce with Standard therapy only.
arm group label: Lipoaspiration and SVF introduction II
arm group type: Experimental
description: Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
arm group label: Standard therapy II.
arm group type: Active Comparator
description: Patients with oligospermia that introduce with Standard therapy only.
intervention type: Biological
intervention name: Lipoaspiration and SVF introduction.
description: Lipoaspiration, isolation of SVF and introduction into testis Interstitium.
arm group label: Lipoaspiration and SVF introduction I.
arm group label: Lipoaspiration and SVF introduction II
intervention type: Drug
intervention name: Standard therapy.
description: Standard therapy include to give up bad habits, to establish a healthy diet, to eliminate excessive physical exertion. eliminate. In the case of endocrine disorders, hormone therapy is prescribed.
arm group label: Lipoaspiration and SVF introduction I.
arm group label: Lipoaspiration and SVF introduction II
arm group label: Standard therapy I.
arm group label: Standard therapy II.
other name: healthy diet, physical exertion eliminate. hormone therapy.
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Olga Tyumina, M.D. P.h.D.
role: Study Chair
affiliation: Medical Centre Dinasty
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: State-Financed Health Facility "Samara Regional Medical Center Dinasty"
investigator full name: Volchkov Stanislav
investigator title: Deputy director, Quality assurance director
mesh term: Azoospermia
mesh term: Oligospermia
mesh term: Hormones