<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/NCT02966925</url>
  </required_header>
  <id_info>
    <org_study_id>2015-SM-001</org_study_id>
    <nct_id>NCT02966925</nct_id>
  </id_info>
  <brief_title>Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness</brief_title>
  <official_title>Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regen Lab SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regen Lab SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms&#xD;
      of vaginal atrophy include dryness, itching, burning and dyspareunia.&#xD;
&#xD;
      This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to&#xD;
      hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from&#xD;
      reference treatments (hormonal therapies).To achieve this, 20 patients suffering from&#xD;
      vulvovaginal dryness will be treated with one session of injections in the vulva, the&#xD;
      posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal&#xD;
      dryness will be primarily appreciated through Friedmann score and pH value, and secondarily&#xD;
      through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6&#xD;
      months after the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A treatment relying on the association of both platelet-rich plasma (PRP) and hyaluronic acid&#xD;
      (HA) could represent a therapeutical alternative for patients suffering from vulvovaginal&#xD;
      dryness who cannot be treated with hormone therapy.&#xD;
&#xD;
      Indeed, hyaluronic acid is widely distributed in all tissues, and most particularly in&#xD;
      vulvovaginal tissues. Due to its hydrating and healing properties, HA plays a key role in&#xD;
      tissue regeneration, facilitating the entry of a large number and variety of cells into the&#xD;
      injured area, reconstructing in this way an extracellular matrix capable of supporting the&#xD;
      proliferation and differentiation of cells for tissue regeneration. In addition,its ability&#xD;
      to retain water at up to 1000x its weight makes it the ideal substance for ensuring hydration&#xD;
      of the skin. Thus, the gynaecological use of HA could be a promising therapeutic option for&#xD;
      the treatment of vulvovaginal dryness.&#xD;
&#xD;
      On the other hand, numerous studies have shown the role of PRP in the healing of soft and&#xD;
      hard tissues. PRP is an autologous preparation from the patient's own blood playing the role&#xD;
      of growth factors reservoir during treatment. Indeed, platelet activation induces&#xD;
      alpha-granules degranulation, releasing synthesized pre-packaged growth factors. Once&#xD;
      released, growth factors induce different cell signaling cascades that activate angiogenesis,&#xD;
      cell proliferation, cell differentiation and new matrix synthesis for tissue regeneration. A&#xD;
      recent clinical study showed that PRP could significantly reduce sexual distress of patients&#xD;
      suffering from dyspareunia and suggests that PRP could improve vaginal vascularization and&#xD;
      physiologic responsivness in patients with vaginal atrophy.&#xD;
&#xD;
      In the present pilot study, a combination of PRP/HA obtained with Cellular Matrix will be&#xD;
      injected in the vulva, vaginal wall and perineum of women with vulvovaginal dryness. Outcomes&#xD;
      will be compared before and at various timepoints after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>case-series</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal pH</measure>
    <time_frame>3 months</time_frame>
    <description>Variation of the vaginal pH between baseline and Month 3 after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Friedmann score</measure>
    <time_frame>3 months</time_frame>
    <description>Variation of the Friedmann score between baseline and Month 3 after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Female Sexual Distress (FSD) score</measure>
    <time_frame>Month 1, Month 3 and Month 6</time_frame>
    <description>Variation of the FSD score between baseline and various timepoints after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Female Sexual Function Index (FSFI) score</measure>
    <time_frame>Month 1, Month 3 and Month 6</time_frame>
    <description>Variation of the FSFI score between baseline and various timepoints after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse device effects</measure>
    <time_frame>Month 1, Month 3 and Month 6</time_frame>
    <description>Safety monitoring through the record of adverse device effects at Month 1, Month 3 and Month 6</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Vulvar Atrophy</condition>
  <arm_group>
    <arm_group_label>Treatment with Cellular Matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with a combination of PRP/HA prepared with Cellular Matrix BCT-HA Kit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cellular Matrix BCT-HA Kit</intervention_name>
    <description>Submucosal injections in the vulva, in the posterior vaginal wall and in the perineum of a combination product made of PRP and HA prepared using the Cellular Matrix BCT-HA medical device</description>
    <arm_group_label>Treatment with Cellular Matrix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from vulvovaginal dryness who cannot benefit from hormonal therapy&#xD;
&#xD;
          -  Patients having signed an Informed Consent&#xD;
&#xD;
          -  Patient capable of understanding the study's imperatives&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulvovaginal inflammation or infection&#xD;
&#xD;
          -  History of vaginal herpes&#xD;
&#xD;
          -  History of vulvar, vaginal or cervical cancer&#xD;
&#xD;
          -  Lichen sclerosus&#xD;
&#xD;
          -  History of allergy to HA&#xD;
&#xD;
          -  Hereditary or acquired hematological or clotting disorders, such as drepanocytosis,&#xD;
             platelet dysfunction, thrombocytopenia (150'000 platelets/µl)&#xD;
&#xD;
          -  Anemia (HGB ≤ 10g/dl)&#xD;
&#xD;
          -  Autoimmune disease (Hashimoto, rheumatoid disease, lupus, etc.)&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Hepatitis B or C&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  No contraception&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Paul Méningaud, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Henri Mondor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 13, 2019</last_update_submitted>
  <last_update_submitted_qc>November 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vulvovaginal dryness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02966925
org study id: 2015-SM-001
nct id: NCT02966925
lead sponsor: 
has dmc: No
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms
      of vaginal atrophy include dryness, itching, burning and dyspareunia.

      This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to
      hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from
      reference treatments (hormonal therapies).To achieve this, 20 patients suffering from
      vulvovaginal dryness will be treated with one session of injections in the vulva, the
      posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal
      dryness will be primarily appreciated through Friedmann score and pH value, and secondarily
      through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6
      months after the treatment.
A treatment relying on the association of both platelet-rich plasma (PRP) and hyaluronic acid
      (HA) could represent a therapeutical alternative for patients suffering from vulvovaginal
      dryness who cannot be treated with hormone therapy.

      Indeed, hyaluronic acid is widely distributed in all tissues, and most particularly in
      vulvovaginal tissues. Due to its hydrating and healing properties, HA plays a key role in
      tissue regeneration, facilitating the entry of a large number and variety of cells into the
      injured area, reconstructing in this way an extracellular matrix capable of supporting the
      proliferation and differentiation of cells for tissue regeneration. In addition,its ability
      to retain water at up to 1000x its weight makes it the ideal substance for ensuring hydration
      of the skin. Thus, the gynaecological use of HA could be a promising therapeutic option for
      the treatment of vulvovaginal dryness.

      On the other hand, numerous studies have shown the role of PRP in the healing of soft and
      hard tissues. PRP is an autologous preparation from the patient's own blood playing the role
      of growth factors reservoir during treatment. Indeed, platelet activation induces
      alpha-granules degranulation, releasing synthesized pre-packaged growth factors. Once
      released, growth factors induce different cell signaling cascades that activate angiogenesis,
      cell proliferation, cell differentiation and new matrix synthesis for tissue regeneration. A
      recent clinical study showed that PRP could significantly reduce sexual distress of patients
      suffering from dyspareunia and suggests that PRP could improve vaginal vascularization and
      physiologic responsivness in patients with vaginal atrophy.

      In the present pilot study, a combination of PRP/HA obtained with Cellular Matrix will be
      injected in the vulva, vaginal wall and perineum of women with vulvovaginal dryness. Outcomes
      will be compared before and at various timepoints after treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: case-series
primary purpose: Treatment
masking: None (Open Label)
measure: Vaginal pH
time frame: 3 months
description: Variation of the vaginal pH between baseline and Month 3 after treatment
measure: Friedmann score
time frame: 3 months
description: Variation of the Friedmann score between baseline and Month 3 after treatment
measure: Female Sexual Distress (FSD) score
time frame: Month 1, Month 3 and Month 6
description: Variation of the FSD score between baseline and various timepoints after treatment
measure: Female Sexual Function Index (FSFI) score
time frame: Month 1, Month 3 and Month 6
description: Variation of the FSFI score between baseline and various timepoints after treatment
measure: Adverse device effects
time frame: Month 1, Month 3 and Month 6
description: Safety monitoring through the record of adverse device effects at Month 1, Month 3 and Month 6
arm group label: Treatment with Cellular Matrix
arm group type: Experimental
description: Patients will be treated with a combination of PRP/HA prepared with Cellular Matrix BCT-HA Kit
intervention type: Device
intervention name: Cellular Matrix BCT-HA Kit
description: Submucosal injections in the vulva, in the posterior vaginal wall and in the perineum of a combination product made of PRP and HA prepared using the Cellular Matrix BCT-HA medical device
arm group label: Treatment with Cellular Matrix
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Paul Méningaud, MD
role: Principal Investigator
affiliation: CHU Henri Mondor
facility: 
country: France
responsible party type: Sponsor
mesh term: Atrophy
sharing ipd: No