Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness
Primary Purpose
Vulvar Atrophy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cellular Matrix BCT-HA Kit
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Atrophy focused on measuring Vulvovaginal dryness
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from vulvovaginal dryness who cannot benefit from hormonal therapy
- Patients having signed an Informed Consent
- Patient capable of understanding the study's imperatives
Exclusion Criteria:
- Vulvovaginal inflammation or infection
- History of vaginal herpes
- History of vulvar, vaginal or cervical cancer
- Lichen sclerosus
- History of allergy to HA
- Hereditary or acquired hematological or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (150'000 platelets/µl)
- Anemia (HGB ≤ 10g/dl)
- Autoimmune disease (Hashimoto, rheumatoid disease, lupus, etc.)
- HIV positive
- Hepatitis B or C
- Pregnancy or breastfeeding
- No contraception
Sites / Locations
- Centre Hospitalier Universitaire Henri Mondor
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Cellular Matrix
Arm Description
Patients will be treated with a combination of PRP/HA prepared with Cellular Matrix BCT-HA Kit
Outcomes
Primary Outcome Measures
Vaginal pH
Variation of the vaginal pH between baseline and Month 3 after treatment
Friedmann score
Variation of the Friedmann score between baseline and Month 3 after treatment
Secondary Outcome Measures
Female Sexual Distress (FSD) score
Variation of the FSD score between baseline and various timepoints after treatment
Female Sexual Function Index (FSFI) score
Variation of the FSFI score between baseline and various timepoints after treatment
Adverse device effects
Safety monitoring through the record of adverse device effects at Month 1, Month 3 and Month 6
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02966925
Brief Title
Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness
Official Title
Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regen Lab SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Atrophy
Keywords
Vulvovaginal dryness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
case-series
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Cellular Matrix
Arm Type
Experimental
Arm Description
Patients will be treated with a combination of PRP/HA prepared with Cellular Matrix BCT-HA Kit
Intervention Type
Device
Intervention Name(s)
Cellular Matrix BCT-HA Kit
Intervention 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
Primary Outcome Measure Information:
Title
Vaginal pH
Description
Variation of the vaginal pH between baseline and Month 3 after treatment
Time Frame
3 months
Title
Friedmann score
Description
Variation of the Friedmann score between baseline and Month 3 after treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Female Sexual Distress (FSD) score
Description
Variation of the FSD score between baseline and various timepoints after treatment
Time Frame
Month 1, Month 3 and Month 6
Title
Female Sexual Function Index (FSFI) score
Description
Variation of the FSFI score between baseline and various timepoints after treatment
Time Frame
Month 1, Month 3 and Month 6
Title
Adverse device effects
Description
Safety monitoring through the record of adverse device effects at Month 1, Month 3 and Month 6
Time Frame
Month 1, Month 3 and Month 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering from vulvovaginal dryness who cannot benefit from hormonal therapy
Patients having signed an Informed Consent
Patient capable of understanding the study's imperatives
Exclusion Criteria:
Vulvovaginal inflammation or infection
History of vaginal herpes
History of vulvar, vaginal or cervical cancer
Lichen sclerosus
History of allergy to HA
Hereditary or acquired hematological or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (150'000 platelets/µl)
Anemia (HGB ≤ 10g/dl)
Autoimmune disease (Hashimoto, rheumatoid disease, lupus, etc.)
HIV positive
Hepatitis B or C
Pregnancy or breastfeeding
No contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Méningaud, MD
Organizational Affiliation
CHU Henri Mondor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness
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