Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness

NCT02966925 | Completed

• 1 other identifier: 2015-SM-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Atrophy

Keywords

Vulvovaginal dryness

Outcome Measures

Primary Outcomes (2)

• Vaginal pH

  Variation of the vaginal pH between baseline and Month 3 after treatment

  3 months

• Friedmann score

  Variation of the Friedmann score between baseline and Month 3 after treatment

  3 months

Secondary Outcomes (3)

• Female Sexual Distress (FSD) score

  Month 1, Month 3 and Month 6

• Female Sexual Function Index (FSFI) score

  Month 1, Month 3 and Month 6

• Adverse device effects

  Month 1, Month 3 and Month 6

Study Arms (1)

Treatment with Cellular Matrix

EXPERIMENTAL

Patients will be treated with a combination of PRP/HA prepared with Cellular Matrix BCT-HA Kit

Device: Cellular Matrix BCT-HA Kit

Interventions

Cellular Matrix BCT-HA Kit DEVICE

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

Treatment with Cellular Matrix

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regen Lab SA: lead

Study Sites (1)

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Study Officials

• Jean-Paul Méningaud, MD

  CHU Henri Mondor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: case-series

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 17, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)