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

Vulvar Atrophy Clinical Trial

Official title:

Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966925
• Other study ID #: 2015-SM-001
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2019
• Source: Regen Lab SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vulvar Atrophy

Intervention

Device:
• Cellular Matrix BCT-HA Kit
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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Regen Lab SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal pH	Variation of the vaginal pH between baseline and Month 3 after treatment	3 months
Primary	Friedmann score	Variation of the Friedmann score between baseline and Month 3 after treatment	3 months
Secondary	Female Sexual Distress (FSD) score	Variation of the FSD score between baseline and various timepoints after treatment	Month 1, Month 3 and Month 6
Secondary	Female Sexual Function Index (FSFI) score	Variation of the FSFI score between baseline and various timepoints after treatment	Month 1, Month 3 and Month 6
Secondary	Adverse device effects	Safety monitoring through the record of adverse device effects at Month 1, Month 3 and Month 6	Month 1, Month 3 and Month 6