Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit (CellularMatrix)

Fundación Santiago Dexeus Font

Status and phase: Enrolling; Phase 4

Conditions: Genitourinary Syndrome of Menopause

Treatments: Drug: Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel); Drug: Cellular Matrix / A-CP-HA Kit

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06425978

FSD-CEL-2023-11

2023-507200-31-00

Details and patient eligibility

About

This study is a randomized, controlled, non-inferiority trial, that will be performed on 192 women on Menopause (absence of menstruation for at least 12 months), with diagnostic of genitourinary syndrome of menopause (SGM) and a vaginal health index <15 points, that are sexually active.

Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel).

Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence.

Full description

This study is a randomized, controlled, non-inferiority trial, with a second blind observer, comparing effectiveness of the use of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) to the standard line of treatment, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) in women with genitourinary syndrome of menopause (SGM). Duration of the study estimated is 24 months.

A total of 192 menopausal women, with absence of menstruation for at least 12 months, ≤70 years old, that are sexually active and who report symptoms and signs of SGM, with a vaginal health index <15 points. Patients will be excluded if are in treatment with systemic or local hormonal treatment in the last 3 months, Tamoxifen or Aromatase inhibitor treatments. Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida). Contraindication for vaginal estrogen therapy. Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases. Women who have had pelvic surgery within 6 months.

Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid), separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel).

Patients will interviewed about their medical history, age of menopause, symptoms related and history of treatments. Evaluation of the Vaginal Health Index (VHIS), Vulvar Health Index (VHI), vaginal pH, and vaginal maturation index (vaginal cytology). The intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria) will be measured using a 5-cm visual analog scale (VAS), and a valuation of Female Sexual Distress (FSD) score. Photographic monitoring during all phases of the procedure. Routine laboratory test serology will requested for both groups (valid up to 3 months).

Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence.

Enrollment: 192 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≤70 years old
• Women that are sexually active
• Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) < 15 points.
• Women who understand the Spanish language
• Willing to participate in the study and sign informed consent.

Exclusion criteria

• Systemic or local hormonal treatment in the last 3 months
• Tamoxifen or Aromatase inhibitor treatments
• Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida) Contraindication for vaginal estrogen therapy
• Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases.
• Women who have had pelvic surgery within 6 months.
• Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups

Cellular Matrix / A-CP-HA Kit

Experimental group

Description:

(a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) is a sterile tube designed for use in the preparation of a mixture of PRP and hyaluronic acid, tube is under vacuum allowing the withdrawal of 6 ml of blood and contains: 2 ml of hyaluronic acid gel (20mg/ml, 40 mg per tube) in phosphate buffer. Not crosslinked, hyaluronic acid is obtained from bacterial fermentation, 3 g of inert cell-selector gel, and 0.6 ml of anticoagulant (sodium citrate 4%). Centrifuged at 1,500 g, 3,000 rpm for 5 min. Platelet recovery of more than 70%, granulocyte depletion of 94.3% and red blood cells of 99.5% are achieved.

Treatment:

Drug: Cellular Matrix / A-CP-HA Kit

Local estrogen therapy

Active Comparator group

Description:

Blissel, estriol 50 micrograms/g vaginal gel

Treatment:

Drug: Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel)