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

NCT06425978 | Recruiting Phase 4

• 2 other identifiers: FSD-CEL-2023-112023-507200-31-00
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with improved symptomatology.

  Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS)

  at 6 months after treatment

Secondary Outcomes (7)

• Healing percentage

  at 6 months after treatment

• Evolution of Vaginal Health Index

  at 3-months and 6-months follow-up

• Evolution of Vulvar Health Index

  at 3-months and 6-months follow-up

• Evolution of vaginal pH

  at 3-months and 6-months follow-up

• Evolution of Vaginal maturation index (vaginal cytology)

  at 3-months and 6-months follow-up

Study Arms (2)

Cellular Matrix / A-CP-HA Kit

EXPERIMENTAL

(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.

Drug: Cellular Matrix / A-CP-HA Kit

Local estrogen therapy

ACTIVE COMPARATOR

Blissel, estriol 50 micrograms/g vaginal gel

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

Interventions

Cellular Matrix / A-CP-HA Kit DRUG

For infiltration, a prior preparation of the region with anesthetic cream is performed, procaine 25 mg/g + lidocaine 25 mg/g (Emla 5% cream) in the vulvar area and vaginal introitus. Occlusion of the area with plastic film is performed for 20 minutes. After asepsis and antisepsis, infiltration is performed with mesotherapy needles 31G 4mm, using the technique of superficial "point-to-point" mesotherapy microinjections, in the vestibule and the first 3 cm of the posterior wall of the vagina.

Cellular Matrix / A-CP-HA Kit

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

Blissel®, Estriol vaginal gel 50 micrograms/g, daily application for 15-21 days in a row, then two times a week for 24 weeks (6 months). Application instructions will be explained to the patients. The gel should be applied in the vagina using an applicator with the marked dose, the full applicator should be inserted into the vagina and emptied, preferably at night.

Local estrogen therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santiago Dexeus Font: lead
• Regen Lab SA: collaborator

Study Sites (1)

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

RECRUITING

Related Links

• Related Info

Central Study Contacts

Antonella de Ponte Davi, MD

CONTACT

0034932274700; ANTPON@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700; nacrod@dexeus.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: May 30, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

ES (1)