## Protocol Section
### Identification Module
**NCT ID:** NCT06425978

**Acronym:** CellularMatrix

**Brief Title:** Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit

**Official Title:** The Efficacy of the Use of Cellular Matrix / A-CP-HA Kit (Combination of Autologous Platelet-rich Plasma and Non-cross-linked Hyaluronic Acid) Compared to Local Estrogen Therapy (Blissel, Estriol 50 Micrograms/g Vaginal Gel) in Women With Genitourinary Syndrome of Menopause. A Randomized Controlled Trial, With a Second Blind Observer.

#### Organization Study ID Info
**ID:** FSD-CEL-2023-11
#### Organization
**Class:** OTHER
**Full Name:** Institut Universitari Dexeus
#### Secondary ID Infos
**ID:** 2023-507200-31-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Regen Lab SA

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundación Santiago Dexeus Font

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Genitourinary Syndrome of Menopause

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 192

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Drug: Cellular Matrix / A-CP-HA Kit

**Label:** Cellular Matrix / A-CP-HA Kit

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Blissel, estriol 50 micrograms/g vaginal gel

**Intervention Names:**

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

**Label:** Local estrogen therapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cellular Matrix / A-CP-HA Kit

**Description:** 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.

**Name:** Cellular Matrix / A-CP-HA Kit

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Local estrogen therapy

**Description:** 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.

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

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Percentage of patients with improved symptomatology.

**Time Frame:** at 6 months after treatment

#### Secondary Outcomes

**Description:** defined as percentage of patients scoring ≥ 15 in the VHIS

**Measure:** Healing percentage

**Time Frame:** at 6 months after treatment

**Measure:** Evolution of Vaginal Health Index

**Time Frame:** at 3-months and 6-months follow-up

**Measure:** Evolution of Vulvar Health Index

**Time Frame:** at 3-months and 6-months follow-up

**Measure:** Evolution of vaginal pH

**Time Frame:** at 3-months and 6-months follow-up

**Measure:** Evolution of Vaginal maturation index (vaginal cytology)

**Time Frame:** at 3-months and 6-months follow-up

**Description:** measured using a 5-cm visual analog scale (VAS)

**Measure:** Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria)

**Time Frame:** at 3-months and 6-months follow-up

**Measure:** Incidence of adverse events and serious adverse events

**Time Frame:** at 3-months and 6-months follow-up

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ANTPON@dexeus.com

**Name:** Antonella de Ponte Davi, MD

**Phone:** 0034932274700

**Role:** CONTACT

**Contact 2:**

**Email:** nacrod@dexeus.com

**Name:** Ignacio Rodríguez, MSc

**Phone:** 0034932274700

**Phone Ext:** 22029

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Barcelona

**Country:** Spain

**Facility:** Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

**Zip:** 08037

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.dexeus.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: T6036

- Name: Menopause

- Relevance: HIGH

- As Found: Menopause

### Condition Browse Module - Meshes

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Ancestors

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M8116

- Name: Estrogens

- Relevance: HIGH

- As Found: Nasal spray

- ID: M4244

- Name: Anticoagulants

- Relevance: LOW

- As Found: Unknown

- ID: M21320

- Name: Citric Acid

- Relevance: LOW

- As Found: Unknown

- ID: M1837

- Name: Sodium Citrate

- Relevance: LOW

- As Found: Unknown

- ID: M14216

- Name: Procaine

- Relevance: LOW

- As Found: Unknown

- ID: M1801

- Name: Lidocaine, Prilocaine Drug Combination

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: T382

- Name: Citrate

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004967

- Term: Estrogens

### Misc Info Module

- Version Holder: 2024-05-31
