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.

2023-507200-31-00 Protocol FSD-CEL-2023-11 Therapeutic use (Phase IV) Ongoing, recruiting

Start 24 May 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol FSD-CEL-2023-11

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 192
Countries 1
Sites 2

genitourinary syndrome of menopause

To establish the effectiveness of the use of Cellular Matrix / A-CP-HA Kit (a 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 (SGM).

Key facts

Sponsor
Santiago Dexeus Font Fundacio Privada
Participant type
Patients
Age range
65+ years
Gender
Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration
24 May 2024 → ongoing
Decision date (initial)
2024-04-26
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
FUNDACION SANTIAGO DEXEUS FONT · Regen Lab SA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To establish the effectiveness of the use of Cellular Matrix / A-CP-HA Kit (a 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 (SGM).

Secondary objectives 5

  1. 1. Evaluate the improvement of the intensity of VVA symptoms with Cellular Matrix / A-CP-HA Kit in the treatment of genitourinary syndrome of menopause.
  2. 2. Evaluate the impact of the treatment with Cellular Matrix / A-CP-HA Kit on vaginal and vulvar health, through validated scales.
  3. 3. Assess through validated scales the effect of the treatment on the female sexual function in patients with genitourinary syndrome of menopause
  4. 4. Describe adverse events and complications in the use of Cellular Matrix / A-CP-HA Kit for the treatment of genitourinary syndrome of menopause.
  5. 5. To compare the efficacy of using Cellular Matrix / A-CP-HA Kit with local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) in women with genitourinary syndrome of menopause

Conditions and MedDRA coding

genitourinary syndrome of menopause

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. menopausal women, with absence of menstruation for at least 12 months
  2. • Women ≤70 years old
  3. • Women that are sexually active
  4. • Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) < 15 points.
  5. • Women who understand the Spanish language
  6. • Willing to participate in the study and sign informed consent.

Exclusion criteria 7

  1. • Systemic or local hormonal treatment in the last 3 months
  2. • Tamoxifen or Aromatase inhibitor treatments
  3. • 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)
  4. • Contraindication for vaginal estrogen therapy
  5. • Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases.
  6. • Women who have had pelvic surgery within 6 months.
  7. • Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary efficacy criteria is the percentage of patients with improved symptomatology. Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS) evaluated at 6 months after treatment.

Secondary endpoints 8

  1. Healing percentage defined as percentage of patients scoring ≥ 15 in the VHIS at 6 months after treatment.
  2. Evolution of Vaginal Health Index at 3-months and 6-months follow-up
  3. Evolution of Vulvar Health Index at 3- and 6-months follow-up
  4. Evolution of vaginal pH at 3- and 6-months follow-up
  5. Evolution of Vaginal maturation index (vaginal cytology) at 3- and 6-months follow-up
  6. Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) will be measured using a 5-cm visual analog scale (VAS) at 3- and 6-months follow-up
  7. Evolution of Female Sexual Distress (FSD) score at 3- and 6-months follow-up
  8. Photographic monitoring at 3- and 6-months follow-up

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Plasma rich in growth factors

PRD10878863 · Product

Active substance
Platelet Concentrate
Substance synonyms
PLATELET RICH PLASMA HUMAN
Other product name
PLATELET RICH PLASMA HUMAN
Pharmaceutical form
GEL
Route of administration
INJECTION
Max daily dose
6 ml millilitre(s)
Max total dose
6 ml millilitre(s)
Max treatment duration
3 Month(s)
Authorisation status
Not Authorised
MA holder
BIOTECHNOLOGY INSTITUE I MAS D S.L.
Paediatric formulation
No
Orphan designation
No

Comparator 1

Blissel 50 microgramos/g gel vaginal.

PRD10850241 · Product

Active substance
Estriol
Pharmaceutical form
VAGINAL GEL
Route of administration
VAGINAL USE
Max daily dose
1 g gram(s)
Max total dose
1 g gram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
G03CA04 — ESTRIOL
Marketing authorisation
72726
MA holder
ITALFARMACO S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Santiago Dexeus Font Fundacio Privada

8 Total trials 5 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Santiago Dexeus Font Fundacio Privada
Address
Gran Via De Carles III 71-75
City
Barcelona
Postcode
08028
Country
Spain

Scientific contact point

Organisation
Santiago Dexeus Font Fundacio Privada
Contact name
Unidad de Apoyo a la Investigación

Public contact point

Organisation
Santiago Dexeus Font Fundacio Privada
Contact name
Unidad de Apoyo a la Investigación

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 192 2
Rest of world — 0 —

Investigational sites

Spain

2 sites · Ongoing, recruiting
Hospital Universitari Dexeus Grupo Quironsalud
Gynaecology, Calle De Sabino Arana 5-19, 08028, Barcelona
Dexeus Midlife
Midlife, C. Bisbe Catala 21, 08034, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2024-05-24 2024-05-30

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Recruitment arrangements (for publication) Email_Cellular Matrix_CAT 1
Recruitment arrangements (for publication) Email_Cellular Matrix_ESP 1
Recruitment arrangements (for publication) Ficha_Web_CellularMatrix_CAT 1
Recruitment arrangements (for publication) Ficha_Web_CellularMatrix_ESP 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Recruitment arrangements (for publication) Post_CellularMatrix_1 1
Recruitment arrangements (for publication) Post_CellularMatrix_2 1
Recruitment arrangements (for publication) Post_CellularMatrix_3 1
Recruitment arrangements (for publication) Story_CellularMatrix_1 1
Recruitment arrangements (for publication) Story_CellularMatrix_2 1
Subject information and informed consent form (for publication) L1_HIPCI_Cellular_Matrix 3
Subject information and informed consent form (for publication) L1_HIPCI_Cellular_Matrix_ES 1
Subject information and informed consent form (for publication) L1_HIPCI_Cellular_Matrix_TC 3

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-02-22 Spain Acceptable
2024-04-26
 2024-04-26
2 SUBSTANTIAL MODIFICATION SM-1 2024-11-26 Spain Acceptable 2025-01-21
3 SUBSTANTIAL MODIFICATION SM-2 2025-04-08 Spain Acceptable 2025-05-15

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