A study of a new treatment for vaginal dryness, pain and other symptoms associated with menopause
| ISRCTN | ISRCTN13211813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13211813 |
| Sponsor | Good Cells LLC |
| Funder | Good Cells LLC |
- Submission date
- 13/08/2026
- Registration date
- 13/08/2026
- Last edited
- 13/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Vaginal dryness, discomfort and pain during sexual intercourse are common during and after the menopausal transition. These symptoms are caused by changes in the vaginal tissues associated with lower estrogen levels and can affect sexual health and quality of life. Hormone treatments can be effective, but they may not be suitable or preferred by all women.
Extracellular vesicles are very small particles naturally released by cells. They carry proteins and other biologically active substances that are involved in communication between cells and may support tissue repair and regeneration. This pilot study aims to assess the safety and potential effects of a treatment containing extracellular vesicles derived from mesenchymal stromal cells in women with symptoms of vulvovaginal atrophy.
Who can participate?
Peri- and postmenopausal women with clinically confirmed symptomatic vulvovaginal atrophy can participate. Symptoms may include vaginal dryness, reduced lubrication, pain during sexual intercourse, reduced sexual desire or other changes in sexual function.
What does the study involve?
Participants receive a single treatment containing extracellular vesicles derived from mesenchymal stromal cells from three different tissue sources: umbilical cord, adipose tissue and dental pulp. A total volume of 1 ml containing 3 billion extracellular vesicle particles is injected into the vaginal tissue using a series of small injections after application of a local anaesthetic cream. No additional treatment specifically for vulvovaginal atrophy is given during the 12-month follow-up period.
Participants are assessed before treatment and at 1, 3, 6 and 12 months after treatment. The assessments include vaginal pH, vaginal tissue health and maturation, sexual function using a standardized questionnaire, and monitoring for any treatment-related side effects.
What are the possible benefits and risks of participating?
The treatment may improve vaginal health and symptoms associated with vulvovaginal atrophy, although individual benefit cannot be guaranteed. As the treatment involves injections into the vaginal tissue, participants may experience temporary local discomfort associated with the procedure. Participants are monitored for treatment-related adverse events throughout the 12-month follow-up period.
Where is the study run from?
Dr Demianenko LLC (Ukraine)
When is the study starting and how long is it expected to run for?
August 2023 to January 2025
Who is funding the study?
Good Cells LLC (Ukraine)
Who is the main contact?
Dr Inna Gordiienko, i.gordienko@goodcells.com
Contact information
Principal investigator
Shchekavytska Street, 30/39
Kyiv
02000
Ukraine
 ORCID ID |
0000-0001-8800-154X |
|---|---|
| Phone | +380 (0)667128894 |
| dr.demianenko@gmail.com |
Scientific, Public
Ivana Kramskoho St., 9
Kyiv
03115
Ukraine
| ORCID ID |
0000-0003-3759-6138 |
|---|---|
| Phone | +380 (0)672428222 |
| i.gordienko@goodcells.com |
Scientific
Ivana Kramskoho St., 9
Kyiv
03115
Ukraine
| ORCID ID |
0000-0002-5834-2834 |
|---|---|
| Phone | +380 (0)672428222 |
| a.zlatska@goodcells.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Treatment |
| Scientific title | One-year outcomes of mesenchymal stromal cell-derived extracellular vesicle therapy in women with vulvovaginal atrophy: a prospective pilot study |
| Study objectives | To evaluate the safety and therapeutic potential of a mesenchymal stromal cell-derived extracellular vesicle (EV) complex in peri- and post-menopausal women with vulvovaginal atrophy (VVA), and to assess its effects on vaginal epithelial maturation, vaginal health, vaginal pH, and sexual function over a 12-month follow-up period. |
| Ethics approval(s) |
Approved 09/03/2023, Bioethics Commission of the Institute of Genetic and Regenerative Medicine, State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology, Clinical and Regenerative Medicine of the National Academy of Medical Sciences of Ukraine (5 Svyatoslava Khorobroho St., Kyiv, 03151, Ukraine; +380 (0)44 275 66 22; stragh.cardio@gmail.com), ref: 9/03-23 |
| Health condition(s) or problem(s) studied | Vulvovaginal atrophy (VVA) in peri- and postmenopausal women |
| Intervention | Participants received a single intramucosal administration of 1 ml of an extracellular vesicle (EV) complex containing 3 × 10⁹ particles suspended in physiological saline. The EV complex consisted of EVs derived from allogeneic mesenchymal stromal cells from three tissue sources: umbilical cord, adipose tissue, and dental pulp. EVs from the three MSC sources were combined at a 1:1:1 ratio based on particle number. The preparation was administered using a micropapular injection technique following topical application of lidocaine cream. No additional VVA-directed treatment was administered during the 12-month follow-up. |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mesenchymal stromal cell-derived extracellular vesicle (EV) complex |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/01/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 48 Years |
| Upper age limit | 53 Years |
| Sex | Female |
| Target sample size at registration | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Peri- or postmenopausal women with clinically confirmed vulvovaginal atrophy (VVA) 2. Presence of symptomatic VVA, including one or more of the following symptoms: vaginal dryness, dyspareunia, reduced lubrication, decreased sexual desire, diminished or absent orgasm, or pain during sexual intercourse. |
| Key exclusion criteria | 1. Stress urinary incontinence 2. Vaginismus 3. Vulvovaginal or urinary tract infections 4. HPV + patients 5. Genital bleeding of unknown origin 6. Hormone-dependent malignancies 7. Previous vulvovaginal or urogynecological surgery 8. Uncontrolled systemic diseases 9. Coagulation disorders 10. History of hypertrophic scar formation |
| Date of first enrolment | 03/08/2023 |
| Date of final enrolment | 29/01/2024 |
Locations
Countries of recruitment
- Ukraine
Study participating centre
Kyiv
02000
Ukraine
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
13/08/2026: Study's existence confirmed by the Bioethics Commission of the Institute of Genetic and Regenerative Medicine, State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology, Clinical and Regenerative Medicine of the National Academy of Medical Sciences of Ukraine.
