Sexual Dysfunction FemalePhase 2NCT05329662
Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female
A Phase 2 study testing Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency in people with Sexual Dysfunction Female, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
Trial summary
Hormones are a chemical substance synthesized and secreted by endocrine gland. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function.- Hormone therapy is used to treat female hormone deficiency and… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Sexual Dysfunction Female
- What is being tested?
- Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteVietnam
- Study dates
- 1 May 2023to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are 40 - 50 years of age or older and have not gone through menopause according to Stages of Reproductive Aging Workshop (STRAW) 2011
- The last menstrual period before participating in the study at least 2 months or more
- FSH, Estrogen above the menopause:
- + FSH > 40 mIU/mL
- + Estradiol < 30 pg/mL
- (tested between the 2nd and the 4th day of the menstrual cycle)
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- FSFI < 26.55 ± signs of decline in sexual or reproductive functions such as symptoms of premenopausal such as hot flashes, excessive sweating, headaches
- Normal liver function
- Normal kidney function
- Normal cardiovascular function
- No active bacterial, fungal and viral (HIV, HBV, HCV, syphilis) infections
- Provide written informed consent
Who cannot join
- Previous surgery to remove gonads
- No sexual activity
- Diagnosed with cancer and is being or has not been treated
- Had an organ transplant
- Has congenital malformations related to the gonads
- Chronic disease such as: Diabetes, hypopituitarism, adrenal insufficiency, blood pressure unresponsive to treatment, etc
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- Any active autoimmune diseases
- Being diagnosed with heart failure, kidney failure, liver failure, respiratory failure, history of cerebral infarction, myocardial infarction, Alzheimer's
- Hypothyroidism or hyperthyroidism
- Any active autoimmune diseases
- Any clinically significant blood coagulation disorders.
- History of allergic reaction to anesthetic agents and antibiotics
- Using hormone therapy within the last 2 weeks or want to use these drugs during the study period
- Planning to become pregnant during the study period
- using hormonal contraceptives
- Absence of menstruation for at least 12 months
- Mental illness, inability to communicate, inability to answer the interview questions correctly
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 100000
Nguyen Thanh Liem, Prof
About this study
Official title: Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female
Hormones are a chemical substance synthesized and secreted by endocrine gland. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function.- Hormone therapy is used to treat female hormone deficiency and results in a significant improvement, but long-term use increases cardiovascular disease or cancer risk. Other treatments do not give apparent results. Therefore, it is necessary to develop new and effective treatments to achieve the requirements of improving health in general and sexual health in particularly in women. AD-MSCs have been widely used as autologous and allogeneic stem cell sources to treat numerous disease recently, and they have been proven to be safe. The phase I trial showed that administration of autologous AD-MSCs at the dose of 1.0 x 10^6 cells/kg patient bodyweight was safe for patients with sex hormone deficiency. The therapy introduced potential improvement in sexual and general quality of life indicating by the increased FSFI. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.
Read the detailed description
Hormones are a chemical substance synthesized and secreted by endocrine gland. They are used by multicellular organism to organize, coordinate, and regulate multiple functions of cells and tissues in the body. They are considered as chemical messenger molecules that send signals from one cell to another within or between various body parts. Hormones are responsible for regulating many physiological processes and behavioral activities such as growth and development of the body, metabolism, homeostasis of intracellular and extracellular fluid, and reproduction. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function. The phase I clinical study named " Single-group, open-label clinical trial, evaluating the safety and efficacy of adipose tissue-derived mesenchymal stem cell therapy for early sex hormone deficiency in middle-aged people" showed that AD-MSC therapy for patients with hormone deficiency is safe, can improve the sexual quality of life in both men and women. A significant statistical increase of testosterone levels was observed in male patients at 3-month, 6-month and 12-month. In female patients, the FSFI was 20.70 at baseline and increased to 27.1 at 12 months after AD-MSC infusion (p<0.05). There were no significant changes in AMH, FSH, or E2 infusion compared to baseline in the 16 enrolled patients. Within those under 45 years old, FSH and E2 tended to increase at 3 months after ADSC infusion and decreased at the follow-up after 6 and 12 months. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.
- Conditions
- Sexual Dysfunction Female
- Being tested
- Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency
- Keywords
- sexual dysfunction Female, adipose mesenchymal stem cell, reproductive hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiencyBiological
- Patients in the two groups will receive two autologous AD-MSC administrations: the group A on day 0 and day 90 ± 7; the group B on day 180 ± 14 and day 270 ± 14.
- Dose: 1.0 x 106 cells/kg patient bodyweight.
- Route: intravenous infusion
ADSCs were collected after the third passage. On the day of transplantation, the ADSCs were harvested, washed twice with NaCl 0.9%, counted and resuspended in NaCl 0.9% in a total volume of 20 ml. Each participant received a dose of 1x10^6 cells/kg body weight infused through the intravenous route within 30 minutes before being discharged after 24 hours
| Study group | Role | What they receive |
|---|---|---|
| AD-MSCs infusions, then Placebo | Active comparator | Patients in group A will receive two autologous AD-MSC administrations on day 0 and day 90 ± 7 Receives: Biological: Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency |
| Placebo, then AD-MSCs infusions | Placebo comparator | Patients in group B will receive two autologous AD-MSC administrations on day 180 ± 14 and day 270 ± 14 Receives: Biological: Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Follicle-stimulating hormone (FSH) hormone level
FSH stimulates granulosa cells in the ovarian follicles to synthesize aromatase, which converts androgens produced by the thecal cells to estradiol. FSH peaks at the same time as the LH surge that causes ovulation. FSH then remains low throughout the luteal phase, preventing the development of new follicles. FSH levels is measured in the serum sample.
Measured: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Change of Estradiol (E2) hormone level
Estrogen is a steroid hormone associated with the female reproductive organs and is responsible for the development of female sexual characteristics.
Measured: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Change in Quality of life using Female Sexual Function Index - FSFI questionaires
The FSFI questionnaire consists of 19 close-ended questions related to sexual activity within the 4 weeks prior to the examination. Points are assigned for each answer (1-5 and 0-5 for questions 1-2 and questions 3-19, respectively), the sum of the scores for the domain is multiplied by the domain factor, the six domain scores are added up, and the total score may vary from 2.0 to 36.0 points.
Measured: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Change in Quality of life using The Utian Quality of life Scale
The UQOL is the first pure QOL measure of this new generation of instruments that can be applied to a menopausal population. Items are scaled using a Likert-type 1 to 5 rating.
Measured: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Secondary outcomes (1)
The safety of AD MSC therapy in the treatment of sexual function impairment in female
The frequency and severity of AEs and SAEs during the intervention and within 12 months after the first cell administration.
Measured: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 May 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Dysfunction FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tan Sinh Nguyen, PhD, Principal investigator, Vinmec Times City International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329662
- Sponsor's protocol ID
- ISC.21.73
- Status last verified
- Jun 2024
- First submitted
- 7 Apr 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female
- ClinicalTrials.gov ID
- NCT05329662
- Acronym / sponsor ID
- ISC.21.73
- Conditions
- Sexual Dysfunction Female
- Keywords
- sexual dysfunction Female, adipose mesenchymal stem cell, reproductive hormones
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hormones are a chemical substance synthesized and secreted by endocrine gland. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function.- Hormone therapy is used to treat female hormone deficiency and results in a significant improvement, but long-term use increases cardiovascular disease or cancer risk. Other treatments do not give apparent results. Therefore, it is necessary to develop new and effective treatments to achieve the requirements of improving health in general and sexual health in particularly in women. AD-MSCs have been widely used as autologous and allogeneic stem cell sources to treat numerous disease recently, and they have been proven to be safe. The phase I trial showed that administration of autologous AD-MSCs at the dose of 1.0 x 10^6 cells/kg patient bodyweight was safe for patients with sex hormone deficiency. The therapy introduced potential improvement in sexual and general quality of life indicating by the increased FSFI. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.
Detailed description
Hormones are a chemical substance synthesized and secreted by endocrine gland. They are used by multicellular organism to organize, coordinate, and regulate multiple functions of cells and tissues in the body. They are considered as chemical messenger molecules that send signals from one cell to another within or between various body parts. Hormones are responsible for regulating many physiological processes and behavioral activities such as growth and development of the body, metabolism, homeostasis of intracellular and extracellular fluid, and reproduction. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function. The phase I clinical study named " Single-group, open-label clinical trial, evaluating the safety and efficacy of adipose tissue-derived mesenchymal stem cell therapy for early sex hormone deficiency in middle-aged people" showed that AD-MSC therapy for patients with hormone deficiency is safe, can improve the sexual quality of life in both men and women. A significant statistical increase of testosterone levels was observed in male patients at 3-month, 6-month and 12-month. In female patients, the FSFI was 20.70 at baseline and increased to 27.1 at 12 months after AD-MSC infusion (p<0.05). There were no significant changes in AMH, FSH, or E2 infusion compared to baseline in the 16 enrolled patients. Within those under 45 years old, FSH and E2 tended to increase at 3 months after ADSC infusion and decreased at the follow-up after 6 and 12 months. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD-MSCs infusions, then Placebo | Active comparator | Biological: Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiencyPatients in group A will receive two autologous AD-MSC administrations on day 0 and day 90 ± 7 |
| Placebo, then AD-MSCs infusions | Placebo comparator | Biological: Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiencyPatients in group B will receive two autologous AD-MSC administrations on day 180 ± 14 and day 270 ± 14 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women who are 40 - 50 years of age or older and have not gone through menopause according to Stages of Reproductive Aging Workshop (STRAW) 2011
- The last menstrual period before participating in the study at least 2 months or more
- FSH, Estrogen above the menopause:
- + FSH > 40 mIU/mL
- + Estradiol < 30 pg/mL
Key exclusion criteria (17 listed)
- Previous surgery to remove gonads
- No sexual activity
- Diagnosed with cancer and is being or has not been treated
- Had an organ transplant
- Has congenital malformations related to the gonads
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency* Patients in the two groups will receive two autologous AD-MSC administrations: the group A on day 0 and day 90 ± 7; the group B on day 180 ± 14 and day 270 ± 14. * Dose: 1.0 x 106 cells/kg patient bodyweight. * Route: intravenous infusion ADSCs were collected after the third passage. On the day of transplantation, the ADSCs were harvested, washed twice with NaCl 0.9%, counted and resuspended in NaCl 0.9% in a total volume of 20 ml. Each participant received a dose of 1x10^6 cells/kg body weight infused through the intravenous route within 30 minutes before being discharged after 24 hours | Biological | AD-MSCs infusions, then Placebo, Placebo, then AD-MSCs infusions |
Primary outcome
Change of Follicle-stimulating hormone (FSH) hormone level
Time frame: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
FSH stimulates granulosa cells in the ovarian follicles to synthesize aromatase, which converts androgens produced by the thecal cells to estradiol. FSH peaks at the same time as the LH surge that causes ovulation. FSH then remains low throughout the luteal phase, preventing the development of new follicles. FSH levels is measured in the serum sample.
Change of Estradiol (E2) hormone level
Time frame: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Estrogen is a steroid hormone associated with the female reproductive organs and is responsible for the development of female sexual characteristics.
Change in Quality of life using Female Sexual Function Index - FSFI questionaires
Time frame: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
The FSFI questionnaire consists of 19 close-ended questions related to sexual activity within the 4 weeks prior to the examination. Points are assigned for each answer (1-5 and 0-5 for questions 1-2 and questions 3-19, respectively), the sum of the scores for the domain is multiplied by the domain factor, the six domain scores are added up, and the total score may vary from 2.0 to 36.0 points.
Change in Quality of life using The Utian Quality of life Scale
Time frame: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
The UQOL is the first pure QOL measure of this new generation of instruments that can be applied to a menopausal population. Items are scaled using a Likert-type 1 to 5 rating.
1 secondary outcome
The safety of AD MSC therapy in the treatment of sexual function impairment in female
Time frame: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tan Sinh Nguyen, PhD principal investigator
Vinmec Times City International Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency in people with Sexual Dysfunction Female, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phuong Nguyen, MSC (0914740683, v.phuongnh9@vinmec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Follicle-stimulating hormone (FSH) hormone level (time frame: 1 month, 3 months, 6 months, 12 months after the first UCMSC infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.