Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female

NCT05329662 | Recruiting Phase 2

• 1 other identifier: ISC.21.73
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sexual Dysfunction Female

Keywords

sexual dysfunction Female; adipose mesenchymal stem cell; reproductive hormones

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  1 month, 3 months, 6 months, 12 months after the first UCMSC infusion

Study Arms (2)

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

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

Biological: Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency

Interventions

Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency BIOLOGICAL

* 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

AD-MSCs infusions, then Placebo; Placebo, then AD-MSCs infusions

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

RECRUITING

Study Officials

• Tan Sinh Nguyen, PhD

  Vinmec Times City International Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuong Nguyen, MSC

CONTACT

0914740683; v.phuongnh9@vinmec.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 15, 2022
• Study Start: May 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 30, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)