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RECRUITING
NCT05329662
PHASE2

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

Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

View on ClinicalTrials.gov

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.

Official title: Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female

Key Details

Gender

FEMALE

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2023-05-01

Completion Date

2025-12-30

Last Updated

2024-06-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

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

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam