Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy for the Treatment of Sexual Function Impairment in Women Aged 40-50

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

February 28, 2025

Study Completion Date

June 30, 2025

Conditions
Female Sexual Dysfunction
Interventions
BIOLOGICAL

Intravenous administration of Autologous, adipose-derived mesenchymal stem cells

"Patients in group A will receive two infusions of autologous, adipose-derived mesenchymal stem cells at day 0 and day 90 ± 14 at a dose of 10\^6 cells/kg.~Autologous, adipose-derived mesenchymal stem cells used in this study were harvested from autologous fat tissue through an enzyme method and expanded using our in-house optimized serum-free and xeno-free culture under a physiological oxygen concentration of 5%. For clinical use, cells at passage 3 will be harvested in 100 mL Ringer's lactate. Therapeutic ASC products must pass the following releasing criteria: (1) negative for bacteria, fungi and mycoplasma; (2) more than 90% viability; (3) expression of more than 95% positivity for CD105, CD73, and CD90 and less than 2% positivity for CD45, CD34, CD11b, CD19, and HLA-DR; and (4) endotoxin \<5 EU/kg. The patient will be infused with 1x106 cells/kg body weight within 60 minutes via the intravenous route."

Trial Locations (2)

100000

RECRUITING

Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi

RECRUITING

Vinmec Times City International Hospital, Hanoi

All Listed Sponsors
lead

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER