Autologous AD-MSC treating Female Sexual Deficiency

Cell & Gene Therapy Clinical Phase 1 Endocrine imbalance

Project Title: Evaluation of adipose tissue-derived mesenchymal stem cell (AD-MSC) therapy for the treatment of sexual function impairment in female: A phase II clinical trial

Principal Investigator (PI):

– Prof. Nguyen Thanh Liem

– Prof. Pham Van Minh

Objective:

To assess the safety and efficacy of autologous ADSC administration for for perimenopausal women with sexual dysfunction.

Project Description (list page – 50 words):

A Phase IIa clinical trial assessing the safety and preliminary efficacy of intravenous autologous adipose derived mesenchymal stem cell infusion for sexual functional deficiency. A total of 130 participants are randomized 1:1 to immediate treatment (group A) or delayed treatment (group B), with clinical, laboratory, and questionnaire assessments over 18 months and crossover of the control group to AD-MSC at later visits under ongoing safety monitoring.

Project Description (main page – 250 words):

This is a randomized Phase II clinical trial designed to evaluate the safety and preliminary efficacy of autologous adipose derived mesenchymal stem cell therapy for individuals with sexual functional deficiency. Eligible participants were adults with a history of reduced sexual activity who met predefined clinical criteria for enrollment. Each participant received two intravenous infusions at a dose of 1 million cells per kg of body weight and was followed for 12 months.

Safety was evaluated throughout follow up by monitoring the occurrence of adverse events and severe adverse events after cell administration. Efficacy was assessed using sex specific clinical and laboratory endpoints. In male participants, outcomes included serum testosterone levels and the International Index of Erectile Function questionnaire. In female participants, outcomes included anti Müllerian hormone, estradiol, and follicle stimulating hormone levels, together with the Female Sexual Function Index questionnaire. Assessments were conducted at baseline and at 3-, 6-, and 12-months post infusion to capture both short term and sustained changes.

The project aims to generate clinical evidence on the feasibility, safety, and potential therapeutic benefit of autologous adipose derived mesenchymal stem cell infusion as a regenerative approach for sexual functional deficiency. Findings from this study can inform protocol refinement, endpoint selection, and the design of larger controlled trials to validate effectiveness and optimize clinical implementation.