Phase I/IIa: UC-MSC treating male Sexual Deficiency

Cell & Gene Therapy Clinical Phase 1 Clinical Phase 2 Endocrine imbalance

Project Title: Evaluation of safety and efficacy of allogenic umbilical cord-derived mesenchymal stem cell administration for the treatment of hormone deficiency in male: A clinical trial phase I and randomized controlled Phase II

Principal Investigator (PI):

– Nguyen Thi Tan Sinh, MD

– Hoang Thanh Van, PhD (Co – PI)

Objective:

To evaluate the safety and efficacy of allogenic umbilical cord-derived mesenchymal stem cell administration for the treatment of hormone deficiency in male.

Project Description (list page – 50 words):

This project is a Phase I and randomized controlled Phase II clinical trial evaluating the safety and efficacy of allogenic umbilical cord derived mesenchymal stem cell administration for the treatment of hormone deficiency in males. The study is conducted at Vinmec International Hospital between April 2022 and December 2027.

Project Description (main page – 250 words):

This study is a combined Phase I and randomized controlled Phase II clinical trial designed to evaluate the safety and efficacy of allogenic umbilical cord derived mesenchymal stem cell administration for the treatment of hormone deficiency in male patients.

Eligible participants are adult male patients diagnosed with hormone deficiency according to predefined clinical and laboratory criteria. Participants are allocated according to the study phase and protocol, with careful monitoring for adverse events and treatment related complications throughout the study period.

This project aims to generate robust clinical evidence on the potential role of allogenic umbilical cord derived mesenchymal stem cells as a novel regenerative therapy for male hormone deficiency, contributing to the development of advanced cell-based therapies within the Vinmec healthcare system and supporting future large scale clinical applications.