Evaluation of the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency: A Phase I/IIa Randomised Crossover Trial
Sexual functional deficiency affects largely the physical conditions, life and sexual quality of the patients. Hypogonadism affects about 4 to 5 million men in the US, and the incidence increases with age. In our recent phase I clinical trial, we have shown that intravenous adipose - derived MSC administration was safe in female and male patients with hormone deficiency. Post-transplantation sexual satisfaction was observed in all patients enrolled in this study. Testosterone levels in males increased significantly after transplantation and were maintained at high levels for up to 6 months before decreasing again at the 12-month follow-up. The aim of this clinical trial was to assess the safety and effectiveness of allogeneic administration of MSCs in middle-aged people with sexual functional deficiency.
• Males with sexual hormone deficiency aged 50 to 70 years
• AMS score ≥ 27
• IIEF \< 14
• SQoL-M ≤ 87
• and Testosterone ≤ 12 nMol/L
• Normal liver function (ALT, AST and Bilirubin are normal according to biological index of Vietnamese people).
• Normal kidney function is usually according to the biological index of Vietnamese people.
• No infection, HIV, HBV, active syphilis.
• Must provide written informed consent.