Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * The patient had surgery to remove the gonads. * Patients with a history of cancer, or undergoing cancer treatment, or are positive for cancer screening tests including: PSA, AFP, Pepsinogen I, Pepsinogen II and erythrocyte smear test. The patient is taking anti-rejection drugs. * Patients with malformations, malformations or tumors of the endocrine glands. * Endocrine impairment due to diabetes (HBA1c \> 7) and other metabolic diseases. * Patients with active autoimmune disease or positive for antinuclear antibodies. * Patients wi