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
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.
Patients with malformations, malformations or tumors of the endocrine glands.
Endocrine impairment due to diabetes (HBA1c > 7) and other metabolic diseases.
Crossover
Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency
Biological/VaccinePatients will receive two administrations at a dose of 1.5 million cells/kg patient bodyweight via the IV route with a 3-month intervening interval. A validated umbilical cord blood mesenchymal stem cells (UC-MSC) line was selected from the Vinmec Tissue Bank and cultured under xeno-free, serum-free and antibiotic-free conditions as previously described. To prepare UC-MSCs for therapy, aliquots of Passage 3 (P3) UC-MSCs will be thawed and cultured to P5 to get approximately 500 million cells and dispensed to 10 million UC-MSCs/ml/vial for cryopreservation. Upon request from the clinical team, aliquots of P5 UC-MSCs will be thawed in a temperature control water bath or incubator on the infusion day. The UC-MSCs will be washed and suspended in Ringer Lactate.
The safety of allogenic umbilical cord-derived mesenchymal stem cell administration for the treatment of hormone deficiency in male
To assess safety, the number of AEs or SAEs during stem cell administration up to the 12-month period following treatment will be evaluated
Testosterone levels
To evaluate the Testosterone levels of the patients with sexual functional deficiency
Changes in sexual life quality using Aging Men Symptom (AMS)
AMS includes 10 items
Changes in sexual life quality through quantification of International Index of Erectile Function (IIEF)
IIEF includes 15 items
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