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

Vinmec Research Institute of Stem Cell and Gene Technology2 个研究点分布在 1 个国家目标入组 158 人开始时间: 2022年4月1日最近更新: 2024年6月4日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Vinmec Research Institute of Stem Cell and Gene Technology
入组人数: 158
试验地点: 2
主要终点: Changes in sexual life quality through quantification of International Index of Erectile Function (IIEF)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Sexual functional deficiency occurs at some point in life and becomes a problematic issue in middle-aged adulthood. Regenerative medicine, especially mesenchymal stem cell (MSC) transplantation, has developed extensively, with preclinical and clinical trials emphasizing the benefits of stem cell therapy for restoration of sexual deficiency. n 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. In phase II, 40 males with hormone deficiency will be recruited and divided randomly into two groups (n=23 each). The group A will receive UC-MSCs intravenously at day 0 and day 90 ± 7, while the group B will be infused with UC-MSCs at day 180 ± 14 and day 270 ± 14. Each group will be monitored for 365 ± 14 days after the first infusion. The phase II is to investigate safety and efficacy of UC-MSC infusion for the treatment of sexual hormone deficiency in males.

The primary outcome are: (1) numbers of AEs or SAEs during UC-MSC infusion and 365 ± 14 days after the first infusion; (2) Testosterone levels and sexual life quality through quantification of Aging Men Symptom (AMS), International Index of Erectile Function (IIEF), and Sexual Quality of Life Questionnaire (SQoL-M) at day 90 ± 7 and day 180 ± 14 of the group A compared to those of the group B.

The secondary outcome are: (1) Testosterone levels and (2) sexual life quality through quantification of AMS, IIEF, and SQoL-M at day 90 ± 7, day 180 ± 14, and day 365 ± 14 after the first UC-MSC infusion of each group compared to the baseline; (3) cytokine concentration (TNFa, IFN-γ, IL1, IL-6, IL-8, IL-4, IL-10, IDO) in serum of the participants and their T cell immunophenotype at day 90 ± 7, day 180 ± 14, and day 365 ± 14 after the first UC-MSC infusion.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: None

入排标准

年龄范围: 50 Years 至 70 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•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.

排除标准

•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 with severe heart failure, severe renal failure, severe liver failure, severe respiratory failure, history of cerebral infarction, myocardial infarction, Alzeimer.
•Patients with hypothyroidism.
•The patient has an acute infection.
•Patients with clinically significant coagulopathy or other hematological diseases.
•History of allergy to anesthetics, anesthetics, antibiotics.
•Patients who are using other hormone-improving drugs or supplements (including Sildenafil) in the last 2 weeks or want to continue using these drugs during the study period.
•The patient is a smoker.

结局指标

主要结局

Changes in sexual life quality through quantification of International Index of Erectile Function (IIEF)