The Outcomes of Intracavernosal Umbilical Cord Mesenchymal Stem Cells Implantation in Patients With Diabetic Erectile Dysfunction

Indonesia University2 个研究点分布在 1 个国家目标入组 12 人开始时间: 2020年10月27日最近更新: 2022年3月31日

适应症

试验速览

阶段: 2 期
发起方: Indonesia University
入组人数: 12
试验地点: 2
主要终点: Changes in Resistive Index after stem cells injection

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

Erectile dysfunction (ED) is a complex condition affecting men worldwide. Diabetes mellitus (DM) is one of the most common causes of ED. The prevalence of ED in DM varies around 35-85%. Recently, stem cell therapy has started to become the focus of experimental and clinical studies for the treatment of ED. Stem cells have been shown to be able to regenerate functionally damaged tissue, depending on the stimuli or signals received. Stem cells studies in experimental animals have been carried out using biomarker parameters, including VEGF, Bcl-2, E-selectin, cGMP, eNOS and have been shown to be successful in increasing cell survival and angiogenesis, stimulating antiapoptotic, proneurogenic, proinflammatory, and antifibrotic effects and improvements to these biomarker parameters. This study aims to determine the efficacy, mechanism of action, and safety of umbilical cord mesenchymal stem cells as a therapy for ED due to type 2 diabetes in human.

详细描述

Prior to conducting clinical trials, researchers asked for written informed consent. If the subject agrees, the study will direct the subject and control to collect basic data in the form of vital signs, blood pressure, filling out the IIEF-5 questionnaire, complete blood count (CBC), lipid profile, fasting blood glucose, HbA1c, and total testosterone, biomarker examination (E-Selectin), VEGF, Bcl-2, miRNA 16, miRNA 126), and penile Doppler ultrasound. The diagnosis of erectile dysfunction was made on the basis of an IIEF-5 score <22.

Penile Doppler ultrasound was performed by a senior radiologist with interpretation of the ultrasound images performed and reported in a blinded fashion (the reader/interpreter does not know the patient's complaints). Penile Doppler ultrasound examination was performed under flaccid conditions and post-sexual stimulation conditions. Prior to the examination, the patient was given sildenafil 100 mg orally, then the flaccid phase was examined. Patients were asked to perform sexual stimulation of themselves and measurements were taken afterwards.

Parallel with the patient recruitment, stem cells processing was carried out based on the production method using xeno-free material.

At the baseline, patient receive intracavernous injection procedure, as a following steps:

The base of the penis is clamped with ethiloop before the injection is performed.
Intracavernous injection was performed in each body of 7.5 x 10^6 cells/1cc.
Clamps are removed after 30 minutes post-injection to increase stem cell residency and grafting time.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Age 18-65 years old
•willing to participate as research subject
•patient with erectile dysfunction and Diabetes Mellitus type 2 with IIEF-5 score <22
•patient has sexual partner and sexually active
•patient is currently not consuming PDE-5 inhibitor drugs

排除标准

•patient has psychopathology and/or mental retardation
•patient with Peyronie's disease
•patient with hypogonadism
•patient has malignancy in urological and non urological fields
•patient has history of cardiovascular disease with intermediate and high risk