Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients with Severe Erectile Dysfunction Non-responsive to Sildenafil
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Visual analog scale
研究概览
简要总结
The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.
详细描述
The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.
- •Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7
- •History of undergoing treatment with sildenafil 100 mg for four sessions.
- •Evaluation of IIEF-5 score < 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4
- •Type II Diabetes Melitus with an HbA1c test result of < 7%.
- •Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits.
- •Patients with undergoing treatment with antidepressant.
排除标准
- •Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.
- •Active and significant systemic or local infection.
- •History of bleeding or blood clotting disorder therapy.
- •History of systemic autoimmune disorders and immunosuppressive treatment
- •History of prostate surgery, history of malignancy, or a PSA level > 4 ng/mL.
- •Untreated hypogonadism or low serum total testosterone (<200 ng/dL).
- •Uncontrolled hypertension or hypotension (systolic blood pressure >170 or <90 mmHg, and diastolic blood pressure >100 or <50 mmHg).
- •Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure).
研究组 & 干预措施
pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection
postreatment group: severe eretile dysfunction non responsive Sildenafil with injection
干预措施: uc-msc secretome intra cavernous injection (Combination Product)
结局指标
主要结局
Visual analog scale
时间窗: one hour and one year
A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Hematomes
时间窗: one hour
Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.
Bleeding
时间窗: one hour
Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Erection hardness score
时间窗: one year
Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)
次要结局
未报告次要终点
研究者
Ria Margiana
Ria Margiana, MD, M.Biomed, PhD
Indonesia University