Phase Ib: Evaluation of the Safety and as a Secondary End Point the Efficacy for Two Doses of Wharton Jelly Stem Cells for the Treatment of Diabetic Erectile Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.
详细描述
This study will be conducted at the Cell Therapy Center (CTC), Jordan, in which nine male patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests.
The patients are followed by clinical assessment, laboratory investigations as well as Doppler ultrasound.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male patients ranging from 25 to 70 years.
- •History of chronic erectile dysfunction for at least six months.
- •Baseline international index of erectile function (IIEF) score of <
- •Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment.
- •Body Mass Index between 20-
- •Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.
排除标准
- •Current urinary tract or bladder infection.
- •Clinical/Laboratory evidence of transmissible diseases.
- •Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
- •Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
- •Current or previous malignancy.
- •Use of any non study treatment for erectile function within 4 weeks of study treatment.
- •Lack of willingness to continue through 6 months after study treatment.
- •Any previous penile implant or penile vascular surgery.
- •Uncontrolled hypertension or hypotension(systolic blood pressure > 170 or < 90 mm Hg, and diastolic blood pressure > 100 or < 50 mm Hg).
- •Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening.
- •Bleeding or clotting disorder, use of anticoagulant therapy.
- •Lab values for complete blood count (CBC), prothrombin time (PT)/ partial thromboplastin time (PTT)/ international normalized ratio (INR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine falling outside the normal lab values.
- •Systemic autoimmune disorder.
- •Significant active systemic or localized infection.
- •Receiving immunosuppressant medications.
- •Post-radical prostatectomy.
研究组 & 干预措施
Dose I
Dose I of Wharton Jelly Mesenchymal stem cells (WJ-MSC) Two intracavernous injections of 20 million of WJ-MSC cells will be given to erectile dysfunction patients at baseline and 4th week of follow up.
干预措施: Wharton Jelly Mesenchymal stem cells (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 6 months
Patients will be assessed for any relevant adverse event resulting from the intracavernous injection of the Wharton jelly mesenchymal stem cells.
次要结局
- Assessment of the efficacy of injecting Wharton Jelly derived Mesenchymal Stem Cells by SHIM/IIEF/EHS questionnaire(12 months)
研究者
Sophia Al-Adwan
Researcher, Msc
University of Jordan