NCT02745808Unknown1 期
Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) for the Improvement of Erectile Function in Men With Diabetes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Tolerability assessed by Adverse Events
研究概览
简要总结
The intent of this clinical study is to answer the questions: 1) is the proposed treatment feasible; 2) is treatment effective in improving the disease pathology of patients with diagnosed diabetic erectile dysfunction.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i
- •Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study
- •Males, age 20-65 years
- •IIEF-5 score is under 16
- •Penile arterial insufficiency or venous leakage (doppler): peak systolic velocity（PSV） <25 cm/sec, or peak systolic velocity（PSV）>25 cm/sec, end-diastolic velocity（EDV）> 5cm/sec, resistance index（RI）<0.75
- •HbA1c is between 6.5%-10%
- •Physical examination with no abnormalities
- •Willing to consent to participate in the study follow-up
- •Willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.
排除标准
- •Severe cardiovascular disease (angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy
- •Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test
- •Testosterone level is less than 200ng/dL
- •Serum AST/ALT >3*upper limit of normal or creatinine >1.5*upper limit of normal
- •HbA1c exhibit greater than 10%
- •In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery
- •Patients partner is trying to conceive during the trial period
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study
- •Unwilling and/or not able to give written informed consent
研究组 & 干预措施
Injectable Collagen Scaffold + HUC-MSCs
Experimental
Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs.
干预措施: Injectable Collagen Scaffold + HUC-MSCs (Biological)
HUC-MSCs
Experimental
Intracavernous injection of 15 million HUC-MSCs.
干预措施: HUC-MSCs (Biological)
结局指标
主要结局
Safety and Tolerability assessed by Adverse Events
时间窗: 1 month after intervention
次要结局
- Improvement in IIEF-5 (International Index of Erectile Function)(1,3,6,9 and 12 months)
- Improvement in penile colour Doppler ultrasonography(1,3,6,9 and 12 months)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences
研究点 (1)
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