Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Improvements in IIEF scores
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.
详细描述
Intracavernous transplantation of stem cells has been shown to improve erectile function in some preclinical studies. However, inadequate cell homing to damaged sites limited its functions. The investigators explore the effect of HUCMSC on improving erectile function of diabetic men, and whether collagen scaffolds contribute to long-term cell retention in the corpus cavernous and improves erectile function of diabetic men.
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): PSV <25 cm/sec, or PSV >25 cm/sec, EDV>5cm/sec, RI<0, 75;
- •HbA1c is between 6.5% 10%;
- •physical examination with no abnormalities;
- •who is 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
HUCMSC injection
once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
干预措施: HUCMSC injection (Biological)
collagen scaffolds/HUCMSC injection
once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells
干预措施: collagen scaffolds/HUCMSC injection (Biological)
结局指标
主要结局
Improvements in IIEF scores
时间窗: 1,3,6,9 and 12 months
The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.
次要结局
- Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection(1,3,6,9 and 12 months)
- Safety and Tolerability assessed by Adverse Events(1 month after intervention)
研究者
Leilei Zhu
science and technology department head
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School