Erectile Dysfunction, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Keywords
erectile dysfunction, stem cell, collagen scaffold
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHUCMSC injection
The subjects will receive intracavernous injection of HUCMSC.'
BIOLOGICALcollagen scaffolds/HUCMSC injection
The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'
Sponsors
Chinese Academy of Sciences
Leilei Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i; 2. have a consistent partner who is willing to engage in sexual activity more than twice per month during the study; 3. males age 20-65 years; 4. IIEF-5 score is under 16; 5. penile arterial insufficiency or venous leakage (doppler): PSV \<25 cm/sec, or PSV \>25 cm/sec, EDV\>5cm/sec, RI\<0, 75; 6. HbA1c is between 6.5% 10%; 7. physical examination with no abnormalities; 8. who is willing to consent to participate in the study follow-up; 9. willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.
Exclusion criteria
1. severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy; 2. positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test; 3. Testosterone level is less than 200ng/dl; 4. serum AST/ALT \>3\*upper limit of normal or creatinine \>1.5\*upper limit of normal; 5. HbA1c exhibit greater than 10%; 6. in the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery; 7. patients partner is trying to conceive during the trial period; 8. 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; 9. unwilling and/or not able to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in IIEF scores | 1,3,6,9 and 12 months | The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed