diabetic erectile dysfunction
Conditions
Interventions
the Patients with Diabetic Erectile Dysfunction:hUC-MSC injection to the Corpus Cavernosum
the Patients with Diabetic Erectile Dysfunction:Collagen Scaffolds Loaded with hUC-MSC injection to the Corpus Cavernosum
Sponsors
Nanjing Drum Tower Hospital affiliated to Nanjing University Medical School
Eligibility
Sex/Gender
Male
Age
20 Years to 65 Years
Inclusion criteria
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, ef(erectile function) domain score is under 16; 5. penile arterial insufficiency or venous leakage (doppler) at the time o inclusion: 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
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 |
|---|---|
| IIEF-5;SEP;GAQ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Penile Doppler;NPT; | — |
Countries
China
Contacts
Public ContactYutian Dai
Outcome results
None listed