Erectile Dysfunction, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
BIOLOGICALHUC-MSCs
The subjects will receive intracavernous injection of HUCMSC.
BIOLOGICALInjectable Collagen Scaffold + HUC-MSCs
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Chinese Academy of Sciences
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): 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 6. HbA1c is between 6.5%-10% 7. Physical examination with no abnormalities 8. 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 |
|---|---|
| Safety and Tolerability assessed by Adverse Events | 1 month after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in IIEF-5 (International Index of Erectile Function) | 1,3,6,9 and 12 months | The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function |
| Improvement in penile colour Doppler ultrasonography | 1,3,6,9 and 12 months | — |
Countries
China
Contacts
Primary ContactZhifeng Xiao, Ph.D
Backup ContactSufang Han, Ph.D
Outcome results
None listed