Clinical trial NCT02745808: Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
Official title: Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) for the Improvement of Erectile Function in Men With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Erectile Dysfunction
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2016-04-20
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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-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

Primary outcomes:
measure: Safety and Tolerability assessed by Adverse Events
timeFrame: 1 month after intervention
Secondary outcomes:
measure: Improvement in IIEF-5 (International Index of Erectile Function)
timeFrame: 1,3,6,9 and 12 months
measure: Improvement in penile colour Doppler ultrasonography
timeFrame: 1,3,6,9 and 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: