Clinical trial NCT02579148: Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
Official title: Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Erectile Dysfunction
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: erectile dysfunction
stem cell
collagen scaffold
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2015-10-19
Enrollment: 0
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.

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.

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): 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.

Primary outcomes:
measure: Improvements in IIEF scores
timeFrame: 1,3,6,9 and 12 months
Secondary outcomes:
measure: Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection
timeFrame: 1,3,6,9 and 12 months
measure: Safety and Tolerability assessed by Adverse Events
timeFrame: 1 month after intervention
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai
role: PRINCIPAL_INVESTIGATOR
References: