Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745808
• Other study ID #: CAS-XDA-DEF/IGDB
• Status: Recruiting
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: April 2016
• Source: Chinese Academy of Sciences
• Contact: Zhifeng Xiao, Ph.D
• Phone: 86-10-82614420
• Email: zfxiao[@]genetics.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Erectile Dysfunction
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Biological:
• HUC-MSCs
The subjects will receive intracavernous injection of HUCMSC.
• Injectable Collagen Scaffold + HUC-MSCs
The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability assessed by Adverse Events		1 month after intervention
Secondary	Improvement in IIEF-5 (International Index of Erectile Function)	The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function	1,3,6,9 and 12 months
Secondary	Improvement in penile colour Doppler ultrasonography		1,3,6,9 and 12 months