Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Collagen Scaffolds Loaded With Human Umbilical Cord Mesenchymal Stem Cells for the Improvement of Erectile Function in Men With Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02579148
• Other study ID #: DTH-922-DYT
• Status: Withdrawn
• Phase: Phase 1
• First received: October 14, 2015
• Last updated: April 7, 2016
• Start date: September 2015
• Est. completion date: April 2017

Study information

• Verified date: October 2015
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• 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): 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

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:
• HUCMSC injection
The subjects will receive intracavernous injection of HUCMSC.`
• collagen scaffolds/HUCMSC injection
The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.`

Locations

Country	Name	City	State
China	Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Leilei Zhu	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in IIEF scores	The subjects must fill in the questionnaire of IIEF-5 every visit to evaluate erectile function.	1,3,6,9 and 12 months	No
Secondary	Penile colour Doppler ultrasonography combined with prostaglandin-E1 injection		1,3,6,9 and 12 months	No
Secondary	Safety and Tolerability assessed by Adverse Events		1 month after intervention	Yes