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

NCT ID: NCT02579148

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-04-30

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.

Conditions

Erectile Dysfunction; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HUCMSC injection

once intracavernous injection of 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells

Group Type: EXPERIMENTAL

HUCMSC injection

Intervention Type: BIOLOGICAL

The subjects will receive intracavernous injection of HUCMSC.'

collagen scaffolds/HUCMSC injection

once intracavernous injection of collagen scaffolds loaded with 15,000,000 Human Umbilical Cord Mesenchymal Stem Cells

Group Type: EXPERIMENTAL

collagen scaffolds/HUCMSC injection

Intervention Type: BIOLOGICAL

The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'

Interventions

HUCMSC injection

The subjects will receive intracavernous injection of HUCMSC.'

Intervention Type: BIOLOGICAL

collagen scaffolds/HUCMSC injection

The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Leilei Zhu

OTHER

Sponsor Role: lead

Responsible Party

Leilei Zhu

science and technology department head

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jianwu Dai

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Sciences

Locations

Drum Tower Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

DTH-922-DYT

Identifier Type: -

Identifier Source: org_study_id