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

Chinese Academy of Sciences

Status and phase: Unknown; Phase 1

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

Treatments: Biological: Injectable Collagen Scaffold + HUC-MSCs; Biological: HUC-MSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT02745808

CAS-XDA-DEF/IGDB

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

HUC-MSCs

Experimental group

Description:

Intracavernous injection of 15 million HUC-MSCs.

Treatment:

Biological: HUC-MSCs

Injectable Collagen Scaffold + HUC-MSCs

Experimental group

Description:

Intracavernous injection of injectable collagen scaffold combined with 15 million HUC-MSCs.

Treatment:

Biological: Injectable Collagen Scaffold + HUC-MSCs