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

Leilei Zhu

Status and phase: Withdrawn; Phase 1

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

Treatments: Biological: HUCMSC injection; Biological: collagen scaffolds/HUCMSC injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02579148

DTH-922-DYT

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.

Full 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.

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): 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

HUCMSC injection

Experimental group

Description:

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

Treatment:

Biological: HUCMSC injection

collagen scaffolds/HUCMSC injection

Experimental group

Description:

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

Treatment:

Biological: collagen scaffolds/HUCMSC injection