Very Small Embryonic-like Stem Cells for Erectile Dysfunction

Fuda Cancer Hospital, Guangzhou

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Organic Erectile Dysfunction

Treatments: Biological: Very small embryonic-like stem cell(VSEL)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03973021

VSEL-ED

Details and patient eligibility

About

The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to organic erectile dysfunction, such as those associated with metabolic syndrome or the treatment of prostate cancer.

Full description

By enrolling patients with organic erectile dysfunction adapted to enrolled criteria, this study will document for the first time the safety and efficacy of underlying penile cellular damage.

The safety will be evaluated by tolerance degree. The efficacy will be evaluated validated scores and color duplex Doppler ultrasound.

Sex: Male

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metabolic and systemic changes in diseases such as diabetes and atherosclerosis or more localized causes such as direct injury to the penile neurovascular supply during prostate surgery
• Diagnosed as an organic erectile dysfunction by at least 2 urological surgeons

Exclusion criteria

• Non-organic erectile dysfunction, such as psychological factors
• Solid cancer patients other than early prostate cancer
• Blood disease patients, thrombocytopenia or dysfunction, hypofibrinogenemia or anticoagulant therapy, long-term use of aspirin
• Older than 70 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

VSEL Max

Experimental group

Description:

Each treatment: 120,000 VSELs each time, suspending with 20 mL platelet-rich plasma(PRP), transfusion for 3 times with a interval of 1 month, intracavernous injection

Treatment:

Biological: Very small embryonic-like stem cell(VSEL)

VSEL Medium

Experimental group

Description:

Each treatment: 90,000 VSELs each time, suspending with 20 mL platelet-rich plasma(PRP), transfusion for 3 times with a interval of 1 month, intracavernous injection

Treatment:

Biological: Very small embryonic-like stem cell(VSEL)

VSEL Mini

Experimental group

Description:

Each treatment: 60,000 VSELs each time, suspending with 20 mL platelet-rich plasma(PRP), transfusion for 3 times with a interval of 1 month, intracavernous injection

Treatment:

Biological: Very small embryonic-like stem cell(VSEL)

Control

No Intervention group

Description:

In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group.