Very Small Embryonic-like Stem Cells for Erectile Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Organic Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this group, the patients will receive intracavernous injection of autologous VSELs. The check indexes are International Index of Erectile Function 5(IIEF-5), Erection Hardness Score(EHS) and penile vascularization assessed using color duplex Doppler ultrasound (CDDU), mainly including erectile function, stretched penile length, sexual drive, intercourse satisfaction, and overall satisfaction.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Different patients receive different numbers of cell for treatment per time

Study Groups

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VSEL Max

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

Group Type EXPERIMENTAL

Very small embryonic-like stem cell(VSEL)

Intervention Type BIOLOGICAL

Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation

VSEL Medium

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

Group Type EXPERIMENTAL

Very small embryonic-like stem cell(VSEL)

Intervention Type BIOLOGICAL

Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation

VSEL Mini

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

Group Type EXPERIMENTAL

Very small embryonic-like stem cell(VSEL)

Intervention Type BIOLOGICAL

Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Very small embryonic-like stem cell(VSEL)

Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No