Very Small Embryonic-like Stem Cells for Erectile Dysfunction

Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03973021

Enrollment

Registered

2019-06-04

Start date

2019-07-01

Completion date

2020-07-01

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organic Erectile Dysfunction

Keywords

erectile dysfunction, very small embryonic-like stem cell

Brief summary

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.

Detailed 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.

Interventions

BIOLOGICALVery 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Different patients receive different numbers of cell for treatment per time

Intervention model description

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.

Eligibility

Sex/Gender

MALE

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Tolerance	1-4 weeks after each injection	Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism

Secondary

Measure	Time frame	Description
Short-term effects on erectile function	3-6 months after each injection	Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
Long-term effects on erectile function	12 months after final injection	Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026