Very Small Embryonic-like Stem Cells for Erectile Dysfunction

Phase 1

Withdrawn

• Conditions: Organic Erectile Dysfunction
• Interventions: Biological: Very small embryonic-like stem cell(VSEL)

• Registration Number: NCT03973021
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-04
• Study Start: 2019-07-01
• Primary Completion: 2020-05-20
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSEL Max	Very small embryonic-like stem cell(VSEL)	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
VSEL Mini	Very small embryonic-like stem cell(VSEL)	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
VSEL Medium	Very small embryonic-like stem cell(VSEL)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Central laboratory in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China