Very Small Embryonic-like Stem Cells for Erectile Dysfunction

Organic Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03973021
• Other study ID #: VSEL-ED
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: May 2019
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Organic Erectile Dysfunction

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Central laboratory in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance	Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism	1-4 weeks after each injection
Secondary	Short-term effects on erectile function	Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function	3-6 months after each injection
Secondary	Long-term effects on erectile function	Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function	12 months after final injection