Very Small Embryonic-like Stem Cells for Erectile Dysfunction

NCT03973021 | Withdrawn Phase 1 DMC

• 1 other identifier: VSEL-ED
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Organic Erectile Dysfunction

Keywords

erectile dysfunction; very small embryonic-like stem cell

Outcome Measures

Primary Outcomes (1)

• Tolerance

  Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism

  1-4 weeks after each injection

Secondary Outcomes (2)

• Short-term effects on erectile function

  3-6 months after each injection

• Long-term effects on erectile function

  12 months after final injection

Study Arms (4)

VSEL Max

EXPERIMENTAL

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

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

VSEL Medium

EXPERIMENTAL

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

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

VSEL Mini

EXPERIMENTAL

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

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

Control

NO INTERVENTION

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

Interventions

Very small embryonic-like stem cell(VSEL) 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 Max; VSEL Medium; VSEL Mini

Eligibility Criteria

• Age: 20 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Guangzhou Four-Leaf Clover HealthTech Co., Ltd.: collaborator

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Different patients receive different numbers of cell for treatment per time
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 4, 2019
• Study Start: July 1, 2019
• Primary Completion: May 20, 2020
• Study Completion: July 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)