Very Small Embryonic-like Stem Cells for Erectile Dysfunction

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Organic Erectile Dysfunction
• Intervention / Treatment: Biological: Very small embryonic-like stem cell(VSEL)

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Central laboratory in Fuda cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Experimental: 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	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
Experimental: 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	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
No Intervention: Control; In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fuda Cancer Hospital, Guangzhou
• Collaborators: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: erectile dysfunction; very small embryonic-like stem cell
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: VSEL-ED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No