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Very Small Embryonic-like Stem Cells for Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03973021
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Organic Erectile Dysfunction Biological: Very small embryonic-like stem cell(VSEL) Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Masking Description: Different patients receive different numbers of cell for treatment per time
Primary Purpose: Treatment
Official Title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Tolerance [ Time Frame: 1-4 weeks after each injection ]
    Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism


Secondary Outcome Measures :
  1. Short-term effects on erectile function [ Time Frame: 3-6 months after each injection ]
    Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function

  2. Long-term effects on erectile function [ Time Frame: 12 months after final injection ]
    Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973021


Contacts
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Contact: Jibing Chen +86-18903068207 jibingchen398@163.com

Locations
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China, Guangdong
Central laboratory in Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jibing Chen, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03973021     History of Changes
Other Study ID Numbers: VSEL-ED
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fuda Cancer Hospital, Guangzhou:
erectile dysfunction
very small embryonic-like stem cell
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders