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Trial record 2 of 60 for:    Recruiting, Not yet recruiting, Available Studies | Impotence

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

Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
Tolerance [ Time Frame: 1-4 weeks after each injection ]
Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03973021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Short-term effects on erectile function [ Time Frame: 3-6 months after each injection ]
    Assessment using International Index of Erectile Function 5, whichi is physicians global assessment to measure erectile function
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Very Small Embryonic-like Stem Cells for Erectile Dysfunction
Official Title  ICMJE Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Organic Erectile Dysfunction
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Biological: Very small embryonic-like stem cell(VSEL)
  • 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
    Intervention: Biological: Very small embryonic-like stem cell(VSEL)
  • 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
    Intervention: Biological: Very small embryonic-like stem cell(VSEL)
  • No Intervention: Control
    In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jibing Chen +86-18903068207 jibingchen398@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973021
Other Study ID Numbers  ICMJE VSEL-ED
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP