Back to resultsVery Small Embryonic-like Stem Cells for Erectile Dysfunction
Primary Purpose
Organic Erectile Dysfunction
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Very small embryonic-like stem cell(VSEL)
Sponsored by
About this trial
This is an interventional treatment trial for Organic Erectile Dysfunction focused on measuring erectile dysfunction, very small embryonic-like stem cell
Eligibility 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
Sites / Locations
- Central laboratory in Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
VSEL Max
VSEL Medium
VSEL Mini
Control
Arm Description
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
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
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
In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group.
Outcomes
Primary Outcome Measures
Tolerance
Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
Secondary Outcome Measures
Short-term effects on erectile function
Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
Long-term effects on erectile function
Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
Full Information
NCT ID
NCT03973021
First Posted
May 29, 2019
Last Updated
October 13, 2020
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03973021
Brief Title
Very Small Embryonic-like Stem Cells for Erectile Dysfunction
Official Title
Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Policy changes have contributed to the failure to carry out smoothly
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Organic Erectile Dysfunction
Keywords
erectile dysfunction, very small embryonic-like stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
Different patients receive different numbers of cell for treatment per time
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VSEL Max
Arm Type
Experimental
Arm Description
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
Arm Title
VSEL Medium
Arm Type
Experimental
Arm Description
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
Arm Title
VSEL Mini
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group.
Intervention Type
Biological
Intervention Name(s)
Very small embryonic-like stem cell(VSEL)
Intervention Description
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
Primary Outcome Measure Information:
Title
Tolerance
Description
Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
Time Frame
1-4 weeks after each injection
Secondary Outcome Measure Information:
Title
Short-term effects on erectile function
Description
Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
Time Frame
3-6 months after each injection
Title
Long-term effects on erectile function
Description
Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
Time Frame
12 months after final injection
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Central laboratory in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Very Small Embryonic-like Stem Cells for Erectile Dysfunction
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