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出境医 / 临床实验 / Very Small Embryonic-like Stem Cells for Erectile Dysfunction
Very Small Embryonic-like Stem Cells for Erectile Dysfunction
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.
| 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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 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 |
| Actual Primary Completion Date : | May 20, 2020 |
| Actual Study Completion Date : | July 1, 2020 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
Eligibility Criteria
| 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
Contacts and Locations
Locations
| China, Guangdong | |
| Central laboratory in Fuda cancer hospital | |
| Guangzhou, Guangdong, China, 510000 | |
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 29, 2019 | ||||
| First Posted Date ICMJE | June 4, 2019 | ||||
| Last Update Posted Date | October 19, 2020 | ||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||
| Actual Primary Completion Date | May 20, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Tolerance [ Time Frame: 1-4 weeks after each injection ] Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 Phase 2 |
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| 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
|
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| 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
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE |
0 | ||||
| Original Estimated Enrollment ICMJE |
40 | ||||
| Actual Study Completion Date ICMJE | July 1, 2020 | ||||
| Actual Primary Completion Date | May 20, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| 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 |
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| IPD Sharing Statement ICMJE |
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| 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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