Organic Erectile DysfunctionPhase 1/2NCT03973021
Very Small Embryonic-like Stem Cells for Erectile Dysfunction
A Phase 1/2 study testing Very small embryonic-like stem cell(VSEL) in people with Organic Erectile Dysfunction, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Organic Erectile Dysfunction
- What is being tested?
- Very small embryonic-like stem cell(VSEL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 Jul 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, 510000
About this study
Official title: 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.
Read the 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.
- Conditions
- Organic Erectile Dysfunction
- Being tested
- Very small embryonic-like stem cell(VSEL)
- Keywords
- erectile dysfunction, very small embryonic-like stem cell
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very small embryonic-like stem cell(VSEL)Biological
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 group | Role | What they receive |
|---|---|---|
| VSEL Max | Experimental | 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 Receives: Biological: Very small embryonic-like stem cell(VSEL) |
| VSEL Medium | Experimental | 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 Receives: Biological: Very small embryonic-like stem cell(VSEL) |
| VSEL Mini | Experimental | 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 Receives: Biological: Very small embryonic-like stem cell(VSEL) |
| Control | No intervention | In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance
Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
Measured: 1-4 weeks after each injection
Secondary outcomes (2)
Short-term effects on erectile function
Assessment using International Index of Erectile Function 5, which is physicians global assessment to measure erectile function
Measured: 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
Measured: 12 months after final injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jul 2019
- Primary completion20 May 2020
- Study completion1 Jul 2020
Why it stopped: Policy changes have contributed to the failure to carry out smoothly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organic Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973021
- Sponsor's protocol ID
- VSEL-ED
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03973021
- Acronym / sponsor ID
- VSEL-ED
- Conditions
- Organic Erectile Dysfunction
- Keywords
- erectile dysfunction, very small embryonic-like stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Policy changes have contributed to the failure to carry out smoothly
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| VSEL Max | Experimental | Biological: Very small embryonic-like stem cell(VSEL)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 |
| VSEL Medium | Experimental | Biological: Very small embryonic-like stem cell(VSEL)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 |
| VSEL Mini | Experimental | Biological: Very small embryonic-like stem cell(VSEL)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 |
| Control | No intervention | –In this group, the patients will receive 20 mL platelet-rich plasma(PRP) treatment and as a control group. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | VSEL Max, VSEL Medium, VSEL Mini |
Primary outcome
Tolerance
Time frame: 1-4 weeks after each injection
Evaluation indicators include postoperative pain at the injection site (VAS score), hematoma, abscess, or priapism
2 secondary outcomes
Short-term effects on erectile function
Time frame: 3-6 months after each injection
Long-term effects on erectile function
Time frame: 12 months after final injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Organic Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Very small embryonic-like stem cell(VSEL) in people with Organic Erectile Dysfunction, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance (time frame: 1-4 weeks after each injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.