Erectile DysfunctionsPhase 1NCT06839651
Umbilical Cord Mesenchymal Stem Cell Secretome in Severe Erectile Dysfunction Non-responsive to Sildenafil
A Phase 1 study testing uc-msc secretome intra cavernous injection in people with Erectile Dysfunctions, run by Universitas Indonesia.
Trial summary
The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunctions
- What is being tested?
- uc-msc secretome intra cavernous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2025to 1 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.
- Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7
- History of undergoing treatment with sildenafil 100 mg for four sessions.
- Evaluation of IIEF-5 score < 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4
- Type II Diabetes Melitus with an HbA1c test result of < 7%.
- Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits.
- Patients with undergoing treatment with antidepressant.
Who cannot join
- Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.
- Active and significant systemic or local infection.
- History of bleeding or blood clotting disorder therapy.
- History of systemic autoimmune disorders and immunosuppressive treatment
- History of prostate surgery, history of malignancy, or a PSA level > 4 ng/mL.
- Untreated hypogonadism or low serum total testosterone (<200 ng/dL).
- Uncontrolled hypertension or hypotension (systolic blood pressure >170 or <90 mmHg, and diastolic blood pressure >100 or <50 mmHg).
- Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients with Severe Erectile Dysfunction Non-responsive to Sildenafil
The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.
Read the detailed description
The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.
- Conditions
- Erectile Dysfunctions
- Being tested
- uc-msc secretome intra cavernous injection
- Keywords
- Erectile dysfunction, secretome, UC-MSC
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uc-msc secretome intra cavernous injectionCombination product
UC-MSC secretome was obtained from UC-MSC cultures with 80% confluence in serum-free medium after 24 hours of incubation The VEGF level in the secretome given was 1400 pg/ml.
The intervention was the administration of 0.5 mL/site of secretome injection injected intra-cavernous to all subjects using a 22-gauge needle according to a sterile protocol. The same volume was given at bilateral sites of the penile shaft. The intra-cavernous injection sites were in the right and left dorsolateral regions of the penis. After the intervention, tolerability was assessed by observing and questioning the subjects regarding pain during injection.
| Study group | Role | What they receive |
|---|---|---|
| pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection | Experimental | postreatment group: severe eretile dysfunction non responsive Sildenafil with injection Receives: Combination Product: uc-msc secretome intra cavernous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Measured: one hour and one year
Hematomes
Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.
Measured: one hour
Bleeding
Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Measured: one hour
Erection hardness score
Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start21 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ria Margiana, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839651
- Sponsor's protocol ID
- KET-1862/ETIK/PPM.00.02/2024
- Other IDs
- PUTI Q1 Universitas Indonesia
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients with Severe Erectile Dysfunction Non-responsive to Sildenafil
- ClinicalTrials.gov ID
- NCT06839651
- Acronym / sponsor ID
- KET-1862/ETIK/PPM.00.02/2024
- Conditions
- Erectile Dysfunctions
- Keywords
- Erectile dysfunction, secretome, UC-MSC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 21 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 21 Feb 2025 (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 study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.
Detailed description
The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection | Experimental | Combination Product: uc-msc secretome intra cavernous injectionpostreatment group: severe eretile dysfunction non responsive Sildenafil with injection |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.
- Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7
- History of undergoing treatment with sildenafil 100 mg for four sessions.
- Evaluation of IIEF-5 score < 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4
- Type II Diabetes Melitus with an HbA1c test result of < 7%.
Key exclusion criteria (8 listed)
- Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.
- Active and significant systemic or local infection.
- History of bleeding or blood clotting disorder therapy.
- History of systemic autoimmune disorders and immunosuppressive treatment
- History of prostate surgery, history of malignancy, or a PSA level > 4 ng/mL.
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 |
|---|---|---|
| uc-msc secretome intra cavernous injectionUC-MSC secretome was obtained from UC-MSC cultures with 80% confluence in serum-free medium after 24 hours of incubation The VEGF level in the secretome given was 1400 pg/ml. The intervention was the administration of 0.5 mL/site of secretome injection injected intra-cavernous to all subjects using a 22-gauge needle according to a sterile protocol. The same volume was given at bilateral sites of the penile shaft. The intra-cavernous injection sites were in the right and left dorsolateral regions of the penis. After the intervention, tolerability was assessed by observing and questioning the subjects regarding pain during injection. | Combination product | pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection |
Primary outcome
Visual analog scale
Time frame: one hour and one year
A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Hematomes
Time frame: one hour
Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.
Bleeding
Time frame: one hour
Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Erection hardness score
Time frame: one year
Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing uc-msc secretome intra cavernous injection in people with Erectile Dysfunctions, run by Universitas Indonesia.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ria Margiana, M.D, PhD (+62 811-1775-515, ria.marrgiana11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: one hour and one year). The study lists 4 primary outcomes in all. 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 25 Feb 2025.