Erectile DysfunctionNCT07245875
Umbilical Cord Mesenchymal Stem Cell Secretome Administration in Severe Erectile Dysfunction Non-responsive to Sildenafil
A study testing Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome in people with Erectile Dysfunction and Diabetes Mellitus Type 2, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The study is an experimental pre-post-test design involving 12 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 Dysfunction, Diabetes Mellitus Type 2
- What is being tested?
- Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Apr 2024to 1 Aug 2025
- Phase
- Interventional
- 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 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
1 site in 1 country.
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 12 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 Dysfunction, Diabetes Mellitus Type 2
- Being tested
- Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome
- Keywords
- erectile dysfunction, non responsive to sildenafil, secretome, Umbilical Cord Mesenchymal Stem Cell
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell SecretomeBiological
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 |
|---|---|---|
| severe erectile dysfunction non responsive to Sildenafil | Experimental | Not described Receives: Biological: Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
A visual analog is used for measuring pain. The patient will be asked to describe the pain on scale 1 to 10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Measured: one day and one month
Hematomes
Hematomes means blue discoloration. 0 scale means ther is no discoloration and 1 means there is discoloration.
Measured: one day and one month
Bleeding
Bleeding is one of the outcomes of the research. If there is bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Measured: one day and one month
Erection Hardness Score
Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 scores. 1 indicate severe erectile dysfunction (worst) and 4 indicates there is optimal erection (good).
Measured: One month
IIEF-5
Rapid diagnostic tool to evaluate erectile dysfunction
Measured: One month
Restrictive Index
Measured: one month
PSV
Measured: one month
SPL
Measured: one month
FPL
Measured: one month
Penile Circumference
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start12 Apr 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT07245875
- Sponsor's protocol ID
- 23-04-0512
- Other IDs
- PUTI Q1
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Nov 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
- NCT07245875
- Acronym / sponsor ID
- 23-04-0512
- Conditions
- Erectile Dysfunction, Diabetes Mellitus Type 2
- Keywords
- erectile dysfunction, non responsive to sildenafil, secretome, Umbilical Cord Mesenchymal Stem Cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 24 Nov 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 12 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 |
|---|---|---|
| severe erectile dysfunction non responsive to Sildenafil | Experimental | Biological: Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome |
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 |
|---|---|---|
| Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell SecretomeUC-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. | Biological | severe erectile dysfunction non responsive to Sildenafil |
Primary outcome
Visual Analog Scale
Time frame: one day and one month
A visual analog is used for measuring pain. The patient will be asked to describe the pain on scale 1 to 10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Hematomes
Time frame: one day and one month
Hematomes means blue discoloration. 0 scale means ther is no discoloration and 1 means there is discoloration.
Bleeding
Time frame: one day and one month
Bleeding is one of the outcomes of the research. If there is bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Erection Hardness Score
Time frame: One month
Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 scores. 1 indicate severe erectile dysfunction (worst) and 4 indicates there is optimal erection (good).
IIEF-5
Time frame: One month
Rapid diagnostic tool to evaluate erectile dysfunction
Restrictive Index
Time frame: one month
PSV
Time frame: one month
SPL
Time frame: one month
FPL
Time frame: one month
Penile Circumference
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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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. 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 study testing Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome in people with Erectile Dysfunction and Diabetes Mellitus Type 2, run by Universitas Indonesia at 1 site in 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: finished, as of the sponsor's last update on 24 Nov 2025. 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 Indonesia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (time frame: one day and one month). The study lists 10 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 24 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.