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Stem cell therapy shows promise for severe erectile dysfunction

NCT ID NCT07245875

Symptom relief Sponsor: Indonesia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether an injection of umbilical cord stem cell secretome is safe and can improve erections in 12 men with severe erectile dysfunction that did not respond to sildenafil (Viagra). All participants had type 2 diabetes. The treatment was given as a single injection, and the researchers monitored for side effects like pain or bleeding and measured erection hardness and questionnaire scores. The goal was to see if this approach could ease symptoms when standard medication fails.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Apr 2024

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 65 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

erectile dysfunction type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Erectile dysfunction

Contacts and locations

Locations

  • Univesitas Indonesia Hospital

    Depok, West Java, 16424, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.