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Could stem cells restore erectile function? new trial tests the idea

NCT ID NCT07544537

Disease control Sponsor: National Scientific Medical Center, Kazakhstan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether stem cells from a patient's own bone marrow or fat can improve erectile dysfunction better than platelet-rich plasma or standard treatments. One hundred men with organic ED who did not respond to pills will receive one of these therapies. The goal is to see if regenerative medicine can offer a new option for this common condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous mesenchymal stem cells (from bone marrow or fat) and platelet-rich plasma
What this could lead to
If successful, this could point toward a regenerative treatment for erectile dysfunction that repairs tissue rather than just managing symptoms.
What could go wrong
This is a mid-stage trial with only 100 participants, so results may not apply to everyone. Stem cell therapies are still experimental and long-term safety is unknown.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 70 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 * Male sex, aged between 18 and 70 years. * Confirmed diagnosis of organic erectile dysfunction (e.g., vasculogenic, diabetic, or post-traumatic) for a duration of at least 6 months. * Documented resistance or inadequate response to first-line therapies, such as Phosphodiesterase type 5 inhibitors (PDE5i). * IIEF-5 (International Index of Erectile Function) score \< 21 at baseline. * Stable relationship with a partner for the duration of the study. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria * Psychogenic erectile dysfunction (not related to organic causes). * Anatomical deformities of the penis (e.g., Peyronie's disease, severe penile curvature, or fibrosis that prevents injection). * Uncontrolled systemic diseases, including decompensated diabetes mellitus (HbA1c \> 9%), severe cardiovascular disease, or uncontrolled hypertension. * History of pelvic malignancy (e.g., prostate or bladder cancer) or undergoing active radiation/chemotherapy. * Active infection (local or systemic) or skin diseases at the site of the intended injection. * Hematological disorders, such as severe anemia, coagulopathy, thrombocytopenia, or current use of anticoagulants that cannot be safely paused. * Testosterone deficiency (Hypogonadism) that has not been stabilized by hormone replacement therapy. * History of drug or alcohol abuse that may interfere with study compliance. * Participation in another clinical trial involving experimental treatments for erectile dysfunction within the last 3 months.

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Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

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

Erectile dysfunction

Contacts and locations

Locations

  • National Scientific Medical Center

    Astana, 010000, Kazakhstan

More trials for these conditions

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