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Could stem cells restore erectile function after prostate surgery?

NCT ID NCT07048314

Disease control Sponsor: The Methodist Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests whether stem cells from donated fat tissue can help men recover erectile function after surgery for localized prostate cancer. Forty men aged 40 to 70 will receive either stem cells or a placebo during or after their prostate removal. The goal is to see if the treatment is safe and improves erections and quality of life.

What this could mean

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

Active substance
allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs)
What this could lead to
If it works, this could offer a new way to help men recover erectile function after prostate cancer surgery, potentially improving quality of life.
What could go wrong
This is a very early phase 1/2 trial with only 40 people, so results may not apply to everyone. Stem cell treatments can cause side effects like inflammation or serious adverse events.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

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 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: 1. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist. 2. Men aged between 40 and 70 (inclusive) years old 3. Localized prostate cancer: Clinical stage T1-T2, N0, M0 4. Gleason score \< 7 5. Pre-op IIEF-5 \>20 (Appendix A) 6. Testosterone serum: \> 300ng/dl with normal Free Testosterone 7. Life expectancy of at least 10 years 8. Performance status of ≤ 2 (Zubrod scale). (Appendix B) 9. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution 10. Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery 11. Supportive partner willing to complete sexual survey questionnaire (Appendix D) 12. PDE5 inhibitors like sildenafil, tadalafil, vardenafil and avanafil are permitted pre and post-surgery if participant was taking this for ED at least 6 months before surgery. 13. Patient need cardiac clearance by the cardiologist Exclusion Criteria: 1. Penile anatomical abnormalities (Peyronie's disease) 2. Hypogonadism 3. Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.) 4. Patients with AST levels above 40U/L ; ALT levels above 33 U/L and Glucose levels above 180 mg/dl and psychiatric disorders that require medication 5. Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug. 6. Any previous penile implant or penile vascular surgery 7. Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery . \-

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Conditions

The condition(s) this trial relates to.

erectile dysfunction prostate cancer prostate carcinoma

As listed by the trial registrant

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

Erectile dysfunction Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

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