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Stem cells shot into penis aim to restore erections after prostate surgery

NCT ID NCT01089387

Disease control Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tested whether injecting a man's own bone marrow stem cells into the penis could help restore erections after prostate cancer surgery. The study included 18 men who had normal erections before surgery but developed erectile dysfunction due to blood vessel damage. Researchers tested four different doses to find the safest and most promising one.

What this could mean

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

Active substance
bone marrow stem cells (mononucleated cells)
What this could lead to
If it works, this could point toward a treatment for erectile dysfunction after prostate removal, potentially restoring natural erections without lifelong medication.
What could go wrong
This is a very small, early-phase trial (18 men) testing safety and dosing. It may not lead to an effective treatment, and risks include priapism or local inflammation.

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

18 people

The number who actually took part.

Start date

May 2010

Finished

Mar 2015

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

45 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: * Localized prostate cancer: PSA (Prostate Specific Antigen) prior to radical prostatectomy \< 10 ng/ml, histopathologic analysis of the prostate showing a prostate cancer with Gleason score ≤ 7, negative margin, absence of effraction of the prostatic capsule, pT1 or pT2 N0 or NX. * PSA=0 ng/ml 6 months after radical prostatectomy. * Normal erectile function prior to radical prostatectomy. * Penile arterial insufficiency and or venous leakage (doppler) at the time of inclusion: PSV \<25 cm/sec, PSV \>25 cm/sec, EDV\>5cm/sec, RI\<0,75. Exclusion Criteria: * Non localized prostate cancer.

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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

Contacts and locations

Locations

  • CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil

    Créteil, 94101, France

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