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Placental tissue implant tested to speed up erection recovery after prostate removal

NCT ID NCT05366842

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 placing a special placental tissue over nerves during prostate cancer surgery helps men regain erections and bladder control faster. Only 3 men participated before the study was stopped early. The approach aimed to protect nerves during surgery, but results are too limited to draw conclusions.

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

3 people

The number who actually took part.

Started

Apr 2022

Finished

Apr 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: 1. Male sex 40 to 65 years of age with localized prostate cancer (clinical stage less than or equal to T2a, Gleason grade less than or equal to 3+4=7 (Gleason 8 or 4+3=7 will be excluded), Prostate-Specific Antigen (PSA) less than or equal to 10 ng/mL) 2. Scheduled to undergo curative radical prostatectomy applying bilateral nerve-sparing procedure 3. Intact pre-surgical erectile function (International Index of Erectile Function \[IIEF\]-5 / Sexual Health Inventory for Men (SHIM) score greater than or equal to 18) 4. Willingness to attempt intercourse at least 5 times per month following surgery. 5. Has a sexual partner of at least 6 months with current sexual activity (within the past 4 weeks) Exclusion Criteria: 1. Known penile deformity or a history of Peyronie's disease 2. Pre or postoperative androgen therapy 3. Pre or postoperative radiation therapy 4. History of high or low blood pressure that is not controlled 5. Taking nitrates medications 6. History of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction 7. History of drug or alcohol abuse 8. Current smoker has a 20 pack/year history of cigarette smoking 9. History of acute or chronic depression 10. History of liver problems or kidney problems 11. History of retinitis pigmentosa or severe vision loss, including a condition called NAION 12. History of spinal trauma or surgery to the brain or spinal cord 13. Other contraindications to the use of phosphodiesterase inhibitor (PDE) 5 inhibitors 14. History of known sensitivities to any of the following reagents used for processing, disinfection, and storage, which may remain on the product: * Lyopreservation Solution: 18.9% w/v Trehalose in Dulbecco's Phosphate Buffered Saline * Disinfection Solution: 0.5% v/v Gentamicin Sulfate, 0.1% v/v Vancomycin reconstituted in Water for Injection (WFI), 1% v/v Amphotericin B, 98.4% Dulbecco's Modified Eagle's Medium (DMEM) * Processing Solution: DMEM, Dulbecco's Phosphate Buffered Saline (dPBS), 11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACD-A), 1.7% w/v Trehalose in Dulbecco's Phosphate Buffered Saline

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

More trials for these conditions

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