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Scientists grow penile tissue in lab for first human trial

NCT ID NCT03463239

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a lab-grown penile tissue made from a man's own cells to repair severe, irreversible damage to the penis. Ten men aged 18-60 who have failed standard treatments will receive the implant. The main goal is to check safety, not effectiveness.

What this could mean

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

Active substance
lab-grown penile tissue made from the patient's own cells
What this could lead to
If it works, this could lead to a new way to repair severe penile damage without using artificial materials or grafts from other body parts.
What could go wrong
This is a very early, small safety trial with only 10 men. The tissue may fail to work, cause clots, or have other side effects. Success is far from guaranteed.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

18 to 60 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. Males aged 18-60 years. 2. Acquired structural abnormalities of the corpora cavernosum secondary to trauma, infection, inflammation, or fibromatosis. These abnormalities will be diagnosed by clinical examination, and/or ultrasound, and/or computerized tomography. 3. Stable abnormalities - at least 6 months with no pain or changes in deformity. 4. At least one failed attempt at management by conventional approaches at least 6 months prior to enrollment 5. Deformities less than 5 cm in length. 6. Written informed consent obtained prior to participation in the study. 7. Patients must be available for all follow up visits. 8. Ability to speak English. Exclusion Criteria: 1. Presence of untreated or incompletely treated urinary tract infection at the time of biopsy. 2. Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders. 3. Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease. 4. ALT or AST value \>1.5 times the upper limit of normal. 5. Albumin \< 3.0 g/dL. 6. Serum direct bilirubin \>0.3 mg/dL OR total bilirubin \> 1.4 mg/dL 7. BM I\>40 kg/m2 8. Uncontrolled diabetes with HbA1C\>9%. (Subjects with controlled diabetes must be under care of diabetologist with treatment goals consistent with ADA criteria). 9. Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure. 10. Unstable pulmonary disorders within the past 6 months including dyspnea on exertion, chronic productive cough, pneumonia, hemoptysis, asthma requiring nebulized therapy. 11. Active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment. 12. Known to be colonization with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms. 13. Immunocompromised subjects or subjects receiving immunosuppressive agents. 14. Any history of alcohol and/or drug abuse. 15. Documented history of, or positive result of HIV, Hepatitis B or C, or any infectious disease. External signs, sequelae, or positive serology of sexually transmitted disease (including HPV). Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study. 16. Concurrent participation in any other clinical investigation during the period of this investigation. Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study. 17. Any circumstance in which the investigator deems participation in the study is not in the subject's best interest. 18. Inability to participate in all necessary study activities due to physical or mental limitations. 19. Inability or unwillingness to return for all required follow-up visits, for instance life expectancy \< 1 year, or subject who knows they will be moving out of the country and unable to return for follow-up visits. 20. Inability or unwillingness to sign informed consent. 21. Patients requiring concomitant use of or treatment with immunosuppressive agents 22. Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease).

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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.

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

  • Wake Forest Institute for Regenerative Medicine

    Winston-Salem, North Carolina, 27157, United States

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