Scientists grow penile tissue in lab for first human trial
NCT ID NCT03463239
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Wake Forest Institute for Regenerative Medicine
Winston-Salem, North Carolina, 27157, United States
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