Scientists grow new urethras in lab to fix blockages
NCT ID NCT03258658
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This early-phase trial tests whether a lab-grown urethra made from a patient's own cells can safely repair urethral strictures (narrowing of the urine tube) in adult men. Ten participants will receive the engineered tissue, and researchers will monitor for side effects and improvements in urine flow. The goal is to see if this approach is safe and works before larger studies.
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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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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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21 to 75 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: * Stricture of the urethra meeting the following criteria: a) History of at least one 15-60 mm in length, as determined by urethrography. c) Contains at least 1 strictured segment through which a 16 Fr flexible cystoscope cannot be atraumatically passed. * Patients must be available for all follow-up visits. * Ability to speak English. Exclusion Criteria: * Strictures of the meatus or prostatic urethra; any urethral stricture associated with or suspected to be urethral carcinoma, or strictures due to pelvic distraction injuries. Strictures \<10 mm or \>60 mm, as determined by urethrography, and criteria for bulbar urethral strictures excluding those with strictures \<20 mm and \>60 mm, as described by urethrography. * Presence of untreated urinary tract infection. * Presence or prior history of lichen sclerosis et atrophicus (previously termed 'balanitis xerotica obliterans'). * Uncontrolled bleeding disorder or patients with a platelet count less than 50,000, hemophilia or patients routinely receiving blood products for bleeding disorders. * Any urological condition that would be likely to require additional urethral instrumentation during the period of investigation, including, but not limited to benign prostatic hyperplasia requiring treatment, use of alpha blockers, active prostate cancer, an unevaluated elevated prostate surface antigen (PSA), bladder cancer, or any recurrent urinary stone formation. Patients with evidence or diagnosis of any coagulation disorder (including concomitant anti-coagulation therapy at enrollment). * Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease. * Patients with abnormal urologic conditions, including vesicoureteral reflux, bladder stones, bladder tumors and renal impairment. * Subjects with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value \>3 times the upper limit of normal. * Subjects with an albumin value \<3.0 g/dL. * Subjects with uncontrolled diabetes, unstable cardiac and/or pulmonary disorders. * Subjects with 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. * Subjects known to be colonized with either methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms. * Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids \[≤0.25 mg/kg prednisone or equivalent per day\] are permitted). * Any history of alcohol and/or drug abuse. * Current smoker. * 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. * 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. * Any current illness that might confound the results of this investigation, including but not limited to bladder atonia, neuropathic/neurogenic bladder, bladder outlet obstruction (other than urethral stricture), sphincteric dysfunction, or spinal cord injury. * Any circumstance in which the investigator deems participation in the study is not in the subject's best interest. * Inability to participate in all necessary study activities due to physical or mental limitations. * Inability or unwillingness to return for all required follow-up visits. * inability or unwillingness to sign informed consent. * Patients requiring concomitant use of or treatment with immunosuppressive agents. * 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
2 sites. 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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University of California San Francisco
NOT_YET_RECRUITINGSan Francisco, California, 94110, United States
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Wake Forest Institute for Regenerative Medicine (WFIRM)
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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- Which laser frequency works best for prostate surgery?
- Water jet surgery: a new wave for prostate relief?
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- Can doctors predict which stricture repairs will hold?