Fat cells may help fix narrowed urethra without long-term drugs
NCT ID NCT05857371
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injecting a patient's own fat-derived cells during standard surgery can safely improve outcomes for urethral narrowing (stenosis). About 20 men aged 18-85 with bulbar stenosis ≤3 cm and at least one prior procedure will receive either standard surgery alone or surgery plus the cell injection. The main goal is to check safety, including pain, infection, and bleeding, over 24 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Apr 2028
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 85 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: * Signed informed consent * Male, aged from 18 to 85 years * Bulbar urethral stenosis ≤ 3 cm. * At least one urethral dilatation or urethrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis * Ability to avoid corticoids or immunosuppressive drugs one month after treatment. For any patients with either corticoid or immunosuppressive treatment the physician in charge of this treatment will be contacted and asked to give a written approval for one month cessation of the therapy * Good general health status according to clinical history and a physical examination * BMI \> 18 to insure adequate access to abdominal or other subcutaneous adipose tissue for adipose tissue harvesting Exclusion Criteria: * Urethral stenosis of other location than bulbar * Urethral stenosis length \> 3 cm * Urethral stenosis on reconstructed penis (transgender, post amputation) * Prior perineal or pelvic radiotherapy * Concurrent urinary tract infection without treatment * Concurrent perineal infection * Penile cancer \< 5 years * Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease * Congenital or acquired immunodeficiencies * Contraindication to the anaesthetic or surgical procedure * Corticoids or immunosuppressive drugs \> 3 months * Any active viral infection among the following: HIV, HTLV I and II, VHB, VHC and syphillis * Administrative restricted rights * Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician * Diagnosis of untreated and unresolved BPH benign prostatic hyperplasia or BNC bladder neck contracture * Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years
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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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Assistance Publique Hopitaux de Marseille
RECRUITINGMarseille, France