Innovative treatment for urethral stenosis using fat-derived stem cells
Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy: Randomized Controlled Trial
PHASE2 · Assistance Publique Hopitaux De Marseille · NCT05857371
This study is testing whether injecting fat-derived stem cells during surgery can help people with recurring urethral narrowing heal better and have fewer problems later on.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille) |
| Trial ID | NCT05857371 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the safety and potential effectiveness of injecting autologous adipose-derived stromal vascular fraction (ADSVF) during endoscopic urethrotomy for patients with recurrent bulbar urethral stenosis. The study aims to improve healing and reduce recurrence rates associated with traditional urethrotomy procedures. Participants will undergo lipoaspiration to obtain ADSVF, which is then administered during the urethrotomy. The trial is designed as a randomized controlled, parallel group, single-blind study to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 85 with bulbar urethral stenosis of 3 cm or less who have had prior urethral interventions.
Not a fit: Patients with urethral stenosis located in areas other than the bulbar region or those with stenosis longer than 3 cm may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce recurrence rates of urethral stenosis and improve patient outcomes.
How similar studies have performed: While the use of ADSVF in urethral treatments is promising, this specific approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Marseille
- Assistance Publique Hopitaux de Marseille — Marseille, France (RECRUITING)
Study contacts
- Study coordinator: Gilles Karsenty, Pr.
- Email: Gilles.KARSENTY@ap-hm.fr
- Phone: 0491435170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urethral Stenosis