NCT05857371 Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction From Autologous Adipose Tissue of URethral Stenosis With Endoscopic Urethrotomy
| NCT ID | NCT05857371 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Urethral Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-03-13 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-03-13 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
SURF is a randomised controlled, parallel group, single blind phase II study designed to assess the safety and potential efficacy of an innovative therapeutic strategy for urethral stenosis based on adjuvant injection of autologous Adipose-Derived Stromal Vascular Fraction of Adipose Tissue (ADSVF) during endoscopic urethrotomy (standard care).
Eligibility 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
Contact & Investigator
FRANCOIX CREMIEUX
STUDY DIRECTOR
ASSISITANCE PUBLIQUE HOPITAUX DE MARSEILLE
Frequently Asked Questions
Who can join the NCT05857371 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 85 Years, studying Urethral Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05857371 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05857371 currently recruiting?
Yes, NCT05857371 is actively recruiting participants. Contact the research team at Gilles.KARSENTY@ap-hm.fr for enrollment information.
Where is the NCT05857371 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT05857371 clinical trial?
NCT05857371 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is FRANCOIX CREMIEUX at ASSISITANCE PUBLIQUE HOPITAUX DE MARSEILLE. The trial plans to enroll 20 participants.