Innovative treatment for urethral stenosis using fat-derived stem cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Assistance Publique Hopitaux de Marseille
  Marseille, France Recruiting

Study contacts

• Study coordinator: Gilles Karsenty, Pr.
• Email: Gilles.KARSENTY@ap-hm.fr
• Phone: 0491435170

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.