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

RCAPHM18_0020_1

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).

2024-03-13

2027-11-01

2028-04-01

Recruiting

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-03-18