Study details
A study evaluating the safety of an innovative cell therapy (SUICell) for stress urinary incontinence in men after radical prostatectomy.
Title: Evaluation of safety of somatic cell based therapy for urinary incontinence in patients after radical prostatectomy, open trial.
Principal Investigator:
prof. Tomasz Drewa, FEBU
Study description
Recruitment status: Coming soon
Study phase: Phase 1 (First in Human)
Simplified inclusion criteria:
- Men ≥18 years after robotic radical prostatectomy
- Moderate stress urinary incontinence
- Confirmed by urodynamic testing
- BMI >20 kg/m² with sufficient fat tissue
- Negative HIV, HBV, HCV, syphilis tests
Simplified exclusion criteria:
- Positive surgical margin or elevated PSA
- Prior radiotherapy or pelvic surgery
- Lower urinary tract dysfunction
- Active infections
- Participation in other trials (last 6 months)
- Significant lab abnormalities
Contact
Clinical trial coordinator
Paulina Ciesińska
e-mail: paulina.ciesinska@cm.umk.pl