Two phase I/II clinical trials for the treatment of urinary incontinence with autologous mesenchymal stem cells.

We proposed to evaluate the safety and feasibility of adipose-derived mesenchymal stem cells to treat endoscopically urinary incontinence after radical prostatectomy in men or female stress urinary. We designed two prospective, nonrandomized phase I-IIa clinical trials of urinary incontinence involving 9 men (8 treated) and 10 women to test the feasibility and safety of autologous mesenchymal stem cells for this use. Cells were obtained from liposuction containing 150 to 200 g of fat performed on every patient. After 4 to 6 weeks and under sedation, endoscopic intraurethral injection of the cells was performed. On each visit (baseline, 1, 3, 6, and 12 months), clinical parameters were measured, and blood samples, urine culture, and uroflowmetry were performed. Every patient underwent an urethrocystoscopy and urodynamic studies on the first and last visit. Data from pad test, quality-of-life and incontinence questionnaires, and pads used per day were collected at every visit. Statistical analysis is made by Wilcoxon signed-rank test. No adverse effects have been collected. Three men (37.5%) and five women (50%) showed an objective improvement of >50% (P < .05) and a subjective improvement of 70% to 80% from baseline. In conclusion, intraurethral application of stem cells derived from adipose tissue is a safe and feasible procedure to treat urinary incontinence after radical prostatectomy or in female stress urinary incontinence. A statistically significant difference was obtained for pad-test improvement in 3/8 men and 5/10 women. Our results encourage studies to confirm safety and to analyze efficacy.

Stem cells translational medicine. 2020 Aug 31 [Epub ahead of print]

Mariano Garcia-Arranz, Sergio Alonso-Gregorio, Pamela Fontana-Portella, Elena Bravo, Jesus Diez Sebastian, María Eugenia Fernandez-Santos, Damian Garcia-Olmo

New Therapies Laboratory, Health Research Institute-Fundación Jiménez Díaz University Hospital (IIS-FJD), Madrid, Spain., Department of Urology, Hospital De la Cruz Roja San José y Santa Adela, Madrid, Spain., Department of Urology, La Paz University Hospital, Madrid, Spain., Department of Plastic Surgery, La Paz University Hospital, Madrid, Spain., Statistics Department, La Paz University Hospital, Madrid, Spain., GMP-Cell Production Unit, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain.