60
Participants
Start Date
December 16, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
allogeneic mesenchymal stem cells
"Cell implantation is carried out in the following steps:~1. \- Patient anesthesia~2. \- Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy.~3. \- Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately.~4. \- Injection of the cell suspension with a long, fine needle (those usually used in endoscopic puncture, \<22G) at 2 points of the sphincter that will coincide with the 3 o'clock and 9 o'clock position of the hands of a clock). The injection will be superficial, trying not to go deeper than 2 mm to create a wheal in each injection visible endoscopically.~5. \- Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste."
Placebo
Placebo implantation is carried out in the same way as the drug implantation
RECRUITING
Fundación Jiménez Díaz, Madrid
RECRUITING
Hospital Universitario Doce de Octubre, Madrid
ACTIVE_NOT_RECRUITING
Hospital Universitario Infanta Elena, Valdemoro
RECRUITING
Hospital Universitario General de Villalba., Villalba
RECRUITING
Hospital Universitario del Henares, Coslada
RECRUITING
Hospital Universitario Rey Juan Carlos, Móstoles
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER