Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Urinary Incontinence Stress
Interventions
DRUG

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."

DRUG

Placebo

Placebo implantation is carried out in the same way as the drug implantation

Trial Locations (6)

28040

RECRUITING

Fundación Jiménez Díaz, Madrid

28041

RECRUITING

Hospital Universitario Doce de Octubre, Madrid

28342

ACTIVE_NOT_RECRUITING

Hospital Universitario Infanta Elena, Valdemoro

28400

RECRUITING

Hospital Universitario General de Villalba., Villalba

28822

RECRUITING

Hospital Universitario del Henares, Coslada

28933

RECRUITING

Hospital Universitario Rey Juan Carlos, Móstoles

All Listed Sponsors
lead

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER