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Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Summary
Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.
Official title: Phase II Clinical Trial to Determine the Safety and Efficacy of the Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106) in the Local Treatment of Female Urinary Incontinence in Women Over 50 Years of Age
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-12-16
Completion Date
2025-12
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
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
Locations (6)
Hospital Universitario del Henares
Coslada, Madrid, Spain
Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Madrid, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Universitario Infanta Elena
Valdemoro, Madrid, Spain
Hospital Universitario General de Villalba.
Villalba, Madrid, Spain