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RECRUITING
NCT06738576
PHASE1

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

View on ClinicalTrials.gov

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

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

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