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

NCT06738576 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-01

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Carmen González Enguita, PhD · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06738576 on ClinicalTrials.gov