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Recruiting Phase 1 NCT06738576

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

Trial Parameters

Condition Urinary Incontinence Stress
Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 60
Sex FEMALE
Min Age 50 Years
Max Age N/A
Start Date 2024-12-16
Completion 2025-12
Interventions
allogeneic mesenchymal stem cellsPlacebo

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Women over 50 years old * Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of urinary incontinence internationally accepted by the ICS (International Continence Society): to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. Mixed UI: any involuntary loss of urine, immediately preceded by exertion or an uncontrollable desire to urinate. The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort. * Women in whom rehabilitative treatment has failed or patients who refuse to undergo rehabilitative or surgical treatment * Patients without active urinary tract infection (negative urine culture) at the time of recruitment and treatment * Signing of the informed consent form Exclusion Criteria: * Patients with a medical history of previous surgery for incontinence, prolapse or urological/gynecolo

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