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

Last updated: April 29, 2025
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Overall Status: Active - Recruiting

Phase

1

Condition

Enuresis

Urinary Incontinence

Treatment

Placebo

allogeneic mesenchymal stem cells

Clinical Study ID

NCT06738576
SUITH
2024-514833-39-00
  • Ages > 50
  • Female

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.

Eligibility Criteria

Inclusion

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 urinaryincontinence internationally accepted by the ICS (International Continence Society):to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. MixedUI: any involuntary loss of urine, immediately preceded by exertion or anuncontrollable 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 undergorehabilitative or surgical treatment

  • Patients without active urinary tract infection (negative urine culture) at the timeof recruitment and treatment

  • Signing of the informed consent form

Exclusion

Exclusion Criteria:

  • Patients with a medical history of previous surgery for incontinence, prolapse orurological/gynecological/colorectal surgery

  • Major surgery or serious trauma of the subject in the previous semester

  • Women with mixed urinary incontinence, with predominant symptoms of urgency

  • History of high-pressure detrusor overactivity

  • Present infravesical obstruction, vesico-ureteral reflux or clinical history ofurinary fistula (it will be ruled out depending on the case by urethrocystoscopy,urethrocystography and flowmetry).

  • Present any malignant neoplasm, unless it is basal cell or squamous cell carcinomaof the skin, or present a history of malignant tumors, unless they have been inremission during the previous 5 years.

  • Cardiopulmonary disease that, in the opinion of the investigator, is unstable orserious enough to exclude the patient from the study.

  • Medical or psychiatric illness of any type that, in the opinion of the researcher,may be a reason for exclusion from the study.

  • History of alcohol or other addictive substance abuse in the 6 months prior toinclusion

  • Subject's allergy to anesthetics

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 16, 2024
Estimated Completion Date:
December 31, 2025

Study Description

It's a controlled trial, in phase I, proof of concept, safety and preliminary analysis of efficacy. It is planned to make 2 cohorts of patients, one with a single dose of 40 million HC016 and another group with saline solution (control).

Connect with a study center

  • Hospital Universitario del Henares

    Coslada, Madrid 28822
    Spain

    Active - Recruiting

  • Hospital Universitario Rey Juan Carlos

    Móstoles, Madrid 28933
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Elena

    Valdemoro, Madrid 28342
    Spain

    Site Not Available

  • Hospital Universitario General de Villalba.

    Villalba, Madrid 28400
    Spain

    Active - Recruiting

  • Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Doce de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

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