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

RecruitingPhase 1Ages 50 Years - anyFemaleInstituto de Investigación Sanitaria de la Fundac…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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/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 of urinary 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 carcinoma of the skin, or present a history of malignant tumors, unless they have been in remission during the previous 5 years. * Cardiopulmonary disease that, in the opinion of the investigator, is unstable or serious 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 to inclusion * Subject's allergy to anesthetics
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What it tests

  • allogeneic mesenchymal stem cells
  • Placebo
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Where

6 sites
Hospital Universitario del Henares
Coslada, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Spain
Hospital Universitario Infanta Elena
Valdemoro, Spain
Hospital Universitario General de Villalba.
Villalba, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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