Using stem cells from fat to treat urinary incontinence in women over 50

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the feasibility and safety of using expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) to treat urinary incontinence in women over 50 years old. It is a phase I controlled trial that aims to gather initial efficacy data by comparing a cohort receiving the stem cells to a control group receiving a saline solution. Participants must have a clinical diagnosis of stress urinary incontinence and have experienced symptoms for at least six months. The study will assess the safety and preliminary effectiveness of this innovative treatment approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Universitario del Henares
  Coslada, Madrid, Spain Recruiting
• Fundación Jiménez Díaz
  Madrid, Madrid, Spain Recruiting
• Hospital Universitario Doce de Octubre
  Madrid, Madrid, Spain Recruiting
• Hospital Universitario Rey Juan Carlos
  Móstoles, Madrid, Spain Recruiting
• Hospital Universitario General de Villalba.
  Villalba, Madrid, Spain Recruiting
• Hospital Universitario Infanta Elena
  Valdemoro, Madrid, Spain Active not recruiting

Study contacts

• Principal investigator: Carmen González Enguita, PhD — Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Study coordinator: Carmen González Enguita, PhD
• Email: cgenguita@fjd.es
• Phone: +34915504957

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.