Using stem cells from fat to treat urinary incontinence in women over 50
Phase II Clinical Trial to Determine the Safety and Efficacy of the Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106) in the Local Treatment of Female Urinary Incontinence in Women Over 50 Years of Age
This study is testing if using stem cells from fat can help women over 50 with urinary incontinence feel better compared to a saline solution.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 6 sites (Coslada, Madrid and 5 other locations) |
| Trial ID | NCT06738576 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women over 50 years old with a clinical diagnosis of genuine or mixed stress urinary incontinence who have not responded to rehabilitative treatment.
Not a fit: Patients with a history of previous surgery for incontinence or those with active urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing urinary incontinence in older women.
How similar studies have performed: While the use of stem cells for urinary incontinence is a novel approach, similar studies have shown promising results in other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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/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 this trial is running
Coslada, Madrid and 5 other locations
- 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 Infanta Elena — Valdemoro, Madrid, Spain (Active_not_recruiting)
- Hospital Universitario General de Villalba. — Villalba, Madrid, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.