Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Urinary Incontinence Stress
In brief
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.
Key facts
- Study ID
- NCT06738576
- Run by
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- People needed
- 60
- Starts
- 2024-12-16
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-05-01
Who can join
Age: 50 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Hospital Universitario del Henares — Coslada, Madrid, Spain (enrolling)
- Fundación Jiménez Díaz — Madrid, Madrid, Spain (enrolling)
- Hospital Universitario Doce de Octubre — Madrid, Madrid, Spain (enrolling)
- Hospital Universitario Rey Juan Carlos — Móstoles, Madrid, Spain (enrolling)
- Hospital Universitario General de Villalba. — Villalba, Madrid, Spain (enrolling)
- Hospital Universitario Infanta Elena — Valdemoro, Madrid, Spain
Full record on ClinicalTrials.gov
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