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

Launched by INSTITUTO DE INVESTIGACIÓN SANITARIA DE LA FUNDACIÓN JIMÉNEZ DÍAZ · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for urinary incontinence, specifically designed for women over 50 years old. The researchers want to see if using expanded stem cells derived from fat tissue (called HC106) is safe and effective for women who have been struggling with stress urinary incontinence for at least six months. Stress urinary incontinence means that women may leak urine when they cough, laugh, or exercise. The study will include women who have tried other treatments that didn’t work or who prefer not to have surgery.

To participate, women must be over 50 and have been diagnosed with stress urinary incontinence. They also need to be free of urinary tract infections and must not have had any prior surgeries for incontinence. Participants will be asked to sign a consent form and will be monitored closely throughout the trial. Since this is a Phase 1 trial, the main focus is on safety and gathering early data on how well the treatment works. If you're considering joining the study, it’s important to discuss any medical history with your doctor to see if you meet the eligibility criteria.

Gender

FEMALE

Eligibility 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