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

It's a controlled trial, in phase I, proof of concept, safety and preliminary analysis of efficacy. It is planned to make 2 cohorts of patients, one with a single dose of 40 million HC016 and another group with saline solution (control).

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