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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
single dose of 40 million HC016	allogeneic mesenchymal stem cells	They will receive 1 single dose 1 dose of 40 million cells of HC016 at a concentration of 10 million cells/mL. N=40
Saline solution	Placebo	They will receive a single dose of the saline solution in which the HC016 cells are conditioned, which consists of lactated ringer's, glucosaline, sodium bicarbonate and human albumin. N=20

Primary Outcome Measures

Name	Time	Method
Proportion of patients with at least one of the complictations derived from the treatment.	7 days	complications derived from treatment will be considered: * Complications during anesthesia. * Complications during treatment administration. * Peri- and postoperative complications. * Adverse effects during follow-up, whether or not associated with the drug

Secondary Outcome Measures

Name	Time	Method
The evaluation of the PAD-test	3 moths and 6 months	quantification of the amount of urine lost during the duration of the test (24h),
Flowmetry values	3 months	improvement in the flowmetry values. It is expressed in cm3 (or ml) divided by second.and the normal values are between 50 and 80 mL/min
Quality of life SF-12 questionnaire	3 moths and 6 months	The score ranges between 0 and 100, where the higher score implies a better health-related quality of life Evaluate the change in the quality of life of the patients with respect to the baseline situation
Quality of life ICQ-SF questionnaire	3 moths and 6 months	Evaluate the change in the quality of life of the patients with respect to the baseline situation. Any score greater than zero is considered urinary incontinence.

Recruitment & Eligibility