Clinical trial NCT06738576: Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Urinary Incontinence Stress
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

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

Primary outcomes:
measure: Proportion of patients with at least one of the complictations derived from the treatment.
timeFrame: 7 days
Secondary outcomes:
measure: The evaluation of the PAD-test
timeFrame: 3 moths and 6 months
measure: Flowmetry values
timeFrame: 3 months
measure: Quality of life SF-12 questionnaire
timeFrame: 3 moths and 6 months
measure: Quality of life ICQ-SF questionnaire
timeFrame: 3 moths and 6 months
Other outcomes:
Locations:
city: Coslada
country: Spain
facility: Hospital Universitario del Henares
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Universitario Infanta Elena
state: Madrid
city: Villalba
country: Spain
facility: Hospital Universitario General de Villalba.
state: Madrid
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
Study officials:
affiliation: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Carmen González Enguita, PhD
role: PRINCIPAL_INVESTIGATOR
References: