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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status and phase: Enrolling; Phase 1

Conditions: Urinary Incontinence Stress

Treatments: Drug: Placebo; Drug: allogeneic mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT06738576

2024-514833-39-00 (EU Trial (CTIS) Number)

SUITH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

single dose of 40 million HC016

Experimental group

Description:

They will receive 1 single dose 1 dose of 40 million cells of HC016 at a concentration of 10 million cells/mL. N=40

Treatment:

Drug: allogeneic mesenchymal stem cells

Saline solution

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo