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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат allogeneic mesenchymal stem cells
  Cell implantation is carried out in the following steps: 1. \- Patient anesthesia 2. \- Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy. 3. \- Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately. 4. \- Injection of the cell suspension with a long, fine needle (those usually used in endoscopic puncture, \<22G) at 2 points of the sphinc
• Препарат Placebo
  Placebo implantation is carried out in the same way as the drug implantation

Первичные конечные точки

• Proportion of patients with at least one of the complictations derived from the treatment. [Срок оценки: 7 days]

Вторичные конечные точки (4)

• The evaluation of the PAD-test [Срок оценки: 3 moths and 6 months]
• Flowmetry values [Срок оценки: 3 months]
• Quality of life SF-12 questionnaire [Срок оценки: 3 moths and 6 months]
• Quality of life ICQ-SF questionnaire [Срок оценки: 3 moths and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 6 центров

• Hospital Universitario del Henares — Coslada
• Fundación Jiménez Díaz — Madrid
• Hospital Universitario Doce de Octubre — Madrid
• Hospital Universitario Rey Juan Carlos — Móstoles
• Hospital Universitario Infanta Elena — Valdemoro
• Hospital Universitario General de Villalba. — Villalba

Идентификаторы

NCT: NCT06738576 · SUITH · 2024-514833-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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