Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: allogeneic mesenchymal stem cells, Placebo.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence Stress. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Drug 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 - Drug Placebo
Placebo implantation is carried out in the same way as the drug implantation
Primary outcome measures
- Proportion of patients with at least one of the complictations derived from the treatment. [Time frame: 7 days]
Secondary outcome measures (4)
- The evaluation of the PAD-test [Time frame: 3 moths and 6 months]
- Flowmetry values [Time frame: 3 months]
- Quality of life SF-12 questionnaire [Time frame: 3 moths and 6 months]
- Quality of life ICQ-SF questionnaire [Time frame: 3 moths and 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 6 centers
- 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
Identifiers
NCT: NCT06738576 · SUITH · 2024-514833-39-00