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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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 sphincter that will coincide with the 3 o'clock and 9 o'clock position of the hands of a clock). The injection will be superficial, trying not to go deeper than 2 mm to create a wheal in each injection visible endoscopically. 5. \- Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste.
Placebo implantation is carried out in the same way as the drug implantation
Hospital Universitario del Henares
Coslada, Madrid, Spain
RECRUITINGFundación Jiménez Díaz
Madrid, Madrid, Spain
RECRUITINGHospital Universitario Doce de Octubre
Madrid, Madrid, Spain
Proportion of patients with at least one of the complictations derived from the treatment.
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
Time frame: 7 days
The evaluation of the PAD-test
quantification of the amount of urine lost during the duration of the test (24h),
Time frame: 3 moths and 6 months
Flowmetry values
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
Time frame: 3 months
Quality of life SF-12 questionnaire
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
Time frame: 3 moths and 6 months
Quality of life ICQ-SF questionnaire
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.
Time frame: 3 moths and 6 months
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Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
RECRUITINGHospital Universitario Infanta Elena
Valdemoro, Madrid, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario General de Villalba.
Villalba, Madrid, Spain
RECRUITING