Urinary incontinence in women due to strain.
Conditions
Interventions
Product Name: Células troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Células troncales mesenquimales au
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signature of informed consent. • Women over 18 years with good general status, according to data from the clinical history and physical examination. • Women in postmenopausal age or older than 18 who take highly effective contraceptives as ICH guidance (M3) of the EMA indicates. • Women who have failed rehabilitation treatment or patients who refuse to submit to rehabilitation. • Women diagnosed with genuine urinary incontinence due to strain or strain predominant mixed with at least 1 year of evolution. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or breast-feeding women. - Present infravesical obstruction (will be discarded by urethrocystoscopy and flowmetry). - Active urine infection. - A history of alcohol abuse or other addictive substances in the 6 months prior to inclusion. - Present any malignancy, except in the case of basocellular carcinoma or epidermoid of skin, or have a history of malignancy, unless they have been found in remission during the previous 5 years. - Cardiopulmonary disease that, in the opinion of the investigator, is unstable or is sufficiently serious to dismiss the patient from the study. - Medical or psychiatric illness of any kind that, according to the investigator, may be a reason for exclusion from the study. - Subjects with congenital or acquired immunodeficiency, Hepatitis B and / or C, tuberculosis or Treponema diagnosed at the time of inclusion. - Allergy subject to anesthetics. - Major surgery or major trauma of the subject in the previous semester. - Administration of any investigational drug at the present time or three months prior to recruitment for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety of ASC to treat urinary incontinence in women due to strain.;Secondary Objective: Obtain some facts about the improved quality of life of treated patients measured with SF-36 test. Obtain some data security preliminales long term (1 year) of the proposed treatment that allows us to design in future clinical trials with a larger number of patients with the same pathology.;Primary end point(s): The primary outcome feasibility and safety study will be performed once the patient has received treatment. To assess the feasibility of the treatment will include a unit in the Data Collection Booklet (CRD), so that the surgical team or cell producer expose the complications that have been around for cell isolation or during surgery (cell implantation). The safety variable is measured at 12 weeks of implant and follow-up year. We define that the process is safe when development and monitoring of the trial has not produced any adverse event that may relate to the proposed therapy in the trial. All clinical adverse events during follow-up will be collected at the same times that the clinical evaluation. The cumulative incidence of adverse effects attributed to therapy in the study will be evaluated as main objective.;Timepoint(s) of evaluation of this end point: at 12 weeks of implant and follow-up year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As part of the evaluation of treatment success will be a clinical examination at 12 weeks after implantation, considering successful treatment when involuntary loss of urine decreases. As part of the evaluation of recurrence will be done a clinical analysis of patients one year later of the cells implant. Both studies will be conducted by clinical investigators of the trial, if there is no agreement in the diagnosis, an urologist from outside of the study will be consulted.;Timepoint(s) of evaluation of this end point: at 12 weeks of implant and follow-up year | — |
Countries
Spain
Contacts
Public ContactUnidad de Terapia Celular
Fundación para la Investigación Biomédica del Hospital
Outcome results
None listed