The proposal is to join a Phase II clinical trial to test the feasibility and safety of a new therapeutic application based on the use of mesenchymal stem cells derived from adipose tissue (ASC) that is being made in various international hospitals.

Phase 1

• Conditions: rinary incontinence in women due to strain.; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2010-024331-16-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-12
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified