Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Criteria

Inclusion Criteria:

1. -Signed informed consen

2. -Good general state of health according to the findings of ythe clinical history and the physical examination

3. -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide

4. -Women having rejected de rehabilitation treatment or in which the treatment had failed

5. -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution

Exclusion Criteria:

1. -Pregnant or lactating women

2. -Active urine infection

3. -Presenting an infravesical obstruction

4. -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion

5. -Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years

6. -Cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study

7. -Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study

8. -Subjects with congenital or aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion

9. -Anesthesic allergy

10. -Major surgery or severe trauma in the previous 6 months

11. -Administration of any drug under experimentation in the present or 3 months before recruitement