Status:
UNKNOWN
Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence
Detailed Description
Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application
Eligibility Criteria
Inclusion
- -Signed informed consen
- -Good general state of health according to the findings of ythe clinical history and the physical examination
- -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide
- -Women having rejected de rehabilitation treatment or in which the treatment had failed
- -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution
Exclusion
- -Pregnant or lactating women
- -Active urine infection
- -Presenting an infravesical obstruction
- -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
- -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
- -Cardiopulmonar illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study
- -Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
- -Subjects with congenital or aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
- -Anesthesic allergy
- -Major surgery or severe trauma in the previous 6 months
- -Administration of any drug under experimentation in the present or 3 months before recruitement
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01804153
Start Date
September 1 2012
End Date
April 1 2014
Last Update
March 5 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046