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

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Urinary Incontinence

Treatments: Drug: Adipose-derived expanded stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01804153

2010-024331-16 (EudraCT Number)

HULPURO-2010-01

Details and patient eligibility

About

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

Full description

Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Autologous expanded stem cells

Experimental group

Description:

Adipose-derived expanded stem cells

Treatment:

Drug: Adipose-derived expanded stem cells