Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO) (FLPURO)

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence

Treatments: Drug: Inject of Autologous Adipose-derived stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01799694

2009-016298-14 (EudraCT Number)

FLPURO-2009-01

Details and patient eligibility

About

The purpose of this study is to evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
2. Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
3. Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months
4. Having urinary incontinence after the surgery
5. Failure in any previous conservative treatment

Exclusion criteria

1. Having had an adjuvant treatment
2. Having a PSA ≥ 0,2 after surgery
3. Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma
4. Active urine infection
5. Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
6. Cardiopulmonary 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 acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
9. Anesthetic allergy
10. Major surgery or severe trauma in the previous 6 months
11. Administration of any drug under experimentation in the present or in the previous 3 months before recruitment

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:

Inject of Autologous Adipose-derived expanded stem cells

Treatment:

Drug: Inject of Autologous Adipose-derived stem cells