Clinical trial NCT01799694: Stem Cells Treatment for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery (HULPURO)
Official title: Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Stem Cells Use Derived From Adipose Tissue (e-ASC) for the Local Urinary Incontinence After a Radical Prostate Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Keywords: Urinary incontinence
Autologous expanded stem cells
Radical prostate cancer surgery
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of life assessment using the SF-12 Questionnaire
timeFrame: 1, 4, 16, 24 weeks
measure: Adverse events
timeFrame: 1, 4, 16, 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz
name: Sergio Alonso Gregorio, MD
role: PRINCIPAL_INVESTIGATOR
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