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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Male

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

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

Details

• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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