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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Urinary Incontinence

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the feasibility and security of the autologous e-ASC for the urinary incontinence after a radical prostate cancer surgery

Outcome Description:

Possibility of inject ASc by cystoscope

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Sergio Alonso Gregorio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz

Authority:

Spain: Spanish Agency of Medicines

Study ID:

FLPURO-2009-01

NCT ID:

NCT01799694

Start Date:

July 2011

Completion Date:

February 2013

Related Keywords:

  • Urinary Incontinence
  • Urinary incontinence
  • Autologous expanded stem cells
  • Radical prostate cancer surgery
  • Prostatic Neoplasms
  • Urinary Incontinence

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