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

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Inject of Autologous Adipose-derived stem cells

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary incontinence, Autologous expanded stem cells, Radical prostate cancer surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Having had an adjuvant treatment
Having a PSA ≥ 0,2 after surgery
Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma
Active urine infection
Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
Cardiopulmonary illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study
Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study
Subjects with congenital or acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
Anesthetic allergy
Major surgery or severe trauma in the previous 6 months
Administration of any drug under experimentation in the present or in the previous 3 months before recruitment

Sites / Locations

Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Expanded Stem Cells

Arm Description

Inject of Autologous Adipose-derived expanded stem cells

Outcomes

Primary Outcome Measures

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

Possibility of inject ASc by cystoscope

Secondary Outcome Measures

Quality of life assessment using the SF-12 Questionnaire

SF-12 questionnaire

Adverse events

Data collected

Full Information

NCT ID

NCT01799694

First Posted

September 4, 2012

Last Updated

March 7, 2013

Sponsor

Instituto de Investigación Hospital Universitario La Paz

1. Study Identification

Unique Protocol Identification Number

NCT01799694

Brief Title

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

Acronym

FLPURO

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

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

Keywords

Urinary incontinence, Autologous expanded stem cells, Radical prostate cancer surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous Expanded Stem Cells

Arm Type

Experimental

Arm Description

Inject of Autologous Adipose-derived expanded stem cells

Intervention Type

Drug

Intervention Name(s)

Inject of Autologous Adipose-derived stem cells

Other Intervention Name(s)

Autologuos eASC

Intervention Description

Inject in muscle of autologous adipose derived stem cells

Primary Outcome Measure Information:

Title

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

Description

Possibility of inject ASc by cystoscope

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Quality of life assessment using the SF-12 Questionnaire

Description

SF-12 questionnaire

Time Frame

1, 4, 16, 24 weeks

Title

Adverse events

Description

Data collected

Time Frame

1, 4, 16, 24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent Men over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination Prostate cancer diagnosed subjects via a biopsy and having had a radical surgery with a healing purpose in the previous 18 months Having urinary incontinence after the surgery Failure in any previous conservative treatment Exclusion Criteria: Having had an adjuvant treatment Having a PSA ≥ 0,2 after surgery Having any sign or symptom that suggest the investigator the non-healing of the adenocarcinoma Active urine infection Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion Cardiopulmonary illness that, in the investigator opinion, could be unstable or could be serious enough to drop the patient from the study Any kind of medical or psychiatric illness that, in the investigator opinion, could be a reason to exclude the patient from the study Subjects with congenital or acquired immunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion Anesthetic allergy Major surgery or severe trauma in the previous 6 months Administration of any drug under experimentation in the present or in the previous 3 months before recruitment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sergio Alonso Gregorio, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

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

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