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Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) (HULPURO)

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Adipose-derived expanded stem cells
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Feminine stress urinary incontinence, Autologous expanded stem cells

Eligibility Criteria

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

Inclusion Criteria:

  1. -Signed informed consen
  2. -Good general state of health according to the findings of ythe clinical history and the physical examination
  3. -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide
  4. -Women having rejected de rehabilitation treatment or in which the treatment had failed
  5. -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution

Exclusion Criteria:

  1. -Pregnant or lactating women
  2. -Active urine infection
  3. -Presenting an infravesical obstruction
  4. -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion
  5. -Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years
  6. -Cardiopulmonar 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 aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion
  9. -Anesthesic allergy
  10. -Major surgery or severe trauma in the previous 6 months
  11. -Administration of any drug under experimentation in the present or 3 months before recruitement

Sites / Locations

  • Hospital Universitario La PazRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous expanded stem cells

Arm Description

Adipose-derived expanded stem cells

Outcomes

Primary Outcome Measures

Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence
compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra)

Secondary Outcome Measures

Quality of life assessment using the SF-12 Questionnaire
SF-12 questionnaire
Adverse events
Data collection

Full Information

First Posted
September 4, 2012
Last Updated
March 1, 2013
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT01804153
Brief Title
Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)
Acronym
HULPURO
Official Title
Phase II Clinical Trial to Study the Feasibility and Safety of the Expanded Autologous Mesenchymal Stem Cells Use Derived From Adipose Tissue (ASC) for the Local Feminine Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

5. Study Description

Brief Summary
Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence
Detailed Description
Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Feminine stress urinary incontinence, Autologous expanded stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous expanded stem cells
Arm Type
Experimental
Arm Description
Adipose-derived expanded stem cells
Intervention Type
Drug
Intervention Name(s)
Adipose-derived expanded stem cells
Intervention Description
Intralesional application ASC
Primary Outcome Measure Information:
Title
Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence
Description
compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra)
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 collection
Time Frame
1, 4, 16, 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Signed informed consen -Good general state of health according to the findings of ythe clinical history and the physical examination -Postmenopausal or over 18 years old women taking highly effective contraceptives following the ICH (M3) EMA guide -Women having rejected de rehabilitation treatment or in which the treatment had failed -Genuine or combined stress urinary incontinence diagnosed with at least 1 year of evolution Exclusion Criteria: -Pregnant or lactating women -Active urine infection -Presenting an infravesical obstruction -Alcohol or other addictive substances abuse antecedents in the previous 6 months to the inclusion -Presenting any other malignant neoplasia unless it is a basocellar or a skin epidermoide carcinoma or presents antecedents of malignant tumours, unless they are in a remission phase for the previous 5 years -Cardiopulmonar 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 aquired inmunodeficiencies, B and/or C Hepatitis, Tuberculose or Treponema diagnosed at the moment of inclusion -Anesthesic allergy -Major surgery or severe trauma in the previous 6 months -Administration of any drug under experimentation in the present or 3 months before recruitement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariano García-Arranz, PhD
Phone
0034 912071022
Email
mgarciaa.hulp@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Alonso Gregorio, MD
Phone
0034 912071022
Email
garavelos@terra.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Alonso Gregorio, MD
Organizational Affiliation
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano García-Arranz, PhD
Phone
0034 912071022
Email
mgarciaa.hulp@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Sergio Alonso Gregorio, MD
First Name & Middle Initial & Last Name & Degree
Mariano García-Arranz, MD
First Name & Middle Initial & Last Name & Degree
Damián García Olmo, MD
First Name & Middle Initial & Last Name & Degree
Fernando de Miguel Pedrero, MD

12. IPD Sharing Statement

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Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)

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