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

March 1, 2013 updated by: Instituto de Investigación Hospital Universitario La Paz

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

Evaluate the feasability and security of the autologous ASC for the femenine stress urinary incontinence

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Evaluate safety of adipose derived stem cells to femenine urinary incontinence with local application

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Sergio Alonso Gregorio, MD
        • Sub-Investigator:
          • Damián García Olmo, MD
        • Sub-Investigator:
          • Fernando de Miguel Pedrero, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Autologous expanded stem cells
Adipose-derived expanded stem cells
Drug: Adipose-derived expanded stem cells
Intralesional application ASC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasability and security of the autologous ASC for the feminine stress urinary incontinence
Time Frame: 16 weeks
compress test (number dthe changes daily) urethrocystoscopy (morphology of urethra)
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment using the SF-12 Questionnaire
Time Frame: 1, 4, 16, 24 weeks
SF-12 questionnaire
1, 4, 16, 24 weeks
Adverse events
Time Frame: 1, 4, 16, 24 weeks
Data collection
1, 4, 16, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Investigators

  • Principal Investigator: Sergio Alonso Gregorio, MD, Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

March 1, 2013

First Posted (ESTIMATE)

March 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULPURO-2010-01
  • 2010-024331-16 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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