Suspended

HULPUROPhase 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

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What is being tested

Adipose-derived expanded stem cells

Drug
Who is being recruted

Urogenital Diseases+8

+ Female Urogenital Diseases and Pregnancy Complications

+ Signs and Symptoms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorInstituto de Investigación Hospital Universitario La Paz
Study ContactMariano García-Arranz, PhDMore contacts
Last updated: March 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01804153
Principal SponsorInstituto de Investigación Hospital Universitario La Paz
Study ContactMariano García-Arranz, PhDMore contacts
Last updated: March 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrinary Incontinence

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Adipose-derived expanded stem cells

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital Universitario La Paz

Madrid, SpainOpen Hospital Universitario La Paz in Google Maps
SuspendedOne Study Center