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Clinical Trials/EUCTR2010-024331-16-ES
EUCTR2010-024331-16-ES
Active, not recruiting
Phase 1

Clinical trial phase II to determine the feasibility and safety of using autologous mesenchymal stem cells derived from autologous expanded adipose tissue (ASC) in the local treatment of female urinary incontinence due to strain - HULPURO-2010-01

Fundación para la Investigación Biomédica del Hospital Universitario La Paz0 sitesDecember 12, 2011
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 12, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Fundación para la Investigación Biomédica del Hospital Universitario La Paz

Eligibility Criteria

Inclusion Criteria

  • •Signature of informed consent.
  • •Women over 18 years with good general status, according to data from the clinical history and physical examination.
  • •Women in postmenopausal age or older than 18 who take highly effective contraceptives as ICH guidance (M3\) of the EMA indicates.
  • •Women who have failed rehabilitation treatment or patients who refuse to submit to rehabilitation.
  • •Women diagnosed with genuine urinary incontinence due to strain or strain predominant mixed with at least 1 year of evolution.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •\- Pregnant or breast\-feeding women.
  • •\- Present infravesical obstruction (will be discarded by urethrocystoscopy and flowmetry).
  • •\- Active urine infection.
  • •\- A history of alcohol abuse or other addictive substances in the 6 months prior to inclusion.
  • •\- Present any malignancy, except in the case of basocellular carcinoma or epidermoid of skin, or have a history of malignancy, unless they have been found in remission during the previous 5 years.
  • •\- Cardiopulmonary disease that, in the opinion of the investigator, is unstable or is sufficiently serious to dismiss the patient from the study.
  • •\- Medical or psychiatric illness of any kind that, according to the investigator, may be a reason for exclusion from the study.
  • •\- Subjects with congenital or acquired immunodeficiency, Hepatitis B and / or C, tuberculosis or Treponema diagnosed at the time of inclusion.
  • •\- Allergy subject to anesthetics.
  • •\- Major surgery or major trauma of the subject in the previous semester.

Outcomes

Primary Outcomes

Not specified

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