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Clinical Trials/EUCTR2012-000292-16-ES
EUCTR2012-000292-16-ES
Active, not recruiting
Not Applicable

Phase IIa clinical trial to test the feasibility and safety of using autologous mesenchymal stem cells from fat in the local treatment of bronchopleural fistula - HULPTOR

Fundación para la Investigación Biomédica del Hospital Universitario La Paz (FIBHULP)0 sitesApril 9, 2013
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DrugsFibrin Sealant Kit

Overview

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

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 9, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundación para la Investigación Biomédica del Hospital Universitario La Paz (FIBHULP)

Eligibility Criteria

Inclusion Criteria

  • •1\. Being over 18 years
  • •2 Having accessible bronchopleural fistula pathology endoscopic approach.
  • •3\. Prior control of the fistula with the usual techniques ((pleural drainage, infection control, open thoracostomy and / or endotracheal prosthesis\-bronchial)
  • •4\. Fistula refracted to conventional medical or surgical treatment.
  • •5\. Have signed the informed consent
  • •6\. Negative pregnancy test and acceptance of the use of highly effective contraceptive methods if applicable.
  • •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 8

Exclusion Criteria

  • •1\. Mental retardation incapacitating signing the informed consent.
  • •2\. Urgency in treatment.
  • •3\. Pleural cavity with uncontrolled infection.
  • •4\. Extreme malnutrition (BMI \<18\.5 kg/m2\) who advise against liposuction.
  • •5\. Presence of uncontrolled malignancy or progression phase.
  • •6\. Inability to tolerate the anesthetic and / or bronchoscopic implant required for ASC.
  • •7\. Administration of any investigational drug at present to three months prior to enrollment for this trial.
  • •8\. Infants and pregnant women.
  • •9\. Adult women of childbearing age not using effective contraception as ICH guidance M3 EMA during the test.

Outcomes

Primary Outcomes

Not specified

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