ocal treatment of bronchopleural fistula with adilts stem cells
- Conditions
- Bronchopleural fistulaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-000292-16-ES
- Lead Sponsor
- Fundación para la Investigación Biomédica del Hospital Universitario La Paz (FIBHULP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method