Bronchopleural fistula
Conditions
Interventions
Product Name: Adipose Derived Stem cells
Product Code: eASC
Pharmaceutical Form: Implantation suspension
INN or Proposed INN: ADSC
Other descriptive name: EXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT S
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz (FIBHULP)
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and safety of ASC in the treatment of fistulas bronchopleural;Secondary Objective: Obtain preliminary data on the effectiveness and cost of the proposed treatment with mesenchymal stem cells. Secondary variables studied quality of life through quality of life questionnaires (SF-12);Primary end point(s): The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 3 and 6 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse clinical events during follow-up will be collected at the same times as the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse events attributed to study therapy. The primary endpoint last patient will be followed by the research team to 3 years;Timepoint(s) of evaluation of this end point: 3 and 6 months. The primary endpoint last patient will be followed by the research team to 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint: As part of the evaluation of the quality of life of patients and clinical assessment of treatment will be at 3 and 6 months after implantation a Test SF-12 quality of life.;Timepoint(s) of evaluation of this end point: 3-6 months | — |
Countries
Spain
Contacts
Public ContactAssignee. Dr. Mariano García Arranz
FIBHULP
Outcome results
None listed