Clinical Trial Phase I/II Prospective, Open Nonrandomized for Treatmen of Postoperative Air Leak After Lung Resection in High Risk Patients Through the Administration of Mesenchymal Autologous Cells

Study Overview
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Brief Summary
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The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded in vitro and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection.

Official Title
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CLINICAL TRIAL PHASE I / II, PROSPECTIVE, OPEN, NONRANDOMIZED, FOR TREATMENT OF POSTOPERATIVE AIR LEAK AFTER LUNG RESECTION IN HIGH RISK PATIENTS THROUGH THE ADMINISTRATION OF MESENCHYMAL AUTOLOGOUS CELLS.

Conditions
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Postoperative Air Leaks in Risk Patients

Intervention / Treatment
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* Biological: Implantation of autologous mesenchymal stem cells (CSM) expanded in vitro and administered directly into the lung suture line


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 70 years Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded) Patients class C or D on the risk scale of air leak Patients included in the study must meet all inclusion criteria. Exclusion Criteria: Patients with any of the following exclusion criteria may not be included in the clinical trial: Those considered by the investigator are not on a good position to tolerate the procedure Clinical criteria and anesthetics that contraindicate surgery Uncontrolled severe disease Pregnant women Patients infected with hepatitis B, hepatitis C, syphilis and HIV + virus People who are taking a drug under clinical investigation or participated in any study under clinical investigation (or an authorized product) within 30 days prior to randomization The absence of informed consent or revocation thereof

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged postoperative air leaks in risk patients.<br>Patients with prolonged postoperative air leaks | Biological: Implantation of autologous mesenchymal stem cells (CSM) expanded in vitro and administered directly into the lung suture line<br>* Patients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the procedure | Security is measured in terms of: Adverse effects derived from the implantation of the CSM | During the procedure and postoperative period (48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the efficacy of the procedure | Clinical: Duration of postoperative air leak Amount of leakage and trends measured by digital memory device Cardiorespiratory complications Radiological: Pneumothorax on chest radiograph. | Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative air leaks in risk patients.