Study population
lung cancer, human immunodeficiency virus (HIV) or syphilis, hepatitis C, cardiovascular disease
HEPATITIS B, VIRUS, SYSTEMIC DISEASE, CARDIOVASCULAR DISEASE, LUNG CANCER, HEPATITIS C, PULMONARY EMPHYSEMA
Before surgery, all the patients diagnosed with lung cancer or with a suspicious pulmonary nodule were studied through an extensive work-up, which included physical examination, haematological and biochemical tests, electrocardiogram, computed tomography scan (CT) of the chest as well as abdomen, positron emission tomography (PET) scan and bronchoscopy. Further investigations were performed only if deemed necessary according to clinical findings or abnormal laboratory results. Patients with a previous history of cardiovascular disease or any suspicious changes in the electrocardiogram were referred for assessment by a cardiologist. Pulmonary function tests were performed in all patients. For this study, we reviewed only forced expiratory volume in the first second in per cent values (FEV1%) according to the patient’s age, gender and height.PAL risk was assessed preoperatively according to the PAL score proposed by Brunelli [Inclusion criteria in the trial were capacity to consent, age between 18 and 70 years old, patients planned to undergo anatomical lung resection (excluding pneumonectomy) and PAL score grade C or D.Exclusion criteria included insufficient fitness to tolerate the surgical intervention, clinical or anaesthetic contraindication for surgery (American Society of Anaesthesiologist (ASA) score IV or V), presence of severe non-controlled systemic disease, pregnancy, positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis and absence or revocation of informed consent (Table Inclusion and exclusion criteriaStudy population also comprised a patient cohort treated with MSCs after lung resection under compassionate use, outside of the clinical trial but with the same criteria. This cohort consisted of a high-risk cases of PAL who required a lung volume reduction surgery due to pulmonary emphysema. All of them signed a specific informed consent.Since the study was designed as a phase I/II trial, a sample size (safety run-in cohort) of 6 to 12 subjects was estimated.