Discussion
malignancy
DISEASE, PULMONARY DISORDERS, ADVERSE EFFECTS, SECONDARY, PULMONARY EMPHYSEMA, PATHOLOGY, CHRONIC LUNG DISEASE
In the last decade, cell therapy and tissue engineering have gained great interest in many disease conditions where no effective and curative treatment options are available, and numerous research studies have explored the potential of cell therapy for the treatment of several entities. In the field of pulmonary disorders, cell therapy with MSCs offers a novel and promising option for various acute and chronic lung diseases due to its immunomodulatory capacity, tissue regeneration, bacterial clearance and proangiogenic and antifibrotic properties [Since the first isolation by Friedenstein et al. [Regarding the application of MSCs in injured lungs, in 2005 Rojas et al. [However, to date, no phase I/II clinical trials using MSCs embedded with a fibrin sealant have been conducted to prevent PAL after lung surgery in humans. In the current study, we include patients with high risk of post-operative PAL according to Brunelli’s score, but they were also high-risk patients according to their pathological diagnosis and preoperative comorbidities. Therefore, 5/6 patients included in the trial had a diagnosis of malignancy, which increased PAL incidence compared with benign pathology (OR: 1.45), and the two patients in whom MSCs were applied under compassionate use had diagnosis of pulmonary emphysema, which is also significantly associated with increased PAL risk (OR 2.35) [Main strengths of our study include that, firstly, it employs MSCs produced in a GMP facility and released according to the ISCT criteria and fulfilling the requirements of the corresponding regulatory agency (AEMPS) to test this ATM in humans. Secondly, our trial is a prospective study where autologous BM-derived MSCs were mixed with a commercially available polymeric sealant (Tissucol DuoOur study has some limitations. First, since the study was designed as a phase I/II trial, the number of patients included is low, although we consider that it is enough to prove the safety and feasibility of the procedure since no secondary adverse effects have been reported during the follow-up. Second, conclusions on efficacy of the procedure must be cautiously considered since the therapeutic effect of MSCs embedded in Tissucol Duo