AN OPEN LABEL, RANDOMISED, CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY OF ENDOBRONCHIAL ADMINISTRATION OF ALLOGENEIC MESENCHYMAL STROMAL CELLS IN PATIENTS WITH LUNG TRANSPLANT CHRONIC REJECTION: Study ENDOSC-CLAD

either unilateral or bilateral and an established diagnosis of BOS ≧ 0p (FEV1≤ 90% and / or FEF 25-75% ≤ of the baseline value with no other justifying cause) in the last 6 months., Patients with lung transplant

Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements., Incidence of adverse events of special interest since randomization: lower respiratory tract infections, acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy), BO worsening (as measured by >10% decline in FEV1 from baseline).

Mean changes in FEV1 at 12-month from baseline., Proportion of patients with >10% decrease in FEV1 from baseline., Time to a >10% decrease in FEV1 from baseline., Proportion of patients progressing to grade 3 BO (as defined by a FEV1 below 50% from best value post-transplant)., Mean changes in FVC from baseline to 12-month, All-cause mortality rate, Re-transplant or CLAD-related mortality rate., Rate of acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy) at any time during the 12-month follow up period., Incidence of presence of specific antibodies against donor HLA., CLAD progression, as defined by > 10% decline in FEV1 in two consecutive time-points, Mean changes in the mMRC Scale at 12-month., Total hospitalization days during 12-month follow-up period., Proportion of patients requiring ambulatory oxygen therapy.

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