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

INTERVENTION: Product Name: PDH‐MSC‐TxP, Product Code:PRD11649306, Pharmaceutical Form: SUSPENSION FOR INJECTION, Other descriptive name: , Strength: CONDITION: Patients with lung transplant, 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. Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: To assess the safety of endobronchial administration of allogeneic MSCs in patients with BO. Primary end point(s): 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). Secondary Objective: To assess the efficacy of endobronchial administration of allogeneic MSCs in the BO progression. SECONDARY OUTCOME: Secondary end point(s):All‐cause mortality rate Secondary end point(s):CLAD progression, as defined by > 10% decline in FEV1 in two consecutive time‐points Secondary end point(s):Incidence of presence of specific antibodies against donor HLA. Secondary end point(s):Mean changes in FEV1 at 12‐month from baseline. Secondary end point(s):Mean changes in FVC from baseline to 12‐month Secondary end point(s):Mean changes in the mMRC Scale at 12‐month. Secondary end point(s):Proportion of patients progressing to grade 3 BO (as defined by a FEV1 below 50% from best value post‐transplant). Secondary end point(s):Proportion of patients requiring ambulatory oxygen therapy. Secondary end point(s):Proportion of patients with >10% decrease in FEV1 from baseline. Secondary end point(s):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. Secondary end point(s):Re‐transplant or CLAD‐related mortality rate. Secondary end point(s):Time to a >10% decrease in FEV1 from baseline. Secondary end point(s):Total hospitalization days during 12‐month follow‐up period. INCLUSION CRITERIA: Patients should have signed written informed consent., Adult patients =18 years of age at the time of enrolment, Patients recipients of a uni or bipulmonary transplant, 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.