@article {Campo00773-2020, author = {Arantza Campo and Jos{\'e} Mar{\'\i}a Gonz{\'a}lez-Ruiz and Enrique Andreu and Ana B. Alcaide and Mar{\'\i}a M. Oc{\'o}n and Juan De-Torres and Jes{\'u}s Pueyo and Rosa Cordovilla and Eva Villaron and Ferm{\'\i}n Sanchez-Guijo and Miguel Barrueco and Jorge Nu{\~n}ez-C{\'o}rdoba and Felipe Pr{\'o}sper and Javier J. Zulueta}, title = {Endobronchial autologous bone marrow-mesenchymal stromal cells in idiopathic pulmonary fibrosis (phase I)}, elocation-id = {00773-2020}, year = {2021}, doi = {10.1183/23120541.00773-2020}, publisher = {European Respiratory Society}, abstract = {Rationale Idiopathic pulmonary fibrosis (IPF) has a dismal prognosis. Mesenchymal stromal cells have shown benefit in other inflammatory diseases.Objectives Evaluate the safety and feasibility of endobronchial administration of bone marrow autologous MSCs (BM-MSC) in patients with mild-to-moderate IPF.Methods A phase-I multicenter clinical Trial (ClinicalTrials.gov:NCT01919827) with a single endobronchial administration of autologous adult BM-MSC in patients diagnosed with mild-to-moderate IPF. In a first escalating-dose phase, 3 patients will be included sequentially in 3 dose cohorts (10{\texttimes}10^6, 50{\texttimes}10^6, and 100{\texttimes}10^6 cells). In a second phase, 9 patients will receive the highest tolerated dose. Follow-up with PFT, 6MWT, and SGRQ were done at 1, 2, 3, 6, and 12 months, and with a computed tomography at 3, 6, and 12 months.Findings Twenty-one bone marrow samples were obtained from 17 patients. Three patients were excluded for treatment due to chromosome aberrations detected in MSCs after culture, and one patient died before treatment. Finally, 13 patients received the BM-MSCs infusion. No treatment related severe adverse events were observed during follow-up. Compared to baseline, the mean FVC showed an initial decline of 8.1\% at three months. The number of patients without functional progression was 6 (46\%) at 3 months and 3 (23\%) at 12 months.Conclusions The endobronchial infusion of BM-MSCs did not cause immediate serious adverse events in IPF patients, but a relevant proportion of patients suffered clinical and/or functional progression. Genomic instability of BM-MSCs during culture found in three patients may be troublesome for the use of autologous MSCs in IPF patients.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: Dr. Campo has nothing to disclose.Conflict of interest: Dr. Gonzalez-ruiz has nothing to disclose.Conflict of interest: Dr. Andreu has nothing to disclose.Conflict of interest: Dr. Alcaide Oca{\~n}a has nothing to disclose.Conflict of interest: Dr. Oc{\'o}n has nothing to disclose.Conflict of interest: Dr. de Torres has nothing to disclose.Conflict of interest: Dr. Pueyo has nothing to disclose.Conflict of interest: Dr. Cordovilla has nothing to disclose.Conflict of interest: Dr. Villaron has nothing to disclose.Conflict of interest: F. Sanchez-Guijo reports lecturing and consulting honoraria, and research support from Novartis; lecturing and consulting honoraria from BMS, Pfizer, Incyte and Gilead; and lecturing honoraria from Roche and Amgen, all outside the submitted work.Conflict of interest: Dr. Barrueco Ferrero has nothing to disclose.Conflict of interest: Dr. Nu{\~n}ez-Cordoba has nothing to disclose.Conflict of interest: Dr. Prosper has nothing to disclose.Conflict of interest: Dr. Zulueta has nothing to disclose.}, URL = {https://openres.ersjournals.com/content/early/2021/03/18/23120541.00773-2020}, eprint = {https://openres.ersjournals.com/content/early/2021/03/18/23120541.00773-2020.full.pdf}, journal = {ERJ Open Research} }