Expression of concern: Clinical transplantation of a tissue-engineered airway

Abstract

The Lancet has received continuing questions over the reliability of the findings and conduct of this reported case,1Macchiarini P Jungebluth P Go T et al.Clinical transplantation of a tissue-engineered airway.Lancet. 2008; 372: 2023-2030Summary Full Text Full Text PDF PubMed Scopus (1198) Google Scholar since Paolo Macchiarini was found guilty of scientific misconduct in 2018.2The LancetThe final verdict on Paolo Macchiarini: guilty of misconduct.Lancet. 2018; 392: 2Google Scholar After an investigation by the head of the institution in Barcelona, Spain, where the patient was originally treated, we were told in 2018 that “upon reviewing all information and after verification of the original documents and records supporting the study, we concluded that there is not enough ground to ask The Lancet for retraction of the article”. We did, however, publish an update of this case from the institution in Barcelona in a letter in 2019 to alert our readers to the subsequent clinical course of the patient.3Molins L Patient follow-up after tissue-engineered airway transplantation.Lancet. 2019; 393: 1099Summary Full Text Full Text PDF PubMed Scopus (0) Google Scholar The Committee on Publication Ethics (COPE) has discussed these concerns at length again and their view, as an expert body in publication ethics, is that these two unretracted articles1Macchiarini P Jungebluth P Go T et al.Clinical transplantation of a tissue-engineered airway.Lancet. 2008; 372: 2023-2030Summary Full Text Full Text PDF PubMed Scopus (1198) Google Scholar, 4Gonfiotti A Jaus MO Barale D et al.The first tissue-engineered airway transplantation: 5-year follow-up results.Lancet. 2014; 383: 238-244Summary Full Text Full Text PDF PubMed Scopus (218) Google Scholar should, at a minimum, have received an Expression of Concern given the severity of the concerns raised and the length of time during which the concerns have persisted. As members of COPE, we are now following this advice and are issuing an Expression of Concern for these two Articles.1Macchiarini P Jungebluth P Go T et al.Clinical transplantation of a tissue-engineered airway.Lancet. 2008; 372: 2023-2030Summary Full Text Full Text PDF PubMed Scopus (1198) Google Scholar, 4Gonfiotti A Jaus MO Barale D et al.The first tissue-engineered airway transplantation: 5-year follow-up results.Lancet. 2014; 383: 238-244Summary Full Text Full Text PDF PubMed Scopus (218) Google Scholar, 5The Editors of The LancetExpression of concern: The first tissue-engineered airway transplantation: 5-year follow-up results.Lancet. 2023; (published online Feb 8.)https://doi.org/10.1016/S0140-6736(23)00292-1Google Scholar Expression of concern: The first tissue-engineered airway transplantation: 5-year follow-up resultsAs with the Expression of Concern1 for the original description of this case,2 given that continuing concerns have persisted over a long time, the Committee on Publication Ethics has also recommended that The Lancet issue an Expression of Concern for this Article.3 We are following this advice. Full-Text PDF Clinical transplantation of a tissue-engineered airwayThe results show that we can produce a cellular, tissue-engineered airway with mechanical properties that allow normal functioning, and which is free from the risks of rejection. The findings suggest that autologous cells combined with appropriate biomaterials might provide successful treatment for patients with serious clinical disorders. Full-Text PDF The first tissue-engineered airway transplantation: 5-year follow-up resultsThese clinical results provide evidence that a tissue-engineering strategy including decellularisation of a human trachea, autologous epithelial and stem-cell culture and differentiation, and cell-scaffold seeding with a bioreactor is safe and promising. Full-Text PDF