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• W2000692458 abstract "We appreciate the comments about our phase 1 trial1Wilson JG Liu KD Zhuo H et al.Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial.Lancet Respir Med. 2015; 3: 24-32Summary Full Text Full Text PDF Scopus (519) Google Scholar of mesenchymal stem cells (MSCs) for the treatment of the acute respiratory distress syndrome. We would like to respond to each of the questions and concerns raised in their correspondence. We completely agree with Guo-You Zhang and colleagues that it is impossible to reach any conclusions about efficacy or long-term safety on the basis of a small trial with a short follow-up and no control group. Most phase 1 trials do not include a randomly assigned control group because the main objective is to establish a dose level that seems safe and reasonable to guide subsequent trials. As we stated in the discussion section of our Article, we can only report that the intravenous infusion of MSCs was well tolerated by all nine patients in each of the three dosing cohorts and no short-term safety issues were identified at 6 month follow-up. Any conclusions about efficacy in the treatment of acute respiratory distress syndrome or about safety beyond 6 months would not be warranted. We also appreciate the opportunity to clarify the screening criteria for MSC donors. Donors were 18–45 years old. They completed an extensive medical health questionnaire, in addition to a physical examination and laboratory testing, before donation. Their eligibility as donors was established according to Food and Drug Administration regulations. Infectious disease testing includes assays for HIV, hepatitis B virus, hepatitis C virus, human T-lymphotropic virus I/II, cytomegalovirus, West Nile virus, and syphilis, which is the standard approach used for blood and marrow donors in the USA. The intravenous route of administration was chosen because our pre-clinical studies indicated no difference in efficacy between the intratracheal and intravenous routes of administration.2Lee JW Krasnodembskaya A McKenna DH Song Y Abbott J Matthay MA Therapeutic effects of human mesenchymal stem cells in ex vivo human lungs injured with live bacteria.Am J Respir Crit Care Med. 2013; 187: 751-760Crossref PubMed Scopus (270) Google Scholar Moreover, intratracheal administration of mesenchymal stem cells in critically ill adults with hypoxaemic respiratory failure would potentially pose substantial logistical challenges, including the difficulty of distribution of the therapy to all lung regions. Zhang and colleagues have also raised an interesting question about endogenous and exogenous MSCs. At present, no suitable way to study this interesting question exists. We are currently working to develop assays to test markers of MSC activity in the serum and mini-bronchoalveolar lavage fluid of patients enrolled in the phase 2, randomised, double-blind portion of our trial. By testing these biomarkers in both the group that received placebo and the group that received MSCs, we might be able to establish some of the biological effects of MSC therapy. With regard to the final question from Zhang and colleagues about the tumorigenic potential of MSCs, no cases of tumorigenic transformation occurred in our phase 1 study, and none have been reported in any of the other trials testing MSCs for other indications (in several thousand patients). Although Røsland and colleagues3Røsland GV Svendsen A Torsvik A et al.Long-term cultures of bone marrow–derived human mesenchymal stem cells frequently undergo spontaneous malignant transformation.Cancer Res. 2009; 69: 5331-5339Crossref PubMed Scopus (518) Google Scholar have reported malignant transformation in long-term cultures of bone marrow-derived human MSCs, these cells were cultured in vitro for up to 105 weeks, which is not in keeping with how the MSCs were prepared for our trial. In our trial,1Wilson JG Liu KD Zhuo H et al.Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial.Lancet Respir Med. 2015; 3: 24-32Summary Full Text Full Text PDF Scopus (519) Google Scholar MSCs were cultured in vitro for 3–4 weeks. Additionally, MSCs were tested by Giemsa banding before cryopreservation. No tumours were detected in patients in our study at 6 months follow-up, nor in the 1-year follow-up we have completed thus far. In addition to the excellent questions raised by Zhang and colleagues, we were pleased to receive Olle Ringdén's correspondence about his experience using MSCs in patients with leukaemia on a compassionate basis. We did not note any evidence of invasive fungal infection in patients who received MSCs in our study; however, patients with ongoing or recent active malignancy were excluded from this trial and baseline risk of invasive fungal infection might be lower in our study population. With regard to the development of anti-HLA antibodies, this would be more of a concern for patients that had received multiple infusions, or with previous exposure through pregnancy or blood transfusions. As Ringdén mentioned, anti-HLA antibodies have not been detected in patients who received MSCs after allogeneic haematopoietic stem cell transplant. Nevertheless, we do know the HLA typing of the MSC donors in this trial and will explore the possibility of testing a convenience sample of phase 2 patients for development of anti-HLA antibodies. Thank you again to Ringdén and Zhang and colleagues for their thoughtful comments and questions. The authors competing interests remain the same as those declared in the original Article. Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trialA single intravenous infusion of allogeneic, bone marrow-derived human MSCs was well tolerated in nine patients with moderate to severe ARDS. Based on this phase 1 experience, we have proceeded to phase 2 testing of MSCs for moderate to severe ARDS with a primary focus on safety and secondary outcomes including respiratory, systemic, and biological endpoints. Full-Text PDF Mesenchymal stem (stromal) cells for treatment of acute respiratory distress syndromeIn their Article, Jennifer Wilson and colleagues1 investigated the use of allogeneic mesenchymal stem (stromal) cells (MSCs) in a pilot study of nine patients with acute respiratory distress syndrome. No cure for acute lung injury or acute respiratory distress syndrome exists, and MSCs hold some promise. Wilson and colleagues reported none of the prespecified adverse events from receiving allogeneic MSCs, including hypoxaemia, cardiac arrhythmia, and ventricular tachycardia.1 In a meta-analysis of more than 1000 patients who were treated for various disorders, such as graft-versus-host disease,2 side-effects of allogeneic MSCs were uncommon and were limited to transient fever. Full-Text PDF Mesenchymal stem (stromal) cells for treatment of acute respiratory distress syndromeWe read with great interest the Article by Jennifer Wilson and colleagues.1 In this phase 1 clinical trial, Wilson and colleagues analysed the safety of a single dose of allogeneic bone marrow-derived mesenchymal stem (stromal) cells (MSCs) in patients with acute respiratory distress syndrome. The authors reported that a single intravenous infusion of allogeneic bone marrow-derived human MSCs was well tolerated in nine patients with moderate-to-severe acute respiratory distress syndrome. However, although findings from this study strongly support the use of MSCs in acute respiratory distress syndrome, we have a few concerns about the interpretation of the results. Full-Text PDF" @default.
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• W2000692458 title "Mesenchymal stem (stromal) cells for treatment of acute respiratory distress syndrome – Authors' reply" @default.
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