Autologous Infusion of Bone Marrow and Mesenchymal Stromal Cells in Patients with Chronic Obstructive Pulmonary Disease: Phase I Randomized Clinical Trial

References

• Global Initiative for Chronic Obstructive Lung Disease. Global initiat chronic obstr lung disease; (2020 report); 2020. Available from: http://www.goldcopd.org/. Accessed November 2, 2021.
   Google Scholar
• Stessuk T, Ruiz MA, Greco OT, et al. Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years. Rev Bras Hematol Hemoter. 2013;35(5):352–357. doi:10.5581/1516-8484.20130113
   PubMedGoogle Scholar
• Labaki WW, Han MLK. Chronic respiratory diseases: a global view. Lancet Respir Med. 2020;8(6):531–533. doi:10.1016/S2213-2600(20)30157-0
   PubMed Web of Science ®Google Scholar
• World Health Organization. The top 10 causes of death; 2021. Available form: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death. Accessed November 2, 2021.
   Google Scholar
• Caramori G, Casolari P, Garofano E, et al. Role of Stem Cells in the Pathogenesis of COPD and Pulmonary Emphysema. Recenti Prog Med. 2012;103(1):31–40. doi:10.1701/1022.11157
   PubMedGoogle Scholar
• de Faria CA, de Las Heras Kozma R, Stessuk T, et al. Experimental Basis and New Insights for Cell Therapy in Chronic Obstructive Pulmonary Disease. Stem Cell Rev Rep. 2012;8(4):1236–1244. doi:10.1007/s12015-012-9410-7
   PubMed Web of Science ®Google Scholar
• Ribeiro-Paes JT, Stessuk T, Kozma RLH. Cell Therapy in chronic Obstructiv Pulmonary Disease: state of The Art and Perspectives. In: Chungong K, editor. Chronic Obstructive Pulmonary Disease- Current Concepts and Practice. Tech, Rijeka; 2012:455–474.
   Google Scholar
• Longhini-dos-Santos N, Barbosa-Oliveira VA, Kozma RH, et al. Cell Therapy with Bone Marrow Mononuclear Cells in Elastase-Induced pulmonary Emphysema. Stem Cell Rev Rep. 2013;9(2):210–218. doi:10.1007/s12015-012-9419-y
   PubMed Web of Science ®Google Scholar
• Tzouvelekis A, Ntolios P, Bouros D. Stem cell treatment for chronic lung diseases. Respiration. 2013;85:179–192. doi:10.1159/000346525
   PubMed Web of Science ®Google Scholar
• Conese M, Piro D, Carbone A, et al. Hematopoietic and mesenchymal stem cells for the treatment of chronic respiratory diseases: role of plasticity and heterogeneity. Sci World J. 2014;2014:1–11. doi:10.1155/2014/859817
   Web of Science ®Google Scholar
• Lipsi R, Rogliani P, Calzetta L, et al. The clinical use of regenerative therapy in COPD. Int J COPD. 2014;9:1389–1396. doi:10.2147/COPD.S49519
   Google Scholar
• De Francesco F, Ricci G, D’Andrea F, et al. Human Adipose Stem Cells: from Bench to Bedside. Tissue Eng Part B Rev. 2015;21(6):572–584. doi:10.1089/ten.TEB.2014.0608
   PubMed Web of Science ®Google Scholar
• Liu X, Fang Q, Kim H. Preclinical studies of mesenchymal stem cell (MSC) administration in chronic obstructive pulmonary disease (COPD): a systematic review and meta-analysis. PLoS One. 2016;11(6):e0157099. doi:10.1371/journal.pone.0157099
   PubMed Web of Science ®Google Scholar
• Cheng SL, Lin CH, Yao CL. Mesenchymal Stem Cell Administration in Patients with Chronic Obstructive Pulmonary Disease: state of the Science. Stem Cells Int. 2017;2017:1–14. doi:10.1155/2017/8916570
   Web of Science ®Google Scholar
• Broekman W, Khedoe PPSJ, Schepers K, et al. Mesenchymal stromal cells: a novel therapy for the treatment of chronic obstructive pulmonary disease? Thorax. 2018;73(6):565–574. doi:10.1136/thoraxjnl-2017-210672
   PubMed Web of Science ®Google Scholar
• Kruk DMLW, Heijink IH, Slebos DJ, et al. Mesenchymal Stromal Cells to Regenerate Emphysema: on the Horizon? Respiration. 2018;96(2):148–158. doi:10.1159/000488149
   PubMed Web of Science ®Google Scholar
• Kokturk N, Yıldırım F, Gülhan PY, et al. Stem cell therapy in chronic obstructive pulmonary disease. How far is it to the clinic? Am J Stem Cells. 2018;7(3):56–71.
   PubMed Web of Science ®Google Scholar
• Sun Z, Li F, Zhou X, et al. Stem cell therapies for chronic obstructive pulmonary disease: current status of pre-clinical studies and clinical trials. J Thorac Dis. 2018;10(2):1084–1098. doi:10.21037/jtd.2018.01.46
   PubMed Web of Science ®Google Scholar
• Naji A, Eitoku M, Favier B, et al. Biological functions of mesenchymal stem cells and clinical implications. Cell Mol Life Sci. 2019;76(17):3323–3348. doi:10.1007/s00018-019-03125-1
   PubMed Web of Science ®Google Scholar
• Behnke J, Kremer S, Shahzad T, et al. MSC Based Therapies - New Perspectives for the Injured Lung. J Clin Med. 2020;9(3):682. doi:10.3390/jcm9030682
   PubMed Web of Science ®Google Scholar
• Garcia-Bernal D, Garcia-Arranz M, Yanez RM, et al. The current status of mesenchymal stromal cells: controversies, unresolved issues and some promising solutions to improve their therapeutic efficacy. Front Cell Dev Biol. 2021;9:650664. doi:10.3389/fcell.2021.650664
   PubMed Web of Science ®Google Scholar
• Hiemstra PS, Wu X, Khedoe PSJ, et al. The role of altered stem cell fusion in airway and alveolar repair and remodelling in COPD. In: Marko X. Nikolic and Brigid L. M. Hogan, editors. Lung Stem Cells in Development, Health and Disease. ERS Monograph. 2021. doi:10.1183/2312508X.erm9121
   Google Scholar
• Ribeiro-Paes JT, Bilaqui A, Greco OT, et al. Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema. Int J COPD. 2011;6:63–71. doi:10.2147/COPD.S15292
   Google Scholar
• Weiss DJ, Casaburi R, Flannery R, et al. A placebo-controlled, randomized trial of mesenchymal stem cells in COPD. Chest. 2013;143(6):1590–1598. doi:10.1378/chest.12-2094
   PubMed Web of Science ®Google Scholar
• Stolk J, Broekman W, Mauad T, et al. A phase I study for intravenous autologous mesenchymal stromal cell administration to patients with severe emphysema. QJM. 2016;109(5):331–336. doi:10.1093/qjmed/hcw001
   PubMed Web of Science ®Google Scholar
• De Oliveira HG, Cruz FF, Antunes MA, et al. Combined bone marrow-derived mesenchymal stromal cell therapy and one-way endobronchial valve placement in patients with pulmonary emphysema: a phase I clinical trial. Stem Cells Transl Med. 2017;6(3):962–969. doi:10.1002/sctm.160315
   PubMed Web of Science ®Google Scholar
• Le Thi Bich P, Nguyen Thi H, Dang Ngo Chau H, et al. Allogeneic umbilical cord-derived mesenchymal stem cell transplantation for treating chronic obstructive pulmonary disease: a pilot clinical study. Stem Cell Res Ther. 2020;11:60. doi:10.1186/s13287-020-1583-4
   PubMed Web of Science ®Google Scholar
• Hoang DM, Nguyen KT, Anh HN, et al. Allogeneic human umbilical cord-derived mesenchymal stem/stromal cells for chronic obstructive pulmonary disease (COPD): study protocol for a matched case–control, phase I/II trial. BMJ Open. 2021;11(5):e045788. doi:10.1136/bmjopen-2020045788
   PubMed Web of Science ®Google Scholar
• Garcia O, Carraro G, Navarro S, et al. Cell-based therapies for lung disease. Br Med Bull. 2012;101(1):147–161. doi:10.1093/bmb/ldr051
   PubMed Web of Science ®Google Scholar
• Murphy MB, Moncivais K, Caplan AI. Mesenchymal stem cells: environmentally responsive therapeutics for regenerative medicine. Exp Mol Med. 2013;45(11):e54. doi:10.1038/emm.2013.94
   PubMed Web of Science ®Google Scholar
• Prockop DJ, Oh JY. Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation. Mol Ther. 2012;20(1):14–20. doi:10.1038/mt.2011.211
   PubMed Web of Science ®Google Scholar
• Gu W, Song L, Li XM, et al. Mesenchymal stem cells alleviate airway inflammation and emphysema emphysema in COPD through down-regulation of cyclooxygenase-2 via p38 and ERK MAPK pathways. Sci Rep. 2015;5:8733. doi:10.1038/srep08733
   PubMed Web of Science ®Google Scholar
• Broekman W, Amatngalim GD, de Mooij-eijk Y, et al. TNF-α and IL-1β-activated human mesenchymal stromal cells increase airway epithelial wound healing in vitro via activation of the epidermal growth factor receptor. Respir Res. 2016;17:3. doi:10.1186/s12931-015-0316-1
   Web of Science ®Google Scholar
• El-Badrawy MK, Shalabi NM, Mohamed MA, et al. The Effect of Bone Marrow Mononuclear Cells on Lung Regeneration and Apoptosis in a Simple Model of Pulmonary Emphysema. Int J Stem Cells. 2016;9(1):145–151. doi:10.15283/ijsc.2016.9.1.145
   PubMed Web of Science ®Google Scholar
• Hou L, Kim JJ, Woo YJ, et al. Stem cell-based therapies to promote angiogenesis in ischemic cardiovascular disease. Am J Physiol Heart Circ Physiol. 2016;310(4):H455–H465. doi:10.1152/ajpheart.00726.2015
   PubMed Web of Science ®Google Scholar
• Savukinas UB, Enes SR, Sjöland AA, et al. Concise Review: the Bystander Effect: mesenchymal Stem Cell-Mediated Lung Repair. Stem Cells. 2016;34(6):1437–1444. doi:10.1002/stem.2357
   PubMed Web of Science ®Google Scholar
• Antoniou KM, Karagiannis K, Tsitoura E, et al. Clinical applications of mesenchymal stem cells in chronic lung diseases. Biomed Rep. 2018;8(4):314–318. doi:10.3892/br.2018.1067
   PubMed Web of Science ®Google Scholar
• Armitaje J, Tan DBA, Troedson R, et al. Mesenchymal stromal cell infusion may provide an alternative immune-based therapeutic option for COPD patients. Eur Respir J. 2018;51:1702369. doi:10.1183/13993003.02369-2017
   Web of Science ®Google Scholar
• Longhini-dos-Santos N, Barbosa-de-oliveira VA, Stessuk T, et al. Cell Therapy Decreases Inflammation and Improves the Morphology of the Lung Parenchyma in a Murine Model of Cigarette Smoke-Induced Emphysema. Int J New Technol Res. 2018;4:58–65. doi:10.31871/IJNTR.4.1.24
   Google Scholar
• Fernández-Francos S, Eiro N, Costa LA, et al. Mesenchymal Stem Cells as a Cornerstone in a Galaxy of Intercellular Signals: basis for a New Era of Medicine. Int J Mol Sci. 2021;22(7):3576. doi:10.3390/ijms22073576
   PubMed Web of Science ®Google Scholar
• Thomas ED, Storb R. Technique for Human Marrow Grafting. Blood. 1970;36(4):507–515. doi:10.1182/blood.V36.4.507.507
   PubMed Web of Science ®Google Scholar
• Aktas M, Radke TF, Strauer BE, et al. Separation of adult bone marrow mononuclear cells using the automated closed separation system Sepax. Cytotherapy. 2008;10(2):203–211. doi:10.1080/14653240701851324
   PubMed Web of Science ®Google Scholar
• Zuk PA, Zhu M, Mizuno H. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001;7(2):211–228. doi:10.1089/107632701300062859
   PubMedGoogle Scholar
• Borgonovo T, Vaz IM, Senegaglia AC, et al. Genetic evaluation of mesenchymal stem cells by G-banded karyotyping in a Cell Technology Center. Rev Bras Hematol Hemoter. 2014;36(3):202–207. doi:10.1016/j.bjhh.2014.03.006
   PubMedGoogle Scholar
• Pereira CADC, Viegas CAA, Alves RR. Capacidade de difusão do monóxido de carbono. J Pneumol. 2002;28:122–138.
   Google Scholar
• Sciurba F, Criner GJ, Lee SM, et al. Six-Minute Walk Distance in Chronic Obstructive Pulmonary Disease: reproducibility and Effect of Walking Course Layout and Length. Am J Respir Crit Care Med. 2003;167(11):1522–1527. doi:10.1164/rccm.200203-1660C
   PubMed Web of Science ®Google Scholar
• Camelier A, Rosa FW, Salim C, et al. Using the Saint George’s Respiratory Questionnaire to evaluate quality of life in patients with chronic obstructive pulmonary disease: validating a new version for use in Brazil. J Bras Penumol. 2006;32(2):114–122. doi:10.1590/s1806-37132006000200006
   PubMedGoogle Scholar
• Dominici M, Le Blanc K, Mueller I, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315–317. doi:10.1080/14653240600855905
   PubMed Web of Science ®Google Scholar
• Brouwer KM, Hoogenkamp HR, Daamen WF, et al. Regenerative medicine for the respiratory system: distant future or tomorrow’s treatment? Am J Respir Crit Care Med. 2013;187(5):468–475. doi:10.1164/rccm.201208-1558PP
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov. website. Available from: https://www.clinicaltrials.gov/ct2/home. Accessed May 29, 2021.
   Google Scholar
• Turinetto V, Vitale E, Giachino C. Senescence in Human Mesenchymal Stem Cells: function changes and implications in stem cell - based therapy. Int j Mol Sci. 2016;17(7):1164. doi:10.3390/ijms17071164
   PubMed Web of Science ®Google Scholar
• Myungshin K, Rhee JK, Choi H, et al. Passage-dependent accumulation of somatic mutations in mesenchymal stromal cells during in vitro culture revealed by whole genome sequencing. Sci Rep Nat. 2017;7:14508. doi:10.1038/s41598-017-15155-5
   PubMed Web of Science ®Google Scholar
• Ruppel GL. What is the clinical value of lung volumes? Respir Care. 2012;57(1):26–35. doi:10.4187/respcare.01374
   PubMed Web of Science ®Google Scholar
• Casanova C, Cote C, De Torres JP, et al. Inspiratory-to-total lung capacity ratio predicts mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005;171(6):591–597. doi:10.1164/rccm.200407-867OC
   PubMed Web of Science ®Google Scholar
• Stocks J, Qof Theuanjer PH. Reference values for residual volume, function residual capacity and total lung capacity. ATS Workshop on lung volume measurements. Official Statement of the European Respiratory Society. Eur Respir J. 1995;8(3):492–506. doi:10.1183/09031936.95.08030492
   PubMed Web of Science ®Google Scholar
• Copland IB, Galipeau J. Death and inflammation following somatic cell transplantation. Semin Immunopathol. 2011;33(6):535–550. doi:10.1007/s00281-011-0274-8
   PubMed Web of Science ®Google Scholar
• Oh DK, Kim YS, Oh YM. Lung regeneration therapy for chronic obstructive pulmonary disease. Tuberc Respir Dis. 2017;80(1):1–10. doi:10.4046/trd.2017.80.1.1
   PubMed Web of Science ®Google Scholar
• Varghese J, Griffin M, Mosahebi A, et al. Systematic review of patient factors affecting adipose stem cell viability and function: implications for regenerative therapy. Stem Cell Res Ther. 2017;8(1):45. doi:10.1186/s13287-017-0483-8
   PubMed Web of Science ®Google Scholar
• Martin C, Olmos E, Collignon ML, et al. Revisiting MSC expansion from critical quality attributes to critical culture process parameters. Process Biochem. 2017;59:231–243. doi:10.1016/j.procbio.2016.04.017
   Web of Science ®Google Scholar
• Bieback K, Kuci S, Schafer R. Production and quality testing of multipotent mesenchymal stromal cell therapeutics for clinical use. Transfusion. 2019;59:2164–2173. doi:10.1111/trf.15252
   PubMed Web of Science ®Google Scholar
• Islam D, Huang Y, Fanelli V, et al. Identification and Modulation of Microenvironment Is Crucial for Effective Mesenchymal Stromal Cell Therapy in Acute Lung Injury. Am J Respir Crit Care Med. 2019;199(10):1214–1224. doi:10.1164/rccm.201802-0356OC
   PubMed Web of Science ®Google Scholar
• Cruz FF, Rocco PRM. The potential of mesenchymal stem cell therapy for chronic lung disease. Expert Rev Respir Med. 2020;14(1):31–39. doi:10.1080/17476348.2020.1679628
   PubMed Web of Science ®Google Scholar