Department of Biological Sciences, Universidade Estadual Paulista, Campus de Assis, Assis, SP, Brazil.
Int J Chron Obstruct Pulmon Dis. 2011 Jan 1;6:63-71. doi: 10.2147/COPD.S15292.
Within the chronic obstructive pulmonary disease (COPD) spectrum, lung emphysema presents, as a primarily histopathologic feature, the destruction of pulmonary parenchyma and, accordingly, an increase in the airflow obstruction distal to the terminal bronchiole. Notwithstanding the significant advances in prevention and treatment of symptoms, no effective or curative therapy has been accomplished. In this context, cellular therapy with stem cells (SCs) arises as a new therapeutic approach, with a wide application potential. The purpose of this study is to evaluate the safety of SCs infusion procedure in patients with advanced COPD (stage IV dyspnea). After selection, patients underwent clinical examination and received granulocyte colony-stimulating factor, immediately prior to the bone marrow harvest. The bone marrow mononuclear cells (BMMC) were isolated and infused into a peripheral vein. The 12-month follow-up showed a significant improvement in the quality of life, as well as a clinical stable condition, which suggest a change in the natural process of the disease. Therefore, the proposed methodology in this study for BMMC cell therapy in sufferers of advanced COPD was demonstrated to be free of significant adverse effects. Although a larger sample and a greater follow-up period are needed, it is possible to infer that BMMC cell therapy introduces an unprecedented change in the course or in the natural history of emphysema, inhibiting or slowing the progression of disease. This clinical trial was registered with ClinicalTrials.gov (NCT01110252) and was approved by the Brazilian National Committee of Ethics in Research (registration no. 14764, CONEP report 233/2009).
在慢性阻塞性肺疾病（COPD）谱内，肺气肿表现为主要的组织病理学特征，即肺实质破坏，并且相应地，终末细支气管远端的气流阻塞增加。尽管在预防和治疗症状方面取得了重大进展，但仍未实现有效的治疗方法。在这种情况下，干细胞（SCs）的细胞治疗作为一种新的治疗方法出现，具有广泛的应用潜力。本研究的目的是评估晚期 COPD（IV 级呼吸困难）患者 SC 输注程序的安全性。选择后，患者在骨髓采集前进行临床检查并接受粒细胞集落刺激因子。分离骨髓单核细胞（BMMC）并注入外周静脉。12 个月的随访显示生活质量显著改善，临床状况稳定，这表明疾病的自然进程发生了变化。因此，本研究中用于晚期 COPD 患者 BMMC 细胞治疗的方法被证明没有明显的不良影响。尽管需要更大的样本量和更长的随访时间，但可以推断 BMMC 细胞治疗在肺气肿的病程或自然史中引入了前所未有的变化，抑制或减缓了疾病的进展。这项临床试验在 ClinicalTrials.gov 上注册（NCT01110252），并获得了巴西国家伦理研究委员会的批准（注册号 14764，CONEP 报告 233/2009）。
