Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema

Abstract

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).

Stem Cell Treatment for Chronic Lung Diseases

“…The first study was recently published by Ribeiro-Paes et al [98] who reported a marginal statistically -significant improvement in functional parameters as well as in exercise capacity in patients with severe COPD after an intravenous administration of autologous BM-derived MSCs. However, this trial was severely hampered by the limited number of patients enrolled (only 3 patients eligible for analysis) posing major limitations to the data presented.…”

Stem cell therapy for end stage COPD: a cautionary tale of direct-to-consumer advertising

“…The search resulted in only two clinical trials with human subjects, the Ribeiro-Paes paper and the Weiss paper. 2,3 There was also a recent systematic review in PLoS ONE that identified these same two trials as the only two clinical trials of stem cells in COPD patients. 4 Therefore, a review of these two articles evaluates the sum total of the knowledge on this subject.…”

Cell Therapy in Chronic Obstructive Pulmonary Disease: State of the Art and Perspectives

“…6. Clinical protocol adopted for cell therapy in patients with advanced pulmonary emphysema (Ribeiro-Paes et al, 2011).…”

“…Notwithstanding the statistical limitations, the pioneer publication of the results by our research group (Ribeiro-Paes et al, 2011), has afforded the preparation of some logical inferences and methodological suggestions which will be incorporated into future projects. The use of MSC obtained from adipose tissue has disclosed a highly promising future perspective.…”