Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease (COPD-01)

Laboratório de Genética Humana e Terapia Celular, Unesp - Assis, Instituto de Molestias Cardiovasculares

The purpose of this study is to determine whether the cell therapy with bone marrow mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease, specifically the pulmonary emphysema.

The main feature of the pulmonary emphysema, included in range of the Chronic Obstructive Pulmonary Disease (COPD), is the airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchiole, without significant pulmonary fibrosis. The existing clinical approaches has contributed to the enlargement and amelioration of the emphysema patients life quality, although no effective or curative treatment has been achieved. The surgical treatment, on the other hand, involves complex procedures and, in the specific case of lung transplantation, a lack of donors. Considering these aspects, several experimental models have been proposed aiming to increase knowledge about the pathophysiological processes and enable new clinical approaches to the pulmonary emphysema. The cell therapy, briefly described as the use of cells in disease treatment, presents itself as a promising therapeutic approach with great potential applicability in degenerative pulmonary diseases. In this way, it is intended in this project, the proposition of a protocol to evaluate the safety of cell therapy with pool of mononuclear cells from bone marrow in patients with clinical and laboratory diagnosis of pulmonary emphysema in advanced stage (stage IV dyspnea).

Chronic Obstructive Pulmonary Disease, Emphysema, Cell therapy, Bone marrow mononuclear cells, stem cells

slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.

Inclusion Criteria: diagnosis of severe chronic obstructive pulmonary disease ineffective clinical treatment limited life expectancy limitations in daily physical activity possibility of pulmonary rehabilitation physiotherapy acceptable nutritional status acceptable cardiac function at least six months smoking cessation family support modified medical research council dyspnea scale stage > 3 Exclusion Criteria: pulmonary or extra-pulmonary infection severe coronary disease and/or ventricular dysfunction significant kidney or liver disease immunosuppressive disease active smoker cancer psychosocial problems established medical protocol family rejection pregnancy

Ribeiro-Paes JT, Stessuk T, Marcelino M, Faria C, Marinelli T, Ribeiro-Paes MJ. A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease. Rev Port Pneumol. 2014 Mar-Apr;20(2):84-91. doi: 10.1016/j.rppneu.2013.06.008. Epub 2013 Nov 26. English, Portuguese.

Ribeiro-Paes JT, Bilaqui A, Greco OT, Ruiz MA, Marcelino MY, Stessuk T, de Faria CA, Lago MR. Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema. Int J Chron Obstruct Pulmon Dis. 2011 Jan 1;6:63-71. doi: 10.2147/COPD.S15292.