Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
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).
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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