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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.
pullout of 200ml of bone marrow through the puncture of the iliac crest
slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
Laboratório de Genética Humana e Terapia Celular
Assis, São Paulo, Brazil
Forced Vital Capacity (FVC)
A pulmonary function test that measures the volume and speed of the inhalated air.
Time frame: baseline and 30 days after procedure
Forced Expiratory Volume (FEV1)
A pulmonary function test that measures the volume and speed of the exhaled air.
Time frame: baseline and 30 days after procedure
Vital Capacity - VC
A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.
Time frame: baseline and 30 days after the procedure
Arterial Blood Gases Test - Pa O2
presence of oxygen in the blood gases.
Time frame: baseline and 30 days after procedure
Arterial Blood Gases Test - Pa CO2
presence of CO2 in the arterial blood.
Time frame: baseline and 30 days after the procedure
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