Title
Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease
Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
Phase
N/ALead Sponsor
Sao Paulo State UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Obstructive Pulmonary Disease Pulmonary EmphysemaIntervention/Treatment
stem cells bone marrow derived mononuclear cells ...Study Participants
4The 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).
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.
emphysema patients evaluated prior to the stem cells infusion
emphysema patients evaluated 30 days after the stem cells infusion
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
| Event Type | Organ System | Event Term |
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A pulmonary function test that measures the volume and speed of the inhalated air.
A pulmonary function test that measures the volume and speed of the exhaled air.
A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.
presence of oxygen in the blood gases.
presence of CO2 in the arterial blood.
