Laboratório de Genética Humana e Terapia Celular
Assis, São Paulo, 19.806-900, Brazil
NCT Number: NCT01110252
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.
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Notify Me40 year–72 year
All sexes
Interventional
Not applicable
Assis, São Paulo, 19.806-900, Brazil
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.
Other names: Filgrastin - ACHÉ Laboratories.
pullout of 200ml of bone marrow through the puncture of the iliac crest
Other names: bone marrow harvest
slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
Other names: adult stem cell infusion
Time frame: baseline and 30 days after procedure
A pulmonary function test that measures the volume and speed of the inhalated air.
Time frame: baseline and 30 days after procedure
A pulmonary function test that measures the volume and speed of the exhaled air.
Time frame: baseline and 30 days after the procedure
A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.
Time frame: baseline and 30 days after procedure
presence of oxygen in the blood gases.
Time frame: baseline and 30 days after the procedure
presence of CO2 in the arterial blood.
UPECLIN HC FM Botucatu Unesp
Other
Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
Acronym: COPD-01
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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