Cell Therapy in Advanced Chronic Obstructive Pulmonary Disease Patients
Chronic Obstructive Pulmonary Disease (COPD)
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring advanced COPD (stage III), Adult stem cells, Cell therapy
Eligibility Criteria
Inclusion Criteria:
- COPD patients with persistent dyspnea in stage 2 or 3 of the dyspnea scale score;
- Eligibility for pulmonary rehabilitation program;
- No smoking or smoking cessation for at least 6 months.
Exclusion Criteria:
- Absence of emphysema on chest tomography;
- Pulmonary or extrapulmonary infection or active infection history in less than 3 months;
- History of coronary artery disease and/or severe ventricular dysfunction (ejection fraction <55%);
- Presence of pulmonary hypertension, ie, estimated systolic pulmonary artery pressure above 35 mmHg at transthoracic Doppler echocardiography;
- Patients in home oxygen therapy;
- Advanced renal failure (serum creatinine greater than 1.5 mg / dL) and liver failure CHILD B or C;
- Immunosuppressive or infectious diseases detected;
- Patients with known malignancies or collagen diseases;
- Psycho-social problems, drug and/or alcohol abuse and not obedient to the established medical protocol;
- No family acceptance;
- Pregnancy or at risk of pregnancy.
Sites / Locations
- Laboratório de Genética e Terapia Celular - GenTe Cel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Group 1 - Control
Group 2 - BMMC
Group 3 - ASC
Group 4 - BMMC + ASC
The patients will be followed during the course of 12 months and evaluated regarding disease progression. No interventions will be performed other than conventional (in-course) treatment.
Patients will be submitted to bone marrow harvesting. Bone marrow mononuclear cells (BMMC) will be obtained by Ficoll separation and returned to patients by systemic infusion (1x10^8 BMMC in 30 mL saline). Three patients will be submitted to Lung perfusion scintigraphy with technetium for cell engraftment evaluation.
Patients will be submitted to liposuction. The obtained fat tissue will be cultivated by 21 days and adipose-derived stem cell (ASC) will be returned to patients by systemic infusion (1x10^8 ASC in 30 mL saline). Three patients will be submitted to Lung perfusion scintigraphy with technetium for cell engraftment evaluation.
Patients will be submitted to liposuction and the obtained fat tissue will be cultivated by 21 days and adipose-derived stem cell (ASC) obtained. Patients will be submitted to bone marrow harvesting and bone marrow mononuclear cells (BMMC) will be obtained by Ficoll separation. BMMC and ASC will be returned to patients by systemic infusion (5x10^7 ASC + 5x10^7 BMMC in 30 mL saline). Three patients will be submitted to Lung perfusion scintigraphy with technetium for cell engraftment evaluation.