Chronic Obstructive Pulmonary Disease, Pulmonary Emphysema
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Emphysema, Cell therapy, Bone marrow mononuclear cells, stem cells
Brief summary
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.
Detailed description
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).
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity (FVC) | baseline and 30 days after procedure | A pulmonary function test that measures the volume and speed of the inhalated air. |
| Forced Expiratory Volume (FEV1) | baseline and 30 days after procedure | A pulmonary function test that measures the volume and speed of the exhaled air. |
| Vital Capacity - VC | baseline and 30 days after the procedure | A pulmonary function test that measures the volume and speed of the inhalated and exhaled air. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Blood Gases Test - Pa CO2 | baseline and 30 days after the procedure | presence of CO2 in the arterial blood. |
| Arterial Blood Gases Test - Pa O2 | baseline and 30 days after procedure | presence of oxygen in the blood gases. |
Countries
Brazil
Participant flow
Recruitment details
From May 2009 to October 2009 four patients with clinical and laboratory diagnosis for advanced pulmonary emphysema were enrolled
Pre-assignment details
Patients signed the Knowledge and Free Consent Instrument (TCLE)
Participants by arm
| Arm | Count |
|---|---|
| Prior Then Post Procedure (Stem Cells Infusion) emphysema patients evaluated prior or after the infusion of the autologous stem cells | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Prior Then Post Procedure (Stem Cells Infusion) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age Continuous | 65.75 years STANDARD_DEVIATION 1 |
| Region of Enrollment Brazil | 4 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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
Population: all patients were evaluated prior and after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior to the Procedure (Stem Cells Infusion) | Forced Expiratory Volume (FEV1) | 0.7 liters | Standard Deviation 0.1 |
| Post Procedure (Stem Cells Infusion) | Forced Expiratory Volume (FEV1) | 0.8 liters | Standard Deviation 0.1 |
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
Population: all patients were evaluated prior and after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior to the Procedure (Stem Cells Infusion) | Forced Vital Capacity (FVC) | 1.5 liters | Standard Deviation 0.2 |
| Post Procedure (Stem Cells Infusion) | Forced Vital Capacity (FVC) | 2.1 liters | Standard Deviation 0.2 |
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
Population: all patients were evaluated prior and after the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior to the Procedure (Stem Cells Infusion) | Vital Capacity - VC | 1.8 liters | Standard Deviation 0.3 |
| Post Procedure (Stem Cells Infusion) | Vital Capacity - VC | 1.4 liters | Standard Deviation 0.3 |
Arterial Blood Gases Test - Pa CO2
presence of CO2 in the arterial blood.
Time frame: baseline and 30 days after the procedure
Population: all patients were evaluated prior and after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior to the Procedure (Stem Cells Infusion) | Arterial Blood Gases Test - Pa CO2 | 48.75 mm Hg | Standard Deviation 2.7 |
| Post Procedure (Stem Cells Infusion) | Arterial Blood Gases Test - Pa CO2 | 89.25 mm Hg | Standard Deviation 2.7 |
Arterial Blood Gases Test - Pa O2
presence of oxygen in the blood gases.
Time frame: baseline and 30 days after procedure
Population: all patients were evaluated prior and after the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior to the Procedure (Stem Cells Infusion) | Arterial Blood Gases Test - Pa O2 | 69 mmHg | Standard Deviation 3 |
| Post Procedure (Stem Cells Infusion) | Arterial Blood Gases Test - Pa O2 | 57 mmHg | Standard Deviation 3 |