Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease, Pulmonary Emphysema

Intervention / Treatment
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* Drug: Stem cells stimulation
* Procedure: stem cells collection
* Genetic: stem cells infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pre-procedure<br>emphysema patients evaluated prior to the stem cells infusion | Drug: Stem cells stimulation<br>* Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.<br>* Other names: Filgrastin - ACHÉ Laboratories.;Procedure: stem cells collection<br>* pullout of 200ml of bone marrow through the puncture of the iliac crest<br>* Other names: bone marrow harvest;Genetic: stem cells infusion<br>* slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.<br>* Other names: adult stem cell infusion;|
| Experimental: post-procedure<br>emphysema patients evaluated 30 days after the stem cells infusion | Drug: Stem cells stimulation<br>* Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.<br>* Other names: Filgrastin - ACHÉ Laboratories.;Procedure: stem cells collection<br>* pullout of 200ml of bone marrow through the puncture of the iliac crest<br>* Other names: bone marrow harvest;Genetic: stem cells infusion<br>* slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.<br>* Other names: adult stem cell infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Vital Capacity (FVC) | A pulmonary function test that measures the volume and speed of the inhalated air. | baseline and 30 days after procedure | 
| Forced Expiratory Volume (FEV1) | A pulmonary function test that measures the volume and speed of the exhaled air. | 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. | baseline and 30 days after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Gases Test - Pa O2 | presence of oxygen in the blood gases. | baseline and 30 days after procedure | 
| Arterial Blood Gases Test - Pa CO2 | presence of CO2 in the arterial blood. | baseline and 30 days after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Emphysema, Cell therapy, Bone marrow mononuclear cells, stem cells