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| Name | Class |
|---|---|
| Laboratório de Genética Humana e Terapia Celular, Unesp - Assis | UNKNOWN |
| Instituto de Molestias Cardiovasculares | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-procedure | Active Comparator | emphysema patients evaluated prior to the stem cells infusion |
|
| post-procedure | Experimental | emphysema patients evaluated 30 days after the stem cells infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cells stimulation | Drug | Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| João T Ribeiro-Paes, PhD MD | geneticist | Principal Investigator |
| Aldemir Bilaqui, MD | surgeon | Study Director |
| Oswaldo T Greco, MD | cardiologist | Study Chair |
| Milton A Ruiz, MD | hematologist | Study Chair |
| José D Araújo, MD | surgeon | Study Chair |
| Mario R Lago, Ms | technician | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratório de Genética Humana e Terapia Celular | Assis | São Paulo | 19.806-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24287082 | Derived | Ribeiro-Paes JT, Stessuk T, Marcelino M, Faria C, Marinelli T, Ribeiro-Paes MJ. A protocol proposition of cell therapy for the treatment of chronic obstructive pulmonary disease. Rev Port Pneumol. 2014 Mar-Apr;20(2):84-91. doi: 10.1016/j.rppneu.2013.06.008. Epub 2013 Nov 26. English, Portuguese. | |
| 21311694 | Derived |
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Patients signed the Knowledge and Free Consent Instrument (TCLE)
From May 2009 to October 2009 four patients with clinical and laboratory diagnosis for advanced pulmonary emphysema were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Prior Then Post Procedure (Stem Cells Infusion) | emphysema patients evaluated prior or after the infusion of the autologous stem cells |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-procedure (Stem Cells Infusion) |
| |||||||||||||
| Post-procedure (Stem Cells Infusion) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prior Then Post Procedure (Stem Cells Infusion) | emphysema patients evaluated prior or after the infusion of the autologous stem cells |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Forced Vital Capacity (FVC) | A pulmonary function test that measures the volume and speed of the inhalated air. | all patients were evaluated prior and after the procedure | Posted | Mean | Standard Deviation | liters | baseline and 30 days after procedure |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prior Then Post Procedure (Stem Cells Infusion) | emphysema patients evaluated prior or after the infusion of the autologous stem cells |
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small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| João Tadeu Ribeiro Paes | Labcel | 55 18 3302 5800 | 5856 | labcel.tronco@gmail.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011656 | Pulmonary Emphysema |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| stem cells collection | Procedure | pullout of 200ml of bone marrow through the puncture of the iliac crest |
|
|
| stem cells infusion | Genetic | slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline. |
|
|
| baseline and 30 days after the procedure |
| Ribeiro-Paes JT, Bilaqui A, Greco OT, Ruiz MA, Marcelino MY, Stessuk T, de Faria CA, Lago MR. Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema. Int J Chron Obstruct Pulmon Dis. 2011 Jan 1;6:63-71. doi: 10.2147/COPD.S15292. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Forced Expiratory Volume (FEV1) | A pulmonary function test that measures the volume and speed of the exhaled air. | all patients were evaluated prior and after the procedure | Posted | Mean | Standard Deviation | liters | baseline and 30 days after procedure |
|
|
|
| Secondary | Arterial Blood Gases Test - Pa O2 | presence of oxygen in the blood gases. | all patients were evaluated prior and after the procedure. | Posted | Mean | Standard Deviation | mmHg | baseline and 30 days after procedure |
|
|
|
| Secondary | Arterial Blood Gases Test - Pa CO2 | presence of CO2 in the arterial blood. | all patients were evaluated prior and after the procedure | Posted | Mean | Standard Deviation | mm Hg | baseline and 30 days after the procedure |
|
|
|
| Primary | Vital Capacity - VC | A pulmonary function test that measures the volume and speed of the inhalated and exhaled air. | all patients were evaluated prior and after the procedure. | Posted | Mean | Standard Deviation | liters | baseline and 30 days after the procedure |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |