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Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease (COPD-01)

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ClinicalTrials.gov Identifier: NCT01110252
Recruitment Status : Completed
First Posted : April 26, 2010
Results First Posted : March 26, 2012
Last Update Posted : March 26, 2012
Sponsor:
Collaborators:
Laboratório de Genética Humana e Terapia Celular, Unesp - Assis
Instituto de Molestias Cardiovasculares
Information provided by (Responsible Party):
João Tadeu Ribeiro Paes, UPECLIN HC FM Botucatu Unesp

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Pulmonary Emphysema Drug: Stem cells stimulation Procedure: stem cells collection Genetic: stem cells infusion Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
Study Start Date : May 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: pre-procedure
emphysema patients evaluated prior to the stem cells infusion
 Drug: Stem cells stimulation
Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.
Other Name: Filgrastin - ACHÉ Laboratories.

Procedure: stem cells collection
pullout of 200ml of bone marrow through the puncture of the iliac crest
Other Name: bone marrow harvest

Genetic: stem cells infusion
slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
Other Name: adult stem cell infusion
Experimental: post-procedure
emphysema patients evaluated 30 days after the stem cells infusion
 Drug: Stem cells stimulation
Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.
Other Name: Filgrastin - ACHÉ Laboratories.

Procedure: stem cells collection
pullout of 200ml of bone marrow through the puncture of the iliac crest
Other Name: bone marrow harvest

Genetic: stem cells infusion
slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
Other Name: adult stem cell infusion


Outcome Measures
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Primary Outcome Measures :
  1. Forced Vital Capacity (FVC) [ Time Frame: baseline and 30 days after procedure ]
    A pulmonary function test that measures the volume and speed of the inhalated air.

  2. Forced Expiratory Volume (FEV1) [ Time Frame: baseline and 30 days after procedure ]
    A pulmonary function test that measures the volume and speed of the exhaled air.

  3. Vital Capacity - VC [ 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.


Secondary Outcome Measures :
  1. Arterial Blood Gases Test - Pa O2 [ Time Frame: baseline and 30 days after procedure ]
    presence of oxygen in the blood gases.

  2. Arterial Blood Gases Test - Pa CO2 [ Time Frame: baseline and 30 days after the procedure ]
    presence of CO2 in the arterial blood.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110252


Locations
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Brazil
Laboratório de Genética Humana e Terapia Celular
Assis, São Paulo, Brazil, 19.806-900
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Laboratório de Genética Humana e Terapia Celular, Unesp - Assis
Instituto de Molestias Cardiovasculares
Investigators
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Principal Investigator: João T Ribeiro-Paes, PhD MD geneticist
Study Director: Aldemir Bilaqui, MD surgeon
Study Chair: 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: João Tadeu Ribeiro Paes, sponsor, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01110252    
Other Study ID Numbers: upeclin/ASSIS Unesp - 001
First Posted: April 26, 2010    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: March 26, 2012
Last Verified: February 2012
Keywords provided by João Tadeu Ribeiro Paes, UPECLIN HC FM Botucatu Unesp:
Chronic Obstructive Pulmonary Disease
Emphysema
Cell therapy
Bone marrow mononuclear cells
stem cells
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
 Emphysema
Respiratory Tract Diseases
Pathologic Processes