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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01110252
First received: April 20, 2010
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Pulmonary Emphysema
 Drug: Stem cells stimulation
Procedure: stem cells collection
Genetic: stem cells infusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

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

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

  • Vital Capacity - VC [ Time Frame: baseline and 30 days after the procedure ] [ Designated as safety issue: Yes ]
    A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.


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

  • Arterial Blood Gases Test - Pa CO2 [ Time Frame: baseline and 30 days after the procedure ] [ Designated as safety issue: Yes ]
    presence of CO2 in the arterial blood.


Enrollment: 4
Study Start Date: May 2009
Study Completion Date: November 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   40 Years to 72 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110252

Locations
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
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

No publications provided by UPECLIN HC FM Botucatu Unesp

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: João Tadeu Ribeiro Paes, sponsor, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01110252     History of Changes
Other Study ID Numbers: upeclin/ASSIS Unesp - 001
Study First Received: April 20, 2010
Results First Received: November 3, 2011
Last Updated: February 22, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Chronic Obstructive Pulmonary Disease
Emphysema
Cell therapy
Bone marrow mononuclear cells
stem cells

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
 Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013