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Completed

NCT Number: NCT01110252

Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

40 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratório de Genética Humana e Terapia Celular

Assis, São Paulo, 19.806-900, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stem cells stimulation

Drug

Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.

Other names: Filgrastin - ACHÉ Laboratories.

stem cells collection

Procedure

pullout of 200ml of bone marrow through the puncture of the iliac crest

Other names: bone marrow harvest

stem cells infusion

Genetic

slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.

Other names: adult stem cell infusion

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Collaborators

  • Instituto de Molestias Cardiovasculares
  • Laboratório de Genética Humana e Terapia Celular, Unesp - Assis

Registry information

Official study title

Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease

Acronym: COPD-01

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 26, 2010
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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