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

February 22, 2012 updated by: João Tadeu Ribeiro Paes, UPECLIN HC FM Botucatu Unesp

Unicentric Study Protocol of Cell Therapy in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Assis, São Paulo, Brazil, 19.806-900
        • Laboratório de Genética Humana e Terapia Celular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Filgrastin - ACHÉ Laboratories.
Procedure: stem cells collection
pullout of 200ml of bone marrow through the puncture of the iliac crest
Other Names:
  • 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 Names:
  • 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 Names:
  • Filgrastin - ACHÉ Laboratories.
Procedure: stem cells collection
pullout of 200ml of bone marrow through the puncture of the iliac crest
Other Names:
  • 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 Names:
  • adult stem cell infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 30 days after procedure
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.
baseline and 30 days after procedure
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.
baseline and 30 days after the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (Estimate)

April 26, 2010

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/ASSIS Unesp - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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