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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

Tracking Information
First Submitted Date  ICMJE April 20, 2010
First Posted Date  ICMJE April 26, 2010
Results First Submitted Date  ICMJE November 3, 2011
Results First Posted Date  ICMJE March 26, 2012
Last Update Posted Date March 26, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
spirometry [ Time Frame: 3 days before theprocedure, 30, 60 and 90 days after the procedure ]
A pulmonary funtion test that measures that volume and speed of the inhaleted and exhaleted air.
Change History Complete list of historical versions of study NCT01110252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
  • Arterial Blood Gases Test - Pa O2 [ Time Frame: baseline and 30 days after procedure ]
    presence of oxygen in the blood gases.
  • Arterial Blood Gases Test - Pa CO2 [ Time Frame: baseline and 30 days after the procedure ]
    presence of CO2 in the arterial blood.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2010)
Blood gas analysis [ Time Frame: 3 days before the procedure and 30 days after the procedure ]
the determination of levels of dissolved gasses in the bloodstream.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease
Official Title  ICMJE Unicentric Study Protocol of Cell Therapy in Chronic Obstructive Pulmonary Disease
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Emphysema
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: pre-procedure
    emphysema patients evaluated prior to the stem cells infusion
    Interventions:
    • Drug: Stem cells stimulation
    • Procedure: stem cells collection
    • Genetic: stem cells infusion
  • Experimental: post-procedure
    emphysema patients evaluated 30 days after the stem cells infusion
    Interventions:
    • Drug: Stem cells stimulation
    • Procedure: stem cells collection
    • Genetic: stem cells infusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2012)
4
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2010)
10
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01110252
Other Study ID Numbers  ICMJE upeclin/ASSIS Unesp - 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party João Tadeu Ribeiro Paes, UPECLIN HC FM Botucatu Unesp
Study Sponsor  ICMJE UPECLIN HC FM Botucatu Unesp
Collaborators  ICMJE
  • Laboratório de Genética Humana e Terapia Celular, Unesp - Assis
  • Instituto de Molestias Cardiovasculares
Investigators  ICMJE
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
PRS Account UPECLIN HC FM Botucatu Unesp
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP