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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
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Obstructive Pulmonary Disease
Pulmonary Emphysema
Interventions: Drug: Stem cells stimulation
Procedure: stem cells collection
Genetic: stem cells infusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From May 2009 to October 2009 four patients with clinical and laboratory diagnosis for advanced pulmonary emphysema were enrolled

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients signed the Knowledge and Free Consent Instrument (TCLE)

Reporting Groups
  Description
Prior Then Post Procedure (Stem Cells Infusion) emphysema patients evaluated prior or after the infusion of the autologous stem cells

Participant Flow for 2 periods

 Period 1:   Pre-procedure (Stem Cells Infusion)
    Prior Then Post Procedure (Stem Cells Infusion)  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  

Period 2:   Post-procedure (Stem Cells Infusion)
    Prior Then Post Procedure (Stem Cells Infusion)  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Prior Then Post Procedure (Stem Cells Infusion) emphysema patients evaluated prior or after the infusion of the autologous stem cells

Baseline Measures
    Prior Then Post Procedure (Stem Cells Infusion)  
Number of Participants  
[units: participants]
 		  4  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  65.75  ± 1  
Gender  
[units: participants]
 		 
Female     0  
Male     4  
Region of Enrollment  
[units: participants]
 		 
Brazil     4  



  Outcome Measures
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1.  Primary:   Forced Vital Capacity (FVC)   [ Time Frame: baseline and 30 days after procedure ]
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2.  Primary:   Forced Expiratory Volume (FEV1)   [ Time Frame: baseline and 30 days after procedure ]
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3.  Primary:   Vital Capacity - VC   [ Time Frame: baseline and 30 days after the procedure ]
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4.  Secondary:   Arterial Blood Gases Test - Pa O2   [ Time Frame: baseline and 30 days after procedure ]
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5.  Secondary:   Arterial Blood Gases Test - Pa CO2   [ Time Frame: baseline and 30 days after the procedure ]
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Measure Type Secondary
Measure Title Arterial Blood Gases Test - Pa CO2
Measure Description presence of CO2 in the arterial blood.
Time Frame baseline and 30 days after the procedure  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
all patients were evaluated prior and after the procedure

Reporting Groups
  Description
Prior to the Procedure (Stem Cells Infusion) emphysema patients evaluated prior to the infusion of autologous stem cells
Post Procedure (Stem Cells Infusion) emphysema patients evaluated 30 days after the infusion of autologous stem cells

Measured Values
    Prior to the Procedure (Stem Cells Infusion)     Post Procedure (Stem Cells Infusion)  
Number of Participants Analyzed  
[units: participants]
 		  4     4  
Arterial Blood Gases Test - Pa CO2  
[units: mm Hg]
Mean ± Standard Deviation 		  48.75  ± 2.7     89.25  ± 2.7  

No statistical analysis provided for Arterial Blood Gases Test - Pa CO2




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small number of subjects analyzed  


Results Point of Contact:  
Name/Title: João Tadeu Ribeiro Paes
Organization: Labcel
phone: 55 18 3302 5800 ext 5856
e-mail: labcel.tronco@gmail.com


No publications provided by UPECLIN HC FM Botucatu Unesp

Publications automatically indexed to this study:


Responsible Party: João Tadeu Ribeiro Paes, 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